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The GE EchoPAC BT10 workstation is indicated for diagnostic review and analysis of ultrasound images acquired under various modes of operation including B, M, Color M modes, Color, Power, Pulsed & CW Doppler modes, Coded Pulse, Harmonic and Realtime 3D. Clinical applications include: Fetal; Abdominal; Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalio; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-Conventional; Transrectal (TR); Transvaginal (TV); and Intraoperative skeletal (abdominal, thoracic, & vascular).

GE EchoPAC provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval of ultrasound images that are acquired via GE Vivid family of ultrasound scanners, primarily for cardiology ultrasound applications but also for general imaging. The EchoPAC software is an integral component of each Vivid system, providing the post acquisition image management and reporting functions of the scanner. Sold as a stand-alone software only product it can be installation on the customer's PC hardware, or as a plug-in to third party PACS. EchoPAC is DICOM compliant, transferring images and data via LAN between scanners, hard copy devices, file servers and other workstations. The modified or added software features for GE EchoPAC BT10 are substantially equivalent to the unmodified device and functionality cleared on GE Vivid E9 and GE Vivid S5/S6.

This document, K101324, describes a 510(k) Premarket Notification for the GE EchoPAC BT10 Review station. It's important to note that this is a submission for a review station software and not a diagnostic AI device in the modern sense. Therefore, many of the performance metrics and study designs typically associated with AI/ML diagnostic tools (like sensitivity, specificity, MRMC studies, training set details) are not applicable here. The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing and verification of design specifications.

Here's an analysis based on the provided text, addressing your questions to the extent possible:

Acceptance Criteria and Device Performance:

Since this is not a diagnostic AI device, the "acceptance criteria" are not framed in terms of clinical performance metrics like sensitivity or specificity. Instead, they are focused on design specifications, compliance with standards, and functional equivalence to predicate devices.

2. Sample size used for the test set and the data provenance:

• Not applicable / Not explicitly stated. This submission focuses on non-clinical testing and verification. There is no mention of a "test set" in the context of clinical data or patient samples being analyzed for performance metrics. The testing would have involved software validation and verification against functional requirements, not clinical diagnostic accuracy.

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

• Not applicable. As there was no clinical "test set" in the diagnostic sense, there was no need for experts to establish ground truth for such a set.

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

• Not applicable. No clinical test set requiring adjudication was used.

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:

• No. An MRMC study was not conducted. This device is a review station, not an AI-powered diagnostic tool, and its purpose is not to assist human readers in a diagnostic capacity that would be measured by an MRMC study.

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

• Not applicable. The GE EchoPAC BT10 is workstation software for image review, analysis, and reporting, which by its nature is a human-in-the-loop system. It is not an algorithm that operates standalone to produce diagnostic outputs.

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

• Not applicable / System Functionality, Compliance, and Equivalence. For this type of device, "ground truth" would relate to the correct functioning of the software, its adherence to design specifications, and its ability to process and display images as intended, consistent with DICOM standards and the functionality of predicate devices. There wouldn't be a clinical "ground truth" in the sense of a disease state.

8. The sample size for the training set:

• Not applicable. As the GE EchoPAC BT10 is not an AI/ML device that requires a "training set" in the machine learning context, this information is not relevant.

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

• Not applicable. There was no training set for a machine learning model.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

The GE Vivid S6 are mobile ultrasound consoles having a wide assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular and general ultrasound imaging. Its intuitive user interface, high level of autooptimization along with significantly reduced size and weight maneuverable, efficient and easy to use.

The provided document K092079 is a 510(k) Premarket Notification for the GE Vivid S5 and Vivid S6 Diagnostic Ultrasound System. This submission focuses on establishing substantial equivalence to a predicate device and introducing new transducers and extended indications for use.

Crucially, the document states "Clinical Tests: None required." (Section b) 2. of Attachment B). This indicates that a study proving the device meets specific acceptance criteria, in the traditional sense of a clinical trial with performance metrics and statistical analysis, was not performed. Instead, the submission relies on the concept of substantial equivalence to a previously cleared predicate device (GE Vivid S5 and Vivid S6 Diagnostic Ultrasound System, K071985), and other previously cleared GE ultrasound systems/transducers for the new indications.

Therefore, the following information cannot be extracted from this document: acceptance criteria with reported device performance (beyond established safety standards), sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study details, standalone performance, or training set details.

The acceptance criteria for this submission are fundamentally satisfied by demonstrating that the modifications (new transducers and expanded indications for use) do not raise new questions of safety or effectiveness and perform as well as or better than legally marketed predicate devices.

Here's a breakdown of the available information relevant to "acceptance criteria" and how they were met in the context of a 510(k) submission focused on substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

The study that proves the device meets the acceptance criteria is the 510(k) submission itself, where GE Healthcare argues for substantial equivalence based on the points above.

Missing Information (as per the document):

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical tests were required or performed.
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. The "ground truth" here is the regulatory precedent of previously cleared devices and transducers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the new indications is the precedent of prior FDA clearance for similar technologies and applications on other GE ultrasound systems, signifying recognized safety and effectiveness.
8. The sample size for the training set: Not applicable, as no clinical tests or algorithm training were explicitly mentioned as part of this 510(k) submission for new device clearance. The device is a hardware/software system, not a machine learning model requiring a training set in the typical sense.
9. How the ground truth for the training set was established: Not applicable.

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