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Intended to be used by or under the direction of a physician and in conjunction with standard ultrasound for 3D clinical imaging in fetal applications

Adds 3D imaging capability to commercial 2D ultrasound imaging systems. Hardware includes a Cyrix 266 MHz processor, Frame Grabber (VHS/S-VHS Input), Video out, and a Handheld controller. Software features include Volume data acquisition w/frame grabbing of video data b/w while using a Gyroscopic sensor system, Conditioning & transformation of the acquired data into a Cartesian volume, Surface rendering, and Segmentation of structures from 3D data.

The provided text is a 510(k) summary for the "Baby Face Digital Ultrasound Image Analysis System" (K994385). This document focuses on establishing substantial equivalence to a predicate device and describing the intended use and basic functionality. It does not contain information about acceptance criteria, device performance studies, or details regarding ground truth establishment and expert involvement, which are typically found in more comprehensive clinical study reports or validation documents.

Therefore, many of the requested details cannot be extracted from this specific document.

Acceptance Criteria and Study Information (Based on Provided Text)

As thoroughly explained above, the provided 510(k) summary does not contain any information regarding acceptance criteria, specific device performance metrics, or the details of a study that proves the device meets such criteria. A 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device.

However, I can provide a table based on the functional description and the intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "Acceptance Criteria" and "Reported Device Performance" below are inferred from the device's stated functionality and the context of a 510(k) submission for a 3D ultrasound image analysis system. The actual performance values and detailed acceptance criteria are not present in the provided text.

The following information cannot be extracted from the provided text:

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

• Not available. The document does not describe any specific test set or clinical study with patient data.

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

• Not available. No information on ground truth experts is provided.

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

• Not available. No information on adjudication is provided.

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 available. No MRMC study is mentioned. This device is an image analysis system, not explicitly described as an "AI" device as we understand it today in 2023. It assists with 3D visualization, but not necessarily with automated interpretation or diagnostic aid in the sense of AI.

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

• Not available. The device's intended use clearly states it's "intended to be used by qualified medical personnel" and "in conjunction with standard ultrasound," indicating it's not a standalone diagnostic tool. The document does not describe performance studies.

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

• Not available. No mention of ground truth is made.

8. The sample size for the training set

• Not available. No training set is mentioned.

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

• Not available. No ground truth for a training set is mentioned.

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