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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 E10s and LOGIQ Fortis are intended for use by a qualified physician for ultrasound evaluation.
Specific clinical applications and exam types include: 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, 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 E10s and LOGIQ Fortis are intended to be used in a hospital or medical clinic.

The LOGIQ E10s 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 high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor.
The LOGIQ Fortis is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 575 mm wide (keyboard). 925 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a digital keyboard (physical keyboard as an option), specialized controls, 12inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor (or 23.8inch High Resolution LED LCD monitor as an option).

The provided text describes three AI features of the LOGIQ E10s and LOGIQ Fortis systems: Auto Renal Measure Assistant, Auto Abdominal Color Assistant, and Auto Preset Assistant. The information provided for each feature allows for a detailed breakdown of their acceptance criteria and the studies conducted to prove they meet these criteria.

Here's the requested information structured for clarity:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance for Test Sets

• Auto Renal Measure Assistant:
  • Test Set Sample Size: 30 patients, resulting in 60 samples (30 longitudinal views, 30 transverse views).
  • Data Provenance: Prospective collection. Data from USA (58%) and Japan (42%).
• Auto Abdominal Color Assistant:
  • Test Set Sample Size: 50+ patients, resulting in 1100+ images.
  • Data Provenance: Not explicitly stated as retrospective or prospective, but collected from USA (77%) and Australia (23%).
• Auto Preset Assistant:
  • Test Set Sample Size: 110+ patients, resulting in 2600+ images.
  • Data Provenance: Not explicitly stated as retrospective or prospective, but collected from USA (41.2%), Austria (3.8%), Australia (1.1%), Japan (41.3%), Italy (0.7%), and Greece (12%).

3. Number of Experts and Qualifications for Ground Truth

• Auto Renal Measure Assistant:
  • Number of Experts: 2 "Readers" and 1 "Board Certified Nephrologist" for arbitration.
  • Qualifications: "certified sonographer/Clinician" for the two readers. "Board Certified Nephrologist" for the arbitrator.
• Auto Abdominal Color Assistant:
  • Number of Experts: Unspecified number of "Readers".
  • Qualifications: "certified sonographer/Clinician" for the readers.
• Auto Preset Assistant:
  • Number of Experts: Unspecified number of "Readers".
  • Qualifications: "certified sonographer/Clinician" for the readers.

4. Adjudication Method for Test Sets

• Auto Renal Measure Assistant:
  • Method: A "Board Certified Nephrologist arbitrated the ground truth between the above two readers to establish the reference standard". This implies a 2+1 (two readers, one arbitrator) method.
• Auto Abdominal Color Assistant & Auto Preset Assistant:
  • Method: The text states, "Readers (certified sonographer/Clinician) to ground truth the 'anatomy' visible in static B-Mode image." There is no mention of multiple readers or an arbitration process, implying no explicit inter-reader adjudication method was described beyond individual expert annotation.

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

• No MRMC comparative effectiveness study was explicitly described in the provided text. The studies focus on the standalone performance of the AI algorithms against a derived ground truth, rather than comparing human reader performance with and without AI assistance. Therefore, no effect size for human readers' improvement with AI assistance is reported.

6. Standalone (Algorithm Only) Performance Study

• Yes, standalone (algorithm only) performance studies were done for all three AI features listed. The studies evaluate the accuracy or success rate of the AI algorithms in performing their intended functions (measurement, view suggestion) against an established ground truth, without a human-in-the-loop component being explicitly tested or reported.

7. Type of Ground Truth Used

• Auto Renal Measure Assistant: Expert Consensus, as it involved two readers and an arbitrator to establish the reference standard for measurements.
• Auto Abdominal Color Assistant & Auto Preset Assistant: Expert Annotation/Consensus, established by "Readers (certified sonographer/Clinician) to ground truth the 'anatomy'visible in static B-Mode image." While not explicitly stated as consensus among multiple readers, it is established by qualified experts.

8. Sample Size for Training Sets

• The training set sample sizes are not explicitly provided in the summaries for any of the AI features. The document only mentions that the "verification data was acquired independently during validation process after the development of the model," and "The exams used for test/training validation purpose are separated from the ones used during training process." This implies training data existed but its size is not detailed.

9. How Ground Truth for Training Sets Was Established

• The document does not explicitly describe how the ground truth for the training sets was established. It focuses primarily on the process for the test/validation sets. However, it can be inferred that a similar process involving expert clinicians/sonographers would have been used to establish ground truth for training data, as is common practice in medical imaging AI development.

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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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The LOGIQ E10s and LOGIQ Fortis are general-purpose diagnostic ultrasound systems intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. LOGIQ E10s and LOGIQ Fortis clinical applications include: Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo- skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M 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 E10s and LOGIQ Fortis are intended to be used in a hospital or medical clinic.

