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The TMC Implant Fixation System is intended for use in stabilization of fresh fractures, revision procedures, 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 TMC Implant Fixation System is comprised of straight, L-shaped, H-shaped, anatomically curved plates, intramedullary plates, cannulated and non-cannulated compression implants, and associated instruments. It includes 2.5 mm, 2.7 mm, 3.0 mm, and 3.3 mm diameter cannulated and non-cannulated, locking, and non-locking screws in lengths ranging from 10-36 mm. The plates, screws, and compression implants are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of the feet. All implantable components are manufactured from implant grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

This document describes the regulatory clearance of a medical device, the "TMC Implant Fixation System," not an AI diagnostic device. Therefore, many of the requested categories for AI-specific studies are not applicable. I will extract the information that is relevant to the provided text.

Here's an analysis of the provided FDA 510(k) clearance letter:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample Size (Test Set): Not explicitly stated. The document refers to "testing and analysis" between the subject and predicate devices for mechanical properties. This typically involves a defined number of test specimens (e.g., plates, screws) for each test type, but the exact quantity is not detailed in this summary.
• Data Provenance: Not applicable in the context of clinical data for an AI device. The testing described is mechanical, performed on physical device samples.

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

• Not applicable. This device is a metallic bone fixation system, and the "ground truth" for mechanical testing is established by recognized engineering standards (like ASTM F382) and FDA guidance, not by expert interpretation of images or clinical outcomes in the same way an AI diagnostic device would.

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

• Not applicable. Mechanical testing results are objective measurements (e.g., force, displacement, cycles to failure) against predefined pass/fail criteria, not subjective human assessments requiring adjudication.

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 diagnostic tool. MRMC studies are used for evaluating diagnostic performance with and without AI assistance.

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

• No. This is a physical implant system, not a software algorithm.

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

• For mechanical performance: The ground truth refers to established engineering standards (ASTM F382) and FDA guidance for orthopedic implants. Performance is measured against physical properties like strength, fatigue resistance, and screw pullout force.

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.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the TMC Implant Fixation System meets acceptance criteria was a series of mechanical performance tests. The primary testing included:

• Static 4-point bend testing
• Dynamic 4-point bend testing
• Axial pullout testing

These tests were conducted in accordance with established standards:

• ASTM F382 Standard Specification and Test Method for Metallic Bone Plates was used for the 4-point bend testing.
• Modified acceptance criteria derived from the FDA Guidance for Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway (issued November 22, 2024) were used for the axial pullout testing.

The document states that "The testing and analysis demonstrated that the subject devices met all acceptance criteria and therefore are substantially equivalent to the predicate devices." This substantial equivalence determination suggests that the new device's mechanical performance is comparable to or better than that of the legally marketed predicate devices, thereby assuring its safety and effectiveness for its intended use.

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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 system is intended to be used for fracture fixation, and joint arthrodesis of the foot and ankle.

TMC Compression Implant System is comprised of staple implants and related instrumentation for implantation. The implants are offered in multiple combinations of bridge lengths, leg lengths, cross sections, and cannulated versions to accommodate various anatomies. This includes two (2x1) or four (2x2, 4x1) legged implants. It also includes locking screws for additional fixation. All implantable components are manufactured from implant grade titanium alloy (Ti-6A1-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

The provided document, a 510(k) Premarket Notification for the "TMC Compression Implant System," primarily focuses on establishing substantial equivalence to previously cleared predicate devices for a physical medical device (bone fixation implants). It does not describe a study involving an AI or software-based device that would require the detailed acceptance criteria and performance study information typically requested for AI/ML-based medical devices.

Therefore, I cannot extract the information required to answer your prompt, such as:

• A table of acceptance criteria and reported device performance: This document does not present performance data in this format for AI/ML metrics (e.g., sensitivity, specificity, AUC). It discusses mechanical testing for the implants.
• Sample size for the test set and data provenance: Not applicable in the context of an AI/ML study.
• Number of experts used to establish ground truth and their qualifications: Not applicable.
• Adjudication method for the test set: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable for AI/ML ground truth; it refers to mechanical testing standards for implants.
• Sample size for the training set: Not applicable.
• How ground truth for the training set was established: Not applicable.

