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510(k) Data Aggregation
(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.
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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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(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.
Ask a specific question about this device
(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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