(76 days)
The Integra Bone Fixation System is intended for use in internal fixation of small bones affected by trauma or for reconstruction or arthrodesis. Burr hole cover plates are intended specifically to cover burr holes and to secure cranial flaps.
The Integra Bone Fixation System includes titanium self-tapping and/or self-drilling screws and plates along with instruments for the internal fixation of bone fragments. The fixation screws are supplied in a variety of diameters and lengths designed to fit Integra's various designs of fixation plates and burr hole covers. The Integra Bone Fixation System includes reusable instruments such as screwdrivers, handles and blades, plate holders, drill bits and instrument trays. The single use fixation plates and screws, and the reusable instruments are provided non-sterile and must be sterilized prior to use. The basic design, intended use, materials, and principles of operation of the Integra Bone Fixation System are equivalent to the predicate devices.
This submission for the Integra Bone Fixation System is a 510(k) premarket notification, which demonstrates substantial equivalence to predicate devices rather than providing a study that establishes acceptance criteria and proves device performance. Therefore, the requested information regarding acceptance criteria, study details, and performance metrics cannot be found in the provided text.
The document states: "The Integra Bone Fixation System is substantially equivalent to other commercially marketed devices and does not raise new issues of safety and effectiveness." This indicates that the regulatory pathway relies on demonstrating similarity to existing, approved devices rather than presenting novel performance data.
Below is a table showing what information would be included in response to your request if it were a performance study, with "Not Provided" filled in based on the current document.
Acceptance Criteria and Device Performance (Not Provided in this 510(k) Document)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Provided | Not Provided |
Detailed Study Information (Not Provided in this 510(k) Document)
- Sample size used for the test set and the data provenance: Not Provided. This 510(k) submission does not include data from a test set. It relies on demonstrating substantial equivalence to predicate devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Provided. Ground truth establishment is not relevant for this type of 510(k) submission.
- Adjudication method for the test set: Not Provided. Adjudication is not relevant for this type of 510(k) submission.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not Provided. This device is a bone fixation system, not an AI-based diagnostic tool. Therefore, an MRMC study and AI assistance metrics are not applicable.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not Provided. This device is a bone fixation system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not Provided. Ground truth is not relevant for this type of 510(k) submission.
- The sample size for the training set: Not Provided. This submission does not involve machine learning algorithms requiring a training set.
- How the ground truth for the training set was established: Not Provided. This submission does not involve machine learning algorithms requiring a training set.
§ 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.