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The aprevo® anterior and lateral lumbar interbody fusion devices are intended for interbody fusion in skeletally mature patients and are to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches may include anterior lumbar interbody fusion or lateral lumbar interbody fusion.

The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® anterior and lateral lumbar interbody fusion devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® transforaminal lumbar interbody fusion device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® transforaminal lumbar interbody fusion device is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® transforaminal lumbar interbody fusion device is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® transforaminal lumbar interbody fusion devices are to be filled with auto graft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended for interbody fusion in skeletally mature patients. The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone and/or corticocancellous bone and is to be used with supplemental fixation cleared for use in the lumbar spine. The device may be implanted via an open or minimally invasive approach.

The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis, kyphosis, or sagittal), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended for standalone use at one or two levels of the spine when used with the screws that accompany the implant and with implants less than or equal to 20° of lordosis. At more than two levels or with implants greater than 20° of lordosis, the aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended to be used with the screws that accompany the implant and with supplemental fixation. When used at more than one level in patients with degenerative scoliosis and/or sagittal deformity, the aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) must be used with the screws that accompany the implant and with supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine. These patients should be skeletally mature and have had at least six months of non-operative treatment. The device is to be filled with autograft bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. The device may be implanted via an open or minimally invasive approach.

The aprevo® TLIF-C Articulating System is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® TLIF-C Articulating System is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® TLIF-C Articulating System is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® TLIF-C Articulating System devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® Cervical ACDF lnterbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. The aprevo® Cervical ACDF lnterbody System must be used with supplemental fixation systems. For hyperlordotic corrections (≥20° lordosis), the system must be used with at least an anterior cervical plate as supplemental fixation.

The aprevo® Cervical ACDF-X lnterbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. When used as a standalone system, the aprevo® Cervical ACDF-X lnterbody implant with integrated screw fixation is intended for use at multiple contiguous levels, or up to two levels when used in trauma, deformity or failed previous fusions. Deformity procedures to correct coronal angulation or any use of hyperlordotic correction (≥20°) must include supplemental fixation such as posterior cervical screw fixation or anterior plating.

The aprevo® Lumbar Intervertebral Body Fusion Devices include ALIF, LLIF, TLIF, ALIF-X and TLIF-CA interbodies. The aprevo® lumbar interbody fusion devices are designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® device incorporates patient specific features to allow the surgeon to tailor the procedure to the individual needs of the patient and includes an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient CT scans. The aprevo® devices are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F3001, while the screws that accompany ALIF-X are machined from material per ASTM F136. The devices are accompanied by an inserter instrument which facilitates the placement of the interbodies. Both the interbody devices and instruments are provided as single use, sterile-packed product to the end user.

The aprevo® Cervical Intervertebral Body Fusion Devices include ACDF, ACDF-X and ACDF-X no cams. The aprevo® Cervical ACDF System, which includes the aprevo® Cervical ACDF Interbody, aprevo® Cervical ACDF-X Interbody, and the aprevo® Cervical ACDF-X (NO CAM) Interbody are designed to stabilize the cervical spinal column and facilitate fusion. The personalized aprevo® devices incorporate patient-specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient and include an aperture for the packing of bone graft. The aprevo® Cervical ACDF System interbodies are additively manufactured from Ti-6Al-4V ELI titanium alloy per F3001, while the screws are machined from Ti alloy per ASTM F136. The devices are accompanied by an inserter instrument which facilitates the placement of the interbodies. Both the interbody devices and the instruments are provided to the end-user as single use, sterile-packed products.

The purpose of this 510(k) is to extend the expiration of imaging used to create 3D surgical plans. There have been no changes made to the software used in the surgical planning process.

The provided FDA 510(k) clearance letter (K250827) for Carlsmed, Inc.'s "aprevo®" interbody fusion devices primarily concerns the renewal of previously cleared devices and the extension of the imaging expiration dating used for 3D surgical planning. Therefore, the document does not contain details of a clinical study assessing the performance of an AI-based device meeting acceptance criteria in the way one might expect for a novel AI/ML medical device submission.

