(66 days)
The Osteonics Silkon" Stainless Steel Cable System is indicated for cervical, thoracic and lumbar spinal trauma and/or the correction of scoliosis, and lordosis deformities. The Osteonics" Silkon" Stainless Steel Cable System is also indicated for trochanteric reattachment. sternotomy indications, and trauma to the shoulder, elbow, hip, knee and ankle.
The Osteonics" Silkon" Stainless Steel Cable System consists of two designs: a single, multistrand, stainless steel cable with an individual monofilament wire leader and a stainless steel crimp; or one multi-strand, stainless steel, double cable with a monofilament Y-Leader and two stainless steel crimps.
This document is a 510(k) premarket notification for a medical device (Osteonics Silkon Stainless Steel Cable System) seeking clearance from the FDA. This specific notification is for adding a sterile offering to an existing system. The document states that "no additional performance data is deemed necessary" because the new offering is identical to a previously cleared predicate device.
Therefore, the provided text does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The core of this submission is based on substantial equivalence to a predicate device, rather than new performance data for the device itself.
Here's a breakdown of why each requested point cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: Not provided. The document relies on substantial equivalence to a predicate, not new performance data against specific criteria.
- Sample size used for the test set and the data provenance: Not provided, as no new performance study was deemed necessary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no new performance study with a test set requiring ground truth was conducted.
- Adjudication method for the test set: Not applicable, as no new performance study with a test set was conducted.
- 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 cable system for bone fixation, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical product, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no new performance study was conducted.
- The sample size for the training set: Not applicable, as this is a physical device and not an AI or algorithm with a training set.
- How the ground truth for the training set was established: Not applicable, as this is a physical device and not an AI or algorithm.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.