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The Thera Vision Ultrasound Ablation System, ACOUSTx Applicators, and accessories are intended for the laparoscopic, intraoperative, and percutaneous coagulation and ablation of soft tissue. It is not indicated for ablation of prostate tissue.

The TheraVision System consists of the following subsystems:

• 4.1 Computer System: The computer system consists of a PC Compatible type computer running Microsoft Windows® Operating system.
• 4.2 Visualization Options: Visualization options include utilization with compatible, legally marketed imaging systems. Patient images may be imported in DICOM format from MRI, CT, US, Fluoroscopic X-Ray, and PET-CT scanners.
• 4.3 Software: A set of user interface and display modules allow user interaction and high-level control over the system, including power generation and safety monitoring. Top-level modules provide top level menu options and implement next-generation Microsoft Windows® display functionality.
• 4.4 Thermometry System: Temperature monitoring is accomplished using an optional multichannel type T patient isolated thermocouple data acquisition system.
• 4.5 RF Generation System: A Multichannel RF power generator system provides the RF enerqy needed drive the piezoelectric transducers for generation of sufficient ultrasound acoustic energy from the applicators to raise the temperature to therapeutic levels in the targeted tissue
• 4.6 Cooling System: Degassed sterile water is pumped through the ultrasound transducers in the applicators and provides ultrasound energy coupling to tissue and also provides a means for cooling the applicator.

ACOUSTx Applicators:
The ultrasound energy generated from ACOUSTx Applicators is absorbed during treatment producing thermal therapy within the targeted tissue region. The ACOUSTx Applicators are sterile and single-use and can be utilized with the TheraVision System and may contain up to four transducers each with angular insonation patterns of 360° or 180° for application of thermal therapy.

The provided FDA 510(k) summary (K150019) describes the TheraVision™ Ultrasound Ablation System and ACOUSTx™ Applicators. The submission aims to demonstrate substantial equivalence to predicate devices, focusing on the device's ability to create comparable ablation patterns.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pre-defined manner typical for clinical trials or formal performance goals. Instead, the performance is demonstrated by showing "comparable ablation patterns and times" to predicate devices. The implicit acceptance criterion is that the device should produce ablation dimensions within a range that is considered safe and effective, and comparable to legally marketed predicate devices.

• Liver: Penetration Depth: 1.4 - 3.4 cm, Pattern Length: 1.1 - 4.7 cm
• Muscle: Penetration Depth: 1.63 - 3.4 cm, Pattern Length: 1.2 - 4.7 cm
• Kidney: Penetration Depth: 1.5 - 2.7 cm, Pattern Length: 1.1 - 2.5 cm*

180° ACOUSTx Applicator:

• Liver: Penetration Depth: 1.9 - 2.8 cm, Pattern Length: 1.1 - 4.6 cm
• Muscle: Penetration Depth: 1.8 - 3.0 cm, Pattern Length: 1.1 - 4.6 cm
• Kidney: Penetration Depth: 1.6 - 2.7 cm, Pattern Length: 1.1 - 2.4 cm*

Comparison to Predicates:

• Sonatherm: penetration depth up to 3 cm (wedge-shaped pattern)
• Cool-tip™: ablation diameter 2.3 – 2.6 cm at lengths of 2.6 – 3.7 cm (ellipsoidal pattern)
• Valleylab: ablation diameter 1.8 - 3 cm at lengths of 3.9 - 5 cm (ellipsoidal pattern) |
  | Ablation times comparable to predicate devices. | The study involved different treatment times (3, 6, and 9 minutes) and concluded "comparable ablation patterns and times with respect to the three listed predicate devices." (Specific comparable times for predicates are not detailed here, but the range of times used demonstrates performance over an operational spectrum). |
  | Safety and efficacy for intended use and technology. | "Results from bench, animal, performance, and safety testing demonstrate the safety and efficacy of this device's intended use and technology." Compliance with IEC 60601-1, IEC 60601-1-2, IEC 61000-3-2, and IEC 61000-3-3. |

*1 or 2 active transducers longitudinally

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

• Sample Size for Test Set: The document does not specify a precise numerical sample size for the in vivo testing (e.g., number of animals). It states that in vivo testing was performed "using a porcine model" and "three tissue types were treated: liver, muscle, and kidney." For ex vivo testing, the text mentions using "360° and 180° ACOUSTx Applicator models to apply thermal therapy to both chicken breast tissue and porcine tissue: liver, muscle, and kidney."
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Prospective, as the testing was conducted specifically to support the 510(k) submission. These are controlled laboratory and animal studies.

