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510(k) Data Aggregation
(60 days)
The Biop Digital Colposcope is intended for magnified viewing of the vagina, cervix and external genitalia, in order to assist doctors in diagnosing abnormalities such as lesions or cancer and selecting areas for biopsy. The images from the Digital Colposcope are to be viewed on a color display. The Biop Digital Colposcope is intended for use in hospitals, clinics, and doctor's offices.
The Biop Digital Colposcope comprises 3 components:
. Biop Digital Colposcope Control unit;
. Biop Digital Colposcope unit;
Dedicated PC (touch screen) containing software and vertical stand.
The Biop Digital Colposcope is designed to be utilized at a working distance (WD) of 8" (200mm) -12" (300mm) from the cervix and acquires magnified images according to the doctor's requirements. The colposcope includes LED illumination and digital green filter capabilities as well.
The user can operate the Biop Digital Colposcope unit using the keypad on the Biop Digital Colposcope Control unit and/or via the touch screen of the PC. Via the operation screen on the monitor, the user can visualize the cervix, take snapshots, take video, and use the green filter and additional illumination functionalities. Each of these functions can be controlled and adjusted by designated menus.
The touch-screen graphical user interface (GUI) consists of three menu options: Menu 1, 2, or 3, which allow control over the Biop Digital Colposcope, including the illumination system, zoom functions and Pan options. Each Operation Screen can be used during the colposcopy exam and shows the video taken by the Biop Digital Colposcope camera in real time. Images acquired during colposcopy are shown on the right of the screen. The user can toggle through all images obtained via the Biop Digital Colposcope unit and, if indicated, can acquire the biopsies in a standard manner. In addition, the system also enables full screen presentation of the images.
This document describes the Biop Digital Colposcope and its equivalence to a predicate device. However, it does not contain specific acceptance criteria for a device's performance in diagnosing abnormalities or selecting areas for biopsy using AI or advanced algorithms, nor does it provide a study proving such criteria are met. The document focuses on the physical and optical specifications of the colposcope itself, and its compliance with general medical device standards.
Therefore, for the specific questions requested, much of the information cannot be found in the provided text.
Here is what can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance
The document lists various specifications and states that the device "met its predefined optical specifications" or "met predefined specifications" for those criteria. It does not provide specific acceptance values or thresholds for all listed specifications, nor does it present "device performance" in terms of diagnostic accuracy, sensitivity, or specificity, as the device itself is a viewing tool, not an AI diagnostic system.
| Acceptance Criteria (from specifications/standards) | Reported Device Performance |
|---|---|
| Illumination (2200 Lux at 300mm WD, Diameter > 60mm at 200mm WD) | Met predefined specifications |
| On-axis spatial resolution (57 line-pairs/mm) | Met predefined specifications |
| On-axis angular resolution (0.005°) | Met predefined specifications |
| Geometric Distortion (<3%) | Met predefined specifications |
| Working Distance (200mm – 300mm) | Met predefined specifications |
| Field of View (e.g., At 200mm WD, min mag 28° or ≥φ99 mm; max mag 3.4° or ≥φ11.8 mm) | Met predefined specifications |
| Depth of Field (85mm (at 200mm) - 95mm (at 300mm)) | Met predefined specifications |
| Focus mode (Manual) | Met predefined specifications (user has manual control) |
| Filter (Digital green, polarizing/glare reducing) | Met predefined specifications (performs function) |
| Magnification (Optical x3.7-x30 at 200mm WD) | Met predefined specifications |
| Freeze function | Yes |
| Video output (USB 3.0) | Yes |
| Compliance with ISO 8600-1:2005 (General requirements for medical endoscopes) | Met applicable requirements |
| Compliance with ISO 8600-3:1997/Amd 1:2003 (Field of view and direction of view) | Met predefined specifications |
| Compliance with ISO 8600-5:2005 (Optical resolution) | Met predefined specifications |
| Compliance with ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012 (Basic safety and essential performance) | Demonstrated to be basic safety compatible |
| Compliance with IEC 60601-1-2:2014 (Electromagnetic compatibility) | Demonstrated to be electromagnetically compatible |
| Compliance with IEC 62471 (Photobiological safety) | Demonstrated to be photo biologically safe |
| Shipping container performance (ASTM D4169-16, ASTM D4332-14) | Successfully passed environmental tests |
| Software requirements (FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices") | Met all Software Requirements Specifications, Moderate Level of Concern |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes bench testing and compliance with various standards related to the physical and software characteristics of the device, not clinical performance for diagnosis or biopsy selection. There is no mention of a human-in-the-loop diagnostic test set.
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 provided in the document. As stated above, there is no mention of a diagnostic test set requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. The device description does not include AI or an algorithm for diagnostic assistance, beyond providing images for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The device is a colposcope for human viewing, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document.
8. The sample size for the training set
This information is not provided in the document. The device does not appear to involve machine learning that would require a "training set" in the context of diagnostic performance. The "Software documentation reflected a Moderate Level of Concern," which refers to the documentation for the device's operational software, not an AI training set.
9. How the ground truth for the training set was established
This information is not provided in the document.
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