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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

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