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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

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

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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The LOGIQ e is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid.

LOGIQ e is intended to be used in a hospital or medical clinic.

LOGIQ e clinical application include: Ophthalmic, fetal/ob; abdominal (gyn & urology); pediatric; small organ (breast, testes, thyroid); neonatal and adult cephalic; cardiac (adult & pediatric); peripheral vascular; musculoskeletal conventional & superficial; transrectal; transvaginal; transesophageal; intraoperative (abdominal, thoracic and peripheral); thoracic/pleural for motion and fluid detection and imaging guidance of interventional procedures (e.g. Nerve block; vascular access). Mode of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD, B/Color/PWD, B/Power/PWD.

The proposed LOGIQ e system is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement, display and analysis of the human body and fluid.

It is an ultrasound imaging & analysis system, consisting of a compact console with LCD, and control panel with new keyboard.

The system has digital acquisition, processing and display capability and operates from an integrated battery or AC/DC power adapter. It has one battery pack as standard configuration and also with an optional battery pack to be provided for additional power for longer scanning time.

The system also has an optional height-adjustable cart for comfortable standing and sitting positions. The cart is approx. 510mm length, 510mm width and adjustable height from 830 to 1130mm with optional battery box consisting of a charger box and 4pcs battery Packs to supply the system power from the cart.

LOGIQ e utilizes a variety of electronic array transducers operating in linear, curved, sector/phased array, TEE.

The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.

The system supports electronic delivery of software. The system allows the user, in addition to service personnel, to update the SW by logging into a GEHC website to download SW available to them and install it on the system. Download from the GEHC website requires an account.

The provided text does NOT contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document is a 510(k) premarket notification for a GE Medical Systems Ultrasound device, the LOGIQ e. It primarily focuses on demonstrating substantial equivalence to a predicate device and other reference devices, not on the performance of a new AI-powered feature with specific acceptance criteria.

The document discusses:

• Device Name: LOGIQ e
• Regulation Number/Name: 21 CFR 892.1550, Ultrasonic Pulsed Doppler Imaging System
• Regulatory Class: Class II
• Product Codes: IYN, IYO, ITX
• Indications for Use: General purpose diagnostic ultrasound for various clinical applications.
• Predicate Device: LOGIQ e (K151028)
• Reference Devices: Vivid iq (K221148), Versana Premier (K210438), Venue Go (K202233)
• Changes/Additions: New transducers, software features (AutoEF, Scan assistant, Strain Elastography, Probe check, Imaging Insights, Tricefy Uplink), hardware (new industrial design, secondary battery option, thermal solution), and accessories.
• Non-Clinical Tests: Acoustic output, biocompatibility, cleaning/disinfection, thermal, electromagnetic, and mechanical safety, compliance with various IEC, ISO, AAMI, and NEMA standards. Quality assurance measures like risk analysis, design reviews, and testing are mentioned.
• Clinical Tests: The document explicitly states: "The subject of this premarket submission, LOGIQ e, did not require clinical studies to support substantial equivalence."

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for the test and training sets, as these details are not present in the provided context. The submission is for a general diagnostic ultrasound system and not for a specific AI algorithm with performance metrics.

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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 that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, LCD touch screen and color widescreen monitor (OLED and HDU monitors). The system utilizes a variety of linear, curved, phased, dual, and matrix array transducers to support the broad imaging capabilities.

The provided text focuses on the 510(k) premarket notification for the GE Healthcare LOGIQ E10 ultrasound system. It primarily discusses the device's indications for use, its technical characteristics, and its comparison to predicate devices to demonstrate substantial equivalence.

Crucially, the document explicitly states in the "Summary of Clinical Tests" section:

"The subject of this premarket submission, LOGIQ E10, did not require clinical studies to support substantial equivalence."

This statement means that the information requested regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment is not available within this document, as no clinical studies were performed or required for this 510(k) submission.

Therefore, I cannot provide the detailed information requested in your prompt based solely on the provided text. The document's purpose is to demonstrate substantial equivalence to a legally marketed predicate device through non-clinical data, rather than presenting a clinical study of the device's efficacy or performance against specific clinical acceptance criteria.

