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 CN2 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 CN2 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). Near Critical Nitrogen (NCN) is utilized as the cryogenic medium. Circulating NCN avoids the 'vapor lock' potential of liquid N2 devices since it is a transition fluid (nitrogen that is neither a liquid, nor a gas).

The Cryocare CN2 System has a fold-down 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 CN2 System can control up to four, single-use, disposable Cryoprobes and monitor up to four independent TempProbes. The console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert liquid nitrogen. An IBM compatible microprocessor serves as the host computer which performs all essential controls and monitoring tasks. Cryoprobe control is achieved via the keypad.

Associated accessories include the following:

• 1.) Cryoprobes that deliver cold temperatures to targeted tissue. Each Cryoprobe incorporates a thermocouple to measure internal Cryoprobe temperatures. Warm room temperature nitrogen gas is used after the freezing process to thaw tissue. The patient contact Cryoprobe (an accessory item to the Cryocare CN2 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 CN2 System.
• TempProbes to monitor temperatures in the surrounding tissue. The TempProbes are 2.) standard T-type thermocouples.
• 3.) A warming system for use in urological applications.

The provided text describes a 510(k) premarket notification for the Cryocare CN2 System, a cryosurgical unit. However, a detailed study proving performance against specific quantitative acceptance criteria is not included in this document. The submission focuses on demonstrating substantial equivalence to predicate devices.

Here's an analysis based on the information provided and what is missing:

The core of this 510(k) submission is based on substantial equivalence to previously cleared predicate devices, not on a new study directly demonstrating performance against quantitative acceptance criteria. Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" is not present in this document.

Detailed Breakdown based on the provided text:

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

   • Acceptance Criteria: Not explicitly stated as quantitative performance metrics. The underlying acceptance criterion for this 510(k) is "substantial equivalence" to predicate devices as defined by the FDA. This typically means the device has the same intended use, operating principles, technological characteristics, and safety/effectiveness profiles as a legally marketed predicate device.
   • Reported Device Performance: No specific quantitative performance data (e.g., specific temperatures achieved, freezing rates, iceball sizes) is reported in this document. The performance is deemed equivalent to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • No specific test set or clinical study data is presented to demonstrate performance against new acceptance criteria. The claim is based on equivalence to predicate devices, which would have had their own validation data.

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 as no independent test set with ground truth established by experts is described for this specific submission.

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

   • Not applicable as no independent 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 is a cryosurgical device, not an AI-assisted diagnostic tool.

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

   • Not applicable. As above, this is a cryosurgical device, not an AI algorithm.

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

   • Not applicable. The ground for approval here is demonstrating equivalence in design, intended use, and operational/safety features to predicate devices that already established their safety and effectiveness through their own approval processes and market use.

8. The sample size for the training set

   • Not applicable as no AI/machine learning model is described.

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

   • Not applicable.

What the document does state about safety and effectiveness:

• "The Cryocare CN2 System complies with the ASTM 'Standard Performance and Safety Specification for Cryosurgical Medical Instruments' [Designation: F 882-84 and Davy 2002)] which reasonably assures the device is safe when used as directed for its prescribed intended use."
  • Implication: Compliance with this ASTM standard serves as a key element of the safety and effectiveness rationale, effectively acting as an "acceptance criterion" that the device meets. The "study" demonstrating this would be engineering and performance testing against the requirements of ASTM F 882-84. The document does not provide the results of this testing but states that the system complies.
• "The Cryocare CN2 System does not raise any new issues of safety, effectiveness or performance of the device when compared to the existing predicate device."
  • This is the core argument for substantial equivalence.

In summary, for this 510(k) submission, the "acceptance criteria" revolve around demonstrating substantial equivalence to predicate devices and compliance with an existing ASTM standard, rather than presenting a new study with specific quantitative performance metrics. The document asserts compliance and equivalence but does not provide the detailed data from the underlying testing or studies.

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

The Cryocare 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 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 Surgical System consists of a compact, easy-to-operate console and associated accessories that include CryoProbes to deliver cold temperatures to the targeted tissue and TempProbes to monitor temperatures in the surrounding tissue.
The control console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert Argon gas. The console can control up to eight, single-use, disposable CryoProbes.
The CryoProbes operate on the Joule-Thompson Principle and the refrigerative capacity is limited to the distal tip of the probes. Each CryoProbe incorporates a thermocouple to monitor probe temperature. Helium gas is used after the freezing process. 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 console can also monitor up to eight independent TempProbes. The TempProbes are standard T-type needle thermocouples.
An IBM-compatible microprocessor serves as the host computer. System control is accomplished through a remote control keypad.
The system can be operated manually or using the AutoFreeze option, which allows users to pre-program specific treatment parameters.

