(413 days)
The GC-3000E Digital Colposcope is intended for the magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and select areas for biopsy. The image can be viewed on a color screen or computer monitor and printed on a color printer. The device is intended to be used in hospitals and clinics.
GC-3000E is a digital colposcope intended to provide magnified viewing of the vagina, cervix and external genitalia. GC-3000E is used to diagnose abnormalities and select areas for biopsy. GC-3000E acquires and displays high-resolution still and sequentially captured images and videos.
GC-3000E offers non-patient contact, fully digital and high-resolution imaging of the cervix. The field of view is illuminated by circular LED group light source; a high-resolution color CCD camera provides crisp magnified color images. The images can be viewed on a commercially available color monitor.
Components: Digital Camera, Vertical Stand
This 510(k) submission is for a traditional medical device (colposcope), not an AI/ML powered device. As such, it does not contain information typically found in submissions for AI/ML devices regarding acceptance criteria, study designs, or performance metrics.
However, based on the provided text, I can infer the acceptance criteria and the study that proves the device meets the acceptance criteria from the perspective of demonstrating substantial equivalence to a predicate device.
Here's the breakdown, addressing the questions where information is available or inferable:
Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence Comparison)
The acceptance criteria for the GC-3000E Digital Colposcope System are largely based on demonstrating that its performance characteristics are either equivalent to or better than the predicate device (SLC-2000A) and that any differences do not affect its effectiveness and safety.
| Specification | Acceptance Criteria (Relative to Predicate SLC-2000A) | Reported GC-3000E Performance | Discussion / Rationale for Acceptance |
|---|---|---|---|
| Color Rendering | Equal to or better than predicate, without affecting effectiveness/safety. | 85 or above (Predicate: 75 or below) | Met. Higher "color rendering" is considered better performance and does not affect effectiveness/safety. |
| Illuminance at 300mm | Sufficient light (≥ 2000 Lux) for visual tasks, not significantly worse than predicate, and without affecting effectiveness/safety. | 2046 Lx (Predicate: 2200 Lx) | Met. Though slightly lower, it still provides sufficient light (≥ 2000 Lux) for visual tasks of low contrast and small size for prolonged periods. The difference does not affect effectiveness/safety. |
| Illuminance Range | Equal to predicate. | ≥ φ60mm, at working distance 200mm (Predicate: ≥ φ60mm, at working distance 200mm) | Met. Identical. |
| Light Source Lifetime | Equal to predicate. | ≥ 10,000 hours (Predicate: ≥ 10,000 hours) | Met. Identical. |
| MTBF (Mean Time Between Failures) | Sufficiently long for normal service life (≤ 10 years for a digital colposcope), even if lower than predicate, without affecting effectiveness/safety. | ~38,000h (Predicate: ≤ 50,000h) | Met. While lower than the predicate, 38,000h translates to 25-26 years of operation (based on 1500 hours/year), which is significantly longer than a normal service life of ≤ 10 years. The difference does not affect effectiveness/safety. |
| System Resolution | Equal to or better than predicate, without affecting effectiveness/safety. | ≥ 500 TVL (Predicate: ≥ 470 TVL) | Met. Higher resolution is considered better visual performance and does not affect effectiveness/safety. |
| Image Geometric Distortion | Equal to or better than predicate (i.e., lower distortion percentage), without affecting effectiveness/safety. | 1.8% (Predicate: 2.6%) | Met. Lower distortion is considered a better visual result and does not affect effectiveness/safety. |
| Magnification | Equal to predicate. | Optical: 1 | Met. Identical. |
| Field of View | Equal to predicate. | 52° or at minimum magnification ≥ 60mm & at maximum magnification ≥ 10mm (Predicate: 52° or at minimum magnification ≥ 60mm & at maximum magnification ≥ 10mm) | Met. Identical. |
| Depth of Field | Equal to predicate. | At min mag ≥ 120mm; At max mag ≥ 5mm (Predicate: At min mag ≥ 120mm; At max mag ≥ 5mm) | Met. Identical. |
| Focus Mode | Functionally equivalent to predicate, providing necessary control, without affecting effectiveness/safety. | Manual and auto focus (Predicate: Auto focus only) | Met. Provides more control capability. Does not affect visual quality, effectiveness, or safety. |
| Multi-spectral light imaging | Equal to predicate. | No (Predicate: No) | Met. Identical. |
