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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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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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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 tissue non-invasively via non-ionizing, non-thermal, mechanical process of focused ultrasound.
By delivering high amplitude, very short (microsecond), focused ultrasound pulses the device can induce 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 rapidly collapse, imparting stress and strain on target soft tissue. After a number of pulses, soft tissue within the bubble cloud is mechanically destroyed, resulting in a homogenous acellular lysate with limited to no recognizable cellular structures. The bubble cloud appears hypoechoic (bright) when viewed on diagnostic (B-mode) ultrasound. Additionally, the bubble cloud is detectable audibly.
The System is comprised of reusable medical equipment and disposable, single-patient use components. 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 setup.
The System is functionally integrated with a GE LOGIQ E10s ultrasound system (K211524), which is provided by HistoSonics with each Edison System. The LOGIO E10s is provided with a preset configuration designed to optimize viewing of the bubble cloud. This configuration falls within the available performance parameters of the LOGIQ E10s covered by K211524.
The Treatment Cart is mobile and contains all hardware and software components necessary to localize, plan and deliver treatments. The Treatment Cart includes a large touchscreen user interface and control panel, a high voltage power supply, integrated amplifier circuitry, waveform generator boards, Control PC, and Treatment Arm/Micropositioning System with connected Treatment Head.
The System user interface guides the user step by step through the required workflow including Patient Preparation, Localize, Plan and Treat.
The treating physician uses the user interface to assess ultrasound images to localize the targeted tissue and define a Planned Treatment Volume (PTV) comprised of a target contour and margin contour. During targeting, the diagnostic ultrasound probe can be extended up to 5 cm in the Z axis to reduce the offset of the ultrasound medium, thereby improving the targeting process versus a non-extended probe. An optional workflow enables the physician to view DICOM images (MRI, CT and PET) adjacent to the live ultrasound to aid the target identification process. Additionally, an image fusion function is an optional workflow that allows physician to fuse the live ultrasound image from the GE LOGIQ E10s onto the previously obtained DICOM images.
The Treatment Arm/Micropositioning System is comprised of a six degree of freedom (6 DOF) dual encoded robotic arm and is used to direct the movement of the Treatment Head. The Treatment Arm provides mechanical support to the Treatment Head (containing the Therapy Transducer and the coaxially aligned GE LOGIQ E10s Diagnostic Imaging Probe) and allows gross and fine positioning prior to initiating therapy. The Treatment Head is available in two configurations with different maximum treatment depths to provide physicians with options based on target anatomy. Both Treatment Heads are supplied with the System.
Electronic signals from the Treatment Cart are applied to the Therapy Transducer to create a bubble cloud at a known focal point. Note that the bubble cloud location is fixed relative to the position of the Treatment Head. The System uses the software-controlled Micropositioning System to move the Treatment Head, and the resulting bubble cloud, through a programmed treatment pathway to enable treatment delivery at all bubble cloud locations included as part of the PTV.

Here's a breakdown of the acceptance criteria and the study proving the Edison System meets them, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Study Details

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Effectiveness Analysis: 40 evaluable patients, corresponding to 44 total tumors/lesions.
  • Safety Analysis: 44 subjects (all enrolled subjects).
• Data Provenance: Multicenter, non-randomized, prospective single-arm study. Data was pooled from 8 US sites (21 subjects) and 6 OUS (Outside US) sites in Europe (23 subjects).

3. Number of Experts and Qualifications for Ground Truth Establishment

• The text explicitly mentions "a third-party laboratory" and "Core Laboratory Adjudicated" for both primary and secondary effectiveness endpoints (technical success and technique efficacy), and "independent Clinical Events Committee (CEC) adjudicated" for safety endpoints.
• The exact number and specific qualifications of the experts within these "third-party laboratories" or "Clinical Events Committee" are not specified in the provided text.

4. Adjudication Method for the Test Set

• For effectiveness endpoints (Technical Success and Technique Efficacy): "Core Laboratory Adjudicated." This implies a centralized review by imaging experts. The specific method (e.g., 2+1, 3+1, etc., for consensus in case of disagreement) is not detailed.
• For safety endpoints (Major Complications and All Adverse Events): "Clinical Events Committee (CEC) Adjudicated." This indicates independent review of reported adverse events. The specific adjudication mechanism by the CEC is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done.
• The study was a single-arm study evaluating the device's performance against pre-specified performance goals, not a comparative study against other human-in-the-loop or unassisted human reader performance. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable to this study design.

6. Standalone Performance (Algorithm Only)

• Not applicable/Not evaluated as a standalone algorithm. The Edison System is a medical device that includes software for treatment planning and delivery, but it is not an AI algorithm intended for standalone diagnostic or clinical decision-making. Its performance is intrinsically linked to the human operator using the system's integrated features for localization, planning, and treatment. The "software" section refers to software validation and verification for a "Major" level of concern, implying robust engineering practices, but not a standalone AI performance evaluation.

7. Type of Ground Truth Used

• Effectiveness: Imaging (CT/MRI) interpretation by a third-party/Core Laboratory. The clinical study leveraged corroboration with histopathology results from preclinical "acute animal studies" to support effectiveness, in lieu of collecting post-treatment liver biopsy samples from human subjects. This suggests that the primary clinical effectiveness ground truth was based on imaging, supported by preclinical pathology.
• Safety: Clinical event adjudication by an independent Clinical Events Committee (CEC) based on reported adverse events, coupled with objective measures like lab tests and follow-up imaging.

8. Sample Size for the Training Set

• The provided document does not detail any specific training set or its sample size for the clinical study. This is expected, as the device is not presented as a machine learning model requiring a distinct clinical training dataset. The "software" section describes standard software development practices (hazard analysis, V&V testing), which would involve internal testing and validation, but not a "training set" in the machine learning sense for a clinical trial.

9. How the Ground Truth for the Training Set Was Established

• As there's no mention of a clinical "training set" or a machine learning component learning from clinical data for its primary function, the concept of ground truth establishment for a training set in this context is not applicable to the clinical study description.
• For the device's inherent functional software (e.g., image overlay, treatment planning tools), ground truth would be established through engineering validation, comparison to known anatomical models, and physical measurements (bench testing), which are described in the non-clinical performance sections (e.g., "Ultrasound Imaging Accuracy," "Therapy output effect... consistent across the planned treatment volume boundaries").

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