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510(k) Data Aggregation
(124 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; Tranesophageal 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 high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor.
Here's an analysis of the acceptance criteria and supporting studies for the LOGIQ E10 ultrasound system, derived from the provided FDA 510(k) Clearance Letter:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Auto Abdominal Color Assistant 2.0 | ||
| Overall Model Detection Accuracy | $\ge 80%$ | $94.8%$ |
| Sensitivity (True Positive Rate) | $\ge 80%$ | $0.91$ |
| Specificity (True Negative Rate) | $\ge 80%$ | $0.98$ |
| DICE Similarity Coefficient (Segmentation Accuracy) | $\ge 0.80$ | $0.82$ |
| Auto Aorta Measure Assistant (Long View AP Measurement) | ||
| Average Accuracy | Not explicitly stated as a target percentage, but implied by strong performance metrics | $87.2%$ (95% CI of $\pm 1.98%$) |
| Average Absolute Error | Not explicitly stated as a target | $0.253$ cm (95% CI of $0.049$ cm) |
| Limits of Agreement | Not explicitly stated as a target range | $(-0.15, 0.60)$ cm (95% CI of $(-0.26, 0.71)$) |
| Auto Aorta Measure Assistant (Short View AP Measurement) | ||
| Average Accuracy | Not explicitly stated as a target percentage, but implied by strong performance metrics | $92.9%$ (95% CI of $\pm 2.02%$) |
| Average Absolute Error | Not explicitly stated as a target | $0.128$ cm (95% CI of $0.037$ cm) |
| Limits of Agreement | Not explicitly stated as a target range | $(-0.21, 0.36)$ cm (95% CI of $(-0.29, 0.45)$) |
| Auto Aorta Measure Assistant (Short View Trans Measurement) | ||
| Average Accuracy | Not explicitly stated as a target percentage, but implied by strong performance metrics | $86.9%$ (95% CI of $\pm 6.25%$) |
| Average Absolute Error | Not explicitly stated as a target | $0.235$ cm (95% CI of $0.110$ cm) |
| Limits of Agreement | Not explicitly stated as a target range | $(-0.86, 0.69)$ cm (95% CI of $(-1.06, 0.92)$) |
| Auto Common Bile Duct (CBD) Measure Assistant (Porta Hepatis measurement accuracy without segmentation scroll edit) | ||
| Average Accuracy | Not explicitly stated as a target percentage, but implied by strong performance metrics | $59.85%$ (95% CI of $\pm 17.86%$) |
| Average Absolute Error | Not explicitly stated as a target | $1.66$ mm (95% CI of $1.02$ mm) |
| Limits of Agreement | Not explicitly stated as a target range | $(-4.75, 4.37)$ mm (95% CI of $(-6.17, 5.79)$) |
| Auto Common Bile Duct (CBD) Measure Assistant (Porta Hepatis measurement accuracy with segmentation scroll edit) | ||
| Average Accuracy | Not explicitly stated as a target percentage, but implied by strong performance metrics | $80.56%$ (95% CI of $\pm 8.83%$) |
| Average Absolute Error | Not explicitly stated as a target | $0.91$ mm (95% CI of $0.45$ mm) |
| Limits of Agreement | Not explicitly stated as a target range | $(-1.96, 3.25)$ mm (95% CI of $(-2.85, 4.14)$) |
| Ultrasound Guided Fat Fraction (UGFF) | ||
| Correlation Coefficient with MRI-PDFF (Japan Cohort) | Strong correlation confirmed | $0.87$ |
| Offset (UGFF vs MRI-PDFF, Japan Cohort) | Not explicitly stated as a target | $-0.32%$ |
| Limits of Agreement (UGFF vs MRI-PDFF, Japan Cohort) | Not explicitly stated as a target range | $-6.0%$ to $5.4%$ |
| % Patients within $\pm 8.4%$ difference (Japan Cohort) | Not explicitly stated as a target | $91.6%$ |
| Correlation Coefficient with MRI-PDFF (US/EU Cohort) | Strong correlation confirmed | $0.90$ |
| Offset (UGFF vs MRI-PDFF, US/EU Cohort) | Not explicitly stated as a target | $-0.1%$ |
| Limits of Agreement (UGFF vs MRI-PDFF, US/EU Cohort) | Not explicitly stated as a target range | $-3.6%$ to $3.4%$ |
| % Patients within $\pm 4.6%$ difference (US/EU Cohort) | Not explicitly stated as a target | $95.0%$ |
| Correlation Coefficient with UDFF (EU Cohort) | Strong correlation confirmed | $0.88$ |
| Offset (UGFF vs UDFF, EU Cohort) | Not explicitly stated as a target | $-1.2%$ |
| Limits of Agreement (UGFF vs UDFF, EU Cohort) | Not explicitly stated as a target range | $-5.0%$ to $2.6%$ |
| % Patients within $\pm 4.7%$ difference (EU Cohort) | Not explicitly stated as a target | All patients |
2. Sample Size for Test Set and Data Provenance
- Auto Abdominal Color Assistant 2.0:
- Test Set Sample Size: 49 individual subjects, 1186 annotation images.
