Search Results

Ask a specific question about this device

MammoSTAR Biopsy Site Identifier is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future surgical procedures.

MammoSTAR Biopsy Site Identifier is a sterile, single use tissue marker consisting of pyrolytic carbon coated zirconium oxide discrete marker e that is visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT) as well as ultrasound and Magnetic Resonance Imaging (MRI) incorporated into lyophilized BiomarC Delivery Gel. MammoSTAR is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.

Based on the provided FDA 510(k) clearance letter, the "MammoSTAR Biopsy Site Identifier" is cleared without new device performance data. The clearance is based on the device being identical to its predicate device (K100994) with only one difference being an added contraindication and an extended shelf life, which was verified through testing. Therefore, there is no specific performance data from a new study presented in this document to describe or prove the device meets acceptance criteria.

The document indicates that no new performance data was required because the device is deemed identical to the predicate device, and thus, already meets the established criteria for safety and effectiveness based on the predicate's clearance.

Here's an attempt to answer your request based on the information provided and inferred within the document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this 510(k) is a "Change Being Effected (CBE) determination" where the device is considered identical to its predicate except for an added contraindication and an extended shelf-life, explicit "acceptance criteria" and "reported device performance" from a new study are not provided for the claims of equivalency in the typical sense. Instead, the acceptance criteria are implicitly met by being identical to the predicate device, which was previously deemed safe and effective.

The only "performance" mentioned that might resemble a test is the shelf-life verification.

Ask a specific question about this device

The KMTI Tesera-k SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-k SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation.

The KMTI Tesera-k SC System is a stand-alone system when used with the locking bolt and bone screws provided and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of two (2) bone screws and the locking bolt.

When used without the locking bolt and two screws, the KMTI Tesera-k SC System is a non-standalone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability and may only be used at one level.

The Tesera-k SC System (Tesera-k SC) is a spinal fusion system consisting of additively manufactured interbody devices and machined titanium bone screws and cage lock. It is designed to provide mechanical support to the cervical spine while arthrodesis occurs. The Tesera-k SC implants are available in a variety of lordosis and footprint options with a superior and inferior porous face and internal lattice structure to offer increased capacity for bone growth.

The Tesera-k SC cages are additively manufactured then machined from Titanium alloy (Ti-6Al-4V) per ASTM F2924 or are additively manufactured from Titanium alloy (Ti-6Al-4V ELI) per ASTM F3001, and the bone screws and cage locks are machined from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The Tesera-k SC System may be implanted as a standalone with two internal fixation screws and the cage lock and without supplemental fixation or may be implanted as a non-standalone system without the internal fixation screws or cage lock but with FDA-cleared supplemental fixation.

The provided FDA 510(k) clearance letter for the Tesera-k SC System focuses on the substantial equivalence of an intervertebral body fusion device. Crucially, as this is a medical device clearance, the performance data provided relates primarily to mechanical testing of the device's structural integrity and does not involve clinical studies with human subjects or AI algorithms to interpret medical images.

Therefore, many of the requested sections (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone algorithm performance, AI training set details) are not applicable to this type of device clearance and the information provided.

Based on the provided document, here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter mentions the following non-clinical performance tests. It states that the "results of this non-clinical testing show that the strength of the Tesera-k SC System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." However, specific numerical acceptance criteria and precise reported device performance values are not detailed in this public summary document. The document only lists the types of tests performed.

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

• Sample Size for Test Set: Not applicable in this context. The testing involved mechanical evaluation of the device as a physical product, not an AI algorithm on a dataset.
• Data Provenance: Not applicable for AI data. The "performance data" refers to the results of standardized mechanical tests on the device, not clinical data or image data.

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

• This question is not applicable as the clearance is for a physical medical device (intervertebral fusion device), not an AI/software device that requires expert-established ground truth on medical images.

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

• This question is not applicable for the same reasons as #3.

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 as the clearance is for a physical medical device, not an AI/software device.

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

• This question is not applicable as the clearance is for a physical medical device, not an AI/software device.

