(255 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 adult and pediatric patients aged >12 years. 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 10-32mm. The plates and screws are intended for use in stabilization and fixation of fractures, revision procedures, fusions, and reconstructions (osteotomy) of the foot.
The purpose of this traditional 510(k) submission is to introduce additional plate and screw options within the Treace Medical Concepts (TMC) Plating System.
All implantable components are manufactured from implant grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.
The provided document is a 510(k) premarket notification for a medical device called the "Treace Medical Concepts (TMC) Plating System." This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through clinical trials with specific acceptance criteria as you might see for novel AI/ML devices.
Therefore, the document does not contain the information requested regarding acceptance criteria related to device performance in an AI/ML context, nor details about a study designed to prove the device meets such criteria. Specifically:
- No acceptance criteria table or reported device performance for an AI/ML system: The document describes a metallic bone fixation system, not an AI/ML diagnostic tool. Its "performance" is evaluated through mechanical bench testing, not clinical metrics like sensitivity, specificity, or AUC.
- No sample sizes for test sets, data provenance, expert ground truth establishment, or adjudication methods: These are all concepts relevant to the validation of AI/ML systems, which are not applicable to the mechanical plating system described.
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study: This is a study design used to assess the impact of AI assistance on human reader performance, which is not applicable here.
- No standalone (algorithm-only) performance: Again, this relates to AI/ML systems.
- No type of ground truth (expert consensus, pathology, outcomes data): Ground truth in this context typically refers to a definitive diagnosis or determination for an AI system's output. For a physical plating system, "ground truth" would be related to its mechanical properties meeting specifications.
- No training set sample size or ground truth establishment for a training set: These concepts are specific to the development and training of AI/ML models.
The "Performance Testing" section states:
"Mechanical testing including static and dynamic 4-point bend testing and static torsion, driving torque, removal torque, and axial pullout based on ASTM F382 and ASTM F543 were performed. Further, engineering analysis of the worst-case cross-sections and geometries on the subject and predicate devices were evaluated. The mechanical testing, cross-sectional, and geometrical analysis demonstrated the subject devices to be substantially equivalent to the predicate devices."
This indicates that the "study" proving the device meets requirements was a series of mechanical tests and engineering analyses to demonstrate substantial equivalence to existing predicate devices. This is distinctly different from the type of performance evaluation required for AI/ML-based medical devices.
In summary, the provided text does not describe an AI/ML device or its associated acceptance criteria and validation study in the manner requested. It is a traditional 510(k) summary for a mechanical orthopedic implant.
§ 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.