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The Philips IntelliSite Pathology Solution (PIPS) 5.1 is an automated digital slide creation, viewing, and management system. The PIPS 5.1 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 5.1 is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.

The PIPS 5.1 comprises the Imagement System (IMS) 4.2, Ultra-Fast Scanner (UFS), Pathology Scanner SG20, Pathology Scanner SG60, Pathology Scanner SG300 and Philips PP270HD display or a Beacon C411W display. The PIPS 5.1 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 5.1.

The Philips IntelliSite Pathology Solution (PIPS) 5.1 is an automated digital slide creation, viewing, and management system. PIPS 5.1 consists of two subsystems and a display component:

• 1. A scanner in any combination of the following scanner models
  • . Ultra Fast Scanner (UFS)
  • . Pathology Scanner SG with different versions for varying slide capacity Pathology Scanner SG20. Pathology Scanner SG60. Pathology Scanner SG300
• 2. Image Management System (IMS) 4.2
• 3. Clinical display
  • PP27QHD or C411W

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. The PIPS does not include any automated image analysis applications that would constitute computer aided detection or diagnosis. The pathologists only view the scanned images and utilize the image review manipulation software in the PIPS.

This document focuses on the Philips IntelliSite Pathology Solution 5.1 (PIPS 5.1) and its substantial equivalence to a predicate device, primarily due to the introduction of a new clinical display. This is a 510(k) submission, meaning it aims to demonstrate that the new device is as safe and effective as a legally marketed predicate device, rather than proving de novo effectiveness. Therefore, the study described is a non-clinical performance study to demonstrate equivalence of the new display, not a clinical effectiveness study.

Based on the provided text, a detailed breakdown of acceptance criteria and the proving study is as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the evaluation was performed following the FDA's Guidance for Industry and FDA Staff entitled, "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices" (TPA Guidance), dated April 20, 2016. The acceptance criteria are essentially defined by compliance with the tests outlined in this guidance and relevant international standards.

Reported Device Performance Summary: The non-clinical performance testing of the new display (Beacon C411W) showed that the proposed device has similar technological characteristics compared to the predicate device (using the PP27QHD display) following the TPA Guidance. It is also in compliance with the aforementioned international and FDA-recognized consensus standards. The verification and validation of existing safety, user, and system integration requirements showed that the proposed PIPS 5.1 with the new clinical display is safe and effective.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a "sample size" in terms of patient cases or images for testing the display. The testing performed was bench testing ("Verification for the new display," "non-clinical performance data"). This implies that the tests were conducted on the display unit itself, measuring its physical and optical properties, and its integration with the system components, rather than on a dataset of patient images reviewed by observers.
• Data Provenance: Not applicable in the context of a display characteristic validation study. The study focused on the performance of the hardware (the new display).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This was a technical, non-clinical validation of a display unit's characteristics against engineering specifications and regulatory guidance, not a study requiring expert clinical read-outs or ground truth establishment from patient data.

4. Adjudication Method for the Test Set

Not applicable. This was a technical, non-clinical validation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, an MRMC comparative effectiveness study was NOT done. The document explicitly states: "The proposed device with the new display did not require clinical performance data since substantial equivalence to the currently marketed predicate device was demonstrated with the following attributes: Intended Use / Indications for Use, Technological characteristics, Non-clinical performance testing, and Safety and effectiveness."
• The purpose of this submission was to demonstrate substantial equivalence for a minor hardware change (new display), not to show an improvement in human reader performance with AI assistance. The PIPS system itself does not include "any automated image analysis applications that would constitute computer aided detection or diagnosis." It is a whole slide imaging system for viewing and managing digital slides.

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

• Not applicable. The PIPS 5.1 is a system for creating, viewing, and managing digital slides for human pathologist review. It is not an AI algorithm that produces a diagnostic output on its own. The "standalone" performance here refers to the display's technical specifications.

7. The Type of Ground Truth Used

• For the non-clinical performance data, the "ground truth" was established by engineering specifications, international consensus standards (e.g., IEC, ISO), and the FDA's TPA Guidance. The aim was to ensure the new display performed equivalently to the predicate's approved display and met relevant technical requirements.

8. The Sample Size for the Training Set

Not applicable. This was a non-clinical validation of hardware (a display), not a machine learning model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. (See #8)

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