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

• This question is not applicable. For this type of device, "ground truth" relates to the physical and material properties meeting engineering specifications and clinical performance criteria established through mechanical testing and comparison to predicates, rather than a diagnostic 'ground truth' from human interpretation or pathology.

8. The sample size for the training set

• This question is not applicable as the clearance is for a physical medical device, not an AI/software device that requires a training set.

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

• This question is not applicable for the same reasons as #8.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the Tesera-k SC System meets acceptance criteria consists of a series of non-clinical mechanical tests designed to assess the device's structural integrity, durability, and resistance to various forces it would encounter in its intended use. These tests were conducted according to recognized ASTM standards.

The specific tests performed were:

• Dynamic axial compression per ASTM F2077
• Dynamic compression shear per ASTM F2077
• Dynamic torsion per ASTM F2077
• Tensile Strength per ASTM F1147
• Shear Fatigue per ASTM F1160
• Abrasion per ASTM F1978

Conclusion of the Study:
The document states that "The results of this non-clinical testing show that the strength of the Tesera-k SC System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This implies that the device successfully met the performance benchmarks implicitly required for devices of its type and demonstrated equivalent or superior performance to the predicate device, K223105 (Tesera-k SC System by Kyocera Medical Technologies, Inc.). The overall technological characteristics and mechanical performance data led to the conclusion of substantial equivalence.

Ask a specific question about this device

The KMTI Hip Replacement System is indicated for patients suffering from:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and
5. Revision procedures where other treatment or devices have failed.

The Initia T3 Acetabular Hemispherical Shell System is intended for cementless applications.

The Kyocera Medical Technologies, Inc. (KMTI) Initia T3 Acetabular Hemispherical Shell System is a cementless shell intended for use in the treatment of hip disorders requiring hip replacement surgery. The Initia T3 Acetabular Hemispherical Shell System includes several components including: Initia T3 Acetabular Hemispherical Shell, Initia Acetabular Liner, Initia Bone Screw, and Delta 22.2 Femoral Head.

The Initia T3 Acetabular Hemispherical Shell is a cementless porous shell manufactured from Ti-6Al-4V ELI per ASTM F136. The Initia Acetabular Liner attaches to the inner surface of the Initia T3 Acetabular Hemispherical Shell and is available in four different configurations. The Initia Acetabular Liner is used to provide a single articulation implant option and is manufactured from Vitamin E infused UHMWPE per ASTM F2695 or UHMWPE per ASTM F648. The femoral head is manufactured from Biolox® delta and is available in two offsets.

This document clears the Initia T3 Acetabular Hemispherical Shell System for marketing. However, the provided text does not contain acceptance criteria or detailed study results in the manner requested for AI/software devices.

This FDA 510(k) clearance is for a physical medical device (an orthopedic implant), not an AI-powered diagnostic or assistive tool. The "performance data" section details various mechanical and material tests conducted on the implant itself to ensure its structural integrity, durability, and biological compatibility. It does not involve "test sets," "ground truth," "expert adjudication," or "multi-reader multi-case studies" in the context of evaluating an AI algorithm's diagnostic performance.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance related to diagnostic accuracy, nor can I provide information on sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. These concepts are not applicable to the type of device described in the provided text.

The "performance data" described in the document relates to non-clinical (laboratory/mechanical) testing of the physical components of the hip replacement system.

If you intended to provide a different document related to an AI/software medical device, please provide that document.

Ask a specific question about this device

The Skyway Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis, or scoliosis), tumor, pseudarthrosis or failed previous fusion.

The 4-Hole 1-Level Plates are limited to use at one contiguous level.

The KMTI Tesera-k SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-k SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. When used with the Skyway Anterior Cervical Plate System plates designed with spacer attachment, the assembly takes on the indications of the KMTI Tesera-k SC Interbody Spacer, with the Skyway Anterior Cervical Plate System acting as the supplemental fixation.

