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The Ergosonix and Modulo Ultrasound Scanners are intended for use in obstetrics/gynecology, general radiology, cardiac examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies. The specific intended uses of this system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), cephalic, small organ (breast, thyroid, testicle), trans-vaginal, trans-rectal, pediatric and fetal imaging, cardiac (adult) and cardiac (pediatric), transcranial, transesophageal.

The Ergosonix Ultrasound Scanner is a highly mobile, software-controlled, diagnostic ultrasound system capable of the following operating modes: 2D B-mode, M, Pulsed and CW Doppler, Color Flow (including amplitude Doppler). The system can generate real-time compound images and harmonic images. The Modulo Ultrasound Scanner is identical to the Ergosonix Ultrasound Scanner, except that it has a different, smaller, enclosure. The Modulo Ultrasound Scanner has the same software and hardware as the Ergosonix Ultrasound Scanner, except for logo displays. These systems have an electrocardiography (ECG) display feature and support a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PA and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage. The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes.

The provided document is a 510(k) summary for the Ultrasonix Ergosonix 500 Ultrasound, updated with new transducers, applications, and imaging modes. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to safety standards. This document does NOT contain information about performance acceptance criteria or a study proving the device meets such criteria.

The 510(k) process for ultrasound systems often relies on demonstrating substantial equivalence to already cleared devices and compliance with recognized safety standards (like acoustic output limits) rather than conducting specific clinical performance studies that define and then meet acceptance criteria as one might see for novel diagnostic AI devices.

Therefore, I cannot fulfill all parts of your request based on the provided text.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as performance criteria in the sense of a clinical outcome metric. The document focuses on compliance with general safety standards and equivalence to predicate devices.
• Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported for clinical use or diagnostic effectiveness. The performance is implied to be equivalent to the predicate devices.

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

• Not provided. This type of information is not typically part of a 510(k) summary for an ultrasound system focused on hardware and mode updates through substantial equivalence. There is no "test set" in the context of clinical performance evaluation against specific criteria here.

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

• Not applicable. There is no "test set" or ground truth establishment described for diagnostic performance evaluation.

4. Adjudication method 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 an ultrasound imaging system, not an AI-powered diagnostic tool. No AI component is mentioned, and therefore no MRMC study or effect size related to AI assistance is present.

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

• Not applicable. This is a hardware/software imaging system, not an algorithm being evaluated for standalone performance.

7. The type of ground truth used:

• Not applicable. No ground truth for diagnostic performance is mentioned. The submission focuses on technical specifications, safety (acoustic output), and substantial equivalence to legally marketed predicate devices. The "ground truth" in this context is the established safety and performance of the predicate devices and adherence to regulatory standards.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device requiring a training set.

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

• Not applicable.

Summary of available information:

The document primarily serves as a 510(k) premarket notification to demonstrate that the Ergosonix and Modulo Ultrasound Scanners, including new transducers and applications, are substantially equivalent to legally marketed predicate devices (Ultrasonix Ergosonix 500 Ultrasound Scanner (K020630), ATL HDI 5000 System (K002003), Acuson Sequoia (K973767)).

Acceptance Criteria (Implied - focused on safety and equivalence):

The acceptance criteria are implicitly tied to:

• Compliance with recognized safety standards for medical electrical equipment and a coustic output.
• Demonstration of technological characteristics and intended uses being substantially similar to predicate devices.

Reported Device Performance (Implied - focused on safety and technical specifications):

• Acoustic Output Limits: The devices comply with the guideline limits set in the September 30, 1997 revision of 510(k) Diagnostic Ultrasound Guidance.
  • ISPTA(d): 720mW/cm²
  • TIS/TIB/TIC: 0.1 - 4.0 (Range)
  • Mechanical Index (MI): 1.9 (Maximum)
  • ISPPA(d): 0 - 700W/cm² (Range)
• The limits are stated to be the same as predicate Track 3 devices.
• The device operates in modes (2D, PW Doppler, Color Flow Mapping Doppler, Power Doppler) identical to predicate devices.
• The beam forming architecture and image quality adjustment parameters are "very similar" or "the same" as predicates.

The study that "proves the device meets the acceptance criteria" in this context is the 510(k) premarket notification process itself, which establishes substantial equivalence through a comparison of technical features, intended use, and adherence to safety standards. No specific clinical performance trial against predefined acceptance criteria is detailed in the provided document.

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