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Philips VISIQ Diagnostic Ultrasound system is intended for diagnostic ultrasound imaging in 2D Auto Scan, Mmode, Pulse Wave Doppler, Color Doppler, Tissue Harmonics & iSCAN.

The system is indicated for diagnostic ultrasound imaging and fluid flow analysis and supports the following Indications for Use: Abdominal, Cardiac other (Fetal), Fetal/Obstetric, Gynecological, and Small Organ (Prostate).

The clinical environments where the VISIQ Diagnostic Ultrasound system can be used include large/small hospitals, clinical and medical office settings, and primary and community healthcare centers for the diagnosis of patients.

VISIO is a new general imaging ultrasound system from Philips Ultrasound. VISIO provides ultrasound capabilities in a portable, lightweight, affordable system. Its function is to acquire ultrasound data and to display the data in various modes of operation. VISIQ supports wireless network connectivity to allow the user to export ultrasound images.

The VISIQ system includes an off-the shelf tablet enclosed within a Philips Ultrasound enclosure. The system contains Philips software featuring a closed Operating System. The system can be used with the C5-2 Curved Linear Array USB Transducer.

The provided document is a 510(k) summary for the Philips VISIQ Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing de novo safety and effectiveness criteria.

Therefore, the document does not contain specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for a new clinical study. The submission instead relies on a comparison of technological characteristics and the established safety and effectiveness of the predicate devices.

Here's how to address each point based on the provided text:

Acceptance Criteria and Study for Philips VISIQ Diagnostic Ultrasound System

1. Table of Acceptance Criteria and Reported Device Performance:

No specific, quantified acceptance criteria for performance are stated in the provided 510(k) summary for the VISIQ device. The submission asserts substantial equivalence based on technological characteristics and regulatory compliance, rather than new performance-based criteria.

• IEC60601-1 (Medical electrical equipment. General requirements for basic safety and essential performance)
• IEC60601-1-2 (Electromagnetic Compatibility Requirements and Tests)
• IEC60601-2-37 (Particular requirements for the safety of ultrasound medical diagnostic and monitoring equipment)
• ISO 10993 (Biological evaluation of medical devices)
• Acoustic output levels are below Track 3 FDA limits.
• Materials have equivalent biosafety as predicates and are safe for application.
• Designed and manufactured to the same electrical and physical safety standards as predicates. |
  | Effectiveness | The device is considered substantially equivalent to predicate devices (Philips Nuvis K133833, Philips ClearVue K120321) in terms of its diagnostic ultrasound imaging and fluid flow analysis capabilities for the specified indications for use (Fetal/Obstetric, Abdominal, Small Organ (prostate), Gynecological). This is based on sharing similar gray-scale and Doppler capabilities, and essentially the same technologies for imaging, Doppler functions, and signal processing as the predicates. |
  | Intended Use & Indications| The device's intended use and indications for use align with the predicate devices, specifying diagnostic ultrasound imaging and fluid flow analysis for Fetal/Obstetric, Abdominal, Small Organ (prostate) and Gynecological applications, across various clinical settings and users. |
  | Technological Characteristics | The device's technological characteristics (transducer type, frequency, modes of operation, patient contact materials) are presented as comparable to, or within the range of, the predicate devices for the claimed indications. |

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

• Not applicable. This 510(k) submission does not describe a new clinical performance study requiring a test set of data samples. The determination of substantial equivalence relies on non-clinical testing for safety and technological comparison to predicate devices, which are already marketed.

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

• Not applicable. As no new clinical study (test set) is described, there is no mention of experts establishing ground truth for such a set.

4. Adjudication method for the test set:

• Not applicable. No test set or clinical study requiring adjudication 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:

• No. The document does not describe an MRMC study or any study involving AI assistance for human readers. This device is a general diagnostic ultrasound system, not an AI-powered diagnostic tool.

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

• No. This is a hardware and software system for image acquisition and display, not a standalone algorithm for diagnosis. Performance is evaluated through comparison to predicate devices and adherence to safety standards.

7. The type of ground truth used:

• Not applicable. Since no specific clinical performance study for the VISIQ device's diagnostic capabilities is detailed, the concept of "ground truth" for a new study is not relevant here. The "truth" for this submission is that the device features and performance are equivalent to predicate devices, which are already considered safe and effective for their intended uses. Clinical safety and effectiveness are "well accepted" for ultrasound systems with these characteristics.

8. The sample size for the training set:

• Not applicable. No machine learning or AI algorithm development and training is described for this device.

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

• Not applicable. No machine learning or AI algorithm development and training is described for this device, so no training set with associated ground truth was established by the submitter for this 510(k).

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