The document states the following regarding performance testing for the physical device:

• Acceptance Criteria Mentioned (Implicit for Mechanical Testing): "The analysis demonstrated that the subject devices met all acceptance criteria..." This refers to mechanical performance criteria outlined in the standards, specifically:
  • ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples for dynamic fatigue strength (four-point bending test, Annex A1)
  • ASTM F564-17 for pull-out strength (Annex A2)
  • ASTM F543-17 for the added screw options.
• Reported Device Performance: The document only states that the devices met these acceptance criteria, rather than providing specific numerical performance results. It concludes that the devices are "substantially equivalent" to predicate devices based on these tests and other factors (materials, design, intended use).
• Study Type: Mechanical testing.
• Ground Truth: The "ground truth" in this context is the performance standard established by ASTM (American Society for Testing and Materials) for metallic bone staples and screws.
• Sample Size: The document does not specify the number of implants tested, but rather refers to meeting the requirements of the ASTM standards.

In summary, this document describes a traditional medical device submission for physical implants, not an AI/ML-driven device. The elements you're asking for are specific to the validation of AI/ML algorithms and are not present in this regulatory submission for the TMC Compression Implant System.

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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.

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The system is intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle.

The TMC Compression Implant System consists of implants and related instrumentation for implantation. The implants are offered in multiple combinations of bridge lengths, leg lengths, and cross sections to accommodate various anatomies. This includes two (2x2, 4x1) legged implants. The system is intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle.

The purpose of this Special 510(k) submission is to expand the implant and instrument options for the TMC Compression Implant System. The subject implants and instruments are modifications of the previously cleared TMC Compression Implant System (K222645).

All implantable components are manufactured from implant grade titanium alloy (Ti-6AI-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

This document describes the Treace Medical Concepts (TMC) Compression Implant System, a device used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle. The FDA has determined it is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study information provided, focusing on what is stated and what is not:

1. A table of acceptance criteria and the reported device performance:

The document explicitly states that mechanical testing, including bending and pull-out performance, was conducted according to ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples.

Note: The specific quantitative acceptance criteria (e.g., minimum bending strength, minimum pull-out force) are not provided in this document. It only states that the device "met all acceptance criteria" as defined by ASTM F564.

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

The document does not specify the sample size used for the mechanical testing (bending and pull-out). It also does not provide information about the data provenance (e.g., country of origin) or whether the tests were prospective or retrospective. Mechanical tests are typically performed in a laboratory setting on new devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable as the study described is a mechanical performance study of a bone fixation device, not a study evaluating diagnostic imaging or clinical outcomes that would require expert review to establish ground truth. The "ground truth" here is the physical performance of the device under stress, measured quantitatively against established engineering standards (ASTM F564).

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

This information is not applicable for a mechanical performance study. Adjudication methods are relevant for studies where subjective interpretation (e.g., by clinicians, radiologists) is involved in determining outcomes or ground truth.

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:

This information is not applicable. This document describes the mechanical testing of a medical implant, not an AI-assisted diagnostic or treatment device involving human readers.

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

This information is not applicable. This document does not describe an algorithm or AI device.

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

The ground truth used for this study is based on established engineering standards and test methods as defined by ASTM F564 Standard Specification and Test Methods for Metallic Bone Staples. The performance metrics (e.g., bending strength, pull-out force) are quantitative and derived directly from these standardized tests.

8. The sample size for the training set:

This information is not applicable. This document describes mechanical performance testing, not a machine learning or AI model that would require a training set.

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

This information is not applicable as there is no training set for a mechanical performance study.

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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 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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The system is intended to be used for fracture fixation, and joint arthrodesis of the foot and ankle.

The Treace Medical Concepts (TMC) Compression Implant System consists of implants and related instrumentation for implantation. The implant is offered in multiple combinations of bridge lengths, leg lengths, cross sections and cannulated versions to accommodate various anatomies. The system is intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle.

This document describes a 510(k) premarket notification for the Treace Medical Concepts (TMC) Compression Implant System, a metallic bone fixation appliance. The information herein pertains to an administrative change to the trade name of the product and its substantial equivalence to predicate devices, rather than an AI/ML-driven medical device. Therefore, much of the requested information regarding acceptance criteria, study methodologies for AI/ML devices, and ground truth establishment (such as those involving expert consensus, MRMC studies, or training/test set sample sizes for AI) is not applicable or cannot be extracted from the provided text.