The Kyocera Medical Technologies, Inc. (KMTI) Skyway Anterior Cervical Plate System consists of anterior cervical plates, bone screws, and a locking screw. The implant components are composed of titanium alloy Ti-6Al-4V ELI per ASTM F136. The Skyway Anterior Cervical Plate System is offered in various sizes to accommodate patient anatomical needs. The subject 1-Level plates are compatible with and may be permanently attached to the Tesera-k SC System interbody spacers.

The purpose of this Special 510(k) is to introduce non-sterile plate options to the sterile packaged plates which were previously cleared and to modify the geometry of the plate's screw holes and the screw heads with minor dimensional changes.

This document is an FDA 510(k) clearance letter for a medical device called the Skyway Anterior Cervical Plate System. It is focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing the kind of performance data (e.g., AI model performance metrics, clinical study outcomes) typically associated with acceptance criteria for novel software-based devices, especially those using artificial intelligence.

The information provided explicitly states: "No performance testing was required for this 510(k)." This is because the submission is a "Special 510(k)" to introduce minor changes (non-sterile plate options and minor geometric modifications) to an already cleared device. Therefore, the questions related to AI model performance, sample size for test/training sets, expert adjudication, MRMC studies, ground truth establishment, etc., are not applicable to this specific 510(k) submission.

Based on the provided text, here's an attempt to answer the questions within the scope of what is stated:

Acceptance Criteria and Device Performance for the Kyocera Medical Technologies, Inc. (KMTI) Skyway Anterior Cervical Plate System (K250486)

As this is a Special 510(k) for minor modifications to an already cleared device, the "acceptance criteria" primarily revolve around demonstrating that the changes do not adversely affect the foundational safety and efficacy already established for the predicate device. The "study" described is a regulatory review process to confirm this, rather than a de novo clinical or performance study of the device's functional performance in a use-case scenario.

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

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

• Sample Size for Test Set: Not applicable for this type of submission. No performance testing on a "test set" of clinical data or patient outcomes was conducted or required. The review focused on engineering changes and regulatory compliance.
• Data Provenance: Not applicable. The "study" was a regulatory review of engineering specifications and manufacturing process changes (sterilization adoption), not a data-driven performance study.

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)

• Number of Experts & Qualifications: Not applicable. Given "No performance testing was required," there was no "test set" requiring ground truth establishment by clinical experts in the context of device performance. The experts involved would be FDA reviewers (e.g., Engineer & Regulatory Specialist Nathan Wright from KMTI, and the FDA's Division of Spinal Devices staff like Colin O'Neill and Maziar Shah Mohammadi), who assess regulatory compliance and engineering specifications against predicate devices.

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

• Adjudication Method: Not applicable. There was no "test set" of performance data requiring adjudication. The FDA's review process serves as the "adjudication" against regulatory standards and comparison to predicate devices.

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

• MRMC Study: No. This device is not an AI-powered diagnostic tool. It is a physical implant (spinal plate system). Therefore, an MRMC study and AI assistance effect size are not applicable.

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

• Standalone Performance: No. This device is a physical implant, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable.

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

• Type of Ground Truth: Not applicable in the context of clinical performance data. The "ground truth" for this 510(k) submission relates to established engineering principles, material science standards (e.g., ASTM F136 for titanium alloy), and regulatory requirements (e.g., ISO 17665-1 for sterilization). The substantial equivalence claim is the ultimate "ground truth" sought.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. No AI model training was involved for this physical medical device.

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

• Ground Truth for Training Set Establishment: Not applicable. No AI model training was involved.

Summary of this Specific 510(k):

This 510(k) clearance (K250486) is a "Special 510(k)" for minor modifications to an existing, already-cleared device. Its purpose is to assure the FDA that changes (adding non-sterile options, minor geometric changes) do not alter the previously established safety and efficacy profiles. Therefore, it does not involve the kind of performance studies, particularly those related to AI model validation, that the questions typically imply. The core "study" is the demonstration of substantial equivalence through regulatory and engineering assessment, not a clinical trial or AI performance evaluation.

Ask a specific question about this device

Bullsai Confirm provides functionality to assist medical professionals in planning the programming of stimulation for patients receiving approved Abbott deep brain stimulation (DBS) devices.

