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Intended to be used by or under the direction of a physician for 3-D clinical imaging in fetal applications. This is only to be used in conjunction with the 2D Ultrasound Imaging System marketed under the model name 'Sonata' or 'Telocin', labeled as 2D Ultrasound Imaging System manufactured by Tetrad Corporation.

Adds 3-D imaging capability to commercial 2-D ultrasound imaging system. Hardware includes Pentium IV 2.8 GHz, Frame Grabber digital via real time memory mapping in RAM, Video out via Sonata System, System keyboard control. Software features include Volume data acquisition w/frame grabbing of digital data b/w while scanning free-hand, Conditioning and transformation of the acquired data into a Cartesian volume, Surface rendering, Segmentation of structures from 3-D data.

Here's an analysis of the provided 510(k) summary regarding the Sonata 3-D device, focusing on acceptance criteria and the study:

Acceptance Criteria and Device Performance for Sonata 3-D

Based on the provided documents, it is not possible to complete a table of acceptance criteria and reported device performance, nor to describe a study proving the device meets these criteria. The 510(k) submission for the Sonata 3-D primarily focuses on establishing substantial equivalence to a predicate device (Sonora Medical Systems Baby Face K994385, later updated to K1722606).

The provided text does not contain any information about:

• Specific performance metrics (e.g., accuracy, sensitivity, specificity, resolution) for the Sonata 3-D.
• Quantitative acceptance criteria established for the device.
• Results of any clinical or technical performance studies that would measure the device's performance against such criteria.
• Details about a test set, ground truth, experts, or adjudication methods for any such study.
• Information on training sets or how their ground truth was established.

The core of this 510(k) is a comparison of technical features and intended use to a legally marketed predicate device. The FDA's decision letter (K042620) confirms substantial equivalence based on a review of the submission, but this process typically involves demonstrating that the new device is as safe and effective as the predicate, often through feature-by-feature comparison rather than independent clinical performance studies that define and meet specific acceptance criteria in the same way a de novo or PMA submission might.

Information from the Provided Documents:

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) filing primarily aims to show that the Sonata 3-D has the "same intended use" and "same technological characteristics" as the predicate device or that differences "do not raise different questions of safety and effectiveness."

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

• Not applicable / Not provided. The document does not describe a performance study with a test set.

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

• Not applicable / Not provided. No ground truth establishment is described for a test set.

4. Adjudication method for the test set:

• Not applicable / Not provided. No test set or ground truth adjudication process is mentioned.

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. The device described is a "3-D Visualization Tool" and a "Digital Ultrasound Imaging System" that adds 3-D imaging capability to 2-D systems. It is not an AI-assisted diagnostic device, and no MRMC study or AI-related effectiveness is mentioned.

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

• No. This is a hardware/software system for 3D visualization, not a standalone algorithm. Performance in the context of 510(k) for this type of device is typically demonstrated through comparison to the predicate's functionality and safety.

7. The type of ground truth used:

• Not applicable / Not provided. No specific ground truth for performance evaluation is described. The "ground truth" in a 510(k) for substantial equivalence often relates to the known performance and safety profile of the predicate device, against which the new device's features and intended use are compared.

8. The sample size for the training set:

• Not applicable / Not provided. This document does not describe a machine learning algorithm requiring a training set.

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

• Not applicable / Not provided. No training set is mentioned.

Summary of the Study (as described in the 510(k) documentation):

The "study" presented in these 510(k) documents is a comparison to a predicate device for the purpose of demonstrating substantial equivalence.

• Predicate Device: Sonora Medical Systems Baby Face (K994385, later referenced as K1722606).
• Methodology: A feature-by-feature comparison was conducted (as shown in "Comparison Chart for Substantial Equivalence" on page 2 of the second document). This comparison highlights:
  • Basic Function: Both add 3-D imaging capability to commercial 2-D ultrasound systems.
  • Hardware: Differences in processor (Cyrix 266 MHz vs. Pentium IV 2.8 GHz), frame grabber technology (VHS/S-VHS input vs. digital via real-time memory mapping in RAM), and control (handheld controller vs. system keyboard control). These hardware differences would typically be reviewed to ensure they don't introduce new safety/effectiveness concerns.
  • Software Features: Both perform volume data acquisition, conditioning/transformation into a Cartesian volume, and surface rendering. Both also perform segmentation of structures from 3-D data. Importantly, both predicate and new device explicitly state "No quantitative evaluation" and "No measurements or calculations." This absence of quantitative metrics is a key point in establishing equivalence concerning performance.
• Conclusion of the Comparison: The submitter concludes, and the FDA agrees, that the Sonata 3-D is substantially equivalent to the predicate. The FDA's letter (K042620, dated Dec 23, 2004) states they "have determined the device is substantially equivalent... to legally marketed predicate devices."

In essence, the "study" for this 510(k) was a detailed technical and functional comparison against a known, legally marketed device, rather than an independent clinical trial with predefined performance acceptance criteria.

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