| Electronic filter | Equal to predicate. | green filter (3 grade) (Predicate: green filter (3 grade)) | Met. Identical. |
| Magnification and timing display | Equal to predicate. | Yes (Predicate: Yes) | Met. Identical. |
| Freeze function | Equal to predicate. | YES (Predicate: YES) | Met. Identical. |
| Stand type | Equal to predicate. | vertical (Predicate: vertical) | Met. Identical. |
| Video output | Equal to predicate. | S-Video, Video (Predicate: S-Video, Video) | Met. Identical. |
| External power source | Equal to predicate. | Voltage: 100 | Met. Identical. |
| Conformance to Industrial Standards | Meet relevant safety and performance standards. | IEC 60601-1, IEC 60601-1-2:2007, ISO 8600-3, ISO 8600-5 (Predicate: IEC 60601-1) | Met. The GC-3000E conforms to more standards than the predicate (including newer versions and additional ISO standards), indicating robust compliance. |
Study Proving Device Meets Acceptance Criteria
The study primarily consisted of nonclinical testing and comparison to the predicate device to demonstrate substantial equivalence.
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Sample size used for the test set and the data provenance:
- This information is not provided in the context of specific "test sets" as would be typical for AI/ML device performance studies involving patient data. The nonclinical tests likely used engineering samples or manufactured units of the GC-3000E.
- Data Provenance: Not applicable in the sense of patient data. The tests would have been performed by the manufacturer.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For a traditional colposcope, "ground truth" isn't established in the same way as for diagnostic AI where expert labels are needed. The "truth" for engineering specifications (e.g., illuminance, resolution) is determined by calibrated measurement equipment and established test protocols.
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Adjudication method for the test set:
- Not applicable. No expert adjudication process is described or implied for these types of nonclinical engineering tests.
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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 is a traditional colposcope, not an AI-powered device. Therefore, no MRMC study comparing human readers with and without AI assistance was performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a traditional colposcope, not an AI-powered device. Therefore, no standalone algorithm performance study was done. The device's performance is inherently "human-in-the-loop" as it is a viewing and imaging tool for clinicians.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the nonclinical tests, the "ground truth" for specifications like illuminance, resolution, distortion, etc., is derived from objective physical measurements using calibrated instruments and adherence to established engineering standards (e.g., ISO and IEC standards). The effectiveness and safety are largely established through comparison to a legally marketed predicate device with similar technological characteristics and intended use.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As it's not an AI/ML device, there's no training set or ground truth for such a set.
Summary of Nonclinical Tests Conducted (from Section 8):
The device meets acceptance criteria by conforming to the following standards and internal tests:
- ISO 8600-3, 1st edition 1997: Endoscopes – medical endoscopes and endoscope accessories – Part 3: Determination of essential technical characteristics.
- ISO 8600-5, 1st edition 2005: Endoscopes – medical endoscopes and endoscope accessories – Part 5: Test methods for safety requirements.
- IEC 60601-1, 2nd edition 1988 (A1:1991 + A2:1995): Medical electrical equipment – Part 1: General requirements for safety.
- IEC 60601-1-2, 3rd edition 2007: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic compatibility – Requirements and tests.
- Thermal Safety Test: Likely an internal test to ensure the device operates within safe temperature limits.
- Image Distortion Test: An internal test to quantify and verify image geometric distortion, as reported in the comparison table.
- Reliability Prediction of Electronic Equipment Standard, 1991: An internal test/methodology used to predict the Mean Time Between Failures (MTBF), as reported in the comparison table.
Conclusion stated in the 510(k): "The non-clinical testing which included the use of recognized performance standards demonstrates that the GC-3000E colposcope is substantially equivalent to the predicate device."
§ 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.