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The Focal One® is an evolution from the previous generation device, designed by EDAP: Ablatherm Integrated Imaging (K153023) and Ablatherm Fusion (K172285). The Focal One® consists of the Focal One® module with a software control system, an endorectal dynamic focusing probe, a leg holder, a set of single use disposables and a coupling liquid pouch.

The Focal One® module consists of a motorized and manual endorectal dynamic focusing probe positioning unit, a RF amplifier to power the transducer, a computer to control device operation, a cooling system to cool Ablasonic (coupling liquid) and built-in safety features. It also allows the user to control the treatment while providing different user interfaces: two dual touch-screens, mouse, keyboard and printer. The Focal One® energy is delivered via an endorectal dynamic focusing probe, which includes an imaging system. The high-energy ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the focal area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The endorectal dynamic focusing probe is attached to a support, enabling movements in the longitudinal, transverse, vertical and angular directions, and in rotation. A coupling liquid pouch (Ablasonic®) included in the FocalPak disposable kit, attached to a stand, maintained at a controlled temperature flows continuously (via a peristaltic pump) into the balloon to preserve the rectal wall from heating associated with the treatment. The module is mounted on four multidirectional wheels allowing an easy positioning of the device in the treatment room.

AI/ML Overview

The document describes the Focal One device, a high-intensity focused ultrasound (HIFU) system for prostate tissue ablation, and its substantial equivalence to predicate devices (Ablatherm Integrated Imaging and Sonablate) for 510(k) clearance. The provided text, however, does not contain a specific table detailing "acceptance criteria" for the device's performance followed by reported device performance against those criteria. Instead, it presents clinical data as evidence for the device's safety and effectiveness to support substantial equivalence.

Based on the information provided in the document, here's an attempt to answer your request, focusing on the evidence presented to demonstrate the device's performance, even without a formal "acceptance criteria table":

The study described is a clinical report summarizing data on subjects treated with the Focal One® HIFU device to provide evidence of the safety and effectiveness of the ablation of prostate tissue.

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

As mentioned, the document does not explicitly state predetermined "acceptance criteria" in a table format that the device had to meet. However, it presents clinical outcomes that serve as performance metrics to demonstrate efficacy and safety. These would implicitly be the "performance targets" or "evidence of effectiveness" that the FDA considered acceptable for substantial equivalence.

Here's an interpretation of the performance metrics and the reported device performance:

Performance Metric (Implicit Acceptance Criteria)	Reported Device Performance (Clinical Study Results)
Prostate Volume Reduction	Demonstrate significant reduction in prostate volume post-HIFU. Reported: Prostate volume reduced from 49.8 ± 23.1 mL (median 44.0 mL) to 38.6 ± 25.5 mL (median 31.5 mL) for paired cases (n=78). This represents a 22.7% reduction (95% CI 17.6%; 27.8%), with p<0.001.
PSA Reduction (Evidence of Ablation)	Demonstrate significant reduction and stability of Prostate-Specific Antigen (PSA) levels post-HIFU. Reported: - Mean PSA reduction at 6 months: -3.7 ng/mL (95% CI -4.3; -3.1), statistically significant (p<0.001). - Percentage PSA reduction at 6 months: -53.0% (95% CI -60.2; -45.8). - Mean PSA reduction at 12 months: -3.7 ng/mL (95% CI -4.2; -3.1), statistically significant (p<0.001). - Percentage PSA reduction at 12 months: -54.4% (95% CI -60.2; -48.6). - Mean PSA nadir: 2.2 ± 1.6 ng/mL, reached around 8 months. - PSA velocity: -0.57 ± 5.30 ng/mL/year (med. 0.018 ng/mL/year).
Histological Evidence of Tissue Ablation	Demonstrate negative biopsy rates in the targeted area post-HIFU. Reported: Negative biopsy rate at the level of the targeted area of 63% (95% CI 53.5%; 72.5%) for 97 of 100 subjects who underwent biopsy. (Subjects who did not undergo control biopsies were considered positive for this analysis).
Safety Profile (Adverse Events)	Demonstrate an acceptable safety profile, consistent with predicate devices for HIFU prostate ablation. Reported: List of adverse events collected, showing occurrences in subjects (e.g., Erectile Dysfunction: 45%; Urinary Tract Infection: 30%, etc.). The majority of adverse events resolved, with some exceptions (erectile dysfunction, urinary dysfunction). The data was audited by a third-party CRO.

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

Sample Size: Data from 100 subjects were included in the clinical report.
Data Provenance:
- Country of Origin: Four prospective clinical trials conducted in Europe.
- Retrospective or Prospective: A retrospective analysis of prospective clinical studies.

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. It mentions prostate volume assessment by MRI, PSA measurements, and biopsy results, which are common clinical methods, but no details on expert consensus for these measurements are provided.

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

The document does not describe an adjudication method for the test set. Data was collected through routine clinical evaluations (MRI, PSA, biopsies). The adverse event data was audited by a third-party CRO to verify reliability and completeness.

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. This was not a study evaluating human reader performance with or without AI assistance. The Focal One is a treatment device, not an image interpretation or diagnostic AI device.

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

The Focal One is a treatment device operated by a human. Its performance is assessed as a system in clinical use, not as a standalone algorithm without human involvement. Bench testing was done for ablative performance (beam steering, acoustical parameters), and animal studies confirmed ablative performance in living tissue. These are technical evaluations, not an "algorithm only" performance assessment in the context of clinical decision-making.

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

The ground truth or evidence of efficacy was established through a combination of:

Clinical Outcomes Data:
- Quantitative measurements: Prostate volume reduction (assessed by MRI).
- Biochemical markers: PSA reduction and stability.
- Histological evidence: Prostate biopsy results (confirming tissue ablation).
Patient Outcomes: Adverse event collection to assess safety.

8. The sample size for the training set

This document describes a clinical study to demonstrate the safety and effectiveness of the Focal One device itself, not a study for an AI algorithm that would typically have a distinct training set. Therefore, there is no mention of a "training set" sample size in the context of AI model development.

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

As there is no mention of a training set for an AI model, this question is not applicable to the provided document. The clinical data collected serves as evidence of the device's performance.

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