(78 days)
The Cryo-Mono Cryogenic System is intended for cryogenic destruction of tissues during surgical procedures. It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurosurgery, thoracic surgery, ENT, gynecology, oncology, proctology, and urology for the ablation of tissue, including liver metastases, skin lesions, warts, and prostate tissues. Cryo-Mono with TUF probe is specifically indicated for the ablation of prostate tissue in cases of benign prostatic hyperplasia ("BPH").
The Cryo-Mono is a modified version of Cryo-Hit. They have the same technological characteristics with several exceptions: The primary technological differences between the Cryo-Mono with TUF probe and the Cryo-Hit are: (1) Cryo-Mono with TUF accepts only one cryoprobe, the TUF probe, which is one of the options for the Cryo-Hit; (2) The Cryo-Mono with TUF probe is smaller than Cryo-Hit; (3) The Cryo-Mono with TUF probe has fewer gas cylinders; (4) The physician manually applies the Cryo-Mono's probe while with the Cryo-Hit, the physician has the option to use the "Stick" mode, which automatically adheres the probe to the tissue; (5) The Cryo-Mono with TUF probe has an optional foot pedal control; (6) The Cryo-Mono with TUF probe delivers preset amounts of argon for cooling while the Cryo-Hit adjusts the amount of argon delivered based on the tissue temperature measured by its thermocouples; (7) The Cryo-Mono with TUF probe's iceball size is monitored by transrectal ultrasound; the use of ultrasound, as well as external theromcouples, is optional with the Cryo-Hit; and (8) The Cryo-Mono's TUF probe is delivered transurethrally through a cystoscope rather than transperineally as with the Cryo-Hit. The only modification to the device' s software was the removal of the "stick" option mentioned above. The Cryo-Mono's single-use probes are within the range of probes that can be used with the Cryo-Hit, i.e. one to eight probes.
The provided text describes a 510(k) premarket notification for the Cryo-Mono Cryogenic System with TUF probe. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with explicit acceptance criteria for device performance. Therefore, many of the requested elements (like sample size for test sets, ground truth establishment, MRMC studies, standalone performance studies, etc.) are not typically included or required in a 510(k) submission focused on substantial equivalence based on technological characteristics and intended use.
The performance data mentioned pertains primarily to biocompatibility and compliance with general safety standards, not a specific clinical performance study for a machine learning algorithm.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) for substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the device is as safe and effective as the predicate devices. There are no explicit performance metrics like "sensitivity" or "specificity" provided for an AI algorithm.
| Acceptance Criteria (Implied by 510(k) process) | Reported Device Performance (from submission) |
|---|---|
| Biocompatibility | Components made of same materials as K980205 (Cryo-Hit) and Impra's Venaflo™ vascular graft, which have FDA premarket clearance. |
| Electrical Safety & EMC | Conformance with IEC 60601-1 and IEC 60601-1-2. |
| Material Safety | Conformance with ASTM F882-84. |
| Intended Use & Indication for Use | Same general intended use as Cryo-Hit. Specifically indicated for ablation of prostate tissue in BPH, similar to CryoCare™ and TUNA system. |
| Technological Characteristics | "Virtually identical technological characteristics" to Cryo-Hit, with minor differences not raising new safety/effectiveness questions (e.g., single probe, smaller size, fewer gas cylinders, no "stick" option, foot pedal, modified software, transurethral delivery for TUF probe). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This submission relies on demonstrating substantial equivalence based on technological characteristics and prior clearances, not on a new clinical study with a test set of patient data to evaluate an algorithm's performance. The "performance data" refers to engineering and material compliance.
3. 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/Not provided. No clinical test set requiring expert ground truth was described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No clinical test set requiring adjudication was described.
5. 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
- No. This device is a cryosurgical system, not an AI software/algorithm designed to assist human readers. Therefore, an MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device is a physical cryosurgical system, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided pertaining to an algorithm's performance. For biocompatibility and safety, the "ground truth" is adherence to established standards (e.g., IEC, ASTM) and the FDA's prior clearances for the predicate materials and devices.
8. The sample size for the training set
- Not applicable/Not provided. This submission does not describe an AI/machine learning component that would require a training set in the typical sense. The "modified software" mentioned simply involved removing a "stick" option, not a re-training of a predictive model.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As there is no described AI training set, there is no ground truth establishment method.
§ 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.