(29 days)
The Synthes TomoFix™ Osteotomy System is intended for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.
The Synthes (USA) TomoFix™ Medial High Tibia Plate is a part of the Synthes TomoFix™ Osteotomy System which is a system consisting of titanium plates with locking and combination holes designed to provide stable fixation close to the knee.
The provided text is a 510(k) summary for the Synthes (USA) TomoFix™ Medial High Tibia Plate, Small. It describes a medical device, its classification, indications for use, and a statement of substantial equivalence to a predicate device. It explicitly states that preclinical testing was performed, but does not describe a clinical study or performance data of the device in a clinical setting against acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment as these details are not present in the provided text.
Based on the information provided in the 510(k) summary:
- A table of acceptance criteria and the reported device performance: Not available. The document states "preclinical testing - including dynamic fatigue and static 3-point bend testing was performed comparing the proposed plate to the predicate plate and the results support substantial equivalence." It does not provide the specific acceptance criteria or the numerical results of these tests, nor does it describe clinical performance.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a clinical test set. The document refers to preclinical testing.
- 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, as no clinical test set or human-based ground truth establishment is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is a bone fixation plate, not an AI diagnostic tool that would involve human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a bone fixation plate, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for a clinical test. Preclinical testing would use established engineering standards or comparisons to the predicate device to establish "ground truth" for mechanical properties.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
§ 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.