(422 days)
The Cryocare CS™ Surgical 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 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, plantar 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 arrhythmic cardiac tissue
- · Ablation of cancerous lesions
The Endocare™ Cryocare CS® Surgical System is a mobile console system intended for cryoablative tissue destruction. The system consists of a compact, easy to operate console and associated accessories that include cryoprobes to deliver cold temperatures to the targeted tissue, and TempProbe® devices to monitor temperatures in the surrounding tissue.
This document is a 510(k) summary for the HealthTronics Cryocare CS Surgical System, indicating FDA clearance. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets a specific set of acceptance criteria for a new clinical application.
Therefore, the requested information about acceptance criteria, detailed study design, reader performance, and ground truth establishment cannot be fully provided from this document as it is not a clinical study report.
Here's what can be inferred or stated based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table of acceptance criteria and reported device performance in the context of clinical efficacy or diagnostic accuracy. Instead, it states that "Appropriate product testing was performed on all subject devices to evaluate conformance to product specifications and equivalence to the predicate designs."
The document lists "Verification /Validation Activities" which are related to engineering and safety performance rather than clinical outcome acceptance criteria:
| Acceptance Criteria Category | Reported Device Performance (as inferred) |
|---|---|
| Conformance to Product Specifications & Equivalence to Predicate | "Appropriate product testing was performed on all subject devices to evaluate conformance to product specifications and equivalence to the predicate designs." "Verification and validation for the proposed modifications were conducted in accordance with internal protocols conforming to international standards and FDA guidance documents." "Based on a comparison of indications for use and technological characteristics, the proposed devices have demonstrated substantial equivalence to their predicates and are shown to be safe and effective for their intended use." |
| Performance Testing | - Isotherm Testing: Performed, implying satisfactory results, but no specific metrics given. |
- Functional Testing (ice-ball necking, shaft leak, noise): Performed, implying satisfactory results, but no specific metrics given. |
| Shelf-Life Testing | Performed, implying acceptable shelf-life. |
| Electrical Safety Testing | Performed, implying compliance with electrical safety standards. |
| Electromagnetic Compatibility Testing | Performed, implying compliance with EMC standards. |
| Software Verification and Validation | Performed, implying software functions as intended and safely. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- This document does not describe a clinical test set with a sample size for evaluating a specific clinical outcome. The testing performed ("non-clinical testing," "verification/validation activities") is related to device engineering specifications, performance, and safety, not a clinical trial.
- Therefore, there is no information on data provenance (country, retrospective/prospective).
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):
- This information is not applicable as this document describes non-clinical engineering and safety testing, not a study requiring expert-established ground truth for a clinical diagnosis or outcome.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable for the same reason as point 3.
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 MRMC or comparative effectiveness study involving human readers or AI assistance is mentioned. This device is a cryosurgical system, not an imaging or diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This document refers to a cryosurgical system, which is a physical medical device. It does not describe an algorithm with standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the engineering and safety testing described, the "ground truth" would be established by technical specifications and international standards, rather than clinical ground truth types like pathology or outcomes data. For example, for "Isotherm Testing," the ground truth would be the expected temperature profile under specific conditions, and for "Electrical Safety Testing," it would be the safety standards.
8. The sample size for the training set:
- This document does not describe a machine learning model or AI, and therefore, no training set or its sample size.
9. How the ground truth for the training set was established:
- This information is not applicable as there is no training set for a machine learning model described.
In summary: The provided document is an FDA 510(k) clearance letter and summary for a physical medical device (Cryocare CS Surgical System). It outlines the device's indications for use, its technological characteristics, and that non-clinical engineering and safety testing was performed to demonstrate substantial equivalence to a predicate device. It does not contain information about clinical studies with specific acceptance criteria, clinical test sets, expert ground truth establishment, or AI/algorithm performance.
§ 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.