(80 days)
Synthes' RapidSorb PLUS screws are indicated for use as fixation in mandibular osteotomy procedures, including: sagital split osteotomy, vertical ramus osteotomy, inferior border osteotomy, subapical osteotomy, genioplasty.
Synthes' RapidSorb PLUS Screw System consists of resorbable screws and related insertion devices, including screwdrivers, drills, and taps, for use as fixation in mandibular osteotomies. The screws themselves are of various sizes and are made of Poly (L-lactide-co-Glycolide) polymer that resorbs in approximately 12 months. RapidSorb PLUS screws are provided sterile in a pouch constructed of a clear-film outer pouch and a foil laminate inner pouch. The screws are provided sterile, for single use only, and should not be resterilized.
The provided document is a 510(k) summary for the Synthes RapidSorb PLUS Screw System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study with acceptance criteria in the typical sense of diagnostic performance or comparative effectiveness.
Therefore, the information requested in the prompt, particularly points 1-9 related to acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not present in this regulatory submission.
The document primarily states:
- Device Description: Resorbable screws and related insertion devices for fixation in mandibular osteotomies, made of Poly (L-lactide-co-Glycolide) polymer that resorbs in approximately 12 months.
- Intended Use: Fixation in various mandibular osteotomy procedures.
- Substantial Equivalence: Documentation was provided demonstrating the RapidSorb PLUS Screw System is "substantially equivalent" to other legally marketed devices, specifically listing Synthes Rapid Resorbable Fixation System (K062789) and Biomet LactoSorb® Screws (K981666) as predicate devices.
Summary of missing information based on your request:
- A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence to existing devices, not on setting and meeting specific performance benchmarks.
- Sample sized used for the test set and the data provenance: Not applicable in this type of submission, as no specific test set data for performance evaluation in the requested manner is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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 physical medical device (screws), not an AI/diagnostic software.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In essence, this 510(k) clearance document demonstrates that the device is similar enough to previously approved devices for its intended use, rather than proving its performance against specific, pre-defined acceptance criteria through a clinical study as might be seen for a novel diagnostic or therapeutic device.
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.