(73 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® is designed to be a flexible and transparent resorbable poly(DL-lactide- co-e-caprolactone) tube to provide a protective environment for peripheral nerve reqeneration after injury and to create a conduit to quide axonal growth across a nerve gap. Neurolac® nerve guides are provided sterile in Tyvek pouch packages and retainer in a variety of sizes. The modification in this submission concerns a line extension to the predicate devices with a thinner wall thickness.
The provided document describes a 510(k) submission for a line extension to the Neurolac® Nerve guide, with the modification being a thinner wall thickness. The study is an in vitro comparison of the new thinner-walled device to the predicate device (K032115).
Here's a breakdown of the acceptance criteria and study as requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical targets for each property. Instead, it demonstrates comparability to the predicate device. The implicit acceptance criterion is that the thinner-walled Neurolac nerve guides perform equivalently to the current cleared Neurolac nerve guides.
| Property | Implicit Acceptance Criteria / Target | Reported Device Performance (Neurolac with 37% wall thickness reduction) |
|---|---|---|
| Dimensional Changes | Comparable to Cleared Neurolac | |
| Inner diameter | Lumen maintained till week 10-11 | Lumen maintained till week 10-11 |
| Outer diameter | Gradual increase | Gradual increase |
| Wall thickness | Gradual increase in outward direction | Gradual increase in outward direction |
| Weight Changes | Comparable to Cleared Neurolac | |
| Swelling (water uptake) | Stable in initial weeks, then gradual increase | Stable in initial weeks and then gradual increase |
| Weight loss | After week 10-11 | After week 10-11 |
| Analysis | Comparable to Cleared Neurolac | |
| NMR (degradation products) | After week 12 | After week 12 |
| DSC (Tg) | Gradual decrease in Tg | Gradual decrease in Tg |
| Intrinsic Viscosity | Slow and gradual decrease | Slow and gradual decrease |
| Mechanical Properties | Comparable to Cleared Neurolac | |
| Mechanical properties | Stable for initial 10-11 weeks | Stable for initial 10-11 weeks |
| Flexural properties | Stable for initial 10-11 weeks | Stable for initial 10-11 weeks |
| Compression properties | Stable for initial 10-11 weeks | Stable for initial 10-11 weeks |
| Suturability | Not explicitly defined as "comparable" but notable improvement | Easy suturing (compared to "Difficult suturing" for cleared device) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample size for the in vitro tests.
The data provenance is presented as in vitro testing, not explicitly stating country of origin, though the submitter is based in The Netherlands. It is a retrospective comparison as it compares to an already cleared predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is an in vitro test for material properties and device performance, not a study requiring expert clinical assessment for ground truth.
4. Adjudication Method for the Test Set
Not applicable. This is an in vitro test for material properties and device performance.
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 not an AI/imaging device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an algorithm/software device. The performance data presented are for the physical device itself.
7. The Type of Ground Truth Used
The "ground truth" here is the established performance characteristics of the predicate device (Neurolac nerve guides K032115), against which the new thinner-walled device is compared. This is based on previously established performance data for the predicate and fundamental material science.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" in this type of in vitro device comparison study. The study focuses on demonstrating comparability to a predicate device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied. The "ground truth" for comparison is the documented performance of the predicate device, which would have been established through its own preclinical studies and regulatory clearance process.
§ 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).