- Data Provenance: Retrospective, all data from the USA.
- Auto Aorta Measure Assistant:
- Test Set Sample Size:
- Long View Aorta: 36 subjects (11 Male, 25 Female).
- Short View Aorta: 35 subjects (11 Male, 24 Female).
- Data Provenance: Retrospective, from Japan (15-16 subjects) and USA (20 subjects).
- Test Set Sample Size:
- Auto Common Bile Duct (CBD) Measure Assistant:
- Test Set Sample Size: 25 subjects (11 Male, 14 Female).
- Data Provenance: Retrospective, from USA (40%) and Japan (60%).
- Ultrasound Guided Fat Fraction (UGFF):
- Test Set Sample Size (Primary Study): 582 participants.
- Data Provenance (Primary Study): Retrospective, Japan.
- Test Set Sample Size (Confirmatory Study 1): 15 US patients + 5 EU patients (total 20).
- Data Provenance (Confirmatory Study 1): Retrospective, USA and EU.
- Test Set Sample Size (Confirmatory Study 2): 24 EU patients.
- Data Provenance (Confirmatory Study 2): Retrospective, EU.
3. Number of Experts and Qualifications for Ground Truth
- Auto Abdominal Color Assistant 2.0: Not explicitly stated, but implies multiple "readers" to ground truth anatomical visibility. No specific qualifications are mentioned beyond "readers."
- Auto Aorta Measure Assistant: Not explicitly stated, but implies multiple "readers" for measurements and an "arbitrator" to select the most accurate measurement. No specific qualifications are mentioned beyond "readers" and "arbitrator."
- Auto Common Bile Duct (CBD) Measure Assistant: Not explicitly stated, but implies multiple "readers" for measurements and an "arbitrator" to select the most accurate measurement. No specific qualifications are mentioned beyond "readers" and "arbitrator."
- Ultrasound Guided Fat Fraction (UGFF): Ground truth for the primary study was MRI Proton Density Fat Fraction (MRI-PDFF %). No human experts were involved in establishing the ground truth for UGFF, as it relies on MRI-PDFF as the reference. The correlation between UGFF and UDFF also used UDFF as a reference, not human experts.
4. Adjudication Method for the Test Set
- Auto Abdominal Color Assistant 2.0: Not explicitly mentioned, however, the process described as "Readers to ground truth the 'anatomy' visible in static B-Mode image. (Before running AI)" and then comparing to AI predictions does not suggest an adjudication process for the ground truth generation itself beyond initial reader input. Confusion matrices were generated later.
- Auto Aorta Measure Assistant: An "Arbitrator" was used to "select most accurate measurement among all readers" for the initial ground truth, which was then compared to AI baseline. This implies a 1 (arbitrator) + N (readers) adjudication method for measurement accuracy. For keystroke comparison, readers measured with and without AI.
- Auto Common Bile Duct (CBD) Measure Assistant: An "Arbitrator" was used to "select most accurate measurement among all readers" for the initial ground truth, which was then compared to AI baseline. This implies a 1 (arbitrator) + N (readers) adjudication method for measurement accuracy. For keystroke comparison, readers measured with and without AI.
- Ultrasound Guided Fat Fraction (UGFF): Ground truth was established by MRI-PDFF or comparison to UDFF. No human adjudication method was described for these.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Auto Aorta Measure Assistant: Yes, a comparative study was performed by comparing keystroke counts with and without AI assistance for human readers.
- Effect Size:
- Long View Aorta AP Measurement: Average reduction from $4.132 \pm 0.291$ keystrokes (without AI) to $1.236 \pm 0.340$ keystrokes (with AI).