However, I can extract information related to the device's performance testing and its comparison to a predicate device, which serves as the basis for its substantial equivalence claim.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance

2. Sample Size & Data Provenance

The document does not specify a "sample size used for the test set" in the context of an AI/ML model or a clinical study with patients. The performance testing mentioned is mechanical testing. Therefore, the concept of data provenance (country of origin, retrospective/prospective) is not applicable in this context. The testing was conducted on the device itself.

3. Number of Experts and Qualifications

Not applicable. The performance testing described is mechanical testing of the implant, not a study requiring human expert evaluation (e.g., radiologists interpreting images).

4. Adjudication Method

Not applicable. This is not a study requiring adjudication of human readings or AI outputs.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/ML device whose performance is being compared to human readers.

6. Standalone Performance

The document states, "The testing demonstrated that the subject device met all acceptance criteria" per ASTM F564. This implies a standalone evaluation of the device's mechanical properties against a predefined standard. However, this is for a physical implant, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context is the mechanical performance standards defined by ASTM F564 for Bone Metallic Staples. The device's performance was compared directly to these established engineering standards.

8. Sample Size for Training Set

Not applicable. This is not an AI/ML device.

9. How Ground Truth for Training Set was Established

Not applicable. This is not an AI/ML device.

Summary of Device and Evidence:

The Treace Medical Concepts (TMC) Compression Implant System is a metallic bone fixation appliance. Its clearance is based on demonstrating substantial equivalence to predicate devices (Z-Medical Z-Staple and Wright Medical FuseForce™ Flex Dynamic Compression System). The primary evidence for this equivalence, specifically regarding performance, is the mechanical testing of the device against the ASTM F564 standard for Bone Metallic Staples. The manufacturer states that the device successfully met all acceptance criteria defined by this standard, indicating similar mechanical properties and safety/effectiveness as the predicate device.

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The TMC Hammertoe Fixation System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the TMC Hammertoe Fixation System can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

The Implantable K-Wires are indicated for use in fixation of bone reconstructions, and as guide pins for insertion of other implants. Additionally, Implantable K-Wires are indicated for the fixation of osteotomies and reconstruction of the lesser toe following correction procedures for hammertoe, claw toe, and metatarsophalangeal joint instability.

The Treace Medical Concepts (TMC) Hammertoe Fixation System is for the fixation of osteotomies and reconstruction of the lesser toes. The cannulated implant is made of PEEK (Polyetheretherketone) according to ASTM F2026 and is available in different sizes. The implants are delivered sterile packaged and for single use only.

The Implantable K-wire is made from stainless steel according to ASTM F138 and available in different sizes. The k-wire is delivered sterile packaged and for single use only.

All implantable components are provided sterile by gamma irradiation.

The provided text describes a 510(k) premarket notification for a medical device called the Treace Medical Concepts (TMC) Hammertoe Fixation System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to prove safety and effectiveness. Therefore, the information typically requested in your prompt regarding acceptance criteria and a study to prove the device meets these criteria is not directly applicable in the context of this 510(k) summary.

Instead, the submission focuses on performance testing to demonstrate that the new device is as safe and effective as the predicate devices. The "acceptance criteria" here implicitly refer to the mechanical properties required to be substantially equivalent to the predicate devices and conform to relevant ASTM standards.

Here's an attempt to structure the information based on your request, understanding that it's framed for a different type of submission (e.g., a de novo or PMA where new clinical data might be generated):

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The performance testing for substantial equivalence typically involves a predetermined number of physical units subjected to mechanical tests, as per the ASTM standards referenced. This is not a patient-based "test set" in the sense of clinical data.
• Data Provenance: The data provenance is from the mechanical testing performed by the manufacturer, Treace Medical Concepts, Inc. This is not clinical data (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable: For a 510(k) submission based on mechanical testing for substantial equivalence, "ground truth" established by human experts in the clinical diagnostic sense is not involved. The "ground truth" for mechanical performance is defined by the relevant ASTM standards and the performance characteristics of the predicate devices.

4. Adjudication Method for the Test Set

• Not Applicable: There is no clinical "test set" in need of adjudication. Mechanical testing results are compared against predefined criteria and predicate device performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No: An MRMC comparative effectiveness study is designed to assess the impact of a device on human reader performance, typically in the context of imaging or diagnostics. This is a surgical fixation device, and the submission is based on mechanical equivalence, not clinical diagnostic performance.

