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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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The intended use of Acoustic MedSystems, Inc. RadVision Dose Planning and Treatment Systems is to provide patient-specific planning, imaging, and implants or applicator device alignment for treating cancer using radioactive seed implants or HDR afterloader devices. In addition to planning and treatment, RadVision also allows volume and dose calculations, 2D and 3D analomy and dose visualizations, and post treatment seed localization.

RadVision is a general purpose brachytherapy planning system used for prospective and confirmation dose calculations for patients undergoing a course of brachytherapy using either temporary or permanent implants of various radioisotopes.

The RadVision system is a brachytherapy dose planning and treatment guidance system. The system consists of a computer, video capture device and software tools. The required software tools are installed in the computer. The system can be used for pre-treatment realtime dose planning in the Operating Room (OR), and for permanent seed implants performing post-implant seed localization assessment and post-implant dose distribution analysis.

The provided document is a 510(k) summary for the RadVision Dose Planning and Treatment System. It focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance and details verification and validation testing of its features. It does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics in a clinical or simulated clinical setting. The document primarily confirms that the software functionalities were tested and passed.

Therefore, for aspects related to "acceptance criteria," "reported device performance," "sample sizes for test and training sets," "data provenance," "number and qualifications of experts," "adjudication method," "MRMC study," "stand-alone study," and "ground truth establishment," the information is not available in the provided text.

Here's a breakdown of what is available and what is not:

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

Not Available. The document states that "RadVision passed all the verification and validation tests successfully," but it does not specify the quantitative or qualitative acceptance criteria for these tests, nor does it provide detailed performance metrics against those criteria. The tests listed are functional and system-level checks rather than performance against pre-defined clinical or dose calculation accuracy thresholds.

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

Not Available. The document does not mention a "test set" in the context of clinical data, nor does it refer to any human subjects or patient data. The "verification and validation testing" refers to software and system testing, not a study involving patient data.

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)

Not Available. As there is no mention of a test set involving human data or expert review, this information is not present.

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

Not Available. This is not applicable as no test set with expert 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

Not Available. This document describes a brachytherapy dose planning and treatment system, which is a software tool, not an AI-assisted diagnostic tool that would typically undergo MRMC studies comparing human reader performance. There is no mention of AI or human reader improvement.

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

Not Available. While the document describes the functions of the software, it does not present a "standalone" study in the typical sense of evaluating algorithm performance on a dataset against ground truth. The "Verification and Validation test procedures" are functional tests of the software system.

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

Not Available. No "ground truth" in the clinical data sense is mentioned or implied for the testing described. The "verification and validation" likely used predetermined correct outputs for the software functions (e.g., correct dose calculations for given inputs, proper display of images).

8. The sample size for the training set

Not Available. There is no mention of a "training set" or machine learning in the document.

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

Not Available. There is no mention of a "training set" or associated ground truth.

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