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LOGIQ E10 is intended for use by a qualified physician for ultrasound evaluation of Fetal / Obstetrics; Abdominal (including Renal, GynecologyPelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vasculo-skeletal Conventional and Superficial; Urology (including Prostate); Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular).

The LOGIQ E10 is a full featured, track 3, general purpose diagnostic ultrasound system which consists of a mobile console that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, LCD touch screen and color widescreen monitor. The system utilizes a variety of linear, curved, phased, dual, and matrix array transducers to support the broad imaging capabilities.

The provided FDA submission for the GE LOGIQ E10 does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML component or performance metrics for diagnostic accuracy beyond general equivalence claims.

The document primarily focuses on establishing substantial equivalence of the LOGIQ E10 ultrasound system to predicate devices based on:

• Intended Use: Similar clinical applications.
• Technology: Same fundamental scientific technology (ultrasound imaging).
• Components: Similar transducers and system capabilities (measurements, digital imaging, reporting).
• Safety Standards: Compliance with electrical, thermal, electromagnetic safety, and biocompatibility.
• Software Features: Identical software features with some migrations from other GE systems (Voluson E10, LOGIQ E9, LOGIQ S8) and a new feature (UGAP) similar to one on another predicate.

The document explicitly states: "The subject of this premarket submission, LOGIQ E10, did not require clinical studies to support substantial equivalence." This means no specific performance metrics comparing the LOGIQ E10 to a gold standard or human readers were presented for this submission.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or any details about MRMC or standalone AI studies, as this information is not present in the provided text.

The information provided only demonstrates that the device is an ultrasound system with various imaging capabilities, and its submission for FDA clearance relies on substantial equivalence to existing predicate devices, rather than a de novo clinical performance study showcasing specific diagnostic accuracy metrics.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (vascular).

The LOGIQ E10 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 900 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 LCD touch screen and color widescreen monitor.

Here's an analysis of the provided text regarding the acceptance criteria and study for the LOGIQ E10 device:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel performance claims. The document explicitly states that "The subject of this premarket submission, LOGIQ E10, did not require clinical studies to support substantial equivalence." Therefore, the information regarding acceptance criteria and a study proving the device meets those criteria will be limited, primarily referencing the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a diagnostic ultrasound system, the "acceptance criteria" are implied to be that the new device performs "as safe, as effective, and its performance is substantially equivalent to the predicate device(s)" (as stated in the conclusion). Specific quantitative acceptance criteria for image quality or diagnostic accuracy are not provided in this document, as clinical studies were not required. The performance is assessed by comparison to the established performance of the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

No specific test set or associated sample size is mentioned for a clinical performance study since none was required. The "testing" referred to in the document is primarily non-clinical, focusing on engineering verification and validation against technical standards and comparisons to existing predicate devices.

• Sample Size for Test Set: Not applicable, as no clinical test set was used/required for performance evaluation.
• Data Provenance: Not applicable for clinical test data. Non-clinical data would originate from internal GE Healthcare testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as no clinical test set was required, and thus no ground truth established by experts for such a set.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. The device described, LOGIQ E10, is a diagnostic ultrasound system, not an AI/CADe (Computer-Aided Detection/Diagnosis) device for image interpretation that would typically necessitate an MRMC study comparing human reader performance with and without AI assistance. The document focuses on the capabilities of the ultrasound system itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Not applicable. The LOGIQ E10 is a diagnostic ultrasound imaging system; its "performance" is inherently tied to image acquisition and display, which is then interpreted by a human physician. It is not an algorithm designed for standalone diagnostic output.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not applicable for clinical performance studies. For non-clinical (engineering) verification, ground truth would be established through defined engineering specifications, phantom measurements (for acoustic output), and compliance with recognized standards.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/Machine Learning device that requires a training set for algorithm development.

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

Not applicable, as this is not an AI/Machine Learning device.

