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The ARIA Radiation Therapy Management product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Therapy Management also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.

ARIA Radiation Therapy Management (ARIA RTM) manages several treatment information such as images and treatment data to prepare plans created for treatment and review post-treatment images and records. It also provides quality assurance options. ARIA RTM does not directly act on the patient. ARIA RTM is applied by trained medical professionals in the process of preparation and management of radiotherapy treatments for patients.

The provided FDA 510(k) summary for ARIA Radiation Therapy Management System (18.1) does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the study proving device performance.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states: "Test results demonstrate conformance to applicable requirements and specifications." However, it does not provide a specific table of acceptance criteria or reported device performance metrics. It implies that underlying V&V documentation exists that confirms the software meets its design requirements, but these details are not present in this summary.

2. Sample size used for the test set and the data provenance

The document states: "No animal studies or clinical tests have been included in this pre-market submission." This indicates that the validation was likely based on non-clinical software testing, not patient data. Therefore, there is no patient-specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective) mentioned. The testing would have involved simulated data, test cases, or internal datasets to verify software functionalities.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Since the testing was non-clinical software verification and validation, there is no mention of experts establishing ground truth for a test set in the traditional sense of clinical evaluation. Software testing typically relies on predefined requirements, specifications, and expected outputs, rather than expert-adjudicated ground truth from medical images or patient cases.

4. Adjudication method for the test set

Similarly, because there are no clinical trials or expert-adjudicated test sets, there is no adjudication method (e.g., 2+1, 3+1) described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document explicitly states: "No animal studies or clinical tests have been included in this pre-market submission." Therefore, no MRMC comparative effectiveness study was conducted or reported for this submission. The device is a radiation therapy management system, not explicitly an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The submission indicates that the software underwent "Software Verification and Validation Testing" and was considered a "major" level of concern. This implies extensive standalone algorithm (software) testing to ensure it meets its functional and safety requirements. However, specific details of these tests (e.g., test cases, scenarios, and their results) are not provided in this summary. The device "does not directly act on the patient" and is "applied by trained medical professionals," suggesting it's an assistive tool within a human workflow, but its core functionalities are tested in a standalone manner.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Given the non-clinical nature of the testing, the "ground truth" would have been established by the software requirements and specifications, test case design, and expected outputs defined by the developers. This is typical for software verification and validation, where the goal is to confirm the software performs as designed.

8. The sample size for the training set

The submission does not mention any training set as there is no indication of machine learning or AI models with external data training involved that would require such information. The changes appear to be feature enhancements to an existing software system.

9. How the ground truth for the training set was established

As no training set is mentioned, this information is not applicable.

In summary, the provided document focuses on the regulatory aspects of a software update (v18.1) to an existing device (v18.0) and highlights software verification and validation as the primary evidence of performance. It explicitly states that no clinical or animal studies were included. Therefore, the detailed performance metrics, test set characteristics, and expert involvement typically associated with clinical efficacy studies are not present.

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icobrain aria is a computer-assisted detection (CADe) and diagnosis (CADx) software device to be used as a concurrent reading aid to help trained radiologists in the detection, assessment and characterization of Amyloid Related Imaging Abnormalities (ARIA) from a set of brain MR images. The software provides information about the presence, location, size, severity and changes of ARIA-E (brain edema or sulcal effusions) and ARIA-H (hemosiderin deposition, including microhemorrhage and superficial siderosis). Patient management decisions should not be made solely on the basis of analysis by icobrain aria.

icobrain aria is a software-only device for assisting radiologists with the detection of amyloid-related imaging abnormalities (ARIA) on brain MRI scans of Alzheimer's disease patients under an amyloid beta-directed antibody therapy. The device utilizes 2D fluid-attenuated inversion recovery (FLAR) for the detection of ARIA-E (edema/sulcal effusion) and 2D T2* gradient echo (T2*-GRE) for the detection of ARIA-H (hemosiderin deposition).

icobrain aria automatically processes input brain MRI scans in DICOM format from two time points and generates annotated DICOM images and an electronic report.

Here's a summary of the acceptance criteria and study that proves the device meets them, based on the provided text:

icobrain aria: Acceptance Criteria and Performance Study Summary

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a single, dedicated table with pass/fail thresholds. Instead, they are implicitly defined by the statistically significant improvements demonstrated in the clinical (MRMC) study, and the "in line with human experts" conclusion from standalone performance. The document focuses on showing the effect size of the improvement rather than pre-defined absolute thresholds for sensitivity, specificity, or AUC for human-AI combined performance. For standalone metrics, it reports specific values and concludes they are "in line with the performance of human experts," suggesting the internal acceptance criteria were met.

