(40 days)
Pediatric Osteotomy Plates are indicated for fixation of intertrochanteric osteotomies for treating congenital or traumatic deformities in children.
Pediatric Osteotomy Plates are made from surgical implant grade 316LVM Stainless Steel conforming to the American Society for Testing and Materials ASTM) material standard ASTM F-138. The plates are affixed to bone utilizing currently marketed stainless steel bone screws. The plates are available in sizes suitable for use in infants, children, and adolescents. Special instrumentation is available including plate driver/extractors, chisels, goniometer guides, impactors, slide hammers, clamps, and guide wires.
This 510(k) summary describes the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance (Bench Testing) |
|---|---|
| Material composition conforms to ASTM F-138 (surgical implant grade 316LVM Stainless Steel) | Device made from surgical implant grade 316LVM Stainless Steel conforming to ASTM F-138. |
| Design is substantially equivalent to predicate devices (Smith and Nephew Orthopaedics, Zimmer, Inc., Synthes, Inc.) in design and materials. | The Biomet Pediatric Osteotomy Plates are similar in design and materials to the listed predicate devices and do not raise new questions regarding safety and effectiveness. |
| Device is suitable for use in infants, children, and adolescents. | Plates are available in sizes suitable for use in infants, children, and adolescents. |
| Potential adverse effects (e.g., nonunion, implant breakage, infection, allergic reaction) are comparable to predicate devices. | Acknowledges potential adverse effects, implying they are not worse than those of predicate devices. |
2. Sample Size and Data Provenance
The provided document describes a 510(k) submission for a medical device and thus does not include information on sample size for a test set or data provenance in the way a clinical study would. The data provenance here is related to the manufacturing specifications and comparison to existing, legally marketed devices.
3. Number of Experts and Qualifications
This document does not specify the number of experts used to establish ground truth or their qualifications. The evaluation is based on regulatory review and comparison to established medical device standards and predicate devices, rather than a clinical ground truth established by experts for a specific data set.
4. Adjudication Method
Not applicable. This is a regulatory submission, not a clinical study with an adjudication process for data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted or is mentioned in this submission. This type of study is typically associated with AI/CAD devices, not traditional implantable devices like an osteotomy plate where the primary assessment is mechanical and material equivalence.
6. Standalone Performance (Algorithm Only)
Not applicable. This device is a physical implant, not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" in this context is established through:
- Material Standards: Adherence to ASTM F-138 for material composition.
- Predicate Device Comparison: Substantial equivalence in design, materials, and intended use to legally marketed predicate devices.
- Regulatory Standards: Compliance with FDA regulations for medical devices (e.g., 21 CFR 888.3030, Good Manufacturing Practice).
8. Sample Size for Training Set
Not applicable. This device is a physical medical implant; there is no training set as would be used for an AI/ML algorithm.
9. How Ground Truth for Training Set was Established
Not applicable, for the same reason as above.
§ 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.