(169 days)
The SONOLINE Elegra ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, and Peripheral Vascular applications. The addition of SieScape with Measurements will not change or add to the intended uses above. which are identical to those included in the original submission for the Elegra.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. The addition of SieScape with Measurements will allow for measurements across a wider field of view than with standard Bmode imaging ultrasound systems.
The SONOLINE Elegra is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire ultrasound data and display it in B-Mode. M-Mode, Color Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppier Mode, or in a combination of modes, on a CRT display .
The provided text is a 510(k) summary for a diagnostic ultrasound system (SONOLINE Elegra with SieScape). This document details the device's technical specifications, intended use, and comparison to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic performance metrics like sensitivity, specificity, or reader studies.
The section titled "The @SONOLINE ELEGRA, has been designed to meet the following product safety standards" lists safety and electromagnetic compatibility (EMC) standards. These are a type of acceptance criteria related to device safety and functionality, but not its diagnostic accuracy in the way typically discussed for AI/CAD devices.
Therefore, many of the requested information points cannot be extracted from this document, as it focuses on regulatory submission for a hardware/software update rather than a new AI diagnostic algorithm.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety Standard | UL 2601 | Designed to meet |
| Safety Standard | CSA 22.2 No. 601-1 | Designed to meet |
| Safety Standard | AIUM/NEMA, 1992 (Standard for Real Time Display of Thermal and Mechanical Indices) | Designed to meet; incorporates on-screen display of MI/TI |
| Safety Standard | 93/42/EEC Medical Devices Directive EN60601 (IEC 601-1-1 + IEC 601-1-2) | Designed to meet |
| Functional/Clinical | Allow for measurements across a wider field of view than standard B-mode imaging ultrasound systems. | "The addition of SieScape with Measurements will allow for measurements across a wider field of view than with standard Bmode imaging ultrasound systems." (This is a statement of design intent/capability, not a quantified performance metric.) |
2. Sample size used for the test set and the data provenance:
- Not provided. This document does not describe a clinical performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. No clinical performance study is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided. No clinical performance study is described.
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. An MRMC study was not described. This submission is for an update to an ultrasound system, not an AI/CAD diagnostic aid in the modern sense. The "SieScape" feature expands the field of view for measurements, assisting users directly, but not necessarily through an AI-driven interpretive enhancement that would typically be evaluated with MRMC studies in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is an ultrasound imaging system with an added feature for wider field-of-view measurements; it's inherently a human-in-the-loop device. No standalone algorithm performance is discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No clinical performance study requiring ground truth is described in this document. The device's "performance" in this context refers to meeting safety standards and providing wider field-of-view measurements, which do not typically rely on diagnostic ground truth in the same way an AI diagnostic algorithm would.
8. The sample size for the training set:
- Not applicable/Not provided. This document describes a traditional medical imaging device with a software feature (SieScape) that allows for panoramic imaging, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. No training set is involved for this device in the context of what is typically asked for AI/ML devices.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.