Bullsai Confirm is intended to assist medical professionals in planning the programming of deep brain stimulation (DBS) by visualizing the Volume of Tissue Activated (VTA) relative to patient anatomy. It is used to visualize patient-specific information within the patient's anatomy. Integrated magnetic resonance imaging (MRI) and computed tomography (CT) images are uploaded to Bullsai Confirm and can be navigated through in multiple 2D projections and 3D reconstructions. Abbott DBS lead models are positioned in the corresponding artifacts and potential stimulation settings and electrode configurations entered. Bullsai Confirm mathematically combines finite element (FE) based electric field model of the lead with an axon based neural activation model to translate potential stimulation settings and electrode configurations into a visualized VTA field to indicate the shape and the area or volume of anatomy that will be activated by the stimulation. Results, including input image quality assessments, are shared in an output PDF report and visualized in a web-based software interface.

Bullsai Confirm is used to do the following:

• Import DICOM images from a picture archiving and communication system (PACS), including . MRI and CT DICOM images.
• . Import preoperative planning outputs (including tractography, structural ROIs, etc.) from AWS S3 Cloud Storage
• . Combine MR images, CT images, and patient specific 3D structures for more detail
• Localize graphical compatible DBS lead models (based on preoperative imaging) .
• . Visualize VTA fields relative to structures of interest in the patient anatomy or lead position

The software provides a workflow for clinicians to:

• Create patient-specific stimulation plans for DBS programming .
• . Export reports that summarize stimulation plans for patients (PNG screenshot)

Here's a breakdown of the acceptance criteria and study details for Bullsai Confirm, based on the provided FDA 510(k) summary:

Device: Bullsai Confirm
Indication for Use: To assist medical professionals in planning the programming of stimulation for patients receiving approved Abbott deep brain stimulation (DBS) devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't present a specific table of quantitative acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy for the Bullsai Confirm product itself. Instead, the acceptance criteria are described in terms of compliance with regulatory requirements and the fulfillment of specific software functionalities as special controls.

The "Performance Data" section states the device meets the special controls under 21 CFR 882.5855, which are:

Note: The document also mentions "technical performance evaluation of the lead artifact detection and registration between image types" but does not provide specific acceptance criteria or performance metrics (e.g., accuracy, precision) for these evaluations. This is a common practice in 510(k) submissions where specific quantitative performance for a planning software like this might not be required in the public summary if the primary claim is substantial equivalence and compliance with special controls.

Study Proving Device Meets Acceptance Criteria

The document outlines that the device's performance was evaluated through various tests to meet the special controls.

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

The document does not explicitly state the number of cases or sample sizes used for the "formative usability testing" or the "technical performance evaluation of the lead artifact detection and registration between image types."

• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). While it mentions importing from PACS and AWS S3, this doesn't detail the origin of the data used for testing.

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

The document does not specify the number of experts or their qualifications involved in establishing ground truth for any test sets. The nature of this software (DBS planning assistant) suggests that "ground truth" would likely relate to the accuracy of lead localization, VTA calculation, and anatomical registration, typically assessed by neurosurgeons or neurologists specializing in DBS.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth or evaluating device performance. This would typically be detailed if a reader study or performance validation against a consensus "gold standard" was performed and the results reported as part of the summary.

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

There is no mention of an MRMC comparative effectiveness study being performed, nor any data on how much human readers improve with AI vs. without AI assistance. The device is described as an assistant for planning, implying a human-in-the-loop, but without a comparative study.

6. Standalone (Algorithm Only) Performance

The document does not provide standalone (algorithm only, without human-in-the-loop) performance metrics. The software is explicitly described as assisting "medical professionals," indicating it's designed for human-in-the-loop use.

7. Type of Ground Truth Used

The specific "type of ground truth" (e.g., expert consensus, pathology, outcomes data) is not explicitly stated for any of the performance evaluations mentioned. For "technical performance evaluation of the lead artifact detection and registration between image types," the ground truth would likely be derived from expert manual localization or highly accurate imaging methods, but this is not detailed.

