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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 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 Valqus treatment (such as Scarf, Chevron, etc.)
• · Akin type osteotomy
• · talonavicular fusions
• · cuboid fusions

Not for sninal 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, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid, appropriate for the size of the device.

All implantable components are manufactured from implant grade titanium alloy (Ti6Al4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

The primary purpose of this Special 510(k) submission is to introduce additional screw options and accompanying instrumentation within the Treace Medical Concepts (TMC) Screw Fixation System. Secondly, Treace is providing the Agency notification regarding minor modifications implemented for the TMC Screw Fixation System via internal documentation.

This document describes a 510(k) premarket notification for the Treace Medical Concepts (TMC) Screw Fixation System. It does not contain information about a study proving the device meets acceptance criteria in the context of clinical performance or AI/software analysis.

The document states:

• "Mechanical testing and analysis per ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws was performed on the subject screws to evaluate torsional strength, driving and removal torque, and axial pullout strength."
• "The subject screws were assessed under the FDA Guidance for Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway, issued December 11, 2020."
• "The subject screws met all acceptance criteria and can be considered substantially equivalent to predicate screws."

This indicates that the "study" conducted was primarily mechanical bench testing of the screws themselves against established engineering standards and FDA guidance for metallic bone screws. It is not a clinical study involving human subjects, nor does it involve AI algorithms with associated performance metrics like sensitivity, specificity, or reader studies.

Therefore, most of the requested information (items 2-9 about sample size, data provenance, experts, adjudication, MRMC, standalone performance, and ground truth for training) are not applicable to the type of device and testing described in this document.

However, based on the provided text, here is the information that can be extracted:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size: Not specified. (Refers to mechanical test samples, not clinical data).
• Data provenance: Mechanical bench testing. Not applicable in the context of clinical data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. Ground truth was established by engineering standards (ASTM F543-17) and FDA guidance for mechanical properties, not expert clinical consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This concept pertains to clinical or imaging ground truth establishment, not mechanical testing.

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

• No. This is a medical device for bone fixation, not an AI or imaging diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• No. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Engineering standards and FDA guidance for mechanical properties of metallic bone screws.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/software device.

9. How the ground truth for the training set was established

• Not applicable.

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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

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.

Ask a specific question about this device