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This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
  Porous components may be used cemented or uncemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and femoral and tibial augment components are indicated for cemented use only.

The Persona Revision Knee System is a semi-constrained total knee prosthesis consisting of anatomically shaped components designed to resurface the articulating surface of the femoral and tibial bones including:

• Femoral components
• Articular surfaces
• Tibial components
• Stem extensions
• Femoral and tibial augments
• Femoral and tibial cones.
  The large modularity of the componentry of the Persona Revision knee system including articular surfaces with different levels of constraint, augments, cones and stem extensions provides numerous possible configurations to optimally address the bone and joint condition of the patient in a primary or revision TKA surgery.
  The Persona Revision Knee System also includes nonimplantable tools, or instrumentation, that facilitate the implantation of above described implant components as well as cases and trays to hold these instruments during sterilization and their subsequent storage.

I'm sorry, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

The provided text is an FDA 510(k) clearance letter for a Persona Revision Knee System, which is a medical device (a knee prosthesis). This document primarily focuses on the regulatory clearance process, stating that the device is "substantially equivalent" to legally marketed predicate devices.

It does NOT contain information about:

• Specific acceptance criteria metrics (e.g., in terms of sensitivity, specificity, accuracy for an AI/algorithm-based device).
• Detailed performance study results for an AI/algorithm-based device.
• Sample sizes for test sets or training sets in the context of an AI/algorithm.
• Information about expert consensus, ground truth establishment methods, multi-reader multi-case studies, or standalone algorithm performance.

The document mentions "Non-Clinical Tests" and "Clinical Tests" but these refer to mechanical and sterility testing of the knee implant and associated instruments, not to the performance evaluation of an AI or algorithmic medical device. For example, "Stem housing cantilever fatigue" and "Cadaveric design validation" are relevant to a physical medical implant, not a software algorithm. The document explicitly states, "Clinical data was not deemed necessary for the subject device," further indicating that a a large-scale clinical performance study (as would be typical for an AI/ML device) was not conducted or required for this particular type of device clearance.

Therefore, your request, which is structured around the evaluation of an AI or algorithm-based medical device, cannot be answered using the provided text, as the text describes a hardware medical implant, not a software device.

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InterGard HemaBridge and InterGard Aortic Arch Collagen Coated Vascular Prostheses are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the thoracic and abdominal aorta, visceral arteries, and proximal peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.

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The provided text does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) clearance letter from the FDA for two vascular prostheses: InterGard HemaBridge Collagen Coated Vascular Prosthesis and InterGard Aortic Arch Collagen Coated Vascular Prosthesis. It confirms that the devices are substantially equivalent to legally marketed predicate devices for the specified indications for use.

While the letter mentions the devices are "substantially equivalent" for specific indications, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about a specific study proving the device meets acceptance criteria.
3. Sample sizes used for test sets or their data provenance.
4. Number or qualifications of experts used for ground truth establishment.
5. Adjudication methods.
6. Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
7. Details on standalone algorithm performance.
8. The type of ground truth used.
9. Sample size for the training set or how ground truth for the training set was established.

The letter is a regulatory approval document, not a clinical study report.

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