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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 previously cleared Treace Medical Concepts, Inc (TMC) Plating System includes the PYTHON® plate. The PYTHON® Plate is a curved plate available in both left and right configurations. The plate is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. This submission adds re-usable device specific trial instruments as Class II Instruments (the subject device) to this system. The trial instruments are manufactured from Titanium alloy conforming to ASTM F136.

The provided text describes a 510(k) premarket notification for the "PYTHON Plate Trial Instruments." This submission focuses on the substantial equivalence of trial instruments to an already cleared plating system. Crucially, the document does not contain information about studies proving the device meets acceptance criteria related to AI/software performance, diagnostic accuracy, or human reader improvement.

The "Performance Testing" section explicitly states: "Engineering analysis has confirmed the subject instruments to be substantially equivalent to the predicate PYTHON® Plates." This indicates the evaluation was likely based on mechanical properties, material safety, and design equivalence, typical for surgical instruments, rather than performance metrics related to diagnostic algorithms or AI assistance.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance: No such criteria or performance data for an AI/software device are present.
2. Sample sizes used for the test set and the data provenance: Not applicable, as there's no diagnostic test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic ground truth establishment process described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable; this device is a surgical instrument, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document pertains to the regulatory clearance of surgical trial instruments, not an AI-powered diagnostic device. Therefore, the requested information regarding AI acceptance criteria and performance studies is not available in this text.

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