8. Sample Size for the Training Set

The document provides no information regarding the size of the training set used for any machine learning components (if applicable) within the Bullsai Confirm software. Given the description focusing on finite element models and neural activation models, it's possible the core algorithms are physics-based rather than exclusively data-driven, or that details of data-driven components (if any) are not disclosed in this summary.

9. How Ground Truth for the Training Set Was Established

As no training set size is provided, there is consequently no information on how ground truth for a training set was established.

Ask a specific question about this device

The Kyocera Medical Technologies, Inc. (KMTI) Tesera-k PL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. KMTI Teresa-K PL System implants are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment prior to implantation. The KMTI Tesera-k PL System is a non-standalone system and is required to be used with additional supplemental fixation that have been cleared by the FDA for use in the lumbar spine.

The Kyocera Medical Technologies, Inc. (KMTI) Tesera-k XL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. KMTI Tesera-k XL System implants are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment prior to implantation. The KMTI Tesera-k XL System is a non-standalone system and is required to be used with additional supplemental fixation that have been cleared by the FDA for use in the lumbar spine.

The Tesera-k Lumbar System (Tesera-k PL (Tk-PL) System and Tesera-k XL System (Tk-XL) System) consist of interbody fusion implants intended to provide stability and facilitate fusion in the lumbar spine.

The Tesera-k PL System implants are offered with straight or curved profiles to accommodate posterior or transforaminal surgical approaches. The Tesera-k PL implants are additively manufactured then machined from Titanium alloy (Ti-6Al-4V ELI) per ASTM F3001.

The Tesera-k XL System implants are offered in a straight profile for the direct lateral surgical approach. The Tesera-k XL cages are additively manufactured then machined from Titanium alloy (Ti-6A1-4V ELI) per ASTM F3001. The Tesera-k XL Bone Screws and Locking Assemblies are machined from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The Tesera-k PL and Tesera-k XL Systems are non-standalone systems and must be used in conjunction with FDA-cleared lumbosacral supplemental fixation.

The provided FDA 510(k) summary does not contain the information requested regarding acceptance criteria and performance studies for a medical image analysis AI device.

The document describes a submission for the Tesera-k PL System and Tesera-k XL System, which are intervertebral body fusion devices (implants for spinal fusion surgery). This is a physical medical device, not a software or AI-driven diagnostic or image analysis tool.

Therefore, I cannot extract details about:

• Acceptance criteria and reported device performance for an AI/software device: The document focuses on mechanical testing of spinal implants (e.g., static and dynamic compression, shear, subsidence, expulsion, tensile strength, fatigue, abrasion).
• Sample size for test sets and data provenance: Not relevant to a mechanical implant test.
• Number of experts and their qualifications for ground truth: Not relevant. Ground truth for an implant is typically physical measurements and engineering standards.
• Adjudication method for test set: Not applicable.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable to a physical implant.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used (expert consensus, pathology, outcomes data): The ground truth for this device is based on standardized mechanical testing (e.g., ASTM standards) to demonstrate structural integrity and long-term performance under simulated physiological conditions.
• Sample size for training set and how ground truth was established for the training set: Not applicable to a physical implant. The "training" for such a device is its design and manufacturing process, optimized through engineering principles and iterative testing against performance standards.

In summary, the provided text describes the regulatory filing for a physical medical implant, not an AI or software-based medical device. As such, it does not contain the information necessary to answer your prompt about acceptance criteria and study details for an AI-driven device.

Ask a specific question about this device

The Initia Knee System is intended for use in total knee arthroplasty for the following indications:

1. Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis where one or more compartments are involved.

2. Correction of varus, valgus, or posttraumatic deformity.

3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

This device is for cemented use only.

The Kyocera Medical Technologies, Inc. (KMTI) Initia Knee System is a patellofemorotibial polymer/ metal/polymer semi-constrained prosthesis intended to replace a knee joint. The system consists of femoral, tibial and patella components intended for use with bone cement. The Initia Knee System includes both posterior-stabilizing (PS) and cruciate-retaining (CR) designs.