Therefore, the table below will summarize the reported performance results from the clinical study, which implicitly met the acceptance criteria by demonstrating significant improvement over unassisted reading.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: 199 cases.
• Data Provenance: MRI datasets from subjects diagnosed with Alzheimer's disease. To guarantee independence, test data subjects were not included in the training set.
  • Country of Origin: More than 100 sites in 20 countries. Approximately half the data originated from the US and the other half from outside the US.
  • Retrospective/Prospective: The study used retrospective data from clinical trials (aducanumab clinical trials PRIME (NCT02677572), EMERGE (NCT02484547), and ENGAGE (NCT02477800)). This data provenance applies to both training and testing datasets.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: A consensus of 3 experts was used for the clinical (MRMC) study ground truth. For standalone testing, the ground truth was established by unspecified "expert neuroradiologists."
• Qualifications of Experts:
  • Clinical Study (MRMC): Experts who performed "safety ARIA reading in clinical trials for Aβ-directed antibody therapies in AD."
  • Standalone Testing: "expert neuroradiologists (with experience performing safety ARIA reading in clinical trials for Aβ-directed antibody therapies in AD) manually segmented both ARIA-H findings." This indicates they had prior, relevant experience.

4. Adjudication Method for the Test Set

• Adjudication Method: "A consensus of 3 experts" was used to establish the ground truth for the clinical (MRMC) study. The specific consensus method (e.g., majority vote, discussion to agreement) is not detailed, but the term "consensus" implies a collective agreement process.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Improvement

• MRMC Study Done: Yes, a fully-crossed MRMC retrospective reader study was conducted.
• Effect Size (AUC difference, Assisted vs. Unassisted):
  • ARIA-E Detection: +0.051 AUC (95% CI [0.020, 0.083]), p=0.001
  • Pooled ARIA-H Detection: +0.044 AUC (95% CI [0.017, 0.070]), p=0.001
  • ARIA-H Microhemorrhages: +0.029 AUC (95% CI [0.002, 0.055]), p=0.032
  • ARIA-H Superficial Siderosis: +0.063 AUC (95% CI [0.023, 0.102]), p=0.003

Readers also showed significant increases in sensitivity, significant decreases in inter-reader variability, and were on average faster when assisted.

6. If a Standalone (i.e. Algorithm only without human-in-the-loop performance) was Done

• Standalone Study Done: Yes, "icometrix conducted standalone performance assessments."
  • Standalone Performance Highlights (Main Test Set on 199 cases):
    • ARIA-E Diagnosis: Sensitivity 0.94, Specificity 0.67, AUC 0.84
    • ARIA-H Diagnosis: Sensitivity 0.87, Specificity 0.66, AUC 0.81
    • ARIA-E Finding-level: True Positive Rate 69.1%, False Positive findings per case 0.7
    • ARIA-H New Microhemorrhages Finding-level: True Positive Rate 66.1%, False Positive findings per case 0.9
    • ARIA-H New Superficial Siderosis Finding-level: True Positive Rate 62.5%, False Positive findings per case 0.1
  • The document concludes that standalone performance was "in line with the performance of human experts."

7. The Type of Ground Truth Used

• Ground Truth Type: Expert consensus for the clinical study (MRMC) and expert manual annotations for the standalone testing.
  • Details: For standalone testing, "expert neuroradiologists ... manually segmented both ARIA-E and ARIA-H findings. Ground truth ARIA measurements were derived from the expert manual annotated masks." For the MRMC study, ground truth was obtained via "a consensus of 3 experts."

8. The Sample Size for the Training Set

• Training Set Sample Size:
  • FLAIR images (for ARIA-E): 475 image pairs from 172 subjects.
  • T2-GRE images (for ARIA-H):* 326 image pairs from 177 subjects.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: The data used for developing the algorithms "have been manually annotated by expert neuroradiologists with prior experience of reading ARIA in clinical trials of amyloid beta-directed antibody drugs." This implies manual annotation by experts served as the ground truth for training.

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Filling material as a treatment for dental caries

The subject devices are a mixture (alloy) of silver and several other metals, used by dentists to make fillings for tooth cavities. Amalgam alloys have been the most commonly used direct restorative filling material for over a 100 years.

The provided text describes a 510(k) summary for several dental amalgam devices, asserting their substantial equivalence to a predicate device. This submission focuses on comparing the physical and chemical properties of the devices to establish this equivalence, rather than on the performance of an AI-powered diagnostic device.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, ground truth for training set) are not applicable to this document as it does not describe a study involving an AI-powered diagnostic device that requires such metrics for validation.

Here's the information that can be extracted relevant to acceptance criteria and performance:

1. A table of acceptance criteria and the reported device performance:

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The ARIA Radiation Therapy Management product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Therapy Management also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.

The ARIA Radiation Therapy Management product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Therapy Management also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA Radiation Therapy Management supports the integration of all data and images in one central database including archiving and restoration. The different ARIA Radiation Therapy Management features support the visualization, processing, manipulation and management of all data and images stored in the system. Images can also be imported through using DICOM, the available image import filters or by means of film digitizers.

The provided text is a 510(k) summary for Varian Medical Systems' ARIA Radiation Therapy Management (v18.0) device. It describes the device, its intended use, comparison to a predicate device, and performance data from non-clinical testing.