Instead, the performance testing summary indicates that "Clinical data was used to evaluate imaging expiration. Expiration dating was validated using statistical analysis (DICE score) with an acceptance criterion of >0.80. Additionally, the performance was evaluated across key cohorts." This suggests that the "device" being evaluated for performance in this context is likely related to the software's ability to accurately segment or generate 3D models from imaging data over time, rather than the interbody fusion implants themselves. The clearance is for the physical implants, which are considered substantially equivalent to previously cleared predicates. The "performance testing" here seems to be an update or validation related to the software component of the surgical planning.

Given this context, I will extract information relevant to the software's performance, as that is the only "acceptance criteria" and "study" mentioned, even if it's not a typical AI model performance study against clinical outcomes.

Here's an interpretation based on the limited information provided, assuming the "device performance" refers to the imaging processing capabilities of the aprevo® system's software, specifically regarding the "expiration" of imaging data for 3D surgical plans:

Acceptance Criteria and Device Performance Study for Imaging Expiration

The context of this FDA 510(k) submission (K250827) indicates that the performance study was specifically undertaken to extend the expiration of imaging used to create 3D surgical plans. This suggests the "device performance" being assessed relates to the consistency and accuracy of the software's ability to process imaging data for surgical planning over time, implying that "aging" of the input imaging data does not degrade the software's output beyond an acceptable threshold.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only specifies the acceptance criterion. The specific numerical performance result (e.g., the exact DICE score achieved) is not provided in this public clearance letter. However, the clearance implies that the criterion was met.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not specified in the provided text.
• Data Provenance: "Clinical data was used." No details on the country of origin or whether the data was retrospective or prospective are provided.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. (e.g., 2+1, 3+1, none).

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

• MRMC Study Done?: No, an MRMC study comparing human readers with and without AI assistance is not mentioned or implied by the description of this performance evaluation, which focuses on "imaging expiration" and DICE score.

6. Standalone (Algorithm Only) Performance

• Standalone Performance Done?: Yes, the use of a "DICE score" for "imaging expiration" strongly suggests an algorithm-only performance evaluation, likely comparing the software's segmentation or 3D reconstruction output against a form of ground truth derived from the clinical data. The phrase "There have been no changes made to the software used in the surgical planning process" further indicates an assessment of the software's intrinsic capabilities.

7. Type of Ground Truth Used

• Type of Ground Truth: The use of "DICE score" typically implies that the ground truth involves expert-annotated segmentations or regions of interest within the medical images. The DICE score measures the spatial overlap between the algorithm's output and the ground truth. While not explicitly stated, it's highly probable that this ground truth was derived from expert consensus or manual annotation of anatomical structures on the clinical imaging data.

8. Sample Size for the Training Set

• Training Set Sample Size: Not mentioned. This submission is for an extension/validation of existing software, not the initial clearance of a newly developed AI model, so details on original training are not typically included here.

9. How Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Not mentioned. As above, this document focuses on a validation study for imaging expiration, not the initial development or training of the AI algorithm.

Summary of Limitations Based on Provided Text:

The provided 510(k) summary (specifically the "Performance Testing Summary") is extremely concise regarding details of the study. It states that "Clinical data was used to evaluate imaging expiration" and that "Expiration dating was validated using statistical analysis (DICE score) with an acceptance criterion of >0.80. Additionally, the performance was evaluated across key cohorts."

Therefore, many typical details requested for robust AI/ML performance studies, such as specific sample sizes, expert qualifications, and adjudication methods, are not present in this public clearance letter. This is common for 510(k) summaries, which are often condensed versions of the full submission. The key takeaway is that the "performance testing" here addresses a specific aspect ("imaging expiration" for 3D surgical planning) of the software rather than a direct clinical efficacy study of the implant or a broad AI diagnostic/prognostic model.

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The aprevo® TLIF-C Articulating System is interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® TLIF-C Articulating System is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® TLIF-C Articulating System is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® TLIF-C Articulating System devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® TLIF-C Articulating System devices are designed to stabilize the lumbar spinal column and promote fusion. The personalized aprevo® interbodies incorporate patient specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient and include an aperture intended for the packing of bone graft.

The aprevo® TLIF-C Articulating interbodies are additively manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F3001. The devices are accompanied by an inserter instrument which facilitates the placement of the interbodies. Both the interbody devices and instrument are provided as single use, sterile-packed product to the end user.

