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The VivaWave™ Microwave Ablation System is intended for coagulation of soft tissue. The Coaxial Introducer is intended to aid insertion of the microwave energy applicator component of the system. The system is not intended for use in cardiac procedures.

The VivaWave™ Microwave Ablation System consists of a microwave power generator and a disposable probe that is the microwave energy applicator. The disposable probe is inserted into soft tissue to coagulate a volume of tissue surrounding the active area of the probe. The Coaxial Introducer may be used to aid insertion of the microwave energy applicator.

The provided text describes a 510(k) submission for a medical device called the "Coaxial Introducer," which is part of the VivaWave™ Microwave Ablation System. This submission is for market clearance through substantial equivalence to predicate devices, not for proving a new device's performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain any information about:

1. Acceptance criteria and reported device performance: This type of information is typically found in design validation or clinical study reports, which are not part of this 510(k) summary. The summary focuses on showing equivalence to existing devices.
2. Sample size used for the test set and data provenance: No test sets or clinical studies are mentioned.
3. Number of experts and their qualifications for ground truth: Not applicable here as no ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The focus is on the device itself, not on human reader performance with or without AI.
6. Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
7. Type of ground truth used: No ground truth is established or discussed.
8. Sample size for the training set: Not applicable, as no training set for an algorithm is discussed.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information related to equivalence:

The 510(k) summary states that the Coaxial Introducer, as an accessory to the VivaWave™ Microwave Ablation System, is substantially equivalent to predicate devices. The basis for this claim is:

• Indications for use: "The VivaWave™ Microwave Ablation System is intended for coagulation of soft tissue. The Coaxial Introducer is intended to aid insertion of the microwave energy applicator component of the system. The system is not intended for use in cardiac procedures." This is similar to the predicate device K011676.
• Basic overall function: The Coaxial Introducer aids in the insertion of the microwave energy applicator.
• Methods of manufacturing: Implied to be similar to existing devices.
• Materials used: "All patient contact materials used in the manufacture of the Coaxial Introducer are suitable for this use and have been used in numerous previously cleared products."

In conclusion, this 510(k) submission seeks market clearance based on substantial equivalence, not on the demonstration of specific acceptance criteria met through a performance study.

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The VivaRing™ Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.

The VivaRing M Microwave Ablation Probe consists of a pre-shaped curved microwave antenna which is contained within a delivery cannula. The electrode is attached to a handle mechanism that deploys the antenna into the targeted tissue. Once deployed, the antenna can be powered by the Vivant Medical VivaWave™ Microwave Generator to coagulate a region of tissue within and around the antenna. VivaRing™ Microwave Ablation Probe also incorporates a saline-cooled shaft for percutaneous and laparoscopic use.

The provided document is a 510(k) summary for the VivaRing™ Microwave Ablation Probe and Accessories, a medical device submission to the FDA. It outlines the device's intended use, description, and claims of substantial equivalence to predicate devices.

However, a critical review of the provided text reveals that it does not contain any information regarding acceptance criteria or the study that proves the device meets specific performance criteria. The document focuses on regulatory approval based on "substantial equivalence" to previously cleared devices rather than providing detailed performance data, clinical study results, or specific acceptance metrics.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them because this information is not present in the input document. The input primarily serves as a regulatory approval letter and a summary of the device for submission purposes, not a performance study report.

To address the prompt as best as possible, I can state that the document does not provide the requested information.

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The VivaTip™ Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.

The VivaTip Microwave Ablation Probe is a needle-like device that is inserted into soft tissue and coagulates a volume of tissue surrounding the active area of the probe. The probe is to be used with the VivaWave™ microwave power generator. Accessories to assist in cooling the shaft of the probe and to hold multiple probes together for simultaneous ablation are included.

This premarket notification (510(k)) does not contain the requested information about acceptance criteria and a study proving the device meets those criteria. The provided text is a 510(k) summary and the FDA's response letter, which primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.

Here's what can be inferred and what is explicitly missing from the provided text:

Inferences from the provided text:

• Device Type: Microwave Ablation Probe. The purpose is for coagulation of soft tissue.
• Regulatory Pathway: 510(k), which implies that the device is being compared to substantially equivalent predicate devices rather than proving safety and effectiveness de novo through extensive clinical trials.
• Substantial Equivalence: The FDA determined the device to be substantially equivalent to the predicate devices (VivaWave™ Microwave Ablation System K011676 and Tri-Loop™ Microwave Ablation Probe K032047) based on "indications for use, basic overall function, methods of manufacturing, and materials used." This suggests that the performance characteristics (e.g., coagulation size, temperature profile) are considered similar enough to the predicates that a new detailed study proving specific acceptance criteria might not have been a primary requirement for this 510(k) clearance.

