(141 days)
The Edison System is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound.
The HistoSonics Edison System (the "System") provides users with a means to identify, target and destroy liver tumors entirely non-invasively using histotripsy, a non-ionizing, non-thermal, mechanical process of focused ultrasound. Histotripsy is created by delivering high amplitude, very short (microsecond), focused ultrasound pulses designed to induce controlled acoustic cavitation at a known focal location in the form of a "bubble cloud". The bubble cloud is a cluster of microbubbles that form, rapidly expand and collapse, imparting significant stress and strain on soft tissue, including liver tissue. After an adequate number of pulses (less than a few seconds at each bubble cloud location), liver tissue within the bubble cloud is mechanically destroyed, resulting in an acellular lysate with limited to no recognizable cellular structures. Acoustic cavitation (and bubble cloud formation) is only created when there is sufficient negative pressure to exceed the cavitation threshold, making it a threshold phenomenon.
The System is comprised of reusable medical equipment and disposable, single-patient use components intended for use in a professional healthcare environment. Reusable portions of the system include the Treatment Cart and a Support Arm and frame that is used to contain ultrasound medium (degassed water) that acoustically couples the system to the patient. Disposable aspects of the system include a clear, acoustically transparent and deformable membrane that holds the ultrasound medium as well as various non-active accessories used during patient set up. The Treatment Cart includes a Treatment Arm/Micropositioning System which is comprised of a six degree of freedom (6 DOF), dual encoded robotic arm. At the end of the arm is the Treatment Head which contains the histotripsy therapy transducer and a coaxially aligned diagnostic ultrasound probe. System software controls the Treatment Arm to direct the bubble cloud through the planned treatment volume.
The System is functionally integrated with a GE LOGIQ E10s ultrasound system (K211524), which is provided by HistoSonics with each Edison System.
The provided text is an FDA 510(k) summary for the Edison System, a medical device for non-invasive destruction of liver tumors. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain the specific information required to complete your request regarding acceptance criteria and the study proving the device meets those criteria.
Here's why and what information is missing:
- Acceptance Criteria and Reported Performance: The document states that "All acceptance criteria were met" for an animal study, but it does not list what those acceptance criteria were or explicitly report the device's performance against them in a table or otherwise.
- Sample Size for Test Set and Data Provenance: An "animal study" (GLP compliant preclinical study) is mentioned. It specifies this was a "porcine model," indicating the species. However, the number of animals (sample size) is not provided, nor is the exact country of origin or whether it was retrospective or prospective (though "preclinical study" generally implies prospective for this type of research).
- Number of Experts and Qualifications: The document mentions "verification and validation testing" and an "animal study," but there is no mention of experts establishing ground truth or their qualifications. This is typically relevant for studies involving human interpretation (e.g., radiologists for imaging studies).
- Adjudication Method: Since there's no mention of experts establishing ground truth, there is no information on adjudication methods.
- MRMC Comparative Effectiveness Study: The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size for human readers improving with AI assistance. The device described appears to be a direct treatment device, not an AI-assisted diagnostic tool for human readers.
- Standalone Performance: The document describes the device itself and its function. The animal study assesses its direct performance, which could be considered standalone performance in terms of its ablative capabilities. However, it's not explicitly framed as "algorithm-only without human-in-the-loop" in the context of an AI device.
- Type of Ground Truth: The animal study's results are used to demonstrate that the modified system "meets the intended use" and "does not raise any different questions of safety and effectiveness." This implies the ground truth for the animal study involved physiological and pathological assessments related to tumor destruction and safety in a porcine model. Details of these specific ground truth metrics (e.g., histological confirmation of ablation, absence of off-target damage) are not elaborated.
- Sample Size for Training Set: The document makes no mention of a training set or its sample size. This is understandable as the device is a physical system with integrated software for control, not a machine learning model that typically requires a separate training set.
- How Ground Truth for Training Set Was Established: Given no training set is mentioned, there is no information on how its ground truth was established.
In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through engineering design verification, software testing, cybersecurity compliance, and a GLP-compliant preclinical animal study. It does not contain the detailed clinical study information (especially concerning human reader performance or detailed acceptance criteria with reported outcomes) that your request is looking for.
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