(61 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), Bladder Neck Suspension.
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 document is a 510(K) summary for a medical device called the "LM Anchor" (K960825). This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study with acceptance criteria and performance metrics in the way that would typically be described for an AI-powered diagnostic device.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this particular type of regulatory submission for a physical medical device like a bone anchor.
However, I can extract the information related to performance data as presented in the summary, which serves as the "study" demonstrating the device meets the implied acceptance criteria of being substantially equivalent to predicate devices.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Substantial equivalence in pullout strength to predicate bone anchors. | "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." (Specifically, Mitek Surgical Products GII Anchor (K915889) and Mitek Surgical Products SuperAnchor (K920213?)). |
| Material Composition | Made from surgical grade materials suitable for implantation. | "Made from surgical grade stainless steel (316L)" |
| Design/Functionality | Designed to provide a means for soft tissue to bone attachment. | "designed with a crown and a center pin through which suture is passed to provide a means for soft tissue to bone attachment." The bony purchase mechanism differs (cantilevered beams vs. nitinol arcs) but the overall function is comparable. |
| Intended Use | Comparable intended use cases to predicate devices, for soft tissue fixation. | A comprehensive list of shoulder, hand/wrist, foot/ankle, elbow, knee, and bladder neck suspension applications is provided, implying equivalence or appropriate application range compared to similar devices. |
| Biocompatibility | (Implied by surgical grade material and substantial equivalence to predicates) | Not explicitly stated as a separate acceptance criterion or tested metric in this summary. However, using "surgical grade stainless steel (316L)" and claiming equivalence to already cleared devices implies biocompatibility is addressed. |
Narrative on Acceptance Criteria and Study:
The primary acceptance criterion for the LM Anchor, as presented in this 510(K) summary, is substantial equivalence to predicate devices in terms of safety and effectiveness. For mechanical performance, this translates to demonstrating that its pullout strength is comparable to established devices like the Mitek anchors. The study performed to meet this criterion was "Pre-clinical testing in cadaver specimen."
Details that cannot be extracted from the provided 510(K) Summary:
- Sample size used for the test set and the data provenance: Not specified. The document only mentions "cadaver specimen" for the pre-clinical testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a physical device performance test, not an image-based diagnostic test requiring expert ground truth for interpretation.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating human performance, often with AI assistance, in interpreting medical images. It's not applicable to a bone anchor.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This applies to AI algorithms.
- The type of ground truth used: For pullout strength, the "ground truth" would be the measured force at which the anchor dislodges from the bone. This is a direct measurement, not an interpreted "ground truth" from experts or pathology.
- The sample size for the training set: Not applicable. This device does not use machine learning with a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of what is known from the document regarding the study:
- Study Type: Pre-clinical mechanical strength testing.
- Study Subject: Cadaver specimens.
- Measurement: Mean pullout strength.
- Comparison: Compared against Mitek Surgical Products GII Anchor and SuperAnchor.
- Conclusion: The LM Anchor's mean pullout strength was "substantially equivalent" to the Mitek anchors.
§ 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.