(90 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 at ic 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 size of 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.
The provided text is a 510(k) premarket notification for a medical device called the "Breakaway Screw System". This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a new device meets specific acceptance criteria through a clinical study. As such, the information typically requested in your prompt (e.g., acceptance criteria, detailed study design, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth establishment) is generally not included in a 510(k) summary of this nature.
The document states:
"Engineering analysis is presented to provide evidence that the original testing and subsequence performance is not adversely affected by the modified screw geometry. The results of the analysis demonstrated the modified design is substantially equivalent to the predicate device."
This indicates that the "study" conducted was an engineering analysis comparing the new device (modified screw geometry) to a predicate device (K140397, Gorilla Plating System). The goal was to show that the modifications did not adversely affect the performance, implying that the existing performance of the predicate device was considered acceptable and the new device maintains that level.
Therefore, most of your requested information is not applicable or not provided in this specific document. However, I can extract what is available:
1. Table of acceptance criteria and the reported device performance:
Since this is an engineering analysis for substantial equivalence, formal acceptance criteria in terms of clinical performance metrics (like sensitivity, specificity, etc.) are not established for the new device. The acceptance criterion is essentially "not adversely affected" compared to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance not adversely affected by modified screw geometry. | "The results of the analysis demonstrated the modified design is substantially equivalent to the predicate device." |
| Same technological characteristics as predicate in terms of: | The modified Gorilla screw possesses the same technological characteristics as the predicate devices: |
| - Performance | - Performance |
| - Basic design | - Basic design |
| - Material, manufacturing | - Material, manufacturing |
| - Sizes (dimensions comparable to predicate) | - Sizes (dimensions are comparable to those offered by the predicate systems) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The "study" was an engineering analysis, not a clinical study involving a test set of data. It would likely involve mechanical testing and comparisons to existing predicate device data.
- Data Provenance: Not applicable in the context of clinical data. The analysis compares the modified screw geometry to the predicate device's original testing and performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No "ground truth" in the clinical sense was established by experts for a test set in this engineering analysis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There was no test set requiring expert adjudication.
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 not an AI/software device and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For an engineering analysis, the "ground truth" would be the established performance characteristics of the predicate device (e.g., mechanical strength, durability, material properties), against which the modified design was compared. This is not clinical ground truth.
8. The sample size for the training set:
- Not applicable. There is no training set mentioned, as this is an engineering analysis, not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable. No training set was used.
§ 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.