The Cryocare CS Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, 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, 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.

The provided document is a 510(k) summary for the Cryocare CS Surgical System. It describes the device, its intended use, and its equivalence to predicate devices, but does not contain details about acceptance criteria, a specific study proving device performance against those criteria, or clinical study specifics like sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information. The document explicitly states "NON-CLINICAL TESTING" was performed, including "Isotherm Testing," but these are not clinical studies with patients and diagnostic performance metrics. The conclusion states that the devices "have demonstrated substantial equivalence to their predicates and are shown to be safe and effective for their intended use," based on a comparison of indications for use, technological characteristics, and isotherm data, rather than a clinical study.

Ask a specific question about this device

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:

• 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.

Ask a specific question about this device

The Cryocare CS Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, 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 hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, 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 CRYOcare V-probe is a CRYOprobe accessory to be used in conjunction with the CRYOcare CS Surgical System. The indications for use have not changed. The V-Probe delivers cold temperatures via Argon gas utilizing the Joules Thompson principle to targeted tissue. The patient contact V-Probe (an accessory item to the CRYOcare CRYOsurgical CS System) is supplied as a single use Sterile Disposable item.

The provided document is a 510(k) summary for the Endocare Cryocare CS Surgical System. This type of regulatory submission establishes substantial equivalence to a predicate device rather than proving performance against specific acceptance criteria through a de-novo study.

Therefore, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or the details of such a study (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance data).

The "SUMMARY OF SUBSTANTIAL EQUIVALENCE" section explicitly states that the device is considered substantially equivalent to predicate devices due to similarities such as:

• Same intended use
• Same operating principle
• Same system design
• Same patient contacting materials
• Same manufacturing materials
• Same packaging and sterilization processes

Since the device is claiming substantial equivalence, a detailed performance study as outlined in your request is typically not required unless there are significant changes that raise new questions of safety and effectiveness.

In summary, the information requested in your prompt is not available in the provided 510(k) summary.

Ask a specific question about this device

The Cryocare CS Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, 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 turnors, dermatofibromas, small hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, 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 Cryocare CS Surgical System consists of a compact, easy-to-operate console that delivers cold temperatures to targeted tissue (via connected CryoProbes) and monitors temperatures in the surrounding tissue (via connected TempProbes).

The Cryocare CS Surgical System has a fold-down 19" LCD high-resolution display screen, a video printer for hard copy prints of the captured images and patient information, a CD-R/W drive for data storage and retrieval, an alphanumeric keypad and a remote keypad.

The Cryocare CS Surgical System can control up to eight, single-use, disposable CryoProbes and monitor up to eight independent TempProbes. The console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon and helium gas. An IBM compatible microprocessor serves as the host computer operating in a Windows environment. CryoProbe control can also be achieved via the remote control keypad. The CryoProbes can be operated manually or using the AutoFreeze mode, which allows users to pre-program specific prostate treatment parameters.

Associated accessories include the following:

I.) CryoProbes that deliver cold temperatures to targeted tissue. The CryoProbes operate on the Joule-Thompson Principle and the refrigerative capacity is limited to the distal end of the probes. Each CryoProbe incorporates a thermocouple to measure internal CryoProbe temperatures.

Helium gas is used after the freezing process to thaw tissue. As the gas passes through the J-T port, there is a significant pressure drop, which conversely results in an increase in the gas temperature.

The patient contact CryoProbe (an accessory item to the Cryocare System) is supplied as a Single use Sterile Disposable item. This probe attaches to a reusable Cryo-Hose, which in turn attaches to the Cryocare System.

• 2.) TempProbes to monitor temperatures in the surrounding tissue. The TempProbes are standard T-type thermocouples.
• 3.) A warming system for use in urological applications.

The provided text describes the Cryocare CS Surgical System, a cryosurgical unit designed to ablate tissue using extreme cold temperatures. The 510(k) submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a new clinical study with specific acceptance criteria and performance metrics.

