(90 days)
EZ Start™ Interference Screws are intended for use in bone - tendon - bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.
EZ Start™ Interference Screws are used to provide bone fixation in orthopedic procedures, including bone-tendon-bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.
The EZStart™ Interference Screw is a dual threaded titanium interference screw with a tapered tip for easy insertion into bone. The screw is cannulated to allow a guidewire through to assist with placement of the screw into the bone tunnel. The screw is used to maintain the fixation of bone - tendon - bone grafts in orthopedic procedures. The device is Gamma Sterilized.
This document does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving device performance as it relates to AI/ML devices. The provided text is a 510(k) summary for a medical device called the "EZStart™ Interference Screw," which is a physical implant for orthopedic procedures, not an AI/ML diagnostic or therapeutic device.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and reported device performance in the context of AI/ML.
- Sample size used for the test set and data provenance for an AI/ML study.
- Number of experts used to establish ground truth and their qualifications for an AI/ML test set.
- Adjudication method for an AI/ML test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study with AI assistance.
- Information on a standalone (algorithm only) performance study.
- Type of ground truth used for an AI/ML study.
- Sample size for the training set for an AI/ML model.
- How the ground truth for the training set was established for an AI/ML model.
However, I can provide the acceptance criteria and performance data for the physical device, the EZStart™ Interference Screw, as described in the document:
The EZStart™ Interference Screw underwent various verification and validation tests to demonstrate its performance and substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance (as described for this physical device):
The document lists the types of tests performed but generally states that "results met the current FDA and USP requirements" or confirmed "substantial equivalence" rather than providing specific numerical acceptance criteria or performance values for many tests. One specific quantitative criterion is mentioned for pyrogenicity.
| Test Type | Acceptance Criteria (where specified) | Reported Device Performance |
|---|---|---|
| Insertion Torque | Implied to meet established performance standards for the device type. | Performed as intended, contributing to substantial equivalence. |
| Fixation Strength | Implied to meet established performance standards for the device type. | Performed as intended, contributing to substantial equivalence. |
| Sterilization | Implied to meet sterility assurance level (SAL) requirements. | Performed as intended, contributing to substantial equivalence. |
| Biocompatibility | Implied to meet ISO 10993 series standards. | Performed as intended, contributing to substantial equivalence. |
| Pyrogenicity |
§ 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.