The provided text describes a medical device, the aprevo® TLIF-C Articulating System, and its substantial equivalence to predicate devices, supported by non-clinical testing. However, it does not contain the specific information required to answer the questions about acceptance criteria for a study demonstrating device performance for an AI/ML-enabled medical device. The information provided is primarily focused on the mechanical and physical performance of the interbody fusion device itself, not on the performance of any AI/ML component.

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and study details for an AI/ML device based on the given input.

Here's a breakdown of why and what kind of information would be needed:

• No AI/ML Component Described: The text describes a physical interbody fusion device and its associated instruments. There is no mention of any AI or machine learning algorithms, software, or intelligent functions associated with the device. The "technological characteristics" mentioned refer to its mechanical properties and materials, not software performance.
• Non-Clinical Testing is for Physical Device: The "non-clinical testing" listed (Static and dynamic axial compression, Static and dynamic compression-shear, Subsidence, Cadaveric study) are standard tests for orthopedic implants to ensure their mechanical integrity and biocompatibility. These tests do not evaluate AI/ML performance.

To answer your questions, the input would need to describe an AI/ML-enabled medical device and its corresponding performance study, which would typically include metrics like sensitivity, specificity, accuracy, AUC, etc., along with details on the ground truth establishment, expert review, and dataset characteristics.

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The Ion™ Endoluminal System (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use.

The Flexision™ Biopsy Needle is used with the Ion™ Endoluminal System to biopsy tissue from a target area in the lung.

The PlanPoint™ Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion™ Endoluminal System.

The Ion™ Endoluminal System (hereinafter referred to as the Ion System) is a software-controlled, electromechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. It consists of a Planning Laptop with PlanPoint™ Software, a System Cart with System Software, a Controller, Instruments, and Accessories. The Ion System Instruments include the Ion™ Fully Articulating Catheter, the Ion™ Peripheral Vision Probe, and the Flexision™ Biopsy Needles. Accessories such as the Catheter Guide, Vision Probe Adapter, Suction Adapter, Swivel Connector, and Vision Probe Bag facilitate use of the Ion System Instruments.

The provided FDA 510(k) summary for the Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000) focuses on demonstrating substantial equivalence for an increase in the device's use life from 5 to 8 uses. This is not a typical submission for a novel AI/ML-based medical device where performance data relates to diagnostic accuracy, sensitivity, or specificity of an AI algorithm.

Therefore, the information required for explaining an AI device's acceptance criteria and proven performance (specifically sections regarding AI/ML performance, sample sizes for test/training sets, expert consensus, MRMC studies, etc.) is not present in this document. This submission primarily relies on bench testing, cleaning validation, and biocompatibility studies to justify the increased reprocessing cycles.

However, I can extract the acceptance criteria and the reports of meeting those criteria based on the information provided, framed within the context of a device durability/reuse validation:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in terms of number of units tested. The documentation refers to "testing" in general.
• Data Provenance: Not applicable in the context of clinical data for AI performance. The tests are laboratory/bench-based.

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

• Not Applicable: This submission does not involve human expert interpretation of data to establish ground truth for a diagnostic AI. The "ground truth" here is the adherence to engineering and safety standards validated through laboratory testing.

4. Adjudication Method for the Test Set

• Not Applicable: There is no adjudication process described as this is not a study assessing human perception or diagnostic accuracy. Performance is determined by passing predefined engineering and biological safety standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

• No: An MRMC study was not performed as this is not a submission for an AI-assisted diagnostic or therapeutic device that impacts human reader performance.

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

• No (Not Applicable): This is not a submission for an AI algorithm. The "System Software" mentioned is likely operating software for the robotic system, not a diagnostic AI.

7. The Type of Ground Truth Used

• Engineering and Safety Standards: The "ground truth" for this device's performance validation is its adherence to established engineering specifications (functional performance over repeated uses) and recognized safety standards (cleaning efficacy, biocompatibility).

8. The Sample Size for the Training Set

• Not Applicable: This document describes validation testing for an increased use life, not the development or training of an AI model.

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

• Not Applicable: No AI training set is discussed or implied.

Summary of why the requested AI-specific information is not present:

The FDA 510(k) submission K240135 for the Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000) is specifically for an increase in the device's reusability/use life (from 5 to 8 uses) of an existing cleared device. It primarily relies on non-clinical performance data (bench testing, cleaning validation, biocompatibility) to demonstrate that increasing the use life does not introduce new safety or effectiveness concerns. This is fundamentally different from a submission for a novel AI/ML-based medical device that would require extensive clinical performance data, ground truth establishment, and often comparative studies with human readers.

