Search Results

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
   The ANTHEM PS Total Knee System is indicated for use only with cement and is a single use device.

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:

1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;

2. Correction of functional deformity;

3. Revision procedures where other treatments or devices have failed: and

4. Treatment of fractures that are unmanageable using other techniques
   Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement.

5. Rheumatoid arthritis.

6. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

7. Failed osteotomies, unicompartmental replacement, or total knee replacement.

8. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
   Smith & Nephew, Inc. Journey II BCS Knee components are indicated for use only with cement and are single use devices.

9. Rheumatoid arthritis.

10. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

11. Failed osteotomies, unicompartmental replacement, or total knee replacement.

12. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    The Journey II Total Knee system components are indicated for use only with cement and are single use devices.

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:

1. Noninflammatory degenerative joint disease including osteoarthritis, or avascular necrosis;
2. Correction of functional deformity;
3. Revision procedures where other treatments or devices have failed; and
4. Treatment of fractures that are unmanageable using other techniques
   Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement.

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:
· Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis:
· Correction of functional deformity;
· Revision procedures where other treatments or devices have failed; and
· Treatment of fractures that are unmanageable using other techniques.
Unicompartmental knee implants are single use only and are intended for implantation only with bone cement.

Total knee components are indicated for rheumatic arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.
The Journey II Total Knee system components are indicated for use only with cement and are single use devices.

1. Degenerative arthritis in the distal femur and patella;
2. A history of patellar dislocation or patellar fracture; and
3. Failed previous surgery (arthroplasty, tibial tubercule elevation, lateral release) where pain, deformity or dysfunction persists.
   The Smith & Nephew Patello-Femoral Implants are intended for implantation with bone cement.

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:

1. Noninflammatory degenerative joint disease including osteoarthritis, or avascular necrosis;

2. Correction of functional deformity;

3. Revision procedures where other treatments or devices have failed; and

4. Treatment of fractures that are unmanageable using other techniques
   Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement.

5. Rheumatoid arthritis.

6. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

7. Failed osteotomies, unicompartmental replacement, or total knee replacement.

8. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

9. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral collateral ligament) are incompetent.

10. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral ligament) are absent or incompetent.
    The Legion Hinge Knee System is for Cemented Use Only.

11. Rheumatoid arthritis.

12. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

13. Failed osteotomies, unicompartmental replacement, or total knee replacement.

14. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

15. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral collateral ligament) are incompetent.

16. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral ligament) are absent or incompetent.
    The LEGION Knee System - Finned Tibial Wedges are for single use only and are intended for implantation with bone cement.

These devices are indicated for patients with:

1. Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
2. Previous tibial condyle or plateu fractures with loss of anatomy or function.
3. Varus or Valgus deformities.
4. Revision of previous arthroplasty procedures.
   The devices are indicated for cemented use only.
   The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

The Engage™ Partial Knee System is intended for medial unicompartmental knee arthroplasty to treat one or more of the following conditions:

• Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
• Revision of previous unsuccessful surgical procedures, including prior unicompartmental knee arthroplasty
• As an alternative to tibial osteotomy in patients with Unicompartmental osteoarthritis.
  The femoral component and tibial tray are intented fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. When the tibial tray is implanted without the use of bone cement, the tibial anchor should be used. When the tibial tray is implanted with bone cement, the tibial anchor should not be used.

Total Knee components are indicated for:

1. Rheumatoid arthritis
2. Post- traumatic arthritis, osteoarthritis, or degenerative arthritis
3. Failed osteotomies, unicompartmental replacement, or total knee replacement
4. The posterior stabilized knee system is designed for use in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
   LEGION Porous CR Narrow Femoral Components are indicated for use without bone cement and are single use devices.
   The Porous Patella and the Porous Tibia Baseplate are indicated for use with or without bone cement, and are single use devices.

