(67 days)
The Guided Growth Plate System Plus is intended for redirecting the growth of long bones. It is indicated for gradually correcting angular growth deformities in growing children. Specific conditions/diseases for which the device will be indicated include: valgus, varus or flexion, extension deformities of the knee (femur and/or tibia); valgus, varus, or plantar flexion deformities of the ankle; valgus or varus deformities of the elbow (humerus), and radial or ulnar deviation, flexion or extension deformities of the wrist (radius).
The Subject new 3.5mm thread diameter screw is a gamma extension of the existing screws (thread Ø4.5mm), components of the predicate Guided Growth Plate System Plus (K172183). The Subject device is a 3.5mm thread diameter screw, available in three lengths and manufactured by the same material (Ti6Al4V), as the 4.5mm diameter gamma screws, included in the predicate Guided Growth Plate System Plus (K172183).
The provided text describes a 510(k) premarket notification for the "Guided Growth Plate System Plus" and a new 3.5mm thread diameter screw, which is an extension of the existing screws for the system. The submission focuses on demonstrating substantial equivalence to a predicate device (K172183) rather than proving the device meets acceptance criteria through a clinical study in the traditional sense of a diagnostic AI device.
Therefore, many of the requested categories for AI/diagnostic device studies are not directly applicable. However, I can extract the relevant information regarding performance testing and how substantial equivalence was demonstrated.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The submission is for a new screw size, so the "performance" is in demonstrating that this new size is as safe and effective as the existing screws within the Guided Growth Plate System Plus. The acceptance criteria relate to mechanical testing standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Testing: Demonstrate mechanical integrity and safety of the 3.5mm thread diameter screw according to established standards. | Testing activities met the established acceptance criteria, demonstrating that the device does not introduce additional risks compared to the predicate device. Specific standards followed: ASTM F564-17, ASTM F1264-16, ASTM F543-17. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated regarding the number of screws or plates tested, but implies tests were conducted on the new 3.5mm thread diameter screws.
- Data Provenance: The testing was mechanical, performed by the manufacturer, Orthofix Srl, in Italy. This is laboratory/bench testing, not patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This is not applicable as the "ground truth" for mechanical testing is adherence to engineering standards and robust physical properties, not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
- Not applicable for mechanical testing. The results are quantitative measurements against defined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is a hardware device (bone plate system components), not an AI/diagnostic software, so an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a hardware device.
7. The Type of Ground Truth Used
- Mechanical Testing Standards: The "ground truth" for the performance data in this submission is the fulfillment of established engineering and material standards (ASTM F564, ASTM F1264, ASTM F543) for bone fixation devices and screws.
- Clinical Literature Analysis: Supported by analysis of clinical literature to demonstrate clinical equivalence between the plate and screw system and staples (the reference devices).
8. The Sample Size for the Training Set
- Not applicable. This is a hardware device, not an AI model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is a hardware device.
Additional Information from the document:
- Device Description: The "Subject new 3.5mm thread diameter screw is a gamma extension of the existing screws (thread Ø4.5mm), components of the predicate Guided Growth Plate System Plus (K172183)." It is made of the same Ti6Al4V material.
- Technological Characteristics & Substantial Equivalence: The submission claims substantial equivalence based on:
- Indications for use
- Intended patient population
- System composition
- Implant material
- Method of fixation
- Packaging configuration
- Sterilization method
- Biocompatibility
- MRI compatibility
- The only change is a design dimensional specification for the new 3.5mm thread diameter screw.
- Biocompatibility Data: No additional assessment was required because the subject device is equivalent in material, manufacturing, sterilization, etc., to the predicate device (K172183).
- Conclusion: The analysis of performance data (mechanical testing and clinical literature review) supports the conclusion that the new 3.5mm thread diameter screw is safe and effective and substantially equivalent to the predicate (K172183).
§ 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.