(121 days)
The LOGIQ Totus 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 Totus clinical applications 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.
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, Contrast Enhanced Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.
The system is intended to be used in Hospital or Clinical environments such as Intensive Care Unit(ICU, CVICU, CCU), Neonatal Intensive Care Unit(NICU), Pediatric Intensive Care Unit(PICU), Emergency Room, Operating Room, Outpatient Surgery Clinic, Radiology, Medical Office (Nurse Practitioner), Observational Units, Cath Lab, Clinic, Physician's Office, Labor/Deliver Unit and Oncology.
The LOGIQ Totus is full featured, Track 3 device, primarily intended for general purpose diagnostic ultrasound system which consists of a mobile console approximately 490mm wide(monitor width: 545mm), 835mm deep and 1415~1815mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls. 14-inch LCD touch screen and color 23.8-inch LCD & HDU image display.
The provided document contains information on two AI features: "Auto preset selection" and "Auto Abdominal Color Assistant". The acceptance criteria and study details for each are presented below.
Auto Preset Selection
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance (Summary Test Statistics) |
|---|---|
| The overall model success rate of the Abdomen, Air, Breast, Carotid, Leg, MSK, Scrotal, Thyroid and Carotid/Thyroid (Mixed) view suggestion is expected to be 80% or higher. | The document states, "The overall model success rate of the Abdomen, Air, Breast, Carotid, Leg, MSK, Scrotal, Thyroid and Carotid/Thyroid(Mixed) view suggestion is expected to be 80% or higher." This indicates the device met this criterion. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- Number of individual patients' images collected from: 50+ patients
- Number of samples (images): 330+ images
- Data Provenance:
- Country of Origin: USA (57%) and Australia (43%)
- Retrospective/Prospective: Not explicitly stated, but the mention of "data collection protocol was standardized" suggests it might be retrospective collection of pre-existing data, or a controlled prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated how many individual sonographers/clinicians were involved.
- Qualifications of Experts: "Certified sonographer/clinician." No years of experience or specific board certifications are mentioned.
4. Adjudication method for the test set:
- Adjudication Method: "For the testing process, the results are generated by the AI software and the same are verified as Pass or Fail by a certified sonographer/clinician." This implies a single expert verification without explicit multi-reader adjudication (e.g., 2+1 or 3+1).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No MRMC comparative effectiveness study was explicitly mentioned for this AI feature. The testing method described focuses on the AI's success rate verified by experts, not on comparing human performance with and without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the "overall model success rate" refers to the algorithm's performance in suggesting views. The "verified as Pass or Fail by a certified sonographer/clinician" is likely a post-hoc verification of the algorithm's output, rather than an interactive human-in-the-loop study.
7. The type of ground truth used:
- Type of Ground Truth: Expert verification by certified sonographer/clinician, determining if the AI's view suggestion was a "Pass or Fail". This can be considered a form of "expert consensus" or "expert truth" (albeit with a single expert verification as mentioned in point 4).
8. The sample size for the training set:
- Not explicitly stated. The document only mentions that "The exams used for test/training validation purpose are separated from the ones used during training process and there is no overlap between the two." The sample size (330+ images from 50+ patients) is specified for the test set.
9. How the ground truth for the training set was established:
- Not explicitly stated. The document mentions that the test data was independent of the training data but doesn't detail the ground truth establishment for the training set. It's generally assumed that ground truth for training data in such AI applications would also be established by experts.
Auto Abdominal Color Assistant
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance (Summary Test Statistics) |
|---|---|
| The overall model success rate of the Aorta, Kidney, Liver, GB and Pancreas view suggestion is expected to be 80% or higher. | The document states, "The overall model success rate of the Aorta, Kidney, Liver, GB and Pancreas view suggestion is expected to be 80% or higher." This indicates the device met this criterion. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- Number of individual patients' images collected from: 40 patients
- Number of samples (images): 280+ images
- Data Provenance:
- Country of Origin: USA (35%) and Australia (65%)
- Retrospective/Prospective: Similar to "Auto preset selection", not explicitly stated, but a "standardized data collection protocol" is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated how many individual sonographers/clinicians were involved.
- Qualifications of Experts: "Certified sonographer / clinician." No years of experience or specific board certifications are mentioned.
4. Adjudication method for the test set:
- Adjudication Method: "For the testing process, the results are generated by the AI software and the same are verified a Pass or Fail by a certified sonographer / clinician." This implies a single expert verification without explicit multi-reader adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No MRMC comparative effectiveness study was explicitly mentioned for this AI feature.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the "overall model success rate" refers to the algorithm's performance. The "verified as Pass or Fail by a certified sonographer / clinician" is likely a post-hoc verification of the algorithm's output.
7. The type of ground truth used:
- Type of Ground Truth: Expert verification by certified sonographer/clinician, determining if the AI's view suggestion was a "Pass or Fail".
8. The sample size for the training set:
- Not explicitly stated. The document only mentions that "The exams used for test/training validation purpose are separated from the ones used during training process and there is no overlap between the two." The sample size (280+ images from 40 patients) is specified for the test set.
9. How the ground truth for the training set was established:
- Not explicitly stated. Similar to the "Auto preset selection" feature, it's assumed expert input would have been used for training data ground truth, but no details are provided.
§ 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.