(30 days)
The BABY GORILLA®/GORILLA® Bone Plates and Bone Screws of the BABY GORILLA®/GORILLA® Plating System are indicated for use in stabilization of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus. The system can be used atric patients.
In addition, the non-locking, titanium screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the device.
The BABY GORILLA®/GORILLA® implants are lower extremity fixation systems. Gorilla Plates are offered in “mini” and “standard” set sizes in a variety of shapes based upon the anatomical fixation required. Screws are also offered in “mini” and “standard” sets and, in addition, in locking and non-locking versions. Size- matched washers are available for use with the non- locking screws when the latter are used for fixation without the plates. Size-matched plate washers are also available for use with plate holes when there is no desire to use a screw.
This FDA 510(k) summary for the SILVERBACK Gorilla Plating System does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and study particulars for a device performance evaluation as it would typically be done for a diagnostic AI/ML device.
This document describes a bone plating system, which is a medical device, but not a diagnostic or AI/ML device. Therefore, the concepts of "acceptance criteria" and "device performance" in the context of sensitivity, specificity, or AUC, as well as aspects like "ground truth" established by experts or "MRMC comparative effectiveness studies," are not applicable in the way they would be for an AI-powered diagnostic tool.
Instead, the "performance data" for this type of device typically refers to engineering analyses and mechanical testing to ensure the device's structural integrity, biocompatibility, and functional equivalence to predicate devices. The document explicitly states:
"Engineering analysis is presented to provide evidence that the original testing and subsequence performance is not adversely affected by the geometry of the modified plates, screws, and washers. The results of the analysis demonstrated the modified designs are substantially equivalent to the predicate devices."
Given this, I can provide the information available in the document, but many sections will indicate "Not Applicable" or explain why the requested information isn't present for this type of device.
1. Table of Acceptance Criteria and Reported Device Performance
This table is generally used for diagnostic devices with quantifiable performance metrics. For a bone plating system, acceptance criteria relate to mechanical properties and equivalence to predicate devices, not diagnostic accuracy.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Material Properties: | Materials used are medical-grade titanium (ASTM F67), stainless steel (ASTM F138), and titanium alloy (ASTM F136). |
| Mechanical Integrity (Implied by Engineering Analysis): | "Original testing and subsequence performance is not adversely affected by the geometry of the modified plates, screws, and washers." |
| Substantial Equivalence: | "The results of the analysis demonstrated the modified designs are substantially equivalent to the predicate devices." |
| Performance (Functional): | "The modified Gorilla plates, screws, and washers possess the same technological characteristics as the predicate devices. These include performance, basic design, material, manufacturing and sizes (dimensions are comparable to those offered by the predicate systems)." |
2. Sample size used for the test set and the data provenance
Not Applicable in the context of a diagnostic test set with human data. The performance was evaluated through engineering analysis. This would involve testing of physical samples (plates, screws, washers) and/or computational modeling, not a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. As this device is not a diagnostic tool, there is no "ground truth" to be established by clinical experts in the context of diagnostic accuracy. The evaluation relies on engineering principles and comparisons to predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not Applicable. Clinical adjudication of a test set is not relevant for the engineering analysis performed for this device.
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 is a hardware device (bone plating system), not an AI-powered diagnostic tool. MRMC studies and AI assistance are 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, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not Applicable in the diagnostic sense. For an orthopedic implant, the "ground truth" for performance is effectively defined by its mechanical properties, biocompatibility, and functional equivalence to established, safe, and effective predicate devices, as demonstrated through engineering analysis and adherence to standards.
8. The sample size for the training set
Not Applicable. This is not an AI/ML device that requires a training set of data.
9. How the ground truth for the training set was established
Not Applicable. As per point 8, there is no training set for this type of device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.