(219 days)
The Colposcope System is intended for magnified viewing of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities and select areas for biopsy. It is intended to be used only by trained and qualified personnel in hospitals, clinics and private offices, and not intended for home use.
The Colposcope System is intended for magnified viewing of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The Colposcope System has two kinds of colposcopes, a video colposcope and a binocular colposcope.
The video colposcope system is a non-patient contacting image capture device (CCD color camera) with a digital magnification of up to x16, working distance supporting 200mm, and a green filtered light source mounted on a vertical stand, swing arm stand or trolley. Tissue is magnified and viewed directly via the LCD screen attached to the capture device or on the commercially available color monitor. The video colposcope system has four models, including KN-2200A, KN-22001 and KN-2200I(H).
The binocular colposcope system is designed based on an optical colposcope. Its imaging system consists of optical imaging and CCD imaging. It permits viewing of the vagina, cervix and external genitalia by a telescopic system and the CCD camera captures digital images. The binocular colposcope system has two models, including KN-2200B and KN-2200BI. The two models have the same binoculars, CCD camera, cables except for the light source size and the stand type.
Both video colposcope system and binocular colposcope come with image management software, which is provided on a CD-ROM. The image management software allows the viewer to view, compare, record and print the image by series peripheral units, such as computer, monitor and printer.
The provided document is a 510(k) Summary for the Xuzhou Kernel Medical Equipment Co., Ltd. Colposcope System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the manner an AI device might.
Therefore, the information required to fully answer the request, particularly regarding specific performance metrics (like sensitivity, specificity, accuracy), sample sizes for test and training sets, expert qualifications, ground truth establishment for a diagnostic AI, or MRMC studies, is not present in this document.
However, I can extract the available information related to non-clinical tests and performance specifications that are analogous to acceptance criteria in this context.
Acceptance Criteria and Device Performance (Derived from Non-Clinical Tests and Specifications)
| Acceptance Criteria (Performance Specification) | Reported Device Performance (Proposed Device) | Predicate Device 1 (K021153) Performance | Predicate Device 2 (K070845) Performance | Predicate Device 3 (K140754) Performance |
|---|---|---|---|---|
| Video Colposcope System (KN-2200/2200A/2200I/2200I(H)) | ||||
| Illumination (at 200-400mm working distance) | ≥1200 Lx | 2200 Lx (at 200-400mm) | N/A | N/A |
| Illumination range (at 200mm working distance) | ≥φ60mm | ≥φ60mm (at 200mm) | N/A | N/A |
| Light source lifetime | ≥ 10,000 hours | ≥ 10,000 hours | N/A | N/A |
| MTBF (Mean Time Between Failures) (KN-2200) | 59817 hours | ≤ 50,000 hours | N/A | N/A |
| MTBF (KN-2200A) | 26985 hours | ≤ 50,000 hours | N/A | N/A |
| MTBF (KN-2200I) | 19778 hours | ≤ 50,000 hours | N/A | N/A |
| MTBF (KN-2200I(H)) | 37301 hours | ≤ 50,000 hours | N/A | N/A |
| System resolution (KN-2200/2200A) | ≥ 700 TVL | ≥ 470 TVL | N/A | N/A |
| System resolution (KN-2200I) | ≥ 550 TVL | ≥ 470 TVL | N/A | N/A |
| System resolution (KN-2200I(H)) | ≥ 1000 TVL | ≥ 470 TVL | N/A | N/A |
| Image geometric distortion |
§ 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.