However, the document does not contain the following information necessary to describe acceptance criteria and the study that proves the device meets those criteria:

• Specific acceptance criteria: The document mentions "applicable requirements were met" and "safeguards against hazards functioned properly" but does not detail what these specific quantitative or qualitative acceptance criteria were for the software verification and validation.
• Reported device performance: While it states "test results showed that applicable requirements were met," it does not provide any specific performance metrics or data (e.g., accuracy, precision, error rates) that were measured and compared against acceptance criteria.
• Sample size and data provenance for test set: No information is given about a test set, as all testing was non-clinical software verification and validation.
• Experts for ground truth and adjudication method: These are typically relevant for studies involving human interpretation or clinical endpoints, which this submission explicitly states were not conducted.
• MRMC comparative effectiveness study: The document clearly states that "No data from animal studies or clinical tests have been included" and "no animal or clinical studies were conducted for the subject device." Therefore, no MRMC study was performed.
• Standalone performance: Since no clinical studies were performed, there are no reported standalone performance metrics in the context of interpretation or diagnosis. The performance mentioned refers to software functionality.
• Type of ground truth: Ground truth is usually associated with clinical or pathological verification in studies, which are absent here.
• Training set information: As this is primarily a software update and management system, not a machine learning algorithm that requires a "training set" in the conventional sense, this information is not applicable and not provided.

Based on the provided text, I can only state what is mentioned regarding performance, rather than providing the requested table and details about a clinical study:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. The submission describes software verification and validation, not a test set of patient data.
• Data Provenance: Not applicable. Testing was based on software functionality and engineering requirements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No test set involving human interpretation or clinical ground truth was used.

4. Adjudication method for the test set:

• Not applicable. No test set requiring expert adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No data from animal studies or clinical tests have been included in this pre-market submission" and "no animal or clinical studies were conducted for the subject device."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Yes, in the context of software verification and validation, the performance of the software (algorithm) was assessed standalone against its functional and safety requirements. However, this is not a standalone diagnostic performance study as typically understood for AI/ML devices. The document states: "The non-clinical data support the safety of the software verification and validation demonstrate that ARIA Radiation Therapy Management should perform as intended in the specified use conditions."

7. The type of ground truth used:

• For the software verification and validation, the "ground truth" was the specified engineering requirements, functional specifications, and regulatory standards (e.g., IEC 62304, IEC 62366-1, ISO 13485, ISO 14971). There was no clinical or pathological ground truth used as no clinical studies were performed.

8. The sample size for the training set:

• Not applicable. This is a software management system, not a machine learning model that typically involves a "training set" in the AI/ML sense.

9. How the ground truth for the training set was established:

• Not applicable, as no training set (in the AI/ML context) was described.

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The Stryker Spine Aero™ -AL is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The Aero™ - AL Lumbar Cage System is to be implanted via an anterior approach.

The Aero™ - AL Lumbar Cage System is intended to be used with supplemental spinal fixation systems that has been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems) in addition to the included fixation anchors.

The Stryker Spine AERO®-C Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-Tl disc.

DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.

The AERO®-C Cervical Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.

The AERO®-C Cervical Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine. In addition, the device must be used with the included fixation anchors.

The Stryker Spine Aero™ - LL is an intervertebral body fusion device indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The Aero™ -LL Lumbar Cage System is to be implanted via a lateral approach.

The Aero™ -LL Lumbar Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems). In addition, the device may be used with or without the included fixation anchors.

When used as a cervical intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to Tl, for the treatment of cervical disc disease (defined as neck pain of disco genie origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.

When used as a lumbar intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S 1, for the treatment of degenerative disc disease (DOD) with up to Grade I spondylolisthesis. ODD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.

When used as vertebral body replacement devices the Aleutian implants are indicated for use in the thoracolumbar spine (TI to LS) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal tissues, and to restore the height of a collapsed vertebral body. The Aleutian implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

For all the above indications the Aleutian implants are intended to be used with supplemental internal fixation appropriate for the implanted level. including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

The Ascential IBD PEEK. Spacers are indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Ascential IBD PEEKc Spacers are to be used with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach.

The Ascential IBD PEEKc Spacer is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The Stryker Spine AVS® AL and AVS® ALign PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used an adjunct to fusion in patients with degenerative disc disease (DDD) and one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the AVS® AL and AVS® ALign PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The AVS® AL and AVS® ALign PEEK Spacers are to be implanted via anterior or anterolateral approach.

The AVS® AL and AVS® ALign PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

The Stryker Spine AVS® Anchor-C Cervical Cage System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The AVS® Anchor-C Cervical Cage is to be used with autogenous bone graft and implanted via an open, anterior approach.

The AVS® Anchor-C Cervical Cage must be used with the internal screw fixation provided by AVS® Anchor-C Fixation Screws. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The Stryker Spine AVS® Anchor-L is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS® Anchor-L Lumbar Cage system is to be implanted via an open, anterior approach.

