(26 days)
The 11mm & 12mm Absolute™ Absorbable Interference Screws are intended for fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
The Absolute™ Absorbable Interference Screw is a biodegradable interference screw intended for interference fit fixation of soft tissue grafts or bone-tendonbone grafts during cruciate ligament reconstruction surgeries of the knee. The device is offered in 11mm and 12mm diameters and 30mm in length.
The provided text describes a 510(k) premarket notification for the Innovasive Absolute™ Absorbable Interference Screw. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from testing) | Reported Device Performance |
|---|---|
| Ultimate holding strength | Demonstrates substantially equivalent performance between the proposed and predicate devices. |
| Force to insert | Demonstrates substantially equivalent performance between the proposed and predicate devices. |
| Force to strip the screw | Demonstrates substantially equivalent performance between the proposed and predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set (e.g., number of screws tested). It mentions "Bone Model Testing," implying in-vitro mechanical testing rather than human subject data. Therefore, data provenance such as "country of origin" or "retrospective/prospective" is not applicable in the traditional sense of clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this type of device (mechanical performance) is established through physical measurement and engineering principles, not expert medical opinion.
4. Adjudication Method for the Test Set
Not applicable. This is a mechanical performance study, not one requiring expert human adjudication.
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. This document describes a medical device (an interference screw), not an AI-powered diagnostic or assistive technology.
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
The ground truth used was physical measurement in a bone model for ultimate holding strength, insertion force, and stripping force.
8. The Sample Size for the Training Set
Not applicable. This is a mechanical performance study of a physical device, and the concept of a "training set" is not relevant.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied for this type of device testing.
§ 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.