(28 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, and its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way that would typically be presented for an AI/ML powered device.
The provided text describes a "Predicate Device" submission, which is a regulatory pathway for demonstrating that a new device is as safe and effective as a legally marketed predicate device. In essence, the "study" is a comparison to the predicate device, not a trial demonstrating novel performance or specific acceptance criteria for an AI model.
Here's an analysis based on the information provided, framed to address your questions where applicable, and noting where the requested information is not present:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This submission is a 510(k) Pre-Market Notification for a medical device (Distal Radio-Ulnar Joint Implant), not an AI/ML-powered device. Therefore, the concept of "acceptance criteria" and a "study to prove the device meets acceptance criteria" for algorithmic performance (e.g., accuracy, sensitivity, specificity) does not directly apply in the usual sense for this type of medical device submission.
Instead, the "acceptance criteria" for this 510(k) submission are met by demonstrating substantial equivalence to a previously legally marketed device (the predicate device). The "study" in this context is the comparison of the new device's characteristics against the predicate device's characteristics. The goal is to show that the new device has the same intended use and similar technological characteristics to the predicate device, or that any differences do not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a predicate device comparison, typical performance metrics like sensitivity, specificity, or AUC are not applicable here. The "acceptance criteria" are based on demonstrating substantial equivalence, and "performance" is implicitly tied to matching the predicate device.
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (Similarity to Predicate) |
|---|---|
| Same Product Name | Met: Both are "Distal Radioulnar Joint Implant" |
| Same Use (Single-use) | Met: Both are "Single use" |
| Same Fixation Method | Met: Both have "stem in intramedullary canal, screw fixation to the distal radius" |
| Same Constraint Type | Met: Both are "Semi constrained" |
| Same Material Composition | Met: Both use "Co-Cr, UHMWPE, CPTi" (No new materials introduced) |
| Comparably Sized (Same sizes for body and stems) | Met: Both offer "2 sizes, 20, 30, body" and "25 size stems" (The document refers to "additional stem lengths and diameters" for the proposed modifications in one section, but then states "both devices are comparably sized" and lists the same sizes in the table, implying that any modifications are within the scope of what is considered "comparable" or the provided table represents the current state of both without detailing the additional sizes mentioned earlier for the proposed modifications. However, the overall conclusion is that they are comparably sized and substantially equivalent.) |
| Identical Indications for Use | Met: Both have the exact same detailed indications for use. |
| Surgical Implantation duration (>30 days) | Met: Both devices are "intended for surgical implantation longer than 30 days." |
| Placement in intramedullary canal of distal ulna | Met: Both devices are "placed into the intramedullary canal of the distal ulna." |
| No new questions of safety or effectiveness raised by modifications (e.g. additional stem lengths/diameters as mentioned in K050349) | Met (implied by FDA clearance): The submission concludes that "the new device is substantially equivalent to the predicate device," indicating that any modifications (like additional stem lengths/diameters) were deemed not to raise new questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance
There is no "test set" in the context of an AI/ML algorithm evaluation mentioned in this document. The "study" for this submission is a comparative analysis of the device's design, materials, and intended use against a predicate device. This process does not involve a sample size of patient data or algorithm outputs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML evaluation requiring expert-established ground truth.
4. Adjudication method for the test set
Not applicable.
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 not an AI-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used
For this type of device submission, the "ground truth" for demonstrating substantial equivalence is the established safety and effectiveness profile of the legally marketed predicate device, as determined by its prior FDA clearance. The new device is compared against this established benchmark.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set in that context. The "training" for the device design would be based on engineering principles and knowledge of orthopedic surgery.
9. How the ground truth for the training set was established
Not applicable. As there's no AI/ML training set, the concept of establishing ground truth for it is irrelevant in this submission.
§ 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.