The provided text describes a 510(k) summary for the Cryocare Surgical System. It details the device, its intended use, and indicates that "in-vitro testing" and "software validation" were performed. However, it does not provide specific acceptance criteria or the results of a study that directly proves the device meets those criteria, especially in a clinical context.

The document states:

• "In-vitro testing of the Cryocare Surgical System included time and temperature performance under simulated use conditions."
• "Software validation was performed in accordance with IEC 60601-1-4 and the General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 11, 2002)."
• "All testing of the product yielded acceptable results."

This is a general statement of compliance, not a detailed report of findings against specific performance metrics. The submission is a 510(k) for a modified device, declaring substantial equivalence to a predicate device (K011074 Cryocare Surgical System), rather than a de novo submission requiring extensive new clinical performance data to establish safety and effectiveness from scratch.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be inferred or explicitly stated based on the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only states that "All testing of the product yielded acceptable results." It does not provide specific numerical targets for temperature, time, or specific metrics for software validation.

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

• Sample Size: Not specified. The testing mentioned is "in-vitro testing," so it refers to bench testing rather than patient data.
• Data Provenance: Not applicable in the context of human data. It refers to "simulated use conditions" in a laboratory setting. No country of origin for clinical data is mentioned as no clinical data is presented.
• Retrospective/Prospective: Not applicable as it's not clinical data.

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

• Not applicable. Ground truth for in-vitro testing would be based on validated measurement instruments and physical principles, not expert human assessment.

4. Adjudication method for the test set

• Not applicable. This is typically for discrepancies in expert assessments in clinical studies.

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 is a medical device (cryosurgical system), not an AI-powered diagnostic tool requiring human reader studies.

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

• Not applicable in the context of AI. The device has software for control ("IBM-compatible microprocessor serves as the host computer," "remote control keypad," "AutoFreeze option"), and software validation was performed, but this is for controlling the medical device's physical functions, not for diagnostic or predictive algorithms.

7. The type of ground truth used

• For "time and temperature performance": Likely physical measurements and calibration against known standards.
• For "software validation": Compliance with software lifecycle processes, functional requirements, and safety standards (IEC 60601-1-4) through testing.

8. The sample size for the training set

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

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

• Not applicable.

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The Cryocare Cardiac Surgical System is indicated for use in minimally invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias. The Cryocare Cardiac Surgical Probes freeze the target tissue and block the electrical conduction pathway by creating an inflammatory response or cryonecrosis.

The modified Cryocare Cardiac Surgical system consists of a control unit that operates one single use, disposable cryoprobe. The control unit is software controlled and operates off standard 120/230 VAC wall power. System control is accomplished directly through keys on the console itself. The Cryoprobes operate on the Joule-Thompson principle and the refrigerative capacity is limited to the freeze zone of the probe. The cryoprobe incorporates a thermocouple to measure temperature at the probe tip. The thermocouple is mounted inside the cryoprobe tip and its signal is used to monitor some operations of the system. The temperature probe is a standard T-type needle thermocouple.

The provided text describes a submission for a Modified Cryocare Cardiac Surgical System, which is a Class II device. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, much of the requested information (like specific acceptance criteria values, sample sizes for test sets, expert qualifications, MRMC studies, and detailed ground truth methods for clinical performance) is not present in the provided documentation, as these are typically features of more rigorous clinical trials (e.g., for PMA applications) or detailed performance studies that go beyond demonstrating substantial equivalence based on in-vitro testing and intended use.

However, I can extract the available information.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "All testing of the product yielded acceptable results" without providing specific quantitative targets or results for each test. This is typical for a 510(k) summary focusing on substantial equivalence.

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

• Sample Size for Test Set: Not specified. The document only mentions "In-vitro performance testing."
• Data Provenance: The testing appears to be internal "in-vitro performance testing" conducted by Endocare, Inc. The country of origin is not specified but presumed to be where Endocare, Inc. is located (Irvine, CA, USA). The testing is not described as retrospective or prospective clinical data but rather as laboratory/bench testing.

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

• Not applicable. The testing described is "in-vitro performance testing" rather than a clinical study requiring expert-established ground truth for diagnostic accuracy or similar clinical outcomes.

