(78 days)
Shoulder (bankart repair, rotator cuff repair, SLAP lesion, acromio-clavicular separation, biceps tenodesis, deltoid repair, capsular shift reconstruction, capsulolabral reconstruction), Hand/Wrist (ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon), Elbow (biceps tendon, tennis elbow, ulnar collateral ligament, radial collateral ligament), Knee (medial collateral ligament, lateral collateral ligament, patellar tendon, patellar ligament avulsions, posterior oblique ligament, joint capsule to tibia, iliotibial band tenodesis).
Made from surgical grade stainless steel (316L), the LM Anchor is designed with a crown and a center pin through which suture is passed to provide a means for soft tissue to bone attachment.
The provided text describes a medical device, the "LM Anchor," and its performance compared to predicate devices. However, the information DOES NOT contain the level of detail required to answer your specific questions regarding acceptance criteria, study design, expert qualifications, and ground truth establishment for an AI/ML-based device.
The provided document is a 510(k) summary for a bone anchor, which outlines its design, intended use, and pre-clinical performance. It describes a physical medical device, not an AI/ML diagnostic or assistive technology. Therefore, the questions about AI/ML-specific study design elements (e.g., test set, training set, ground truth experts, adjudication methods, MRMC studies) are not applicable to this document.
Here's an attempt to answer the relevant questions based on the provided text, while highlighting the absence of AI/ML-specific information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Criterion: Substantial equivalence in pullout strength related to predicate devices. | Performance: "Pre-clinical testing in cadaver specimen showed that the mean pullout strength of the LM Anchor was substantially equivalent to the mean pullout strength of the Mitek anchors." |
2. Sample sized 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. The document mentions "cadaver specimen" but does not provide the number of specimens or anchors tested.
- Data Provenance: Not specified, but the data is from "pre-clinical testing in cadaver specimen," implying a controlled laboratory environment rather than patient data. No country of origin is mentioned. The study is prospective in nature for a pre-clinical assessment.
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 relates to an AI/ML diagnostic device where experts establish ground truth for image or data interpretation. For a physical bone anchor, the "ground truth" is measured physical properties (e.g., pullout strength) determined by mechanical testing, not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used in AI/ML performance studies to resolve discrepancies in expert labeling or diagnoses. For mechanical testing of a physical device, the outcome is a measurable physical property, not subject to expert interpretation disputes in the same way.
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. MRMC studies are specific to evaluating AI-assisted diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This document describes a physical surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This question pertains to the performance of an AI algorithm operating independently. The LM Anchor is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Mechanical Measurement: The "ground truth" for the LM Anchor's performance is its mean pullout strength as measured in pre-clinical cadaveric testing. This is a direct physical measurement.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML model and therefore does not have a "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI/ML model, this question is not relevant.
In summary, the provided K960439 document is for a physical medical device (bone anchor) and does not contain the information requested for AI/ML device evaluation.
§ 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.