(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.
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Appendix 4
Summary of Safety and Effectiveness
| Submitter: | Orthopedic Innovations, Inc.6188 Olson Memorial HighwayMinneapolis, MN 55422Telephone: (612) 591-0001 | |
|---|---|---|
| Product: | Classification Name: | Single/multiple component metallic bone fixation appliances and accessories(21 CFR 88.3030) |
| Common Name: | External Fixation System | |
| Trade/Proprietary Name: | Cobra External Fixator | |
| SubstantiallyEquivalentProducts | Orthopaedic Innovations Practifix (K960014), Synthes AO/ASIF andHowmedica Mini Hoffman External Fixation Systems | |
| Description: | The device a two-piece hinged external fixator. Set-screws are used to secureorthopedic pins or K-wires to the fixator and establish the fixation angle. | |
| IntendedUse: | The intended use is similar to that for other external fixation systems. | |
| Comparisonto SubstantialEquivalentProducts: | All devices have the same intended use, principle or operation and materialrequirements. Differences between the new and other predicate devicesdo not affect safety and effectiveness. |
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4 1998 DEC
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1998 DEC
Mr. Todd J. Hein Vice President Orthopaedic Innovations 6188 Olson Memorial Highway Golden Valley, Minnesota 55422
Re: K983881 Cobra External Fixator Regulatory Class: II Product Code: HRS Dated: October 28, 1998 November 2, 1998 Received:
Dear Mr. Hein:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. Todd J. Hein
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M
a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix 2
Intended Use
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.
Prescription Use
(Per 21 CFR 801.109)
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§ 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.