(30 days)
The Treace Medical Concepts (TMC) Screw Fixation System is intended for use for adult and pediatric patients aged >12 years, and indicated for small or long bones requiring fixation of fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones, including scaphoid and other carpal bones, metacarpals, tarsals, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid.
In the foot, the following specific examples are indicated with screws appropriate for the size of the device:
- · mono or bicortical osteotomies
- · distal or proximal metatarsal osteotomies
- · weil osteotomy
- · fusion of the metatarsalphalangeal joint
- · fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- · Akin type osteotomy
- · talonavicular fusions
- cuboid fusions
Not for spinal use.
Treace Medical Concepts (TMC) Screw Fixation System includes headed and headless cannulated screws. The TMC Screw Fixation System is intended for use for adult and pediatric patients aged >12 years, and indicated for small or long bones requiring fixation of fractures, fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid, appropriate for the size of the device.
The purpose of this special 510(k) submission is to add a new non-cannulated screw option known as the Rapid Insertion Implant System.
All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.
The provided text does not contain information about an AI device or a study proving its acceptance criteria. Instead, it is an FDA 510(k) clearance letter for the Treace Medical Concepts (TMC) Screw Fixation System, which is a traditional medical device (bone fixation fastener).
Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI device. The document describes performance testing for a non-AI medical device through bench testing in accordance with ASTM F543.
Here's the information about the acceptance criteria and study as presented in the document for the Treace Medical Concepts (TMC) Screw Fixation System (a non-AI device):
Acceptance Criteria and Device Performance for Treace Medical Concepts (TMC) Screw Fixation System
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Torque To Failure and Insertion & Removal Torque | Met all acceptance criteria (specific criteria not detailed in the provided text) | Demonstrated |
| Axial Pullout - Driver Disengagement | Met all acceptance criteria (specific criteria not detailed in the provided text) | Demonstrated |
| Axial Pullout - Bone Screw Disengagement | Met all acceptance criteria (specific criteria not detailed in the provided text) | Demonstrated |
Note: The specific numerical acceptance criteria and performance results are not detailed in the provided FDA clearance letter. The letter states that "Testing demonstrated that the subject screws met all acceptance criteria" and are "considered substantially equivalent to the predicate screws."
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting, not using human or animal clinical data. The data provenance is a controlled laboratory environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the testing was physical bench testing against engineering standards (ASTM F543), not expert-driven evaluation of medical data.
4. Adjudication method for the test set:
- Not applicable for bench testing. The evaluation is based on meeting predefined engineering and performance specifications outlined in ASTM F543.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI devices or diagnostic tools where human interpretation of medical images or data is involved. The TMC Screw Fixation System is a physical implant, and its performance is evaluated through mechanical testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm or an AI product.
7. The type of ground truth used:
- The "ground truth" for this device's performance testing was adherence to established industry standards and mechanical properties as defined by ASTM F543. The device's performance was compared against the predicate device to establish substantial equivalence.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
§ 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.