(194 days)
The CRYOFOS and Accessories indicated for use when cold therapy is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).
The CRYOFOS and Accessories is a topical refrigerant that acts as a vapocoolant. The CRYOFOS system consists of a pistol grip handpiece, console for controlling operations, a rechargeable battery (Panasonic R127R2PG), and a cvlinder of compressed medical grade Carbon Dioxide (CO2) gas (sold separately). The CRYOFOS has a user interface that displays treatment activation. The CRYOFOS system delivers a topical spray of compressed medical grade (CO2) that is pure, dry bacteriostatic and non-explosive via the pistol grip handpiece. The device uses the natural expansion of liquid CO2 in the atmosphere to create a cold spray of microcrystals delivered under pressure. The expansion cooling of the treatment gas forms a micro-crystalline dry-ice mist with which the cooling effect required for treatment is achieved. The end-user uses a gradual circular or panning motion with the handpiece to apply the CO2 to the treatment site for 30-60 seconds at a distance of approximately 7cm. Rapid cooling (thermal shock) of the skin occurs at temperatures of 2-4°C in 30 sec when the spray sublimates (pass directly from solid / ice phase to gas phase) as it contacts the skin.
The provided text describes the 510(k) premarket notification for the CRYOFOS and Accessories device, claiming substantial equivalence to a predicate device (CRYOTRON 2 Cryotherapy Device). However, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML-based medical device.
The document pertains to a cryosurgical unit that delivers a topical spray of CO2 for cold therapy. The "testing" section primarily focuses on:
- Bench testing: Electrical safety (IEC 60601-1), EMC testing (IEC 60601-1-2), software verification, and performance/benchmark testing against the predicate device to confirm physical parameters like temperature reached and treatment time.
- Literature review: An "extensive literature review of studies" was used to establish clinical efficacy for cryotherapy in general, not a specific clinical study of the CRYOFOS device itself.
Therefore, I cannot fulfill your request for details on (all points below cannot be found from the provided text):
- A table of acceptance criteria and the reported device performance: The document mentions that the CRYOFOS reached a temperature of 2-4°C in 30 seconds, and the lowest temperature is -78.5°C, but these are performance characteristics, not formal acceptance criteria presented in a table format with corresponding results for a specific clinical study designed to prove the device meets these criteria.
- Sample size used for the test set and the data provenance: No clinical test set is described. The clinical efficacy was based on a literature review.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set requiring expert ground truth was used.
- Adjudication method for the test set: Not applicable.
- 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, as this is not an AI/ML device and no MRMC study was conducted.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Clinical efficacy was derived from an "extensive literature review" of existing cryotherapy studies, not new ground truth data collected for this specific device.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
In summary, the provided document is a 510(k) submission for a physical medical device (cryosurgical unit) and relies on substantial equivalence to a predicate device, bench testing, and a literature review for general cryotherapy efficacy rather than a specific clinical study with ground truth and expert involvement for the CRYOFOS device itself as would be typical for an AI/ML product.
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.