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(308 days)
The allay Nerve Cap is indicated for use in adults aged 22 years or older as a physical barrier to separate the peripheral nerve end from the surrounding environment to reduce the risk of the development of a symptomatic neuroma.
The allay Nerve Cap is a sterile, absorbable, in situ formed, hydrogel composed of water and polyethylene glycol (PEG). The hydrogel forms in seconds after delivery of the precursor solutions around a nerve seated in a temporary silicone Cap Form (Figure 1). The hydrogel provides a transparent, compliant nerve cover that conforms to and provides non-constricting encasement of the nerve. The Cap Form is removed and discarded after the implantation procedure. The hydrogel nerve cap is absorbed within 8 months.
The allay Nerve Cap system is provided in a plastic tray sealed in a sterile, peelable outer pouch. The product is available in two sizes of a Small Nerve Set, for nerves less than 4 mm in diameter, and a Large Nerves greater than 4 mm in diameter and less than 7 mm in diameter. The allay Nerve Cap system includes a Powder Vial/Vial Adapter. Diluent Solution. Acceleration Solution, Dual Applicator and Adapter, Delivery Tip with Blunt Needle, and the Cap Forms [Small Nerve Set (1, 2, 3, and 4 mm) and Large Nerve Set (5, 6, and 7 mm)].
The provided text describes a medical device, the "allay Nerve Cap," and its regulatory information, device description, nonclinical/bench studies, animal studies, labeling, risks, and benefits. It does not describe an AI/ML device or a study that uses AI/ML.
Therefore, many of the requested criteria such as "number of experts used to establish the ground truth," "adjudication method," "effect size of how much human readers improve with AI," "standalone algorithm performance," and "sample size for training set" are not applicable as they relate to AI/ML device performance evaluation, which is not present in the provided document.
However, I can extract the acceptance criteria and performance data for the physical device as described.
Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity (allay Nerve Cap) | Non-cytotoxic | Non-cytotoxic |
| Sensitization | Non-sensitizing | Non-sensitizing |
| Intracutaneous Irritation (allay Nerve Cap) | Non-irritant | Non-irritant |
| Acute Systemic Toxicity (allay Nerve Cap) | Non-toxic | Non-toxic |
| Implantation (Local Subcutaneous) | Non-irritant | Non-irritant |
| In vivo Animal Study Efficacy - Local | Non-irritant, Non-compressive, No migration or adverse tissue responses or effects observed | Non-irritant, Non-compressive, No migration or adverse tissue responses or effects observed |
| Neurotoxicity | Non-irritant, No adverse responses observed | Non-irritant, No adverse responses were observed |
| Repeated Exposure Systemic Toxicity | Non-toxic | Non-toxic (based on Chemical Characterization and TRA) |
| Hemolysis (Indirect Contact) | Non-hemolytic | Non-hemolytic |
| Pyrogenicity (allay Nerve Cap) | Non-pyrogenic | Non-pyrogenic |
| Genotoxicity | Non-genotoxic | Non-genotoxic |
| Reproductive Toxicity | Non-toxic | Non-toxic (based on Chemical Characterization and TRA) |
| Carcinogenicity | Non-carcinogenic | Non-carcinogenic (based on Chemical Characterization and TRA) |
| Cytotoxicity (Sterile Cap Forms) | Non-cytotoxic | Non-cytotoxic |
| Intracutaneous Irritation (Sterile Cap Forms) | Non-irritant | Non-irritant |
| Acute Systemic Toxicity (Sterile Cap Forms) | Non-toxic | Non-toxic |
| Pyrogenicity (Sterile Cap Forms) | Non-pyrogenic | Non-pyrogenic |
| Cytotoxicity (Sterile Applicator) | Non-cytotoxic | Non-cytotoxic |
| Cytotoxicity (Sterile Tray Packaging) | Non-cytotoxic | Non-cytotoxic |
| Infrared Spectroscopy | No adverse effects observed | No adverse effects observed |
| Nonvolatile Residue | Residue ≤ 15 mg | Residue ≤ 15 mg |
| Particulates | No adverse particulates observed | No adverse particulates observed |
| Shelf Life/Sterility | ||
| Shelf Life Validation | Maintained sterility, package integrity, and device functionality over identified shelf life (2 years) under worst-case shipping, handling, and storage conditions. | Validated for a shelf life of 2 years; results showed the final product packaging protects the product and maintains sterility under worst-case shipping, handling, and storage conditions. |
| Sterility Assurance Level | SAL of 10-6 | SAL of 10-6 achieved using E-beam radiation. |
| Bacterial Endotoxin | Endotoxin limit of 0.25 N/cm and rebound > 95%. | Withstands compressive forces > 0.25 N/cm and rebounds > 95%. |
| Compressive Modulus | Minimum of 30 KPa of crosslinked hydrogel after 24 hours in PBS. | Minimum of 30 KPa. |
| Ease of Preparation | Prepared in less than 10 minutes. | Achieved within 5 minutes by all users in human factors study. |
| Pressure Testing | No increase in pressure on an artificial nerve after formation and equilibration. | Demonstrated no pressure exerted on the artificial nerve at any time. Non-compressive. |
| Device Migration | Adhere to clinically relevant range of nerve sizes (diameters) for up to one week under physiologic conditions; no migration off the nerve or from implant site. | Not possible to remove after firmly pulling with forceps; consistent with in vivo animal testing results demonstrating adherence to the transected nerve stump. Does not migrate off the nerve end. |
| Wear Resistance Testing | No mass loss and no visible particulates released from the hydrogel after accelerated wear testing. | Passed the acceptance criteria: no mass loss and no visible particulates released. |
| Mass Loss | Minimal mass loss over 3-month period post implantation (comparable to 2.8% at 6 days in vitro). | Minimal mass loss occurred over the 3-month period (2.8% at 6 days in vitro); 6.6% mass loss in first phase (~4 months in vivo). |
| Exaggerated Clinical Use Conditions | Hydrogel formed successfully in presence of blood or saline, integrating to form intact allay Nerve Cap; no visible particulates formed. | Hydrogel formed successfully in the presence of blood or saline, integrating with them to form an intact allay Nerve Cap. No visible particulates were formed. |
| Use Errors | Use errors (bubble generation, incomplete dissolution, exceeding delivery window, fluids) do not result in significantly earlier degradation, impair hydrogel quality, or affect durability. | Use errors did not result in significantly earlier degradation of the hydrogel, impair hydrogel quality, or affect the durability of the hydrogel. |
| Human Factors and Usability | Intended user(s) in intended use environment can correctly and safely use the device following the instructions for use; all critical tasks performed without failures or use-related errors. | Demonstrated that the device and IFU could be followed without any use errors; use time of |
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