This document is a 510(k) summary for the Kyocera Medical Technologies, Inc. (KMTI) Initia Knee System. It details the device, its intended use, and its substantial equivalence to a predicate device, the KMTI A200 Knee System.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with specific pass/fail values. Instead, it lists various non-clinical performance tests that were conducted and states that the results were "acceptable." The implication is that the performance of the Initia Knee System met the requirements established for these tests, likely aligned with the standards cited.

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

• Sample Size: The document does not specify the exact sample sizes used for each individual non-clinical performance test. It mentions "components" and "trials" which implies multiple units were tested per category.
• Data Provenance: The data is generated from non-clinical performance tests conducted by Kyocera Medical Technologies, Inc. ("KMTI"). The provenance is therefore internal testing by the manufacturer. The document does not specify the country of origin of the data beyond the manufacturer's location in Redlands, CA, USA. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate device performance.

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

This section is not applicable as the document describes non-clinical performance testing for a medical device (knee prosthesis), not an AI/software device that requires expert-established ground truth for a test set. The "ground truth" for these tests are the established engineering principles, material science properties, and consensus standards (e.g., ASTM, ISO) that define acceptable performance for orthopedic implants.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. Performance is evaluated against objective engineering criteria and consensus standards, not through expert adjudication of subjective interpretations.

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 section is not applicable. The subject device is a physical knee prosthesis, not an AI or software-based diagnostic or assistive tool. Therefore, a MRMC study involving human readers and AI assistance would not be relevant.

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

This section is not applicable. The subject device is a physical knee prosthesis, not an algorithm or software. No standalone algorithm performance was assessed for this device.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" is based on:

• Established engineering principles and biomechanical requirements: These tests assess the physical and mechanical properties of the device.
• Consensus standards: The document explicitly lists numerous ASTM and ISO standards (e.g., ASTM F1672-14 for patellar prosthesis, ASTM F1800-12 for tibial tray fatigue, ISO 7207-2 for articulating surfaces). These standards define test methodologies and acceptable performance metrics, which serve as the "ground truth" for assessing device safety and effectiveness.
• Comparison to predicate device: The fundamental basis of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device. Therefore, the predicate's known safe and effective performance also acts as a reference for the "ground truth" of what is considered acceptable.

8. The Sample Size for the Training Set

This section is not applicable. The subject device is a physical knee prosthesis. There is no concept of a "training set" as there would be for an AI/machine learning model. The design and manufacturing process are informed by established engineering knowledge and previous experience with similar devices.

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

This section is not applicable for the same reasons as point 8.

Ask a specific question about this device

The Skyway Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis, or scoliosis), tumor, pseudarthrosis or failed previous fusion.

The 4-Hole 1-Level Plates are limited to use at one contiguous level.

The KMTI Tesera-k SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-k SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. When used with the Skyway Anterior Cervical Plate System plates designed with spacer attachment, the assembly takes on the indications of the KMTI Tesera-k SC Interbody Spacer, with the Skyway Anterior Cervical Plate System acting as the supplemental fixation.

The KMTI Skyway Anterior Cervical Plate System is an anterior cervical plating fixation system consisting of implants and associated instrumentations to provide supplemental fixation between two adjacent cervical vertebral bodies as an adjunct to fusion or for spinal correction. The Skyway Anterior Cervical Plate System is implanted via an anterior surgical approach.

The subject devices proposed in this submission are a line extension of the Skyway Anterior Cervical Plate System (K231766) with the introduction of additional length and configuration options for the 1-Level Plates and 2-hole and 3-hole 1-Level Plates. This subject line extension also includes non-sterile bone screw and locking screw options. The Skyway Anterior Cervical Plate System plates, bone screws, and locking screws are manufactured from Ti-6Al-4V per ASTM F136.

I am sorry, but the provided text is a 510(k) premarket notification for a medical device (Skyway Anterior Cervical Plate System) and does not contain information related to software, imaging, or AI studies. Therefore, I cannot extract the acceptance criteria for a device from this text, nor can I describe any study proving that the device meets such criteria because the information is not present.