- Short View Aorta AP and Trans Measurement: Average reduction from $7.05 \pm 0.158$ keystrokes (without AI) to $2.307 \pm 1.0678$ keystrokes (with AI).
- Effect Size:
- Auto Common Bile Duct (CBD) Measure Assistant: Yes, a comparative study was performed by comparing keystroke counts with and without AI assistance for human readers.
- Effect Size: Average reduction of $1.62 \pm 0.375$ keystrokes (mean and standard deviation) from manual to AI-assisted measurements.
- Other features (Auto Abdominal Color Assistant 2.0, UGFF): The documentation does not describe a MRMC study for improved human reader performance with AI assistance for these features.
6. Standalone (Algorithm Only) Performance Study
- Auto Abdominal Color Assistant 2.0: Yes, the model's accuracy (detection accuracy, sensitivity, specificity, DICE score) was evaluated in a standalone manner against the human-annotated ground truth.
- Ultrasound Guided Fat Fraction (UGFF): Yes, the correlation and agreement of the UGFF algorithm's values were tested directly against an established reference standard (MRI-PDFF) and another device's derived fat fraction (UDFF).
7. Type of Ground Truth Used
- Auto Abdominal Color Assistant 2.0: Expert consensus/annotations on B-Mode images, followed by comparison to AI predictions.
- Auto Aorta Measure Assistant: Expert consensus on measurements (human readers with arbitrator selection) and keystroke counts from these manual measurements and AI-assisted measurements.
- Auto Common Bile Duct (CBD) Measure Assistant: Expert consensus on measurements (human readers with arbitrator selection) and keystroke counts from these manual measurements and AI-assisted measurements.
- Ultrasound Guided Fat Fraction (UGFF): Established clinical reference standard: MRI Proton Density Fat Fraction (MRI-PDFF %). For one confirmatory study, another cleared device's derived fat fraction (UDFF) was used as a comparative reference.
8. Sample Size for the Training Set
- The document states that "The exams used for test/training validation purpose are separated from the ones used during training process" but does not provide the sample size for the training set itself for any of the AI features.
9. How the Ground Truth for the Training Set was Established
- The document implies that the ground truth for training data would have been established similarly to the test data ground truth (e.g., expert annotation for Auto Abdominal Color Assistant, expert measurements for Auto Aorta/CBD Measure Assistants). However, the specific methodology for the training set's ground truth establishment (e.g., number of experts, adjudication, qualifications) is not detailed in the provided text. It only explicitly states that "Before the process of data annotation, all information displayed on the device is removed and performed on information extracted purely from Ultrasound B-mode images" for annotation. Independence of test and training data by exam site origin or overall separation is mentioned, but not the process for creating the training set ground truth.
Ask a specific question about this device
(125 days)
The LOGIQ E10s is 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 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 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 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 provided text describes three AI features: Auto Abdominal Color Assistant 2.0, Auto Aorta Measure Assistant, and Auto Common Bile Duct (CBD) Measure Assistant, along with a UGFF Clinical Study.
Here's an analysis of the acceptance criteria and study details for each, where available:
1. Table of Acceptance Criteria and Reported Device Performance
For Auto Abdominal Color Assistant 2.0
| Acceptance Criteria | Reported Device Performance | Meets Criteria? |
|---|---|---|
| Overall model detection accuracy (sensitivity and specificity): $\ge 80%$ (0.80) | Accuracy: 94.8% | Yes |
| Sensitivity (True Positive Rate): $\ge 80%$ (0.80) | Sensitivity: 0.91 | Yes |
| Specificity (True Negative Rate): $\ge 80%$ (0.80) | Specificity: 0.98 | Yes |
| DICE Similarity Coefficient (Segmentation Accuracy): $\ge 0.80$ | DICE score: 0.82 | Yes |
For Auto Aorta Measure Assistant
| Acceptance Criteria | Reported Device Performance | Meets Criteria? |
|---|---|---|
