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The Cry-Ac® Cryosurgical Devices and Accessories are intended for use as cryosurgical tools in the field of dermatology. The Cry-Ac® Cryosurgical Devices and Accessories are indicated for:

· Ablation or freezing of skin cancers and other cutaneous disorders

· Destruction of skin tags, warts or lesions, angiomas, sebaceous hyperplasia, basal cell carcinoma, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, mucocele cysts, multiple warts, plantar warts, actinic and sebortheic keratosis, cavernous hemangiomas, perianal condylomata, and palliation of tumors of the skin

The Cry-Ac® Cryosurgical Devices (Cry-Ac-38, and Cry-Baby®) are hand-held, refillable, cryosurgical devices which dispense pressurized liquid nitrogen via open spray and closed probe applicators.

The cryosurgical devices are provided in three (3) sizes: 4 oz (125 mL; Cry-Baby®), 10 oz (300 mL, Cry-Ac-3®), and 16 oz (500 mL; Cry-Ac®). The open spray applicators include apertures, bent and straight spray extensions (1 in and 3 in), and cryochambers (6 mm to 18 mm) in various gauges. The probe applicators include mini probes (1 mm to 6 mm), conical probes (1 mm to 6 mm), ball probes (6 mm to 3 cm) and flat probes (8 mm to 3 cm). Additional accessories include a back-vent adapter, luer lock adapter, malleable extension, and right-angle and 45° adapters. The apertures are manufactured from brass, the probes are manufactured from stainless steel and brass, and coated with Teflon. Extension tubing is manufactured from silicon.

The Cry-Ac® Cryosurgical Devices, open spray and closed probe applicators, and adapters are provided non-sterile and are autoclavable.

I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and a study proving device performance. The document is a 510(k) summary for a medical device (Cry-Ac® Cryosurgical Devices and Accessories), which primarily focuses on arguing substantial equivalence to predicate devices rather than presenting the full details of a performance study with acceptance criteria.

While Section VII lists "Performance Data" such as cleaning validation, sterilization validation, shelf-life testing, biocompatibility testing, reservoir/collar bond verification and validation, finger trigger validation, and temperature testing, it does not provide:

1. A table of acceptance criteria and reported device performance: The document lists what tests were done but not the specific criteria (e.g., "temperature must remain below X for Y seconds") or the quantitative results from those tests.
2. Sample size used for the test set and data provenance: These details are not mentioned for any of the listed performance tests.
3. Number of experts used to establish ground truth and their qualifications: This is irrelevant for the types of tests described (e.g., sterilization, biocompatibility) as they do not involve expert interpretation of medical data.
4. Adjudication method: Not applicable for engineering and materials tests.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: This is not relevant. The device is a cryosurgical tool, not an imaging or diagnostic AI device that would involve human readers.
6. Standalone (i.e., algorithm only without human-in-the-loop performance): Not applicable for a physical medical device.
7. Type of ground truth used: For the types of tests mentioned, the "ground truth" would be established by validated scientific methods and standards (e.g., microbiological tests for sterilization, chemical assays for biocompatibility), not expert consensus in a clinical diagnostic sense.
8. Sample size for the training set: Not applicable as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Therefore, without additional information not present in the provided text, I cannot fulfill your request.

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