(105 days)
The device is a general-purpose ultrasonic imstrument intended for use by a qualified clinician for evaluation of Fetal/OB, Abdominal (GYN & Urology), Pediatric, Small Organ (breast, testes, thyroid), Cardiac (Adult & Pediatric), Peripheral Vascular, Vascular Access, Musculo-skeletal Conventional & Superficial.
The Site -Rite Halcyon device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ability to dock it with a Docking station or mobile Docking cart.The primary means of control is graphical user interface implemented by a touch sensitive screen over the color LED display providing additional command input and keyboard entry. It utilizes interchangeable electronic-array transducers operating B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Color Doppler Mode, or a combination of these modes. with digital acquisition, processing and display capability operating under a Linux OS. Powered by an integrated battery in the docking station , the Site~Rite Halcyon is used primarily where portability, size and convenience are essential.
The provided text does not contain detailed acceptance criteria for a diagnostic ultrasound system's performance, nor does it describe a study specifically designed to prove the device meets such criteria. Instead, it is an FDA 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance metrics against specific acceptance criteria.
The document states that "No clinical testing was required" [7]. This means that the submission does not include data from a clinical trial demonstrating the device's performance in a real-world setting against specific clinical endpoints or acceptance criteria.
While the document lists various safety standards the device complies with (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004, NEMA UD3: 2004, ISO 10993-1) [8], these are general safety and performance standards for medical electrical equipment and ultrasound devices, not specific performance acceptance criteria for diagnostic accuracy, sensitivity, specificity, etc., that would typically be evaluated in a clinical study.
Therefore, many of the requested details cannot be extracted from this document, as they are not present in a 510(k) summary that did not require clinical testing.
Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document lists general device specifications and modes of operation but does not specify quantitative acceptance criteria for diagnostic accuracy or image quality, nor does it present device performance against such criteria. The "Comparison to Predicate Device" table [8] lists features and controls, showing they are "Same" as the predicate, but this is not a performance comparison against acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided as no clinical testing was required for this 510(k) submission [7].
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)
This information is not provided as no clinical testing was required [7].
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as no clinical testing was required [7].
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
A multi-reader, multi-case (MRMC) comparative effectiveness study was not done, as explicitly stated: "No clinical testing was required" [7]. The device is a diagnostic ultrasound system, not an AI software, and the document makes no mention of AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as the device is a diagnostic ultrasound system operated by a clinician, not an algorithm, and no standalone performance study was mentioned [7].
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided as no clinical testing was required [7].
8. The sample size for the training set
This information is not provided as no clinical testing was required [7]. The device is not described as an AI/ML algorithm that would typically have a "training set."
9. How the ground truth for the training set was established
This information is not provided as no clinical testing was required [7].
§ 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.