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

This section is not applicable. The measurements of ablation dimensions (penetration depth, pattern length) are objective physical measurements taken from the ablated tissue, not subjective expert interpretations requiring consensus. Therefore, no experts were used to establish a "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable, as the data collection involved objective physical measurements, not subjective evaluations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This study focuses on the physical ablation properties of a device, not on diagnostic performance or human reader interpretation.

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

This device is an ablation system, not a diagnostic algorithm. The "standalone" performance in this context refers to the device's ability to produce specific thermal lesions. The in vivo and ex vivo testing conducted are effectively "standalone" performance tests of the device itself (without human interpretation of diagnostic output).

7. The Type of Ground Truth Used

The ground truth used was physical measurement of tissue ablation dimensions (penetration depth, pattern length) resulting from the device's operation. This is directly observable and measurable data from the treated tissue (ex vivo and in vivo).

8. The Sample Size for the Training Set

Not applicable. This device is a physical ablation system, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. The device's operational parameters and design are based on engineering principles and preclinical testing, rather than data-driven learning from a large "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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HS AMICA is intended for coagulation (thermoablation) of soft tissues. Not for use in cardiac procedures.

HS AMICA (Apparatus for MICrowave Ablation) is an integrated system for interstitial thermoablation of soft tissues through controlled emission of microwaves. The system is composed by three interactive devices, namely: AMICA-GEN: a digitally controlled microwave power source, operating at 2450 MHz and delivering up to 100 W CW (continuous wave); it features a single output channel. AMICA-PROBE: an interstitial single-use coaxial microwave applicator, fed by AMICA--GEN. AMICA-PUMP: a peristaltic pump for convective applicator cooling through continuous circulation of liguid coolant, fully controlled by AMICA-GEN.

The provided text is a 510(k) summary for the HS AMICA Microwave Tissue Coagulation System. It describes the device's technical characteristics, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, specific device performance data (like sensitivity, specificity, accuracy), sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case (MRMC) studies.

The "Performance testing" mentioned on page 3 is a general statement: "Performance testing was executed to ensure that HS AMICA functions as intended and meets design specifications. Sufficient data were obtained to show that the device meets safety and effectiveness criteria and is substantially equivalent to the predicate device." This statement, while confirming testing was done, does not provide any of the quantitative details requested.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and qualifications
4. Adjudication method
5. MRMC comparative effectiveness study details
6. Standalone performance details
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

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The Valleylab Microwave Ablation Generator is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors.

The Valleylab Microwave Ablation Generator is designed to provide microwave power for the ablation of soft tissue in medical procedures. It was cleared for commercial distribution (K011676) by demonstrating substantial equivalence to existing Radiofrequency and Microwave Ablation systems.

The Microwave Ablation Generator is designed to be used with proprietary microwave antennas (cleared in K011676 and K032702) which are placed directly into the tissue to be ablated. The Valleylab Microwave Ablation Generator is a nonsterile electrical device that is not intended to contact the patient.

The Microwave Ablation Generator is used with a pump to circulate cooling fluid (sterile saline) to the antennas, and an optional integrated cart. The device's power output and duration (time) are controlled by the user via manual controls on the front panel of the generator. The display on the front of the device shows power (watts), duration of power delivery (minutes and seconds), and elapsed time.

