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PERI-LOC Locking Hole Inserts and Cable Accessories are intended for use with existing PERI-LOC Periarticular Locked Plating Systems and their cleared indications for use as listed below:

The PERI-LOC Periarticular Locked Plating System including Locking Hole Inserts and Cable Accessories 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.

PERI-LOC Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws, Locking Hole Inserts and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. PERI-LOC Proximal Femur Locking Bone Plates, Bone Screws, Locking Hole Inserts and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multi-fragmentary, and fractures with medial cortex instability: proximal femur fractures combined with ipsilateral shaft fractures; pathological fractures of the proximal femur including metastatic fractures; proximal femur osteotomies; fixation of fractures in osteopenic bone; fixation of nonunions and malunions; basi/transcervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures.

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

Subject of this premarket notification are PERI-LOC™ Locking Hole Inserts and Cable Accessories. The PERI-LOC Locking Hole Inserts and Cable Accessories are line additions to the PERI-LOC Periaticular Locked Plating System cleared under K033669, K051735, K072818, and K082516. The subject Locking Hole Inserts and Cable Saddles are accessory components that may be used in coniunction with various PERI-LOC locking bone plates for the upper and lower extremities. The subject devices are made from 316L stainless steel.

When compared to the predicate PERI-LOC Screw Hole Plug and Cable Saddles, the subject PERI-LOC Locking Hole Inserts and Cable Saddles have been modified as follows:

• Designed to be used independently or in conjunction with one another .
• Addition of a Hexalobular drive feature .
• Addition of a 3.5mm Locking Hole Insert .

The subject devices are available in the following size ranges:

The provided document, K100325, describes a 510(k) premarket notification for PERI-LOC™ Locking Hole Inserts and Cable Accessories. This document is a regulatory submission for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical study results.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document explicitly states "Performance Data" and then details "Pre-clinical testing included four point bend fatigue testing of plate constructs with appropriate accessory devices." It then states that "Substantial equivalence is based on similarities in design features and overall indications for use" with the predicate devices. This implies that the acceptance criteria for these accessory devices revolved around demonstrating sufficient mechanical strength for their intended orthopedic application and proving they are functionally similar to previously cleared devices.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document only mentions "plate constructs" without providing the number of samples tested for the four-point bend fatigue tests.
• Data Provenance: Not explicitly stated, but it's a pre-clinical study, meaning it was conducted in a lab setting by the manufacturer (Smith & Nephew, Inc.). It is retrospective in the sense that the testing was completed before the submission to FDA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a pre-clinical, mechanical performance study, not a study involving human interpretation or clinical outcomes data that would require expert ground truth establishment.

4. Adjudication method for the test set

Not applicable. There was no human interpretation or decision-making in the testing that would require adjudication. The testing involved mechanical measurements.

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 document pertains to a medical device (orthopedic fixation accessories), not an AI/software device that would involve human readers or AI assistance.

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

Not applicable. This is a physical medical device; there is no algorithm involved.

7. The type of ground truth used

For the pre-clinical performance testing, the "ground truth" would be the engineering specifications and industry standards for mechanical strength and fatigue resistance for orthopedic implants. The failure modes and stress limits observed during the four-point bend fatigue testing would be compared against these established benchmarks.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable. As above, there is no training set for this type of device.

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