(58 days)
The Neurolac nerve guide is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.
Neurolac® (4-10 mm) is designed to be a flexible and transparent resorbable poly(DL-lactide-co-s-caprolactone) tube to provide a protective environment for peripheral nerve regeneration, for nerves with an internal diameter ≤ 9.5 mm, after injury and to create a conduit to guide axonal growth across a nerve gap. Neurolac® (4-10mm) nerve guides are provided sterile in Tyvek pouch packages and retainer in a variety of sizes (4, 5, 6, 7, 8, 10 mm).
The provided text describes a 510(k) premarket notification for the Neurolac® (4-10 mm) nerve guide. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive new clinical trials with specific acceptance criteria and detailed performance metrics.
Therefore, many of the requested details about acceptance criteria, specific performance studies with sample sizes, expert involvement, and ground truth establishment are not typically part of a 510(k) submission and are not present in the provided documents.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document because this is a 510(k) submission demonstrating substantial equivalence to predicate devices, rather than a de novo submission or PMA requiring explicit performance acceptance criteria and reporting. The "Performance Data" section in {1} outlines what kind of tests were performed (in vitro, in vivo), but doesn't list specific quantitative acceptance criteria or results in a table format.
2. Sample Size Used for the Test Set and Data Provenance
Again, this level of detail for specific test sets with sample sizes and data provenance (country, retrospective/prospective) is not explicitly provided in the context of the 510(k) submission. The document mentions "design verification tests and analyses" and "in vivo nerve function recovery," but doesn't detail the sample sizes or provenance for these tests. The primary "study" is the comparison to predicate devices and reliance on pre-existing data (K032115).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. The 510(k) process for this device relies on demonstrating equivalence rather than establishing new clinical ground truth through expert consensus.
4. Adjudication Method for the Test Set
This information is not provided.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This information is not provided. MRMC studies are typically for evaluating diagnostic imaging devices or other technologies where human readers interpret results, which is not directly applicable to a nerve guide.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable/not provided. The Neurolac® nerve guide is a medical device, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the Neurolac® (4-10 mm) nerve guide's safety and effectiveness relies on:
- Substantial Equivalence to Predicate Devices: The primary "ground truth" is that the Neurolac® (4-10 mm) nerve guide is substantially equivalent in design, fundamental technology, and intended use to previously cleared devices:
- Pre-clinical data: "Biocompatibility, mechanical and chemical and physical property testing, in vitro degradation testing and performance testing, clinical testing and testing in an animal model provide scientific evidence that Neurolac (1-3 mm) nerve quide (510(k) 032115) is safe for implantation." {1}
- Literature and Comparison: "Evaluation of the Polyganics Neurolac (4-10 mm) nerve guide based on results from literature and the comparison of the Neurolac (4-10 mm) nerve guide with its predicate devices, shows that the material of which the Neurolac (4-10mm) nerve guide is made, is safe for implantation." {1}
8. The Sample Size for the Training Set
This information is not provided. The concept of a "training set" is typically associated with machine learning algorithms, which is not applicable here. The safety and effectiveness are established through reference to predicate devices and pre-clinical data, not an AI training process.
9. How the Ground Truth for the Training Set Was Established
As explained above, this concept of "training set" and associated ground truth establishment is not applicable to this device.
§ 882.5275 Nerve cuff.
(a)
Identification. A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).(b)
Classification. Class II (performance standards).