(80 days)
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.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantially equivalent to predicate devices based on mechanical testing per ASTM F382 and ASTM F543. | Results shown to be substantially equivalent to predicate devices. |
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.
§ 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.