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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 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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