The antenna is connected to the generator and radiates power to the tissue under treatment. The antennas are provided sterile, for single use only. The shaft of each antenna is made of insulated stainless steel. Three antennas of different lengths are available for use in percutaneous procedures, and a single length antenna fing surgical procedures. The active portion of the antenna is 3.7cm in length for all models. The percutaneous antennas are cooled by circulating sterile saline through the antenna. The surgical antennas are not internally cooled. The system pump circulates fluid from a reservoir to the antenna through sterile tubing. Sterile fluid is confined within the antenna and tubing, and does not contact the patient.

This appears to be a 510(k) summary for the Valleylab Microwave Ablation Generator, seeking to expand its intended use to include the ablation of non-resectable liver tumors.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for the expanded indication in a quantitative, tabular format. Instead, it describes comparative non-clinical testing and refers to existing clinical studies.

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

• Non-clinical Testing (Bench and In-vivo):

  • Sample Size: Not explicitly stated (e.g., number of livers, number of ablations). It mentions "single and multiple antenna comparisons."
  • Data Provenance:
    • Bench Testing: Bovine livers (ex-vivo, not human or patient data).
    • In-vivo Testing: Porcine livers (animal model, not human or patient data).
    • Retrospective/Prospective: These were likely prospective studies designed for this submission.

• Clinical Testing:

  • Sample Size: Not explicitly stated. The document refers to "A review of the existing studies," implying a synthesis of previously conducted research rather than a new clinical trial undertaken for this submission.
  • Data Provenance: Not specified, but generally, human clinical studies would be prospective or retrospective patient data from various clinical sites. The text indicates "existing studies," so it would be entirely retrospective in relation to this 510(k) submission.

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

This information is not provided in the document for either the non-clinical or clinical testing.

4. Adjudication Method for the Test Set

This information is not provided in the document. For the non-clinical testing, it mentions lesions were "evaluated histologically and physically," which implies some form of assessment, but not an adjudication method. For the clinical testing, as it's a "review of existing studies," the adjudication method would depend on the individual studies reviewed, which are not detailed here.

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

This document describes a device for microwave ablation, not an AI/CAD (Computer-Aided Detection/Diagnosis) device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not conducted as described in this summary.

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

This device is not an algorithm. It's a medical device (generator and antennas) for tissue ablation. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

• Non-clinical Testing (Bovine/Porcine Livers):

  • Histology: Lesions were "evaluated histologically." This implies detailed microscopic examination of tissue.
  • Physical Evaluation: Lesions were also evaluated "physically," likely referring to gross measurements and visual inspection.
  • This combines expert assessment (histology interpretation) with direct measurement.

• Clinical Testing (Review of Existing Studies):

  • The document states the review "shown that the use of the system to be clinically safe and effective." This often implies ground truth established through a combination of:
    • Pathology: Confirmation of tumor type and complete ablation in excised specimens or biopsies.
    • Imaging Follow-up: Assessment of tumor recurrence or residual disease using modalities like CT, MRI, or ultrasound.
    • Clinical Outcomes Data: Patient survival, complications, quality of life, etc.
  • The specific methods for establishing ground truth within the "existing studies" are not detailed in this summary.

8. The Sample Size for the Training Set

This document does not describe the development of an algorithm that would require a "training set." It's a hardware device (microwave ablation generator). Therefore, the concept of a training set sample size is not applicable.

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

As explained above, this concept is not applicable to the device described.

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The VivaWave™ Microwave Ablation System is intended for coagulation (ablation) of soft tissue.

The VivaWave™ Microwave Ablation System is not intended for use in cardiac procedures.

Valleylab recommends against the use of microwave ablation in the following situations:

• . Pregnant patients - potential risks to the patient and/or fetus have not been established.
• Patients with implantable pacemakers and other electronic . implants. Implanted electronic devices may be adversely affected by microwave power output.

The VivaWave™ Microwave Ablation System consists of one or two microwave output modules and a pump for circulating cooling fluid, installed in an integrated cart. Each microwave module has three output channels, allowing one, two, or three microwave antennas (a.k.a. probes, applicators, accessories, or instruments) to be used simultaneously. Multiple antennas may be positioned to ablate separate areas, or placed closer together to produce larger single ablations. Each output channel is limited to 65 watts maximum; a microwave module can power all three channels simultaneously at full power if desired. Systems with two microwave modules have six output channels available for simultaneous use.

