(81 days)
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:
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- 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
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- Image Management System (IMS) 4.2
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- 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.
| Acceptance Criteria (Measured Performance Aspect) | Performance Standard/Acceptance Limit (Implicitly based on TPA Guidance & Predicate Equivalence) | Reported Device Performance (Summary from "Conclusion") |
|---|---|---|
| TPA Guidance Items related to Display: | ||
| Spatial resolution | As per predicate device and TPA Guidance | Verified to be similar to predicate device |
| Pixel defects | As per predicate device and TPA Guidance | Verified to be similar to predicate device |
| Artifacts | As per predicate device and TPA Guidance | Verified to be similar to predicate device |
| Temporal response | As per predicate device and TPA Guidance | Verified to be similar to predicate device |
| Maximum and minimum luminance | As per predicate device and TPA Guidance | Verified to be similar to predicate device |
| Grayscale | As per predicate device and TPA Guidance | Verified to be similar to predicate device |
| Luminance uniformity | As per predicate device and TPA Guidance | Verified to be similar to predicate device |
| Stability of luminance and chromaticity | As per predicate device and TPA Guidance | Verified to be similar to predicate device |
| Bidirectional reflection distribution function | As per predicate device and TPA Guidance | Verified to be similar to predicate device |
| Gray tracking | As per predicate device and TPA Guidance | Verified to be similar to predicate device |
| Color scale response | As per predicate device and TPA Guidance | Verified to be similar to predicate device |
| Color gamut volume | As per predicate device and TPA Guidance | Verified to be similar to predicate device |
| International & FDA-recognized Consensus Standards: | Compliance Required | Compliance Achieved |
| IEC 60601-1 Ed. 3.2 (Medical electrical equipment - General requirements for basic safety and essential performance) | Compliance | Compliant |
| IEC 60601-1-6 (4th Ed) (Usability) | Compliance | Compliant |
| IEC 62471:2006 (Photobiological safety) | Compliance | Compliant |
| ISO 14971:2019 (Risk management) | Compliance | Compliant |
| Other: | Compliance Required | Compliance Achieved |
| Existing functional, safety, and system integration requirements related to the display | Verified to function as intended without adverse impact from new display | Verified to be safe and effective |
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)
§ 864.3700 Whole slide imaging system.
(a)
Identification. The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides. The system generates digital images that would otherwise be appropriate for manual visualization by conventional light microscopy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the following information:
(i) The indications for use must specify the tissue specimen that is intended to be used with the whole slide imaging system and the components of the system.
(ii) A detailed description of the device and bench testing results at the component level, including for the following, as appropriate:
(A) Slide feeder;
(B) Light source;
(C) Imaging optics;
(D) Mechanical scanner movement;
(E) Digital imaging sensor;
(F) Image processing software;
(G) Image composition techniques;
(H) Image file formats;
(I) Image review manipulation software;
(J) Computer environment; and
(K) Display system.
(iii) Detailed bench testing and results at the system level, including for the following, as appropriate:
(A) Color reproducibility;
(B) Spatial resolution;
(C) Focusing test;
(D) Whole slide tissue coverage;
(E) Stitching error; and
(F) Turnaround time.
(iv) Detailed information demonstrating the performance characteristics of the device, including, as appropriate:
(A) Precision to evaluate intra-system and inter-system precision using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included.
(B) Reproducibility data to evaluate inter-site variability using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included.
(C) Data from a clinical study to demonstrate that viewing, reviewing, and diagnosing digital images of surgical pathology slides prepared from tissue slides using the whole slide imaging system is non-inferior to using an optical microscope. The study should evaluate the difference in major discordance rates between manual digital (MD) and manual optical (MO) modalities when compared to the reference (
e.g., main sign-out diagnosis).(D) A detailed human factor engineering process must be used to evaluate the whole slide imaging system user interface(s).
(2) Labeling compliant with 21 CFR 809.10(b) must include the following:
(i) The intended use statement must include the information described in paragraph (b)(1)(i) of this section, as applicable, and a statement that reads, “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 this device.”
(ii) A description of the technical studies and the summary of results, including those that relate to paragraphs (b)(1)(ii) and (iii) of this section, as appropriate.
(iii) A description of the performance studies and the summary of results, including those that relate to paragraph (b)(1)(iv) of this section, as appropriate.
(iv) A limiting statement that specifies that pathologists should exercise professional judgment in each clinical situation and examine the glass slides by conventional microscopy if there is doubt about the ability to accurately render an interpretation using this device alone.