(60 days)
The DIAGNOSTIC ULTRASOUND SYSTEM APLIO ARTIDA (Model SSH-880CV) is intended to be used for the following types of studies: cardiac, transesophageal, abdominal and peripheral vascular.
The APLIO ARTIDA, Model SSH-880CV is a mobile diagnostic ultrasound system. This is a Track 3 device that employs a wide array of probes including convex, pencil, flat linear array and sector array, with a frequency range of approximately 2.0 MHz to 7.5 MHz. This system supports basic measurements including distance, time, angle, and trace, as well as combinations of some basic measurements.
The provided 510(k) summary for the Toshiba Aplio Artida (SSH-880CV), V3.2, describes modifications to an already cleared diagnostic ultrasound system. It does not contain information about a study proving the device meets specific acceptance criteria in the typical sense of a clinical performance study with defined metrics.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Aplio Artida (SSH-880CV), V3.0) and confirming that "modifications to the cleared device which improves upon existing features including contour tracing and expansion of the sector display function for two existing transducers and use of a proprietary 4D render" do not change the indications for use or intended use.
Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as the submission relies on bench testing, software validation, risk management, and design controls to demonstrate safety and effectiveness for the modified features.
Here's a breakdown of the information that can be extracted or inferred, and what is explicitly not present:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table with specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for clinical performance, nor does it report device performance against such criteria. The "performance" demonstrated is that the modified features function as intended and do not compromise safety or effectiveness compared to the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information on a "test set" in the context of clinical performance data is provided. The testing mentioned is "bench testing" and "software validation," which are likely internal engineering verification and validation activities.
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, as no external clinical test set and ground truth establishment by experts is described for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no external clinical test set and adjudication process is described for this submission.
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:
Not applicable. This submission is for modifications to a diagnostic ultrasound system (hardware/software features), not an AI algorithm intended to assist human readers in interpretation. There is no mention of AI or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm submission. The device is a diagnostic ultrasound system operated by a human user.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the context of clinical performance. The "ground truth" for the modified features would be their proper functioning as verified through engineering tests and adherence to specifications.
8. The sample size for the training set:
Not applicable, as this is not an AI/machine learning device that involves a training set.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/machine learning device.
Summary of Device Acceptance and Study as Per Document:
- Acceptance Criteria (Implicit):
- The modified features (contour tracing, expanded sector display for two transducers, proprietary 4D render) function as intended.
- The modifications do not change the indications for use or the intended use of the device.
- The device continues to comply with relevant safety standards (e.g., IEC60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, NEMA UD3).
- The device is designed and manufactured under Quality System Regulations (21 CFR § 820 and ISO 13485 Standards).
- Study That Proves Device Meets Acceptance Criteria:
- The submission refers to "Risk Analysis and verification testing conducted through bench testing" to demonstrate that "requirements for the improved/added features have been met."
- "Software Documentation for a Moderate Level of Concern" and "software validation" were included to support the software modifications.
- Testing was conducted in accordance with applicable IEC standards for Medical Devices.
- The conclusion states: "Based upon bench testing and successful completion of software validation, application of risk management and design controls, it is concluded that this device is safe and effective for its intended use."
In essence, this 510(k) submission for the Toshiba Aplio Artida V3.2 is for a modification to an existing device, and the "study" described is a series of engineering and software verification and validation activities rather than a clinical performance study with predefined acceptance metrics against patient data. The primary goal was to establish substantial equivalence and ensure the modifications did not introduce new safety or efficacy concerns.
§ 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.