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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. 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.

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