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The ClearVue850 Diagnostic Ultrasound system is a general purpose, portable, cart based ultrasound system, intended for use by customers in various clinical settings (private offices, clinics, small hospitals, primary and community healthcare centers) by different users (General Practitioners, Paraprofessionals, physician specialists including OBG's, Ultrasound Lab physicians, and nurse practitioners, etc.,

The System is intended for diagnostic ultrasound imaging in the following modes: B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Tissue Harmonics, iSCAN, X-Res, Angio, 3D (freehand), 4D and SonoCT, Combined modes includes FloVue, Elastography (strain).

The system is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications, as listed in FDA 's Diagnostic Ultrasound Indications for Use Form section 1.3 which includes Fetal / OB, Abdominal, Pediatric, Small Organ (breast, thyroid, testicle), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculo-skel. (Conventional), Musculo-skel. (Superficial), Other: GYN, Other: Urology, Cardiac Pediatric, Transesophageal (Cardiac), Other (Fetal Echo), Peripheral vessel and Cerebral Vascular.

The ClearVue850 Diagnostic Ultrasound System is a general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation.

The ClearVue 850 System is substantially equivalent to the currently marketed and predicate ClearVue350/550 system(K120321) in terms of design and fundamental scientific technology. The ClearVue850 Model is provided with additional transducers D2CWC and L12-5 and software features and additional modes. The software feathres of the ClearVue 850 System include -Live Panoramic Imaging, FloVue, Strain Elastography Imaging, Curved ROI Tool, QLAB plug-ins IMT and GI3DQ, Stress Echo protocol.

The ClearVue 850 System supports CW Doppler transducer with external CW adapter module which gets attached to the SAM transducer connector, an Up/down mechanism for control panel. The system is designed to be highly reliable and easily serviceable.

This document is a 510(k) premarket notification for the Philips ClearVue 850 Diagnostic Ultrasound System. It aims to demonstrate substantial equivalence to previously cleared devices.

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Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in a pass/fail manner. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly demonstrated by stating that the ClearVue 850 shares the same fundamental scientific technology, has similar intended uses and technological characteristics, and has undergone non-clinical testing for compliance with relevant safety and EMC standards.

The closest to "acceptance criteria" are the Indications for Use outlined in the tables (pages 4-11), which detail the clinical applications and modes of operation for the system and its various transducers. The device "meets" these by being listed for these applications. The "reported device performance" is a general statement of equivalency rather than specific metrics.

Table of Acceptance Criteria and Reported Device Performance:

Since explicit quantitative acceptance criteria are not presented, this table lists the stated "Indications for Use" as the de facto "acceptance criteria" that the device is intended to meet, and the "Reported Device Performance" as the claim of substantial equivalence for these indications.

The ClearVue 850 is demonstrated to meet these indications for use through substantial equivalence to predicate devices (K120321, K132304, K141261). The document repeatedly states that the device introduces "no new indications for use, features, or technologies as compared to the currently marketed and predicate devices (EPIQ/ClearVue) that require clinical testing."

Specific additions/equivalences mentioned:

• L12-5 and D2CWC transducers: Added with equivalent additional indication for use to K132304.
• FloVue: New indication, substantially equivalent to the coded pulse mode of GE K141261 (both help in simultaneous imaging of tissue and blood flow).
• Elastography: Already cleared with EPIQ K132304.
• Other software features: Live Panoramic Imaging, Strain Elastography Imaging, Curved ROI Tool, QLAB plug-ins IMT and GI3DQ, Stress Echo protocol, CW Doppler transducer with external CW adapter module. |
  | Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-37 standards (Non-clinical performance data). | Non-clinical tests were performed to demonstrate compliance with these standards. |

Study Information:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document explicitly states: "Summary of Clinical Tests: The ClearVue850 System introduces no new indications for use, features, or technologies as compared to the currently marketed and predicate devices (EPIQ/ClearVue) that require clinical testing." This indicates that no new primary clinical testing (test set) was performed specifically for this 510(k) submission. The substantial equivalence relies on the performance of the predicate devices. Therefore, there is no information about a test set sample size or its provenance in this document.

2. 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 new clinical testing was performed for this submission, this information is not provided. The ground truth for the predicate devices' clearances would have involved relevant medical experts, but details are not in this document.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as no new clinical test set was used for this submission.

4. 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 study was performed or is mentioned. The device is a diagnostic ultrasound system and not an AI-assisted diagnostic tool in the sense of providing automated interpretations to readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is a diagnostic ultrasound system, which inherently involves a human operator and interpreter. It is not an algorithm that provides standalone diagnostic outputs without human interaction.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the purposes of this 510(k) submission, the "ground truth" relies on the established safety and effectiveness of the predicate devices. The document implies that the clinical safety and effectiveness of ultrasound systems with these characteristics are "well accepted." For the predicate devices, their ground truth would likely have been established through a combination of expert clinical interpretation, correlation with other imaging modalities, and potentially pathology or surgical outcomes, depending on the specific application. However, these details are not provided for the ClearVue 850 in this submission.

7. The sample size for the training set:
   Not applicable. This document describes a traditional 510(k) for an ultrasound system, not an AI/Machine Learning device that requires a distinct "training set" in the computational sense. The "training" for the device's development would be through extensive engineering, design, and internal validation processes based on established ultrasound principles and medical knowledge.

8. How the ground truth for the training set was established:
   Not applicable for the same reasons as above.

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