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These single use, disposable, flexible sheath injection needles are intended to be used for the injection of various types of media through flexible endoscopes.

The Carr-Locke and Articulator Injection Needles are single use, disposable, flexible sheath injection needles that are intended to be used for the injection of various types of media through flexible endoscopes. All the needles have the same general design and consist of a handle luer, a handle hypo tube, a compression spring (except for PN 00711808), a PEEK tube, a spring sheath, a distal hub and an injection needle.

The Carr-Locke and Articulator needles are sterile, disposable devices that are used through the working channel of flexible endoscopes for the purpose of injecting media into the gastrointestinal tract.

The information provided is about the substantial equivalence of the STERIS Articulator and Carr-Locke Injection Needles (K232826) to a predicate device. This document is a 510(k) summary, which focuses on comparing a new device to a legally marketed predicate device to demonstrate that it is as safe and effective. It does not describe a study involving algorithms, AI, or human reader performance.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth used, training set sample size, ground truth for training set) are not applicable to this type of device and submission.

However, I can extract the acceptance criteria and device performance from the tables in the "Summary of Nonclinical Tests" section.

Acceptance Criteria and Device Performance

The STERIS Articulator and Carr-Locke Injection Needles (K232826) underwent nonclinical testing to demonstrate substantial equivalence to the predicate device. The following table summarizes the acceptance criteria and reported results:

Study Information (Relevant to this type of device)

1. Sample size used for the test set and the data provenance: The document does not specify the exact sample sizes (number of devices or tests performed) for each nonclinical test. It only states that testing was performed. Data provenance is not described as this is a device performance study, not a clinical trial or AI model validation.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The tests are engineering/performance evaluations, not clinical diagnoses requiring expert ground truth.
3. Adjudication method for the test set: Not applicable for nonclinical device performance tests.
4. 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: Not applicable. This is not an AI/imaging device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm.
6. The type of ground truth used: For these nonclinical tests, the "ground truth" is defined by the "design requirements" which are established engineering and performance specifications for the device.
7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

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General Indications:
The LinkSymphoKnee is intended for primary and revision total knee replacement in skeletally mature patients with the following conditions.
This device is intended for cemented use only unless a cementless modular stem is indicated for use.

Indications:

• Primary degenerative arthritis / osteoarthritis
• Secondary arthritis resulting from rheumatoid arthritis
• Fracture

The LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface is available in cPE and E-Dur. In cases of good joint stability, where the ligaments and capsule are intact the FB UC version is available. This configuration is provided for PCL retaining joint reconstruction or if the posterior cruciate ligament is sacrificed.

The Fixed Bearing Ultracongruent (FB UC) Articulating Surface is compatible with the already cleared LinkSymphoKnee (K202924). The LinkSymphoKnee is available in multiple versions with different applications, characteristics, and materials.

This document does not describe an AI/ML device but rather a knee joint prosthetic. Therefore, many of the requested fields and information are not relevant or present in the provided text.

Based on the information provided for the LinkSymphoKnee - Fixed Bearing Ultracongruent (FB UC) Articulating Surface:

1. Table of acceptance criteria and the reported device performance:

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

• Sample size for test set: Not applicable/Provided. The performance testing described is for a medical device (knee implant), not an AI/ML system. The testing likely involved mechanical testing of device samples.
• Data provenance: Not explicitly stated, but the testing was non-clinical performance testing.

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

• Not applicable. This device is not an AI/ML system requiring expert-established ground truth. Performance was evaluated through non-clinical mechanical testing standards.

4. Adjudication method for the test set:

• Not applicable. Performance was evaluated through non-clinical mechanical testing standards, not expert 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:

• Not applicable. This is not an AI-assisted device.

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

• Not applicable. This is not an AI-driven algorithm.

7. The type of ground truth used:

• For mechanical performance testing, the "ground truth" would be established physical and engineering standards (e.g., ISO 14243-1, ISO 17853, ASTM F1877, ASTM F1223-20) and benchmark data from predicate devices.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML system, so there is no training set in the context of machine learning.

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

• Not applicable. There is no training set.

