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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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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.

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 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.

Ask a specific question about this device

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

The TMC Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the system can be used in both adult and pediatric patients. 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 first metatarsalcuneiform joint (Lapidus Fusion)

• 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
  • 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
  • Intercuneiform Fusions
  • Navicular-Cuneiform (NC) Fusion
  • Talo-Navicular (TN) Fusion
  • Calcaneo-Cubiod (CC) Fusion

• Medial Column Fusion

• Arthrodesis of the first metatarsophalangeal joint (MTP)

The previously cleared Treace Medical Concepts (TMC) Plating System includes straight, Lshaped, H- shaped, and Python plates and 2.5mm-3.0mm diameter screws in lengths ranging from 10-32mm. 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) submission is to add the Lapiplasty® Mini-Incision™ Plates to the TMC Plating System. The subject plates are based on the design of the previously cleared Lapiplasty® S1 Plate (K192504). The subject plates are used with the same screws as the predicate plate.

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

This document describes a 510(k) premarket notification for the Treace Medical Concepts (TMC) Plating System, specifically an update to include Lapiplasty® Mini-Incision™ Plates. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K192504).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance target with a specific threshold. Instead, it relies on demonstrating substantial equivalence to a predicate device through bench testing and engineering analysis. The "performance" is reported as the subject device being substantially equivalent to the predicate.

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

The study described is bench testing and engineering analysis of the physical device components.

• Sample Size for Test Set: Not explicitly stated as "sample size" in the context of patient data. For bench testing (e.g., dynamic 4-point bend), a certain number of plates would have been tested. This number is not provided, but standard ASTM F382 testing protocols would dictate the number of samples.
• Data Provenance: The data originates from laboratory bench testing and engineering analysis, rather than human subjects. Therefore, "country of origin of the data" and "retrospective or prospective" are not applicable in the typical clinical study sense. It's a prospective engineering evaluation of the manufactured device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not a study involving human interpretation of medical images or data requiring expert consensus for ground truth. The "ground truth" for material properties and mechanical performance is established by the standardized methods of ASTM F382 and engineering principles.

4. Adjudication Method for the Test Set

Not applicable. There is no ambiguous data requiring adjudication by multiple experts. The tests are mechanical and analytical, yielding objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission focuses on the mechanical substantial equivalence of a medical device (surgical plates) through bench testing, not on the interpretative performance of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device (surgical plates), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims is based on standardized biomechanical testing methods (ASTM F382) and engineering principles/analysis which predict and measure the mechanical properties of the plates. The "ground truth" is the empirically measured mechanical characteristics and the theoretical predictions from engineering models.

8. The Sample Size for the Training Set

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

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

Not applicable, as no training set (for AI/ML) was used or is relevant to this device submission.

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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 adult and pediatric patients. 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 first metatarsalcuneiform joint (Lapidus Fusion)

• 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
• · 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
• · Intercuneiform Fusions
• · Navicular-Cuneiform (NC) Fusion
• · Talo-Navicular (TN) Fusion
• Calcaneo-Cubiod (CC) Fusion
• Medial Column Fusion
• Arthrodesis of the first metatarsophalangeal joint (MTP)

The previously cleared Treace Medical Concepts (TMC) Plating System includes straight, Lshaped, and H- shaped , and Python plates and 2.5mm diameter screws in lengths ranging from 10-28mm. 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) submission is to expand the size ranges offered for the plates and screws, as well as add a curved plate option.

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 describes a 510(k) premarket notification for the Treace Medical Concepts (TMC) Plating System. However, this submission focuses on expanding the size ranges of existing plates and screws and adding a curved plate option. The core of the testing described is mechanical performance testing of these physical devices, not an AI/algorithm-based medical device.

Therefore, many of the requested criteria related to AI/algorithm performance (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission as described in the provided document.

Here's a breakdown of what can be extracted or inferred from the text regarding acceptance criteria and device performance for this specific submission:

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

Since this is a mechanical device, the "acceptance criteria" are implied to be that the new components perform at least as well as, or better than, the predicate devices, and that they meet relevant ASTM standards for bone fixation devices.

