(122 days)
Axoguard HA+ Nerve Protector is indicated for the management and peripheral nerve injuries where there is no gap, or following closure of the gap.
Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for peripheral nerve injuries. Axoguard HA+ Nerve Protector is designed to aid in coaptation and protection of peripheral nerve injuries by serving as an interface between the nerve and the surrounding tissue and also providing tension relief when used as a coaptation aid. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, Axoguard HA+ Nerve Protector is easy to handle, soft, pliable, nonfriable, and porous. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the joint and has sufficient mechanical strength to hold sutures. Axoguard HA+ Nerve Protector is provided sterile, for single use only, and in a variety of sizes to meet the surgeon's needs.
The provided text describes a 510(k) premarket notification for a medical device called "Axoguard HA+ Nerve Protector." This submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove the device's efficacy through a clinical study in the same way an AI/ML device would be.
Therefore, the requested information elements related to AI/ML device studies (e.g., sample sizes for test/training sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable to this document. This document focuses on demonstrating the safety and performance of a physical surgical implant through bench testing, biocompatibility studies, and non-clinical (animal) studies, primarily by showing it meets predetermined acceptance criteria and is comparable to an existing device.
However, I can provide the acceptance criteria and performance results that are present in the document.
Acceptance Criteria and Reported Device Performance
For this medical device (Axoguard HA+ Nerve Protector), the acceptance criteria are met when the results of various bench tests and biocompatibility assessments demonstrate that the device performs as intended and is safe for its indicated use, showing substantial equivalence to the predicate device. The performance data presented are primarily from bench testing and biocompatibility studies, along with a non-clinical GLP (Good Laboratory Practice) study in rats.
Here's a table summarizing the acceptance criteria (implied by the "Test Method Summary" and the general expectation for medical devices) and the reported device performance:
| Test | Test Method Summary | Acceptance Criteria (Implied) | Reported Device Performance/Result |
|---|---|---|---|
| Bench Testing | |||
| Coefficient of Friction | Aged and unaged devices evaluated for static coefficient of friction (lubricity) based on ASTM D1894-14. | Must meet pre-defined lubricity specifications for intended use. | "Test articles met the acceptance criteria." |
| Suture Retention Strength | Aged and unaged devices evaluated for suture retention strength by measuring the force required to pull a suture free, based on ANSI/AAMI/ISO 7198. | Must demonstrate sufficient strength to securely hold sutures without pull-through at specified forces. | "Test articles met the acceptance criteria." |
| Ultimate Tensile Strength | Aged and unaged devices evaluated for ultimate tensile strength by measuring the separation force required for device failure, based on ASTM D882-18. | Must exhibit adequate tensile strength to withstand surgical handling and in-vivo stresses. | "Test articles met the acceptance criteria." |
| Bubble Emission (Packaging) | Aged and unaged devices underwent ethylene oxide sterilization and visual inspection prior to bubble leak testing, evaluated per ASTM F2096-11(2019). | Packaging must maintain integrity to ensure sterility and product protection. | "Test articles met the acceptance criteria." |
| Seal Strength (Packaging) | Aged and unaged devices underwent ethylene oxide sterilization and visual inspection prior to seal strength testing, subjected to testing per ASTM F88/F88-21. | Packaging seals must meet specified strength requirements to prevent bacterial ingress. | "Test articles met the acceptance criteria." |
| Biocompatibility | (All based on ISO 10993-1 and relevant sub-parts) | Must demonstrate no adverse biological reactions. | All endpoints met. |
| Sensitization | Test article extracts evaluated for potential to cause delayed dermal contact sensitization in a guinea pig maximization test based on ISO 10993-10. | Must show no evidence of causing sensitization. | "Test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig." |
| Irritation | Test article extracts evaluated for potential to cause irritation following intracutaneous injection in rabbits based on ISO 10993-23. | Must be non-irritating. | "Test article extracts met the requirements of the test and were considered non-irritants." |
| Acute Systemic Toxicity | Test article extracts evaluated for acute systemic toxicity in mice based on ISO 10993-11. | Must show no mortality or evidence of systemic toxicity. | "There was no mortality or evidence of systemic toxicity from the test article extracts. Each test article extract met the requirements of the study." |
| Pyrogenicity | Test article extracts evaluated for potential to induce a pyrogenic response following intravenous injection in rabbits based on USP 43- NF38, General Chapter , ISO 10993-11. | Must meet requirements for the absence of pyrogens. | "The test article met the requirements for the absence of pyrogens." |
| Genotoxicity (Ames) | Test article extracts evaluated for mutagenic potential in Escherichia coli or Salmonella typhimurium strains (with/without S9 metabolic activation) based on ISO 10993-3. | Must be non-mutagenic. | "Test article extracts met the requirements of the test and were considered non-mutagenic." |
| Genotoxicity (Mouse Lymphoma Assay) | Test article extracts evaluated for mutagenic potential using the mouse lymphoma forward gene mutation assay based on ISO 10993-3. | Must be non-mutagenic. | "Test article extracts met the requirements of the test and were considered non-mutagenic." |
| Endotoxin | Test article extracts evaluated for bacterial endotoxins using the Kinetic-Turbidimetric test method per USP 43-NF38, General Chapter , USP43-NF38, General Chapter , and ANSI/AAMI ST72. | Must meet USP requirements for endotoxin levels. | "Test article extracts met USP requirement." |
| Cytotoxicity | Test article extracts evaluated for potential to cause cytotoxic effects using an in vitro mammalian cell culture test based on ISO 10993-5. | Must show no evidence of cell lysis or toxicity. | "Test article extracts showed no evidence of causing cell lysis or toxicity and each had a grade of 0 (no reactivity)." |
| Non-Clinical GLP Study (Animal) | Evaluated effects of Axoguard HA+ Nerve Protector on nerve regeneration after implantation in a rat sciatic nerve transection injury model. 60 Lewis Rats (10 males, 10 females per group) divided into Sham, Test, and Control groups. Endpoint at 6 or 12 weeks. | Must demonstrate safety and efficacy comparable to control/sham for nerve regeneration and related outcomes. | "The study met set acceptance criteria regarding safety and local effects related to nerve regeneration following implantation... The nerve regeneration-related outcomes in the Test device... were not statistically significantly different when compared to the Control device." |
Regarding the AI/ML specific questions:
- Sample sized used for the test set and the data provenance: Not applicable. This is a physical device, not an AI/ML diagnostic or therapeutic. The "test set" here refers to physical samples used in bench tests and animals in a non-clinical study. The non-clinical study used 60 Lewis Rats. The provenance is a laboratory study, not human data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like this comes from standardized material testing, chemical analyses, and biological observations in animal models, not human expert consensus on images.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For bench testing, the ground truth is defined by the physical or chemical properties measured against established standards (e.g., ASTM, ISO). For biocompatibility, it's the biological response in standardized in-vitro and in-vivo tests. For the non-clinical study, the ground truth was established by histology endpoints for axonal outgrowth, axonal myelination, and gastrocnemius muscle weight in the rat model. This is essentially biological/pathological assessment in an animal model.
- The sample size for the training set: Not applicable, as there is no AI/ML algorithm involved.
- How the ground truth for the training set was established: Not applicable.
§ 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).