(90 days)
FullFocus™ is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret, and manage digital images of pathology slides for primary diagnosis. FullFocus is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.
It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. FullFocus is intended for use with Philips Ultra Fast Scanner and monitor displays validated with verified test methods to meet required performance characteristics.
FullFocus is a web-based software-only device for viewing and manipulating digital pathology images of glass slides obtained from the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner (UFS) on the monitor displays that are validated with verified test methods to meet required performance characteristics. FullFocus reproduces the whole slide images and is an aid to the pathologist to review. interpret and manage digital images of pathology slides for primary diagnosis.
Here's a breakdown of the acceptance criteria and the study information for the FullFocus device, based on the provided FDA 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pixel-wise comparison | Visually adequately reproduces digital pathology images to human readers with respect to its intended use (compared to PIPS, including zooming and panning). |
| Turnaround time (Case selection) | Not longer than 10 seconds until the image is fully loaded. |
| Turnaround time (Panning) | Not longer than 7 seconds until the image is fully loaded (for panning one quarter of the monitor). |
| Measurements Accuracy | Performs accurate measurements (verified using a test image containing objects with known sizes). |
| Human factors testing | Found to be safe and effective for the intended users, uses, and use environments; user interface is intuitive, safe, and effective for the range of intended users. |
Further Study Information
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Sample size used for the test set and data provenance:
- Clinical Study: No clinical study involving diagnosis by human readers for diagnostic accuracy comparison is mentioned in this document. The "studies" described are non-clinical technical performance assessments and human factors testing.
- Pixel-wise comparison: The document doesn't specify a sample size for slides or images, only that it "was conducted to compare color images reproduced by FullFocus and PIPS IMS." Data provenance is not mentioned, but it's implied the images were generated by a Philips Ultra Fast Scanner, given the device's compatibility and comparison to the PIPS IMS.
- Measurements: "a test image containing objects with known sizes" was used. Specific sample size is not indicated.
- Human Factors Testing: "Task-based usability tests" were performed. The number of participants (intended users) is not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the pixel-wise comparison, the "ground truth" was essentially the visual fidelity to images produced by the predicate device (PIPS IMS). The "human readers" mentioned in the performance description are not described as experts establishing ground truth, but rather as observers confirming visual adequacy. No specific number or qualifications of these readers are given.
- For measurements, the ground truth was the "known sizes" of objects within a test image. This would not require expert pathologists to establish.
- For human factors testing, the "ground truth" relates to usability and safety, which is assessed directly by intended users during task performance, rather than established by an "expert" in the diagnostic sense.
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Adjudication method for the test set:
- Not applicable as there was no study described that involved diagnostic interpretations requiring adjudication.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- No. The document explicitly states that FullFocus is a "software only device intended for viewing and management of digital images... It is an aid to the pathologist to review, interpret, and manage digital images...". It is a viewer, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed or described.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. FullFocus is a viewing and management system for pathologists, not a standalone diagnostic algorithm. Its function is to facilitate human review.
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The type of ground truth used:
- For Pixel-wise comparison, the ground truth was the visual representation and fidelity of images from the predicate device (PIPS IMS).
- For Measurements, the ground truth was "known sizes" of objects in a test image.
- For Turnaround time and Human factors testing, the ground truth was based on pre-defined system requirements and direct usability observations/feedback.
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The sample size for the training set:
- Not applicable. FullFocus is described as a viewing and management software, not an AI or machine learning algorithm that requires a training set in the typical sense for diagnostic performance.
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How the ground truth for the training set was established:
- Not applicable, as no training set for an AI/ML 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.