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The allay™ Nerve Cap is indicated for use in individuals weighing 25 kg or more 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 forming, hydrogel barrier composed of water and polyethylene glycol (PEG) that reduces the risk of neuroma formation by providing a protective cover around the end of a nerve. The hydrogel forms in seconds after delivery of the precursor solutions around a nerve placed in a temporary silicone Cap Form. The Cap Form is then readily removed and discarded, leaving the nerve end wrapped in a transparent compliant gel that conforms to the nerve to prevent nerve outgrowth from the proximal stump for over 3 months, the critical period during which neuroma formation can occur. The hydrogel Nerve Cap is biocompatible, non-constrictive and non-neurotoxic and is absorbed from the site within 8 months with no evidence of systemic toxicity.

The device consists of various components for the preparation of the hydrogel, a dedicated applicator for the mixing and delivery of the two-component PEG/Accelerator Solutions, and temporary silicone Cap Forms. 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 Nerve Set, for 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 (l, 2, 3, and 4 mm) and Large Nerve Set (5, 6, and 7 mm)]. As a convenience for users, Delivery Tips are also provided separately if needed. They are provided in boxes that consist of six independently packaged, sterile Delivery Tips. They are identical to the Delivery Tips provided in the complete allay™ Nerve Cap kit, including with respect to dimensions, materials, use, and manufacturing.

The allay™ Nerve Cap is a single use device that is provided sterile and is strictly for prescription (Rx) use only.

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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

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • Bench Test (performance testing): Sample sizes for specific tests are not explicitly stated for all "parts" of the bench tests (e.g., how many hydrogel cylinders for dissolution). However, for the Human Factors & Usability Study, the sample size was 20 participants (15 surgeons, 5 surgical scrub nurses). Data provenance is internal lab testing.
   • Animal Studies:
     • GLP Rat Sciatic Nerve Transection Study: Sample size not explicitly stated for each group, but compares "allay Nerve Cap" group, "Polyganics Innovation BV NeuroCap" control group, and "transected nerve alone" negative control group. Data provenance: Pre-clinical animal study.
     • Non-GLP Implantation Study on Intact Rabbit Sciatic Nerve: 14 New Zealand white rabbits, receiving bilateral implants (allay Nerve Cap on left sciatic nerve, silicone cuff on right sciatic nerve). Data provenance: Pre-clinical animal study.

2. 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):

   • Not Applicable for AI/ML Ground Truth. The "ground truth" for this medical device is established through physical/chemical testing, direct observation in bench studies, and histological/clinical assessments in animal studies, not expert labeling of data for an algorithm.
   • For the Human Factors & Usability Study, 15 surgeons were used to evaluate usability. Their qualifications are described as having "relevant surgical experience on nerve repair, including hand surgeons, plastic surgeons, orthopedic surgeons, and podiatrists." They had "no prior knowledge or relationship with the sponsor."

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. This relates to human expert consensus or adjudication in AI/ML tasks, which is not applicable here.

4. 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 a physical medical device, not an AI/ML system evaluated with human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. No algorithm is described.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Bench Studies: Established through various in vitro measurements, physical properties tests, and observational assessments based on pre-defined scientific and engineering protocols (e.g., dissolution time, gel time, dimensional stability, compression/rebound, visual inspection, mass measurement, pressure transducer readings).
   • Biocompatibility Studies: Established via standardized in vitro and in vivo biological evaluations following ISO 10993 standards, including laboratory analytical results (e.g., cytotoxicity, genotoxicity assays), and macroscopic/microscopic tissue assessments in animals (e.g., irritation, implantation responses). Chemical characterization and toxicological risk assessment were also used.
   • Animal Studies:
     • Pathology: Gross pathology, histopathologic assessment (e.g., for neuroma formation, tissue response, neurotoxicity, axonal escape).
     • Outcome Data (Behavioral/Physiological): Clinical and neurological observations (e.g., lameness, gait abnormalities, autotomy scores), body weights, clinical pathology (hematology, serum chemistry, urinalysis).
     • Direct Observation: Device integrity, presence of migration, hydrogel formation.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a "training set." The development and testing of this physical device involved R&D, pre-clinical studies, and bench testing, but not in the context of machine learning.

8. How the ground truth for the training set was established:

   • Not applicable. As above, no AI/ML training set is involved.

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