Search Results

The device is indicated for use in general surgery, gynecology and oncology. The system is designed to destroy tissue by the application of extreme cold temperatures. In addition the system is intended for use in the following indications:

General Surgery

• Ablation of breast fibroadenoma .
• Localization of breast lesions .

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

The Visica Treatment System consists of a control unit that controls one single-use, disposable (Visica Treatment Device or "cryoprobe"). The system utilizes incrt argon gas as a cooling agent and helium for thawing. The cystem unit operates from standard 120/240 VAC wall power and is control by a CPLD (Complex Programmable Logic Device). An LED screen displays the status of the system. System control is accomplished directly through keys on the console itself.

The cryoprobe operates on the Joule-Thompson principle and the refrigerative capacity is limited only the distal tip of the probe. The cryoprobe incorporates a thermocouple to measure temperature near the probe tip. The thermocouple is mounted inside the cryoprobe tip and its signal is used to monitor and control some operations of the system. The control unit can also accommodate two independent on the ts manitant to monitor temperatures in the surrounding tissues. The temperature probes use standard T-type needle thermocouples.

The provided text is a 510(k) summary for the Sanarus Visica Treatment System, which is a cryosurgical unit. This document is a regulatory submission to the FDA, primarily focusing on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria in the way new AI/ML device submissions might.

Therefore, much of the requested information regarding acceptance criteria, performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, and human-in-the-loop studies is not present in this document. The 510(k) summary aims to show that the modified device has the "same indications for use and technological characteristics" as its predicate and that "performance testing confirms that modifications to the Instructions for Use meet applicable specifications and performance standards and are equivalent to the predicate device."

However, I can extract the available information and indicate what is not present.

Here's a breakdown of the available information based on your request:

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

This information is not present in the provided 510(k) summary. The document states that "Performance testing confirms that modifications to the Instructions for Use meet applicable specifications and performance standards and are equivalent to the predicate device," but it does not detail specific acceptance criteria or the reported performance metrics of those tests.

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

This information is not present in the provided 510(k) summary. The document does not describe a clinical study with a test set of data for performance evaluation in the context of AI/ML device assessment.

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 present in the provided 510(k) summary. Since this is a cryosurgical device, and not an AI/ML diagnostic tool, the concept of "ground truth" derived from expert consensus on a test set (as typically seen in AI/ML performance studies) is not applicable here.

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

This information is not present in the provided 510(k) summary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not present in the provided 510(k) summary. This type of study is relevant for AI/ML diagnostic systems, not for a cryosurgical treatment device like the Sanarus Visica Treatment System.

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

This information is not present in the provided 510(k) summary. The device is a physical cryosurgical system, not a standalone algorithm.

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

This information is not present in the provided 510(k) summary.

8. The sample size for the training set

This information is not present in the provided 510(k) summary. Training sets are typically associated with AI/ML model development, which is not the focus of this 510(k) for a physical cryosurgical device.

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

This information is not present in the provided 510(k) summary.

Summary of Device and Regulatory Context (based on provided text):

• Device Name: Sanarus Visica® Treatment System
• Device Type: Cryosurgical unit and accessories (Class II, Product Code: GEH)
• Indications for Use:
  • General Surgery: Ablation of breast fibroadenoma, Localization of breast lesions.
  • 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.
• Predicate Device: Sanarus Visica Treatment System (K022314, Oct 15, 2002; K052861, Nov 15, 2005)
• Substantial Equivalence Claim: The current device has the "same indications for use and technological characteristics as the predicate device," including identical patient contact components, materials, packaging, sterilization methods, and sterility assurance level.
• Performance Testing Mention: "Performance testing confirms that modifications to the Instructions for Use meet applicable specifications and performance standards and are equivalent to the predicate device." This statement implies that engineering and functional tests were conducted to ensure the device performs as intended and equivalently to its predicate, but the details of these tests, acceptance criteria, and specific performance results are not included in this summary.

In essence, this 510(k) summary is for a traditional medical device demonstrating substantial equivalence, not for an AI/ML-driven device, which would typically involve the detailed performance study information you've requested.

Ask a specific question about this device

The Sanarus Visica™ Treatment System is intended for use in general surgery, gynecology and oncology. The system is designed to destroy tissue by the application of extreme cold temperatures. In addition, the system is intended for use in the following indications:

General Surgery

• Ablation of breast fibroadenoma
• Localization of breast lesions

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

The Visica™ Treatment System consists of a control unit that controls one single-use, disposable cryoprobe (Visica™ Treatment Device). The system utilizes inert argon gas as a cooling agent and helium for thawing. The control unit operates off standard 110/230 VAC wall power and is controlled by a CPLD (Complex Programmable Logic Device). An LED screen displays the status of the system. System control is accomplished directly through keys on the console itself. A remote foot-pedal can be used to start and stop the system.

The cryoprobe operates on the Joule-Thompson principle and the refrigerative capacity is limited only to the distal tip of the probe. The cryoprobe incorporates a thermocouple to measure temperatures at the probe tip. The thermocouple is mounted inside each cryoprobe tip and its signal is used to monitor and control some operations of the system. The control unit can also control two independent temperature probes to monitor temperatures in surrounding tissues. The temperature probes are standard T-type needle thermocouples.

