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(90 days)
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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(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 < 20 EU/device | Met the endotoxin limit of < 20 EU/device. |
| Performance Testing - Bench | ||
| Color Additive Exposure | Dissolution of color additive within 72 hours, leaving colorless, transparent hydrogel; extracts show no change in color or turbidity, no visible particulates. | Confirmed through in vitro dissolution testing on hydrogel cylinders and in situ formed hydrogel; extracts show no change in color or turbidity and no visible particulates. |
| Hydrogel Deliverability | Reproducible and homogenous hydrogel delivery across full range of Cap Form sizes, successful delivery under worst-case conditions (angles, injection locations, bubbles), suitable for nerve sizes per IFU, Cap Form successfully removed without breaking/damaging hydrogel. | Successful across all worst-case conditions in all Cap Form sizes; successfully delivered around the range of nerve sizes per IFU, and the Cap Form was successfully removed without breaking or damaging the in situ formed allay Nerve Cap. |
| Dimensional Evaluation | Encapsulation of nerve within hydrogel, gel dimensions (length, width, volume) confirmed for each Cap Form size, appropriate nerve sizes for each Cap Form. | Conducted to assess hydrogel physical dimensions and volume, including confirming nerve encapsulation within the hydrogel for each nerve size per IFU, measurement of gel dimensions, and assessment of appropriate nerve sizes for each Cap Form. (Implied successful as "All tests met pre-defined acceptance criteria.") |
| Dimensional Stability | Maintain integrity as protective layer without significant loss of mechanical strength for at least 3 months; maintain hydrogel integrity without cracks or collapse; mechanical strength and lumen patency without substantial dimensional loss; minimal swelling; no significant changes in hydrogel integrity, dimensions, or swelling at extreme osmolarity. | Maintained integrity for at least 4 months (16 weeks); demonstrated maintenance of integrity without cracks or collapse, mechanical strength (compressive modulus), and lumen patency with no substantial dimensional loss; minimal swelling; no significant changes to integrity, dimensions, or swelling at 240-320 mOsm/kg. |
| Dissolution Time | Dissolution time maintained under 5 minutes. | Dissolution time is maintained under 5 minutes. |
| Gel Time | Consistently fill Cap Form with gel time of less than 10 seconds. | Consistently fills Cap Form with a gel time of less than 10 seconds. |
| Percent Swelling | Between 0% and 45% swelling of crosslinked hydrogel as measured by weight 24 hours after immersion in PBS @ 37 °C. | Characterized as between 0% and 45%. |
| Compression and Rebound Testing | Withstand compressive forces > 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 < 5 minutes achieved; all surgeons (100%, n=15/15) performed all critical tasks without failures or use-related errors. |
| Performance Testing - Animal | ||
| GLP Rat Study - Neuroma Formation | Reduction in risk of neuroma formation; no evidence of axonal escape. | 0% (none) of animals with neuroma formation within 3 months; no evidence of axonal escape. |
| GLP Rat Study - Sensorimotor Function | Restore normal sensorimotor function. | Animals were able to restore normal sensorimotor function. |
| GLP Rat Study - Device Migration | No device migration. | No evidence of device migration. |
| GLP Rat Study - Systemic Safety | Comparable safety to Polyganics NeuroCap and negative control (transection only) for tissue response (non-irritant, non-neurotoxic), animal health, body weights, clinical/neurological observations, autotomy scores, clinical pathology (with exception of slight irritation relative to negative control due to biomaterial). | Comparable safety to Polyganics NeuroCap and negative control for tissue response (non-irritant, non-neurotoxic), animal health, body weights, clinical/neurological observations, autotomy scores, and clinical pathology (slight irritant relative to negative control). No device-related adverse effects. |
| Non-GLP Rabbit Study - Biocompatibility | Hydrogel has acceptable biocompatibility and does not cause adverse inflammatory response to nerve or surrounding tissue; similar biocompatibility to comparator control group (silicone cuff). | All animals in good health, no adverse neurological/behavioral effects (lameness, dropped hocks, gait abnormalities), normal weight gain, no clinical signs related to device/procedure, able to ambulate normally, no signs of pain/autotomy/infection, supported by normal clinical pathology/urinalysis/hematology/serum chemistry/coagulation. |
Study Details:
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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.
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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."
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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.
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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.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. No algorithm is described.
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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.
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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.
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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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