Microwave module controls provided to the operator include ablation power and ablation time. All output channels that have an antenna connected operate simultaneously. Each channel receives the same power, corresponding to the power setting on the microwave module front panel. Power delivery is initiated by pushing the Ablate button on the microwave module front panel. Power delivery continues until the duration time setting is reached, or until the Ablate button is pushed again.

The VivaWave™ Microwave Ablation System is designed for use with proprietary microwave antennas such as those cleared for Vivant Medical in submissions K011676 and K032702. (Note: Vivant Medical is owned by Valleylab, a Division of Tyco Healthcare Group LP.) The antennas are connected to the VivaWave System with a proprietary connector incorporating an identification device that allows the microwave module to verify that a correct antenna is attached.

Antennas designed for percutaneous use are cooled internally with sterile saline. They are connected to the VivaWave system cooling fluid pump via sterile tubing. The pump has capacity to supply coolant to six antennas simultaneously if desired. The microwave module monitors coolant temperature within each antenna using an internal thermocouple. Delivery of microwave energy is stopped if an unsafe temperature is reached. Coolant is confined within the antenna and tubing, and does not contact the patient. The pump is controlled by an ON/OFF/Speed Control switch located adjacent to the pump.

Each microwave module can also accommodate up to three proprietary auxiliary temperature probes. (Existing device, refer to K031556.) When auxiliary temperature probes are in use, the temperature at the probe tip is displayed on the microwave module front panel. Auxiliary temperature probes are not required for operation of the VivaWave™ system.

Here's an analysis of the provided text regarding the VivaWave™ Microwave Ablation System, structured to address your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific, quantifiable acceptance criteria or report performance metrics in a way that suggests a formal acceptance criteria table. Instead, it describes general performance testing to ensure the device "functions as intended, and meets design specifications." The primary "performance data" presented is that the device was found to be "substantially equivalent" to its predicate device. This substantial equivalence determination inherently suggests that the device performs comparably to the predicate, which is itself a legally marketed device.

Therefore, since explicit criteria and direct performance values are absent, I cannot create such a table from the given information. The "performance" assessment is based on regulatory substantial equivalence rather than a detailed list of engineering or clinical performance metrics.

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

The document does not specify a sample size for a "test set" in the context of clinical or performance data. The performance data section vaguely states, "Performance testing was performed to ensure that the VivaWave™ Microwave Ablation System functions as intended, and meets design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria."

There is no mention of data provenance (e.g., country of origin, retrospective or prospective) for any performance data. The focus is on technical equivalence to a predicate device.

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

This information is not provided in the document. The submission is a 510(k) for substantial equivalence, which often relies more on engineering and design specifications compared to a predicate device than on extensive clinical trials with expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in the provided text. The document focuses on the device's technical specifications and its substantial equivalence to a predicate device, not on assessing human reader performance with or without AI assistance. The VivaWave™ system is an ablation device, not an AI diagnostic tool.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study

This concept is not applicable to the VivaWave™ Microwave Ablation System as described. It is a medical device for tissue ablation, not an AI algorithm. Its "performance" would be related to its ability to ablate tissue effectively and safely, as demonstrated through engineering tests and comparison to a predicate, rather than an "algorithm only" performance.

7. Type of Ground Truth Used

The document does not detail specific "ground truth" establishment in a clinical sense. The "ground truth" for this 510(k) submission appears to be regulatory substantial equivalence to the predicate device (Vivant Medical VivaWave™ Microwave System K011676). This implies that if the new device functions similarly and meets the same safety and effectiveness criteria as the predicate, it is considered safe and effective. The "Performance Data" section states, "Sufficient data were obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria."

8. Sample Size for the Training Set

The document does not mention a "training set" as would be relevant for an AI or machine learning model. The VivaWave™ system is a hardware device with software controls, not a learning algorithm that undergoes traditional "training."

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

As no "training set" is described for this device, the question of how its ground truth was established is not applicable.

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