Regarding the other points, they are largely not applicable due to the nature of the device:

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

• Not applicable in the context of clinical data/AI validation. For mechanical testing, the "sample size" would refer to the number of physical plates/screws tested. This detail is not provided in the summary. The data provenance would be laboratory testing.

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

• Not applicable. Ground truth for mechanical devices is established through adherence to engineering standards and direct physical measurements, not expert consensus on medical images or patient outcomes.

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

• Not applicable. This refers to clinical image interpretation or diagnosis consensus, which is not relevant to mechanical device 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:

• Not applicable. This is a study design for evaluating AI systems in assisted reading scenarios, not for mechanical implants.

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

• Not applicable. This describes AI performance, not mechanical device performance.

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

• For mechanical devices, the "ground truth" is adherence to established mechanical properties and engineering standards. This is determined by validated test methods (e.g., ASTM F382, ASTM F543) and physical measurements of strength, fatigue, pullout force, etc.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the AI sense for a mechanical device.

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

• Not applicable. As above, no training set for a mechanical device.

In summary, the provided document details a 510(k) submission for a physical medical device (bone plating system) where the primary "study" is mechanical performance testing to ensure the new component sizes and shapes are substantially equivalent to existing cleared devices based on relevant ASTM standards. The document does not describe the validation of an AI/algorithm-based device.

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The Treace Medical Concepts, Inc (TMC) Snap-Off Screw System is intended for use for adult and pediatric patients, as 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, 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
• fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
• Akin type osteotomy

Not for spinal use.

The Treace Medical Concepts, Inc (TMC) Snap -Off Screw System includes self-drilling and selftapping screws provided in diameters of 2.0mm (lengths 10mm-20mm) and 2.7mm(lengths 8mm-20mm).

The screws are composed of titanium alloy conforming to ASTM F136.

When evaluating medical device submissions, the FDA scrutinizes various aspects, including performance, safety, and substantial equivalence to legally marketed predicate devices. The document provided, a 510(k) summary for the Treace Medical Concepts (TMC) Snap-Off Screw System (K183363), outlines the device's characteristics and the testing conducted to support its substantial equivalence.

Based on the provided text, the device in question is a bone fixation fastener, specifically the Treace Medical Concepts, Inc (TMC) Snap-Off Screw System. The regulatory classification for this device is Class II, under regulation 21 CFR 888.3040 for Smooth or threaded metallic bone fixation fasteners.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for demonstrating substantial equivalence for this type of device typically involve mechanical performance characteristics that demonstrate the device is as safe and effective as its predicate. Based on the document, the key performance criteria evaluated were:

The document states, "This testing confirmed the subject screws to be substantially equivalent to the predicate Integra SPIN Snap-Off Screw." This implies that the performance of the TMC Snap-Off Screw System fell within the acceptable range or met the same performance standards established by the predicate device for torsion and pull-out strength.

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

• Sample Size for Test Set: The document does not explicitly state the sample size used for the performance testing (torsion and pull-out). It only mentions that performance testing was performed.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given that it's a 510(k) submission to the US FDA, the testing would generally be expected to follow US standards, but the origin of the data samples (e.g., specific manufacturing batches) is not detailed. The mechanical testing described is typically conducted in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• Not Applicable. For the mechanical performance testing described (torsion and pull-out), the "ground truth" is established by physical measurements against recognized ASTM standards (ASTM F543), not by expert interpretation. Therefore, the concept of "experts" establishing ground truth in the context of human interpretation of data (e.g., medical imaging) does not apply here.

4. Adjudication Method for the Test Set:

• Not Applicable. As the ground truth is established through standardized mechanical testing, there is no need for an adjudication method as would be used in a study involving human interpretation or clinical endpoints.

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

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned or implied. The submission focuses on substantial equivalence based on device design, materials, indications for use, and mechanical performance testing against a predicate device. This type of study is more common for diagnostic imaging AI algorithms where human reader performance is a key aspect.