| No explicit numerical acceptance criteria were provided for keystrokes or measurement accuracy. The study aims to demonstrate improvement in keystrokes and acceptable accuracy. The provided results are the performance reported without specific targets for acceptance. | Long View Aorta:- Average keystrokes: 4.132 (without AI) vs. 1.236 (with AI)- Average accuracy: 87.2% with 95% CI of +/- 1.98%- Average absolute error: 0.253 cm with 95% CI of 0.049 cm- Limits of Agreement: (-0.15, 0.60) with 95% CI of (-0.26, 0.71)Short View AP Measurement:- Average accuracy: 92.9% with 95% CI of +/- 2.02%- Average absolute error: 0.128 cm with 95% CI of 0.037 cm- Limits of Agreement: (-0.21, 0.36) with 95% CI of (-0.29, 0.45)Short View Trans Measurement:- Average accuracy: 86.9% with 95% CI of +/- 6.25%- Average absolute error: 0.235 cm with 95% CI of 0.110 cm- Limits of Agreement: (-0.86, 0.69) with 95% CI (-1.06, 0.92) | N/A |
For Auto Common Bile Duct (CBD) Measure Assistant
| Acceptance Criteria | Reported Device Performance | Meets Criteria? |
|---|---|---|
| No explicit numerical acceptance criteria were provided for keystrokes or measurement accuracy. The study aims to demonstrate reduction in keystrokes and acceptable accuracy. The provided results are the performance reported without specific targets for acceptance. | - Average reduction in keystrokes (manual vs. AI): 1.62 +/- 0.375Keystrokes for Porta Hepatis measurement with segmentation scroll edit- Average accuracy: 80.56% with 95% CI of +/- 8.83%- Average absolute error: 0.91 mm with 95% CI of 0.45 mm- Limits of Agreement: (-1.96, 3.25) with 95% CI of (-2.85, 4.14)Porta Hepatis measurement accuracy without segmentation scroll edit- Average accuracy: 59.85% with 95% CI of +/- 17.86%- Average absolute error: 1.66 mm with 95% CI of 1.02 mm- Limits of Agreement: (-4.75, 4.37) with 95% CI of (-6.17, 5.79) | N/A |
For UGFF Clinical Study
| Acceptance Criteria (Implied by intent to demonstrate strong correlation) | Reported Device Performance | Meets Criteria? |
|---|---|---|
| Strong correlation between UFF values and MRI-PDFF (e.g., correlation coefficient $\ge 0.8$) | Original study: Correlation coefficient = 0.87Confirmatory study (US/EU): Correlation coefficient = 0.90(Confirmatory study (UGFF vs UDFF): Correlation coefficient = 0.88) | Yes |
| Acceptable Limits of Agreement with MRI-PDFF (e.g., small offset and LOA with high percentage of patients within LOA) | Original study: Offset = -0.32%, LOA = -6.0% to 5.4%, 91.6% patients within LOAConfirmatory study (US/EU): Offset = -0.1%, LOA = -3.6% to 3.4%, 95.0% patients within LOA | Yes |
| No statistically significant effect of BMI, SCD, and other demographic confounders on AC, BSC, and SNR measurements (Implied) | The results of the clinical study indicate that BMI, SCD, and other demographic confounders do not have a statistically significant effect on measurements of the AC, BSC, and SNR. | Yes |
2. Sample size used for the test set and the data provenance
Auto Abdominal Color Assistant 2.0:
- Sample Size: 49 individual subjects (1186 annotation images)
- Data Provenance: Retrospective, from the USA (100%).
Auto Aorta Measure Assistant:
- Sample Size:
- Long View Aorta: 36 subjects
- Short View Aorta: 35 subjects
- Data Provenance: Retrospective, from Japan and USA.
Auto Common Bile Duct (CBD) Measure Assistant:
- Sample Size: 25 subjects
- Data Provenance: Retrospective, from USA (40%) and Japan (60%).
UGFF Clinical Study:
- Sample Size:
- Original study: 582 participants
- Confirmatory study (US/EU): 15 US patients and 5 EU patients (total 20)
- Confirmatory study (UGFF vs UDFF): 24 EU patients
- Data Provenance: Retrospective and Prospective implicitly (clinical study implies data collection).
- Original Study: Japan (Asian population)
- Confirmatory Study (US/EU): US and EU (demographic info unavailable for EU patients, US patients: BMI 21.0-37.5, SCD 13.9-26.9)
- Confirmatory Study (UGFF vs UDFF): EU
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Auto Abdominal Color Assistant 2.0:
- Number of Experts: Not specified. The text mentions "Readers to ground truth the 'anatomy'".
- Qualifications of Experts: Not specified.
Auto Aorta Measure Assistant:
- Number of Experts: Not specified. The text mentions "Readers to ground truth the AP measurement..." and an "Arbitrator to select most accurate measurement among all readers." This implies multiple readers and a single arbitrator.
