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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, 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 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 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.

I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request. The document is an FDA 510(k) clearance letter and its associated summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics for a novel AI device.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance: While it mentions "bench performance," "software validation," "electrical safety," and "electromagnetic compatibility testing," it does not specify any quantitative acceptance criteria or the actual performance values achieved for the Cryocare CS Surgical System.
• Sample sized used for the test set and the data provenance: There is no mention of a test set, sample sizes, or data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications: No information about ground truth experts is provided.
• Adjudication method for the test set: No adjudication method is described.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: The document does not describe such a study.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device described is a surgical system, not an AI algorithm, so this type of study is not applicable in this context.
• The type of ground truth used: Not applicable as there is no mention of a ground truth for performance evaluation in the context of an AI device.
• The sample size for the training set: Not applicable as this is not an AI device being trained.
• How the ground truth for the training set was established: Not applicable.

The document states: "Appropriate verification and validation activities were performed on the subject device to evaluate conformance to product specifications and equivalence to the predicate design. Testing included bench performance, software validation, electrical safety and electromagnetic compatibility testing. The results of all studies confirmed equivalency between the subject and predicate device, and that no new issues of safety or efficacy were raised." This generic statement confirms general testing was done for regulatory purposes, but provides no specifics about the criteria or results.

Therefore, I cannot extract the requested information from the provided text.

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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.

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The LithoDiamond is indicated for use in patients with renal and upper ureteral calculi between 4mm and 20mm in size.

The LithoDiamond is an Extracorporeal Shock Wave Lithotripter. The primary difference in the devices is that the LithoDiamond has a new imaging system.

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the context of device performance metrics like sensitivity, specificity, or human-AI comparative effectiveness.

The document is a 510(k) summary for the LithoDiamond, indicating its substantial equivalence to a predicate device (LithoTron). The primary difference noted is a "new imaging system" for the LithoDiamond. The equivalence argument was supported by bench data as outlined in FDA's "Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters." It also states that "An initial report on the imaging system (x-ray component) is also on file at FDA."

Therefore, based only on the provided text, I can infer the following about the study and acceptance criteria:

1. Acceptance Criteria and Reported Device Performance:
   The document does not specify quantitative acceptance criteria or reported device performance in terms of clinical outcomes or diagnostic accuracy for the "new imaging system." Instead, the acceptance criteria are implicitly linked to demonstrating substantial equivalence to the predicate device (LithoTron) through bench data. The primary performance aspect mentioned is the device's ability to fragment renal and upper ureteral calculi between 4mm and 20mm, which is aligned with the predicate device's function.

   Acceptance Criteria (Inferred from context)	Reported Device Performance (Inferred from context)
   Demonstrate substantial equivalence in shock wave characteristics, safety data, and imaging system performance to the predicate device (LithoTron).	"Detailed shock wave characteristics as well as safety data were presented in the 510(k)."

"An initial report on the imaging system (x-ray component) is also on file at FDA."
The FDA found the device "substantially equivalent" for the stated indications. |
| Indications for use: fragment renal and upper ureteral calculi between 4mm and 20mm. | The device is indicated for this use, implying it meets the performance for this indication, likely demonstrated through bench data and comparison to the predicate. |

2. Sample Size and Data Provenance:
   The text refers to "bench data" and an "initial report on the imaging system (x-ray component)." This implies in vitro or engineering tests rather than patient studies. The sample size for such bench tests is not specified, nor is the country of origin of the data. It's safe to assume these are not patient-derived data (retrospective or prospective imaging studies) but rather engineering/laboratory data.

3. Number of Experts and Qualifications for Ground Truth:
   Not applicable, as the equivalence was primarily based on bench data and comparison to a predicate device, not on expert-established ground truth for a diagnostic test.

4. Adjudication Method:
   Not applicable for the type of study described. This applies to studies involving human readers or expert review of medical images/data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
   No, an MRMC study is not mentioned. The device is a lithotripter with an imaging system, and the submission focuses on its physical characteristics and equivalence to a predicate, not an AI-assisted diagnostic workflow. There's no mention of human readers or AI assistance in a diagnostic context that would warrant an MRMC study.

6. Standalone (Algorithm Only) Performance Study:
   No, a standalone algorithm performance study is not mentioned. While there's an "imaging system (x-ray component)," the documentation focuses on its substantial equivalence through bench data, not on its isolated diagnostic performance as an algorithm.

7. Type of Ground Truth Used:
   The ground truth for the equivalence argument was primarily derived from:

   • Predicate device characteristics: The LithoTron's established performance and characteristics served as the benchmark.
   • Bench data: Measurements and engineering tests performed on the LithoDiamond to assess shock wave characteristics and safety.
   • Imaging system report: Data from the x-ray component, likely technical specifications and performance metrics rather than ground truth derived from patient-specific diagnoses.

8. Sample Size for the Training Set:
   Not applicable. The description refers to a 510(k) submission based on substantial equivalence and bench data, not an AI/Machine Learning model that would require a training set.

9. How the Ground Truth for the Training Set Was Established:
   Not applicable, as there is no mention of a training set for an AI/ML model.

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