(30 days)
The Arthrex Mini Hip PushLock is intended to be used for suture (soft tissue) to bone in the hip. Specifically, Acetabular Labral Repair.
The Arthrex Mini Hip PushLock is a barbed push-in suture anchor pre-loaded on a disposable inserter. The anchor is manufactured from PLLA/ $\u03b2$ TCP and is offered sterile, single use.
The provided document is an FDA 510(k) Premarket Notification for a medical device called the "Arthrex Mini Hip PushLock." This type of submission is for non-AI/software medical devices, specifically a suture anchor.
Therefore, the requested information about acceptance criteria, study design for AI devices (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training data, etc.) is not applicable to this document. The document describes a traditional medical device, not an AI/ML-driven device.
The "Performance Data" section in the document details mechanical testing (pull-out testing) and biocompatibility, which are standard for physical medical devices.
Here's a breakdown of what is in the document regarding "acceptance criteria" and "study":
1. Acceptance Criteria and Device Performance (for a physical device):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pull-out strength of 20 lbf (pounds-force) | Demonstrated to meet 20 lbf after 26-week degradation. (The document states "demonstrating that the proposed device is substantially equivalent to the predicate device") |
| Meets pyrogen limit specifications | Bacterial endotoxin testing per EP 2.6.14/USP demonstrates the device meets these specifications. |
| Biocompatibility (implicit) | Not directly tested on this device. Satisfied by being made of the same materials and processed the same way as a previously cleared reference device (K101679). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for pull-out testing, but mechanical testing typically involves a statistically relevant number of samples.
- Data Provenance: The testing was conducted by or for Arthrex Inc. as part of their 510(k) submission. The document doesn't specify if it was external lab testing or internal, but it's part of the regulatory submission process.
3. Number of Experts Used to Establish Ground Truth / Qualifications of Experts:
- Not applicable for this type of mechanical and biocompatibility testing. The "ground truth" is based on established engineering and materials science principles and validated testing methods.
4. Adjudication Method for the Test Set:
- Not applicable. Mechanical and biological tests are typically objective and follow standardized protocols, rather than requiring human adjudication of subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is a physical device, not an AI system. MRMC studies are for evaluating diagnostic performance of imaging interpretation, often with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical device, not an AI system. "Standalone performance" refers to the accuracy of an algorithm.
7. The Type of Ground Truth Used:
- For pull-out strength: Engineering specifications (20 lbf) established for acetabular labral repair.
- For pyrogenicity: Regulatory standards (EP 2.6.14/USP ) for bacterial endotoxin limits.
- For biocompatibility: Equivalence to a previously cleared device (referencing its known biocompatibility).
8. The Sample Size for the Training Set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. There is no "training set."
In summary, the document describes the regulatory clearance of a physical medical device based on mechanical and material performance attributes, not an AI-driven diagnostic or therapeutic system.
§ 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.