Here's a breakdown based on the provided information, noting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) is a submission for substantial equivalence, which means it compares the new device to a legally marketed predicate device rather than establishing new performance criteria or conducting a clinical trial that measures device performance against predefined acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. As no new clinical study (with a "test set" of patients or cases) was conducted for this 510(k) submission to demonstrate performance, there is no sample size or data provenance to report. The submission relies on the established safety and effectiveness of the predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided. Since no new clinical study requiring ground truth establishment was conducted, there are no experts or qualifications to specify.

4. Adjudication Method for the Test Set

This information is not provided. As no new clinical study was conducted, there was no test set requiring an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence to a predicate device, not on comparing performance with or without AI assistance, or assessing human reader improvement.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable/not provided. The Cryocare CS Surgical System is a physical medical device (cryosurgical unit), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance does not apply.

7. The Type of Ground Truth Used

This information is not applicable. Since no new clinical performance study was conducted to generate specific performance data requiring ground truth, there is no type of ground truth to report for this 510(k) submission. The basis for safety and effectiveness is through comparison to the predicate device.

8. The Sample Size for the Training Set

This information is not applicable/not provided. As the Cryocare CS Surgical System is a physical medical device and not an AI/ML system, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided. For the same reasons as above, there is no training set or ground truth establishment method to describe for this device.

Summary of the Study (Basis for Substantial Equivalence):

The "study" in this context is the submission of information to the FDA to demonstrate substantial equivalence to a previously cleared predicate device, the Cryocare CST Surgical System (K050347) marketed by Endocare, Inc.

The rationale for substantial equivalence is based on the following claims:

• Similarity of Design: The Cryocare CS Surgical System patient interface accessory CryoProbe and Cryo-Hose design are "very similar" to the predicate device.
• Identical Intended Uses and Operating Principles: The new device shares the exact same intended uses and operating principles (effectiveness) as the predicate device.
• Identical Operational and Safety Features: The new device's operational features and safety features are the same as those offered by the predicate device.
• Compliance with Standards: The Cryocare CS Surgical System complies with the ASTM "Standard Performance and Safety Specification for Cryosurgical Medical Instruments" [Designation: F 882-82 (reapproved 2002)].

Conclusion of the Submission:

The submission concludes that the data demonstrates the CryoProbe and Cryo-Hose accessory items are substantially equivalent with respect to indications for use, operating principles, operational features, and safety features. No new issues of safety, effectiveness, or performance were identified compared to the predicate device. This led to the FDA's "Substantial Equivalence" decision.

Ask a specific question about this device

The Cryocare CS Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, 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 hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, 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 intended use of the 10LAP4 probe, when used as a part of the Cryocare CS Surgical System, is for diagnostic ultrasound imaging or fluid flow analysis of the human body and is a subset of the uses cleared under K043278, and is documented in Section 4.3 of this submission.

The Cryocare CS Surgical System consists of a compact, easy-to-operate console that delivers cold temperatures to targeted tissue (via connected CryoProbes) and monitors temperatures in the surrounding tissue (via connected TempProbes).

The Cryocare CS Surgical System has a fold-down 19" LCD high-resolution display screen, a video printer for hard copy prints of the captured images and patient information, a CD-R/W drive for data storage and retrieval, an alphanumeric keypad and a remote keypad.

The Cryocare CS Surgical system unit integrates the functions of the existing Cryocare surgical system and the CryoGuide system into one console. The CryoGuide software is an optional brachy-like intraoperative real-time guidance and planning system, which identifies and guides CryoProbe placement for prostate procedures.

The Cryocare CS Surgical System has an ultrasound system with available a trans-rectal transducer for prostate imaging or a laparoscopic transducer. The transducers operate in B, Power Doppler, Color Doppler (including directional and non-directional Power Doppler), and Harmonic Imaging. The Trans-rectal transducer is capable of transverse and sagittal views.

Ultrasound images may be obtained either from an external ultrasound (via video connection) or the integrated ultrasound module. The user screen simultaneously displays the real-time ultrasound image along with the treatment screen. For prostate procedures, the treatment screen displays the prostagraph showing the anatomical CryoProbe and TempProbe placements and associated temperature readings.

