(60 days)
The CRYOCARE TOUCH™ System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, oncology, oncology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition, the system is intended for use in the following indications:
General Surgery
- · Destruction of warts or lesions
- · Palliation of tumors of the oral cavity, rectum and skin
- · Ablation of breast fibroadenomas
- Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions
Urology
· Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia
Gynecology
· Ablation of malignant neoplasia or benign dysplasia of the female genitalia
Oncology
- · Ablation of cancerous or malignant tissue
- Ablation of benign tumors
- · Palliative intervention
Neurology
- · Freezing of nerve tissue in pain management/cryoanalgesia
Dermatology
· Ablation or freezing of skin cancers and other cutaneous disorders
Proctology
- Ablation of benign or malignant growths of the anus or rectum
- · Ablation of hemorrhoids
Thoracic Surgery
· Ablation of cancerous lesions
The CRYOCARE TOUCH™ System and accessories are a cryotherapy delivery system that is used to freeze/ablate tissue by the application of extreme cold temperatures.
The CRYOCARE TOUCH System is a standalone surgical system consists of a compact, easyto-operate console and associated accessories that include Endocare™ Cryoprobe devices to deliver cold temperatures to the therapeutic tissue and Endocare TempProbe™ Devices to monitor temperatures in the surrounding tissue. The system utilizes the Joule-Thomson effect and inert argon and helium gases to provide cryotherapy and is comprised of the following:
- . CRYOCARE TOUCH Control Console
- 15-inch LCD Touchscreen Monitor with folding Monitor Arm
- Side Handles to facilitate mobility ●
- Wheels with wheel locks
- . Power Supply
- . Argon Port, Regulator, and Supply Line
- . Helium Port, Regulator, and Supply Line
- . Cryoprobe Interface with eight (8) cryoprobe connections
- . TempProbe Interface with eight (8) TempProbe connections
- Alarm Audio Output on Back Panel
- . Remote Keypad
The CRYOCARE TOUCH system software manages the therapy delivered to the patient by the Endocare cryoprobes. The cryoprobes are designed to deliver cold temperatures for cryotherapy using highpressure argon gas circulated through the cryoprobe. Active tissue thawing is achieved by circulating helium gas through the cryoprobe. The refrigerative and warming capacity is limited to the distal end of the probe shaft.
The provided text describes a 510(k) premarket notification for the CRYOCARE TOUCH™ System and Accessories. This document mainly addresses the substantial equivalence of the new device to a predicate device (Cryocare CS™ Surgical System), detailing changes in user interface and accessories, and providing general statements about performance testing.
However, the document does not contain the detailed information required to answer all parts of your request, especially regarding acceptance criteria for an AI/algorithm's performance and the specific studies that prove it meets these criteria at a statistical level. This is because the CRYOCARE TOUCH™ System is a cryosurgical unit, a hardware medical device with associated software to manage its operation, rather than an AI/algorithm for diagnostic or prognostic purposes.
The "software" mentioned in the document relates to controlling the cryosurgical unit, managing displays, and responding to alarms, rather than an AI performing an analytical task that would require a test set, ground truth experts, MRMC studies, or training/validation data in the context of machine learning.
Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth for training sets, are not applicable or not present in this document for an AI/algorithm-based device.
Here's a breakdown of what can be extracted or inferred based on the provided text, and what cannot:
1. Table of acceptance criteria and reported device performance:
The document lists performance specifications and mentions that testing demonstrated conformance. However, it does not provide a quantitative table of acceptance criteria alongside the specific measured performance values for each criterion. The criteria are described qualitatively.
| Criterion | Reported Performance |
|---|---|
| Individual port displays probe type. | "Each individual port displays the type of the probe connected adjacent to the port controls." (Implied: Met) |
| Monitor/Screen displays temperature values for each probe (Cryoprobe and TempProbe). | "Monitor/ Screen must display temperature values of each probe (Cryoprobe and TempProbe) used for the cryoablation treatment." (Implied: Met and within accuracy range) |
| Temperature values within +/- 3 °C of displayed value from -150°C to 40°C. | "Temperature values shall be within +/- 3 °C of the displayed value from -150°C to 40°C." (Implied: Met) |
| Monitor/Screen displays freeze, stick, and thaw duration time with +/- 1 second accuracy. | "Monitor/ Screen must display the freeze, stick and thaw duration time; the time shall have an accuracy of +/- 1 second." (Implied: Met) |
| System displays warning and alarm if unexpected behavior is observed. | "System must display a warning and alarm if unexpected behavior is observed." (Implied: Met) |
| Electrical Safety | "Electrical Safety Testing in accordance with IEC 60601-1." (Reported: Conformance) |
| Electromagnetic Compatibility | "Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2." (Reported: Conformance) |
| Human Factors and Usability | "Human Factors and Usability Testing in accordance with IEC 60601-1-6 and IEC 62366." (Reported: Conformance) |
| Alarm System | "Alarm system testing in accordance with IEC 60601-1-8." (Reported: Conformance) |
| Software Development | "Software development in accordance with IEC 62304 and the FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'" (Reported: Conformance – "major" level of concern implies rigorous testing, but specific metrics are not provided.) |
| Biocompatibility (for PCS-17RS Cryoprobe) | "PCS-17RS Cryoprobe Biocompatibility Testing in accordance with ISO 10993 series of standards, including ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-12." (Reported: Demonstrated biological safety) |
| Sterilization Validation (for PCS-17RS Cryoprobe) | "PCS-17RS Cryoprobe Sterilization Validation in accordance with ISO 11137-1, ISO 11137-2, 11137-3, ISO 11737-1, and ISO 11737-2." (Reported: Demonstrated gamma radiation sterilization method achieves cryoprobe sterility) |
| Overall Performance | "Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly." "The assessment following the outcomes observed in the performance testing and software design verification and design validation determines that the CRYOCARE TOUCH System and Accessories conforms to the defined user needs and intended uses." (General statement of successful verification and validation) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document. The testing described is bench testing and verification/validation activities for a hardware device and its control software. It's not a "test set" in the context of an AI model evaluated on a dataset of patient data.
- Data Provenance: Not applicable in the context of patient data samples for AI. The "data" refers to measurements and observations from engineering tests, not clinical patient data. The document explicitly states "No animal studies or clinical tests have been included in this pre-market submission."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. Ground truth experts are typically used for assessing the performance of diagnostic or prognostic AI models against clinical data (e.g., radiologist reads vs. AI reads). This document describes a cryosurgical device, not an AI for image analysis or diagnosis. The "ground truth" for this device would be established by physical measurements and engineering specifications, not by human experts interpreting clinical cases.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable. Adjudication methods are used to resolve disagreements among human experts when establishing ground truth for AI model evaluation.
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:
This is not applicable. MRMC studies are performed to demonstrate the clinical utility of AI tools by comparing human performance with and without AI assistance. The CRYOCARE TOUCH™ System is a surgical device, not an AI assistant for diagnostic reading or interpretation. The document explicitly states, "No animal studies or clinical tests have been included in this pre-market submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. This question pertains to the performance of an AI algorithm independently of human interaction. The software in the CRYOCARE TOUCH™ System controls the hardware and provides user interface functions; it is not a standalone "algorithm" in the AI sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is based on engineering specifications, physical measurements, and adherence to recognized standards (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility). For example, the accuracy of temperature readings would be verified against calibrated measurement devices, not expert consensus on pathology slides.
8. The sample size for the training set:
This is not applicable. The device's software is a control system for a medical device, not a machine learning model that requires a "training set" of data in the AI sense.
9. How the ground truth for the training set was established:
This is not applicable. See the explanation for point 8.
§ 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.