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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.

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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 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.

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 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.

Ask a specific question about this device