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The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

The device is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The Sanarus InCore Rotational Core Biopsy System consists of a fully integrated control unit, sticking needle, cutting cannula and sample collection tray. The sticking needle is operated by the control unit and uses cold temperatures at its tip to engage the tissue to be sampled. The cutting cannula is coaxially mounted around the sticking needle and is used to core the tissue specimen. The cutting cannula will be available in several gauge sizes and lengths.

The provided text describes a 510(k) summary for the Sanarus InCore Rotational Core Biopsy System. It states that the device is substantially equivalent to a predicate device and includes a "Performance Testing Summary" that confirms the quality of samples obtained with the new device is equivalent to that of the predicate device. However, the document does not provide specific acceptance criteria, detailed study results, sample sizes, ground truth establishment, or expert qualifications for performance testing. It only makes a general statement about equivalence.

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

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance

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

• Sample size for test set: Not specified.
• Data provenance: Not specified (e.g., country of origin, 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)

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

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

• Not specified.

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 device is a biopsy system, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. This device is a biopsy system, not an algorithm.

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

• The performance testing summary mentions "quality of samples." This implies that the ground truth would likely involve histologic examination of the tissue samples, which is a form of pathology. However, the specific method for establishing a "ground truth" for sample quality (e.g., against a gold standard or expert assessment) is not detailed.

8. The sample size for the training set

• Not applicable. This device is a physical biopsy system, not a machine learning algorithm that requires a training set.

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

• Not applicable. This device is a physical biopsy system, not a machine learning algorithm that requires a training set.

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Ask a specific question about this device

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 V2 Treatment System consists of a control unit that controls one single-use, disposable V2 ICE Probe. The system utilizes a cryogen as a cooling agent and a resistance heater for thawing.

The V2 Console is a self-contained, mobile unit, which features an easy-to-use touch screen interface for complete control and monitoring of the cryoablation procedure. The touch screen allows users to select treatment modes and times and control the system and its cycles. The screen is mounted on the system and will tilt and swivel as needed. The Console operates off standard 120/240 VAC (60/50 Hz) power.

The V2 ICE Probe is a single use, disposable probe designed for use with the V2 Treatment System. The primary components of the V2 ICE Probes consist of a surgical stainless steel probe with an electrical warming component and an integrated T-Type Thermocouple for internal temperature feedback. The V2 Probe temperature is internally and continuously monitored by the V2 Console.

The Sanarus V2 Treatment System is a cryoablation device, and its performance testing focused on meeting specifications and demonstrating substantial equivalence to a predicate device. This type of submission (Traditional 510k) primarily relies on showing that the new device is as safe and effective as a legally marketed predicate device, rather than conducting extensive clinical studies with specific acceptance criteria that demonstrate disease detection or diagnostic accuracy.

Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication), MRMC studies, standalone performance, and training set ground truth are not explicitly described or required for this type of submission.

Here's a breakdown of what is available and what is typically not found in a 510(k) for a device like this:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as diagnostic performance metrics (e.g., sensitivity, specificity). For a cryoablation system, acceptance criteria would typically relate to engineering specifications for temperature control, cooling rates, thawing rates, probe integrity, safety features, and functional performance.
• Reported Device Performance: The submission states "Performance testing confirms that the Sanarus V2 Treatment system meet its applicable specifications and performance standards and is substantially equivalent to the Sanarus Visica Treatment System predicate device." Specific numerical performance data for these engineering and functional specifications are not provided in the summary.

2. Sample size used for the test set and the data provenance: Not applicable. This 510(k) submission primarily relies on engineering and functional testing, not a clinical study with a "test set" in the context of diagnostic accuracy.

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 diagnostic accuracy is not the focus here.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. These studies are typically for diagnostic imaging devices where human readers interpret images.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a cryoablation system, not an AI algorithm.

7. The type of ground truth used: For a device like this, the "ground truth" for performance testing would likely refer to established engineering standards, physical measurements (e.g., of temperature, volume ablated in a controlled medium), and comparisons to the predicate device's known performance. It would not typically involve expert consensus, pathology, or outcomes data in the way a diagnostic device would.

8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary regarding the Sanarus V2 Treatment System:

The Sanarus V2 Treatment System is a cryoablation device cleared via a Traditional 510(k) pathway. The primary method of demonstrating its safety and effectiveness was through showing substantial equivalence to a predicate device (Sanarus Visica Treatment System). This involved:

• Demonstrating the same indications for use.
• Highlighting similar technological characteristics.
• Confirming identical patient contact components and materials.
• Ensuring equivalent packaging, sterilization methods, and sterility assurance levels.
• Providing performance testing results that confirmed the device "meet its applicable specifications and performance standards."