- Qualifications of Experts: Not specified.
Auto Common Bile Duct (CBD) Measure Assistant:
- Number of Experts: Not specified. The text mentions "Readers to ground truth the diameter..." and an "Arbitrator to select most accurate measurement among all readers." This implies multiple readers and a single arbitrator.
- Qualifications of Experts: Not specified.
UGFF Clinical Study:
- Number of Experts: Not applicable, as ground truth was established by MRI-PDFF measurements, not expert consensus on images.
4. Adjudication method for the test set
Auto Abdominal Color Assistant 2.0:
- Adjudication Method: Not explicitly described as a specific method (e.g., 2+1). The process mentions "Readers to ground truth" and then comparison to AI predictions, but no specific adjudication among multiple readers' initial ground truths.
Auto Aorta Measure Assistant:
- Adjudication Method: Implies an arbitrator-based method. "Arbitrator to select most accurate measurement among all readers." This suggests multiple readers provide measurements, and a single arbitrator makes the final ground truth selection.
Auto Common Bile Duct (CBD) Measure Assistant:
- Adjudication Method: Implies an arbitrator-based method. "Arbitrator to select most accurate measurement among all readers." Similar to the Aorta assistant.
UGFF Clinical Study:
- Adjudication Method: Not applicable. Ground truth was established by MRI-PDFF measurements.
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
Auto Abdominal Color Assistant 2.0:
- MRMC Study: Not explicitly stated as a comparative effectiveness study showing human improvement. The study focuses on the algorithm's performance against ground truth.
- Effect Size (Human Improvement with AI): Not reported.
Auto Aorta Measure Assistant:
- MRMC Study: Yes, an implicit MRMC study comparing human performance with and without AI. Readers performed measurements with and without AI assistance.
- Effect Size (Human Improvement with AI):
- Long View Aorta (Keystrokes): Average keystrokes reduced from 4.132 (without AI) to 1.236 (with AI).
- Short View Aorta (Keystrokes): Average keystrokes reduced from 7.05 (without AI) to 2.307 (with AI).
- (No specific improvement in diagnostic accuracy for human readers with AI is stated, primarily focuses on efficiency via keystrokes).
Auto Common Bile Duct (CBD) Measure Assistant:
- MRMC Study: Yes, an implicit MRMC study comparing human performance with and without AI. Readers performed measurements with and without AI assistance.
- Effect Size (Human Improvement with AI):
- Porta Hepatis CBD (Keystrokes): Average reduction in keystrokes for measurements with AI vs. manually is 1.62 +/- 0.375.
- (No specific improvement in diagnostic accuracy for human readers with AI is stated, primarily focuses on efficiency via keystrokes).
UGFF Clinical Study:
- MRMC Study: No, this was a standalone algorithm performance study compared to a reference standard (MRI-PDFF) and a predicate device (UDFF). It did not involve human readers using the AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Auto Abdominal Color Assistant 2.0:
- Standalone Performance: Yes. The reported accuracy, sensitivity, specificity, and DICE score are for the algorithm's performance.
Auto Aorta Measure Assistant:
- Standalone Performance: Yes, implicitly. The "AI baseline measurement" was compared for accuracy against the arbitrator-selected ground truth. While keystrokes involved human interaction to use the AI, the measurement accuracy is an algorithm output.
Auto Common Bile Duct (CBD) Measure Assistant:
- Standalone Performance: Yes, implicitly. The "AI baseline measurement" was compared for accuracy against the arbitrator-selected ground truth.
UGFF Clinical Study:
- Standalone Performance: Yes. The study directly assesses the correlation and agreement of the UGFF algorithm's output with MRI-PDFF and another ultrasound-derived fat fraction algorithm.
7. The type of ground truth used
Auto Abdominal Color Assistant 2.0:
- Ground Truth Type: Expert consensus for anatomical visibility ("Readers to ground truth the 'anatomy' visible in static B-Mode image.")
Auto Aorta Measure Assistant:
- Ground Truth Type: Expert consensus from multiple readers, adjudicated by an arbitrator, for specific measurements ("Arbitrator to select most accurate measurement among all readers.")
Auto Common Bile Duct (CBD) Measure Assistant:
- Ground Truth Type: Expert consensus from multiple readers, adjudicated by an arbitrator, for specific measurements ("Arbitrator to select most accurate measurement among all readers.")