The purpose of this Traditional 510(k) is to add MR safety information to the labeling (instructions for use, product labeling and patient implant card) of the subject Smith & Nephew Knee Systems. The technological characteristics, function of the devices, packaging and sterilization remain unchanged. As these products have been in distribution for several years, some parts have undergone changes in the technological characteristics that were assessed in compliance with the FDA's guidanceon "Deciding When to Submit a 510(k) for a Change to an Existing Device" or the FDA predecessor guidance on how to review changes to an existing device. These are not cumulative changes for all Smith & Nephew Knee Systems, but are rather specific changes that only affect certain parts. In the context of this submission, no modifications have been made to the device design, materials, sterilization, or the manufacturing process of the previously cleared devices due to the addition of MR Labeling for this 510(k).

The provided text describes a 510(k) premarket notification for various Smith & Nephew knee systems. The purpose of this submission is not to introduce a new device or significantly change an existing one that would require a new performance study to demonstrate clinical effectiveness or safety based on patient outcomes. Instead, the core of this submission is to add MR safety information to the labeling of existing, already cleared devices.

Therefore, the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic or AI-driven devices (which you are asking about) are not applicable to this 510(k) submission.

The "performance data" section in the document, despite its heading, refers specifically to Magnetic Resonance Imaging (MRI) compatibility testing, not clinical performance of the knee implants themselves. This testing aims to demonstrate that the presence of the knee implants does not pose an undue risk or create excessive artifacts during MRI scans.

Here's why the questions you asked cannot be fully answered or are not relevant to this specific regulatory submission:

• No new device performance for clinical outcomes: This submission isn't about proving a device (like an AI algorithm) is effective at diagnosing or treating a condition. It's about ensuring an existing physical implant is safe in an MRI environment.
• No diagnostic or AI algorithm: The "device" in question here is a knee implant, not a software algorithm that generates clinical insights or diagnoses. Therefore, terms like "multi reader multi case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," "ground truth," or "training set" are not applicable.

However, I can extract the relevant information regarding the MR safety testing which serves as the "study" for this particular 510(k) submission:

Acceptance Criteria and Study for MR Safety Labeling (as described in the document):

Since this 510(k) is specifically for adding MR safety information to the labeling of already cleared devices, the "acceptance criteria" and "study" revolve around demonstrating the device's compatibility with MRI environments, not its clinical performance as a knee implant.

1. Table of Acceptance Criteria and Reported Device Performance (for MR Safety)

Summary of Device Performance: The document states that "MR Safety testing/assessments support the appropriate MR parameters and symbols found in the subject device labeling." This implies that the devices met the requirements of the referenced ASTM and IEC standards for MR compatibility, allowing defined MR conditions (e.g., specific field strengths, gradients, RF levels) for imaging patients with these implants.

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

• Sample Size: The document does not specify the sample size for the MR safety testing. These tests are typically conducted on representative samples of the implant devices themselves, not on human patients.
• Data Provenance: The testing references industry standards (ASTM, IEC, ISO/TS), indicating that the tests were performed in a controlled laboratory environment in accordance with these established protocols. The country of origin of the data is not specified but is presumed to be where Smith & Nephew conducted their R&D and testing. Since it's device testing, not patient data, the retrospective/prospective distinction is not applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable: For MR safety testing of physical implants, "ground truth" as established by human experts (like radiologists interpreting images) is not the primary method. The "ground truth" for MR safety is determined by the physical properties of the materials and the design of the device, measured against established engineering and safety standards. The experts involved would be engineers and physicists specializing in MRI safety and material science.

4. Adjudication Method for the Test Set:

• Not Applicable: Adjudication methods (like 2+1 or 3+1 for clinical interpretations) are not relevant here. The results of MR safety testing are quantitative measurements (e.g., temperature rise, displacement force, torque, artifact size) subject to direct measurement and comparison against defined thresholds in the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No: This is not applicable. MRMC studies are used to assess the impact of a diagnostic tool (like an AI algorithm) on human reader performance. This submission is about the physical safety of an implant in an MRI scanner.