The specific details you've asked for related to clinical study design, diagnostic accuracy metrics, and AI/ML model validation are not typically part of a 510(k) for a therapeutic device like a cryoablation system when substantial equivalence is established through engineering and functional comparisons to a predicate device.

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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.

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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 inert argon gas as a cooling agent and helium for thawing. The control 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 temperature probes to monitor temperatures in the surrounding tissues. The temperature probes use standard T-type needle thermocouples.

The Sanarus Visica Treatment System is substantially equivalent to the Sanarus Visica Treatment System that was determined to be substantially equivalent on Oct 15, 2002 (reference K022314). The predicate device's performance data is used to establish the current device's substantial equivalency.

The submission is for modifications to the cryoprobe, resulting in the addition of an additional cryoprobe configuration to Sanarus Visica Treatment System.

Acceptance Criteria and Device Performance:

No specific performance criteria or metrics (e.g., sensitivity, specificity, accuracy) are provided in this document. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new performance data against pre-defined acceptance criteria for a novel device.

Study Details:

• Sample size used for the test set and the data provenance: Not applicable. This submission is for modifications to an existing device and relies on performance testing to demonstrate equivalence rather than clinical study data with a test set.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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 not an AI-assisted device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established performance and safety of the predicate device.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The study referenced in the document is a "Performance Testing Summary" which confirms that modifications to the cryoprobe, resulting in the addition of an additional cryoprobe configuration to the Sanarus Visica Treatment System, meet applicable specifications and performance standards. This testing also demonstrated equivalency to the predicate device (Sanarus Visica Treatment System, K022314).

The basis for acceptance is "Substantial Equivalence" to the predicate device. The document explicitly states:

• "The Sanarus Visica Treatment System has the same indications for use and technological characteristics as the predicate device."
• "The patient contact components and component materials in both the new and predicate device are the same."
• "The packaging materials, packaging configurations, sterilization methods and sterility assurance level are also equivalent."
• "Based on the indications for use; technological characteristics and performance testing results, the Sanarus Visica Treatment System does not raise significant new questions of safety and effectiveness."

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The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

The device is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The Sanarus Cassi II Rotational Core Biopsy System consists of a fully integrated control unit (Handle), Biopsy Needle Unit (comprised of a sticking needle and cutting cannula) and sample collection tray. The sticking needle is operated by the control unit and uses cold temperatures at its tip to engage the tissue to be sampled. The cutting cannula is coaxially mounted around the sticking needle and is used to core the tissue specimen. The cutting cannula will be available in several gauge sizes and lengths.

The Sanarus Cassi™ II Rotational Core Biopsy System is a medical device used for obtaining biopsies from soft tissues. The information provided is from a 510(k) premarket notification (K051581) to the FDA, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a comprehensive clinical study to "prove" the device meets specific performance criteria.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" or detailed "reported device performance" metrics in the way one might expect from a clinical trial with pre-defined endpoints (e.g., sensitivity, specificity, accuracy, or specific biopsy yield rates). Instead, the core of the submission is to demonstrate equivalence to a predicate device.

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

The document states "Performance testing confirms that the quality of samples obtained with the Sanarus Cassi II Rotational Core Biopsy System is equivalent to the predicate device." However, it does not provide any details on:

• The sample size used for this "performance testing."
• The data provenance (e.g., country of origin, retrospective or prospective).

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

No information is provided regarding the number of experts, their qualifications, or how ground truth was established for any test set. The submission relies on demonstrating equivalence rather than an independent clinical validation with expert-derived ground truth.

4. Adjudication Method for the Test Set

No information is provided regarding an adjudication method for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No mention of an MRMC comparative effectiveness study, nor any effect size of human readers improving with AI vs. without AI assistance. This device is a biopsy system, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable, as this is a physical medical device (biopsy system), not an algorithm or AI product.

7. Type of Ground Truth Used

The document does not specify the type of "ground truth" used for performance testing, other than stating "quality of samples obtained." Given it's a biopsy device, the implicit "ground truth" for sample quality would likely involve histological assessment by a pathologist, but this is not explicitly stated, nor are details of such assessment provided.

8. Sample Size for the Training Set

Not applicable. This is a physical biopsy system, not an AI/ML algorithm that requires a training set.

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

Not applicable.

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The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

The device is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The Sanarus Cassi Rotational Core Biopsy System consists of a sticking needle, cutting cannula, fully integrated control unit and specimen container. The sticking needle is operated by the control unit and uses cold temperatures at its tip to engage the tissue to be sampled. The cutting cannula is coaxially mounted around the sticking needle and is used to core the tissue specimen. The cutting cannula will be available in several gauge sizes and lengths.

