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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 TMC Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of the feet. The system can be used in both pediatric (aged >12-21) and adult (aged 22 and over) patients. In the foot, the system can be used for the following specific examples:

• Osteotomy of the 1st metatarsal for the treatment of deformity (e.g., hallux valgus) such as:

• Opening base wedge osteotomy
• Closing base wedge osteotomy
• Crescentic osteotomy
• Proximal Chevron osteotomy
• Distal Chevron osteotomy (Austin)
• Transverse osteotomy

• Arthrodesis of the tarsometatarsal (TMT) joints or the 1st metatarsophalangeal (MTP) joint for the treatment of deformity (e.g., hallux valgus, hallux rigidus, metatarsus adductus) and/or arthritis
• First metatarsal fracture fixation
• Flatfoot Osteotomies

• Lateral Column Lengthening (Evans Osteotomy)
• Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)

• Mid / Flatfoot Fusions

• LisFranc Arthrodesis and/or Stabilization
• Intercuneiform Fusions
• Navicular-Cuneiform (NC) Fusion
• Talo-Navicular (TN) Fusion
• Calcaneo-Cuboid (CC) Fusion

• Medial Column Fusion

The Treace Medical Concepts (TMC) Plating System includes straight, L-shaped, anatomically curved plates, and intramedullary plates. The system includes 2.5mm, 2.7mm, and 3.0mm diameter cannulated and non-cannulated, locking, and non-locking screws ranging in lengths from 10-36mm. The plates and screws are intended for use in stabilization and fixation of fractures, revision procedures, fusions, and reconstructions (osteotomy) of the foot. All implantable components are manufactured from implant grade titanium alloy (Ti6A14V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

The provided text is a 510(k) summary for the Treace Medical Concepts (TMC) Plating System. It focuses on demonstrating substantial equivalence to a predicate device for a orthopedic plating system used in foot surgery.

It does not contain information about an AI/ML powered device, nor does it discuss acceptance criteria and performance data related to an AI/ML algorithm's effectiveness in medical image analysis or similar tasks.

Therefore, I cannot extract the information required to populate the fields you listed, as they are specific to the validation of AI/ML software in medical devices. The document describes mechanical performance testing for an orthopedic implant, not software performance.

The fields you requested are relevant to AI/ML device validation and would typically be found in a different type of submission (e.g., a De Novo request or a 510(k) for an AI/ML diagnostic software).

To reiterate, the document contains no information on:

• Acceptance criteria for an AI/ML algorithm.
• Reported device performance for an AI/ML algorithm.
• Sample size for test sets or data provenance for AI/ML validation.
• Number of experts or their qualifications for establishing ground truth for AI/ML.
• Adjudication methods for AI/ML ground truth.
• MRMC comparative effectiveness study for AI/ML.
• Standalone performance for an AI/ML algorithm.
• Type of ground truth, training set size, or training set ground truth establishment for AI/ML.

Ask a specific question about this device

The TMC Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of the feet. The system can be used in both adult and pediatric patients aged >12 years. In the foot, the system can be used for the following specific examples:
· Osteotomy of the 1st metatarsal for the treatment of deformity (e.g., hallux valgus) such as:

• Opening base wedge osteotomy
• Closing base wedge osteotomy
• Crescentic osteotomy
• Proximal Chevron osteotomy
• Distal Chevron osteotomy (Austin)
• Transverse osteotomy
  • Arthrodesis of the tarsometatarsal (TMT) joints or the 1st metatarsophalangeal (MTP) joint for the treatment of deformity (e.g., hallux valgus, hallux rigidus, metatarsus adductus) and/or arthritis
• First metatarsal fracture fixation
• · Flatfoot Osteotomies
• Lateral Column Lengthening (Evans Osteotomy)
• Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
• · Mid / Flatfoot Fusions
• LisFranc Arthrodesis and/or Stabilization
• Intercuneiform Fusions
• Navicular-Cuneiform (NC) Fusion
• Talo-Navicular (TN) Fusion
• Calcaneo-Cuboid (CC) Fusion
• Medial Column Fusion

The Treace Medical Concepts (TMC) Plating System includes straight, L-shaped, anatomically curved plates, and intramedullary plates. The system includes 2.5mm, 2.7mm, and 3.0mm diameter cannulated and non-cannulated. locking, and non-locking screws ranging in lengths from 10-32mm. The plates and screws are intended for use in stabilization and fixation of fractures, revision procedures, fusions, and reconstructions (osteotomy) of the foot.
The purpose of this traditional 510(k) submission is to introduce additional plate and screw options within the Treace Medical Concepts (TMC) Plating System.
All implantable components are manufactured from implant grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

The provided document is a 510(k) premarket notification for a medical device called the "Treace Medical Concepts (TMC) Plating System." This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through clinical trials with specific acceptance criteria as you might see for novel AI/ML devices.

Therefore, the document does not contain the information requested regarding acceptance criteria related to device performance in an AI/ML context, nor details about a study designed to prove the device meets such criteria. Specifically:

• No acceptance criteria table or reported device performance for an AI/ML system: The document describes a metallic bone fixation system, not an AI/ML diagnostic tool. Its "performance" is evaluated through mechanical bench testing, not clinical metrics like sensitivity, specificity, or AUC.
• No sample sizes for test sets, data provenance, expert ground truth establishment, or adjudication methods: These are all concepts relevant to the validation of AI/ML systems, which are not applicable to the mechanical plating system described.
• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study: This is a study design used to assess the impact of AI assistance on human reader performance, which is not applicable here.
• No standalone (algorithm-only) performance: Again, this relates to AI/ML systems.
• No type of ground truth (expert consensus, pathology, outcomes data): Ground truth in this context typically refers to a definitive diagnosis or determination for an AI system's output. For a physical plating system, "ground truth" would be related to its mechanical properties meeting specifications.
• No training set sample size or ground truth establishment for a training set: These concepts are specific to the development and training of AI/ML models.

The "Performance Testing" section states:

"Mechanical testing including static and dynamic 4-point bend testing and static torsion, driving torque, removal torque, and axial pullout based on ASTM F382 and ASTM F543 were performed. Further, engineering analysis of the worst-case cross-sections and geometries on the subject and predicate devices were evaluated. The mechanical testing, cross-sectional, and geometrical analysis demonstrated the subject devices to be substantially equivalent to the predicate devices."

This indicates that the "study" proving the device meets requirements was a series of mechanical tests and engineering analyses to demonstrate substantial equivalence to existing predicate devices. This is distinctly different from the type of performance evaluation required for AI/ML-based medical devices.

In summary, the provided text does not describe an AI/ML device or its associated acceptance criteria and validation study in the manner requested. It is a traditional 510(k) summary for a mechanical orthopedic implant.

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