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The A200 Knee System is intended for use in total knee arthroplasty for the following indications:

1. Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
   This device is for cemented use only.

The Renovis A200 PS Knee System is a patellofemorotibial polymer/metal/polymer semiconstrained prosthesis intended to be implanted to replace a knee joint. The system consists of femoral, tibial and patella components intended for use with bone cement.

The subject of this 510k Premarket Notification are additional offerings to the Renovis A200 Knee System (K120038) resulting from customer requests to better meet patient need (anatomy and surgical technique). The additional offerings are part of the FDA cleared A200 Knee System and are called the A200 PS Knee System. The PS Knee System is a primary, posterior stabilized (PS), tri-compartmental knee replacement system to treat knee disorders resulting from degenerative diseases where the posterior cruciate ligament is absent.

The new A200 PS Knee System includes:

• Femoral components in nine (9) sizes (1, 2, 3, 3N, 4, 4N, 5, 6, and 7) in a posterior stabilized (PS) design, each for left and right sides, manufactured from CoCrMo in compliance with ASTM F75-18 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants
• Tibial insert components in three (3) footprint sizes; each for the left and right sides; with articulating thicknesses ranging from 10 mm to 23 mm; in two levels of constraint - PS and PS Plus. The tibial inserts have a mechanical lock to the tray (snap mechanism). Tibial inserts are manufactured from highly cross-linked UHMWPE (with and without 0.1% by wt Vit E), and 1020 UHMWPE in compliance with ASTM F648-14 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants and ASTM F2695 -12 Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
• Patellar components in five (5) sizes in sombrero and five (5) sizes in domed design. Patellar components are manufactured from highly cross-linked UHMWPE (with and without 0.1% by wt Vit E), and 1020 UHMWPE in compliance with ASTM F648-14 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants and ASTM F2695 -12 Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
• FDA cleared (K120038) Tibial tray (baseplate) components in (9) sizes, each for the left and right sides, and in each in two designs, a conical design (CoCrMo) and a keeled design (Ti6A14V)

The system also includes reusable instrumentation.

The provided text is a 510(k) Premarket Notification for the Renovis A200 PS Knee System. This document focuses on demonstrating substantial equivalence to a predicate device and provides details on the device description, indications for use, and performance testing. However, it does not include information about user studies or clinical trials with human participants, which would be necessary to derive acceptance criteria and performance data for AI-assisted human reading or standalone AI performance.

Therefore, I cannot fulfill the request as the information regarding acceptance criteria, reported device performance (in the context of AI), sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for an AI device is not present in the provided document.

The document discusses bench testing of the physical knee implant components, such as fatigue strength and locking mechanisms, to ensure the device performs as expected. This type of testing is relevant to the mechanical integrity and functionality of the surgical implant itself, not to the performance of an AI diagnostic/assistive tool.

In summary, the provided content is for a knee implant device and does not contain the information requested about the acceptance criteria and study proving an AI device's performance.

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The A200 Knee System is intended for use in total knee arthroplasty for the following indications:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
   This device is intended for cemented use only.

The A200 Knee System consists of the following components: Femoral Components - nine (9) sizes in a cruciate-retained (CR) design, each for left and right sides, manufactured from Co-Cr-Mo allov: Tibial Tray Components - nine (9) sizes, each for the left and right sides, and each in two stem designs, a conical design manufactured from Co-Cr-Mo alloy, and a keeled design manufactured from Ti 6Al 4V alloy: Tibial Insert Components - three (3) footprint sizes, each for the left and right sides, with articulating thicknesses ranging from 10 mm to 20 mm, all in CR designs, in standard and deep dish configurations, manufactured from highly crosslinked ultra-high molecular weight polyethylene with and without vitamin E: Patellar Components five (5) sizes, in dome design, manufactured from highly crosslinked ultra-high molecular weight polvethylene with and without vitamin E: and A200 Knee Instrumentation including instruments for use with the system components, trial implant components, and general instruments.
The A200 Knee System implants are manufactured from Co-Cr-Mo alloy conforming to ASTM F75, Ti-6A1-4V alloy conforming to ASTM F136, and ultra-high molecular weight polyethylene conforming to ASTM F648 and ASTM F2695. All UHMWPE is crosslinked by gamma irradiation. The metallic implant components (femoral components and tibial tray components) are sterilized by Co6 gamma irradiation, and all UHMWPE components are sterilized by ethylene oxide.

