(64 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small organs (Thyroid, Breast, Testicle), Adult Cephalic, Cardiac, Transesophageal, Transvaginal, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
Mode of Operation: A, B, M, PW D, CW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD).
The UF-870AG is an ultrasound instrument intended to perform the following diagnostic ultrasound investigations: Imaging (B-mode), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Color Flow Mapping (CFM) and Color Time motion (CM mode). The submission also includes the transducers necessary for these procedures. The system is a mobile console approximately 19" wide, 31" deep and 53-57" high equipped with a keyboard control panal, a large TFT screen, assorted transducers and image storage or hard-copy devices.
This document is a 510(k) premarket notification for the Fukuda Denshi UF-870AG Diagnostic Ultrasound System. It details the device's intended use and claims substantial equivalence to predicate devices, therefore, it does not contain a study and acceptance criteria proving device performance in the way a clinical trial or performance study would for a novel device.
Here's an analysis of the provided information:
1. Table of acceptance criteria and reported device performance:
This section is not applicable as the document is a 510(k) submission asserting substantial equivalence, not a performance study with acceptance criteria and measured performance metrics for a novel AI device. The "performance data" mentioned refers to non-clinical tests for safety and conformance with standards, not performance metrics of an AI algorithm against a specific ground truth.
2. Sample size used for the test set and the data provenance:
This is not applicable. The submission states: "Clinical tests: Since the UF-870AG uses the same technology and principles as existing E. devices, clinical tests are not required." Therefore, there is no test set, no sample size, and no data provenance from a clinical study for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as no clinical tests were performed to establish a ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as no clinical tests were performed.
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:
This is not applicable. The device is an ultrasound imaging system, not an AI-assisted diagnostic tool for which MRMC studies are typically conducted to evaluate reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable. The device is a traditional ultrasound system, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This is not applicable as no clinical performance studies requiring ground truth were conducted for this 510(k) submission.
8. The sample size for the training set:
This is not applicable. The UF-870AG is a conventional medical diagnostic ultrasound imaging system; it does not utilize AI algorithms that require a training set in the context of machine learning.
9. How the ground truth for the training set was established:
This is not applicable. As it's not an AI device, there's no training set or ground truth in that context.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.