(27 days)
The Rotium™ Bioresorbable Wick is intended to be used in conjunction with suture anchors for the reattachment of tendon to bone in rotator cuff repairs.
The Rotium™ Bioresorbable Wick is an accessory to be used in conjunction with suture anchors for rotator cuff repair. The wick is placed between the bone and the tendon and is designed to facilitate tendon-bone attachment. The wick is an electrospun, non-woven, microporous, microfiber matrix. The wick is made from two types of polymer fibers: Poly(lactide-co-caprolactone) (PLCL) and Polyglycolic acid (PGA). The wick is packaged in a primary foil pouch with a desiccant pouch, sealed within a secondary Tyvek pouch. The device is supplied gamma-sterilized. The device is single use only.
This document is a 510(k) premarket notification for a medical device called the "Rotium™ Bioresorbable Wick." It asserts substantial equivalence to a predicate device and states that no new performance data is required because the labeling changes made to the device will have no impact on the Biocompatibility, Bench Testing, or Animal Testing results the predicate (K183236). Therefore, the information requested about acceptance criteria and a study proving the device meets these criteria is not available within the provided text.
The document explicitly states:
- "No new performance data is required because the labeling changes made to the device will have no impact on the Biocompatibility, Bench Testing, or Animal Testing results the predicate (K183236)."
- "The Rotium™ Bioresorbable Wick accessory is identical to the predicate, Rotium™ Bioresorbable Wick (K183236). The labeling changes raise no new safety or effectiveness questions."
This indicates that the submission relies on the prior clearance of the predicate device (K183236) and does not present new studies for the current submission (K201414) in relation to acceptance criteria for device performance.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.