The AVS® Anchor-L Lumbar Cage system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the AVS® Anchor-L Lumbar Cage must be used with the internal screw and plate fixation provided by the AVS® Anchor-L Fixation Screws and Locking Plate. If AVS® Anchor-L is used with less than three or none of the provided screws, then additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine must be used to augment stability. The accompanying Locking Plate must be vice is used with any number of screws.

The Stryker Spine AVS® ARIA PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the AVS® ARIA PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The AVS® ARIA PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

The Stryker Spine AVS® AS PEEK Spacers are indicated for use in cervical interbody fusion procedures in sketally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AVS® AS PEEK Spacers are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach.

The AVS® AS PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The Stryker Spine AVS® Navigator PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the AVS® Navigator PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The AVS® Navigator PEEK Spacers are to be implanted via a posterolateral approach.

The AVS® Navigator PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

The Stryker Spine AVS® PL and AVS® UniLIF™ PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the AVS® PL and AVS® UniLIFIM PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are to be implanted via posterior approach.

The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

The Stryker Spine AVS® TL PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used an adjunct to fusion in patients with degenerative disc disease (DDD) and one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the AVS® TL PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The AVS® TL PEEK Spacers are to be implanted via posterior approach.

The AVS® TL PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

The Stryker Spine AVS® PL and AVS® UniLIF™ PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the AVS® PL and AVS® UniLIFIM PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are to be implanted via posterior approach.

The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

CAPRI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.

When used in the cervical spine (C2-T1), CAPRI Static and Expandable cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal tissues in cervical degenerative disorders. These cages are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

When used in the thoracolumbar spine (T1-L5), CAPRI Static and Expandable cages are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). These are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.

When used in the thoracolumbar spine, the CAPRI Static and Expandable Corpectorny cages are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and K2M Spinal Plate Systems.

When used in the cervical spine at one or two levels, the CAPRI Static and Expandable cages with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA.

The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be sketally mature and have six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The CASCADIA hyperlordotic lateral lumbar implants (≥22°), are intended for levels L2-L5 and are to be used with CAYMAN United plates in addition to posterior supplemental fixation. The CASCADIA non-hyperlordotic lateral lumbar implants may optionally be used with CAYMAN United plates, in addition to supplemental spinal fixation systems.

The CASCADIA cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be sketally mature and have had six weeks of non-operative treatment. The CASCADIA cervical implants are also to be used with supplemental fixation; the hyperlordotic CASCADIA cervical implants (i.e., ≥10°) are required to be used with an atterior cervical plate as the form of supplemental fixation.

When used as a cervical intervertebral body fusion device, the CHESAPEAKE Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.

When used as a lumbar intervertebral body fusion device, the CHESAPEAKE Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.

The hyperlordotic lumbar implants (i.e., > 15°) must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Otherwise, the Chesapeake Stabilization System implants (i.e., ≤15°) may be used as a stand-alone device, which is intended to be used with the bone screws provided (i.e., 2 or 3 screws for the 2-screw and 3-screw implants, respectively).

The MOJAVE Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DOD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the MOJAVE lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. MOJAVE lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The Stryker Spine Monterey™ AL Interbody System - Stand-Alone) is an interbody fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy.

Additionally, the Monterey™ AL Stand-Alone System can be used as adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Monterey™ AL Stand-Alone System is intended to be implanted via an anterior approach.

The Monterey™ AL Stand-Alone System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Monterey™ AL Stand-Alone System must be used with the bone screws provided and requires no additional supplemental fixation. If Monterey™ AL Stand-Alone System is used with less than three or none of the provided bone screws, then additional supplemental fixation that has been cleared by the FDA for use in the lumbosacral spine must be used to augment stability. Hyperlordotic implants (>20° lordosis) are intended to be used with supplemental fixation (e.g., posterior fixation),

The Stryker Spine Monterey™ AL Interbody System – Spacer) is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy.

Additionally, the Monterey™ AL Spacer System can be used as adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Monterey™ AL Spacer System is intended to be implanted via an anterior approach.

The Monterey™ AL Spacer System is intended to be used with supplemental fixation systems that have been cleared by the FDA for use in the lumbosacral spine.

The SAHARA Stabilization System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the SAHARA implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

Hyperlordotic (angles > 15°) and Lateral implants must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Additional supplemental fixation (i.e. pedicle screw and rod system) is needed when used as an adjunct to fusion for degenerative scoliosis. Otherwise, the SAHARA Stabilization System implants may be used as a stand-alone device, which is intended to be used with the bone screws provided.

SANTORINI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.

When used in the cervical spine (C2-T1), SANTORINI cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectorny performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These cages are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

When used in the thoracolumbar spine (TI-L5), SANTORINI cages are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). These cages are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.

When used in the thoracolumbar spine, the Santorini Corpectomy cages are intended to be used with supplemental internal fixation appropriate for the implanted level. including K2M Pedicle Screw and K2M Spinal Plate Systems.

When used in the cervical spine at one or two levels, the SANTORINI Corpectomy Cage System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA.

The Tritanium® C Anterior Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 to T1 disc.

DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.

