(35 days)
The Osteo 4.0mm Cannulated Screw System is indicated for osteochrondritis dissecans, ligament fixation, and long and small bone fracture fixation, which may include the following:
- Fractures of the olecranon, distal humerus
- Fractures of the ulna and radius .
- Patellar fractures .
- Distal tibia and pilon fractures .
- Fractures of the tarsals and metatarsals .
- Tarso-metatarsal and metatarso-phalangeal arthrodeses .
- Metatarsal and phalangeal osteotomies .
- Fractures of the posterior wall of the acetabulum and other fractures of the pelvic ring
- Other small fragment, cancellous bone fractures
The Osteo 4.0mm Cannulated Screw System consists of one self-tapping cannulated screw of various lengths, and one washer. All components of the system are provided both sterile and non-sterile. The screw and washer are manufactured from Titanium 6Al-4V ELI alloy. The screw thread diameter is 4.0mm. The washer has an outer diameter of 7.0mm and an inner diameter of 4.0mm.
The provided text describes a medical device, the Osteo 4.0mm Cannulated Screw System, and its 510(k) premarket notification. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a regulatory submission summary for a medical device (a screw system for bone fixation), not a clinical study report or a technical performance evaluation. Regulatory submissions like 510(k)s often demonstrate substantial equivalence to predicate devices, focusing on design, materials, and intended use, rather than presenting novel performance studies against predefined acceptance criteria for AI or software.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving device performance because that information is not present in the provided text.
The numbered points below reflect that the requested information is absent:
1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The document describes a medical device (cannulated screw system) and its intended uses, but it does not specify performance acceptance criteria or report on device performance metrics against such criteria.
2. Sample size used for the test set and the data provenance: Not applicable. This document is a regulatory submission for a physical medical device, not a study involving a "test set" in the context of an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment for a "test set" is not relevant to this document.
4. Adjudication method for the test set: Not applicable.
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 document pertains to a physical medical device (cannulated screw system), not an AI-based diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
§ 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.