(227 days)
Gynecological and (Obstetrical colposcope MEDISCOPE, Diagnostic Device), is intended for magnified viewing of the tissues of cervix.
MEDISCOPE, colposcope ( Obstetrical and Gynecological Diagnostic Device ) is a medical camera unit and accessories to be used to magnify and view tissues of the cervix and diagnose abnormalities and select areas for biopsy. Mediscope consists of a main unit ( power source ) and probe. MEDISCOPE is designed for effective communication and education between doctors and patients. MEDISCOPE can be connected to a TV, CCTV, or Color Video Printer.
This document is a 510(k) premarket notification for a colposcope, which is a medical device. As such, the information provided focuses on demonstrating substantial equivalence to a predicate device and adherence to safety standards, rather than the kind of clinical study data typically associated with novel AI-driven diagnostic devices. Therefore, many of the requested fields regarding acceptance criteria and performance against a gold standard derived from clinical studies will not be found in this type of document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | "SOMETECH INC. BELIEVES THE MEDISCOPE IS SUBSTANTIALLY EQUIVALENT TO THE WELCH ALLYN COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM (510(K) NUMBER K955635)." |
| Design Specifications | "MEDISCOPE MEETS ALL DESIGN SPECS" |
| Electrical Safety Standards | Met IEC 60601-1 (Medical electrical equipment Part 1: General requirements for safety.) |
| Electromagnetic Compatibility (EMC) Standards | Met En 60601-1-2 (Standard for Electromagnetic Compatibility.) |
| General Safety Requirements for Medical Devices | "MEDISCOPE meets or exceeds all safety requirements for a medical device in its class." |
2. Sample size used for the test set and the data provenance
This document does not describe a clinical performance study with a "test set" in the context of diagnostic accuracy. The device is a colposcope, a visual magnification tool for examination. The evaluation focuses on safety and technical equivalence to a predicate device, not on diagnostic output.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As noted above, this submission is for a medical device (colposcope) that is a tool for visual examination, not a diagnostic AI algorithm. Therefore, no "ground truth" establishment by experts in the context of a diagnostic performance study is described.
4. Adjudication method for the test set
Not applicable. No diagnostic performance test set 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
Not applicable. This is not an AI-driven device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" used for this submission is adherence to established medical device standards for design, safety, and equivalence to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. No machine learning model or training set is described.
9. How the ground truth for the training set was established
Not applicable. No machine learning model or training set is described.
§ 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.