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The Nuvis Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, and the Combined Mode (B+Color). The device is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal/Obstetric, Abdominal, Other-Urology, Other-Gynecology, and Other-Cardiac Fetal.

The clinical environments where Nuvis can be used include hospital, clinic, and medical office settings for the diagnosis of patients.

The Nuvis Diagnostic Ultrasound systems is a mobile, general purpose, software The Navis Diagnostic Ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. Nuvis supports wireless network connectivity to allow the user to export (non-DICOM) ultrasound images.

The Nuvis system includes:

• A commercial off-the-shelf Android tablet (COTS) . O
• Nuvis software running as an app on the off-the-shelf tablet 0
• The C5-2 Curved linear array USB transducer ಂ

The provided text describes a Premarket Notification (510(k)) for the Philips Nuvis Diagnostic Ultrasound System. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its effectiveness through a new clinical trial against specific acceptance criteria for a novel indication.

Therefore, the document does not contain information regarding traditional acceptance criteria and a study proving a device meets these criteria in the way one might expect for a new, unproven technology. Instead, it focuses on demonstrating substantial equivalence.

Here's an analysis of the provided information in relation to your request:

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

This information is not applicable in the context of a 510(k) submission for substantial equivalence where no new indications or underlying technologies are being introduced. The "performance" described is largely comparison to predicate devices and compliance with relevant standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document states: "The first release of Nuvis introduces no new indications for use, modes, features, or technologies relative to the predicate devices that require clinical testing."

Therefore, no specific test set or clinical study data is reported as it was deemed unnecessary for this type of submission.

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):

As no clinical testing was deemed necessary, this information is not provided. Establishing ground truth by experts is typically part of a clinical validation study, which was not performed here.

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

Since no clinical testing data is presented, no adjudication method is described.

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:

This is not applicable. The Nuvis system is a diagnostic ultrasound system, which is a hardware and software system for acquiring and displaying ultrasound data. It is not an AI algorithm designed to assist human readers, and therefore no MRMC study, particularly one comparing AI assistance, was performed or needed.

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

This is not applicable. The device is an ultrasound system, not a standalone algorithm. Its performance is inherent to its functionality as a diagnostic imaging tool.

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

Since no clinical testing was performed for the purpose of demonstrating effectiveness for new indications, no ground truth was established in the context of clinical validation data. The "ground truth" for this submission revolves around demonstrating that the device functions according to its technical specifications and is safe, comparable to predicate devices.

8. The sample size for the training set:

This is not applicable. The document does not describe an AI algorithm that would require a training set in the conventional sense. The "Nuvis software" mentioned is an application for controlling the ultrasound system, not a machine learning model for image interpretation.

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

This is not applicable for the same reasons as point 8.

Summary of Device Performance and Substantial Equivalence Basis:

Instead of direct acceptance criteria, the document focuses on demonstrating substantial equivalence to predicate devices by addressing:

• Technological Comparison: Nuvis uses the same fundamental scientific technology as Philips ClearVue, leveraging a common software platform. The C5-2 transducer is similar to ClearVue's, with USB connectivity like Interson USB transducers. Nuvis, as a mobile system on a COTS tablet, is similar to Interson USB and Mobisante MobiUS.
• Intended Use, Modes, and Features: The document explicitly states: "The first release of Nuvis introduces no new indications for use, modes, features, or technologies relative to the predicate devices that require clinical testing." The intended uses (Fetal/Obstetric, Abdominal, Urology, Gynecology, Cardiac Fetal imaging in B, Color Doppler, and Combined modes) are equivalent to those of the predicate devices.
• Non-Clinical Performance Data: Compliance with recognized international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993) for safety, electromagnetic compatibility, and biological evaluation.
• Quality Assurance Measures: Design and development included Risk Analysis, Product Specifications, Design Reviews, and Verification and Validation.
• Acoustic Output: Nuvis has acoustic output levels below Track 3 FDA limits, similar to predicate devices.
• Materials and Manufacturing: Nuvis is manufactured under the same quality system as predicates and uses equivalent biosafety materials, consistent with electrical and physical safety standards.

Conclusion from the document: The Nuvis device is considered substantially equivalent to the identified predicate devices based on its similar intended use, technological characteristics, safety profiles, and adherence to relevant performance standards, thus not requiring new clinical studies to prove effectiveness.

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