Search Results

The Continuum Knee System® Cobalt Chromium Alloy Tibial Component is intended for use where severe degeneration, trauma, or pathology of the knee joint indicates cemented total knee arthroplasty.

The Continuum Knee System® Cobalt Chromium Alloy Tibial Component

The provided text is a 510(k) summary for the Implex Continuum Knee System® Cobalt Chromium Alloy Tibial Component. This document does not describe a study involving algorithms, AI, or performance criteria in the context of diagnostic accuracy or reader improvement. Instead, it focuses on demonstrating substantial equivalence of a medical device (a knee implant component) to predicate devices already on the market.

Therefore, most of the requested information regarding acceptance criteria, study details, ground truth, and AI-related metrics is not applicable to this document. The existing information pertains to the physical and material characteristics of a medical implant and its regulatory approval process, not an AI or algorithm-based diagnostic tool.

Here's a breakdown of what can be extracted and what cannot:

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

• Not Applicable. This document is about a physical medical device (knee implant component), not an algorithm or diagnostic tool. The "acceptance criteria" here would be related to material properties, design specifications, and manufacturing processes, which are not detailed in this summary for reporting. The main "performance" reported is its substantial equivalence to existing devices.

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

• Not Applicable. No "test set" in the context of an algorithm's performance is mentioned. The "study" here is a regulatory comparison against predicate devices.

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. No experts were used to establish ground truth for a test set in the context of an algorithm. The "experts" involved would be FDA reviewers assessing the submission and mechanical/material engineers within the company designing and testing the device.

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

• Not Applicable. No adjudication method for a test set is mentioned.

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. No MRMC study or AI assistance is mentioned.

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

• Not Applicable. This is not an algorithm.

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

• Not Applicable. For a medical implant, "ground truth" would relate to its biocompatibility, mechanical integrity, and clinical safety/efficacy, which are established through general regulatory standards and predicate device comparisons, not in the way "ground truth" is used for AI validation.

8. The sample size for the training set

• Not Applicable. No training set is mentioned as this is not an algorithm.

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

• Not Applicable. No training set is mentioned.

The key information from the document related to "acceptance criteria" and "study" is encapsulated in the Conclusion section:

"The Implex Continuum Knee System® Cobalt Chromium Alloy Tibial Component is substantially equivalent to the identified predicate devices."

This statement, along with the detailed comparison of "Technological Characteristics and Comparison to Predicate Device" and "Materials Comparison," serves as the basis for its regulatory acceptance. The study proving this involves a comparison of the new device's design, materials (Cobalt-Chromium Alloy), and indications for use against already legally marketed predicate devices (titanium alloy and cobalt-chromium alloy fixed keel tibial components). The acceptance criteria are that these characteristics must be sufficiently similar to the predicate devices such that the new device is as safe and effective.

Ask a specific question about this device