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

• No: This is not applicable as there is no algorithm being tested in this submission.

7. The Type of Ground Truth Used:

• Technical Standards and Physical Measurements: The "ground truth" for MR safety is established by international and national technical standards (ASTM, IEC, ISO/TS) that define acceptable limits for magnetic force, torque, heating, and image artifact. The studies involve physical measurements of these parameters using specialized testing equipment.

8. The Sample Size for the Training Set:

• Not Applicable: There is no "training set" in the context of MR safety testing of physical implants, as this is not an AI/machine learning submission.

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

• Not Applicable: As there is no training set, this question is not relevant.

In summary, this 510(k) submission is a prime example of a regulatory clearance based on engineering and performance testing against recognized standards for physical device properties (MR compatibility), rather than clinical efficacy studies or AI performance metrics.

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The Overture Resurfacing Uni Knee Resurfacing System is intended to be used in the partial replacement of the articulating surfaces of the knee in instances where, due to compartmental degenerative disease, post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity, or previous arthroplasty, only the one side of the joint is affected. This device is intended to be used with bone cement.

The Uni Knee Resurfacing System is comprised of femoral implants, and a set of ancillary instruments. The femoral implants are titanium and feature a spherical polished articulating surface with a titanium nitride (TIN) coating. The tibial implants are comprised of a titanium tibial tray with an integrated ultra-high molecular weight polyethylene (UHMWPE) tibial insert. The femoral implants and tibial trays utilize cemented pegs and porous titanium bone-contacting surfaces to allow for fixation. The femoral implant articulates against the tibial insert in a non-constrained manner.

The implants are provided in a variety of configurations and sizes to accommodate various patient anatomy. Femoral implants are offered in oblong and round configurations. The oblong femoral implants are offered in lengths ranging 25-40mm and diameters ranging 17.5-27.5mm, and the round femoral implants are offered in diameters ranging 17.5-27.5mm. The tibial implants are offered in diameters ranging 17.5-22.5mm.

The implants are provided gamma sterilized and individually packaged. The ancillary instruments are provided non-sterile and are to be sterilized by the end user.

This document is a 510(k) summary for the Uni Knee Resurfacing System. It focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and performance testing, rather than an AI/ML-based device requiring extensive clinical study for performance metrics like accuracy, sensitivity, or specificity.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria in the context of AI/ML performance (e.g., sample size, data provenance, expert ground truth, MRMC studies) is not applicable to this submission.

The "Performance Testing" section (page 4) details bench testing conducted for the Uni Knee Resurfacing System, which typically involves mechanical and material evaluations, not clinical performance metrics for an AI algorithm.

To specifically address the prompts:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document describes engineering and material-based performance tests, not AI-related performance metrics. The conclusion states that these tests "indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate." Specific numerical acceptance criteria for each bench test are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document refers to bench testing of physical implants, not an AI algorithm's performance on clinical data.

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): Not applicable. Ground truth as typically defined for AI validation (e.g., expert consensus on medical images) is not relevant to this device's testing.

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 consensus, pathology, outcomes data, etc.): Not applicable in the context of AI. The "ground truth" for the performance testing would be established by objective measurements and scientific standards for material properties, mechanical strength, wear, etc., as per the listed ASTM and other relevant engineering standards.

8. The sample size for the training set: Not applicable. There is no AI algorithm being trained.

9. How the ground truth for the training set was established: Not applicable.

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The patient-specific BC Reflex Unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with:

· joint impairment due to osteoarthritis or traumatic arthritis of the knee,

· varus deformitv of the knee, and

· as an alternative to tibial osteotomy in patients with unicompartmental OA.

The patient-specific BC Reflex Uni™ components fit within an envelope of dimensions that are specific to each patient. The BC Reflex Uni™ femoral component and tibial baseplate are intended for cemented fixation.

