(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.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.