The provided text does not contain information about the acceptance criteria or a study that proves the device meets specific performance metrics. It primarily focuses on regulatory approval (510(k)) and establishing substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria, ground truth, or sample sizes for testing or training sets.

Therefore, I cannot provide the requested information from the given text.

Here's why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: No such criteria or performance data are present.
2. Sample size used for the test set and the data provenance: No test set or study details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information about ground truth establishment or experts.
4. Adjudication method: Not mentioned.
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 study or AI component is discussed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No standalone algorithm performance is discussed.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: No training set or algorithm is discussed.
9. How the ground truth for the training set was established: Not applicable as no training set is mentioned.

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical trial results with specific performance metrics and acceptance criteria for this specific submission. It states that the "Visica™ Treatment System has comparable technological characteristics and performance specifications to the predicate devices," but doesn't elaborate on what those specifications are or how they were met for this current submission.

Ask a specific question about this device

The Visica™ Treatment System is intended for use in general surgery, gynecology and oncology. The system is designed to destroy tissue by the application of extreme cold temperatures. In addition, the system is intended for use in the following indications:

General Surgery

• Ablation of breast fibroadenoma .
  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

The Visica™ Treatment System consists of a control unit that controls one single-use, disposable cryoprobe. The system utilizes inert argon gas as a cooling agent and helium for thawing. The control unit operates off standard 110/230 VAC wall power and is controlled by a CPLD (Complex Programmable Logic Device). An LED screen displays the status of the system. System control is accomplished directly through keys on the console itself. A remote foot-pedal can be used to start and stop the system.

The cryoprobe overates on the Joule-Thompson principle and the refrigerative canacity is limited only to the distal tip of the probe. The cryoprobe incorporates a thermocouple to measure temperatures at the probe tip. The thermocouple is mounted inside each cryoprobe tip and its signal is used to monitor and control some operations of the system. The control unit can also control 2 independent temperature probes to monitor temperatures in surrounding tissues. The temperature probes are standard T-type needle thermocouples.

The provided text describes the Sanarus Visica™ Treatment System but does not contain information about specific acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) premarket notification for a cryosurgical unit, and it primarily focuses on establishing substantial equivalence to a predicate device.

Therefore, I cannot fulfill your request for the detailed table and study information as the necessary data is not present in the provided text.

Here's a breakdown of why I cannot answer each point based on the given information:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on the intended use and technological characteristics rather than specific performance metrics against pre-defined acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or clinical study data is provided in the document.
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): No ground truth establishment or expert involvement for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set or adjudication method 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: No MRMC study or AI assistance is mentioned. This device is a cryosurgical system, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device for tissue ablation, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): As no study data is presented, no ground truth type is specified.
8. The sample size for the training set: No training set is mentioned as there's no machine learning or AI component to this device.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

The document's purpose is to demonstrate that the "new" Sanarus Visica™ Treatment System is substantially equivalent to a previously cleared Sanarus Visica™ Treatment System (K020605). This type of submission relies on showing that the new device has "the same technological characteristics and performance specifications as the predicate device" rather than presenting new clinical study data against defined acceptance criteria.

Ask a specific question about this device

The Sanarus Visica™ Treatment System is intended for use in general surgery, gynecology and oncology. The system is designed to destroy tissue by the application of extreme cold temperatures. In addition, the system is intended for use in the following indications:

General Surgery

• Ablation of breast fibroadenoma .
  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 ●

The Visica™ Treatment System consists of a control unit that controls one to eight single-use, disposable cryoprobes. The control unit is software-controlled and operates off standard 110/230 VAC wall power. A 486 IBM-compatible microprocessor serves as the host computer and a screen displays the status of the system. System control is accomplished either directly through keys on the console itself (e.g., 1-probe system) or through a remote control keypad (e.g., 4 and 8-probe system). The cryoprobes operate on the Joule-Thompson principle and the refrigerative capacity is limited only to the distal tip of the probe. The cryoprobes incorporate a thermocouple to measure temperatures at the probe tip. The thermocouple is mounted inside each cryoprobe tip and its signal is used to monitor and control some operations of the system. The control unit can also control one to eight independent temperature probes to monitor temperatures in surrounding tissues. The temperature probes are standard T-type needle thermocouples.

The system utilizes inert argon gas as a cooling agent. The system is available in 1, 4 and 8-Cryoprobe configurations. The performance characteristics and internal design of each model are equivalent. The primary differences are the number of valves to control the cryoprobes (e.g., 1-8), number of thermocouple inputs (e.g., 1-8) and the size of the outer case.

This document, K020605, is a 510(k) premarket notification for the Sanarus Visica™ Treatment System. It does not contain a study providing acceptance criteria and performance data for the device. Instead, it is a submission to the FDA demonstrating substantial equivalence to a predicate device, the Endocare Cryocare® Surgical System.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study that proves the device meets them from this document. The document primarily focuses on:

• Device Description: What the Visica™ Treatment System is and how it works.
• Indications for Use: The medical conditions and procedures for which the device is intended.
• Predicate Device: The existing legally marketed device to which the Visica™ system is compared.
• Substantial Equivalence Claim: The assertion that the Visica™ system is as safe and effective as the predicate device.
• FDA Clearance Letter: The FDA's determination that the device is substantially equivalent.

Without a performance study included in this submission, I cannot complete any of the requested sections about acceptance criteria, sample sizes, ground truth establishment, or human reader performance.

Ask a specific question about this device