FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis . presenting with the following findings:
Pain and weakness of the wrist joint not improved by non-operative treatment .
Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of . the distal radioulnar joint
Failed ulnar head resection; eg. Darrach resection .
Primary replacement after fracture of the ulnar head or neck. .
Revision following failed ulnar head arthroplasty. .

Device Description

The ulnar head implant like the predicate device includes various sizes of implants and surgical instruments. The implant allows for replacement of the distal ulnar head.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Wrist joint ulnar (hemi-wrist) prosthesis), which primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria.

Here's a breakdown of why the requested information cannot be fully provided based solely on the input, and what can be inferred or stated about the nature of this submission:

This 510(k) submission is for an expanded product line (additional stem lengths and diameters) of an already existing, legally marketed predicate device (the Aptis Medical Distal Radio-Ulnar Joint Implant). The focus of such a submission is usually to demonstrate that the new sizes do not introduce new questions of safety or effectiveness compared to the predicate. This often relies on comparative analysis, materials testing, and mechanical testing, rather than clinical efficacy studies with ground truth.

Given this context, here's an attempt to address your points, explaining where information is absent:

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

This information is not present in the provided 510(k) summary. A 510(k) for a device like this, especially for additional sizes of an existing product, typically relies on comparison to a predicate device and engineering/bench testing rather than clinical performance criteria (like sensitivity/specificity or other metrics for diagnostic/AI devices). If any specific performance criteria were used (e.g., maximum stress, fatigue life), they are not disclosed in this summary document.

2. Sample size 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 a 510(k) for an orthopedic implant and is not present in the document. There is no mention of a "test set" in the sense of patient data for evaluating performance against ground truth. The "test" in this context would likely refer to mechanical or materials testing, for which sample sizes are not provided in this summary.

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)

This is not applicable and not present. Ground truth, expert consensus, or clinical adjudication by experts are typically relevant for diagnostic devices or AI algorithms that interpret medical data. This document describes a surgical implant.

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

This is not applicable and not present for the same reasons as point 3.

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

This is not applicable. An MRMC study is relevant for diagnostic devices, particularly those involving human interpretation of images or data, often in conjunction with AI. This document pertains to a medical implant.

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

This is not applicable. This device is a physical implant, not an algorithm.

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

This is not applicable for this type of device and submission. The "ground truth" for an orthopedic implant is generally its mechanical integrity, biocompatibility, and clinical outcomes over time, which are usually assessed through a combination of engineering tests, pre-clinical studies, and post-market surveillance for established devices. No specific "ground truth" data is detailed in this summary.

8. The sample size for the training set

This is not applicable and not present. There is no "training set" as this is not an AI/ML device.

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

This is not applicable and not present for the same reasons as point 8.

Summary of the Study (as described in the 510(k) summary):

The "study" or justification for substantial equivalence in this 510(k) involves a comparative analysis of the proposed device (Aptis Medical Distal Radio-Ulnar Joint Implant with additional stem lengths and diameters) to its legally marketed predicate device (the original Aptis Medical Distal Radio-Ulnar Joint Implant).

The document states:

"The legally marketed predicate device to which this device is substantially equivalent is the same device, the Aptis Medical Distal Radio-Ulnar Joint Implant"
"Comparison of original Aptis Medical Distal Radioulnar Joint to the new configuration the additional stem lengths and diameters."
The comparison table highlights similarities in product name, use, fixation, constraint, material, and crucially, identical indications for use.
The summary explicitly notes: "Both devices are made of the same industry standard materials. No new materials are introduced in either product; Both devices are comparably sized; Both devices have the identical indications for use."
"The device and the predicate device have the same design characteristics and intended use. The new device is substantially equivalent to the predicate device."

Conclusion:

This 510(k) summary provides a justification for substantial equivalence based on the similarity in design, materials, and intended use between the new device (additional sizes) and its existing predicate. It primarily relies on demonstrating that the changes are minor and do not alter the safety or effectiveness profile as established by the predicate device. It does not describe a clinical performance study with acceptance criteria, ground truth, or expert evaluation typically associated with diagnostic or AI-driven devices.

Summary

Regulation Number and Section

§ 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.

(a)
Identification. A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.(b)
Classification. Class II.