(217 days)
The Guided Growth System plates are designed for the express and sole purpose of redirecting the angle of growth of long bone(s). This is useful for gradually correcting angular 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), radial or ulnar deviation, flexion or extension deformities of the wrist (radius).
The Guided Growth System is designed for the gradual correction of pediatric deformities in both the upper and lower extremities. The device can be used for correction of congenital deformities as well as correction of acquired deformities, provided that the physis (growth plates) are not fused. The plates feature a contoured waist and low profile for pediatric usage. There is a center hole in the plate for a temporary guide pin to be implanted to ensure accurate application of the plate. The plates are attached to the external surface of the bone over the growth plate by two or four screws. These screws are not locked to the plate, but rather are allowed to swivel and diverge in their position as bone growth occurs. The implant acts like a flexible hinge, permitting growth at the growth plate to gradually straighten the limb. Immediately after implantation, the patient is allowed mobility and weight bearing.
The provided document describes the Orthofix Guided Growth System Quad-Plate, a medical device designed for correcting angular deformities in growing children. The submission focuses on demonstrating substantial equivalence to a predicate device through biomechanical testing, rather than a clinical study evaluating the device's diagnostic or predictive capabilities.
Therefore, many of the requested points, particularly those related to a study proving diagnostic performance, ground truth establishment, expert review, MRMC studies, or standalone algorithm performance, are not applicable to this type of device and submission.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" are related to mechanical performance and substantial equivalence to a predicate, rather than diagnostic accuracy.
| Acceptance Criteria (related to substantial equivalence) | Reported Device Performance |
|---|---|
| Mechanical properties necessary to perform intended use. | Biomechanical testing according to ASTM F564-02 "Standard Specification and Test Method for Metallic Bone Staples" was successfully completed, demonstrating the Quad-Plate performs as well as the Guided Growth System Eight-Plate (predicate device). |
| Substantial equivalence in design. | The Guided Growth System Quad-Plate is substantially equivalent in design and function to the Guided Growth System Eight-Plate. (The Quad-Plate has four fixation points vs. two for the Eight-Plate, and slightly different size ranges, but core features like contoured waist, low profile, and material are identical). |
| Substantial equivalence in material. | Material (Ti6AL-4V ELI conforming to ASTM F136) is identical to the predicate device. |
| Substantial equivalence in intended use. | Indications for Use are identical to the predicate device: "redirecting the angle of growth of long bone(s) for gradually correcting angular 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), radial or ulnar deviation, flexion or extension deformities of the wrist (radius)." |
2. Sample size used for the test set and the data provenance
Not applicable for a biomechanical testing submission. The "test set" here refers to the actual physical devices tested, not a dataset of patient information. The testing was conducted in a laboratory setting. No patient data (e.g., country of origin, retrospective/prospective) was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in this context would refer to the true mechanical properties. These were established by standardized testing protocols (ASTM) rather than expert consensus on patient data.
4. Adjudication method for the test set
Not applicable. This concept applies to human review of data, not to standardized mechanical testing.
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
No. This is a hardware device (bone plate) submission, not an AI/software device. Therefore, no MRMC study or AI-related effectiveness study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This is a hardware device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the device's mechanical performance was established using standardized biomechanical testing methods (ASTM F564-02). For the purpose of substantial equivalence, the "ground truth" for its clinical purpose is its similarity in function and indications to the legally marketed predicate device.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, this question is irrelevant.
§ 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.