(86 days)
Shoulder:. Bankart repairSLAP Lesion repair acromio-clavicular separation, rotator cuff repair,capsule shift/capsulo-labral reconstruction, biceps tenodesis, deltoid repair. Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, midfoot reconstruction. Foot: Hallux Valgus reconstruction. Elbow: Tennis Elbow repair, biceps tendon reattchment. Knee: Extra capsular repairs,Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament, or joint capsule to tibia and joint capsult closure to anterior proximal tibia, extra capsular reconstruction, ITBtenodesis, patellar ligament and tendon avulsions
The device is 0.430″ lg by 0.109″ wide with with two 0.026″ by 85 degree arcs. Titanium body and Nitinol arcs. Hold soft tissue in apposition during healing process.
The provided text primarily details a 510(k) summary for the Mitek Knotless Anchor, focusing on its substantial equivalence to a predicate device. While it mentions bench-top tests, it does not explicitly define acceptance criteria in terms of specific performance metrics or studies proving the device meets them. Instead, it indicates that clinical tests were done "in accordance with IDE G880026" but does not provide results or details of these tests.
Therefore, many of the requested details cannot be extracted directly from this document.
However, I can extract information related to the bench-top tests:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Statistically equivalent strength to the predicate device (Mitek GII) | Mitek GII pull-out failure force: 26.03 lbs (SD 17.12) |
| Knotless Anchor pull-out failure force: 60.96 lbs (SD 14.29) | |
| Implied: Demonstrate sufficient pull-out strength in pig femora. | Knotless Anchor (60.96 lbs) showed significantly higher pull-out strength than the GII (26.03 lbs). |
Note: While the document states "statistically equivalent strength," the reported mean pull-out forces (60.96 lbs vs. 26.03 lbs) and standard deviations (14.29 vs 17.12) suggest the Knotless Anchor was actually stronger, not just equivalent. This phrasing could be interpreted as "at least equivalent" or could be a simplification in the summary. For the purpose of answering, I've reported the stated requirement and the performance provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for pull-out tests.
- Data Provenance: The tests were conducted using "pig femora." The country of origin of the data is not specified, and it's a bench-top test, not human data. This would be considered a prospective bench study.
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)
Not applicable. This was a physical bench-top test measuring mechanical properties, not a study requiring expert interpretation or ground truth establishment in that sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was a physical bench-top test measuring mechanical properties.
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
No, this information is not present. This document describes a medical device, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench-top test, the "ground truth" was the measured physical pull-out force from pig femora, determined through mechanical testing.
8. The sample size for the training set
Not applicable. There's no mention of a "training set" as this is a physical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.