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510(k) Data Aggregation
(81 days)
The Vivid ig is high-performance compact diagnostic ultrasound system designed for Cardiovascular and Shared Services. It is intended for use by qualified and trained Healthcare professionals for Ultrasound imaging, measurement, display and analysis of the human body and fluid.
Vivid in clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transcranial, Transvaginal, Transesophageal, Interventional Guidance (including Biopsy, Vascular access), Thoracic/Pleural, Intraoperative (Vascular), Intracardiac and Intraluminal.
Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M, Power Doppler, Harmonic Imaging, Real-Time (RT) 3D Mode (4D), Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/Color/PWD, B/Color/CWD, B/Power/PWD.
The device is intended for use in an indoor hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab, in private medical offices, and in limited settings outside of professional Healthcare facilities.
The proposed Vivid ig system is a general-purpose, Track 3, diagnostic ultrasound device, primarily intended for cardiovascular diagnostic use and shared service imaging. It is an ultrasound imaging & analysis system, consisting of a compact console with control panel including a track pad, color LCD Touch Panel that includes an on-screen alphanumeric keyboard. The system also has standard height-adjustable new ergonomic mobile cart for comfortable standing and sitting positions. The Charge Box in the Mobile Cart provides Vivid iq up to 4 hours scanning time without power supply.
There are options for image storage, USB wireless connectivity, cardiac signal input for cardiac gating and output capabilities to printing devices. Vivid ig utilizes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array, or dual array format, including dedicated CW transducers and real time 3D transducer. The system can also be used with compatible ICE transducers.
The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.
The provided text is a 510(k) Summary for the GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Vivid iq. It details the device's characteristics and its comparison to predicate devices, but it explicitly states that no clinical studies were required to support substantial equivalence for this particular submission. Therefore, it is not possible to provide acceptance criteria or a study that proves the device meets those criteria, as such studies were not conducted or submitted for this 510(k).
The document is primarily focused on demonstrating substantial equivalence to a predicate device (Vivid iq K221148) through design similarities, conformance to recognized performance standards, and non-clinical performance testing.
Here's what can be extracted based on the provided text, while acknowledging the absence of clinical study data for this submission:
| Information Category | Description |
|---|---|
| 1. Acceptance Criteria and Reported Device Performance | Not applicable. The submission states, "The subject of this premarket submission, Vivid iq, did not require clinical studies to support substantial equivalence." Therefore, no specific clinical acceptance criteria or reported device performance from such a study are provided in this document. Device performance is implicitly accepted through compliance with non-clinical standards and substantial equivalence to the predicate. |
| 2. Sample size and Data Provenance (Test Set) | Not applicable. No clinical test set was used or described for this 510(k) submission. |
| 3. Number and Qualifications of Experts (Test Set) | Not applicable. No clinical test set was used or described for this 510(k) submission. |
| 4. Adjudication Method (Test Set) | Not applicable. No clinical test set was used or described for this 510(k) submission. |
| 5. MRMC Comparative Effectiveness Study | No. The document explicitly states that no clinical studies were required. Therefore, no MRMC study was conducted or reported for this submission. |
| 6. Standalone Performance Study | No. The document explicitly states that no clinical studies were required. Therefore, no standalone algorithm-only performance study was conducted or reported for this submission. |
| 7. Type of Ground Truth Used | Not applicable. No clinical studies requiring ground truth were conducted or reported for this submission. |
| 8. Sample Size for Training Set | Not applicable. The submission does not describe a machine learning algorithm that would require a training set. The device is a diagnostic ultrasound system, and its performance is evaluated through engineering and safety standards, as well as comparison to a predicate device. |
| 9. How Ground Truth for Training Set was Established | Not applicable. Please see response for point 8. |
Summary of Non-Clinical Tests (from the document):
The document does list the non-clinical tests conducted and the standards to which the device conforms:
- Acoustic output
- Biocompatibility
- Cleaning and disinfection effectiveness
- Thermal, electrical, electromagnetic and mechanical safety
Voluntary Standards Complied With:
- AAMI/ANSI ES60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 2005/A2:2021
- AAMI TIR69:2017/(R2020) Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems
- IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbance - Requirements and Tests, Edition 4.1, 2020
- IEC 60601-2-37, Medical Electrical Equipment Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, Edition 2.1, 2015
- ISO 10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within Risk Management Process, Fifth edition, 2018
- ISO 14971, Application of risk management to medical devices. 2019
- NEMA PS 3.1 3.20, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology), 2022d
- IEC 62359, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, Edition 2.1, 2017
Quality Assurance Measures:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification & Validation)
- Safety testing (Verification)
In conclusion, for this specific 510(k) submission (K243620), "Vivid iq," the device met acceptance criteria by demonstrating substantial equivalence to a predicate device through non-clinical testing and adherence to recognized standards, rather than through clinical studies with specific performance metrics.