The BC Reflex Uni™ Knee System is a patient-specific unicompartmental knee system that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patient-specific femoral and tibial implants and single-use instruments are manufactured from CAD and CAM files generated from Bodycad software, which are based on MRI or CT images of the patient's knee and input from the surgeon. The BC Reflex Uni™ is for cemented use only and is sterilized to a SAL of 10-6.

The primary reasons for this 510(k) notification are to notify the FDA: (1) that the tibial insert will be manufactured from vitamin E stabilized and 100 kGy crosslinked UHMWPE (Vit-E HXLPE), (2) that a 5 mm thick tibial insert was added as a thickness option, and (3) of minor design updates to the implants and single use instruments.

Materials: Wrought Cobalt-28Chromium-6Molybdenum Alloy (ASTM F1537-11) for the femoral component, wrought Titanium-6Aluminum-4Vanadium ELI Alloy (Ti6AI4V ELI; ASTM F136-13) for the tibial baseplate and locking pin, Ultra-High-Molecular-Weight Polyethylene (UHMWPE) or Vit-E HXLPE for the tibial insert.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The text describes a 510(k) premarket notification for a knee system, detailing its features, intended use, and comparison to predicate devices, along with performance data related to material properties and wear testing. However, it does not specify any acceptance criteria in numerical or qualitative terms, nor does it present a study designed to demonstrate performance against such criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study details.
6. Stand-alone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device

The patient-specific BC Reflex Unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with:
· joint impairment due to osteoarthritis or traumatic arthritis of the knee,
· varus deformity of the knee, and
· as an alternative to tibial osteotomy in patients with unicompartmental OA.
The patient-specific BC Reflex Uni™ components fit within an envelope of dimensions that are specific to each patient. The BC Reflex Uni™ femoral component and tibial baseplate are intended for cemented fixation.

The BC Reflex Uni™ Knee System is a patient-specific unicompartmental knee system that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patient-specific femoral and tibial implants and single-use instruments are manufactured from CAD and CAM files generated from Bodycad software that are based on MRI or CT images of the patient's knee and surgeon input.

This FDA 510(k) summary does not contain information about an AI-powered device or software. It pertains to a physical medical device, the BC Reflex Uni™ Knee System, which is a patient-specific unicompartmental knee system. The submission focuses on changes to sterilization methods and minor design updates, not on a diagnostic or prognostic algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies for an AI device. The document does not discuss:

• Acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, accuracy).
• Any study that proves an AI device meets such criteria.
• Sample sizes for test sets, data provenance, expert qualifications, or adjudication methods for AI ground truth.
• MRMC studies or standalone AI performance.
• Training set details for an AI model.

The "performance data" section (G) in the document refers to validation and verification activities for device sterilization, biocompatibility, packaging, and cleaning processes, which are standard for physical medical devices and unrelated to AI performance.

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The patient-specific BC Reflex Uni™ is indicated for unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with:

· joint impairment due to osteoarthritis or traumatic arthritis of the knee,

· varus deformitv of the knee, and

· as an alternative to tibial osteotomy in patients with unicompartmental OA.

The patient-specific BC Reflex Uni™ components fit within an envelope of dimensions that are specific to each patient. The BC Reflex Uni™ femoral component and tibial baseplate are intended for cemented fixation.

The BC Reflex Uni™ Knee System is a patient-specific unicompartmental knee system that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patient-specific femoral and tibial implants and single-use instruments are manufactured from CAD and CAM files generated from Bodycad software, which are based on MRI or CT images of the patient's knee and input from the surgeon. The BC Reflex Uni™ is for cemented use only and is sterilized by gamma radiation.

The subject device of this 510(k) is the same as the primary predicate device. The purpose of this Special 510(k) Device Modification is to notify the FDA of minor changes to the design and contents of the patient specific kits and reusable instruments for the BC Reflex Uni™ Knee System.

