(30 days)
The Philips IntelliSite Pathology Solution (PIPS) is an automated digital slide 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 sub-systems and a display component:
- . Image Management System (IMS)
- Ultra Fast Scanner (UFS)
- . Display
The provided document is a 510(k) Summary for a minor modification to an existing device, the Philips IntelliSite Pathology Solution (PIPS). The modification is a new display panel. Therefore, the information primarily focuses on demonstrating that this new panel does not adversely affect the device's performance compared to the predicate device.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format of a table with specific numerical thresholds for performance. Instead, it refers to compliance with international and FDA-recognized consensus standards and verification tests. The "reported device performance" is framed as demonstrating similarity to the predicate device and compliance with these standards.
| Acceptance Criteria Category | Reported Device Performance (with new display panel) |
|---|---|
| Compliance with Standards | Complies with IEC 60601-1-2 (4th Ed), ANSI/AAMI ES60601-1:2005/(R)2012, ISO 14971:2007, IEC 62471: 2006; EN 62471: 2008. |
| Technological Characteristics | Similar technological characteristics (Panel type, Technology, Physical display size) to the predicate device (Bi-Search Korea Inc./LG display Co., Ltd. panel). The new panel is from Innolux Corporation. |
| Display Performance Tests (following TPA guidance) | Spatial resolution: Verified to not be affected. |
| Pixel defects: Verified to not be affected. | |
| Temporal response: Verified to not be affected. | |
| Grayscale: Verified to not be affected. | |
| Luminance uniformity and Mura test: Verified to not be affected. | |
| Stability of luminance and chromaticity: Verified to not be affected. | |
| Specular and diffuse reflection coefficients: Verified to not be affected. | |
| Gray tracking: Verified to not be affected. | |
| Color scale response: Verified to not be affected. | |
| sRGB (standard Red Green Blue) color gamut: Verified to not be affected. | |
| Safety and Effectiveness | Demonstrated to be as safe and effective as the predicate device without raising any new safety and/or effectiveness concerns. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical performance testing of a new display panel. It does not mention a "test set" in the context of patient data or clinical imaging for diagnostic performance evaluation. The tests performed were on the display itself.
- No information on sample size for a test set of patient data.
- No information on data provenance (country of origin, retrospective/prospective).
- The tests were performed on the hardware (display panel).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The study described is not a clinical study on diagnostic accuracy or interpretation where expert ground truth would be established. It is a non-clinical study verifying the technical performance of a hardware component (display).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reason as point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. The device (Philips IntelliSite Pathology Solution) is a whole slide imaging system, not an AI-assisted diagnostic tool. This submission is for a hardware change (display panel) to an existing cleared device. The document explicitly states: "The proposed device with the new display panel 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, no improvement with AI assistance was measured or is relevant to this specific submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a whole slide imaging system, not an algorithm, and this submission concerns a display hardware change.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable as there was no clinical study involving patient data or diagnostic interpretation for which ground truth would be established. The "ground truth" for the non-clinical tests would be the established technical specifications and performance limits for display devices.
8. The sample size for the training set
This is not applicable. The device is a whole slide imaging system, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 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.