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The LOGIQ e is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: ophthalmic: fetal/ob; abdominal (gyn & urology); pediatric; small organ (breast, testes, thyroid); neonatal and adult cephalic; cardiatric); peripheral vascular; musculosketal conventional & superficial; transrectal; transvaginal; transesophageal; intraoperative (abdominal, thoracic and peripheral); thoracic/pleural for motion and fluid detection and imaging guidance of interventional procedures (e.g. Nerve block; vascular access).

The LOGIQ e device is a laptop ultrasound console approximately 70mm in height, 295mm in width and 346mm in length with integrated keyboard, a color video LCD type display and several interchangeable electronic-array transducers. It has digital acquisition, processing and display capability and operates from an integrated battery or separate power supply/charger.

The provided document is a 510(k) Premarket Notification Submission for the GE LOGIQ e ultrasound system. This type of submission is for demonstrating "substantial equivalence" to a predicate device, rather than proving the device meets specific acceptance criteria in the manner of a new device approval or efficacy study for a novel AI/software function.

Therefore, the document does not contain the information requested regarding acceptance criteria met by a proven device performance, sample size for test sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment relevant to an AI/software as a medical device (SaMD) study.

The closest information available that might be interpreted in a similar vein would be the "Determination of Substantial Equivalence," which details how the LOGIQ e compares to its predicate devices. However, this is focused on technological characteristics and intended use, not on quantitative performance metrics derived from a study designed to meet specific clinical acceptance criteria.

Here's why the document doesn't fit the request's framework:

• Device Type: The LOGIQ e is an ultrasound imaging system, an established medical device. The submission focuses on its equivalence to existing ultrasound systems, not on a novel AI or software component requiring clinical validation against specific performance targets.
• Regulatory Pathway: A 510(k) submission primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This is different from a PMTA (Premarket Approval) or De Novo submission, which might require extensive clinical data demonstrating safety and effectiveness against predefined performance endpoints.
• "Acceptance Criteria" in this context: The "acceptance criteria" here are implicitly the regulatory requirements for showing substantial equivalence (e.g., similar intended use, technological characteristics, safety, and effectiveness). The "reported device performance" is not a set of quantitative metrics from a clinical study, but rather a qualitative comparison to the predicate device, stating it performs in the same manner.
• Absence of Clinical Studies: The document explicitly states: "The subject of this premarket submission, LOGIQ e, did not require clinical studies to support substantial equivalence." This immediately negates the possibility of finding the detailed information requested about test sets, ground truth, experts, and statistical studies.

In summary, the provided document relates to a 510(k) clearance for a general-purpose ultrasound system based on substantial equivalence, not a performance study for a medical device that would have specific acceptance criteria and detailed study designs for its performance metrics.

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The LOGIQ e is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Ophthalmic; Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast. testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transvaginal; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures (e.g. Nerve Block; Vascular Access).

The LOGIQ e device is a laptop ultrasound console approximately 70mm in height, 295mm in width and 346mm in length with integrated keyboard, a color video LCD type display and several interchangeable electronic-array transducers. It has digital acquisition. processing and display capability and operates from an integrated battery or a separate power supply/charger.

The GE LOGIQ e Diagnostic Ultrasound System is a Class II device intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications.

1. Table of Acceptance Criteria and Reported Device Performance:

The document provided does not specify quantitative acceptance criteria or a direct performance study comparing the device against such criteria. Instead, the substantial equivalence determination is based on the device employing the "same fundamental scientific technology as its predicate devices" and being equivalent in "intended use, imaging capabilities, technological characteristics and safety and effectiveness."

The document details the device's intended uses and modes of operation for various clinical applications with different transducers. It indicates whether an indication is "new" (N) or "previously cleared by FDA" (P) with a predicate device. This implies that for "P" indications, the device performance is considered equivalent to the predicate, and for "N" indications, the performance meets established safety and effectiveness standards, likely through non-clinical testing.

2. Sample Size Used for the Test Set and Data Provenance:

The document states, "The subject of this premarket submission, LOGIQ e, did not require clinical studies to support substantial equivalence." This means there was no specific "test set" of patient data used in a clinical study to evaluate the device's performance against pre-defined acceptance criteria, as the assessment was primarily based on non-clinical evaluations and comparison to predicate devices. Therefore, there is no information on sample size or data provenance from a clinical test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Since no clinical studies were conducted to establish performance with a test set, there is no information on the number or qualifications of experts used to establish ground truth in this context.