The provided information is for device premarket submission and describes the Sanarus Cassi Rotational Core Biopsy System. This document does not contain details about acceptance criteria or a study proving that the device meets specific performance criteria related to AI or algorithm-only performance.

Instead, this submission is a Special 510(k) for a medical device that aims to demonstrate substantial equivalence to a previously legally marketed device (predicate device). In such submissions, the primary "acceptance criterion" is proving that the new device is as safe and effective as the predicate, often through shared technological characteristics and performance testing that confirms equivalence.

Here's a breakdown of the requested information based on the provided text:

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

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 provided in the document. The submission states "Performance testing confirms...", but does not detail the nature of this testing, sample sizes, or data provenance.

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 provided in the document. As this is a mechanical biopsy device, "ground truth" would likely refer to histopathological analysis of obtained tissue samples. However, no details on how this was established for test purposes are given.

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

This information is not provided in the document.

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

There is no mention of an MRMC study or AI in this submission. The device is a physical biopsy system, not an AI software/diagnostic tool.

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

This is not applicable. The device is a physical biopsy system, not an algorithm.

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

The document implies that the performance testing for the new device compared the "quality of samples obtained" to the predicate device. For a core biopsy device, the ground truth would typically be histopathology/pathology of the tissue samples. However, the document does not explicitly state this or provide details of the pathology assessment.

8. The sample size for the training set

This information is not provided and is not applicable as this is not an AI/ML device.

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

This information is not provided and is not applicable as this is not an AI/ML device.

Ask a specific question about this device

The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

The device is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.q., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The Sanarus Centrica II Rotational Core Biopsy System consists of a sticking needle, cutting cannula, fully integrated control unit and specimen container. The sticking needle is operated by the control unit and uses cold temperatures at its tip to engage the tissue to be sampled. The cutting cannula is coaxially mounted around the sticking needle and is used to core the tissue specimen. The cutting cannula will be available in several qauge sizes and lengths.

The provided text describes the Sanarus Centrica™ II Rotational Core Biopsy System and its substantial equivalence to a predicate device. However, it does not contain information on specific acceptance criteria and a study proving the device meets those criteria in the context of diagnostic accuracy, sensitivity, specificity, or other performance metrics typically associated with AI/software devices.

The document focuses on demonstrating substantial equivalence for a physical medical device (a biopsy system) based on similar indications for use, technological characteristics, and performance testing confirming equivalent sample quality. It does not involve AI or software performance evaluation as would be typical for the detailed questions asked.

Therefore, many of your requested points about acceptance criteria, sample sizes for test and training sets, expert consensus, MRMC studies, or standalone algorithm performance cannot be answered from the provided text.

Here's what can be extracted based on the information given:

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

Note: The document implies acceptance criteria by stating how the new device is equivalent to the predicate. Specific numerical targets (e.g., sensitivity, specificity, or specific tissue quality scores) are not provided.

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

This information is not provided in the document. The text only vaguely refers to "Performance testing."

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 provided in the document. The evaluation focuses on sample quality for histological examination, presumably by pathologists, but no details are given.

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

This information is not provided in the document.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported for this device, as it is a physical biopsy system, not an AI/software diagnostic tool.

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

No, this device is not an algorithm, so a standalone performance study in that context is not applicable.

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

The "ground truth" implicitly referred to is the histological examination of tissue samples, which would involve pathologists. The document states the device provides "breast tissue for histologic examination."

8. The sample size for the training set

This information is not provided in the document. As this is not an AI/ML device, a "training set" in the conventional sense is not applicable.

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

This information is not provided in the document, and a "training set" is not relevant for this type of device submission.

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The Sanarus Indica Marker System is indicated for use to attach to soft tissue, including breast tissue, following an open surgical or percutaneous biopsy procedure and to radiographically and radiologically mark the location of the biopsy procedure.

The Sanarus Indica Marker System consists of a delivery device (applier), introducer cannula and non-absorbable tissue marker that is clearly visible on standard radiographs and ultrasound.

This document is a 510(k) premarket notification for the Sanarus Indica Marker System. It outlines the device description, indications for use, and claims substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document states:

• "Biocompatibility and bench testing have demonstrated that the device is safe and effective and that its performance is equivalent to the predicate devices."

This is a general statement about testing, but it does not provide specific acceptance criteria, performance metrics, study designs, sample sizes, or details about ground truth or expert involvement as requested.

Therefore, I cannot provide the requested table and information because the provided text does not contain the necessary details about specific acceptance criteria and a study to prove they were met.

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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.

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