(60 days)
Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of auto- and allo- grafts.
The MectaScrew PEEK® is an implantable device used for the reconstructive treatment of knee ligament ruptures. The primary purpose of the MectaScrew PEEK interference screw is to provide, via interference between the graft and the bone tunnel, a suitable and secure intra - tunnel graft fixation of the implanted ligament replacement giving stability, pain relief due to restoration of the normal anatomy, and improving articular functionality for patients treated. The MectaScrew PEEK® portfolio is composed of 19 different configurations ranging from 6 to 12 mm in diameter and 15 to 35 mm in length.
The provided text is a 510(k) summary for the Medacta MectaScrew PEEK Interference Screw. This document is a premarket notification for a medical device seeking substantial equivalence to existing predicate devices, not a study describing the performance of an AI/ML medical device.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and performance studies for an AI/ML device. The criteria listed in the prompt are specific to the evaluation of AI/ML diagnostic or prognostic tools (e.g., accuracy, sensitivity, specificity, expert ground truth, MRMC studies), which are not relevant to a bone fixation screw.
The document discusses:
- Device description: A PEEK interference screw for ACL reconstruction.
- Predicate devices: Smith&Nephew BIOSURE PK® Interference screw (K083635) and Conmed MATRYX® Interference Screw (K063588).
- Technological characteristics: Comparison with predicate devices, noting material (PEEK), external shape, sterilization, and usage are similar, with differences in driver connection.
- Performance data (Non-Clinical Studies):
- Design Validation (Cadaver Workshop)
- MR compatibility
- Pull Out Strength
- Torque Resistance
- Pyrogenicity (Bacterial endotoxin and Pyrogen tests)
- Clinical Studies: "No clinical studies were conducted."
In summary, this document describes a traditional medical device (an implantable screw) and its premarket clearance process based on substantial equivalence, primarily through non-clinical performance data and comparison to predicates, not an AI/ML device evaluation.
§ 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.