4. Adjudication Method for the Test Set:

As no clinical studies were conducted, there is no mention of an adjudication method used for a test set.

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

No MRMC comparative effectiveness study was mentioned or conducted. The submission explicitly states that clinical studies were not required.

6. Standalone Performance:

Standalone performance (algorithm only without human-in-the-loop) in a clinical context was not directly assessed via a clinical study, as the device is an ultrasound system requiring human operation. However, the non-clinical tests assess the inherent performance of the system against various safety and technical standards (e.g., acoustic output, electrical safety).

7. Type of Ground Truth Used:

For the purpose of establishing substantial equivalence, the "ground truth" primarily relied on:

• Comparison to Predicate Devices: The performance and safety characteristics of the GE LOGIQ e were compared against its predicate devices (LOGIQ i/e, Vivide - K113690; LOGIQ S8 - K131527; SonoSite Edge - K113156; Voluson S6/S8 - K120741). The assumption is that if the new device is technologically equivalent and intended for similar uses as a legally marketed device, its performance is also equivalent.
• Compliance with Voluntary Standards: Non-clinical tests were conducted to ensure compliance with a range of safety and performance standards (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3 & 2, ISO10993-1, ISO14971, DICOM). These standards act as a form of "ground truth" for technical, electrical, acoustic, and biological safety and efficacy.

8. Sample Size for the Training Set:

This information is not applicable as the submission discusses a medical device (ultrasound system), not an AI algorithm that would typically have a "training set" of data in the context of machine learning. The "development of the system" involved quality assurance measures such as risk analysis, requirements reviews, design reviews, unit-level testing, integration testing, performance testing, safety testing, and simulated use testing, but these activities do not involve a "training set" in the sense of machine learning.

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

This question is not applicable for the same reason as point 8.

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The LOGIQ i/e & Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.

The LOGIQ ife & Vivid e is a full-featured, compact and extremely portable ultrasound system consisting of a main console chassis with integrated keyboard, a color video LCD type display and several interchangeable electronic-array transducers. It has digital acquisition, processing and display capability and operates from an integrated battery or a separate power supply/charger. It is used primarily where portability, size and convenience are essential and is available in three variations: LOGIQ e is for general purpose radiology imaging having a variety of options to tailor it for use by the medical specialist for use in various departments and patient care areas (e.g., OR, ER & outpatient care). Accordingly it has various configurations (Software option/standard and probes supporting) for different packages (Nerve, ED, and GI). LOGIO i is a full-featured premium radiology system suitable for physician rounds in a hospital, nursing home where a broader range of high performance is needed. Vivid e is similar to the LOGIO e with an emphasis on cardiology examinations.

The provided 510(k) Premarket Notification Submission for the GE Healthcare LOGIQ i, LOGIQ e, and Vivid e ultrasound systems does not include acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like sensitivity, specificity, or image quality statistics.

Instead, this submission is centered on demonstrating substantial equivalence to existing predicate devices (LOGIQ i, LOGIQ e, Vivid e, K102256, and LOGIO E9 K110943). The document explicitly states:

• "The subject of this premarket submission, LOGIQ i/e & Vivid e, did not require clinical studies to support substantial equivalence." (Page 2)
• "GE Healthcare considers the LOGIQ i/e & Vivid e to be as safe, as effective, and performance is substantially equivalent to the predicate device(s)." (Page 2)

The 510(k) summary focuses on non-clinical tests and compliance with voluntary standards to assert equivalence. These include: Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), and Simulated use testing (Validation).

Therefore, many of the requested categories related to performance studies, sample sizes, expert ground truth, and comparative effectiveness cannot be extracted from this document as these types of studies were not conducted or reported for this submission.