The Trianium® C Anterior Cervical Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.

The Tritanium® C Anterior Cervical Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.

The Stryker Spine Tritanium® PL Cage is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD pairents may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the Tritanium® PL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Tritanium® PL Cage is to be implanted via a posterior approach.

The Tritanium® PL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The Stryker Spine Tritanium® TL cage is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the Tritanium TL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Tritanium TL Cage is to be implanted via a posterior approach.

The Tritanium TL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are intended for intervertebral body fusion with autografic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.

Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are always to be used with supplemental internal spinal fixation. Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Trianium® X TL Expandable Curved Posterior Lumbar Cage are to be used with autograff and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion.

The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are intended for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.

Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are always to be used with supplemental internal spinal fixation. Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

Stryker Spine VLIFT™ is a vertebral body replacement system intended to replace a vertebral body or an entire vertebra. It is for use in the thoracolumbar spine (TI-LS) to replace a collapsed, or unstable vertebral body or vertebra resected or excised during total and partial corpectomy and vertebrectomy procedures due to turnor of trauma (i.e., fracture). For both corpectomy and vertebrectomy procedures, the VLIFT™ system is intended to be used with supplemental internal fixation systems. The supplemental internal fixation systems that may be used with VLIFTM include, but are not limited to Stryker Spine plate or rod system, Spiral Radius 90D, and Trio). The use of bone graft with VLIFTTM is optional.

VLIFT®-s Vertebral Body Replacement System is indicated for use in the cervical spine (C3-C7) and the thoracolumbar spine (TI-L5) in skeletally mature patial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectorny performed to achieve decompression of the spinal cord and neural tissue in degenerative disorders.

The VLIFT®-s Vertebral Body Replacement System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The VLIFT®-s Vertebral Body Replacement System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The VLIFT®-s Vertebral Body Replacement System is intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

The subject devices consist of a variety of intervertebral body fusion devices and spinal vertebral body replacement devices designed to provide support across implanted levels of the cervical, thoracolumbar, and lumbosacral spine until fusion is achieved and have been previously cleared by FDA. The purpose of this submission is to establish an MR Conditional labeling claim for these implants.

This document is a 510(k) Summary for a range of spinal implants. The purpose of this submission is to establish an MR Conditional labeling claim for these implants. The submission does not detail specific acceptance criteria or performance metrics beyond stating that MR Compatibility testing was performed and met acceptance criteria.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria or reported device performance for the various spinal implants. It states generally:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample size for the test set (number of devices tested).
• Data Provenance: The data appears to be from laboratory testing ("MR Compatibility testing per ASTM F2503-13 was performed"). There is no mention of country of origin for data or whether it was retrospective or prospective. Given the nature of MRI compatibility testing for medical implants, it would typically be prospective laboratory testing on a selection of devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. The "ground truth" for MRI compatibility testing of physical implants is based on validated test methods (ASTM F2503-13) and physical measurements of artifacts, heating, and forces, not expert consensus on interpretations.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images by multiple readers to establish a "ground truth" for diagnosis or assessment. MRI compatibility testing involves physical measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states this submission is to establish an MR Conditional labeling claim for physical implants. It is not a study comparing human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. This submission is for physical medical devices (spinal implants) and their MRI compatibility, not an algorithm or AI system.

7. Type of Ground Truth Used

The ground truth for this type of submission is established through physical measurements and adherence to recognized standards (ASTM F2503-13) for evaluating MRI safety and compatibility of medical implants.

8. Sample Size for the Training Set

This information is not applicable. There is no AI or algorithm that requires a training set mentioned in this submission.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for an AI/algorithm.

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The ARIA Radiation Therapy Management product is a treatment application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Therapy Management also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.

The ARIA Radiation Therapy Management product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Therapy Management also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA Radiation Therapy Management supports the integration of all data and images in one central database including archiving and restoration. The different ARIA Radiation Therapy Management features support the visualization, processing, manipulation and management of all data and images stored in the system. Images can also be imported through using DICOM, the available image import filters or by means of film digitizers.

The provided text describes the ARIA Radiation Therapy Management (v16.1 MR3) device, which is a treatment plan and image management application. It states that the device was cleared based on non-clinical testing and refers to software verification and validation as the primary performance data.

However, the text does not contain the specific information requested regarding acceptance criteria, reported device performance, details of a study (sample sizes, data provenance, expert qualifications, adjudication methods), multi-reader multi-case (MRMC) comparative effectiveness study, standalone performance, or ground truth details for testing and training sets.

The document states:

• "No data from animal studies or clinical tests have been included in this pre-market submission."
• "Since the predicate device was cleared based only on the results of non-clinical testing, no animal or clinical studies were conducted for the subject device. The non-clinical data support the safety of the software verification and validation demonstrate that ARIA Radiation Therapy Management should perform as intended in the specified use conditions."

Therefore, I cannot provide the requested information from the given text. The provided document focuses on regulatory compliance, outlining the device's intended use, comparison with a predicate device, and adherence to software verification and validation testing and various regulatory standards (e.g., IEC 62304, ISO 13485, ISO 14971).

