(30 days)
The TMC Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of the feet. The system can be used in both pediatric (aged >12-21) and adult (aged 22 and over) patients. In the foot, the system can be used for the following specific examples:
- Osteotomy of the 1st metatarsal for the treatment of deformity (e.g., hallux valgus) such as:
- Opening base wedge osteotomy
- Closing base wedge osteotomy
- Crescentic osteotomy
- Proximal Chevron osteotomy
- Distal Chevron osteotomy (Austin)
- Transverse osteotomy
- Arthrodesis of the tarsometatarsal (TMT) joints or the 1st metatarsophalangeal (MTP) joint for the treatment of deformity (e.g., hallux valgus, hallux rigidus, metatarsus adductus) and/or arthritis
- First metatarsal fracture fixation
- 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
- Intercuneiform Fusions
- Navicular-Cuneiform (NC) Fusion
- Talo-Navicular (TN) Fusion
- Calcaneo-Cuboid (CC) Fusion
- Medial Column Fusion
The Treace Medical Concepts (TMC) Plating System includes straight, L-shaped, anatomically curved plates, and intramedullary plates. The system includes 2.5mm, 2.7mm, and 3.0mm diameter cannulated and non-cannulated, locking, and non-locking screws ranging in lengths from 10-36mm. The plates and screws are intended for use in stabilization and fixation of fractures, revision procedures, fusions, and reconstructions (osteotomy) of the foot. All implantable components are manufactured from implant grade titanium alloy (Ti6A14V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.
The provided text is a 510(k) summary for the Treace Medical Concepts (TMC) Plating System. It focuses on demonstrating substantial equivalence to a predicate device for a orthopedic plating system used in foot surgery.
It does not contain information about an AI/ML powered device, nor does it discuss acceptance criteria and performance data related to an AI/ML algorithm's effectiveness in medical image analysis or similar tasks.
Therefore, I cannot extract the information required to populate the fields you listed, as they are specific to the validation of AI/ML software in medical devices. The document describes mechanical performance testing for an orthopedic implant, not software performance.
The fields you requested are relevant to AI/ML device validation and would typically be found in a different type of submission (e.g., a De Novo request or a 510(k) for an AI/ML diagnostic software).
To reiterate, the document contains no information on:
- Acceptance criteria for an AI/ML algorithm.
- Reported device performance for an AI/ML algorithm.
- Sample size for test sets or data provenance for AI/ML validation.
- Number of experts or their qualifications for establishing ground truth for AI/ML.
- Adjudication methods for AI/ML ground truth.
- MRMC comparative effectiveness study for AI/ML.
- Standalone performance for an AI/ML algorithm.
- Type of ground truth, training set size, or training set ground truth establishment for AI/ML.
§ 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.