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• Intra-articular fractures of the calcaneus .
• Extra-articular fractures of the calcaneus ●
• Osteotomies of the calcaneus .

The Biomet Calcaneal Plate is an open structure bone plate with a cross-strut in the center manufactured from 316 LVM Stainless Steel. The device has 11 or 13 screw holes, depending on plate size, to ensure bone purchase of screws. The devices is slightly malleable, to conform to each patient's anatomy at the time of surgery. The device can also be cut in the operating room it achieve better fit.

The device is universal in design and therefore may be used on either the right or left foot. Three sizes are available, small, large and extra-large. A series of 3.5mm cortical screws are used in conjunction with the device.

The presented document is a 510(k) premarket notification for the Biomet Calcaneal Plate, a bone plate used for fixation of calcaneal fractures and osteotomies.

Based on the provided information, no acceptance criteria or study demonstrating device performance are described.

The document explicitly states:

• Non-Clinical and Clinical Testing: None provided (from the "Summary of Safety and Effectiveness" section).

This indicates that the submission for the Biomet Calcaneal Plate did not include specific performance criteria or a study to demonstrate its performance against such criteria. The device's approval or "substantial equivalence" determination by the FDA was based on its similarity to legally marketed predicate devices, not on a new study showing its performance against pre-defined acceptance criteria.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: Not applicable as no testing was provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
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 device is a physical bone plate, not an AI or imaging device).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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