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The Sonablate® is indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue.

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The provided document is a 510(k) clearance letter from the FDA for a device called Sonablate, which is a High Intensity Ultrasound System for Prostate Tissue Ablation. This type of document typically provides regulatory clearance based on substantial equivalence to a predicate device and does not include detailed information about acceptance criteria or a specific study proving the device meets those criteria.

Therefore, based solely on the provided text, I cannot extract the information required to answer your questions about acceptance criteria and a study proving their fulfillment. The document focuses on regulatory compliance and substantial equivalence, not on the performance metrics of the device itself.

To answer your questions, one would typically need access to the 510(k) submission itself, which would contain the performance testing data and acceptance criteria that the FDA reviewed.

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The Sonablate® 450 is indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue.

The Sonablate® 450 is a computer-controlled device designed for transrectal delivery of high intensity focused ultrasound (HIFU) energy to the prostate to ablate regions of unwanted prostatic tissue via thermal ablation. The device makes use of integrated biplanar ultrasound imaging for real-time monitoring, planning, and pre- and post-ablation imaging of the prostate. The system consists of the following main components: Sonasource Console, Sonablate Probe 30/40, Sonachill, Sonablate Multi-Axis Stepper and Probe Arm, and Single Use Components (Probe Tip Kit and Water Path Kit).

The provided text describes the Sonablate® 450, a High Intensity Focused Ultrasound (HIFU) system for prostate tissue ablation. The information covers device description, non-clinical studies (biocompatibility, shelf life, electrical safety, software), animal studies, and a clinical study. The acceptance criteria and the study proving the device meets these criteria are detailed, primarily within the "PERFORMANCE TESTING - BENCH" and "SUMMARY OF CLINICAL INFORMATION" sections, and implicitly derived from the "Special Controls" which outline the requirements for devices of this type.

Here's a breakdown of the requested information:

Acceptance Criteria and Device Performance

The acceptance criteria for the Sonablate® 450 are primarily outlined in the "PERFORMANCE TESTING - BENCH" section and in the "SPECIAL CONTROLS" section. The reported device performance is presented in the "Results" columns of the tables in the "PERFORMANCE TESTING - BENCH" section and summarized in the "SUMMARY OF CLINICAL INFORMATION" and "Clinical Results Summary" sections.

Table of Acceptance Criteria and Reported Device Performance

2. Sample sizes used for the test set and the data provenance

Test Set (Bench Testing):

• Transducer Characterization: n=7 for Schlieren, Electrostatic, and Force balance tests.
• Imaging Verification: n=1 for Phantom testing, Imaging frame rate test, and Image display test.
• HIFU Verification/Safety: n=1 for Ex vivo tissue phantom tests and HIFU ON-time/OFF-time Verification Testing.

Test Set (Animal Studies):

• Study 1 ("Safety and Effectiveness of Tissue Ablation"): n=5 dogs.
• Study 2 ("Efficacy Improvement Software Test Report Localization and Ablation"): n=4 dogs.
• Study 3 ("Treatment Volume and Accuracy Study Report"): Preliminary dog study (n not specified, but likely small).
• Study 4 ("Thermocouple Response to Treatment Test"): Preliminary dog study (n not specified, but likely small).
• Study 5 ("Safety of HIFU Energy Application to Adjacent Tissues"): Preliminary dog study (n not specified, but likely small).

Test Set (Clinical Study):

• Clinical Dataset: Interim analysis of the initial 117 patients enrolled, with 116 undergoing HIFU application.
• Data Provenance: Multi-center, prospective, single-arm study involving 20 sites across the U.S. and Canada. The study was structured as a clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The provided text does not specify the number or qualifications of experts used to establish ground truth for the test set.

• For bench and animal studies, "ground truth" is established through physical measurements, ex-vivo tissue analysis, and histological evaluation. These are typically performed by trained technical personnel and pathologists, but specific expert involvement (e.g., number and qualifications of pathologists for dog study histology) is not detailed.
• For the clinical study, "ablation effectiveness" was assessed by analyzing changes in prostate volume, PSA level, and negative biopsy rate. PSA levels are objective measurements. Prostate volume changes and biopsy results would involve radiologists/urologists for imaging interpretation and pathologists for biopsy analysis. However, the exact number and qualifications of these healthcare professionals serving as ground truth experts are not given in the document.

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

The text does not describe any explicit adjudication method for observations or interpretations in the test set (bench, animal, or clinical).

• For the clinical study, "investigator reported adverse events" were collected, implying individual site investigators reported. It does not mention a central adjudication committee for AEs or efficacy endpoints. The endpoint for negative biopsy rate notes that "30 patients who did not have a 12-month biopsy were considered 'positive'," which is a pre-defined rule for handling missing data, not an adjudication method for conflicting interpretations.

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 done. The Sonablate® 450 is a therapeutic device for tissue ablation, not an imaging diagnostic device assisted by AI. Therefore, the concept of human readers improving with AI assistance is not applicable in this context.

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

The Sonablate® 450 is a medical device for therapeutic ablation, not a diagnostic algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in the typical sense of AI/ML software. The device's performance is inherently linked to its physical operation and the physician's control and monitoring. The "PERFORMANCE TESTING - BENCH" section details the device's functional performance in controlled (standalone power/accuracy) environments, but this is not an "algorithm only" evaluation.

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

• Bench Testing: Ground truth established via physical measurements (e.g., beam width, focal length, acoustic power, frame rate) and ex-vivo tissue analysis for lesion characterization.
• Animal Studies: Ground truth established via histological evaluation of ablated tissue, temperature measurements using thermocouples, and comparison of planned vs. actual ablation zones.
• Clinical Study: Ground truth for effectiveness was established using objective clinical outcomes data:
  • Prostate volume reduction (measured via imaging, presumably ultrasound, pre and post).
  • PSA level reduction (blood test, an objective biochemical marker).
  • Negative biopsy rate (histopathology, which is a gold standard for malignancy/tissue presence).
  • Ground truth for safety was established by investigator-reported adverse events and patient-completed questionnaires.

8. The sample size for the training set

The provided text does not include information about any training set. This is because the Sonablate® 450 is a hardware device for therapeutic ablation, not an AI/ML diagnostic or therapeutic algorithm that typically undergoes distinct training/test phases. While the system involves software that controls its functions, the documentation focuses on the verification and validation of this software, not its "training" on a dataset in the machine learning sense.

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

As there is no explicit "training set" described for an AI/ML algorithm, the concept of establishing ground truth for it is not applicable in this context. The software's functionality is validated against design specifications and performance requirements through the various bench and animal tests, rather than being "trained" on a dataset with external ground truth.

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