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510(k) Data Aggregation
(246 days)
The Gynocular is intended to provide magnified visualization of the tissues of the vagina, cervix and external genitalia. It is used to evaluate these tissues and select areas for biopsy.
The Gynocular is a hand-held, colposcope, which provides a magnified visualization of the tissues of the cervix, vagina, vulva and anogential area. It is used to evaluate these tissues and select areas for biopsy, without contacting the patient. The user is a medical physician, or a trained colposcopist. The Gynocular is a colposcope with similar specifications to traditional colposcopes. The Gynocular has a 300 mm focal distance, 3-magnifications: 5x, 8x, and 12x. It is a handheld device that comes with a tripod-mounting clip that screws into a standard tripod enabling the medical professional to also perform colposcopy hands-free mode for ease of biopsy. The Gynocular uses high intensity LEDs for illumination, has a green filter, and is powered by a rechargeable lithium-ion battery. We also provide a charging base for the Gynocular.
Acceptance Criteria and Device Performance for Gynocular Colposcope
The Gynocular colposcope's acceptance criteria and reported performance are detailed below, based on the provided 510(k) submission.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Optical Properties: | |
| Distortion | Minimal Barrel type geometrical distortion: 0.47% (5x), 0.75% (8x), 0.81% (12x). |
| Negligible chromatic distortion: 3.3 um (5x), 5.8 um (8x), 3.3 um (12x). | |
| Magnification | 4.81x ± 0.15 (at 5x setting), 7.74x ± 0.15 (at 8x setting), 12.40x ± 0.15 (at 12x setting) |
| Optical Resolution | 28.6 cy/mm (5x), 40.5 cy/mm (8x), 56.8 cy/mm (12x) |
| Thermal Safety | |
| Device Surface Temperature (after 1hr 55 min continuous use) | 39.1 degrees C (in 24 degrees C ambient) |
| Battery Performance | |
| Charging Time (empty to full) | 2.5 hours or less |
| Illumination Time (full intensity, from full charge) | Approximately 2 hours |
| Battery Life Cycle | 500 full charging cycles |
| Clinical Agreement with Standard Colposcope | |
| Agreement of diagnosis of cervical lesions (Swede scores vs. histological diagnosis) | 70% overall agreement |
Note: The document states that the observed distortion and chromatic distortion levels are considered "negligible" for visual examination and "equal and below the levels of visual acuity of the human eye," implying these values met the internal acceptance limits. The thermal safety performance is also implicitly accepted as the device has an automatic shut-off mechanism for unsafe temperatures, and the reported temperature is within a safe range. The specific acceptance criteria for magnification and optical resolution are not explicitly stated as numerical thresholds, but the reported values are presented as performance achievements.
2. Sample Size and Data Provenance for the Test Set
- Sample Size for the test set: 69 women.
- Data Provenance: The study was a "randomized, crossover, pilot clinical trial" but the country of origin is not explicitly stated. However, Gynius AB is based in Stockholm, Sweden, and the study was published in "The Journal of Lower Genital Tract Disease in May 2013," suggesting a prospective clinical trial, likely conducted in Sweden or a similarly regulated environment.
3. Number of Experts and their Qualifications for Ground Truth
The document does not explicitly state the number of experts or their qualifications used to establish the ground truth for the test set. It mentions that "Swede scores were given at the time of colposcopy and compared with the final histological diagnosis after directed cervical biopsy." This implies that the initial "Swede scores" were given by the medical professionals conducting the colposcopy, and the histological diagnosis (pathology) served as the primary ground truth.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method for disagreements. It directly compares "Swede scores" from both the Gynocular and a standard colposcope with the "final histological diagnosis after directed cervical biopsy."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance. The study described is a comparison of two colposcopes (Gynocular vs. standard colposcope) used by human medical professionals, not evaluating AI assistance.
6. Standalone (Algorithm Only) Performance
No, a standalone (algorithm only without human-in-the-loop performance) was not done. The Gynocular is a medical device (colposcope) that is used by a human operator (medical physician or trained colposcopist) for visual examination. It does not employ an AI algorithm for diagnosis.
7. Type of Ground Truth Used
The primary ground truth used for the clinical trial was pathology ("final histological diagnosis after directed cervical biopsy"). The "Swede scores" obtained during colposcopy were compared against this histological diagnosis.
8. Sample Size for the Training Set
The document does not mention any training set. This is because the Gynocular is a visual diagnostic tool (colposcope) operated by a human, and not an AI/machine learning algorithm requiring a training set in the conventional sense. The "clinical tests" described represent a validation study, not a training phase for an algorithm.
9. How Ground Truth for the Training Set Was Established
As there was no AI/machine learning component to the Gynocular described in the submission, there was no "training set" and therefore no ground truth established for a training set.
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