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The Stryker Q Guidance System, with the Cranial Guidance Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer-assisted surgery. The system is indicated for any medical condition in which the use of computer-assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a rigid anatomical structure can be identified. The system assists in the positioning of instruments for cranial procedures, including: Cranial biopsies Craniotomies Craniectomies Resection of tumors and other lesions Skull base procedures Transnasal neurosurgical procedures Transsphenoidal pituitary surgery Craniofacial procedures Skull reconstruction procedures Orbital cavity reconstruction procedures General ventricular catheter and shunt placement Pediatric ventricular catheter and shunt placement

The Q Guidance System is intended as an aid for precisely locating anatomical structures in open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate and where reference to a rigid anatomical structure such as the skull, vertebra, or long bone can be identified.

The Stryker CranialMask Tracker is intended to be used as an accessory to the CranialMap and the Cranial Guidance software applications. It is intended to be placed on the patient's facial skin and used in combination with preoperative and intraoperative imaging devices to enable automatic patient registration for open or percutaneous computer-assisted surgery. The Stryker CranialMask Tracker can be used as a noninvasive patient tracker to support open or percutaneous cranial neurosurgical procedures.

The Stryker EM Stylet is indicated for use as an accessory to the Stryker Q Guidance System when used with the Cranial Guidance Software and electromagnetic navigation. It is indicated for use in locating anatomical structures during navigated cranial procedures. The system is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. The EM Stylet is indicated for use in the following procedures: General ventricular catheter and shunt placement Pediatric ventricular catheter and shunt placement

The Stryker Navigated Biopsy Needle is intended to be used as an accessory to the Stryker Q Guidance System when used with the Cranial Guidance Software. It is a side cutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula for use in the stereotaxic biopsy of cranial tissue. The Stryker Navigated Biopsy Needle may be used as part of the Stryker Cranial Guidance System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.

The Q Guidance System with Cranial Guidance Software is a computer-assisted stereotaxic, image-guided, planning, and intraoperative guidance system intended to enable open or percutaneous computer-assisted surgery. It assists the surgeon in precisely positioning instruments and locating patient anatomy during cranial surgery. The Q Guidance System with Cranial Guidance Software system is comprised of a computer platform. Cranial Guidance Software, navigated instruments (e.g., patient/ instrument trackers, pointers), and various system components. The system provides intraoperative guidance to the surgeon using electromagnetic, passive and active wireless optical tracking technologies. The computer platform consists of a computer, camera, electromagnetic field generator and box to plug in electromagnetic instruments, big touchscreen monitor, and a small touchscreen monitor. The Cranial Guidance Software is dedicated to cranial surgical procedures as defined in the indications for use. Required navigated instruments include instruments such as a patient tracker, an instrument tracker, pointers, suction tubes, seekers, etc. An instrument battery is required when a battery powered instrument or calibration device is used. The Cranial Guidance Software displays the intraoperative location of navigated surgical instruments relative to imported patient medical images via electromagnetic or wireless optical tracking technology. The software provides the functions to perform the indicated navigated cranial surgical procedures. The software guides the user through the necessary preoperative and intraoperative steps required to set-up and perform the navigated cranial surgical procedures. The Q Guidance System was initially cleared in premarket notification K220593. The only change to this device from its initial clearance is the addition of the electromagnetic tracking technology and the integration of the Zeiss Microscope using the Zeiss Microscope Tracker. The Cranial Guidance Software includes the following system components described below.

Here's a breakdown of the acceptance criteria and study information for the Stryker Q Guidance System with Cranial Guidance Software, EM Stylet, and Navigated Biopsy Needle, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document explicitly states the system's design goal for accuracy is a mean of 2mm positional and 2° angular displacement. The reported performance includes a 99% Confidence Interval (Upper) which exceeds the 2mm/2° stated design goal in some instances (e.g., Optical Nav Positional Displacement 2.65mm, Optical Nav Trajectory Angle Displacement 2.93°, EM Nav Positional Displacement 2.57mm, EM Nav Trajectory Angle Displacement 2.82°). However, the document concludes that "All requirements were met and no new issues of safety or effectiveness were raised," implying these results were considered acceptable within the overall context of the safety and performance evaluation.