Materials: Wrought Cobalt-28Chromium-6Molybdenum Alloy (CoCrMo; ASTM F1537-11) for the femoral component, wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (Ti6Al4V ELI; ASTM F136-13) for the tibial baseplate and locking pin, Ultra-High-Molecular-Weight Polyethylene (UHMWPE; F648-14) for the tibial insert.

This document, a 510(k) Premarket Notification from Bodycad Laboratories, Inc., describes a medical device, the BC Reflex Uni™ Knee System, and its substantial equivalence to previously cleared devices. However, it does not contain the detailed information necessary to answer your specific questions about acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/algorithm-driven medical device requiring performance metrics like sensitivity, specificity, or human reader improvement.

The document primarily focuses on demonstrating substantial equivalence (a regulatory pathway for medical devices) for a traditional knee implant, not an AI-powered diagnostic or therapeutic tool. The "Performance Data" section mentions "Software V&V accounting for all changes" and "Verification testing of usability of updated devices," but these are general statements about engineering and design controls, not clinical performance studies with acceptance criteria for an AI system.

Here's why the provided text cannot fulfill your request, along with what would be needed if this were an AI device:

Missing Information & Why it's Absent from This Document:

1. A table of acceptance criteria and the reported device performance: This document is about a physical knee implant. Acceptance criteria for such devices typically revolve around mechanical properties (fatigue, wear, strength), biocompatibility, and sterilization, along with manufacturing process validation. It wouldn't include AI performance metrics like sensitivity, specificity, or AUC.
2. Sample sizes used for the test set and data provenance: Not relevant for this type of device submission.
3. Number of experts used to establish ground truth & qualifications: Not relevant. Ground truth for an implant is its physical and material properties meeting specifications, and clinical outcomes for safety and effectiveness.
4. Adjudication method for the test set: Not relevant.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: MRMC studies are for evaluating diagnostic image interpretation by humans, often with and without AI assistance. This device is an implant, not an imaging interpretation tool.
6. If a standalone (algorithm only) performance was done: Not relevant, as there is no standalone algorithm being validated here in the typical AI sense. The "Bodycad software" mentioned is for design and manufacturing, not for making diagnostic or treatment decisions.
7. The type of ground truth used: For this knee implant, ground truth would be based on engineering specifications, material standards (ASTM), and potentially clinical outcomes from previous versions or similar devices. It's not based on expert consensus on image interpretation or pathology in the way an AI diagnostic would be.
8. The sample size for the training set: Not applicable. The "Bodycad software" is a design tool, not a machine learning model that undergoes "training."
9. How the ground truth for the training set was established: Not applicable.

What little "performance data" is mentioned:

• "Software V&V accounting for all changes per Bodycad procedures, which are the same procedures presented to FDA previously for the predicate and reference devices."
• "Risk analysis and design control review confirming no new or changed risks relative to the indications for use and efficacy of product."
• "Verification testing of usability of updated devices."

These indicate standard regulatory steps for medical device changes, focusing on ensuring the software and design changes for the manufacturing and design of the physical implant do not introduce new safety or effectiveness concerns. They do not describe performance evaluation of an AI-driven decision-making system in a clinical trial context.

In summary, the provided document is a 510(k) clearance letter for a mechanical knee implant system and does not contain the information requested about AI device acceptance criteria and performance studies.

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The patient-specific BC Reflex Unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with:

· joint impairment due to osteoarthritis or traumatic arthritis of the knee,

· varus deformity of the knee, and

· as an alternative to tibial osteotomy in patients with unicompartmental OA.

The patient-specific BC Reflex Uni™ components fit within an envelope of dimensions that are specific to each patient. The BC Reflex Uni™ femoral component and tibial baseplate are intended for cemented fixation.