The 10LAP4 Probe is intended for use with Cryocare CS Surgical System's ultrasound imaging system. Technical specifications for the probes is as follows:
Frequency: 7.0 MHz

Elements: 128

Array type: Linear
Pitch (mm): 0.30
Elevation width (mm): 5.0
Geometric focus (mm): 25
Azimuth radius (mm): N/A
Azimuth length (mm): 38.4

The Cryocare CS Surgical System can control up to eight, single-use, disposable CryoProbes and monitor up to eight independent TempProbes. The console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon and helium gas. An IBM compatible microprocessor serves as the host computer operating in a Windows environment. CryoProbe control can also be achieved via the remote control keypad. The CryoProbes can be operated manually or using the AutoFreeze mode, which allows users to pre-program specific prostate treatment parameters.

The provided text is a 510(k) summary for the Endocare Cryocare CS Surgical System. This document describes the device, its intended use, and claims substantial equivalence to previously cleared predicate devices. It does not present any clinical study data or acceptance criteria for a device's performance, as would be found in a study demonstrating the efficacy or safety of a new medical device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance, because this information is not present in the provided document.

The document indicates that the device has the "same intended use" and "same operating principle and has not altered the fundamental technology" as its predicate devices (K032333 and K043278). This suggests that substantial equivalence was established primarily through comparison to existing devices rather than new clinical performance data.

Ask a specific question about this device

The Cryocare CS Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, 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 hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, 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 Cryocare CS (Combo System) Surgical System consists of a compact, easy-to- operate console that delivers cold temperatures to targeted tissue (via connected CryoProbes) and monitors temperatures in the surrounding tissue (via connected TempProbes).
The Cryocare CS Surgical System has a fold-down 19" LCD high-resolution display screen, a video printer for hard copy prints of the captured images and patient information, a CD-R/W drive for data storage and retrieval, an alphanumeric keypad and a remote keypad.
The Cryocare CS unit integrates the functions of the existing Cryocare surgical system and the CryoGuide system into one console. The CryoGuide software is an optional brachy-like intraoperative real-time guidance and planning system, which identifies and guides CryoProbe placement for prostate procedures.
An added feature to the Cryocare CS Surgical System is integration of the Terason 2000 ultrasound trans-rectal probe for dedicated prostate imaging. The ultrasound module utilizes the Terason Model 2000 Handheld Ultrasound System using Model 8EC4 Endocavity Smart Probe. It is capable of transverse and sagital views, and operates in B, Power Doppler, Color Doppler (including directional and non-directional Power Doppler), and Harmonic Imaging. This use includes ultrasound guidance for placement of needles, cryosurgery, and brachytherapy.
Ultrasound images may be obtained either from an external ultrasound (via video connection) or from the integrated Terason 2000 ultrasound module. The user screen simultaneously displays the real-time ultrasound image along with the treatment screen. For prostate procedures, the treatment screen displays the prostagraph showing the anatomical CryoProbe and TempProbe placements and associated temperature readings.
The Cryocare CS Surgical System can control up to eight, single-use, disposable CryoProbes and monitor up to eight independent TempProbes. The console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon and helium gas. An IBM-compatible microprocessor serves as the host computer operating in a Windows environment. CryoProbe control can also be achieved via the remote control keypad. The CryoProbes can be operated manually or using the AutoFreeze mode, which allows users to pre-program specific prostate treatment parameters.

The provided text is a 510(k) summary for the Endocare Cryocare CS Surgical System. This document focuses on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a study demonstrating the device meets specific acceptance criteria based on performance metrics.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not available in the provided text.

The document primarily describes the device, its intended use, and argues for its substantial equivalence to predicate devices (K023757, K002615, and K030191) based on shared:

• Intended use
• Operating principle
• Fundamental technology
• CryoProbes
• System design
• Patient contacting materials
• Manufacturing materials
• Packaging and sterilization methods

The information needed to fill out the table and answer the questions about performance studies is not part of a 510(k) summary focused on substantial equivalence for this type of device (a cryosurgical unit). Performance data for such devices typically revolves around safety and functional aspects (e.g., cooling rates, temperature accuracy), which are generally demonstrated through bench testing and, if applicable, pre-clinical animal studies, rather than clinical studies with "acceptance criteria" and "reported performance" in the way one might see for an AI/ML diagnostic device.

Ask a specific question about this device