(16 days)
This device is intended to be used for the following type of studies; cardiac, transesophageal and peripheral vascular.
This device is a mobile system is a Track 3 device that employs a wide range of probes that include flat linear array and sector array with a frequency range of approximately 2.5 MHz to 7.5 MHz.
This device is a Diagnostic Ultrasound System called APLIO ARTIDA MODEL SSH-880CV. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study that proves each criterion.
Therefore, the information regarding specific acceptance criteria and a study proving device performance in the format requested cannot be fully extracted from this document. This type of document typically references compliance with general industry standards and regulations, and lists intended uses and transducers, but does not usually include a dedicated performance study with acceptance criteria in the manner requested for AI/algorithm-based devices.
However, based on the information provided, here's what can be gathered, with limitations:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or device performance metrics like sensitivity, specificity, or AUC as one would find for an AI-enabled diagnostic device. Instead, it demonstrates compliance through substantial equivalence to predicate devices and adherence to relevant industry standards.
| Acceptance Criteria | Reported Device Performance (as implied by predicate equivalence & standards) |
|---|---|
| Safety: Device compliance with safety standards | Designed and manufactured in conjunction with Quality System Regulation, IEC 60601-1, IEC 60601-1-2, IEC60601-2-37, and AIUM-NEMA UD2/UD3 Output Measurement & Display Standards. |
| Effectiveness/Performance: Substantial equivalence to legally marketed predicate devices for intended uses. | Determined substantially equivalent to: |
- Toshiba Ultrasound Diagnostic System APLIO ARTIDA MODEL SSH-880A (K072826)
- Toshiba Ultrasound Diagnostic System APLIO XG MODEL SSA-790A (K072000) for cardiac, transesophageal, and peripheral vascular studies. |
| Acoustic Output: Within approved levels | A post-clearance special report containing complete information, including acoustic output measurements based on production line devices, is required. (This implies an ongoing acceptance criterion, not a pre-market performance metric for AI). |
2. Sample size used for the test set and the data provenance:
This information is not provided in a 510(k) summary for a diagnostic ultrasound system. Clinical test sets, data provenance, and sample sizes are typically associated with performance studies for devices with novel clinical claims, especially AI/ML devices, which is not the primary focus of this submission. The determination of substantial equivalence relies on comparison to predicate devices, not on a new clinical study with a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. As explained above, this 510(k) relies on substantial equivalence to predicate devices and not on a de novo clinical study with a ground truth established by experts.
4. Adjudication method for the test set:
This information is not provided.
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 explicitly not an AI-enabled device. This document describes a traditional diagnostic ultrasound system. Therefore, no MRMC comparative effectiveness study involving AI or assessing improvement of human readers with AI assistance was performed or would be relevant for this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not an AI/algorithm-only device. It is a diagnostic ultrasound system. Therefore, a standalone algorithm performance study was not done.
7. The type of ground truth used:
Not applicable in the context of this 510(k) summary, as it relies on substantial equivalence rather than a new clinical performance study requiring ground truth.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.
§ 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.