(77 days)
The Philips IntelliSite Pathology Solution (PIPS) is an automated digital siide 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.
The Philips IntelliSite Pathology Solution (PIPS) is an automated digital slide creation, viewing, and management system. The PIPS consists of two sub-systems and a Display component:
- Image Management System (IMS)
- Ultra Fast Scanner (UFS)
- Display
PIPS 2.6.1 introduces one major change compared to the predicate device PIPS 2.5:
- New display PP27QHD
This document is a 510(k) summary for the Philips IntelliSite Pathology Solution (PIPS) 2.6.1, which introduces a new display (PP27QHD) to the system. The submission claims substantial equivalence to the predicate device, PIPS 2.5, and focuses on demonstrating that the new display does not alter the safety or effectiveness of the overall system. Therefore, the study details provided are primarily related to non-clinical verification and validation of the display, rather than a clinical study evaluating diagnostic performance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria for diagnostic performance or specific clinical metrics. Instead, it focuses on demonstrating that the new display (PP27QHD) maintains the same technological characteristics and performance as the predicate display (PS27QHDCR) with respect to image quality and calibration.
| Item | Acceptance Criteria (Implied) | Reported Device Performance (New Display PP27QHD) |
|---|---|---|
| Dithering Functionality | Temporal and spatial dithering algorithm should remain identical and produce identical images to the predicate device to maintain grayscale resolution and visual effects. Implementation location should not negatively impact image quality. | The temporal and spatial dithering algorithm is identical to the previous device. The implementation location moved from the graphics board to the medical display itself, but "Images remain identical to the predicate device." |
| Supported Color Spaces | Should support sRGB as the default configuration, similar to the predicate. Addition of other color spaces should not negatively impact primary diagnostic use. | sRGB remains the default configuration. Additionally, DICOM and Native color spaces are supported but locked by default. This change is an enhancement that does not degrade the core functionality. |
| Display Interface | Must support existing interfaces (Display Port, USB). Addition of new interfaces should not compromise existing functionality or safety. | Display Port (DP) and Universal Serial Bus (USB 2.0) are supported. Additionally, DVI-D Dual-link is supported. This adds connectivity options without compromising existing functionality. |
| Color Calibration Tools & Method | Calibration software and hardware should ensure accurate color reproduction. Calibration target (sRGB, 350 cd/m2) must be maintained. | Calibration software: QAWeb Agent software installed on the workstation (implements same functions as Nucleus software). Calibration hardware: Built-in front sensor (similar performance to Barco LCD sensor). Calibration target: Unchanged (sRGB with a target luminance of 350 cd/m2). Performance is maintained due to similar sensor performance and software functionality. |
| Frequency & Nature of Quality-Control Tests (User) | Ensure continued display performance and quality checks. Automation of checks and clear user feedback on status are desirable. | The display is calibrated automatically using the built-in front sensor. Calibration and QA checks are performed in the background (weekly by default, controlled by QAWeb Agent software). User is informed via a small balloon in the Windows system tray and a green/red indicator. This is an improvement in convenience and frequency of checks while maintaining quality. |
| General Verification & Validation (PIPS 2.6.1) | All new and updated requirements (including risk control measures) are met. Integration and regression testing ensure system stability. User needs are validated. | Verification testing (new/updated reqs, risk control, integration, regression) performed and passed. In-house validation with user representatives using Design Validation Survey demonstrated user needs are met. (Conclusion: Passed, supports safety/effectiveness, conforms to intended use/user needs). |
| Compliance to Standards & Regulations | PIPS 2.6.1 and the PP27QHD display must comply with relevant international and FDA recognized consensus standards, special controls, and guidance documents. | PIPS 2.6.1 complies with ISO 13485, ANSI/AAMI/ISO 15223-1, ISO 14971, IEC 62304, IEC 62366-1, IEC 61010-1, IEC 61010-2-101, EN 61326-1, EN 61326-2-6, CLSI AUTO11-A, ASTM D4169-16, FCC Part 15, FDA guidance "Technical Performance Assessment...", and Special control for WSI System (DEN160056). The PP27QHD display complies with EN 60601-1, IEC 60601-1, IEC 60601-1-2, ANSI/AAMI ES60601-1, CSA CAN/CSA-C22.2 NO. 60601-1, IEC 60529, IEC 62471, IEC 60950-1, and FCC Part 15. Compliance is affirmed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical test set in the traditional sense for diagnostic performance. The "test set" for the PIPS 2.6.1, as described, appears to be related to non-clinical verification and in-house validation with user representatives.
- Sample Size for Test Set: Not explicitly stated in terms of number of cases or images. For the "in-house validation with user representatives," it mentions "Each user was provided a Design Validation Survey," implying a number of users, but the exact count is not given.
- Data Provenance: Not applicable as a clinical study with patient data was not conducted. The testing described is primarily technical and user experience validation of a hardware change.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to the documented study for PIPS 2.6.1. The study focuses on technical and user validation of a display change, not diagnostic performance where expert ground truth for specific cases would be established. For the "in-house validation with user representatives," these are described as "users" but their specific qualifications (e.g., pathologists with x years of experience) are not detailed, nor are they establishing ground truth for diagnostic purposes.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication of diagnostic interpretations. The "in-house validation" used a "Design Validation Survey" for user feedback, which is a different type of assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
No, an MRMC comparative effectiveness study was not explicitly stated or described. The document explicitly states: "PIPS 2.6.1 did not require clinical studies to establish substantial equivalence to the predicate device PIPS 2.5." The focus was on demonstrating that the display change did not negatively impact the system's performance, eliminating the need for a new clinical study. Therefore, there is no reported effect size for human readers with vs. without AI assistance. The Philips IntelliSite Pathology Solution is a Whole Slide Imaging (WSI) system for pathologists to review digital images, and the AI component (if any beyond image processing) is not the focus of this 510(k).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. The Philips IntelliSite Pathology Solution, including the new display, is explicitly described as "an aid to the pathologist to review and interpret digital images." It is a system designed for human-in-the-loop interpretation, not a standalone diagnostic algorithm.
7. The Type of Ground Truth Used
Not applicable for a diagnostic performance study. The "ground truth" in this context would be compliance with technical specifications and user satisfaction/usability, rather than expert consensus on disease diagnosis or pathology.
8. The Sample Size for the Training Set
Not applicable. This 510(k) does not describe the development or training of an AI algorithm; it pertains to an update of a Whole Slide Imaging system, specifically a new display.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set for an AI algorithm is described.
§ 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.