(87 days)
The ENDOcare CRYOcare™ Cryosurgical System is intended for use in general surgery, urology, gynecology, oncology, neurology, thoracic surgery, dermatology, ENT, and proctology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate, kidney, and breast tissue, liver metastases, tumors, skin lesions, and warts.
The ENDOcare CRYOcare™ Cryosurgical System consists of a console which can control one to eight single-use, disposable CRYOprobes™ and one to eight independent inouts to monitor temperatures from standard T-type needle thermocouples. The system is compact and operates off of standard 110 VAC wall power.
Several models will be provided depending on the needs of the customer. Currently, the system is available in a 1, 4 and 8-CRYOprobe™ configuration. The performance characteristics and internal design of each model are equivalent. The only differences are the number of valves to control the CRYOprobes™ (e.g., 1-8), number of thermocouple inputs (e.g., 1-8) and the size of the outer case.
The provided text describes the ENDOcare CRYOcare™ Cryosurgical System and its clearance by the FDA. However, the document does not contain information about specific acceptance criteria related to device performance metrics for a study and the results of such a study. Most of the document focuses on regulatory aspects, substantial equivalence, and sterilization/shelf-life validation.
Based on the provided text, I can only provide information on the shelf-life determination study.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Shelf Life (1 Year) | |
| Microbial penetration | All test results met the acceptance criteria. |
| Functional integrity | All test results met the acceptance criteria. |
| Package seal integrity | Not explicitly stated, but implied by overall success of the shelf-life study. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Ten (10) simulated products and one (1) control for the shelf-life determination.
- Data Provenance: Not specified, but likely proprietary data from ENDOcare, Inc. The study appears to be prospective as it involves accelerated aging and subsequent testing.
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. The shelf-life determination involves laboratory testing (microbial challenge, functional testing, package integrity), not expert assessment of clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The shelf-life determination involves laboratory testing against predefined criteria, not expert adjudication.
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 document does not describe an AI or imaging device; it describes a cryosurgical system. Therefore, an MRMC comparative effectiveness study is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This document does not describe an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the shelf-life study, the "ground truth" was based on predefined laboratory test results and regulatory standards for microbial penetration and functional integrity after accelerated aging and environmental challenges.
8. The sample size for the training set
Not applicable. This device is a cryosurgical system, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a cryosurgical system, not an AI algorithm.
§ 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.