The BC Reflex Uni™ Knee System is a patient-specific prosthesis that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patientspecific femoral and tibial components and single-use cutting guides are manufactured from CAD and CAM files generated from Bodycad and off the shelf software, which are based on MRI or CT images of the patient's knee and input from the surgeon. The BC Reflex Uni™ is for cemented use only and is sterilized by gamma radiation.

The subject of this 510(k) is an updated / new design of the femoral component and instruments for implantation, relative to the femoral component described in K163700 and K181302 for the predicate BUKS.

Materials: Wrought Cobalt-28Chromium-6Molybdenum Alloy (CoCrMo; ASTM F1537-11) for the femoral component, wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (Ti6A4V ELI; ASTM F136-13) for the tibial baseplate and locking pin, Ultra-High-Molecular-Weight Polyethylene (UHMWPE; F648-14) for the tibial insert.

The provided text is a 510(k) summary for the BC Reflex Uni™ Knee System, a medical device for unicompartmental knee arthroplasty. It describes the device, its intended use, and the performance data that supports its substantial equivalence to predicate devices. However, the document does not contain information about an AI/ML-based device, nor does it detail acceptance criteria or a study with human-in-the-loop or standalone AI performance, ground truth establishment, or expert involvement in a way that aligns with the questions posed in the prompt.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert involvement, and ground truth establishment from the provided document. The document discusses the substantial equivalence of the knee system based on mechanical testing and cadaver surgeries, not on the performance of a diagnostic AI system.

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The Tahoe Unicompartmental Knee System (TUKS) is designed as a system and is not intended for substitution of components from other systems. The indications for use are as follows:

Primary medial or lateral compartmental intervention of (1) primary non-inflammatory degenerative disease, including osteoarthritis, traumatic arthritis, or osteonecrosis; (2) posttraumatic degenerative disease; (3) varus or valgus deformities; and (4) damage due to previous surgical intervention when the opposite compartment is preserved and when the anterior cruciate, posterior cruciate, medial collateral, and lateral collateral ligaments are present and functional.

All TUKS implants are single use only, and are intended for implantation only with bone cement.

The Tahoe Uni Knee System (TUKS) is a primary fixed-bearing, round-on-flat unicompartmental knee system offering flexibility to restore function in the affected medial or lateral tibial compartments. The femoral and tibial components are intended use only. The femoral component is made from cast CoCr alloy (ASTM F75), whereas the tibial baseplate is made from wrought CoCr alloy (ASTM F1537). The tibial insert is made from UHMWPE (ASTM F648) or Vitamin-E polyethylene (VitalitE, ASTM F2695). The tibial insert is designed to snap into the baseplate via an anterior-posterior locking mechanism.

I am sorry, but the provided text is a document from the FDA related to a 510(k) premarket notification for a medical device (Tahoe Uni Knee System). It does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML device.

The document discusses:

• The product name, classification, and indications for use.
• The device description and its components.
• Substantial equivalence to predicate devices.
• Non-clinical performance data, which includes bench testing, FEA simulations, and engineering justifications for the physical knee implant components, such as fatigue testing and contact characteristics. It mentions "Wear testing was deemed unnecessary due to meeting the minimum requirement for poly thickness in the load bearing region (6mm) per ISO 21536. Pyrogenicity testing was completed and was deemed to be within 20 Endotoxin Units per surgical construct per the FDA Guidance Document Pyrogen and Endotoxins Testing."

This information pertains to the physical characteristics and safety of the knee implant itself, not to the performance or validation of an AI/ML device. Therefore, I cannot extract the requested details regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for an AI/ML device from this text.

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BrainLAB uni-knee is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on an individual 3D model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray, or MR-based model of the anatomy.

The system aids the surgeon in accurately navigating a knee endoprosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by BrainLAB uni-knee.

