Search Results

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.

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 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.

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 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.

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)

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.

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. 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-Cuboid (CC) Fusion
• -- Medial Column Fusion
• -- Arthrodesis of the first metatarsophalangeal joint (MTP)

The Treace Medical Concepts (TMC) Plating System includes a curved PYTHON™ plate to accommodate the tarso-metatarsal (TMT) joint, which is an indication of the TMC Plating System. The plate is available in both right and left configurations and is used with compatible 2.5 mm diameter screws in lengths ranging from 10-28 mm. 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).

The provided document is a 510(k) summary for the Treace Medical Concepts (TMC) Plating System. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, as typically understood for AI/ML or diagnostic device performance evaluation.

Here's why and what information is available:

• Device Type: The TMC Plating System is a metallic bone fixation appliance, not an AI/ML or diagnostic device. Its clearance relies on demonstrating that its mechanical performance is equivalent to an already cleared device, not on diagnostic accuracy metrics.
• Regulatory Pathway: A 510(k) submission generally requires demonstration of substantial equivalence through design comparisons, material testing, and mechanical performance testing, rather than clinical efficacy trials that would generate acceptance criteria and detailed performance statistics like sensitivity, specificity, or ROC AUC.

However, I can interpret some of the information in the context of "acceptance criteria" as applied to mechanical testing and "study" as referring to the mechanical testing performed:

1. Table of "Acceptance Criteria" and Reported Device Performance (as interpreted for a mechanical device):

Study That Proves Device Meets "Acceptance Criteria":

The "study" referenced is mechanical testing, specifically dynamic 4-point bend testing performed according to ASTM F382.

Regarding the other requested information, it is not present in the document because it pertains to AI/ML or diagnostic performance studies, which were not conducted for this type of device submission:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This was mechanical testing, not a clinical study on a patient test set.
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. Ground truth for mechanical equivalence is established through engineering specifications and comparison to a predicate device's known mechanical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. No human reader involvement or AI assistance for implantable hardware.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is involved. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, the "ground truth" for substantial equivalence is based on:
   • Mechanical equivalence to the predicate device (as determined by ASTM F382 testing).
   • Material equivalence (both devices use medical grade titanium alloy Ti6Al4V-ELI).
   • Design and dimensional equivalence to the predicate device.
8. The sample size for the training set: Not applicable. There is no training set for a mechanical device.
9. How the ground truth for the training set was established: Not applicable.

In summary, the document describes a 510(k) submission for a bone plating system, where "acceptance criteria" are demonstrated through engineering specification comparison and mechanical testing to an already cleared predicate device, rather than through clinical performance metrics and expert-derived ground truth as would be relevant for AI/ML or diagnostic devices.

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. 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-Cuboid (CC) Fusion
• · Medial Column Fusion
• · Arthrodesis of the first metatarsophalangeal joint (MTP)

The Treace Medical Concepts (TMC) Plating System includes straight, L-shaped, and H- shaped 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. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).

The provided documents are a 510(k) premarket notification for a medical device called the "Treace Medical Concepts (TMC) Plating System." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria, sample sizes, and ground truth establishment in the way an AI/ML device would.

Therefore, the specific information requested about acceptance criteria, study design parameters (sample sizes for test and training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, standalone performance), and ground truth types are not applicable to this 510(k) submission for the TMC Plating System.

The provided text describes performance testing focused on mechanical properties to demonstrate substantial equivalence to predicate devices. Here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Mechanical testing, including static and dynamic 4 point bend testing and static torsional and pullout testing have been performed per ASTM F382 and ASTM F543 on the subject TMC Plating System and the results have shown them to be substantially equivalent to the predicate devices."

This indicates that the acceptance criterion was "substantially equivalent to the predicate devices" based on the results of the specified ASTM tests. The specific numerical performance values are not provided in this summary.

2. Sample size used for the test set and the data provenance: Not applicable to a mechanical testing study for a 510(k) submission. No patient data was used.

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 testing is based on engineering standards and measurements, not expert consensus.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 not an AI/ML device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used: For mechanical testing, the "ground truth" would be the established engineering standards (ASTM F382 and ASTM F543) and the measured physical properties of the materials and designs.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

In summary: The provided document is for a traditional medical device (bone plating system) seeking 510(k) clearance based on substantial equivalence. The "study" referenced is mechanical performance testing, not a clinical study involving patients or an AI/ML algorithm. Therefore, many of the requested details, which are typical for AI/ML device evaluations, are not present or not relevant here.

Ask a specific question about this device