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(78 days)
The Vivid T9/Vivid T8 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by qualified and trained Healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid.
The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab, and in private medical offices.
The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transcranial, Transesophageal, Transrectal, Transvaginal, Interventional guidance (including Biopsy, Fluid Drainage, Vascular Access), Thoracic/Pleural, Intraoperative(Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/ PWD, B/Color/PWD, B/Power/PWD.
Vivid T9/Vivid T8 is a Track 3, diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system that provides digital acquisition, processing, analysis and display capability.
The Vivid T9/Vivid T8 consists of a mobile console with control panel color LCD touch panel, LCD display monitor and optional image storage and printing devices. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array, and dual array including dedicated CW transducers.
The user-interface includes an operator control panel, a 21.5-inch-wide screen LCD monitor (mounted on an arm for rotation and/or adjustment of height), a 10.1-inch touch panel with multi-touch capabilities and alphanumeric keyboard.
The smart standby battery is an option to allow the system to not have to be powered down when moving from room to room. Imaging is not allowed when it is not plugged in.
The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.
Vivid T8 and Vivid T9 are based on the same SW platform and similar HW design. Each system may have different configurations available. The configurations may differ by available SW-options and transducers provided commercially. Vivid T9 has height-adjustable control panel, while Vivid T8's control panel can't be adjustable. Vivid T9 has monitor flexible arm, while Vivid T8 has a monitor fixed arm and monitor flexible arm as an option.
The product named Vivid T9 represents the system that has the full functionality and is offered with full support for transducers.
The provided text is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria for a new, innovative device.
Therefore, much of the requested information regarding detailed acceptance criteria, specific study design, sample sizes, expert qualifications, and ground truth establishment for performance claims cannot be found in this document.
The document primarily states that the device is "substantially equivalent" to predicate devices, and relies on non-clinical tests (safety, electrical, etc.) and design similarities to justify this claim. It explicitly states: "The subject of this premarket submission, Vivid T9/Vivid T8, did not require clinical studies to support substantial equivalence."
Below is a table summarizing the information that could be extracted from the provided text, and noted where information is explicitly not available or not applicable based on the content.
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Clinical Performance | Not applicable per document; no clinical studies were required to support substantial equivalence. The device is considered substantially equivalent to its predicate. |
| Acoustic Output Conformity | Device has been evaluated for acoustic output and found to conform with applicable medical device safety standards. |
| Biocompatibility | Device has been evaluated for biocompatibility and found to conform with applicable medical device safety standards. Transducer materials and other patient contact materials are biocompatible. |
| Cleaning and Disinfection Effectiveness | Device has been evaluated for cleaning and disinfection effectiveness and found to conform with applicable medical device safety standards. |
| Thermal Safety | Device has been evaluated for thermal safety and found to conform with applicable medical device safety standards. |
| Electrical Safety | Device has been evaluated for electrical safety and found to conform with applicable medical device safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-2-37). |
| Electromagnetic Safety | Device has been evaluated for electromagnetic safety and found to conform with applicable medical device safety standards (e.g., IEC 60601-1-2). |
| Mechanical Safety | Device has been evaluated for mechanical safety and found to conform with applicable medical device safety standards. |
| Risk Management | Application of risk management to medical devices (ISO 14971) is applied. |
| Quality Assurance | Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification & Validation), Safety testing (Verification) are applied to development. |
| DICOM Conformity | Conforms to NEMA PS 3.1 - 3.20. Digital Imaging and Communications in Medicine (DICOM) Set (Radiology), 2022d. DICOM Encapsulated PDF reports feature allows transfer through DICOM data flows. |
| Ultrasonics Field Characterization | Conforms to IEC 62359. Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, Edition 2.1, 2017. |
Study Details
- Sample size used for the test set and the data provenance: Not applicable. The document explicitly states: "The subject of this premarket submission, Vivid T9/Vivid T8, did not require clinical studies to support substantial equivalence." Therefore, no "test set" in the context of clinical performance evaluation is described. The non-clinical tests (acoustic, electrical, thermal, etc.) inherently involve testing of the device itself rather than patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring expert ground truth was performed for substantial equivalence.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set requiring adjudication was performed.
