Search Results

noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of . the natural femoral head;
rheumatoid arthritis; .
correction of functional deformity; .
femoral fracture; .
This device may also be indicated in the salvage of previously failed surgical attempts.

Device Description

The modification consists of a change to the Instructions for Use to minimize the necessity for multiple IFU's and to update the contents to reflect current practice.

AI/ML Overview

This document, K070221, is a 510(k) premarket notification for three hip joint devices: FMP™ Metal/Metal Acetabular Insert, Metal/Metal Hip System, and CLP® Offset Total Hip System. The core of this submission is a change to the Instructions for Use (IFU) to simplify the number of IFUs and update content to current practice.

Crucially, this submission is NOT for a new device requiring performance studies or acceptance criteria related to efficacy or safety in the way an AI/ML device would. It's a regulatory change based on the existing predicate devices. Therefore, the questions regarding acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable to this type of submission.

The FDA's review as detailed in the letter (pages 3-4) is based on substantial equivalence to legally marketed predicate devices, meaning the FDA has determined that the modified device is as safe and effective as a previously cleared device. There is no new clinical data or performance study required for this type of IFU change.

However, to directly address the prompt's requirements, I will explain why each point is not applicable based on the provided document:

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

Not Applicable. This submission is for a change to the Instructions for Use (IFU) of an already marketed device, not for a new device requiring specific performance acceptance criteria for clinical efficacy or safety beyond what was established for its predicate devices. The "performance" mentioned in the document refers to the general functional performance of the hip joint prostheses, which has already been established and is not being re-evaluated through new clinical trials as part of this submission. The change is purely regulatory and administrative.

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

Not Applicable. No new test set data was used or required for this IFU modification. The safety and effectiveness are established through substantial equivalence to predicate devices, which implies that their original clinical data (if any was required for those predicates) supports the device.

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 new ground truth establishment was needed. The submission is a regulatory update to existing device documentation, not a clinical study involving diagnosis or interpretation.

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

Not Applicable. No test set was used, therefore no adjudication method was employed.

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 is a hip implant device, not an AI/ML diagnostic or assistive device. MRMC studies are irrelevant to this submission.

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

Not Applicable. This is a hip implant device, not an algorithm.

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

Not Applicable. No new ground truth was established for this submission. The basis for marketing approval is substantial equivalence to legally marketed predicate devices, meaning the safety and effectiveness are considered comparable based on previously accepted data and scientific principles for those predicates.

8. The sample size for the training set