(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:
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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.
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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.
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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.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set information is provided.
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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.
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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.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No clinical test set information is provided.
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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.
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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)
§ 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.