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510(k) Data Aggregation
(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 | <2.5% | 2.6% | N/A | N/A |
| Binocular Colposcope System (KN-2200B/2200BI) | ||||
| MTBF | 41445 hours | N/A | Unknown | Unknown |
| Illumination | ≥30,000 lx | N/A | 80,000 lx | 23,000-35,000 lx |
| Image geometric distortion | ≤2.5% | N/A | Unknown | Less than 7% |
1. A table of acceptance criteria and the reported device performance:
See table above. The "acceptance criteria" are derived from the performance specifications tested and compared against predicate devices.
2. Sample size used for the test set and the data provenance:
Not applicable as this is a physical medical device (colposcope) and not an AI/software as a medical device (SaMD) that typically undergoes testing with a "test set" of patient data. The non-clinical tests likely involved technical measurements on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable for this type of device and submission.
4. Adjudication method for the test set:
Not applicable for this type of device and submission.
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-powered diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used:
For the non-clinical tests performed (Illuminance Test, Image Distortion Test, System Resolution test), the "ground truth" would be established by objective measurement standards and validated reference equipment, not clinical ground truth like pathology or outcomes data.
8. The sample size for the training set:
Not applicable. This device does not use machine learning, so there is no training set.
9. How the ground truth for the training set was established:
Not applicable. There is no training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications and is substantially equivalent to the predicate devices." These tests demonstrated compliance with relevant international standards and the device's own performance specifications. The specific non-clinical tests mentioned are:
- IEC 60601-1-2005+CORR.1:2006+CORR.2:2007: General requirements for basic safety and essential performance.
- IEC 60601-1-2:2007: Electromagnetic compatibility.
- ISO 8600-3:1997: Determination of field of view and direction of view of endoscopes with optics.
- ISO 8600-5:2005: Determination of optical resolution of rigid endoscopes with optics.
- Illuminance Test: Assessed the light intensity produced by the colposcope.
- Image Distortion Test: Measured the geometric distortion in the captured images.
- System Resolution Test: Evaluated the imaging system's ability to distinguish fine details (measured in TVL - Television Lines).
The document notes that "The test results demonstrated that the proposed device complies with the following standards" and met its performance specifications listed in the comparison tables, which often show the proposed device meeting or exceeding the performance of the predicate devices in these technical aspects. The comparison to predicates is the primary method used to argue for substantial equivalence, implying that since the predicate devices are legally marketed and safe/effective, and the proposed device performs comparably or better on key technical specifications, it also meets the necessary safety and effectiveness criteria.
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