Missing Information (and why it's missing from this type of document):

The provided text is a 510(k) summary, which is a high-level overview. Detailed performance studies and acceptance criteria are typically found in the full 510(k) submission, which is not publicly available in its entirety. The summary focuses on establishing equivalence rather than detailing internal validation studies.

Therefore, I cannot provide the requested table or detailed study information based solely on the provided text. To answer your questions, I would need access to the full 510(k) submission document, particularly the sections related to performance testing and validation.

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The Tri-Loop™ Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.

The device consists of 3 pre-shaped curved microwave antennas which is contained within 3 delivery cannulas. The cannulas are attached to a handle mechanism that deploys the antennas into the targeted tissue. RF energy can be used to facilitate deployment of the antennas into tissue. The Vivant VivaWave™ Microwave Generator (K011676) is used to deliver the microwave energy to the curved antennas which heats the tissue within and around the antennas.

The provided text is a 510(k) summary for the Tri-Loop™ Microwave Ablation Probe. It states the device's intended use and claims substantial equivalence to a predicate device. However, it does not contain any studies, acceptance criteria, or performance data to directly answer your specific questions about device performance and study methodology.

The supplied document is a regulatory submission for premarket clearance, which focuses on demonstrating equivalence to an already legally marketed device (predicate device). Such submissions typically do not include detailed performance studies with acceptance criteria in the way you've described for AI/diagnostic devices.

Therefore, I cannot populate the table or answer the subsequent questions based on the provided input. The document explicitly states:

• "Summary of Substantial Equivalence: The Tri-Loop™ Microwave Ablation Probe is equivalent to the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent."

This indicates that the clearance was based on equivalence, not on independent performance studies against defined acceptance criteria for a novel functionality.

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The VivaTherm™ Temperature Measurement System is intended to monitor tissue temperatures during clinical procedures requiring temperature feedback.

The VivaTherm™ Temperature Measurement System consists of a multi-channel electronic temperature monitor (T-Box™) and single-use thermocouple-based temperature probes (T-ProbeTM).

The provided document, K031556 for the VivaTherm™ Temperature Measurement System, mentions "Bench testing of the VivaTherm™ Temperature Measurement System confirmed similar performance as compared to a predicate device." However, it does not provide specific acceptance criteria, reported device performance metrics in a table, or detailed information about a study to prove these criteria were met.

Therefore, many of the requested sections cannot be filled from the given text.

Here's a breakdown of what can and cannot be extracted:

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

• Acceptance Criteria: Not explicitly stated in the document.
• Reported Device Performance: Not explicitly stated in the document. The document only mentions "confirmed similar performance as compared to a predicate device."

2. Sample size 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 (country of origin, retrospective/prospective): Not specified.

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 applicable, as no expert-based ground truth establishment is described.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable, as no expert-based adjudication 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

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. The device is a direct temperature measurement system, not an AI-assisted diagnostic tool for human readers.
• Effect Size of Human Reader Improvement: Not applicable.

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

• Standalone Performance Study: The document states "Bench testing... confirmed similar performance as compared to a predicate device." This implies a standalone (device only) test, but no specific metrics or study details are provided beyond this general statement. No "algorithm only" study is discussed as this is a hardware device for direct measurement.

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

• Type of Ground Truth: Not explicitly stated. For a temperature measurement device, the "ground truth" would likely be a highly accurate reference thermometer or controlled temperature environment. The document only refers to comparison with a predicate device.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a temperature measurement device, not an AI/ML model that requires a training set in that context.

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

• Ground Truth for Training Set Establishment: Not applicable.

Summary of Available Information:

• Acceptance Criteria: Not explicitly stated. Implied to be "similar performance" to a predicate device.
• Study Description: "Bench testing...confirmed similar performance as compared to a predicate device." No details provided.
• Device Type: VivaTherm™ Temperature Measurement System, consisting of a multi-channel electronic temperature monitor (T-Box™) and single-use thermocouple-based temperature probes (T-Probe™).
• Intended Use: To monitor tissue temperatures during clinical procedures requiring temperature feedback.
• Predicate Devices: Luxtron Multichannel 2000 Fluoroptic Thermometer (K841105), Endocare Electronic Thermometer System (K961365), URI Therm-X Model TX-100 Multichannel Thermocouple Thermometry System (K843381).

The provided text focuses on the substantial equivalence argument based on general performance similarity and device characteristics (indications for use, basic function, materials, manufacturing), rather than detailed performance study results against specific acceptance criteria.

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The Loop™ Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.

