(141 days)
A Colposcope is a device designed to permit viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. A Colposcope is used to diagnose and examine abnormalities of the vagina and cervix. The patient's population for which the Colposcope is intended is any person of the feminine sex.
A Colposcope is a device designed to permit viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. The device consists of Stands, Power supply, and Microscope head.
The provided text is a 510(k) summary for the DFV CPG Colposcope from October 25, 2002. It describes the device and its intended use but does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically seen in AI/ML performance evaluations.
This document is a traditional premarket notification for a medical device (a colposcope), not an AI/ML-driven device. Therefore, the questions related to AI/ML specific performance evaluation (like sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable to this submission.
The document focuses on demonstrating substantial equivalence to existing colposcopes already cleared by the FDA, primarily by comparing physical and technical characteristics.
Here's the closest information available in the document, interpreted for a traditional medical device:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the way an AI/ML study would define performance metrics. Instead, it provides physical and optical specifications that are implicitly expected to meet industry standards for colposcopes and be comparable to predicate devices.
| Specification | Reported Device Performance |
|---|---|
| Resolution (USAF 51 reticule) | Selector A: 20 line-pairs/mm |
| Selector B: 28 line-pairs/mm | |
| Selector C: 45 line-pairs/mm | |
| Selector D: 56 line-pairs/mm | |
| Selector E: 72 line-pairs/mm | |
| Depth of Field (USAF 51 reticule & comparator clock) | Selector A: ~15 mm |
| Selector B: ~9 mm | |
| Selector C: ~3 mm | |
| Selector D: ~2 mm | |
| Selector E: ~1 mm | |
| Distortion (%) | Ranges from approximately 0% to 10% (from graph) |
Note: The document doesn't provide explicit acceptance criteria values (e.g., "resolution must be at least X line-pairs/mm"). The reported performance implicitly serves as proof that the device operates within acceptable parameters for a colposcope.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is not an AI/ML device and does not involve study on a 'test set' of patient data in this context. The performance metrics (resolution, depth of field) are measured using optical standards (USAF 51 reticule, comparator clock) on the device itself.
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):
Not applicable. Ground truth as typically understood for AI/ML is not relevant for this traditional device's performance claims.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not an AI/ML device.
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:
Not applicable. This is a traditional colposcope, not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. For resolution and depth of field, the "ground truth" is established by physical measurement standards (USAF 51 reticule, comparator clock).
8. The sample size for the training set:
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.
§ 884.1630 Colposcope.
(a)
Identification. A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.(b)
Classification. Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.