Search Results

The Mitek Mini QuickAnchor® Plus is indicated for:

shoulder (Bankart repair) ankle (Mid-foot reconstruction) foot (Hallux valgus reconstruction) hand (Ulnar or lateral collateral ligament reconstruction) wrist (Scapholunate ligament reconstruction) pubis (For relief from Stress Urinary Incontinence due to urethral or bladder neck hypermobility with minimal or no cystocele).

The device described in this 510(k) is a sterile, disposable bone anchor consisting of a titanium alloy shaft with nickel-titanium shape-memory alloy arcs. The anchor is supplied pre-loaded on an inserter with a polyester suture.

The provided 510(k) Premarket Notification for the Mitek Mini QuickAnchor® Plus is for a medical device (bone anchor) and not for an AI/ML powered device. As such, most of the requested information (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set, etc.) is not applicable to this submission.

However, I can extract information related to the device's acceptance criteria and the study that proves it meets those criteria, as presented in the document.

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

The document states that the safety and performance data was provided to support substantial equivalence due to a design modification. The performance testing focused on mechanical properties relevant to a bone anchor.

Note: The 510(k) summary typically does not include the specific numerical acceptance criteria or detailed results of the performance tests. The FDA's determination of "substantial equivalence" implies that these tests were conducted and the device performed comparably or better than the predicate devices.

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 as this is a traditional medical device (bone anchor), not an AI/ML device relying on diagnostic or prognostic data. The "test set" here refers to physical performance tests on the device itself. The document does not specify sample sizes for these mechanical tests, nor the "provenance" of such test data (e.g., conducted in a lab, no patient data involved).

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. The "ground truth" for a bone anchor's performance is objective mechanical measurements (e.g., force in Newtons). There are no human experts establishing a "ground truth" in the way it would be for an AI diagnostic algorithm.

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

This is not applicable. Adjudication methods are relevant for subjective interpretations or disagreements in diagnostic assessments, which is not the case for mechanical performance testing of a bone anchor.

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. MRMC studies are for evaluating the performance of diagnostic tools (often involving image interpretation by human readers, sometimes with AI assistance). This device is a surgical implant.

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

This is not applicable. This device is not an algorithm.

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

The "ground truth" for this device would be based on objective physical measurements derived from standard mechanical testing protocols (e.g., ASTM standards or equivalent internal protocols) for bone anchors. This would include measurements of force (insertion, pull-out) and assessment of material integrity/interface. There is no expert consensus, pathology, or outcomes data used as "ground truth" for these performance tests.

8. The sample size for the training set

This is not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

This is not applicable. There is no training set for this device.

Ask a specific question about this device