The provided 510(k) summary for the Renovis Surgical Technologies, LLC A200 Knee System (K120038) does not contain the acceptance criteria or a study proving the device meets those criteria in the format requested.

This document is a premarket notification for a medical device (a knee prosthesis system) and focuses on demonstrating substantial equivalence to legally marketed predicate devices. This type of submission generally does not involve a clinical study with a test set, ground truth, or expert adjudication in the way typically seen for AI/software-as-a-medical-device (SaMD) clearances.

Instead, the "proof" is based on non-clinical testing data and a comparison of technological characteristics to existing devices.

Here's a breakdown of why the requested information cannot be fully provided from this document:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds in the document. The general acceptance criterion for a 510(k) is "substantial equivalence" to predicate devices, meaning it is as safe and effective.

• Reported Device Performance: The document lists several types of non-clinical tests performed, such as:

  • Component testing (tibial tray fatigue, contact area, contact stress, constraint, and tibial insert-tray interlock strength)
  • UHMWPE material characterization (density, swell ratio, oxidation index, trans-vinylene index, melting point, crystallinity, vitamin E content, free-radical content, assessment of consolidation, and analysis of extraction residues)
  • UHMWPE mechanical testing (Izod impact resistance, tensile properties, compressive properties, small punch testing, fatigue crack propagation, and environmental stress cracking)
  • Force-control wear testing according to ISO 14243-1 and ISO 14243-2.

  The performance is described qualitatively as "demonstrated the A200 Knee System to be substantially equivalent" or "was substantially equivalent to the predicate devices." No specific numerical results or thresholds are given.

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

• This information is not applicable in the context of this 510(k) submission. There is no "test set" of patient data in the sense of a clinical trial used to evaluate an AI algorithm. The device is a physical implant. The "testing" refers to laboratory-based, non-clinical mechanical and material characterization.

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. There is no "ground truth" established by experts in this context. The "proof" is based on engineering and material science standards and comparisons to accepted devices.

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

• Not applicable. There is no adjudication in this type of submission.

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 device is a physical knee implant, not an AI software. Therefore, an MRMC study related to human readers and AI assistance is entirely irrelevant to this submission.

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

• Not applicable. This is not an algorithm or software.

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

• Not applicable in the typical sense. The "ground truth" for a knee implant's safety and effectiveness in a 510(k) context is established by adherence to recognized standards (e.g., ASTM, ISO), mechanical properties, material biocompatibility, and demonstrated performance (e.g., wear rate, fatigue strength) compared to devices already on the market that have a known safe and effective history.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable.

Summary of what the document does provide regarding "proof" of meeting requirements:

The "study that proves the device meets the acceptance criteria" in this context is the compilation of non-clinical testing data that demonstrates the A200 Knee System is substantially equivalent to legally marketed predicate devices.

• Acceptance Criteria (Implicit): The device must be as safe and effective as the predicate devices, and any differences in technological characteristics must not raise new issues of safety or efficacy.
• Study Design/Methodology: Non-clinical (benchtop) testing, material characterization, and comparison to predicate devices.
• Key Findings: The document states that:
  • Constraint, contact area, and contact stress testing demonstrated substantial equivalence to predicate devices K923277, K892800, K932837, and K935080.
  • Wear rate testing of the UHMWPE with vitamin E was substantially equivalent to predicate devices K103223 and K100048.
  • Overall, the device "has the same intended use," "uses the same operating principles," "incorporates the same basic designs," "incorporates the same or very similar materials," and "has similar packaging and is sterilized using the same materials and processes" as the predicate devices.

In essence, for a physical implant like the A200 Knee System, "meeting acceptance criteria" in a 510(k) means successfully proving substantial equivalence through a battery of engineering tests and a detailed comparison to existing, cleared devices.

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