(45 days)
The TC Plating System is intended for essentially non-load bearing stabilization of small bone fragments in fresh fractures, revision procedures, joint fusion of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe and pelvis.
Specific examples of use in the foot include:
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
- First metatarsal osteotomies for hallux valgus correction including:
- · 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)
- Arthrodesis of the first metatarsophalangeal joint (MTP) including:
- Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
- · Revision MTP Fusion
- · Revision of failed first MTP Arthroplasty implant
The TOTAL COMPRESSION PLATING SYSTEM is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of small bone fragments. Most of the plates are scalloped in shape to allow easier bending to fit the contour of the bone. There are also non-scalloped plates to provide greater strength. The plates include straight, right, and left configurations.
This document is a 510(k) premarket notification for a medical device called the "Total Compression Plating (TCP) System." It is primarily focused on demonstrating substantial equivalence to predicate devices based on mechanical testing and engineering analysis, rather than clinical studies with human participants or AI performance.
Therefore, the requested information about acceptance criteria, study design, and performance metrics related to AI or human reader improvement with AI assistance, expert review, training sets, etc., is not applicable or cannot be extracted from this type of regulatory submission. This document details the physical device itself (plates for bone fixation), not a diagnostic or interpretive AI tool.
Here's an attempt to answer the questions based only on the provided text, noting where information is explicitly not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Goal for Equivalence) | Reported Device Performance |
|---|---|
| Performance of the subject plating system is statistically equivalent or greater than the predicate plating system across metrics of ultimate load, yielding bending moment, bending stiffness, and maximum deflection (as per ASTM F2193 for cantilever bend testing). | Mechanical testing and engineering analysis has shown that the performance of the subject plating system is statistically equivalent or greater than the predicate plating system. Specifically, cantilever bend testing was performed and demonstrated equivalence or superiority across ultimate load, yielding bending moment, bending stiffness, and maximum deflection according to ASTM F2193. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated in terms of a "test set" like for an AI algorithm. The testing described is mechanical testing of the physical device. The number of samples (plates, screws) tested would be part of the detailed mechanical test report, which is not included in this summary.
- Data Provenance: Not applicable in the context of clinical data for AI. This relates to mechanical testing of physical products.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This device is a physical bone fixation system, not a diagnostic tool requiring expert interpretation or ground truth establishment in a clinical sense. The "ground truth" for mechanical testing is derived from the testing standards (ASTM F2193) and the results obtained from the physical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are used in clinical studies involving human interpretation or challenging diagnoses. This submission relies on objective mechanical engineering tests.
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
- No. An MRMC study was not done. This is a physical medical device (bone plate), not an AI-assisted diagnostic tool. No AI assistance or human readers are involved in its primary function or the equivalence testing described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This refers to an AI algorithm. The device is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Mechanical Test Standards and Results: For the mechanical testing, the "ground truth" is defined by the physical properties measured according to established standards (ASTM F2193) and compared against a predicate device. This is an objective measurement of material and structural performance, not a clinical "ground truth."
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of an AI algorithm for this device submission.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set or associated ground truth for 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.