The document discusses the regulatory approval of a physical medical implant (a cervical plate system) and its mechanical testing, not software performance. As such, sections related to sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, ground truth, and training set information are not applicable to the content of this document.

Ask a specific question about this device

TrueFit/TrueFlex Bolus is indicated for and intended to be placed on the patient's skin as an accessory to attenuate and/or compensate the external beam (photon or electron) radiation during the treatment of various types of cancer.

The device is for a single patient's use only and can be reused throughout the entirety of the treatment course.

The device is designed by the radiation therapy professional using patient imaging data as input and must be verified and approved by the trained radiation therapy professional prior to use.

The device is restricted to sale by on the order of a physician and is by prescription only.

TrueFit/TrueFlex Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiation therapy by providing a patient-specific fit.

Patient imaging data from the treatment planning system (TPS) are used as inputs to generate digital design of the radiation therapy bolus (TrueFlex) by 3D Bolus Software Application (K213438), previously developed by Adaptiv. The resulting output Stereolithography (STL) file is compatible with the third-party 3D printers. A TrueFit Bolus is 3D printed by MJF technology using polyamide or polyurethane material. A Final TrueFlex Bolus device is manufactured by filling a mould with silicone.

The bolus is used in radiation therapy when a patient requires the total prescription dose to be delivered on or near the skin surface. The bolus acts as a tissue-equivalent material placed on the patient skin to account for the buildup region of the treatment beam.

This document, a Special 510(k) Summary for K243057, does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria. The provided text is a regulatory submission focused on demonstrating substantial equivalence to a predicate device rather than a comprehensive report of a clinical performance study.

However, I can extract and present the information that is available within the document:

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

The document mentions "acceptable spatial fidelity" and "acceptable physical and radiological properties" as performance outcomes, but it does not specify quantitative acceptance criteria for these. It states that tests "verified that the chosen methods performed as intended" and "did not affect the overall safety and effectiveness of the device."

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

• Sample size: The document states "worst-case geometrical test samples and real-patient final devices" were used for Verification and Validation activities. It does not provide a specific number for the sample size.
• Data provenance: 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 information is not provided in the document. The general indication statement mentions that "the device is designed by the radiation therapy professional using patient imaging data as input and must be verified and approved by the trained radiation therapy professional prior to use." This refers to the clinical use process, not the establishment of ground truth for device testing.

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

This information is not provided in the document.

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 document describes a medical device (TrueFit Bolus, TrueFlex Bolus) which is a 3D-printed accessory for radiation therapy, applied to the patient's skin. It is not an AI-powered diagnostic or decision support software. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device type.

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

The device itself is a physical bolus. Its design process involves software (3D Bolus Software Application - K213438), which generates a digital design, and then a physical product is manufactured. The software component, by its nature, is "standalone" in generating the STL file, but the overall product (the bolus) is applied by a human and is a physical accessory designed to interact with external beam radiation. The document focuses on the physical and radiological properties of the manufactured bolus rather than the performance of an algorithm in isolation for diagnostic or interpretive tasks.

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

The document focuses on "acceptable spatial fidelity" and "acceptable physical and radiological properties." Ground truth for these aspects would typically involve:

• Precise measurements of the 3D printed objects against the digital design for spatial fidelity.
• Laboratory measurements of material density, Hounsfield units (for radiological properties), and physical characteristics (e.g., flexibility, rigidity) for physical/radiological properties.
  The document does not detail the specific ground truth methods or references.

8. The sample size for the training set

This information is not applicable and is not provided. This is a medical device clearance document for a manufactured product, not an AI/machine learning model where a training set size would be relevant. The "design" of the bolus is based on patient imaging data as input to software, but the software itself (K213438) has been previously developed, and details of its training (if applicable, as it's not explicitly stated to be an AI/ML product) are not covered here.

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

Not applicable, as it's not an AI/ML model for which a training set and its ground truth would be described in this context.

Ask a specific question about this device