(86 days)
The Gridlock Ankle Plating System is intended for use in trauma and reconstructive procedures of the hand/foot, ankle, distal tibia, fibula, and other bones appropriate for the size of the device.
The plates (implant), screws (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.
Gridlock Ankle Plating System consists of various shape and size plates for the management of orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and diameters and the necessary instruments to facilitate the placement of these implants.
The provided document, a 510(k) summary for the "Gridlock Ankle Plating System," does not describe a study involving an algorithm or artificial intelligence (AI) for diagnostic purposes. Instead, it details the system's design, materials, and non-clinical mechanical performance tests to demonstrate substantial equivalence to existing predicate devices for bone fixation.
Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI performance, cannot be extracted from this document. The document focuses on the physical characteristics and mechanical properties of a surgical implant system.
Here's an analysis of what is present in the document related to "acceptance criteria" and "studies," acknowledging it's not in the context of AI performance:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a specific table of acceptance criteria with numerical targets and reported performance values in the way one might expect for a diagnostic AI. However, it implicitly uses a standard for equivalence to predicate devices based on mechanical testing.
| Acceptance Criteria (Implicit from Equivalence Claim) | Reported Device Performance (from Non-clinical Test Summary) |
|---|---|
| Equivalence to predicate devices in mechanical safety and performance (specifically for Screw Torque to Failure and Plate 4-Point Bending) | "The results of these evaluations indicate that the Gridlock Ankle Plating System is equivalent to predicate devices." (Specific numerical results are not provided in this summary, but the conclusion states equivalence was met.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated for each test (Screw Torque to Failure, Plate 4-Point Bending). These are likely conducted on a defined number of devices according to the ASTM standards.
- Data Provenance: Not applicable as these are non-clinical, in-vitro mechanical tests, not based on patient data.
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. Ground truth in this context refers to mechanical properties measured during laboratory testing, not medical diagnoses made by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This pertains to expert review of diagnostic findings, not 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 MRMC comparative effectiveness study was done. The device is a surgical implant, not a diagnostic tool where human readers would interpret results with or without AI assistance. The "Clinical Test Summary" explicitly states: "No clinical studies were performed."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical bone fixation system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance evaluation is based on established mechanical standards (ASTM F543 for Screw Torque to Failure and ASTM F382 for Plate 4-Point Bending). The comparison is made against the performance of predicate devices tested under similar conditions.
8. The sample size for the training set:
- Not applicable. This refers to an AI training set, which is not relevant to this device.
9. How the ground truth for the training set was established:
- Not applicable. This refers to an AI training set, which is not relevant to this device.
§ 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.