(89 days)
The Gynex brand 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 CO-1000 Colposcope is a precise optical instrument designed specially for the gynecologic examination. The Gynex brand colposcope can be used to view vaginal and cervical tissues using stereoscopic optics. The Gynex CO-1000 Colposcope has detailed features that include wide field of view, long focal length, uniform illumination, adjustable brightness, ease of operation, and exceptional optics. It is an essential instrument for any gynecologic examination. The general features of the device are as follows: Eyepiece magnification: 12.5X. Overall Magnification: 9X Focal length: 320mm. Individually adjustable evepieces. Smooth adjustable controls for fine focus. Universal Teflon ball joint gives you 360° easy motion for gross focus. Built-in green filter for enhanced contrast. Built-in rheostat. Easy replacement of halogen light bulb. Unit is completely assembled and ready for use once power is on.
The provided text describes a 510(k) Premarket Notification for the CO-1000 Colposcope. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive new clinical studies and acceptance criteria. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets said criteria in the way one might expect for a novel device or a Premarket Approval (PMA) application.
Instead, the submission asserts that the CO-1000 Colposcope is substantially equivalent to the DFV CPG Colposcope (K021854). Substantial equivalence is established by comparing the device's intended use, basic design, materials, method of manufacture, physical dimensions, and clinical utility to the predicate device.
Given this, I cannot extract the specific information requested in your prompt regarding acceptance criteria and studies demonstrating their fulfillment, as this information is not part of this 510(k) summary.
However, I can provide available information based on the document's content:
Summary of Device Information based on 510(k) Submission:
The GYNEX CO-1000 Colposcope is a Class II device intended for direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina, used to diagnose abnormalities and select areas for biopsy.
1. A table of acceptance criteria and the reported device performance:
- This document does not define specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) for diagnosis or examination.
- The "performance" described relates to the device's functional features (e.g., magnification, focal length, illumination) and its claim of substantial equivalence to a predicate device.
| Criterion Type (Implied for Colposcopes based on description) | Reported Device Performance / Feature |
|---|---|
| Optical System | |
| Eyepiece Magnification | 12.5X |
| Overall Magnification | 9X |
| Focal Length | 320mm |
| Field of View | Wide |
| Optics Quality | Exceptional |
| Individually adjustable eyepieces | |
| Illumination | Uniform Illumination |
| Adjustable Brightness | |
| Built-in rheostat | |
| Ergonomics / Functionality | Ease of Operation |
| Smooth adjustable controls for fine focus | |
| Universal Teflon ball joint for 360° easy motion (gross focus) | |
| Enhancement Features | Built-in green filter for enhanced contrast |
| Maintenance | Easy replacement of halogen light bulb |
| Assembly | Completely assembled and ready for use once power is on |
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 / Not provided. This 510(k) submission does not describe a clinical study with a test set. The substantial equivalence argument relies on comparing the CO-1000 Colposcope's specifications and design to a legally marketed predicate device, not on new clinical data demonstrating its performance against a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. No test set or ground truth establishment is described in this regulatory submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No test set or adjudication is described.
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. This device is a colposcope, an optical instrument, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This device is a physical optical instrument, not an algorithm. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided. No new clinical study requiring ground truth is described. The basis for clearance is substantial equivalence to a predicate device, which inherently means the predicate device's existing regulatory clearance and presumed safety and effectiveness serve as the "ground" for the new device's clearance.
8. The sample size for the training set:
- Not applicable / Not provided. No training set is mentioned as this device is a physical instrument, not a learned algorithm.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. No training set or ground truth establishment is described.
In summary, the provided document is a 510(k) premarket notification for a Class II medical device, a colposcope. The regulatory pathway for this device is based on demonstrating substantial equivalence to a predicate device, not on presenting new clinical data from studies designed to meet specific performance acceptance criteria. Therefore, most of the detailed questions regarding study design, sample sizes, and ground truth establishment are not addressed in this type of submission.
§ 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.