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The Aplio XG is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).

The Aplio XG Ultrasound System is a mobile system 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.

The provided document is a 510(k) summary for the Toshiba SSA-790A, Aplio XG Version 2.00 Diagnostic Ultrasound System. This document focuses on establishing substantial equivalence to previously cleared predicate devices and does not contain detailed information about specific acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment typically found in performance studies for new algorithms or AI-driven devices.

The information provided primarily relates to the intended use and safety considerations based on existing standards, rather than the results of novel performance studies. The "acceptance criteria" discussed in the document are about the device's adherence to regulatory standards and its equivalence to predicate devices, not specific performance metrics in a clinical study.

Therefore, many of the requested items (e.g., specific acceptance criteria values, sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for training/test sets) cannot be extracted from this document as it does not describe such a study.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the nature of this 510(k) (substantial equivalence to predicate devices), the "acceptance criteria" are implied to be the safety and performance characteristics of the predicate devices. The "reported device performance" is that the new device is substantially equivalent to these predicates.

The document lists various transducers and the clinical applications they are cleared for, along with the available operating modes. "P" indicates "Previously Cleared by FDA" (implying equivalence to previous versions/predicate devices) and "E" indicates "Added under Appendix E (LTF)", meaning these indications were already covered by the previous 510(k) for that specific transducer model. "N" indicates "new indication" for the specific transducer and mode combination.

Since this document is a 510(k) summary for an ultrasound system, the acceptance criteria are generally based on meeting the performance and safety standards of the predicate devices and applicable industry standards. There are no quantitative performance metrics (e.g., sensitivity, specificity for disease detection) for a specific clinical task mentioned in this document that would be applicable for the requested table format.

The "performance" is demonstrated by its substantial equivalence to the following predicate devices:

1. Toshiba SSA-790A, Aplio XG Version 1.00 Diagnostic Ultrasound; 510(k) control number K063130
2. Siemens Medical Solutions U.S.A. Acuson Sequoia Ultrasound System; 510(k) control number K052410

The device (Aplio XG Version 2.00) meets the acceptance criteria by being demonstrated as substantially equivalent to these predicate devices for the listed clinical applications and operating modes. Specific performance characteristics for images for each clinical indication (e.g., image resolution, penetration depth, contrast) are usually detailed in the full 510(k) submission, not typically summarized quantitatively in the publicly available summary letter like this one.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document is a 510(k) summary establishing substantial equivalence to predicate devices and adherence to consensus standards. It does not describe a clinical performance study with a test set of patient data to evaluate a new algorithm or AI device.

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. This document does not describe a study involving expert-established ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This document does not describe a study involving ground truth adjudication.

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 document does not describe an MRMC study. It is a 510(k) for a diagnostic ultrasound system, not an AI-assisted interpretation device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. This document does not describe a study with a ground truth dataset in the context of diagnostic accuracy. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This document does not describe the development or testing of an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This document does not describe the development or testing of an AI algorithm requiring a training set.

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