(159 days)
OrthoPediatrics' PediLoc Fragment System is intended to provide temporary internal fixation and stabilization of long bones, short (small) bones, pelvis, and scapula. This includes fractures, osteotomies, mal-unions, and non-unions in all pediatric subgroups (except neonates), and small stature adults.
The OrthoPediatrics' PediLoc Fragment System combines implants and instruments in one convenient and comprehensive system. This System provides immediate stability and temporary fixation of bones during the healing process with conventional plating technology and fixation techniques.
This document describes the acceptance criteria and the study conducted for the OrthoPediatrics' PediLoc Fragment System, as presented in the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Technological Characteristics | Fundamental scientific principles, intended use, material, general design, and sizes are the same as or similar to predicate devices. | The device's fundamental scientific principles, intended use, material, and general design, and sizes are reported to be the same as, or similar to, the predicate devices. | Comparison with Predicate Devices |
| Mechanical Performance | Performs as well as or better than predicate devices. | Performed as well as or better than the predicate devices. | Nonclinical (Bench) Testing |
| Static Testing | Meets established static performance standards. | Demonstrated satisfactory performance as per ASTM Standards. | Nonclinical (Bench) Testing |
| Dynamic Testing | Meets established dynamic performance standards. | Demonstrated satisfactory performance as per ASTM Standards. | Nonclinical (Bench) Testing |
| FEA Analysis | Results are comparable or superior to predicate devices. | FEA analysis along with comparisons demonstrated satisfactory performance. | Nonclinical (FEA Analysis) |
| Dimensional Comparison | Dimensions are comparable and supported by engineering rational. | Dimensional comparison review and analysis with engineering rational provided supportive data. | Nonclinical (Dimensional Review) |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not mention a "test set" in the context of clinical data or human subject studies. The nonclinical testing performed involved mechanical laboratory (bench) testing, FEA analysis, and dimensional comparisons. Therefore, there is no information about a sample size for a test set or data provenance in terms of country of origin or retrospective/prospective nature for human data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts or a ground truth establishment process for a human-related test set. The study detailed is entirely nonclinical (bench testing and analysis).
4. Adjudication Method for the Test Set
Not applicable, as there was no test set involving human data or expert review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The study presented is nonclinical and focuses on the physical and mechanical properties of the device compared to predicate devices.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Not applicable. This device is a physical medical implant (fragment system), not a software algorithm or AI-driven system. Therefore, the concept of "standalone performance" in the context of algorithms does not apply.
7. The Type of Ground Truth Used
For the nonclinical studies, the "ground truth" was established based on:
- ASTM Standards: Recognized industry standards for mechanical testing of medical devices.
- Predicate Device Performance: The established performance characteristics of legally marketed predicate devices.
- Engineering Rational: Principles of engineering analysis and design for comparison of dimensions and performance.
8. The Sample Size for the Training Set
Not applicable. The device is not an AI/ML algorithm or system that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for an algorithm.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.