(123 days)
Axoguard HA+ Nerve Protector is indicated for the management of peripheral nerve injuries where is no gap.
The Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for peripheral nerves. Axoguard HA+ Nerve Protector is designed to be an interface between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. 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 associated tendons 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 surgeons' needs.
The provided document is a 510(k) summary for the Axoguard HA+ Nerve Protector. It describes the device, its intended use, and a comparison to a predicate device. It also briefly mentions performance data. However, this document does not contain the detailed information necessary to answer all parts of your request. Specifically, it lacks information on acceptance criteria for each test, the reported performance against those criteria beyond a summary statement, and detailed information about any clinical studies involving human readers or ground truth for training sets.
Here's a breakdown of the information that can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Not Explicitly Stated for Most) | Reported Device Performance |
|---|---|---|
| Coefficient of Friction | (Implicitly: a specific range/value) | "Test articles met the acceptance criteria." |
| Suture Retention Strength | (Implicitly: a specific force) | "Test articles met the acceptance criteria." |
| Ultimate Tensile Strength | (Implicitly: a specific force) | "Test articles met the acceptance criteria." |
| Bubble Emission (Packaging) | (Implicitly: no detectable leaks) | "Test articles met the acceptance criteria." |
| Seal Strength (Packaging) | (Implicitly: a specific strength) | "Test articles met the acceptance criteria." |
| Endotoxin | USP requirement | "Test article extracts met USP requirement." |
| End-user Validation | (Implicitly: device ease of use, conformance to user needs) | "Test articles met the acceptance criteria." |
Missing: The document only states that "Test articles met the acceptance criteria" for most tests and "met USP requirement" for Endotoxin. The actual acceptance criteria (e.g., specific force values, friction coefficients, etc.) are not detailed in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing: The document does not specify the sample sizes used for each performance test. It also does not explicitly state the provenance of the data (e.g., country of origin, retrospective/prospective). These are typically non-clinical laboratory tests.
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)
Missing: This information is not relevant to the types of performance tests described (physical, chemical, and end-user validation of a medical device). "Ground truth" in the context of image analysis or diagnostic AI is not applicable here. The "end-user validation" involved "Surgeon end-users," but the number and specific qualifications (beyond being surgeons) are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing: Adjudication methods are typically relevant for studies where expert opinion on subjective assessments (e.g., image interpretation) is being reconciled. It is not applicable to the objective physical and chemical tests described. For the "End-user Validation," it's not clear if there was any formal adjudication process beyond surgeons assessing ease of use and conformance.
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
Missing: This is a physical medical device, not an AI or diagnostic tool. Therefore, an MRMC comparative effectiveness study is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing: This question is not applicable as the device is a physical nerve protector, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing: This question is not applicable in the typical sense for this device. For the physical and chemical tests, the "ground truth" would be the measured physical properties themselves against predefined standards. For end-user validation, it's subjective feedback from surgeons.
8. The sample size for the training set
Missing: This question is not applicable as the device is a physical medical device and does not involve AI or machine learning models that require training sets.
9. How the ground truth for the training set was established
Missing: This question is not applicable as the device is a physical medical device and does not involve AI or machine learning models that require training sets or establishment of ground truth for training.
Summary of what the document does provide regarding acceptance criteria and studies:
The document describes several performance tests, including:
- Coefficient of Friction
- Suture Retention Strength
- Ultimate Tensile Strength
- Bubble Emission (Packaging)
- Seal Strength (Packaging)
- Endotoxin
- End-user Validation
These tests were performed to support the substantial equivalence determination for the Axoguard HA+ Nerve Protector. The study concludes that "These evaluations demonstrate that the device meets the requirements for its intended use" and "Test articles met the acceptance criteria" for the listed tests (or "met USP requirement" for Endotoxin).
Additionally, non-clinical GLP biocompatibility studies were performed to evaluate the effects and biocompatibility of the device on the nerve and surrounding muscle tissue, ensuring compliance with ISO 10993-1. These studies "met all necessary endpoints according to the standard."
The overall conclusion is that "The non-clinical data support the safety of the device and demonstrate that the Axoguard HA+ Nerve Protector performs as intended in its specified use conditions, and is substantially equivalent to its predicate device and does not raise different questions of safety and effectiveness."
§ 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).