6. Standalone Performance:

• A standalone performance evaluation was conducted in terms of mechanical properties. The torsion and pull-out testing evaluates the intrinsic physical properties of the device (the screws themselves) in a simulated environment, independent of human interaction during surgery or in a clinical setting for outcome. The testing aims to show the device's inherent mechanical strength.

7. Type of Ground Truth Used:

• The ground truth for the performance testing was based on engineering standards and specifications, specifically ASTM F543 for torsion and pull-out properties. The "truth" is whether the device meets or exceeds the mechanical properties demonstrated by the predicate device when tested according to this standard.

8. Sample Size for the Training Set:

• Not Applicable. Since this is a mechanical device, not a machine learning or AI algorithm, there is no "training set" in the context of data used to train a model. The design and manufacturing processes are established based on engineering principles and material science.

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

• Not Applicable. As there is no training set for an algorithm, the concept of establishing ground truth for it does not apply. The device's design is based on established engineering principles and the performance of existing predicate devices.

Summary of Key Findings based on the document:

The 510(k) summary demonstrates substantial equivalence of the TMC Snap-Off Screw System to its predicate devices (Integra SPIN Snap-Off Screw and TMC Compression Screw System) primarily through:

• Comparison of Indications for Use, Design, Dimensions, and Materials: The subject device's features are compared side-by-side with the predicates to show similarity.
• Mechanical Performance Testing: Specifically, torsion and pull-out properties tested according to ASTM F543 were found to be substantially equivalent to the predicate Integra SPIN Snap-Off Screw.

The document does not delve into clinical efficacy studies, multi-reader studies, or large-scale clinical outcome data, as these are generally not required for 510(k) clearance of Class II orthopedic fixation devices when substantial equivalence can be demonstrated through design, material, and mechanical property comparisons to legally marketed predicate devices.

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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 system can be used in both adult and pediatric patients. 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 first metatarsalcuneiform joint (Lapidus Fusion)
• 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
• · 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
• · Intercuneiform Fusions
• · Navicular-Cuneiform (NC) Fusion
• · Talo-Navicular (TN) Fusion
• Calcaneo-Cubiod (CC) Fusion
• Medial Column Fusion
• Arthrodesis of the first metatarsophalangeal joint (MTP)

This traditional 510(k) is to obtain clearance for expanded indications for the Treace Medical Concepts (TMC) Plating System implants. The subject TMC Plating System implants include a variety of previously cleared bone plates and screws. The plates and screws are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F136.

The Treace Medical Concepts (TMC) Plating System is a medical device intended for stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the feet in both adult and pediatric patients.

Acceptance Criteria and Device Performance:

Since this submission aimed to expand the indications for use to include pediatric patients and the device itself (implants) had been previously cleared in other 510(k)s, no new performance testing was provided for this specific submission (K183321). This is explicitly stated: "Performance testing was not required to support the expanded indications for the subject device." The substantial equivalence determination was based on the similarity of the revised indications to those of predicate devices that already included pediatric use.

Therefore, for this specific 510(k) submission, a table of acceptance criteria and reported device performance (in terms of specific quantitative outcomes like accuracy, sensitivity, specificity, etc.) is not applicable as no new performance testing was conducted or provided to prove the device meets new acceptance criteria. The acceptance was based on demonstrating substantial equivalence to already cleared devices with similar expanded indications.

Details of the Study (or lack thereof for this submission):

• 1. A table of acceptance criteria and the reported device performance: Not applicable for this specific submission as no new performance testing was conducted. The acceptance was based on substantial equivalence.

• 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 new test set data was provided.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set was used.

• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set was used.

• 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 plating system, not an AI-assisted diagnostic or treatment planning tool.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a plating system.

• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No new ground truth data was generated for this submission. The substantial equivalence was based on existing predicate devices.

• 8. The sample size for the training set: Not applicable. This device is a plating system, not an AI/machine learning device requiring a training set.

• 9. How the ground truth for the training set was established: Not applicable. This device is a plating system.

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