4. Adjudication Method for the Test Set

• Not applicable. As described above, this was "in-vitro performance testing," not a clinical study involving human judgment that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not applicable. This device is a cryosurgical system, not an AI-assisted diagnostic or imaging device that would typically undergo an MRMC study. There is no mention of AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a medical instrument (Cryocare Cardiac Surgical System) and not an AI algorithm.

7. The Type of Ground Truth Used

• For the in-vitro performance tests, the "ground truth" would be engineering specifications, physical measurements, and pass/fail criteria for the various mechanical and functional tests (dimensional, flex, endurance, burst pressure, simulated use). The document does not detail these specific criteria.

8. The Sample Size for the Training Set

• Not applicable in the context of the described testing. This is a physical medical device, and the testing outlined is in-vitro performance testing, not a machine learning model's training. While the device is "software controlled," the document refers to "in-vitro performance testing" of the physical system, not the software's learning phase.

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

• Not applicable, for the same reasons as #8.

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The Classic and Esteem vacuum systems are intended to artificially produce an erection in males suffering from erectile dysfunction (impotence) in order to facilitate sexual intercourse. A vacuum is applied to the penis, causing it to become erect and rigid as blood is drawn into the corpora cavernosa. A constriction ring is then placed on the base of the penis to restrict venous blood flow out of the penis. The device is intended to be used at home or in a doctor's office or clinic.

The silicone Freedom Ring™ was developed as an alternative constriction ring for the ErecAid Classic and Esteem vacuum erection devices. It is similar to the existing polyisoprene Pressure-Point™ Ring (PPR) in that it contains both a urethral notch and dorsal pressure points. It is designed to deliver the same sealing pressure to the penis, thus preventing escape of blood after an erection is achieved. The Freedom Ring makes the vacuum seal against the base of the penis rather than against the groin, thereby reducing the probability of scrotal tissue or pubic hair entrapment.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ErecAid® Classic and Esteem vacuum erection systems with the new Freedom Ring:

The provided document (K020082) describes a modification to an existing device, a vacuum erection system, specifically the introduction of a new constriction ring called the "Freedom Ring." The core of the submission revolves around demonstrating that this new ring does not introduce new safety or efficacy issues compared to the previously accepted "Pressure-Point Ring" (PPR).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "bench tests" of the Freedom Ring and the vacuum systems. Given the nature of physical property and pressure measurements, it likely involved a sample of manufactured rings and representative vacuum devices.
• Data Provenance: The data originates from bench testing conducted by Timm Medical Technologies, Inc. This is a prospective evaluation of the newly designed Freedom Ring. The country of origin is not explicitly stated but can be inferred as the USA, where the manufacturer is located (Eden Prairie, MN).

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

• Number of Experts: Not applicable. For bench testing of physical properties and mechanical performance, "ground truth" is established by measurement against predefined engineering specifications and comparisons to known performance characteristics of the predicate device (PPR). This typically involves engineers, quality control personnel, and technicians rather than medical experts for establishing ground truth for device performance in this context. While the design was for patient comfort, the testing was against objective benchmarks.
• Qualifications of Experts: Not explicitly stated, as no "experts" in the medical sense were used to establish ground truth for this type of testing. The work would have been performed by qualified technical staff.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based evaluations where there is subjective interpretation or diagnostic uncertainty requiring consensus among human readers. For the bench testing described, the measurements are objective, and the results are compared directly to engineering specifications or the predicate device's measured performance. Discrepancies would be resolved through re-testing or analysis of measurement methodologies rather than expert adjudication.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study was required to demonstrate safety or effectiveness of the new Freedom constriction ring when used with either the ErecAid Classic or Esteem vacuum erection system."
• Effect Size: Not applicable. Since no MRMC study was conducted, there is no reported effect size regarding human readers' improvement with or without AI assistance. (It's important to note this device is not an AI-based diagnostic tool, so such a study would not be relevant in this context anyway.)

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a mechanical medical device, not an algorithm or AI system. Therefore, standalone algorithm performance testing is not relevant or performed.

7. The Type of Ground Truth Used

• The ground truth for the bench testing was based on objective engineering and manufacturing specifications for the vacuum devices themselves (initial vacuum seal, maximum vacuum pressure, leak rate) and comparative physical/mechanical properties against the predicate "Pressure-Point Ring" (PPR) for the new Freedom Ring (dimensions, physical properties, and pressure exerted on the penis).

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm. There is no "training set."

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

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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