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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

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.

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The ENDOcare Urethral Warming System is an accessory to the cryosurgical system and is indicated to transfer heat to the urethral tissue during urological cryosurgery procedures using the ENDOcare CRYOcare™ Cryosurgical System.

The ENDOcare Urethral Warming System consists of a balloon catheter, PVC tubing set, heater/heater stand and roller pump. The urethral catheter consists of a polyurethane shaft with a polyester balloon. The system provides a steady flow of warm water or saline from an I.V. bag to the catheter in order to transfer heat to the urethral tissue during urological cryosurgery procedures. The catheter has an inlet port which allows the warm water or saline to flow into the balloon, warming the surrounding urethral tissue. An outlet port allows the water or saline to exit the catheter and return to the I.V. bag. The water or saline in the I.V. bag is maintained at a set temperature of 37.5℃ by the heater. A shutoff feature prevents the temperature from exceeding 42°C. The water or saline is circulated by a roller pump from the catheter to the I.V. bag in a closed circuit.

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria in the typical sense of a clinical or performance study with specific metrics, sample sizes, and ground truth establishment.

Instead, the document describes the Endocare Urethral Warming System and focuses on demonstrating its substantial equivalence to a predicate device (Cryomedical Sciences Urethral Warmer) and compliance with general medical device requirements (biocompatibility, sterilization).

Here's a breakdown of the available information, addressing your points where possible, and noting where information is absent:

1. A table of acceptance criteria and the reported device performance:

Missing Information/Not Applicable: The document describes engineering benchmarks and regulatory compliance rather than performance criteria that would typically be associated with a "study" involving human subjects or algorithmic performance.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable in the context of the described testing. The "bench testing" for functional performance likely involved a small number of physical units, but no specific sample size is reported.
• Data Provenance: Not applicable. The testing was in vitro (bench testing) and involved physical devices, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. There was no "ground truth" establishment by experts in the context of a clinical study. The functional performance was a direct measurement comparison between two physical systems. Biocompatibility and sterility are based on established standards and laboratory validations, not expert consensus on performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No adjudication process for a test set is 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:

• Not applicable. This device is a Urethral Warming System, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Functional Performance: The "ground truth" for the functional performance comparison was the direct measurement of temperature maintenance and flow characteristics of the predicate device, which the new device aimed to match. This is an engineering benchmark, not a clinical ground truth.
• Biocompatibility/Sterilization: Ground truth is established by adherence to recognized international standards (ISO-10993, AAMI guidelines) and validation testing against those standards.

8. The sample size for the training set:

• Not applicable. This is not a machine learning/AI device.

9. How the ground truth for the training set was established:

• Not applicable. This is not a machine learning/AI device.

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