The LOGIQ E10s 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 high- resolution color touch screen and 23.8-inch High Contrast LED LCD monitor (or an optional 22-inch color OLED widescreen monitor).

The LOGIQ Fortis is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 575 mm wide (keyboard), 925 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a digital keyboard (physical keyboard as an option), specialized controls, 12-inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor (or 23.8-inch High Resolution LED LCD monitor as an option).

The provided text is a 510(k) Premarket Notification from the FDA for GE Healthcare's LOGIQ E10s and LOGIQ Fortis diagnostic ultrasound systems. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific clinical studies with acceptance criteria, sample sizes, or ground truth establishment in the way typically found for AI/ML-driven medical devices that require such studies for de novo or PMA applications.

Therefore, most of the requested information cannot be extracted from this document as it explicitly states: "The subject of this premarket submission, LOGIQ E10s, LOGIQ Fortis, did not require clinical studies to support substantial equivalence."

However, I can provide available information:

1. Table of acceptance criteria and the reported device performance:

This document does not specify quantitative acceptance criteria or reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) for clinical applications. Instead, it relies on demonstrating substantial equivalence to a predicate device by comparing intended use, technology, imaging modes, safety, and functionality.

2. Sample size used for the test set and the data provenance:

Not applicable. The document states that clinical studies were not required.

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

Not applicable. The document states that clinical studies were not required.

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

Not applicable. The document states that clinical studies were not required.

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. The document states that clinical studies were not required, and this device is primarily a diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool as described in the context of improving human reader performance.

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

Not applicable. The document states that clinical studies were not required. This device is a diagnostic ultrasound system operated by a human.

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

Not applicable. The document states that clinical studies were not required.

8. The sample size for the training set:

Not applicable. The document states that clinical studies were not required. This is for a general-purpose ultrasound system, not an AI/ML algorithm requiring a specific training set with ground truth in the context described.

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

Not applicable. The document states that clinical studies were not required.

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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 LOGIQ E10s is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. LOGIQ E10s clinical applications include : Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); 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).

Modes of operation include: B, M, PW Doppler, CW 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/Color/PWD. B/Power/PWD. The LOG10 E10s is intended to be used in a hospital or medical clinic.

The LOGIQ E10s 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, high resolution color touch screen, and color widescreen monitor. The system utilizes a variety of linear, curved, phased and matrix array transducers to support the broad imaging capabilities.

The provided text states that the LOGIQ E10s did not require clinical studies to support substantial equivalence. Therefore, there is no information available in the document regarding acceptance criteria or a study proving the device meets acceptance criteria through clinical trials.

The document focuses on non-clinical tests and comparisons to predicate devices to establish substantial equivalence.

Here's a breakdown of the available information based on your requested points, highlighting the absence of clinical study data:

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

   • Not available. The document does not provide a table of acceptance criteria or reported device performance from a clinical study. It discusses non-clinical compliance with safety standards and similarity to predicate devices.

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

   • Not applicable. No clinical test set information is provided as clinical studies were not required.

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 information is provided.

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

   • Not applicable. No clinical test set information is provided.

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. No MRMC comparative effectiveness study was done or reported. This device is a diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool as described in the question.

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

   • Not applicable. This question pertains to AI algorithms. While the device connects to "Koios DS for Breast" (K190442), which is an AI-based system, the document refers to the LOGIQ E10s as a diagnostic ultrasound system, not an AI algorithm itself. No standalone performance of an algorithm is reported for the LOGIQ E10s.

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

   • Not applicable. No clinical test set information is provided.

8. The sample size for the training set

   • Not applicable. No clinical test information or AI training set information is provided for the LOGIQ E10s itself.

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

   • Not applicable. No clinical test information or AI training set information is provided.

Instead of clinical studies, the submission relies on documentation of compliance with safety standards and a comparison to predicate devices, stating: "The subject of this premarket submission, LOGIQ E10s, did not require clinical studies to support substantial equivalence." The conclusion is that the LOGIQ E10s is considered "as safe, as effective, and performance is substantially equivalent to the predicate device(s)."

The non-clinical tests performed included:

• Acoustic output
• Biocompatibility
• Cleaning and disinfection effectiveness
• Thermal, electrical, electromagnetic, and mechanical safety

The device was found to conform with applicable medical device safety standards, including:

• AAMI/ANSI ES60601-1
• IEC 60601-1-2
• IEC 60601-2-37
• ISO 10993-1
• ISO 14971
• NEMA PS 3.1-3.20 (DICOM Set)
• IEC 62359

Quality assurance measures applied during development included:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification)
• Safety testing (Verification)

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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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