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The PERI-LOC Periarticular Locked Plating System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bones 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.

Components in the PERI-LOC™ Periarticular Locked Plating System are for single use only.

Hexalobular Bone Screws are line additions to the PERI-LOC™ Periarticular Locked Plating System cleared under K033669, K051735, K061352, and K993106. Like the predicate devices listed below, the subject components include various sizes of locking/non-locking Cortex and partially/fully threaded Cancellous bone screws made from stainless steel that are intended for use with locking bone plates for both the upper and lower extremity. The subject screws are designed for use with the PERI-LOC™ locking bone plates, which incorporate a screw-to-plate locking feature forming a locked, fixed angle construct to aid in holding fracture reduction.

This is a 510(k) premarket notification for a medical device called the PERI-LOC™ Periarticular Locked Plating System Hexalobular Bone Screws. These documents are generally used to demonstrate substantial equivalence to a predicate device, rather than to present a study demonstrating the device meets specific acceptance criteria in the way a clinical trial for a new drug or novel medical software would.

Therefore, the requested information about acceptance criteria and a study proving those criteria are met for this type of device submission is largely not applicable in the conventional sense of a clinical performance study. Instead, the "study" is a comparison to a predicate device and a demonstration that the new device shares similar technological characteristics, materials, and intended use as the legally marketed predicate.

Here's a breakdown based on the provided document:

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

• Acceptance Criteria: For this 510(k) submission, the "acceptance criteria" are primarily established by the features and performance of the predicate devices. The new device must demonstrate that its technological characteristics (design, materials, intended use) are substantially equivalent to these predicates and do not raise new questions of safety or effectiveness.
• Reported Device Performance: The document states that the PERI-LOC™ Hexalobular Bone Screws are "similar to legally marketed devices listed below in that they share similar indications for use, are manufactured from similar materials, and incorporate similar technological characteristics." This inherent similarity to the existing, cleared predicate devices is the "reported performance" for a 510(k) submission. Specific quantitative performance metrics (e.g., tensile strength, fatigue life) would have been part of the full submission, but are not detailed in this summary. However, the summary asserts that these characteristics are comparable.

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

• Not applicable in the context of a typical clinical trial. This submission relies on a comparison to existing predicate devices and likely includes in vitro mechanical testing data (which is not detailed in this summary). There is no mention of a "test set" of patients or data provenance in the way one would for an AI/software or drug trial. The "test" is the comparison to the predicate device's established performance and characteristics.

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. There is no "test set" requiring expert ground truth in the context of clinical interpretation for this orthopedic implant. The "ground truth" for showing substantial equivalence for this type of device largely comes from engineering specifications, material standards, and the known clinical performance and regulatory history of the predicate devices.

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

• Not applicable. No such adjudication method is mentioned or relevant for this type of medical device submission.

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 submission is for an orthopedic implant (bone screws), not an AI-assisted diagnostic device. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed or is relevant.

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

• Not applicable. This is not an algorithm or software device.

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

• For this device, the "ground truth" for demonstrating substantial equivalence includes:
  • Engineering specifications and material science: Demonstrating the new screws meet established standards for mechanical properties (e.g., strength, fatigue) comparable to the predicates.
  • Regulatory precedent: The predicate devices have already been deemed safe and effective by the FDA. The "ground truth" is that devices with similar characteristics have a history of safe and effective use.
  • Clinical experience with predicate devices: The established performance and safety profile of the predicate PERI-LOC systems.

8. The sample size for the training set

• Not applicable. This device submission 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. As above, no training set for machine learning is involved.

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