(36 days)
APTUS® Cannulated Compression Screws 5.0, 7.0 are intended for the treatment of fractures, osteotomies and arthrodeses of bones with the appropriate screw size.
APTUS® Cannulated Compression Screws 5.0, 7.0 are headless screws intended for the treatment of fractures, osteotomies and arthrodeses of bones. The design of the screw, incorporating various diameters, threads on the head and tip, provides compression of the bone segments upon insertion of the screw. The submission includes the associated Kwires, intended to be used for internal fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of the implants.
APTUS Cannulated Compression Screws 5.0, 7.0 are available in two diameters (5.0 mm and 7.0 mm) and come in partially-threaded or fully-threaded designs. The 5.0 mm screws are provided in overall lengths ranging from 30 to 70 mm. The 7.0 mm screws are provided in overall lengths ranging from 40 to 140 mm. The 5.0 and 7.0 mm screws are used with the 1.6 and 2.2 mm diameter K-wires, respectively.
APTUS® Cannulated Compression Screws 5.0, 7.0 are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and the K-wires are made of stainless steel conforming to ASTM F138 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673).
Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and study proving device performance:
This 510(k) summary is for a medical device (APTUS® Cannulated Compression Screws 5.0, 7.0), not an AI/software device. Therefore, many of the typical acceptance criteria and study aspects related to AI (e.g., sample size for test set, data provenance, ground truth experts, MRMC studies, standalone performance, training set) are not applicable.
The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical data, primarily engineering and mechanical testing. Clinical data was explicitly not submitted.
1. Table of Acceptance Criteria and Reported Device Performance
Note: Since this is a hardware device submission, the "acceptance criteria" are related to mechanical performance and regulatory standards, not diagnostic accuracy or AI model performance.
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| ASTM F543 Standard Specification and Test Method for Metallic Bone Screws | Side-by-side testing of screws performed, demonstrating substantial equivalence to predicate devices. |
| Engineering Analysis | Performed to establish substantial equivalence. |
| Dimensional Analysis | Performed to establish substantial equivalence. |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not applicable in the context of AI/software performance. For mechanical testing, the specific number of screws tested is not detailed in this summary, but it would typically involve a statistically relevant number of samples to demonstrate compliance with ASTM F543.
- Data provenance: Not applicable in the context of data used for AI training/testing. The tests were performed on the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically defined for AI (e.g., expert consensus on medical images) is not relevant for mechanical testing of bone screws. The "ground truth" here is compliance with established engineering and material standards.
4. Adjudication method for the test set
- Not applicable. No expert adjudication process as understood in AI performance evaluations. Mechanical tests have pass/fail criteria based on standards.
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
- No. This is a hardware device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used
- Engineering and material standards compliance: The "ground truth" for this device revolves around its conformance to established material specifications (e.g., ASTM F136 for titanium alloy, ASTM F138 for stainless steel) and mechanical performance standards (ASTM F543 for metallic bone screws). The tests demonstrated that the device performs equivalently to previously cleared predicate devices when subjected to these standards.
8. The sample size for the training set
- Not applicable. This is a hardware device; there is no "training set" in the AI sense.
9. How the ground truth for the training set was established
- Not applicable. This is a hardware device.
§ 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.