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The OrthoPediatrics PediLoc™ Locking Plate System is used for pediatric patients as indicated for pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle. Indications for buttressing multifragmentary distal femoral fractures include: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur.

A pediatric small fragment set offers advantages of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non-locking screws Pedi-Loc will offer a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction. The OrthoPediatrics PediLoc™ Locking Plate System is used for pediatric patients as indicated for pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle. Indications for buttressing multifragmentary distal femoral fractures include: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur. Materials: The devices are manufactured from 316L stainless steel which meets the ASTM-F138 standard. Function: The system functions to provide immediate stability and temporary fixation during the natural healing process.

The provided text is a 510(k) summary for the OrthoPediatrics PediLoc™ Locking Plate System. This document outlines the general characteristics and intended use of a medical device and its substantial equivalence to previously marketed predicate devices. It does not contain acceptance criteria for a study, nor does it present the results of a study designed to prove the device meets specific performance criteria.

Therefore, most of the information requested in your prompt cannot be extracted from this document, as it pertains to clinical study design and results, which are not part of this 510(k) summary.

Here's what can be gathered, and what cannot:

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

• Cannot be provided. This document does not describe performance acceptance criteria or report device performance in the context of a study. 510(k) summaries primarily focus on demonstrating substantial equivalence to predicate devices based on similarities in design, materials, and intended use, rather than presenting new clinical performance data with acceptance criteria.

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

• Cannot be provided. No test set or study data is mentioned.

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)

• Cannot be provided. No study or ground truth establishment is mentioned.

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

• Cannot be provided. No study or adjudication method is mentioned.

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

• Cannot be provided. This device is a mechanical bone fixation system, not an AI or imaging device. No MRMC study is mentioned.

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

• Cannot be provided. As above, this is a mechanical device, not an algorithm.

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

• Cannot be provided. No study or ground truth is mentioned.

8. The sample size for the training set

• Cannot be provided. No training set is mentioned.

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

• Cannot be provided. No training set or ground truth is mentioned.

What can be extracted from the document:

• Device Name: OrthoPediatrics PediLoc™ Locking Plate System
• Intended Use/Indications: For pediatric patients as indicated for pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle. Indications for buttressing multifragmentary distal femoral fractures include: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur.
• Materials: 316L stainless steel meeting ASTM-F138 standard.
• Function: Provides immediate stability and temporary fixation during the natural healing process.
• Basis for Substantial Equivalence: Similarities in design, materials, and indications to legally marketed predicate devices (S&N Locking Bone Plate System (K033669), Smith & Nephew S&N Peri-Loc Locking Bone Plate System (K051735), Smith & Nephew Pedi-Plate Bone Plate System (K073344, K081407), OrthoPediatrics, Corp. Synthes Locking Compression Plate System (K062564), Synthes (USA)).

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