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510(k) Data Aggregation
(178 days)
Agfa's Skintell is an Optical Coherence Tomography (OCT) system indicated for use in two-dimensional, cross-sectional, real-time imaging of external tissues of human body.
Agfa's Skintell is an optical coherence tomography imaging device (OCT) weighing approximately 105kg. It is used to create images of non-open wounded human skin and the corresponding close-to-surface tissue. Skintell offers users the following functions: volume and cross-sectional imaging, high resolution rendering of structures, geometrical length- measurements.
Here’s an analysis of the acceptance criteria and supporting study for the Agfa Skintell OCT system, based on the provided 510(k) summary:
The 510(k) summary for Agfa Skintell (K132800) is a substantial equivalence submission, meaning it aims to demonstrate that the new device is as safe and effective as a legally marketed predicate device (Michelson Diagnostics VivoSight Topical OCT System, K093520). Therefore, the "acceptance criteria" are primarily defined by the performance of the predicate device and relevant product safety/quality standards. The "study" largely consists of verification and validation testing, including comparative evaluations with the predicate and histological analysis.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a substantial equivalence submission relying heavily on a predicate device, the "acceptance criteria" are implicit in demonstrating performance that is equivalent or superior in key aspects, while adhering to relevant standards. The performance aspects are compared directly to the predicate.
| Acceptance Criteria (Implicit from Predicate & Standards) | Reported Device Performance (Agfa Skintell) |
|---|---|
| Functional Equivalence to Predicate K093520 | Provides volume and cross-sectional imaging, high resolution rendering of structures, geometrical length-measurements. |
| Optical Resolution (Predicate: < 7.5 µm lateral, < 5 µm axial) | 3 µm lateral and axial (Superior to predicate). The filing implicitly states this is an improvement that yields "sharper and clearer images." |
| Image Depth (Predicate: Up to 2.0 mm) | Up to 1.0 mm (Less than predicate). The filing argues this shallower depth is still suitable as significant structures are often within this range, and the improved resolution at this depth compensates for the reduced penetration. |
| Scanning Range (Predicate: 5mm x 5mm) | 1.8mm x 1.5mm (enface) (Less than predicate). The filing states the probe is movable, allowing the smaller field of view to be positioned as needed, implying this difference does not impact safety or effectiveness. |
| Image Quality & Visualization of Skin Structures | "Produces sharper and clearer images than the Michelson device." "Typical patterns of normal skin as well as typical patterns of lesions itself visible on the standard HE stained histopathology section can be linked to image patterns visible in the slice- and enface-images of the Skintell device. Thus, Skintell offers the possibility to visualize skin-structures in-vivo." |
| Compliance with Product Standards (e.g., IEC 60601-1, IEC 60601-1-2, EN 1041) | Device "conforms to product safety, radiology, and imaging standards." Specifically lists compliance with IEC 60601-1: 2005, IEC 60601-1-2: 2007, EN 1041:2008. |
| Compliance with Quality Management & Biocompatibility Standards (e.g., ISO 14971, ISO 13485, ISO 10993 series) | "Conforms to product safety, radiology, and imaging standards." Specifically lists compliance with ISO 14971:2007, ISO 13485:2003, ISO 10993-1:2009, ISO10993-5: 2009, ISO10993-10: 2010, ISO10993-12: 2007. Also states "Biocompatibility tests" were performed. |
| Safety and Effectiveness (Compared to Predicate) | "Differences in devices do not alter the intended therapeutic/diagnostic effect." "Differences are minor and would not be expected to impact safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document simply states "Images were taken using both the slice and enface modes of the Skintell device and anlaysed histopathologically." It does not specify the number of images, cases, or subjects used for this analysis.
- Data Provenance: Not explicitly stated, but the submission is from Agfa HealthCare N.V. (Belgium). The study involved "histopathologically analyzed" images, suggesting human tissue samples. It is not specified if the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: The document mentions "external and internal experts" comparing Agfa's Skintell device to the predicate for image quality evaluations. It does not specify the number of experts involved.
- Qualifications of Experts: The qualifications of these experts are not provided.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method for reconciling varying expert opinions, if multiple experts were indeed used for image quality evaluation. It broadly mentions "image quality evaluations with external and internal experts."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not explicitly mentioned or performed in the context of human readers improving with AI vs. without AI assistance. This submission is for an imaging device (OCT system), not an AI-powered diagnostic algorithm. The comparison was primarily between the new device and a predicate device, and the demonstration of image quality and ability to visualize structures.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, this is not applicable. The Agfa Skintell is an imaging device, not an algorithm. Its "performance" refers to its ability to acquire high-quality images and show anatomical structures, not to an automated diagnostic output. The evaluation focused on the physical characteristics of the images produced by the device and their correlation with histopathology.
7. Type of Ground Truth Used
The primary ground truth used for evaluating the Skintell device's ability to visualize skin structures was histopathology (standard HE stained histopathology section). The document states: "Typical patterns of normal skin as well as typical patterns of lesions itself visible on the standard HE stained histopathology section can be linked to image patterns visible in the slice- and enface-images of the Skintell device."
8. Sample Size for the Training Set
Not applicable. This is an imaging device, not an AI/machine learning algorithm requiring a training set. The device produces images based on physical principles of optical coherence tomography.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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