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510(k) Data Aggregation
(145 days)
The C3A, C6A video colposcope is intended for gynecological examination. It provides magnified visualization of the vagina, cervix and external genitalia, which can help diagnose 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 or to touch the patient.
The Edan video colposcope, including models C3A and C6A, consists of the camera module (CCD color camera), stand (vertical or swing arm stand), video capture box, foot switch, and video colposcope software. The Edan video colposcope is a non-patient contacting medical device. The C3A, C6A video colposcope is a digital imaging equipment that works as follows: The loop group LED light illumines the target, and the CCD camera takes images of the target. The images are converted into video signals, which are then captured and transmitted to a commercially available computer or monitor. The video colposcope software implements the functions of displaying images, capturing images or taking videos, storing and managing images and providing reports.
The provided text is a 510(k) summary for the Edan Instruments, Inc. Video Colposcope, models C3A and C6A. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria in a clinical context.
Here's an attempt to extract and infer information based on the request, acknowledging that a direct "study proving acceptance criteria" as might be found in a clinical trial report is not present in this regulatory document.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a tabulated format for direct comparison with performance results for clinical outcomes. Instead, it lists technical specifications and compares them to a predicate device. The performance data section refers to bench testing and compliance with standards.
| Acceptance Criteria (Implied from Predicate Comparison & Standards) | Reported Device Performance (Edan C3A, C6A) |
|---|---|
| Power Supply | |
| Voltage: 100 V-240 V~ | 100 V-240 V~ |
| Frequency: 50 Hz/60 Hz | 50 Hz/60 Hz |
| Input power (Maximum): Comparable to predicate | C3A, C6A: 48 VA (Predicate: 500 VA) - Different, but deemed acceptable for substantial equivalence. |
| Specifications | |
| Standard Configuration: Digital CCD camera, Stand | Digital CCD camera, Stand |
| Light module: Comparable to predicate | C3A: Single loop group LED light; C6A: Double loop group LED light (Predicate: Double loop group LED light) - Different, but deemed acceptable. |
| Light source: White LED light | White LED light |
| Illumination: Comparable to predicate | C3A: 1600 lux at 300 mm; C6A: 3000 lux at 300 mm (Predicate: 2200 lux at 300 mm) - Different, C6A better, C3A lower but still acceptable. |
| Illumination range: ≥φ60 mm at 200 mm | ≥φ60 mm at 200 mm |
| Light source lifetime: ≥10,000 hours | ≥10,000 hours |
| System resolution: Comparable to predicate | ≥500 TVL (Predicate: ≥470 TVL) - Better. |
| Space resolution: Comparable or sufficient (Predicate: N/A) | ≥10 lpm - Specific value provided. |
| Image geometric distortion: Comparable to predicate | <3% (Predicate: <2.6%) - Slightly higher distortion, but deemed acceptable. |
| Magnification: Comparable to predicate | C3A: 1 ~ 28X; C6A: 1 ~ 36X (Predicate: 1 ~ 40X) - Different, but within a functional range. |
| Operation Distance: 200 mm-300 mm | 200 mm-300 mm |
| Field of view: Comparable to predicate | 3X: ≥φ80 mm OR ≥16.5°; 18X: ≥φ12 mm OR ≥2.5° (Predicate: At min mag 52° or ≥φ60 mm; At max mag ≥φ10 mm) - Different measurements, implied as functionally similar. |
| Depth of field: Comparable to predicate | 6X: ≥120 mm; 18X: ≥6 mm (Predicate: 1X: ≥ 120 mm; 40X: ≥ 5 mm) - Different measurements, implied as functionally similar. |
| Focus mode: Electronic control | Electronic control: Manual and auto focus (Predicate: Auto focus only) - Improved functionality. |
| Electronic Filter: Green filter (3 grades) | Green filter (3 grades) |
| Magnification and timing display: YES | YES |
| Freeze function: YES | YES |
| Stand type: Vertical | Vertical, swing arm (optional) - More options. |
| Video Output: S-Video, Video | S-Video - Different, but common and compatible. |
| MBTE: Comparable to predicate | < 48,956h (Predicate: < 50,000h) - Slightly lower, but still meeting reliability expectations. |
| Standards Compliance | |
| IEC 60601-1, IEC 60601-1-2, ISO 8600-3, ISO 8600-5 | IEC 60601-1:2005/A1:2012, IEC 60601-1-2:2007 (Specific compliance listed for electrical safety & EMC). Bench testing in line with ISO 8600-3 and ISO 8600-5. |
| Software Level of Concern | "Moderate" |
| Image Geometric Distortion | Performed, results not explicitly detailed percentage-wise but deemed acceptable. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of this 510(k) summary. The document describes engineering and performance bench testing rather than clinical study data with test sets of patient cases.
- Data Provenance: The 'data' in this context refers to engineering test results, not patient data. It's generated from testing the physical device in a lab setting, presumably by Edan Instruments, Inc. in P.R. China, where the company is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This is not a study involving expert-established ground truth for a test set of images or cases. It's a technical specification and bench testing summary.
4. Adjudication Method for the Test Set
Not applicable. There is no test set of cases requiring adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. The document does not describe human reader performance or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a video colposcope, which is a physical imaging tool used by a human clinician. It does not involve a standalone algorithm for diagnosis.
7. The Type of Ground Truth Used
For the technical performance aspects, the "ground truth" is established by direct physical measurements and functional testing against recognized standards (e.g., IEC, ISO) and comparison to the predicate device's specifications. For instance, illumination is measured in lux, resolution in TVL, and lifetime in hours.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI models that require a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an algorithm.
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