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The Philips IntelliSite Pathology Solution (PIPS) is an automated digital side creation, viewing, and management system. The PIPS is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The PIPS is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.

The PIPS comprises the Image Management System (IMS), the Ultra Fast Scanner (UFS) and Display. The PIPS is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using PIPS.

Philips IntelliSite Pathology Solution (PIPS) is an automated digital slide creation, viewing, and management system. PIPS consists of two subsystems and a display component:

• . Ultra Fast Scanner (UFS)
• Image Management System (IMS)
• Display

This document does not contain the information requested for acceptance criteria and a study proving device performance as it is a 510(k) summary for a modified device (K203845) that claims substantial equivalence to a predicate device (K192259) without requiring new clinical performance data.

The key reason for not needing a new clinical performance study is explicitly stated: "The subject device with the modified IMS subsystem did not require clinical performance data to demonstrate substantial equivalence to the currently marketed predicate device, as image quality was not impacted by the introduced change."

Instead of a new clinical study, the document describes non-clinical verification testing to support the substantial equivalence claim. This included:

• A pixel comparison test to determine pixel equivalence.
• Testing of requirements, risk control measures, integration, and regression.

Therefore, since no new clinical study was conducted for this specific 510(k), I cannot provide the requested information about acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment for a clinical performance study. The information provided relates to the non-clinical verification of a software change impacting rendering, not a full clinical validation of the device's diagnostic performance for its intended use.

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