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The ARIA Radiation Therapy Management product is a treatment application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Therapy Management also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.

The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

The ARIA Radiation Therapy Management product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Therapy Management also stores the treatment histories including dose delivered to defined sites, and provides tools to verify performed treatments. ARIA Radiation Therapy Management supports the integration of all data and images in one central database including archiving and restoration. The different ARIA Radiation Therapy Management features support the visualization, processing, manipulation and management of all data and images stored in the system. Images can also be imported through the network using DICOM, the available image import filters or by means of film digitizers.

The Varian Eclipse™ Treatment Planning System (Eclipse TPS) provides software tools for planning the treatment of malignant or benign diseases with radiation. Eclipse TPS is a computer-based software device used by trained medical professionals to design and simulate radiation therapy treatments. Eclipse TPS is capable of planning treatments for external beam irradiation with photon, electron, and proton beams, as well as for internal irradiation (brachytherapy) treatments.

The provided text describes a 510(k) premarket notification for two medical devices: ARIA Radiation Therapy Management (v15.8) and Eclipse Treatment Planning System (v15.8).

Based on the provided text, the following information can be extracted:

• Acceptance Criteria and Device Performance: The document states that the devices were "verified and validated according to the FDA Quality System Regulation (21 CFR §820) and other FDA recognized consensus standards." It also mentions, "Test results demonstrate that the device conforms to design specifications and meets of the intended users, including assuring risk mitigations were implemented and functioned properly."
  However, the document does not provide a specific table of acceptance criteria with reported numerical device performance metrics. The performance assessment is general, confirming adherence to regulatory standards and design specifications rather than specific quantitative thresholds for accuracy, sensitivity, specificity, or other performance indicators typical for AI/ML-driven devices.

• Study That Proves the Device Meets Acceptance Criteria:
  The study that proves the device meets the acceptance criteria is Software Verification and Validation Testing.

Here's a breakdown of the specific points requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance:
* Acceptance Criteria: The acceptance criteria are broadly defined as conformance to design specifications, meeting intended user requirements, and assuring risk mitigations were implemented and functioned properly. This is according to FDA Quality System Regulation (21 CFR §820) and other FDA recognized consensus standards (listed below).
* Reported Device Performance: "Test results demonstrate that the device conforms to design specifications and meets of the intended users, including assuring risk mitigations were implemented and functioned properly." No specific numerical performance metrics (e.g., accuracy, sensitivity, specificity values) are provided for a direct comparison in a table format.

2. Sample size used for the test set and the data provenance:
* Sample Size: The document does not specify the sample size (e.g., number of cases or patients) used for the software verification and validation testing.
* Data Provenance: The document does not mention the country of origin of the data, nor does it specify if the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* This information is not provided. The document primarily focuses on software engineering and regulatory compliance rather than clinical performance validation involving experts establishing ground truth for a test set.

4. Adjudication method for the test set:
* This information is not provided. There's no mention of a clinical test set requiring adjudication in the context of this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* No MRMC comparative effectiveness study was done. The document explicitly states: "No data from animal studies or clinical tests have been included in this pre-market submission." This indicates that the regulatory submission primarily relies on software verification and validation and comparison to predicate devices, not studies demonstrating human reader improvement with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* The document implies that standalone software verification and validation testing was done, as it states "Software Verification and Validation Testing" was performed to ensure conformance to design specifications and risk mitigation. However, it does not explicitly detail "algorithm only" performance metrics in a clinical sense. The devices are described as tools for trained medical professionals, suggesting a human-in-the-loop operation, but the provided V&V is on the software itself.

7. The type of ground truth used:
* The term "ground truth" in a clinical performance context is not explicitly mentioned. For software verification and validation, ground truth would relate to the correctness of the software's output against its design specifications and expected behavior, rather than clinical outcomes or expert consensus on medical images.

8. The sample size for the training set:
* This information is not applicable and therefore not provided. These devices are not described as AI/ML systems that undergo a machine learning training phase on a dataset. They are software tools for treatment planning and management.

9. How the ground truth for the training set was established:
* This information is not applicable and therefore not provided, as these are not AI/ML training data sets.

In summary, the provided document focuses on regulatory compliance through software verification and validation and substantial equivalence to predicate devices, rather than detailed clinical performance studies often associated with novel AI/ML device submissions. The "acceptance criteria" are compliance with quality system regulations and standards, and "performance" is demonstrated by successful verification and validation tests against design specifications.

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Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the devices are indicated for:

• · Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• · Inflammatory joint disease including rheumatoid arthritis
• · Correction of functional deformity including congenital hip dysplasia
• · Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• · Failed previous hip surgery including internal fixation, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics' Origin, Aria, Remedy, TSI and Pegasus femoral stems and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants) and Cemented Origin femoral stems are intended for cemented fixation only.

Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

• · Acute femoral head or neck fracture
• Fracture dislocation of the hip
• · Avascular necrosis of the femoral head
• Non-union of femoral neck fractures
• · Certain high subcapital and femoral neck fractures in the elderly
• · Degenerative arthritis involving only the femoral head

The purpose of this 510(k) application is to extend the compatibility of the subject devices between Signature Orthopaedics and Encore Medical components. The subject devices themselves have not undergone any changes.

The provided document is a 510(k) premarket notification for hip replacement prostheses. It details the device name, regulation, and a claim of substantial equivalence to previously marketed predicate devices. However, it does not describe specific acceptance criteria and a study demonstrating the device meets those criteria, as typically found in clinical performance sections of submissions for new or significantly modified devices.

Instead, this document focuses on extending the compatibility of existing subject devices with other components. The core argument for substantial equivalence is that the devices themselves have not undergone any changes, only their compatibility with other components has been extended. Therefore, the "performance testing" described refers to engineering evaluations to ensure that the performance remains equivalent to predicate devices when used in these new combinations.

As such, many of the requested items related to acceptance criteria, clinical studies, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not present or not applicable in this specific FDA clearance document, as it's not a de novo clearance or a submission for a novel AI/software as a medical device (SaMD).

Here's an analysis based on the information provided, with an emphasis on what is not present given the nature of the document:

1. A table of acceptance criteria and the reported device performance

No explicit "acceptance criteria" table for a clinical performance study is provided. The document states that "engineering evaluations concluded that the performance of the subject devices will remain at least equivalent to the predicate devices when used in combinations as per the expanded compatibility." The performance testing listed appears to be bench testing rather than clinical study.

Performance Testing (Engineering Evaluations/Bench Testing):

2. Sample sized used for the test set and the data provenance

Not applicable for a clinical study. The testing described appears to be bench/laboratory testing of the physical hip prostheses components. The document does not specify sample sizes for these engineering evaluations, nor does it refer to patient data (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no mention of experts establishing a ground truth for a test set, as this is not a clinical or AI/SaMD performance study.

4. Adjudication method for the test set

Not applicable. No adjudication method is mentioned as there is no test set in the context of a clinical performance study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This document does not pertain to an AI/SaMD device, and therefore no MRMC study or AI assistance evaluation was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This document does not pertain to an AI/SaMD device, and therefore no standalone algorithm performance study was conducted.

7. The type of ground truth used

Not applicable in the context of clinical "ground truth." The "ground truth" for these engineering evaluations would be the established performance characteristics and safety criteria defined by the relevant ISO and ASTM standards (e.g., specific fatigue limits, wear rates, pull-out forces), against which the tested devices' physical properties are measured.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/SaMD device.

9. How the ground truth for the training set was established

Not applicable. There is no mention of a training set.

In summary: This FDA 510(k) clearance document for hip replacement prostheses makes a claim of substantial equivalence based on the fact that the actual devices have not changed, only their compatibility with other components has been extended. The "performance testing" referenced is a series of engineering/bench tests against international standards (ISO and ASTM) to ensure that the performance of the components remains equivalent to predicate devices in these extended combinations. It is not a clinical study involving patients, human readers, or AI/software performance.

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MEDO ARIA is designed to view and quantify ultrasound image data using machine learning techniques to aid trained medical professionals in diagnosis of developmental dysplasia of the hip (DDH). The device is intended to be used on neonates and infants, aged 0 to 12 months.

MEDO ARIA is a cloud-based standalone software as a medical device (SaMD) that helps qualified users with image-based assessment of developmental hip dysplasia (DDH) of pediatric patients (e.g., ages 0 to 12 months). It is designed to support the workflow by helping the radiologist to evaluate, quantify, and generate reports for hip images. MEDO ARIA Software takes as an input imported Digital Imaging and Communications in Medicine (DICOM) images from ultrasound scanners and allows users to upload, browse, and view images, measure alpha angle and acetabular coverage, and manipulate 2D and 3D infant hip ultrasound images, as well as create and finalize examination reports. It provides users with a specific toolset for viewing pediatric ultrasound hip images, placing landmarks, and creating reports.

Here's an analysis of the provided text to extract the acceptance criteria and study details for the MEDO ARIA device:

The provided document, a 510(k) summary for the MEDO ARIA device, offers limited details specifically on acceptance criteria and a dedicated "study that proves the device meets the acceptance criteria." The document primarily focuses on demonstrating substantial equivalence to a predicate device and outlining the device's features and indications for use.

However, we can infer some information from the "Performance Data" and the general context.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It generally states: "Safety and performance of MEDO ARIA have been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing."

Without specific numerical targets, it's impossible to create a precise table. However, based on the functionalities listed, the implied performance criteria would likely revolve around the accuracy, precision, and usability of its quantitative analysis tools (alpha angle and coverage measurement), landmark placement (manual and semi-automatic), and Graf classification.

