(64 days)
The Stryker Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures.
The Stryker Delta Resorbable Fixation System is a cranio-maxillofacial plating system, intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in mandible and/or full load bearing procedures. It consists of resorbable bone fixation plates, meshes and screws made of a copolymer of poly lactide and poly glycolide. The copolymer degrades and resorbs in vivo by hydrolysis into lactic and glycolic acid which are metabolized in the body to water (H₂O) and carbon dioxide (CO₂). The Delta Resorbable Fixation System is color coded and currently offered in two diameters, 1.7 mm and 2.2 mm with an emergency screw option of 2.6 mm. As the resorbable bone fixation plates and other devices already cleared in the earlier submission have not been modified, they are not described in this Special 510(k).
This submission is a Special 510(k) for modifications to an already cleared device, the Stryker Leibinger Resorbable Fixation System (K993061). The document states that the Stryker Resorbable Fixation System has the same intended use, indications for use, material, and fundamental scientific technology as the previously cleared predicate device.
Therefore, the acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to its predicate device (K993061) regarding the proposed modifications. The study proving this involves a comparison of the modified features to the predicate, focusing on whether these changes introduce new questions of safety or efficacy.
Here's the breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K993061) | |
| Same Intended Use | Met: "The subject Stryker Resorbable Fixation System has the same intended use..." |
| Same Indications for Use | Met: "...and indications for use..." |
| Same Material | Met: "...is constructed from the same material..." |
| Same Fundamental Scientific Technology | Met: "...and has the same fundamental scientific technology as the previously cleared Leibinger Resorbable Fixation System under K993061." |
| Assessment of Modifications | |
| 0.5 mm Low Profile Mesh: No new safety/efficacy concerns compared to existing 0.7 mm size range. | Implicitly met: The FDA cleared the device, indicating no new safety/efficacy concerns were identified. |
| Increase in thread pitch of screws: No new safety/efficacy concerns. | Implicitly met: The FDA cleared the device, indicating no new safety/efficacy concerns were identified. |
| Increase in thread pitch of standard and self-drilling taps: No new safety/efficacy concerns. | Implicitly met: The FDA cleared the device, indicating no new safety/efficacy concerns were identified. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided text does not contain information about a specific test set, its sample size, or data provenance for performance evaluation of the modified device. For a Special 510(k) where modifications are minor and substantial equivalence is being claimed, often the testing involves engineering analysis, bench testing, and comparison to existing predicate data rather than new clinical trials with 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)
This information is not provided in the given document. As mentioned above, a traditional "test set" for ground truth establishment may not be applicable for this type of Special 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given document.
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
This is not applicable to this device. The Stryker Resorbable Fixation System is a physical medical device (implants and screws), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to this device. As a physical medical device, there is no "algorithm only" performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the nature of a Special 510(k) for minor modifications to a physical device, the "ground truth" for demonstrating acceptance would primarily be engineering and material specifications, biomechanical testing results (if conducted), and a comparison to the predicate device's established safety and performance profile. The document does not explicitly detail what specific tests were performed, but the clearance implies that the modifications were deemed to not negatively impact safety or effectiveness.
8. The sample size for the training set
This information is not provided and is not applicable to this type of device and submission. There is no concept of a "training set" for a physical medical device like this.
9. How the ground truth for the training set was established
This information is not provided and is not applicable to this type of device and submission.
§ 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.