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The PERI-LOC™ Bone Plating and Screw System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC™ bone plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus and clavicle.

The PERI-LOC™ Bone Plating and Screw System represents titanium versions of stainless steel PERI-LOC™ Periarticular Locked Plating System bone plates and bone screws previously cleared under K082516, K061352, K051735, and K033669. Like the predicate devices, the PERI-LOC™ Bone Plating and Screw System devices feature various lengths of straight and contoured locking bone plates: locking and non-locking bone screws, washers, plus a screw adapter accessory. Bone plates in the PER/-LOC™ Bone Plating and Screw System feature a screw to-plate locking feature, which forms a locked, fixed-angle construct to aid in maintaining fracture reduction.

The provided text is a 510(k) summary for the PERI-LOC™ Bone Plating and Screw System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) pathway is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies to prove performance against specific acceptance criteria like those outlined in your request. While the device's technological characteristics are mentioned as being similar to predicate devices, there's no discussion of quantitative performance metrics, study designs, sample sizes, or ground truth establishment.

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text. The document focuses on regulatory approval through substantial equivalence, not on a detailed performance study with defined acceptance criteria.

Here's what I can infer or explicitly state based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not applicable and not mentioned in the document. The 510(k) submission does not describe a performance test set.
• Data provenance: Not applicable. No performance data is presented.

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. The document does not describe a study involving ground truth establishment by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No test set or adjudication process is described.

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 bone plating and screw system, not an AI-based diagnostic tool for which MRMC studies are typically performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This device is a mechanical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. The document does not reference performance studies that would require ground truth. The substantial equivalence argument relies on the established safety and effectiveness of predicate devices.

8. The sample size for the training set

• Not applicable. This submission doesn't describe an algorithm or a training set.

9. How the ground truth for the training set was established

• Not applicable. This submission doesn't describe an algorithm or a training set.

Summary of what the document does communicate regarding evidence for substantial equivalence:

The "study" referenced in a 510(k) context is often the comparison to legally marketed predicate devices. The device's safety and effectiveness are supported by demonstrating that it has:

• Similar intended use.
• Similar technological characteristics (e.g., made of titanium like some predicate devices, screw-to-plate locking feature).
• No new questions of safety or effectiveness compared to those predicates.

The acceptance criteria for a 510(k) largely revolve around demonstrating this substantial equivalence, which is typically shown through engineering comparisons, material biocompatibility, and sometimes mechanical testing (though specific results of such tests are not detailed in this summary). The document lists several predicate devices (K082516, K072818, K061352, K051735, K033669, K993106, K000682, K000684, K011815) to which the PERI-LOC™ Bone Plating and Screw System is compared. The "study" proving it meets acceptance criteria is the regulatory review finding of substantial equivalence based on the submitted documentation comparing the device to these predicates.

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