Example orthopedic surgical procedures include but are not limited to:

• · Unicondylar Knee Replacement
• · Ligament Balancing
• · Range of Motion Analysis
• · Patella Tracking

BrainLAB uni-knee is intended to enable 3 dimensional implant planning and navigation for unicompartimental orthopedic knee surgery. The SW links a surgical instrument tracked by passive markers to a 3D-model of the patient's bone, which is generated by acquiring multiple landmarks on the bone surface. Uni-knee 2.0 uses the registered landmarks to navigate the femoral and tibial cutting quides to the preplanned position.

Uni-knee 2.0 allows 3-dimensional reconstruction of the mechanical axes and alignment of the implants. The uni-knee 2.0 software has been designed to read in implant data and tool data from different manufacturers and offers to individually choose the prosthesis during each surgery. The uni-knee 2.0 software registers the patient data needed for planning and navigating intra-operatively. No preoperative CT-scanning is necessary.

The provided text does not contain detailed information about specific acceptance criteria or an explicit study proving the device meets those criteria. The document is a 510(k) summary for the BrainLAB uni-knee, which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed report of a performance study with acceptance criteria.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details of expert involvement for a test set.
• Adjudication methods.
• Details of a multireader multicase (MRMC) comparative effectiveness study or its effect size.
• Confirmation of a standalone performance study.
• Type of ground truth used for a test set.
• Sample size for the training set or how ground truth was established for it.

The document states:

• "VectorVision® uni-knee has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system."

This indicates that some form of validation was performed, but the specifics of that validation, including acceptance criteria, study design, and results, are not detailed in this 510(k) summary. The summary focuses on showing equivalence to predicate devices (K041899, K021306, K052966) as the basis for regulatory clearance.

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The ACCIN UNI-Knee System components are for use in Unicompartmental knee arthroplasty as a result of: Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis; Correction of functional deformities: Revision of previous unsuccessful unicompartmental knee replacement or other procedure; As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis. These components are single use only and are intended for implantation with bone cement.

The ACCIN UNI-Knee System consists of Cobalt Chrome femoral component and tibial tray and a polyethylene tibial insert.

This document describes a Special 510(k) submission for a line extension to the ACCIN UNI-Knee System. The modification is the addition of new tibial bearing components with thicknesses of 11mm, 13mm, and 14mm, expanding the thickness range from 8mm-10mm to 8mm-14mm. No other changes were made.

The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Accin UNI-Knee System - K060670 and Zimmer Unicompartmental Knee System - K033363) rather than proving general safety and effectiveness through extensive clinical trials. Therefore, the information provided does not align with a typical AI/software device evaluation.

Here's an analysis based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: For a device modification of this nature (a line extension adding different sizes), the "acceptance criteria" are implied to be that the new components perform equivalently to the existing ones and the predicate device in terms of mechanical properties, biocompatibility, and manufacturing quality, and that the new sizes do not introduce new safety or effectiveness concerns. The "study" proving this is often through bench testing, material characterization, and comparison to design specifications and predicate devices, demonstrating that the change in thickness does not alter the fundamental safety and effectiveness. The FDA's substantial equivalence determination confirms that these criteria were met to their satisfaction for market clearance.

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

• Sample Size: Not explicitly stated as a "test set" in the context of clinical data. For mechanical testing or design verification in medical devices, the sample size would refer to the number of components tested to ensure their performance meets specifications. This information is not detailed in the provided summary.
• Data Provenance: Not applicable in the context of clinical "data provenance" as this is not a study relying on patient data. The provenance for the device modification would be the manufacturing process and design documentation for the new components.