- 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: Not applicable. This document pertains to a general-purpose ultrasound system without specific mention of AI features that would necessitate an MRMC study for improved human reader performance. The "Clarity +" feature is described as "real-time image processing/filtering technique," not an AI-driven diagnostic aid that would directly impact human reader performance in a quantifiable way for this type of submission.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is an ultrasound system, not a standalone algorithm. Its "Clarity +" feature is an image processing technique integrated into the system, not a separate diagnostic algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a clinical performance evaluation, as no clinical studies were deemed necessary. For the non-clinical tests (e.g., safety, electrical, acoustic), the "ground truth" is adherence to recognized performance standards and internal quality assurance measures.
- The sample size for the training set: Not applicable. As this device did not require clinical studies, there is no mention of a "training set" for algorithm development related to diagnostic performance.
- How the ground truth for the training set was established: Not applicable, as no training set for diagnostic algorithm development is mentioned or required in this submission.
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(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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(127 days)
LOGIQ E10 is intended for use by a qualified physician for ultrasound evaluation of Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular).
Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The LOGIQ E10 is intended to be used in a hospital or medical clinic.
The LOGIQ E10 is a full featured, track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 991 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 12-inch highresolution color touch screen and 23.8-inch High Contrast LED LCD monitor.
Here's a breakdown of the acceptance criteria and study details for the "Auto Renal Measure Assistant" and "Auto Abdominal Color Assistant" features of the GE LOGIQ E10, based on the provided FDA 510(k) summary:
The document provides information for two distinct AI features: "Auto Renal Measure Assistant" and "Auto Abdominal Color Assistant". I will detail the information for each separately.
Auto Renal Measure Assistant
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Longitudinal Model: | |
| Accuracy > 80% | 96.45% accuracy with 95% CI of ±1.26% |
| Transverse Model (Width Measurements): | |
| Accuracy > 70% | 92.94% accuracy with 95% CI of ±3.02% |
| Transverse Model (Height Measurements): | |
| Accuracy > 70% | 93.13% accuracy with 95% CI of ±3.63% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 30 patients, resulting in 60 images (30 Longitudinal views and 30 Transverse views).
- Data Provenance:
- Country of Origin: USA (58%) and Japan (42%).
- Retrospective/Prospective: Prospectively collected.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: 2 Readers (certified sonographer/Clinician) and 1 Board Certified Nephrologist.
- Qualifications: "Certified sonographer/Clinician" for the initial readers; "Board Certified Nephrologist" for the arbitrator. Specific years of experience are not mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: A Board Certified Nephrologist arbitrated the ground truth between the two initial readers to establish the reference standard. This resembles a "2+1" or "tie-breaker" adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a "Multi-Reader Multi-Case (MRMC) comparative effectiveness study" comparing human readers with and without AI assistance was not specified for this feature. The study focused on the algorithm's performance against expert-established ground truth.
6. If a Standalone (Algorithm Only) Performance Study Was Done
- Yes, the reported accuracies (96.45%, 92.94%, 93.13%) represent the standalone performance of the algorithm in measuring renal dimensions against the established ground truth.
7. The Type of Ground Truth Used
- Type of Ground Truth: Expert consensus (between two sonographers/clinicians, arbitrated by a nephrologist).
8. The Sample Size for the Training Set
- The document states that the verification data was acquired independently during validation after the development of the model. The sample size for the training set is not provided in this summary.
9. How the Ground Truth for the Training Set Was Established
- The method for establishing ground truth for the training set is not specified in this summary. Only the method for the independent verification (test) set is described.
