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The indications for Biomet's Non-Cemented Porous Coated Knee Components include:

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 of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure

All devices are metallic knee femoral and tibial base-plate components. The components are identical to those cleared in previous 510(k) submissions for cemented application.

The porous coated components that are subject of this 510(k) are intended for use with components (tibial bearings, all polyethylene patellar components, non-porous coated femoral and tibial base-plates) previously covered by 510(k) submission for cemented use.

This 510(k) summary for the Biomet's Non-Cemented Porous Coated Knee Components explicitly states "Clinical and Non-Clinical Testing: None provided." Therefore, there is no study described in this document that proves the device meets acceptance criteria.

The submission is based on substantial equivalence to predicate devices that were previously cleared for cemented application. The current submission seeks clearance for non-cemented application of the same metallic knee femoral and tibial base-plate components.

As no testing was provided, the following information cannot be extracted from the document:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are provided as no testing was submitted.
2. Sample sizes used for the test set and the data provenance: Not applicable, as no test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, no studies were done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable, as no testing and thus no ground truth establishment for a test set occurred.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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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.

The device is a single use implant intended for implantation with bone cement.

The Maxim Accel Knee System is intended to replace the articular portions of the knee joint. The system consists of three femoral components with augmentation pieces and three modular tibial bearings.

The provided text describes a 510(k) premarket notification for the "Maxim Accel Knee System." This document is a summary of safety and effectiveness, and it focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study for a novel device or AI algorithm.

Therefore, the requested information elements related to acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in this context.

Here's a breakdown of why these elements are not present and what the document does provide:

• Acceptance Criteria and Reported Device Performance: This device is a traditional medical implant (knee replacement system). Its "performance" is primarily assessed through mechanical testing and comparison to predicate devices, not through performance metrics like accuracy, sensitivity, or specificity found in AI/diagnostic device studies. The document only states "All mechanical testing was done in accordance to 1994- Draft guidance for the preparation of Premarket Notifications (510(j)s) for cemented, semi-constrained total knee prostheses." This indicates compliance with established mechanical testing standards for knee prostheses, but no specific acceptance criteria or reported values are listed in this summary.
• Clinical Testing / Studies: The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This means no human clinical studies were conducted or submitted for this 510(k) application to prove the device meets specific clinical performance criteria. The device's approval is based on its similarity to previously cleared devices.
• Sample Sizes, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set: All of these elements are typically associated with studies involving human data, particularly for diagnostic devices, AI algorithms, or comparative effectiveness studies, none of which were performed for this 510(k) submission.

In summary, the provided document is a regulatory submission for a physical medical implant (knee system) based on substantial equivalence, not a study evaluating an AI algorithm or diagnostic device with defined acceptance criteria and clinical performance metrics.

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