However, I can extract information regarding the intended use and modes of operation for various transducers, which were likely evaluated for functionality and safety, but not for specific performance metrics in comparison to clinical outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, no specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) or corresponding device performance results from clinical studies are stated in this 510(k) for the purpose of demonstrating device performance against specific metrics. The "acceptance criteria" for this submission appear to be based on compliance with voluntary standards and verification/validation testing of the system's functionality and safety, asserting substantial equivalence to predicate devices.

The tables within the document (e.g., Pages 7-21) indicate the intended clinical applications and modes of operation for the main system and each transducer (4C-RS, 8C-RS, E8C-RS, 8L-RS, 9L-RS, 12L-RS, 16L-RS, i12L-RS, i/t739-RS, 3S-RS, 6S-RS, P2D, 6Tc-RS, L8-18i-RS). These tables list whether a particular mode (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse) is "P" (previously cleared by FDA) or "N" (new indication) for a given anatomical region/clinical application. This indicates the functional scope of the device for which substantial equivalence is claimed, rather than performance against a quantitative criterion.

Example Table Structure (based on the provided information, but without performance data):

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 applicable. No clinical test set data is reported as clinical studies were not required for this substantial equivalence submission.
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No clinical test set or ground truth established by experts is reported.

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

• Not applicable. No clinical test set data is reported.

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

• Not applicable. This device is an ultrasound imaging system, not an AI-assisted diagnostic tool as understood in the context of MRMC studies for AI. No MRMC study was performed or reported.

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

• Not applicable. This device is an ultrasound imaging system, not an algorithm being evaluated in a standalone performance study.

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

• Not applicable. No clinical ground truth data is reported. The foundational ground truth for this submission is the established safety and effectiveness of the identified predicate devices.

8. The sample size for the training set

• Not applicable. This premarket notification does not describe an AI/machine learning model where a training set sample size would be relevant.

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

• Not applicable. As above, this submission does not describe an AI/machine learning model.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/OB: Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional, Transrectal and Transvaginal.

The GE Compact Ultrasound is a very compact and portable diagnostic ultrasound system having three variations: LOGIQ-i, LOGIQ-e and Vivid-e, each with options and features suited for its market niche. It has an integrated keyboard, LCD display and several interchangeable electronic-array transducers with an approximate size of 34 cm wide, 29 cm deep and 6 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

The provided Special 510(k) Premarket Notification for the GE LOGIQ-i/e & Vivid-e Compact Ultrasound system explicitly states that no clinical tests were required for this submission. The rationale given is: "Diagnostic ultrasound has accumulated a long history of safe and effective performance."

Therefore, the document does not contain acceptance criteria in the context of clinical performance metrics (like sensitivity, specificity, accuracy) derived from a study validating the device's diagnostic capabilities, nor does it describe a study to prove those criteria are met. The acceptance criteria and "reported device performance" in this context relate to demonstrating substantial equivalence to a predicate device through non-clinical testing and verification of intended use without introducing new safety or effectiveness concerns.

Here's a breakdown of the requested information based on the provided text, while acknowledging the absence of clinical performance data:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical outcome-based acceptance criteria are presented or met via clinical study, the acceptance criteria here are derived from the regulatory requirements for establishing substantial equivalence for an ultrasound device.

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

• Test Set Sample Size: Not applicable. No clinical test set.
• Data Provenance: Not applicable. No clinical data was used for testing against acceptance criteria in this submission. The submission relies on non-clinical evaluations and the substantial equivalence to a previously cleared predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No clinical ground truth was established for a test set. The determination of "substantial equivalence" was a regulatory decision based on documented non-clinical tests and comparison to a predicate device.

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

• Not applicable. No clinical test set requiring adjudication was performed.

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 MRMC comparative effectiveness study was done. This submission is for a diagnostic ultrasound system, not an AI-assisted diagnostic tool.

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

• No standalone algorithm performance study was done. This submission is for a diagnostic ultrasound system.

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

• Not applicable. No clinical ground truth was used. The basis for clearance was a demonstration of substantial equivalence to a predicate device through non-clinical testing and design documentation.

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm-based device requiring a training set.

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

• Not applicable. This is not an AI/algorithm-based device requiring a training set.

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