(55 days)
The AOS Cannulated Bone Screw System is intended for fracture fixation of small and long bones and of the pelvis. This system is not intended for spinal use.
The AOS Cannulated Bone Screw System consists of titanium alloy self-drilling, self-tapping cannulated screws in diameters of 4.0mm, 5.0mm and in lengths ranging from 10mm to 150mm. The screws are either partial threaded or fully threaded. There are two washers in the system, one for use with the 4.0mm and 5.0mm screws and one for use with the 7.0mm screws. All screw are packaged and sold as non-sterile.
This document, K014185, is a 510(k) premarket notification for a medical device called the "AOS Cannulated Bone Screw System." It seeks to demonstrate substantial equivalence to previously marketed devices rather than presenting a de novo study with specific performance acceptance criteria and a detailed study report. Therefore, much of the requested information regarding acceptance criteria, study findings against those criteria, sample sizes, expert involvement, and ground truth establishment, which are typical for clinical performance studies, is not applicable or not provided in this regulatory submission.
The core of a 510(k) submission like this is to show that the new device is as safe and effective as a legally marketed predicate device, not necessarily to prove its absolute performance against predefined metrics in a clinical study.
Here's an attempt to address the request based on the provided text, indicating where information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicit for performance in this 510(k) submission. The core "acceptance criteria" here is substantial equivalence to predicate devices. This means the device must have the same intended use, technological characteristics, and safety/effectiveness profile as the predicates. | The device's technological characteristics (titanium alloy self-drilling, self-tapping cannulated screws in 4.0mm, 5.0mm, and 7.0mm diameters, lengths 10mm-150mm, partial or fully threaded) are described and asserted to be substantially equivalent to the predicate devices. |
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 / Not provided. This 510(k) submission relies on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than presenting a new clinical study with a test set of patient data. There is no mention of a test set of patient data or its provenance.
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 / Not provided. As there is no clinical test set mentioned, there are no experts establishing ground truth for such a set within this document. The "experts" involved are likely the device manufacturer's engineers and regulatory specialists, and the FDA reviewers themselves, assessing the substantial equivalence claim.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set or adjudication method is described.
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 physical bone screw system, not an AI or imaging device, so MRMC studies and AI assistance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. For a 510(k) submission of this type, the "ground truth" is effectively the established safety and effectiveness of the identified predicate devices in the market, demonstrated through their long-term use and regulatory clearance. The submission aims to show the new device meets that de facto standard through design and material comparison.
8. The sample size for the training set
- Not applicable / Not provided. No training set for an algorithm is mentioned as this is a physical device submission.
9. How the ground truth for the training set was established
- Not applicable / Not provided.
§ 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.