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The Aptis Medical Distal Radio Ulnar Joint Implant is intended for replacement of the distal radio ulnar 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 radio ulnar joint
• · Failed ulnar head resection; e.g. Darrach resection
• · Primary replacement after fracture of the ulnar head or neck.
• · Revision following failed ulnar head arthroplasty.

This prosthesis is intended for single use only.

The Aptis Medical Distal Radio Ulnar Joint Implant system, like the predicate device includes various sizes of implants (10-30 and multiple stems) to accommodate the anatomy of the distal ulna. The implants are made from the same materials as the predicate including: Co-Cr, UHMWPe and CPTi. Surgical instruments are also available to facilitate surgical placement of the implant. The implant allows for the replacement of the distal ulnar head.

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The document is a 510(k) premarket notification summary for the Aptis Medical Distal Radio Ulnar Joint Implant. The key information provided relates to its substantial equivalence to a predicate device, regulatory classifications, and indications for use.

Specifically, Section VII, "Performance Data," states: "Evaluation in the MRI environment of the subject device was performed through computational modeling and simulation of radiofrequency induced heating. No clinical data was submitted to support substantial equivalence." This explicitly indicates that a study demonstrating device performance against acceptance criteria, particularly clinical performance, was not conducted or submitted for this specific premarket notification.

Therefore, I cannot extract the requested information from the provided text.

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The Aptis Medical Distal Radio Ulnar Joint 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; e.g. Darrach resection
• Primary replacement after fracture of the ulnar head or neck.
• Revision following failed ulnar head arthroplasty.

This prosthesis is intended for single use only.

The Aptis Medical Distal Radio Ulnar Joint Implant system, like the predicate device includes various sizes of implants (10-30) to accommodate the anatomy of the distal ulna. The implants are made from the same materials as the predicate including; Co-Cr, UHMWPe and CPTi. Surgical instruments are also available to facilitate surgical placement of the implant. The implant allows for the replacement of the distal ulnar head. The device consists of a plate of various sizes which is fixed to the radius and a stem of various sizes which is fixed to the ulna.

The provided document is a 510(k) premarket notification for the Aptis Medical Distal Radio Ulnar Joint Implant. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study that measures performance against those criteria.

Therefore, the document does not contain the information requested in categories 1-6 and 8-9 regarding acceptance criteria, study details, sample sizes, expert involvement, or multi-reader studies.

However, it does provide information partially relevant to category 7, which is about the type of ground truth used.

Here's a breakdown based on the categories provided, explaining why certain information is absent:

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

• Information not provided. The document describes a medical implant seeking substantial equivalence, not an AI/software device with performance metrics like sensitivity or specificity. The "performance" discussed is related to mechanical testing, not diagnostic or predictive accuracy.

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

• Information not provided. No clinical test set or data provenance is mentioned. The "performance data" refers to mechanical testing of the implant itself, not a test set of patient data.

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)

• Information not provided. Since no clinical test set or diagnostic ground truth establishing is discussed, there is no mention of experts for this purpose.

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

• Information not provided. Adjudication methods are relevant for studies involving human interpretation or consensus, which is not applicable here as no clinical test set is described.

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

• Information not provided. This device is a physical implant, not an AI or software component, so an MRMC study related to AI assistance is irrelevant.

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

• Information not provided. As mentioned, this is a physical medical device, not an algorithm.

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

• The document describes mechanical testing as the basis for performance evaluation. The "ground truth" in this context would be the physical properties and mechanical integrity of the implant when subjected to various forces (static compression, static tension, dynamic compression). The comparison is against the predicate device's mechanical performance, establishing "comparable loads under similar test conditions."

8. The sample size for the training set

• Information not provided. This concept is only applicable to machine learning models, not physical implants.

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

• Information not provided. This concept is only applicable to machine learning models, not physical implants.

In summary, the document concerns the regulatory approval of a physical medical implant based on substantial equivalence to a predicate device, primarily through mechanical performance data. It does not involve AI or software, and therefore lacks the detailed information on clinical study design, acceptance criteria, and ground truth establishment typically found in submissions for such devices.

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