(89 days)
Shoulder: Bankart Repair
Ankle: Midfoot Reconstructions
Foot: Hallux Valgus Reconstruction
Wrist: Scapholunate Ligament Reconstruction
Hand: Ulnar or Lateral Collateral Ligament Reconstruction
Pubis: Fixation in the pubis for bladder neck suspension to resolve stress urinary incontinence
The Mitek Mini Anchor is also indicated for the repair, repositioning or reattachment of soft tissues, ligaments and tendons to the mandible for surgical stabilization of the TMJ articular disc.
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 with a polyester suture.
The provided text is a 510(k) summary for the Mitek Mini Anchor and does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria in the requested format. It primarily focuses on demonstrating substantial equivalence for an expanded indication.
Here's an analysis of why the requested information cannot be fully provided based on the extract:
- Acceptance Criteria and Reported Device Performance Table: The document lists "Performance testing" (Pull-out force, Strength comparison), "Long-term stability" (Evaluation of osteointegration and positional stability), and "Clinical data" (Long-term patient follow-up). However, it does not provide specific numerical acceptance criteria (e.g., minimum pull-out force in Newtons) for these tests nor does it report the actual test results or performance metrics of the device against any such criteria.
- Sample size and data provenance for the test set: Not mentioned.
- Number of experts and qualifications for ground truth: Not applicable as the studies described are in vitro (cadaveric) and in vivo (clinical follow-up) performance tests, not AI model evaluation requiring expert consensus for ground truth.
- Adjudication method for the test set: Not applicable for the type of studies described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable as this is a medical device, not an AI/imaging algorithm.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth used:
- For "Pull-out force" and "Strength comparison," the ground truth would be the direct measurement of force from the cadaveric specimens.
- For "Long-term stability," it would involve observations/measurements of osteointegration and positional stability.
- For "Clinical data," it would be patient outcomes as observed during follow-up.
- Sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How ground truth for the training set was established: Not applicable.
In summary, the provided 510(k) summary is a regulatory document affirming substantial equivalence based on a comparison to predicate devices and general safety/performance data, but it does not detail the specific acceptance criteria, study methodologies (like sample size), or results in the manner requested for an AI/diagnostic device.
To provide the requested table, I would need a document that presents specific quantitative performance metrics and the associated acceptance thresholds for the device.
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.