(13 days)
The Nemio XG system is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, musculo-skeletal (both conventional and superficial).
The Nemio XG will be offered in one variation which is a mobile system. It is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.
This document is a 510(k) summary for the Toshiba Nemio XG, SSA-580A Ultrasound Imaging System. It declares substantial equivalence to a predicate device (Toshiba SSA-550A/NEMIO, K010631) rather than presenting a study to prove new acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics for a novel device is not applicable or not provided in this 510(k) summary.
The document primarily focuses on establishing equivalence and listing the intended uses and associated transducers.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not present quantitative acceptance criteria or device performance data for the Nemio XG, SSA-580A. Instead, it relies on demonstrating substantial equivalence to a previously cleared device (K010631). The premise of a 510(k) submission is that if a new device is substantially equivalent to a legally marketed predicate device, it meets the same safety and effectiveness standards.
The acceptance criteria implicitly refer to the continued satisfactory performance of the predicate device (SSA-550A/NEMIO) and the new device's ability to maintain that level of performance for its stated intended uses.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Device is substantially equivalent to predicate device K010631 | "This unit is similar to that of the Toshiba SSA-550A/NEMIO and engineering assessments identify no new issues of risk or safety." |
| Meets safety standards | "The device is designed and manufactured in conjunction with the Quality System Regulation, IEC- 60601 (applicable portions), and IEC 60601-2-37. international standard for ultrasound safety." (This is a statement of compliance with standards, not performance results). |
| Performs for stated intended uses | The device is intended for the same types of studies as the predicate device, including fetal, abdominal, pediatric, small organs, neonatal/adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, musculo-skeletal (conventional and superficial). The numerous transducer tables show that existing indications ("P") for the predicate are maintained. |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This is a 510(k) submission asserting substantial equivalence, not a clinical study with a test set of data. The "test" for this type of submission involves demonstrating that the new device's technological characteristics, intended use, and safety/effectiveness are comparable to the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable for this 510(k) submission. This process does not involve expert adjudication of a test set for a new algorithm's performance. The "ground truth" here is the established safety and effectiveness of the predicate device.
4. Adjudication Method for the Test Set:
Not applicable. No test set was used in the context of comparing a new device's performance against ground truth created by expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This document pertains to an ultrasound imaging system, not an AI-assisted diagnostic tool. No MRMC study is mentioned or implied.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm but an ultrasound imaging system.
7. The Type of Ground Truth Used:
The ground truth implicit in a 510(k) substantial equivalence submission is the established safety and effectiveness of the legally marketed predicate device (Toshiba SSA-550A/NEMIO, K010631). The new device is deemed "substantially equivalent" if it can demonstrate it performs as safely and effectively as this predicate, without raising new questions of safety or effectiveness.
8. The Sample Size for the Training Set:
Not applicable. The Nemio XG is an ultrasound system and does not involve AI/machine learning requiring a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As above, there is no AI component or training set discussed in this 510(k) summary.
§ 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.