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

• Experts and Qualifications: Not applicable. This submission is for a device modification (size extension) rather than a diagnostic or AI device requiring expert consensus for ground truth on patient data. The "ground truth" here is based on engineering specifications, material science, and manufacturing standards for the knee implant components. The FDA reviewers and the manufacturer's internal team would be the "experts" assessing this.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no "test set" in the context of diagnostic performance or clinical outcomes that would require adjudication by multiple experts. The approval process is regulatory in nature.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No. This is not an AI or diagnostic imaging device; it is a physical implant. Therefore, an MRMC study is not relevant or performed for this type of device modification.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Ground Truth: For this device modification, the "ground truth" would be established by:
  • Engineering Specifications: Mechanical properties (e.g., strength, wear resistance, fatigue life) designed for the new components.
  • Material Standards: Conformance to established standards for cobalt chrome and polyethylene used in implantable devices.
  • Bench Testing: Results from laboratory tests demonstrating the physical performance of the new components meet established safety and effectiveness benchmarks, often comparing them directly to the predicate devices.
  • Design Rationale: Justification that the increased thickness does not negatively impact performance or safety, based on biomechanical principles.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. There is no AI algorithm being "trained" in this context.

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

• Ground Truth for Training Set Establishment: Not applicable. There is no training set for an AI algorithm.

In summary: The provided document is a regulatory submission for a medical device line extension, not an AI or diagnostic performance study. The "acceptance criteria" and "study" refer to the demonstration of substantial equivalence to predicate devices through engineering, material, and manufacturing standards, as reviewed and approved by the FDA. The questions posed are primarily relevant to AI/diagnostic device evaluations and are mostly not applicable to this type of medical implant modification.

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The UNI KNEE SURGETICS Navigation System is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for : - UniKnee Arthroplasty .

As the equivalent Surgetics ORTHO KNEELOGICS Navigation System and TOTAL KNEE SURGETICS Navigation System, the UNI KNEE SURGETICS navigation System consists of the following major components and subsystems: - The Surgetics Station or the NanoStation, consisting of a mobile computer . system and an optical localizer - Ancillary instruments and reflective markers used for reference and . registration - UNI KNEE SURGETICS software . The main modifications to the predicate devices concern the internal architecture of the software, allowing more easily to integrate new implants and to better adapt the workflow to different surgical techniques. New instruments adapted to new implants are also incorporated.

The provided document, a 510(k) summary for the UNI KNEE SURGETICS Navigation System, describes performance testing. However, it does not detail specific quantitative acceptance criteria or a study designed to prove the device met such criteria in the manner requested.

Instead, the document states that the system was tested to assess that no new safety and efficiency issues were raised compared to its predicate devices. The conclusion is based on an assessment that the "accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate devices." This is a qualitative statement of equivalence rather than a report of specific metrics meeting predefined thresholds.

Therefore, many of the requested details, such as a table of acceptance criteria and reported performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC study results, and detailed ground truth establishment for training sets, are not present in the provided text.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified. The study was a "non clinical setting (bench testing, specimen)". This implies the use of anatomical specimens or phantoms, rather than human patient data, and was conducted by the manufacturer (Praxim).

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

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

4. Adjudication method for the test set:

• Adjudication Method: Not specified.

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 a surgical navigation system, not an AI-assisted diagnostic tool. No human "readers" are involved in the performance testing described.

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

• Standalone Performance: The described "non clinical setting (bench testing, specimen)" appears to be a standalone performance assessment of the system's accuracy and performance. However, specific metrics are not provided. The system is designed to aid the surgeon, implying a human-in-the-loop during actual clinical use, but the testing described focuses on the system's inherent capabilities.

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

• Type of Ground Truth: Not specified beyond "bench testing, specimen." For a navigation system, ground truth would typically refer to highly accurate measurements of actual anatomical positions or implant alignments, often established using precise measurement tools (e.g., CMM, optical trackers or highly accurate physical models) during bench testing.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable/not specified. The document describes a "navigation system" and software modifications, but not a machine learning model that would typically require a training set in the conventional sense. The "training" here refers to software development and validation, not model training.

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

• Ground Truth for Training Set: Not applicable/not specified.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through qualitative assessment of "accuracy and performance," rather than presenting a detailed, quantitative study against explicit acceptance criteria as would be expected for a novel device or an AI/ML product.

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