(192 days)
The Guided Growth Plate is 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 two hole plate features a contoured waist and low profile for pediatric usage. There is a center hole for accurate application of the plate over a temporary guide pin. This is to facilitate precise and reproducible placement of the implant relative to the adjacent growth plate that is localized radiographically.. The plate is available in two sizes (small / large) to accommodate the variations of bone size and geometry. It is transfixed to the bone using two parallel cannulated titanium screws. The Guided Growth Plate is made out of titanium which is (by design) flexible and compatible with both radiographic imaging and MRI.
The provided text is a 510(k) summary statement for a medical device called the "Guided Growth Plate Device." This type of document is for regulatory clearance, specifically demonstrating "substantial equivalence" to a predicate device, not typically for performance studies with acceptance criteria in the way you've outlined for AI/software.
Therefore, an exhaustive answer to your request, particularly concerning acceptance criteria, ground truth, training sets, and MRMC studies, cannot be fully provided from the given input. The 510(k) process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving a specific performance metric against a defined acceptance criterion through a clinical study for novel functions.
Here's an attempt to extract and interpret information based on your categories, given the nature of the document:
1. A table of acceptance criteria and the reported device performance
The concept of "acceptance criteria" and "reported device performance" are not presented in the context of a clinical trial demonstrating efficacy against a pre-defined metric for this device. Instead, the document focuses on regulatory acceptance based on substantial equivalence to a predicate device.
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance (as per 510(k) submission) |
|---|---|
| Safety: Device is safely implanted and removed without undue harm. | Designed to be made of titanium, which is flexible and compatible with radiographic imaging and MRI. Applied sub-muscular but extra-periosteal. Screws diverge as deformity corrects, and implant is eventually removed. The predicate device (Blount Zimmalloy staple) has been on the market since 1950, implying a long history of safe use for similar indications. |
| Effectiveness: Device achieves its intended purpose. | Intended Use: Redirecting the angle of growth of long bone(s) to gradually correct angular deformities in growing children. |
| Specific Indications: Correction of valgus, varus, flexion/extension deformities of the knee (femur and/or tibia), ankle, elbow (humerus), and wrist (radius). | |
| Mechanism: Inhibits longitudinal growth of the physis (growth plate) – implicitly assumed to be effective based on the predicate's known mechanism of action. | |
| Material/Design Equivalence: Device materials and design are comparable to legally marketed devices. | Materials: Titanium. |
| Features: Two-hole plate, contoured waist, low profile, center hole for guide pin, parallel cannulated titanium screws. | |
| Comparison to Predicate: Substantially equivalent to the Blount Zimmalloy staple (Zimmer, Inc.) which inhibits longitudinal growth of the physis. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a clinical study with a test set of data in the manner an AI/software device would. The 510(k) submission primarily relies on demonstrating equivalence through design, materials, and intended use to an existing, legally marketed device (the predicate). There is no mention of patient data, clinical trials, or any "test set" in this context.
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)
Not applicable. As there is no "test set" or clinical study described for performance evaluation, there's no mention of experts establishing ground truth for data for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or clinical study described.
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
Not applicable. This device is a physical orthopedic implant, not an AI/software device. Hence, no MRMC studies or human reader improvement with AI assistance are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of an AI/software performance study. The "ground truth" for this device's efficacy is the clinical observation of growth plate modulation and angular deformity correction, which is implicitly assumed to be similar to the predicate device.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
Summary based on 510(k) Submission:
The provided document is a 510(k) Premarket Notification. For such submissions, the primary objective is to demonstrate substantial equivalence to a predicate device. This means showing that the new device has the same intended use and technological characteristics as a legally marketed device, or, if there are different technological characteristics, that these differences do not raise new questions of safety and efficacy.
The "study" that proves the device meets the acceptance criteria in this context is the comparison to the predicate device and the rationale provided by the manufacturer (Morphpgraphics LC) and reviewed by the FDA. The "acceptance criteria" are the regulatory requirements for substantial equivalence, which are implicitly met if the FDA clears the device. The "device performance" relies on the established performance and safety profile of the predicate device (Blount Zimmalloy staple) and the new device's design and material specifications. No clinical trials or performance studies with defined endpoints and statistical significance are detailed in this 510(k) summary.
§ 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.