(29 days)
The Panalok RC QuickAnchor Plus and Dual Suture Panalok RC QuickAnchor Plus are intended for fixation of USP size #2 suture to bone for the indication listed below. Shoulder: Rotator cuff repair.
The PANALOK RC QuickAnchor Plus is a preloaded disposable anchor/inserter assembly system designed to facilitate the fixation of USP size #2 suture to bone. The absorbable polylactic acid (PLA) anchor is the identical anchor as that of the Mitek Toggle Anchor, and the sutures are similar to those used in the Mitek Toggle Anchor System and other Mitek Anchor systems. The Panacryl and Ethibond sutures are manufactured by Ethicon, Inc. The absorbable anchor is a one-piece suture anchor constructed of molded Poly(1 - lactide) polymer.
The Dual Suture PANALOK RC QuickAnchor Plus is preloaded disposable anchor/inserter assembly system designed to facilitate the fixation of USP size #2 suture to bone. The absorbable polylactic acid (PI.A) anchor is similar to the Mitek Toggle Anchor; the only change is a dimensional change to accommodate two strands of suture instead of onc. The sutures are similar to those used in the Mitck Toggle Anchor System and other Mitek Anchor systems. The Panacryl and Ethibond sutures are manufactured by Ethicon, Inc. The absorbable anchor is a one-piece suture anchor constructed of molded Poly(Llactide) polymer.
This document is a 510(k) Premarket Notification for the Panalok RC QuickAnchor Plus and Dual Suture Panalok RC QuickAnchor Plus. It is not an AI/ML device, therefore, the requested information pertaining to AI/ML device studies and performance metrics cannot be found or fabricated from the provided text.
The document describes a medical device, its intended use, and its classification, and asserts its substantial equivalence to a previously marketed device (Mitek Absorbable Toggle Anchor K964013).
Here's the information that can be extracted from the provided text, related to the device and its assessment:
1. Acceptance Criteria and Reported Device Performance:
The document primarily focuses on establishing "substantial equivalence" to a predicate device rather than defining new, specific performance acceptance criteria or reporting detailed performance metrics for this particular device in a table format.
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Substantial Equivalence Basis: The core "acceptance criterion" for this 510(k) submission is that the Panalok RC QuickAnchor Plus and Dual Suture Panalok RC QuickAnchor Plus are substantially equivalent to the original Mitek Absorbable Toggle Anchor (K964013). This equivalence is based on:
- Representing the "same fundamental scientific technology."
- The Panalok RC QuickAnchor Plus uses an "identical anchor" to the Mitek Toggle Anchor.
- The Panalok RC QuickAnchor Plus uses "similar" sutures to those in the Mitek Toggle Anchor System.
- The Dual Suture Panalok RC QuickAnchor Plus is similar, with a "dimensional change to accommodate two strands of suture instead of one."
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Safety "Performance":
- Biocompatibility: "Biocompatibility studies have demonstrated the Panalok RC QuickAnchor Plus and Dual Suture Panalok RC QuickAnchor Plus Anchors to be non-toxic, non-irritating, and non-cytotoxic." This is a key safety performance aspect, indicating the device meets biological safety requirements.
A table of acceptance criteria and reported device performance cannot be generated as the document does not contain this specific type of data for novel device performance, but rather a claim of substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not provide information on specific test set sample sizes or data provenance for performance testing. Biocompatibility studies are mentioned, but details of those studies (sample size, design, origin) are not included in this summary. The 510(k) process often relies on existing data or equivalence to predicate devices, and full study reports are typically not included in these summaries.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a medical device submission, not a study evaluating an AI/ML system where expert ground truth for interpretation would be established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is a medical device submission, not a study requiring adjudication of expert interpretations for an AI/ML system.
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 is a medical device submission for a physical implantable device, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a medical device submission for a physical implantable device, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the biocompatibility claims, the ground truth would be based on validated laboratory testing methods for toxicity, irritation, and cytotoxicity, rather than expert consensus on images or pathology in the context of an AI study.
- For the substantial equivalence claim, the "ground truth" is the performance and safety profile of the predicate device (Mitek Absorbable Toggle Anchor K964013), established through its own regulatory clearance and post-market experience.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is a physical medical device, not an AI/ML system.
§ 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.