Implied Acceptance Criteria and Reported Performance (Inferred)

2. Sample Size for the Test Set and Data Provenance

The document does not provide any specific information regarding the sample size used for the test set or the provenance (e.g., country of origin, retrospective/prospective) of the data used for any testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not provide any information about the number or qualifications of experts used to establish ground truth for a test set.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any effect size for human reader improvement with AI assistance. The device is described as an aid to "trained medical professionals," implying human-in-the-loop, but formal comparative studies are not detailed.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

The entire description of the software, particularly its role in "helping the radiologist to evaluate, quantify, and generate reports" and "aid trained medical professionals in diagnosis," suggests a human-in-the-loop context. However, the quantitative analyses (alpha angle, coverage, Graf classification) are likely performed by the algorithm in a standalone manner before the user's final decision. The document does not explicitly state if a standalone performance study (algorithm only) was conducted for these specific measurements, separate from interaction with a human.

7. The Type of Ground Truth Used

The document does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data). Given the nature of hip ultrasound measurements, expert consensus from radiologists or orthopedic specialists reviewing the images and confirming measurements would be a likely ground truth, but this is not explicitly stated.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set.

9. How the Ground Truth for the Training Set Was Established

The document does not provide any information on how the ground truth for the training set was established.

Summary of Missing Information:

The provided 510(k) summary is very high-level regarding the performance evaluation. It lacks critical details that would typically be found in a detailed clinical or validation study report, such as:

• Specific quantitative acceptance criteria (e.g., "alpha angle measurement must be within X degrees of ground truth").
• Performance metrics (e.g., sensitivity, specificity, AUC, mean absolute error, inter-reader variability improvement).
• Details about the datasets used (size, characteristics, provenance).
• Information about expert review for ground truth (number, qualifications, adjudication).
• Details of any comparative studies (MRMC or standalone algorithm performance).

The current document focuses on demonstrating that software verification and validation activities were performed in accordance with applicable standards and that the device is substantially equivalent to a predicate, without delving into the specifics of how well it performs against defined metrics.

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The Aria sequential circulator is a programmable sequential, pneumatic compression device intended for use by medical professionals and patients at home, for the treatment of the following conditions:

• Chronic edema
• Lymphedema
• Venous insufficiency
• Wound healing

The Aria system consists of two main components: A flow generator and a garment. The garment is to be wrapped around the limb, providing a comfortable fit. The garment has seven (7) chambers that are filled with air by the flow generator to provide compression on the extremity. The Aria system uses a compressand-release massage action, similar to the predicate, in order to stimulate lymphatic vessels in the treated area and encourage fluid clearance.

The Aria system retains similar hardware and performance features of the predicate device. Key features include flow generator, valves, A/C plug pack, lower limb garment, tubing, no-LCD User Interface and ON/OFF button. The Aria System contains a microprocessor-controlled flow generator/blower system that generates pressure from 0-45 mmHG to provide for effective treatment of the conditions described in the IFU.

The Aria flow generator has no control settings and delivers one pre-programmed therapy mode.

This document describes the Inova Labs Aria System, a programmable sequential, pneumatic compression device. It is intended for the treatment of chronic edema, lymphedema, venous insufficiency, and wound healing. The submission is a 510(k) premarket notification, indicating a claim of substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" against which the device performance is reported with specific numerical targets. Instead, it describes "bench testing" which included performance comparisons to a predicate device. The results of this testing are stated to "demonstrate that the Aria system raises no new safety or effectiveness concerns and is substantially equivalent to the predicate device."

Here's a summary of the characteristics compared with the predicate device (Entre Model PD08-U, K143185):

The "bench testing" areas mentioned for the Aria System were:

• Pressure stability
• Sleeve burst test
• Sleeve leakage test
• Sleeve integrity test
• Pressure accuracy test
• Chamber filling cycle time testing
• Total therapy time

The report generally states that the Aria system "met the Aria System Specification when compared to the predicate device" for these tests, implying that the performance was either equivalent or acceptable relative to the predicate. Specific numerical values for acceptance criteria or detailed results are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily discusses non-clinical bench testing. There is no "test set" in the context of patient data described for evaluating device performance. The testing involved physical device units. The provenance of the device units used for bench testing (e.g., country of manufacture) is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable as there was no clinical test set requiring expert ground truth establishment. The evaluation was based on bench testing against engineering specifications and comparison to a predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable as there was no clinical test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. The Aria System is a pneumatic compression device, not an AI-assisted diagnostic or interpretative device that would involve human "readers." No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable. The Aria System itself is a standalone medical device (hardware) that delivers therapy; it's not an algorithm whose performance needs to be assessed independently. While it contains a microprocessor and potentially firmware/software for control, the evaluation focuses on the overall device's physical and functional performance through bench testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical testing, the "ground truth" or reference for evaluating performance was based on engineering specifications for the Aria System and the performance characteristics of the legally marketed predicate device (Entre Model PD08-U, K143185). For example, pressure accuracy would be compared to a calibrated standard.

8. The sample size for the training set

This question is not applicable. This device is not an AI/ML algorithm that requires a "training set" of data for learning.

9. How the ground truth for the training set was established

This question is not applicable as there was no training set.

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