The device consists of a pre-shaped curved microwave antenna which is contained within a delivery cannula. The electrode is attached to a handle mechanism that deploys the antenna into the targeted tissue. The electrode comes with a connector that can be attached to a standard RF electrosurgical generator to assist in deployment of the curved microwave antenna into tissue. Once the curved antenna is fully deployed, the RF connector can be removed and the remaining microwave cable is connected to the Vivant VivaWave™ Microwave Generator. The microwave energy is then transmitted to the curved antenna which heats the tissue within and around the antenna.

The provided text describes a 510(k) summary for the Vivant Medical Loop™ Microwave Ablation Probe. It focuses on regulatory approval and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

Therefore, I cannot populate the requested table and answer questions 1 through 9 with the provided text.

The document is a regulatory approval letter and a summary of the device for that approval. It states the intended use and compares it to predicate devices to establish substantial equivalence for market clearance. It does not include performance data or studies that would typically define and demonstrate meeting acceptance criteria in the way a clinical or technical study would.

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The enCircle™ Localization Device is intended for localization of non-palpable breast lesions.

The enCircle™ Localization Device is a disposable instrument consisting of a curved localization element and a needle cannula delivery system. The device is used to localize non-palpable breast lesions to facilitate surgical excision of the lesions.

The enCircle™ Localization Device is intended for the localization of non-palpable breast lesions. The submission to the FDA focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving a specific performance metric against acceptance criteria in a clinical study.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not explicitly stated. The "Testing" section mentions "In-Vitro testing." This suggests a laboratory-based evaluation of the device's physical and functional characteristics, potentially involving a certain number of device units or simulations.
• Data Provenance: Not explicitly stated. The testing was "In-Vitro," meaning it was conducted in a controlled laboratory environment, not on human subjects. This type of testing typically wouldn't involve country of origin data or be classified as retrospective/prospective in a clinical sense.

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

• Not applicable. As the testing was "In-Vitro" and focused on device performance characteristics rather than diagnostic accuracy, there was no need for expert ground truth establishment in the traditional sense of clinical image interpretation or diagnosis.

4. Adjudication Method for the Test Set:

• Not applicable. There was no clinical ground truth to adjudicate.

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

• No. An MRMC comparative effectiveness study was not conducted or mentioned. The submission relies on "In-Vitro testing" for performance comparison, not a study involving human readers or clinical cases.

6. Standalone Performance Study:

• Yes, in spirit, but not as a typical clinical standalone study. The "In-Vitro testing" compared the "performance of the enCircle™ Localization Device" (algorithm only, if applicable to a physical device) against a predicate. However, it's not a standalone in the sense of an AI algorithm's diagnostic accuracy. It's a standalone evaluation of the physical device's function.

7. Type of Ground Truth Used:

• Performance characteristics (likely engineering specifications or functional outcomes). For "In-Vitro testing," the "ground truth" would be defined by the expected functional parameters of the device (e.g., successful deployment, consistency of deployment, mechanical integrity, material properties), often against predetermined engineering specifications or the performance of a predicate device. This is distinct from clinical ground truth like pathology or expert consensus on patient data.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical medical instrument, not an AI or machine learning algorithm that requires a training set.

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

• Not applicable, as there is no training set for this type of device.

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The VivaWave™ Microwave System is intended for coagulation of soft tissue

The VivaWave™ Microwave System consists of an external microwave generator and probe. The generator is manually set at the desired power levels by the operator. Procedure time is also preset by the operator. The generator is connected to the probe through a connector.

The external generator unit measures approximately ( 13"H x 17"W x 3.5"D) The exterior housing is formed of aluminum coated with plastic.

The unit contains electric circuits, circuit boards, and integrated control panel. The major components of the generator are cooling fans, power supply, microwave module and the front panel/control board assembly.

The probe is a specifically designed antenna coated with Teflon (PTFE). The probe is permanently attached to a cable that carries the energy from the generator to the tip of the probe. The proximal end of the cable has a connector that fits into the generator and allows the energy to be delivered to the probe.

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets those criteria. The provided document is a 510(k) premarket notification letter from the FDA, a summary of the device, its intended use, and a comparison to predicate devices for substantial equivalence.

It outlines:

• The device name: VivaWave™ Microwave System
• Its intended use: Coagulation of soft tissue.
• That it consists of an external microwave generator and a probe.
• Electrical safety, electromagnetic compatibility, and biocompatibility testing were performed to comply with standards (EN60601-1, EN60601-1-2, ISO 10993).

However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Details on sample size, data provenance, or expert involvement in any studies.
3. Information on adjudication methods.
4. Data from multi-reader multi-case (MRMC) comparative effectiveness studies.
5. Standalone algorithm performance.
6. Specifics on ground truth establishment or training set details.

The document primarily focuses on establishing substantial equivalence to previously marketed devices based on indications for use, basic function, manufacturing methods, and materials, rather than presenting detailed performance study results against specific acceptance criteria.

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