(335 days)
Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:
- 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.
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.
This 510(k) summary describes a medical device, the Aptis Medical Distal Radio-Ulnar Joint Implant, seeking substantial equivalence to a predicate device. As such, the documentation provided does not include acceptance criteria for standalone device performance, nor details of a study demonstrating such performance in the way a clinical trial for a novel AI device would.
Instead, the "acceptance criteria" here are based on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. The study proving this involves a comparison of design characteristics and intended use.
Here's an breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence to Predicate) | Reported Device "Performance" (Comparison to Predicate) |
|---|---|
| Primary Goal: Substantial Equivalence to WMT Modular Ulnar Head Implant in terms of safety and effectiveness. This is assessed by comparing: | |
| Intended Use: Device must have the same indications for use as the predicate. | Identical Indications for Use: Both the Aptis Medical Distal Radio-Ulnar Joint Implant and the WMT Modular Ulnar Head Implant are intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty for rheumatoid, degenerative, or post-traumatic arthritis (pain/weakness, instability, failed ulnar head resection), primary replacement after ulnar head/neck fracture, and revision following failed ulnar head arthroplasty. |
| Technological Characteristics (similar design, materials, etc.): | Similar Design Characteristics: Both are single-use devices, intended for surgical implantation longer than 30 days, placed into the intramedullary canal of the distal ulna, and made of industry-standard materials (Co-Cr, UHMWPe, CPTi for Aptis; Co-Cr, Titanium Alloy, Plasma Spray for WMT). The Aptis device also has screw fixation to the distal radius, which is a difference, but not deemed to preclude substantial equivalence in this context. |
| Comparable Size: Both devices offer various sizes (Aptis: 2 sizes; WMT: 8 heads, 6 stems). | |
| Fixation: Aptis has a stem in the intramedullary canal and screw fixation to the distal radius; WMT has a stem in the intramedullary canal. | |
| Constraint: Aptis is Semi constrained; WMT is non-constrained. These differences are implicitly deemed acceptable for substantial equivalence based on the positive FDA determination. | |
| Performance Data (e.g., mechanical testing, biocompatibility): | While not explicitly detailed as "acceptance criteria" in this summary, the basis for substantial equivalence typically includes supporting studies like mechanical testing (fatigue, wear, tensile strength) to demonstrate that the new device performs comparably to the predicate device and meets established standards for implantable devices. The summary states "The device and the predicate device have similar design characteristics and intended use," implying such underlying testing supported this conclusion. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a 510(k) submission for a medical implant, not an AI/software device. Therefore, the concept of a "test set" in the context of machine learning (i.e., a dataset used to evaluate an algorithm's performance) is not applicable here. The "test" is a comparison of the device's characteristics and intended use against a legally marketed predicate device.
- Test Set Sample Size: Not applicable in the context of an AI device's performance evaluation. The "sample" here refers to the characteristics of the device itself and its comparison to the predicate.
- Data Provenance: Not applicable for an AI device. The "data" are the specifications and indications for use of the proposed and predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. "Ground truth" in an AI/imaging context refers to definitive labels or diagnoses. For a device like this, the "ground truth" is established by regulatory standards, engineering specifications, and clinical consensus on indications for use.
- Qualifications of Experts: The review was conducted by the FDA, specifically the Division of General, Restorative and Neurological Devices at the Office of Device Evaluation, Center for Devices and Radiological Health. The Director at the time was Celia M. Witten, Ph.D., M.D. This implies review by medical and regulatory experts involved in orthopedic devices.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable in the context of an AI device's performance evaluation. The "adjudication" in this regulatory context is the FDA's decision-making process based on the submitted application and comparison to the predicate device.
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
- MRMC Study: No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a physical medical implant like a joint prosthesis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: No, a standalone study was not done. This concept is specific to AI algorithms.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this context is the FDA's regulatory framework and the established safety and effectiveness of the legally marketed predicate device. This involves:
- Predicate Device's Known Performance: The WMT Modular Ulnar Head, having been legally marketed, is accepted as safe and effective for its indicated uses.
- Engineering Standards and Biocompatibility Data: Although not explicitly detailed in the summary, implantable devices are subject to rigorous testing against international and national standards for materials, mechanical properties, and biocompatibility. The "industry standard materials" and the comparison of fixation methods suggest adherence to these established engineering principles.
- Clinical Consensus on Indications for Use: The listed indications are based on established medical practice for orthopedic surgery.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is not an AI/machine learning algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for an AI model.
§ 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.