6. Standalone (Algorithm Only) Performance Study

• No: This is a physical medical device (implants and K-wires), not an algorithm or AI-based system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

• Mechanical Standards and Predicate Device Performance: The "ground truth" for this submission is adherence to established ASTM mechanical testing standards (e.g., F382-17, F543-17) and demonstrating performance comparable to the legally marketed predicate devices (In2Bones SAS, Duafit® interphalangeal implant (K132912) and Wright Medical Technology Inc., PRO-TOE® Hammertoe Fixation System (K140148)).

8. Sample Size for the Training Set

• Not Applicable: There is no "training set" in the context of a 510(k) submission for a physical device. This terminology relates to machine learning models, which are not involved here.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable: As there is no training set or machine learning involved, this question is not relevant.

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The TMC Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the feet. The system can be used in both and pediatric patients aged > 12 years. In the foot, the system can be used for the following specific examples:

• First metatarsal osteotomies for hallux valgus correction such as:
• Opening base wedge osteotomy
• · Closing base wedge osteotomy
• · Crescentic osteotomy
• · Proximal Chevron osteotomy
• · Distal Chevron osteotomy (Austin)
• First metatarsal fracture fixation
• 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
• 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-Cubiod (CC) Fusion
• Medial Column Fusion

The Treace Medical Concepts (TMC) Plating System includes straight, L-shaped, H- shaped, curved and Python plates and associated screws. The plates and screws are intended for use in stabilization and fixation of fractures, revision procedures, fusions, and reconstructions (osteotomy) of small bones of the foot.
The purpose of this special 510(k) is to clarify the indications for use for the Treace Medical Concepts (TMC) Plating System (K192504 and K200961).
All implantable components are manufactured from medical grade titanium alloy (Ti-6AI-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

This document is a 510(k) premarket notification for a medical device called the "Treace Medical Concepts (TMC) Plating System." It is a submission to the FDA seeking clearance to market a device that is demonstrably "substantially equivalent" to legally marketed predicate devices.

Crucially, this document focuses on demonstrating substantial equivalence through a clarification of 'indications for use' and states that 'performance testing was not required.' This implies that the device is a modification or re-statement of an existing cleared device, rather than an entirely new device requiring extensive new performance validation studies.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for de novo device approvals or for devices requiring complex performance validation (e.g., AI/ML-based diagnostic devices), is not present in this document.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

Not applicable/Provided. The document states: "Performance testing was not required to support the clarification of the indications statement." The basis for clearance is "substantial equivalence" to predicate devices, not performance against specific acceptance criteria developed for a new device study.

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

Not applicable. No performance studies with test sets were conducted or reported in this document, as "Performance testing was not required."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment for a test set was performed or reported.

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

Not applicable. No test set adjudication was performed or reported.

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

Not applicable. This device is a metallic bone fixation system, not an AI/ML-based diagnostic or assistive technology. Therefore, MRMC studies and AI-related effectiveness are irrelevant to this submission.

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

Not applicable. This is not an algorithm or software device.

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

Not applicable. No specific ground truth was established for performance testing as no such testing was required. The "ground truth" for this submission is effectively the established safety and effectiveness of the multiple predicate devices to which the TMC Plating System is demonstrated to be substantially equivalent.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary of the document's approach to "proving" the device meets acceptance criteria:

The "acceptance criteria" in this context are not quantitative performance metrics from a new study, but rather the qualitative assessment of "substantial equivalence" to existing, legally marketed devices.

The "study that proves the device meets the acceptance criteria" in this case is a comparison to predicate devices and a risk analysis, as stated:

• "The subject TMC Plating System is manufactured from titanium (Ti-6Al-4V-ELI) and is intended to be used in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet, identical to the predicate devices."
• "Indications for use have been clarified and were found through a risk analysis including literature review to be equivalent to the predicate device."
• "Thus, it can be concluded that the subject changes to the Indications for Use do not raise new questions about safety and effectiveness."
• "The Treace Medical Concepts (TMC) Screw Fixation System has identical design and construction to the predicate devices. A risk analysis found that the Indications for Use statement remain substantially equivalent to those of the system in previous clearances. Therefore, it can be concluded that the subject device is as safe, as effective, and performs as safely and effectively as the predicate device."

In essence, the "proof" is the argument that the refined indications for use and the device's design and materials are so similar to previously cleared devices that no new performance testing is necessary to establish its safety and effectiveness.

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