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

• Accuracy Testing:
  • Pediatric patients: Non-clinical accuracy testing was performed using pediatric models made based on a neonate image set. The exact number of models is not specified.
  • Adult patients: Accuracy testing was performed via a Simulated Use study with cadavers. The exact number of cadavers is not specified.
• Intended Use/User Needs Validation: Conducted in "cadaver labs or simulated use tests." The exact number of participants or cases is not specified.
• Data Provenance: The document does not explicitly state the country of origin for the datasets used in testing (pediatric models, cadavers). The testing seems to be prospective (i.e., designed as part of the validation process) rather than retrospective clinical data.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth specifically for the accuracy testing of the device (i.e., for the positional and angular displacement measurements). The "Intended Use/User Needs" validation involved "intended users," but their specific number or qualifications (e.g., years of experience as surgeons) are not detailed.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth for the performance metrics. The accuracy measurements appear to be objective, engineering-style measurements against a known reference. For the "Intended Use/User Needs" validation, it simply states that all requirements were met, implying a qualitative assessment by the "intended users."

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. The 510(k) summary explicitly states: "No clinical testing was performed." Therefore, no MRMC comparative effectiveness study was conducted, and no effect size on human reader improvement with AI assistance is reported.

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

The primary performance data reported (positional and angular displacement accuracy) are standalone algorithm/device accuracy metrics, as they quantify the device's ability to precisely locate structures and guide instruments in a controlled testing environment (using pediatric models and cadavers), independent of a human surgeon's subjective interpretation or decision-making beyond the act of using the device. This testing is focused on the device's intrinsic measurement capabilities.

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

For the accuracy measurements (positional and angular displacement), the ground truth would be based on precisely measured, known physical locations or trajectories within the test setup (pediatric models or cadavers). This is an engineering- or physics-based ground truth, where the "true" position or angle is established by highly accurate measurement systems or a known fiducial reference.

8. The sample size for the training set

The document does not provide any information about a training set size. This 510(k) summary describes a navigation system and its accessories, not a machine learning or AI algorithm that typically requires a separate training set. While the "Cranial Guidance Software" is mentioned, the performance evaluation focuses on the accuracy of the navigation system components rather than a pattern recognition or diagnostic AI.

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

Since no information on a training set or its size is provided, the method for establishing its ground truth is also not described. As noted above, the device's evaluation is primarily based on the accuracy of its navigation capabilities, which rely on precise physical measurements rather than annotated data for training.

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Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

The ARTICUL/EZE Ceramic Heads are a zirconia toughened alumina composite ceramic femoral head designed to be used as one component of a system of prostheses in hip arthroplasty. The femoral heads are available in a wide range of outer diameter sizes and offsets.

This document does not contain an AI device or any information about acceptance criteria and performances related to AI devices. The document is a 510(k) premarket notification for a medical device called "ARTICUL/EZE Ceramic Heads," which are ceramic femoral heads for hip arthroplasty. The content mainly discusses the substantial equivalence of this device to previously marketed predicate devices based on non-clinical performance testing.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI device.

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The Ion™ Endoluminal System (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use.

The Flexision™ Biopsy Needle is used with the Ion™ Endoluminal System to biopsy tissue from a target area in the lung.

The PlanPoint™ Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion™ Endoluminal System.

The Ion™ Endoluminal System (Model IF1000) is a software-controlled, electromechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. It consists of a Planning Laptop with PlanPoint™ Software, a System Cart with System Software, a Controller, Instruments, and Accessories. The Model IF1000 Instruments include the Ion™ Fully Articulating Catheter, the Ion™ Peripheral Vision Probe, and the Flexision™ Biopsy Needles. Accessories such as the Catheter Guide, Vision Probe Adapter, Suction Adapter, Swivel Connector, and Vision Probe Bag facilitate use of the Model IF1000 Instruments.

The provided document is a 510(k) summary for the Ion™ Endoluminal System (specifically the Ion™ Fully Articulating Catheter and the Ion™ Peripheral Vision Probe). The submission primarily focuses on changes to the reprocessing methods for these devices, introducing an alternative automated cleaning process and reducing rinsing steps for the existing manual cleaning process. It does not describe a study involving an AI algorithm in the traditional sense of diagnostic or predictive performance.

Therefore, the requested information regarding acceptance criteria and study details for AI performance (such as sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set information) is largely not applicable to this document. The "device" in this context refers to the physical medical instruments, and the "performance" being evaluated is related to their reprocessability and safety after cleaning, not an AI's analytical capabilities.

However, I can extract the acceptance criteria and performance data related to the reprocessing validation and biocompatibility aspects, as these are the core performance assessments presented in this 510(k) summary.