UGFF Clinical Study:
- Ground Truth Type: Outcomes data / Quantitative Reference Standard: MRI Proton Density Fat Fraction (MRI-PDFF %).
8. The sample size for the training set
Auto Abdominal Color Assistant 2.0:
- Training Set Sample Size: Not specified beyond "The exams used for test/training validation purpose are separated from the ones used during training process".
Auto Aorta Measure Assistant:
- Training Set Sample Size: Not specified beyond "The exams used for regulatory validation purpose are separated from the ones used during model development process".
Auto Common Bile Duct (CBD) Measure Assistant:
- Training Set Sample Size: Not specified beyond "The exams used for regulatory validation purpose are separated from the ones used during model development process".
UGFF Clinical Study:
- Training Set Sample Size: Not specified. The study describes validation but not the training phase.
9. How the ground truth for the training set was established
Auto Abdominal Color Assistant 2.0:
- Training Set Ground Truth: Not explicitly detailed, but implied to be similar to the test set ground truthing process: "Information extracted purely from Ultrasound B-mode images" and "Readers to ground truth the 'anatomy'".
Auto Aorta Measure Assistant:
- Training Set Ground Truth: Not explicitly detailed, but implied to be similar to the test set ground truthing process: "Information extracted purely from Ultrasound B-mode images" and "Readers to ground truth the AP measurement...".
Auto Common Bile Duct (CBD) Measure Assistant:
- Training Set Ground Truth: Not explicitly detailed, but implied to be similar to the test set ground truthing process: "Information extracted purely from Ultrasound B-mode images" and "Readers to ground truth the diameter...".
UGFF Clinical Study:
- Training Set Ground Truth: Not specified for the training set, but for the validation set, the ground truth was MRI-PDFF measurements.
Ask a specific question about this device
(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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(125 days)
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
| AI Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Auto Renal Measure Assistant | Longitudinal model accuracy for length measurements expected to be > 80%. Transverse model accuracy for width measurements expected to be > 70%. | Longitudinal model for length measurements: Average accuracy of 96.45% (95% CI: ±1.26%), average absolute error of 0.35cm (95% CI: ±0.12 cm). Transverse model for width measurements (first mention): Average accuracy of 92.94% (95% CI: ±3.02%), average absolute error of 0.38cm (95% CI: ±0.14 cm). Transverse model for width measurements (second mention, likely a typo/repetition): Average accuracy of 93.13% (95% CI: ±3.63%), average absolute error of 0.37cm (95% CI: ±0.14 cm). |
| Auto Abdominal Color Assistant | Overall model success rate for Aorta, Kidney, Liver, GB, and Pancreas view suggestion expected to be 80% or higher. | Specific accuracy percentages for each view are not individually reported in the summary, but the success rate is implied to have met or exceeded the 80% threshold, as the device is deemed substantially equivalent. The summary states "Calculated the accuracies of the algorithm against each class," which suggests these were evaluated. |
| Auto Preset Assistant | Overall model success rate for Abdomen, Air, Breast, Carotid, Leg, MSK, Scrotal, Thyroid, and Carotid/Thyroid (Mixed) view suggestion expected to be 80% or higher. | Specific accuracy percentages for each view are not individually reported in the summary, but the success rate is implied to have met or exceeded the 80% threshold, as the device is deemed substantially equivalent. The summary states "Calculated the accuracies of the algorithm against each class," which suggests these were evaluated. |
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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(120 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 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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(102 days)
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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(86 days)
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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(71 days)
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:
-
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.
-
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.
-
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.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set information is provided.
-
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.
-
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.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No clinical test set information is provided.
-
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.
-
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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(33 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety equivalent to predicate devices | Conforms to applicable medical device safety standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, ISO14971, NEMA UD 2). Acoustic power levels are below FDA limits. Transducer materials are biocompatible. |
| Effectiveness equivalent to predicate devices | Employs the same fundamental scientific technology as predicate device(s). Has the same clinical intended use and imaging modes as the predicate LOGIQ E9. Similar capability in terms of measurements, digital image capture, review, and reporting studies. |
| Substantial Equivalence to predicate devices | The new platform (LOGIQ E10) is substantially equivalent to the predicate devices (K163077 LOGIQ E9, K170445 LOGIQ S8, K172342 Voluson E6/E8/E10). This equivalence is based on similar technology, intended use, imaging modes, safety, and performance characteristics. Specific probes and features were migrated from other cleared GE 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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