(32 days)
The Cobra device is designed to externally connect and stabilize pins and/or k-wires inserted into bone fragments allowing the fragments to heal in the proper orientation. The device is intended for fractures near the wrist joint, specifically fractures of the distal extremity of the radius, to include; extra-articular fractures, intra-articular fractures and impacted or die-punch fractures.
The device a two-piece hinged external fixator. Set-screws are used to secure orthopedic pins or K-wires to the fixator and establish the fixation angle.
This document describes a 510(k) premarket notification for the "Cobra External Fixator", a medical device. 510(k) clearances are based on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a novel device.
Therefore, the typical concepts of "acceptance criteria," "reported device performance," and "study that proves the device meets the acceptance criteria" in the sense of a rigorous clinical or performance study with defined endpoints are not directly applicable in the same way they would be for a new drug or a more complex, novel medical device.
Based on the provided document, here's a breakdown of the requested information, focusing on what is available and an explanation of why certain information is absent in a 510(k) submission:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: For a 510(k) submission like this, the primary "acceptance criteria" is demonstrating substantial equivalence to a previously legally marketed device (the predicate). This is achieved by showing that the new device has the same intended use, principle of operation, and material requirements, and that any differences do not affect safety and effectiveness. The document states: "All devices have the same intended use, principle or operation and material requirements. Differences between the new and other predicate devices do not affect safety and effectiveness."
- Reported Device Performance: The document does not provide specific quantitative performance metrics (e.g., strength, durability, biocompatibility test results) in a results table format. It relies on the equivalence to the predicate device to infer performance. The summary mentions that the device is a "two-piece hinged external fixator" that uses "set-screws to secure orthopedic pins or K-wires to the fixator and establish the fixation angle." This describes its functional mechanism, implying it performs the same function as predicate devices.
| Acceptance Criteria (510(k) context) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Same intended use as predicate devices. | Intended use is "to externally connect and stabilize pins and/or k-wires inserted into bone fragments allowing the fragments to heal in the proper orientation." |
| Same principle of operation as predicate devices. | Functions as a two-piece hinged external fixator that uses set-screws to secure pins/K-wires and establish fixation angle, similar to predicate systems. |
| Same material requirements as predicate devices. | Metallic, suitable for bone fixation appliances. |
| Differences do not affect safety and effectiveness. | Design (two-piece hinged fixator, set-screws) is deemed to not introduce new questions of safety or effectiveness compared to predicate fixation systems (K960014, Synthes AO/ASIF). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for this 510(k) document. This submission primarily relies on demonstrating equivalence through comparison of design, materials, and intended use, rather than presenting a performance study with a test set of data. If any bench testing (e.g., mechanical strength) was performed, the details would typically be in a separate, more extensive submission document, not summarized in this brief safety and effectiveness statement. Such testing is usually conducted in a lab and wouldn't have "data provenance" in the clinical sense.
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 no clinical "test set" with "ground truth" established by experts is described in this 510(k) summary, this information is not provided. The review process involves regulatory experts at the FDA assessing the submission against existing regulations and predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring expert adjudication is described in the provided summary.
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 mechanical external fixator, not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating diagnostic image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. As there is no described performance study requiring "ground truth" to evaluate the device, this is not present. The "ground truth" in a 510(k) is effectively the established safety and effectiveness of the predicate device(s).
8. The sample size for the training set
- Not applicable. This device is a physical medical device, not an AI or machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth to establish for it.
In summary:
This 510(k) submission for the Cobra External Fixator demonstrates substantial equivalence to existing predicate devices. The "acceptance criteria" revolve around matching the predicate's intended use, principle of operation, and materials, and ensuring any differences do not impact safety or effectiveness. The document itself is a summary provided to the FDA to support the claim of substantial equivalence, and therefore, it does not contain the detailed performance study data, expert reviews, or AI-related metrics that would be expected for a novel, more complex device or an AI/ML product.
§ 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.