(30 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 over the tendon and is designed to facilitate tendon-bone reattachment. 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.
The provided document is a 510(k) premarket notification for a medical device called the "Rotium™ Bioresorbable Wick." This submission is for updating the labeling of an already cleared device, K183236 and K201414, to allow for its placement on top of the rotator cuff tendon.
Therefore, the document explicitly 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 of the predicate (K183236, K201414)."
This means there is no new study described in this document to prove that the device meets acceptance criteria for the current labeling changes. The device's performance data and its ability to meet acceptance criteria were established during the clearance of the predicate devices (K183236, K201414).
Given this, it is not possible to provide detailed information on acceptance criteria and a study from this specific document, as no new study was conducted for this 510(k) submission.
To answer your request, I would typically need information about the original studies for the predicate devices (K183236, K201414), which are not included in this document.
However, based on the information provided in this document, here's what can be inferred or stated about the lack of a new study:
1. A table of acceptance criteria and the reported device performance:
- Not applicable to this submission. This document states no new performance data was required. The original acceptance criteria and performance data would have been part of the K183236 and K201414 submissions.
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 to this submission. No new test set was used as no new performance data was generated.
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 to this submission. No new ground truth was established for the purpose of this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable to this submission. No new test set required adjudication for this submission.
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. The device is a bioresorbable wick, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The device is a bioresorbable wick, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable to this submission. No new ground truth was established. For medical devices like this, ground truth for performance would typically come from bench testing standards, animal studies, and potentially human clinical outcomes from previous studies.
8. The sample size for the training set:
- Not applicable. This submission doesn't involve training data as it's not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. This submission doesn't involve training data.
§ 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.