Acceptance Criteria and Device Performance (Related to Reprocessing and Biocompatibility)

The device in question is the Ion™ Endoluminal System (Ion™ Fully Articulating Catheter and Ion™ Peripheral Vision Probe). The study described relates to validating new reprocessing methods (automated cleaning and reduced manual rinsing steps) for these devices.

Due to the nature of this 510(k) submission, which focuses on device reprocessing validation, many of the typical AI-related study components (like expert ground truth, MRMC, training sets) are not present.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Reprocessing Validation (Cleaning Efficacy): The document does not specify the exact "sample size" in terms of number of devices tested for cleaning efficacy. It states that "AER equipment were validated" and "Testing was performed on the Model IF1000 devices subjected to the automated cleaning process."
• Biocompatibility (TOC Testing): Similar to reprocessing, the exact number of devices tested for TOC is not specified, but it was performed "on the Model IF1000 devices."
• Usability Testing: The document does not specify the number of users or sessions in the human factors study.
• Data Provenance: The studies described are prospective validation studies conducted by the manufacturer for the specific purpose of this submission. The origin of "data" in terms of patient information is not relevant here as these are laboratory and human factors studies, not clinical trials on patient data.

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

This information is not applicable as the "test set" in this context refers to devices undergoing reprocessing and human factors testing, not an AI algorithm being evaluated against expert-annotated medical image data. The "ground truth" for cleaning validation is objective laboratory measurement against standards, and for usability, it's successful task completion by trained users.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 typically apply to resolving discrepancies in expert labeling for AI ground truth, which is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document does not describe the evaluation of an AI algorithm assisting human readers. It focuses on the reprocessing of physical instruments.

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

No, a standalone algorithm performance study was not done. This submission does not pertain to an AI algorithm.

7. The type of ground truth used

• Reprocessing Validation: The ground truth for cleaning efficacy was established through objective laboratory measurements of residual soil levels (e.g., proteins, hemoglobin) against pre-defined limits, as guided by AAMI standards (TIR12, TIR30).
• Biocompatibility: The ground truth for biocompatibility was established through objective laboratory measurements of Total Organic Carbon (TOC) residuals, evaluated against acceptable limits defined by ISO 10993-1.
• Usability Testing: The ground truth was based on participants successfully and safely completing the specified reprocessing tasks as described in the updated instructions.

8. The Sample Size for the Training Set

This information is not applicable. This document does not describe an AI system, and therefore there is no "training set" in the context of machine learning.

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

This information is not applicable as there is no AI training set discussed in this document.

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The Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.

The Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads are sterile. single patient use instruments that simultaneously cut and staple tissue through a battery powered firing system. The Power Stapler and Reloads are sterilized by irradiation. The instruments deliver six staggered rows of staples, three on either side of the cut line. The instruments are available in three shaft lengths: compact (192±20mm), regular (252±20mm) and long (352±20mm). The shaft can rotate freely in both directions and incorporates an articulation mechanism, which enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site.

This document is a 510(k) Pre-market Notification for a medical device, specifically a "Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads." This type of document is filed with the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than to prove its safety and effectiveness through a comprehensive clinical study per se.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/Software device performance is not applicable to this document. This document describes a physical surgical stapler and its reloads, not a software or AI medical device.

The "Performance Data" section (Section 9) describes non-clinical performance tests conducted to demonstrate substantial equivalence to a predicate device, not to establish performance criteria for an AI or software algorithm.

Here's why each of your requested points cannot be answered from this document:

1. A table of acceptance criteria and the reported device performance: The document lists non-clinical tests (e.g., Visual Appearance, Sterility, Hardness, Anastomosis and Cutting Performance) and states, "During verification testing, all data meets pre-defined criteria." It does not provide specific numerical acceptance criteria or reported performance values for these physical device attributes. It also doesn't relate to AI/software performance.
2. Sample sized used for the test set and the data provenance: Not applicable. The tests are for a physical device, not an algorithm's test set. There's no "data provenance" in the sense of clinical 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. Ground truth for an AI/software device is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. There is no training set mentioned as this is not an AI/software device.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission focuses on demonstrating the substantial equivalence of a physical surgical stapler to an existing one. It does not involve AI or software, and therefore, the questions about acceptance criteria and study design for such devices are not relevant to the information provided in this document.

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