(48 days)
The TMC Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the feet. 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
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· Lateral Column Lengthening (Evans Osteotomy)
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· 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-Cubiod (CC) Fusion
- Medial Column Fusion
- Arthrodesis of the first metatarsophalangeal joint (MTP)
The previously cleared Treace Medical Concepts (TMC) Plating System includes straight, Lshaped, and H- shaped , and Python 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.
The purpose of this special 510(k) submission is to expand the size ranges offered for the plates and screws, as well as add a curved plate option.
All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.
The provided text describes a 510(k) premarket notification for the Treace Medical Concepts (TMC) Plating System. However, this submission focuses on expanding the size ranges of existing plates and screws and adding a curved plate option. The core of the testing described is mechanical performance testing of these physical devices, not an AI/algorithm-based medical device.
Therefore, many of the requested criteria related to AI/algorithm performance (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission as described in the provided document.
Here's a breakdown of what can be extracted or inferred from the text regarding acceptance criteria and device performance for this specific submission:
1. A table of acceptance criteria and the reported device performance:
Since this is a mechanical device, the "acceptance criteria" are implied to be that the new components perform at least as well as, or better than, the predicate devices, and that they meet relevant ASTM standards for bone fixation devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets or exceeds mechanical performance of predicate devices | "The results have shown the larger plates and screws to be substantially equivalent to the previously cleared devices." |
| Complies with ASTM F382 (4-point bend testing for metallic bone plates) | "Mechanical testing, including static and dynamic 4-point bend testing... have been performed per ASTM F382" |
| Complies with ASTM F543 (Static and torsional pullout testing for metallic bone screws) | "...static torsional and pullout testing have been performed per... ASTM F543 on the subject plates and screws." |
| No new worst-case scenario introduced by new sizes/shapes | "Thus, the addition of these plates and screws does not present a new worst case." |
| Biocompatibility (material) | "All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136" (implies biocompatibility suitability) |
Regarding the other points, they are largely not applicable due to the nature of the device:
2. Sample sized used for the test set and the data provenance:
- Not applicable in the context of clinical data/AI validation. For mechanical testing, the "sample size" would refer to the number of physical plates/screws tested. This detail is not provided in the summary. The data provenance would be laboratory testing.
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 devices is established through adherence to engineering standards and direct physical measurements, not expert consensus on medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This refers to clinical image interpretation or diagnosis consensus, which is not relevant to mechanical device testing.
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 a study design for evaluating AI systems in assisted reading scenarios, not for mechanical implants.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This describes AI performance, not mechanical device performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For mechanical devices, the "ground truth" is adherence to established mechanical properties and engineering standards. This is determined by validated test methods (e.g., ASTM F382, ASTM F543) and physical measurements of strength, fatigue, pullout force, etc.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the AI sense for a mechanical device.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for a mechanical device.
In summary, the provided document details a 510(k) submission for a physical medical device (bone plating system) where the primary "study" is mechanical performance testing to ensure the new component sizes and shapes are substantially equivalent to existing cleared devices based on relevant ASTM standards. The document does not describe the validation of an AI/algorithm-based device.
§ 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.