(28 days)
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:
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First metatarsal osteotomies for hallux valgus correction such as:
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· Opening base wedge osteotomy
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Closing base wedge osteotomy
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· Crescentic osteotomy
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Proximal Chevron osteotomy
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· Distal Chevron osteotomy (Austin)
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First metatarsal fracture fixation
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Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
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Flatfoot Osteotomies
- · Lateral Column Lengthening (Evans Osteotomy)
- Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
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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
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Medial Column Fusion
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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.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Dynamic 4-point bend performance (per ASTM F382) equivalent to predicate. | "Dynamic 4-point bend testing has been performed per ASTM F382 on the subject plates. The results have shown subject device to be substantially equivalent to the primary predicate." |
| Static 4-point bend performance equivalent to predicate. | "Additionally, an engineering analysis of the subject device concluded that its performance with respect to static 4-point bend testing is equivalent to the predicate device. Thus, the addition of these plates does not present a new worst case with respect to static or dynamic 4-point bend testing." |
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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.