(90 days)
For fracture fixation of small bones and small bone fragments including odontoid fractures.
DePuy Synthes Spine Dens Access System is comprised of screws and instruments. The screws are available in multiple lengths and will be offered non-sterile. The screws feature self-drilling, self-tapping tips, reverse cutting flutes and cancellous threads.
The K132910 submission describes the DePuy Synthes Spine Dens Access System, a bone fixation fastener intended for fracture fixation of small bones and small bone fragments, including odontoid fractures. The submission relies on mechanical testing to demonstrate substantial equivalence to predicate devices.
Here's an analysis of the provided information:
Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state acceptance criteria in a quantitative table. Instead, it mentions that "Mechanical testing was provided in order to provide data to support a substantial equivalence determination. These tests were performed to characterize the properties and functionality of the screw, as well as to allow comparison with established acceptance criteria." This implies that the device's performance in the mechanical tests met or exceeded the acceptance criteria, which were likely derived from the performance of the predicate devices or relevant industry standards.
The mechanical tests conducted were:
- Torque to failure test
- Cantilever bend test
- Pull-out strength test
- Insertion torque test
While the specific numerical results and acceptance thresholds are not detailed in this summary, the FDA's clearance (K132910) indicates that the device's performance was deemed acceptable for its intended use and substantially equivalent to the predicate devices.
Study Details
Detailed information regarding the specific studies (sample sizes, data provenance, ground truth establishment, etc.) directly related to this device's performance validation is not extensively provided in the summary. The provided submission is a 510(k) summary, which often provides a high-level overview rather than granular study details.
Based on the available text:
- Sample size used for the test set and the data provenance: Not explicitly stated for each mechanical test. The data provenance is implied to be from internal lab testing conducted by Synthes Spine. No country of origin for the data is specified, but given the submitter is "Synthes Spine, West Chester, PA", it's reasonable to assume the testing occurred within the US or under their oversight. The studies were non-clinical.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for this device's performance is established through objective mechanical testing against engineering specifications and predicate device performance, not expert consensus on medical images or clinical outcomes.
- Adjudication method for the test set: Not applicable for mechanical testing.
- 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 is a medical device (bone screw and instruments), not an AI-powered diagnostic or assistive tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
- The type of ground truth used: The "ground truth" for the mechanical tests would be the established engineering specifications (e.g., maximum torque, bend strength, pull-out force) derived from industry standards (e.g., ASTM) and/or the performance characteristics of the predicate devices. The objective measurements from the tests are compared against these predetermined values.
- The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
Summary of Device Performance and Equivalence
The K132910 submission for the DePuy Synthes Spine Dens Access System demonstrates substantial equivalence to predicate devices (Synthes 4.0mm Cannulated Screw - K963192, HBS Headless Bone Screw - K020791, Headless Compression Screw - K112672) based on mechanical testing. The testing covered torque to failure, cantilever bend, pull-out strength, and insertion torque. While explicit numerical acceptance criteria and performance values are not detailed in this summary, the FDA's clearance indicates that the performed tests supported the claim of substantial equivalence in terms of design, materials, performance, intended use, and other relevant characteristics. No clinical studies were necessary for this determination.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.