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When used by a qualified physician, this device is intended for displaying and analyzing ultrasound images for medical diagnosis in obstetric/gynecology and general examinations.

This device is not intended for diagnosis of lossy compressed images.

The USWP-100A is a software package that may be applied to an existing workstation that is capable of receiving volume data sets via DICOM from Toshiba Ultrasound systems that are configured for 4D imaging. This nofitware consists of measurement packages that were cleared on the predicate device, SSA-790A, AplioXG Diagnostic Ultrasound System.

This 510(k) premarket notification for the Toshiba America Medical Systems, Inc. USWP-100A, 4D Viewer Radiological device does not include information about specific acceptance criteria or an analytical study with performance metrics.

The submission is focused on demonstrating substantial equivalence to a predicate device (Toshiba Aplio XG; SSA-790A V2.2 [K081065]) rather than presenting a detailed performance study with defined acceptance criteria. The core argument is that the new device offers similar functionality and safety as the already cleared predicate device.

Therefore, many of the requested sections regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be provided based on the provided text.

However, I can extract the following relevant information:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in the document. The document's premise is showing substantial equivalence to a predicate device, implying that its performance should be "similar" to or "no worse than" the predicate device for its intended use.
• Reported Device Performance: Not explicitly reported in terms of specific metrics (e.g., sensitivity, specificity, accuracy). The device is described as "displaying and analyzing ultrasound images for medical diagnosis in obstetric/gynecology and general examinations." The document states it offers "measurement packages that were cleared on the predicate device."

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

• This information is not provided in the document. No specific test set or data provenance is mentioned.

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

• This information is not provided in the document. No ground truth establishment using experts is described for a test set.

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

• This information is not provided in the document.

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 MRMC comparative effectiveness study is mentioned. This device is a "4D Viewer" for displaying and analyzing images, not an AI-assisted diagnostic tool.

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

• This information is not provided. The device is described as software for displaying and analyzing images, implying human interaction is central to its intended use. There is no mention of a standalone algorithmic performance evaluation.

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

• This information is not provided.

8. The sample size for the training set

• This information is not provided in the document. The device is a "software package" and does not explicitly state the use of machine learning models requiring training data in the context provided.

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

• This information is not provided in the document.

Summary of the document's approach:

The manufacturer, Toshiba America Medical Systems, Inc., pursued a 510(k) premarket notification for the USWP-100A, 4D Viewer radiological device. The primary method for demonstrating safety and effectiveness was by establishing substantial equivalence to a previously cleared predicate device, the Toshiba Aplio XG; SSA-790A V2.2 [K081065].

The rationale for substantial equivalence is based on:

• The device being a "software package" with "measurement packages that were cleared on the predicate device."
• Displaying and analyzing ultrasound images for medical diagnosis in obstetric/gynecology and general examinations, which are "identical to those included with the predicate device."
• "No new indications for use that are not already available in devices already marketed in the U.S."
• The device provides "information to the user that is similar to that which is provided by the predicate device" and is "obtained in a manner that is similar to the predicate device."

Therefore, the submission relies on the prior clearance of the predicate device and the assertion that the new device does not introduce new safety or effectiveness concerns, indications, or functions. It does not present a de novo performance study with specific acceptance criteria and performance metrics.

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