(132 days)
Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular, transvaginal and trans-rectal applications in B, M, PWD and Color Doppler modes.
The Color Doppler Ultrasound Systems are integrated preprogrammed color ultrasound imaging system, capable of producing a resolution intended for clinical diagnostic imaging applications. Their basic function is to acquire ultrasound signal and display the images in the imaging operation modes of B, M, PWD and Color Doppler.
This document describes the Color Doppler Ultrasound System Models mEye1 and mEye2 (K182165) and its substantial equivalence determination to a predicate device. There is no study described within this document that performs a comparative effectiveness study with human readers or standalone algorithm performance, or establishes acceptance criteria based on diagnostic performance.
The acceptance criteria and study described are for non-clinical performance and safety standards, not for the diagnostic accuracy of the ultrasound system's output. The document explicitly states: "No clinical study is included in this submission." This means that no study was conducted to demonstrate the device's diagnostic performance for the specified indications for use, nor were acceptance criteria related to diagnostic performance established or met through a clinical study.
Therefore, many of the requested items cannot be answered given the provided text.
Here's a breakdown of what can be extracted:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" here refer to conformance with established medical device safety and performance standards, rather than diagnostic accuracy metrics.
| Acceptance Criteria (Standard/Requirement) | Reported Device Performance |
|---|---|
| IEC 60601-1-2005+A1:2012 (Electrical Safety) | Complied |
| IEC 60601-1-2:2014 (EMC) | Complied |
| IEC 60601-2-37:2007 (Performance - Ultrasonic Medical Diagnostic) | Complied |
| ISO 10993-5:2009 (Biocompatibility - Cytotoxicity) | Complied |
| ISO 10993-10:2010 (Biocompatibility - Irritation & Sensitization) | Complied |
| NEMA UD 2-2004 (R2009) (Acoustic Output) | Complied |
| Software Level | Moderate level of concern |
2. Sample sized 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 or data provenance related to diagnostic performance is mentioned. The tests were non-clinical, likely performed in manufacturing facilities.
3. 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 or establishment of ground truth by experts for diagnostic performance is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication for diagnostic performance is mentioned.
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
No, a multi-reader, multi-case comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." This device is a diagnostic ultrasound system, not an AI-powered CAD (Computer-Aided Detection) or CADx (Computer-Aided Diagnosis) system, so the concept of "human readers improve with AI vs without AI assistance" does not apply here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This is a medical imaging device, not an AI algorithm. Its performance is evaluated through compliance with technical and safety standards, and by demonstrating substantial equivalence to a predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical tests conducted, the "ground truth" was established by the technical specifications and requirements of the referenced standards (e.g., whether the device successfully met electromagnetic compatibility limits, or whether biocompatibility tests showed no cytotoxicity). There was no clinical ground truth established for diagnostic accuracy.
8. The sample size for the training set
Not applicable. This document describes a medical imaging device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.