Auto Abdominal Color Assistant / Auto Preset Assistant
(Note: The document lists "Auto Abdominal Color Assistant" and then immediately below it, and seemingly as a continuation or related feature, "Auto Preset Assistant" with similar testing information. I will treat them as two related or broadly similar features based on the provided structure.)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Auto Abdominal Color Assistant: | |
| Overall model success rate of Aorta, Kidney, Liver, GB, and Pancreas view suggestion is expected to be 80% or higher. | Not explicitly stated in a single number, but implied to meet criteria given context of a 510(k) summary. |
| Auto Preset Assistant: | |
| Overall model success rate of Abdomen, Air, Breast, Carotid, Leg, MSK, Scrotal, Thyroid and Carotid/Thyroid (Mixed) view suggestion is expected to be 80% or higher. | Not explicitly stated in a single number, but implied to meet criteria given context of a 510(k) summary. |
2. Sample Size Used for the Test Set and Data Provenance
- Auto Abdominal Color Assistant:
- Sample Size: 50+ patients, resulting in 1100+ images.
- Data Provenance:
- Country of Origin: USA (77%) and Australia (23%).
- Retrospective/Prospective: Not explicitly stated, but "collected from:" implies existing data or a mix.
- Auto Preset Assistant:
- Sample Size: 110+ patients, resulting in 2600+ images.
- Data Provenance:
- Country of Origin: USA (41.2%), Austria (3.8%), Australia (1.1%), Japan (41.3%), Italy (0.7%), and Greece (12%).
- Retrospective/Prospective: Not explicitly stated, but "collected from:" implies existing data or a mix.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Unspecified number of "Readers (certified sonographer/Clinician)".
- Qualifications: "Certified sonographer/Clinician". Specific years of experience or precise number of experts not mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. The summary states, "Readers (certified sonographer/Clinician) to ground truth the "anatomy" visible in static B-Mode image." It doesn't mention multiple readers for the same image or an adjudication process if there were discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not specified for these features. The testing described is for the standalone algorithm's accuracy in view suggestion.
6. If a Standalone (Algorithm Only) Performance Study Was Done
- Yes. The core of the testing involved running the AI and comparing its predictions to the ground truth to calculate the accuracy of the algorithm against each class. This represents standalone performance.
7. The Type of Ground Truth Used
- Type of Ground Truth: Expert annotation by "certified sonographer/Clinician" on B-mode images ("anatomy visible").
8. The Sample Size for the Training Set
- The document states that exams used for test/training validation were separated with no overlap. However, the specific sample size for the training set is not provided.
9. How the Ground Truth for the Training Set Was Established
- The method for establishing ground truth for the training set is not specified. Only the method for the independent test set is described.
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(308 days)
GE LOGIQ E10s (K211524)
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
| Acceptance Criteria (Performance Goal) | Reported Device Performance | Comments |
|---|---|---|
| Primary Effectiveness Endpoint: Complete tumor ablation rate of 70% or higher (Technical Success), as determined by CT/MRI imaging obtained ≤36 hours after initial treatment. | 95.5% [95% CI 83.72 - 100%] of the lesions achieved technical success within 36 hours of the procedure. | This criterion was met. The observed rate significantly exceeded the performance goal. |
| Primary Safety Endpoint: Rate of 25% or less of index-procedure device-related major complications (CTCAE Grade 3 or higher) at 30-days. | 6.8% [95% CI 2.35 - 18.23%] of subjects had a reported procedure-related major complication (CTCAE ≥3) within 30 days post-procedure. | This criterion was met. The observed rate was well below the performance goal. |
| Secondary Effectiveness Endpoint: Technique efficacy defined as the lack of a nodular or mass-like area of enhancement within or along the edge of the treatment volume at 30-days post-procedure. | 83.3% [95% CI 67.65-92.11%] | No specific performance goal was designated for this secondary endpoint, but the result is provided. |
| Secondary Safety Endpoint: All adverse events reported within 30 days post-index procedure. | 101 AEs reported within 30 days, with 43.6% device-related. Most common non-serious ADEs: abdominal pain (22.7%), procedural pain (22.7%), pyrexia (15.9%). Serious AEs: pleuritic pain (2%), procedural pain (2%), sepsis (2%), liver failure (2%). | This was a descriptive endpoint, and no specific performance goal was set, but the rates were deemed consistent with established risk analyses and literature. |
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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