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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, nonthermal, 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 (K231989), which is provided by HistoSonics with each Edison System.

The provided text is a 510(k) Summary for the HistoSonics Edison System, indicating FDA clearance. It describes the device, its intended use, and compares it to a predicate device. However, it does not explicitly detail the acceptance criteria for a study or the specific "reported device performance" against those criteria in a table format as requested.

The document states that a GLP compliant preclinical study was conducted in a porcine model utilizing the reference device and modified Edison System, and "All acceptance criteria were met." However, it does not provide the specific numerical acceptance criteria themselves or the detailed results demonstrating how they were met.

Therefore, many of the requested details about the study that proves the device meets acceptance criteria are not present in this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be fully provided. The document states that "All acceptance criteria were met" in an animal study, but it does not explicitly list the acceptance criteria or the specific reported device performance against them. It only generally states that the study demonstrated the modified system meets its intended use and does not raise different safety and effectiveness concerns.

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

• Sample Size for Test Set: Not specified. The document mentions "a porcine model" for an animal study, but not the number of animals.
• Data Provenance: Not specified, other than "a porcine model." It's a preclinical study. The document does not mention the country of origin of the data or whether it was retrospective or prospective, though preclinical studies are typically prospective.

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

• Not specified. The document does not mention experts establishing ground truth for the animal study.

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

• Not specified.

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, an MRMC study was not done. This device is a focused ultrasound system for mechanical tissue ablation, not an AI-assisted diagnostic tool for human readers. The performance data mentioned relates to engineering and biological compliance, and a preclinical animal study for the device's physical effects.

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

• The performance data refers to various engineering and biological tests for the device itself (e.g., electrical safety, electromagnetic disturbance, acoustic characterization, software testing, system/sub-system verification, cybersecurity, and an animal study). This is testing of the device's standalone performance, though "algorithm only" is not entirely applicable as it's an electromechanical system with software. The device's software is tested according to ISO 62304.

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

• For the animal study, while not explicitly stated, the ground truth would likely be pathology or direct observation of the tissue ablation results in the porcine model, as it aims to demonstrate the "destruction of liver tumors" and the mechanical process.

8. The sample size for the training set

• Not specified. This document does not refer to a "training set" in the context of machine learning, which would have a distinct sample size. The device itself is an ablation system, and its development likely involved iterative testing and refinement rather than a single training set.

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

• Not applicable. As above, the concept of a "training set" with established ground truth in the context of machine learning for an ablation device is not directly addressed in this type of 510(k) summary. Device development involves engineering specifications and verification/validation, not typically machine learning model training in the sense implied by this question.

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