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TE7/TE5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intra-operative(abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-esoph. (Cardiac), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, peripheral vessel, adult and pediatric cardiac exams.

TE7/TE5 is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-mode, Color-Mode, Power/Dirpower Mode, THI, LVO, Color M, Smart 3D, TDI or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).. This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.0 MHz to 13.5 MHz.

This document describes a 510(k) premarket notification for the TE7 and TE5 Diagnostic Ultrasound Systems. The submission focuses on demonstrating substantial equivalence to previously cleared devices rather than proving a new level of performance through extensive clinical studies. Therefore, many of the typical elements of an AI/ML device study (like MRMC studies, specific ground truth methods for image interpretation, and detailed performance metrics beyond equivalence) are not present in this type of submission.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Reported Device Performance:

The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to existing legally marketed predicate devices. This means showing that the new device is as safe and effective as the predicate and does not raise new questions of safety or effectiveness. The device performance is generally presented by stating its comparability to the predicate in key features and functions.

The document lists various modes of operation and clinical applications for which the TE7/TE5 Diagnostic Ultrasound System is intended. The "P" in the tables indicates that an indication/mode was previously cleared by FDA K143472 (a predicate device). "N" indicates a new indication/mode for the current submission that is being demonstrated as substantially equivalent to other predicates (M9 K152543, Resona 7 K152763, M7 K131690).

Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) for an ultrasound system, the acceptance criteria are not typically phrased as specific performance metrics like sensitivity/specificity for an AI algorithm. Instead, they relate to meeting safety and performance standards comparable to predicate devices. The "performance" is implicitly deemed equivalent if the device meets these standards and functions as intended for the specified applications.

Study Details (based on the provided text):

1. Sample sizes used for the test set and the data provenance:

   • The document explicitly states "Clinical Studies: Not applicable." and "The subject of this submission, TE7/TE5 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."
   • This implies that no specific "test set" of clinical cases (e.g., patient images interpreted by the device) was used for performance evaluation in the way an AI/ML device would be. Instead, the testing relies on non-clinical tests (acoustic output, biocompatibility, safety standards, etc.) and comparisons to previously cleared predicate devices.
   • Therefore, there is no sample size for an clinical test set and no provenance information for such data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • As no clinical studies were performed, there was no test set with ground truth established by experts for device performance evaluation in the context of diagnostic accuracy.
   • The "ground truth" for demonstrating substantial equivalence here would be the validated performance and safety of the predicate devices, and the established industry standards the new device conforms to.

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

   • Not applicable, as no clinical test set was used for diagnostic performance evaluation or expert review.

4. 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 MRMC study was done. The device is an ultrasound system, not an AI-assisted diagnostic tool that aids human readers in image interpretation for specific findings. The submission is for the imaging system itself.

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

   • Not distinctly applicable in the context of an ultrasound system. The "algorithm" here refers to the core image acquisition and processing capabilities of the ultrasound machine and its transducers. The performance of these functionalities is assessed through engineering tests and compliance with recognized standards, not as a standalone AI algorithm interpreting images.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):

   • The "ground truth" for this 510(k) submission is primarily based on engineering and performance standards conformity (e.g., acoustic output limits, electrical safety, biocompatibility, etc.) and the established performance and safety profiles of the predicate devices that the new device claims substantial equivalence to. There is no mention of clinical ground truth (like pathology or outcomes) being used to evaluate the diagnostic accuracy of the device itself in this submission.

7. The sample size for the training set:

   • Not applicable as this is not an AI/ML device that requires a "training set" in the context of machine learning model development. The development of an ultrasound system involves design, engineering, and testing processes, not a "training set" in the AI sense.

8. How the ground truth for the training set was established:

   • Not applicable for the same reasons as #7.

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