(259 days)
MedGyn's Digital Video Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities such as lesions or cancer, and selecting areas for biopsy. The images from the Digital Video Colposcope are to be viewed on a color monitor. The Digital Video Colposcope is intended for use in hospitals, clinics, and doctors' offices.
The MedGyn Digital Video Colposcope, models AL-106, AL-106SA and AL-106B (collectively, the "MedGyn Colposcope"), has the same application as traditional colposcopes. However, while traditional optical colposcopes use binocular eyepieces for magnification, the MedGyn Colposcope uses electronic imaging technology to assist doctors in reviewing, checking, analyzing, and diagnosing abnormalities or lesions of the vulva, vagina, cervix and external genitalia. It is designed to be used in hospitals, doctors' offices and clinics by qualified or trained personnel.
The MedGyn Colposcope is an active, non-contact examination device. It uses a HAD CCD color digital video camera with a digital magnification of up to 40x (or only 32x for model AL-106B), a field of view of 52° at 1x and 2° at 32X, and a green filtered light source. The camera is attached to a floor stand; model AL-106SA has a swing-arm floor stand. A cable coming from the bottom of the floor stand connects to the signal conversion box. The customer then uses the composite video cable or the s-video cable to connect a commercially available monitor to the conversion signal box.
Tissue is magnified and viewed on the doctor's own computer monitor (not included with device). Both the doctor and the patient can observe the monitor's screen, thus helping the doctor explain the abnormalities and the suggested treatments to the patient, and allowing patient to see the abnormalities for herself and better understand her medical situation.
The provided document is a 510(k) summary for the MedGyn Digital Video Colposcope, which outlines its substantial equivalence to a predicate device. This type of submission relies on non-clinical performance testing rather than clinical studies to demonstrate safety and effectiveness. Therefore, the device does not have "acceptance criteria" in the sense of a clinical trial's endpoint metrics, nor does it present a study that proves the device meets such criteria for diagnostic accuracy or clinical outcomes.
Instead, the document focuses on demonstrating that the MedGyn Colposcope meets relevant performance standards and technical specifications that are comparable to a legally marketed predicate device.
Here's an analysis based on the provided text, addressing your points where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a non-clinical submission, "acceptance criteria" are tied to engineering specifications and compliance with voluntary performance standards. There are no diagnostic "performance" metrics (like sensitivity, specificity) derived from a clinical application in this document.
| Metric/Standard | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Voluntary Performance Standards | Compliance with recognized international standards for medical electrical equipment and endoscopes. | - IEC60601-1:1988 + A1:1001 + A2: 1995 (Medical Electrical Equipment Safety) |
- IEC60601-1-1:2000 (Medical Electrical Equipment Safety - Collateral Standard: Medical Electrical Systems)
- IEC60601-1-2:2007 (Medical Electrical Equipment EMC)
- ISO 8600-3:1997 (Endoscopes - Field of View and Direction of View)
- ISO 8600-5:2005 (Endoscopes - Optical Resolution) |
| On-Axis Resolution | (Implied: Sufficient for intended use, comparable to predicate, or within established industry benchmarks for colposcopes) | 11.31 line-pairs/mm |
| On-Axis Angular Resolution | (Implied: Sufficient for intended use, comparable to predicate, or within established industry benchmarks for colposcopes) | 0.02534 degrees |
| Geometrical Distortion | ≤ 3% (explicitly stated as acceptable) | - AL-106B = +1% - AL-106 & AL-106SA = +2.49% |
| Thermal Safety | (Implied: Minimal temperature rise, meeting safety standards) | From 200mm, temperature rise of only 0.20 Celsius after 30 minutes continuous working. |
| Magnification | Up to 40x digital (AL-106, AL-106SA), up to 32x digital (AL-106B) and 1-36x optical (AL-106, AL-106SA), 1-18x optical (AL-106B) | AL-106, AL-106SA: Digital 1-40x, Optical 1-36x
AL-106B: Digital 1-32x, Optical 1-18x |
| Field of View (200mm WD) | (Implied: Sufficient for intended use, comparable to predicate) | At 1x >= 195mm (52°), At 32x >= 6.978mm (2°) |
| Depth of View | (Implied: Sufficient for intended use, comparable to predicate) | 5mm~120mm |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of clinical "test sets" for diagnostic accuracy. The testing mentioned in Section 7 ("Discussion of Non-Clinical Tests Performed") refers to engineering and bench testing of the device itself (e.g., resolution targets, distortion grids, temperature sensors) rather than patient data.
- Data Provenance: Not applicable. The "data" are measurements and compliance certificates from device testing, not patient data from a specific country or collected retrospectively/prospectively.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. This submission does not involve a clinical test set requiring expert-established ground truth for diagnostic accuracy since it's a non-clinical performance evaluation focused on engineering specifications.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable for the same reason as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers' performance changes with or without AI assistance, which is beyond the scope of a 510(k) summary relying on non-clinical testing to demonstrate substantial equivalence for a colposcope that is essentially an imaging tool, not a diagnostic AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: No. This device is a colposcope, an imaging instrument used by a human clinician. It does not incorporate an independent algorithm for diagnosis that would typically warrant a standalone performance evaluation.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the clinical sense. The "ground truth" for the non-clinical tests involved objective physical measurements and compliance verification against established engineering standards (e.g., resolution charts, distortion grids, temperature probes).
8. Sample Size for the Training Set
- Sample Size: Not applicable. This device does not use machine learning or AI that would require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this device.
In summary: The K122973 submission for the MedGyn Digital Video Colposcope is a demonstration of substantial equivalence based on non-clinical performance testing and compliance with voluntary international standards. It explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This means no clinical studies were conducted, and therefore, no "acceptance criteria" related to diagnostic accuracy or clinical outcomes were evaluated using patient data or expert ground truth. The acceptance criteria are engineering specifications and safety standards defined by regulatory bodies and consensus organizations.
§ 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.