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510(k) Data Aggregation
(243 days)
AxoGen Nerve Cap
AxoGen Nerve Cap is indicated to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of symptomatic or painful neuroma.
The AxoGen Nerve Cap is a surgical implant that is a tubular device with one open end, one sealed end (cap) and internal channels designed to provide protection for a peripheral nerve end or stump where repair is unattainable or not desired. The device prevents dislocation of the nerve end by pulling the nerve into the tube, suturing the nerve within the cap, and securing the tab to the surrounding tissue.
AxoGen Nerve Cap is an extracellular matrix (ECM) and is fully remodeled during the healing process. The device is manufactured from processed porcine small intestinal submucosa (SIS) which is vacuum pressed prior to packaging. After hydration, the device is easy to handle, soft, pliable, non-friable and porous.
AxoGen Nerve Cap is flexible to accommodate movement of the joints and surrounding soft tissues and has sufficient mechanical strength to hold appropriately sized nonabsorbable suture. It is supplied in nominal tube diameters ranging from 1.5mm up to 8mm, and a length of 13mm-38mm. AxoGen Nerve Cap is provided sterile, for single use only, and in a variety of sizes to meet clinical needs.
The provided text describes the AxoGen Nerve Cap, a medical device, and its journey through the 510(k) premarket notification process for FDA clearance. The submission focuses on demonstrating substantial equivalence to predicate devices based on various performance specifications and biocompatibility testing.
However, the provided text does not contain any information related to a study involving human or expert readers, AI assistance, complex ground truth establishment for a test or training set, or sample sizes related to such studies. The performance specifications primarily relate to the physical and biological properties of the device itself (e.g., suture retention strength, tensile strength, biocompatibility, usability in a handling context).
Therefore, I cannot fulfill most of your request as the information is not present in the provided document. I can only extract criteria and performance related to the physical device.
Here's what I can provide based on the given text:
Acceptance Criteria and Reported Device Performance for AxoGen Nerve Cap
The acceptance criteria here refer to the performance specifications of the physical device and its material properties, not the performance of an AI algorithm or human reader study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance (Results) |
|---|---|
| End Tab Shear Test | End tab is of sufficient size to hold a class I, 8-0 USP suture as measured by lap shear of a 6-layer SIS sample with an overlap representative of the device configuration. |
| Suture retention strength | The suture retention of a 4-layer SIS sample (representative of the lumen material) meets specifications ( $\geq$ 560.8 gf) after aging for 19 months. There was no loss of the ability of the material to hold suture after aging. (Shelf life is 18 months). |
| Ultimate Tensile Strength | Ultimate Tensile Strength was not reduced with aging for 19 months. (Shelf life is 18 months). |
| Usability | The usability study demonstrated that the design was sufficient to show that the Nerve Cap can cover the nerve, is easy to handle and suture, and the lumen did not collapse during handling. |
| Biocompatibility - Cytotoxicity | Pass (Non-cytotoxic) |
| Biocompatibility - Sensitization | Pass (No evidence of sensitization) |
| Biocompatibility - Intracutaneous/Irritation | Pass (No evidence of intracutaneous reactivity) |
| Biocompatibility - Acute Systemic Toxicity | Pass (No mortality or evidence of acute systemic toxicity) |
| Biocompatibility - Subchronic/chronic Systemic Toxicity | Pass (Non-irritating to subcutaneous tissue; No evidence of subchronic or chronic toxicity) |
| Biocompatibility - Genotoxicity | Pass (Device extracts are non-mutagenic) |
| Biocompatibility - Implantation | Pass (Irritation not greater than control materials at 24 weeks) |
| Sterilization (Ethylene Oxide Residuals) | Verified to be less than the maximum allowable limits as defined by ISO 10993-7:2008. |
| Sterilization (Sterility Assurance Level - SAL) | Validated to a sterility assurance level (SAL) of 10⁻⁶ in conformance with EN ISO 11135:2014. |
| Non-clinical Testing (Animal Study - Safety/Efficacy for Neuroma Formation) | AxoGen Nerve Caps (both Partition and Spiral) and Open Tubes nerve cuffs had similar tissue and inflammatory responses at 56 and 84 days. Partially remodeled, but still present at 84 days post-surgery. Provided containment of nerve end and subsequent outgrowth, a reduction in nerve width measurements, and overall reduced sensitivity to mechanical stimulation, indicating a reduced likelihood of symptomatic and painful neuroma formation (compared to Surgical Controls). |
The following sections are either "Not Applicable" (N/A) or "Not Provided" in the text, as the document discusses a physical medical device and not an AI/human-reader study.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for a "test set" in the context of an AI/human reader study. For physical testing (e.g., shear, tensile, biocompatibility), the document refers to "samples" without specifying the number per test. The animal study involved a "chronic rat tibial nerve transposition (TNT) model" and "Control groups were also implanted," but specific group sizes are not given.
- Data Provenance: Not applicable in the context of typical AI/human reader study data provenance (e.g., country of origin, retrospective/prospective). The studies are laboratory and animal-based performance tests of the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. Ground truth for an AI/human reader study is not applicable here. The "ground truth" for the device's performance is established by the results of the physical and biological tests against specified criteria and through the animal study.
4. Adjudication method for the test set
- N/A. No adjudication method for a test set of human/AI readings is described.
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
- N/A. No MRMC study was described. This is a physical medical device, not an image analysis or diagnostic AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. There is no AI algorithm. The "standalone performance" refers to the physical device itself meeting its specifications.
7. The type of ground truth used
- For the physical properties and biocompatibility: These are based on mechanical testing standards, biological evaluation standards (ISO 10993-1, ISO 10993-7), and sterilization standards (EN ISO 11135:2014).
- For the non-clinical efficacy (neuroma reduction): This was established through an animal model (chronic rat tibial nerve transposition (TNT) model), with outcomes measured by "containment of nerve end and subsequent outgrowth, a reduction in nerve width measurements, and overall reduced sensitivity to mechanical stimulation."
8. The sample size for the training set
- N/A. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- N/A. There is no "training set" or AI-specific ground truth.
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