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The Tandry Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies. The Tandry Locking Plate System is indicated for the clavicle, pelvis, scapula and calcaneus, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.

In addition, the Tandry Locking Hip Plate System is indicated for fixation of fractures to the proximal femur. The plates are indicated for use in trochanteric, intertrochanteric, and basilar neck fracture.

Each plate is indicated for the following anatomic regions:

• 1.5mm and 2.0mm locking plates Metacarpals, metatarsals, tarsals, and phalanges
• 2.4mm locking plates Radius, wrist, and ulna
• 3.5 mm locking plates Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneal, and tibia
• 5.0 mm locking plates Femur and tibia

The Tandry Locking Plate System consists of various sized plates, screws and instruments. The plates are designed to distribute for local anatomies and can accept locking, cortex, shaft and cancellous screws. The screws are designed with self-tapping to promote the operation efficiency to insert the bones. The instruments are used for completing the surgery.

This document describes the Tandry Locking Plate System, a medical device for bone fixation. However, it does not include information about acceptance criteria and a study that proves the device meets those criteria in the way typically expected for an AI/ML powered device. This submission is for a traditional medical device (bone plates and screws), and its clearance is based on substantial equivalence to a predicate device, rather than a performance study against specific acceptance criteria for diagnostic or prognostic accuracy.

Therefore, many of the requested fields cannot be extracted or are not applicable.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria for device performance in terms of diagnostic accuracy, sensitivity, specificity, or similar metrics typically found for AI/ML devices. Instead, the "acceptance criteria" for clearance appear to revolve around demonstrating substantial equivalence to a predicate device through non-clinical testing (biomechanical, biocompatibility, reprocessing, and sterilization).

Since this is not a diagnostic device, there are no metrics like sensitivity or specificity.

Study Details

1. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of diagnostic performance evaluation. The device undergone non-clinical testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not relevant for this type of device.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 not an AI-assisted diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the conventional sense. "Ground truth" for this device would refer to the successful demonstration of mechanical properties, biocompatibility, and sterilization effectiveness through standardized tests.
7. The sample size for the training set: Not applicable. This is not a machine learning device.
8. How the ground truth for the training set was established: Not applicable.

Summary from Document:

This device, the Tandry Locking Plate System, received FDA clearance (K230690) based on substantial equivalence to a predicate device (Tandry Locking Plate System, K171904). The evaluation focused on non-clinical tests including biomechanical, biocompatibility, and reprocessing/sterilization studies. The document explicitly states: "Clinical studies are not required to support substantially equivalent." The biomechanical and reprocessing/sterilization performance of the proposed device are deemed equivalent to the predicate device, thus utilizing the predicate's testing results. Biocompatibility testing was performed on representative samples according to ISO standards. The modifications to the device (material, anodization, and some length specifications) were deemed not to change its intended use, fundamental scientific technology, or biocompatibility requirements.

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