(101 days)
The TriMed ASET™ Foot Plating System is intended for use in stabilization of fractures, revision procedures, joint fusion, reconstruction, deformity corrections, osteotomies, and non-unions of small bones of the feet.
Specific examples include:
First metatarsal osteotomies for hallux valgus and hallux varus correction including:
- Opening/closing base wedge osteotomies,
- Distal and proximal chevron osteotomies,
Arthrodesis of the first metatarsal cuneiform joint (Lapidus Fusion);
Arthrodesis of the first metatarsophalangeal joint (MTP) including: - Primary MTP fusion due to hallux rigidus and/or hallux valgus,
- Revision MTP fusion,
- Revision of failed first MTP arthroplasty implant,
Metatarsal and Phalanges: - Metatarsal and phalanges fractures and osteotomies;
Mid / Hindfoot Fusions: - Tarsometatarsal (TMT) fusions/stabilization,
- Intercuneiform fusions.
The TriMed ASET™ Foot Plating System is a multi-indication total foot plating system which provides surgical options for fractures, osteotomes and arthrodesis of the forefoot, midfoot and hindfoot. Plates and screws are made from implant grade titanium alloy. Implant offerings are as followed: 15 MTP fusion plates, Lapidus (With and without hooks) plates, Universal Straight plates, Universal Hook plates, and Universal T-Plates. 2.7mm, 3.5mm, and 4.0mm variable angle and nonlocking screws are also included.
The provided text describes a 510(k) premarket notification for a medical device called the "TriMed ASET™ Foot Plating System." This document is a regulatory submission to the FDA (Food and Drug Administration) to demonstrate substantial equivalence to a legally marketed predicate device, not a study proving the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity in an AI/imaging context.
The document discusses mechanical and biological acceptance criteria for the physical device (plates and screws), not performance criteria related to a diagnostic or AI-driven medical device.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of device and submission.
Here's how the available information relates to your request:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Plates (Static Bending) | Subject plates were stronger than the predicate. |
| Plates (Fatigue Bending) | Subject plates were equivalent to the predicate. |
| Screws (Torsional Strength) | Subject screws were stronger than the predicate. |
| Screws (Axial Pullout Testing) | Subject screws were stronger than the predicate. |
| Screws (Insertion/Removal Torque) | Insertion torque was equivalent to the predicate and appropriate compared to torsional strength. |
| Biological/Structural | Similar technological characteristics, indications for use, and performance testing support substantial equivalence. Designs do not adversely affect product performance, cleanability, and sterilization. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document describes mechanical testing of physical implants, not a clinical study involving human data or a test set in the context of an AI/imaging device. The "test set" would refer to the physical samples of the plates and screws used in the mechanical tests. The document does not specify the number of physical samples tested.
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. Ground truth in this context refers to the measured mechanical properties. These are established through standardized engineering tests, not human expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This pertains to consensus among experts in interpreting clinical data, which is not relevant for mechanical 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
- No. This is a mechanical device, not an AI or imaging device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the device's performance is based on engineering standards and mechanical testing results (e.g., measured strength, fatigue life, torque, pullout force) as compared to the predicate device.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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.