(79 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 PP27QHD display, a Beacon C411W display or a Barco MDCC-4430 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 or MDCC-4430 .
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. 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 5.1.
This document is a 510(k) summary for the Philips IntelliSite Pathology Solution (PIPS) 5.1. It describes the device, its intended use, and compares it to a legally marketed predicate device (also PIPS 5.1, K242848). The key change in the subject device is the introduction of a new clinical display, Barco MDCC-4430.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on demonstrating substantial equivalence of the new display (Barco MDCC-4430) to the predicate's display (Philips PP27QHD). The acceptance criteria are largely derived from the FDA's "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices" (TPA Guidance) and compliance with international consensus standards. The performance is reported as successful verification showing equivalence.
| Acceptance Criteria (TPA Guidance 항목) | Reported Device Performance (Subject Device with Barco MDCC-4430) | Conclusion on Substantial Equivalence |
|---|---|---|
| Display type | Color LCD | Substantially equivalent: Minor difference in physical display size is a minor change and does not raise any questions of safety or effectiveness. |
| Manufacturer | Barco N.V. | Same as above. |
| Technology | IPS technology with a-Si Thin Film Transistor (unchanged from predicate) | Substantially equivalent: Proposed and predicate device are considered substantially equivalent. |
| Physical display size | 714 mm x 478 mm x 74 mm | Substantially equivalent: Minor change, does not raise safety/effectiveness questions. |
| Active display area | 655 mm x 410 mm (30.4 inch diagonal) | Substantially equivalent: Slightly higher viewable area is a minor change. Verification testing confirms image quality is equivalent to the predicate device. |
| Aspect ratio | 16:10 | Substantially equivalent: This change does not raise any new concerns on safety and effectiveness. Proposed and predicate device are considered substantially equivalent. |
| Resolution | 2560 x 1600 pixels | Substantially equivalent: Slightly higher resolution and pixel size is a minor change. Verification testing confirms image quality is equivalent to the predicate device. Conclusion: This change does not raise any new concerns on safety and effectiveness. Proposed and predicate device are considered substantially equivalent. |
| Pixel Pitch | 0.256 mm x 0.256 mm | Same as above. |
| Color calibration tools (software) | QAWeb Enterprise version 2.14.0 installed on the workstation | Substantially equivalent: New display uses different calibration software, but calibration method (built-in front sensor), calibration targets, and frequency of quality control tests remain unchanged. Conclusion: This change does not raise new safety/effectiveness concerns. |
| Color calibration tools (hardware) | Built-in front sensor (same as predicate) | Same as above. |
| Additional Non-clinical Performance Tests (TPA Guidance) | Verification that technological characteristics of the display were not affected by the new panel, including: Spatial resolution, Pixel defects, Artifacts, Temporal response, Maximum and minimum luminance, Grayscale, Luminance uniformity, Stability of luminance and chromaticity, Bidirectional reflection distribution function, Grav tracking, Color scale response, Color gamut volume. | Conclusion: Verification for the new display showed that the proposed device has similar technological characteristics compared to the predicate device following the TPA guidance. In compliance with international/FDA-recognized consensus standards (IEC 60601-1, IEC 60601-1-6, IEC 62471, ISO 14971). Safe and effective, conforms to intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "sample size" in terms of cases or images for the non-clinical performance tests. The tests were performed on "the display of the proposed device" to verify its technological characteristics. This implies testing on representative units of the Barco MDCC-4430 display.
The data provenance is not specified in terms of country of origin or retrospective/prospective, as the tests were bench testing (laboratory-based performance evaluation of the display hardware) rather than clinical studies with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications
This information is not applicable to this submission. The tests performed were technical performance evaluations of hardware (the display), not clinical evaluations requiring expert interpretation of medical images. Ground truth for these technical tests would be established by objective measurements against specified technical standards and parameters.
4. Adjudication Method for the Test Set
This information is not applicable to this submission. As the tests were technical performance evaluations of hardware, there would not be an adjudication process involving multiple human observers interpreting results in the same way there would be for a clinical trial.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done.
The submission 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."
Therefore, there is no effect size reported for human readers with and without AI assistance, as AI functionality for diagnostic interpretation is not the subject of this 510(k) (the PIPS 5.1 "does not include any automated image analysis applications that would constitute computer aided detection or diagnosis").
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The PIPS 5.1 is a digital slide creation, viewing, and management system, not an AI algorithm for diagnostic interpretation. The focus of this 510(k) is the display component. The device itself is designed for human-in-the-loop use by a pathologist.
7. The Type of Ground Truth Used
For the non-clinical performance data, the "ground truth" was based on:
- International and FDA-recognized consensus standards: This includes IEC 60601-1, IEC 60601-1-6, IEC 62471, and ISO 14971.
- TPA Guidance: The "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices" guidance document, which specifies technical parameters for displays.
- Predicate device characteristics: Demonstrating that the new display's performance matches or is equivalent to the legally marketed predicate device's display across various technical parameters.
In essence, the ground truth was established by engineering specifications, technical performance targets, and regulatory standards for display devices.
8. The Sample Size for the Training Set
This information is not applicable. The PIPS 5.1, as described, is a system for digital pathology, not an AI algorithm that requires a training set of data. The 510(k) specifically mentions: "The PIPS does not include any automated image analysis applications that would constitute computer aided detection or diagnosis." Therefore, there is no AI training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no AI training set.
§ 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.