(23 days)
Shoulder - rotator cuff repair
Shoulder: rotator cuff repair
Made from surgical grade PLL (homopolymer poly (L(-) -lactide), the LM Anchor is designed as a propeller blade type anchor device through which suture is passed to provide a means for soft tissue to bone attachment.
Here's an analysis of the provided text regarding the acceptance criteria and study for the LM Anchor, formatted as requested:
Acceptance Criteria and Study for LM Anchor
The provided 510(k) summary for the Li Medical RotorBlade™ (LM Anchor) focuses on demonstrating substantial equivalence to a predicate device rather than establishing novel safety and effectiveness through a rigorous performance study with predefined acceptance criteria. The primary evidence presented is preclinical testing showing substantial equivalence in pullout strength.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Premarket Definition: The new device (LM Anchor) must be substantially equivalent to the predicate device (Li Medical RotorBlade™ K983435) in terms of safety and effectiveness, specifically regarding pullout strength. | The study found that "the mean pullout strength of the LM Anchor was substantially equivalent to the mean pullout strength of the predicate device." No specific quantifiable metric (e.g., within X% of the predicate mean, or exceeding a certain force threshold) is provided as an acceptance criterion. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided text. The summary only mentions "Pre-clinical testing."
- Data Provenance: Not explicitly stated. However, "Pre-clinical testing" typically implies laboratory or ex-vivo testing rather than in-vivo human data. It's likely conducted in a controlled lab setting, not geographically specific patient data. It is retrospective in the sense that it aims to compare against an already marketed predicate, but the testing itself would have been newly performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable as the study described is a pre-clinical, mechanical comparison of pullout strength. Ground truth in this context would likely be defined by physical measurements and engineering standards, not expert medical opinion.
4. Adjudication Method for the Test Set
- This information is not applicable as the study described is a pre-clinical, mechanical comparison. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints. Physical measurements for pullout strength would be objective and not require adjudication by human experts in the medical sense.
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, an MRMC comparative effectiveness study was not done. This device is a mechanical surgical anchor, not an AI-powered diagnostic or assistive tool for human readers. Therefore, questions regarding AI assistance and human reader improvement are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, this is not an AI algorithm. It is a physical medical device (suture anchor). Therefore, the concept of standalone algorithm performance is not applicable. The performance evaluated was the mechanical pullout strength of the physical device itself.
7. The Type of Ground Truth Used
- The "ground truth" for the pre-clinical pullout strength testing would have been objective physical measurement of the force required to pull the anchor out of the test substrate (likely bone or a bone substitute). This is a direct physical property measurement, not based on expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- This information is not applicable. This is a physical device subject to mechanical testing, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as there is no training set for a physical device.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.