(211 days)
The Cooper Surgical Leisegang Colposcope Systems are intended for the 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 Cooper Surgical Leisegang Colposcope Systems may be viewed directly and/or on a color monitor (if so equipped). The Cooper Surgical Leisegang Colposcope Systems are intended for use in hospitals, clinics, and doctor's offices.
The Cooper Surgical Leisegang Colposcope(s) and accessories are optical colposcopes designed for non-contact visualization of the tissues of the cervix, vulva, vagina, and anogenital areas. Depending on the model and/or mode selected, they provide direct visual, photographic, and/or high resolution color imaging of the selected area.
The provided text describes the Cooper Surgical Leisegang Colposcope System, a medical device for magnified viewing of tissues. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense for an AI/CADe device.
Therefore, the information typically requested for AI/CADe devices (such as clinical study sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and training set details) is not applicable or available in this document. The "Performance Data" section specifically states "Non-clinical testing and attribute comparisons have been used to establish that the features and performance of the subject devices are substantially equivalent to the predicates."
The acceptance criteria here are implicitly met if the device's technical specifications and non-clinical performance are deemed substantially equivalent to the predicate devices, and if it complies with relevant electrical safety and electromagnetic compatibility standards.
Here's a breakdown based on the information provided, recognizing that it pertains to a traditional medical device and not an AI/CADe system:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Specification | Acceptance Criteria (Implied by Predicate Equivalence & Standards) | Reported Device Performance |
|---|---|---|
| Illumination | Safe and effective light (similar to predicate) | Light Emitting Diode (LED) |
| Working Distance | 300mm (similar to predicate) | 300mm for all models |
| Diopter adjustment | Functional adjustment (similar to predicate) | ±7 for all models |
| Interpupillary distance | Functional adjustment (similar to predicate) | Individually, continuously adjustable on all models |
| View Direction | As designed (0° or 45° oculars) | With 0° oculars, straight; with 45° oculars, inclined |
| Depth of Field | 290mm to 310mm at 300mm working distance (similar to predicate) | 290mm to 310mm at the fixed Working Distance of 300mm ± 10mm |
| Distortion | ≤ +7% at all magnifications (similar to predicate) | Less than +7% at the specified 300mm Working Distance |
| Resolution | Specified resolution (similar to predicate) | 18 (for oculars), Camera resolution varies (e.g., 5.6, 12.5, 18) |
| LED Illumination Safety | No significant UV, safe temp, appropriate spectrum | No significant spectrum below 400 nm, Ra=92, no undesirable temp rise, UV irradiance = 5.81569 uW/m², Enclosure surfaces not exceeding 74°C |
| Electrical Safety | Compliance with IEC 60601-1 | Met IEC 60601-1:2005 + COOR. 1 (2006) + COOR. 2 (2007) |
| EMC | Compliance with IEC 60601-1-2 | Met IEC 60601-1-2: 2007 (310 Edition) |
| Surgical Luminaries | Compliance with IEC 60601-2-41 | Met IEC 60601-2-41 |
2. Sample size used for the test set and the data provenance:
Not applicable. This is a traditional optical device, not an AI/CADe system. Testing involved non-clinical attribute comparisons and compliance with electrical/EMC standards. No patient data or test set in the AI/CADe sense was utilized.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth based on expert medical review was established for the technical performance of this optical colposcope for the purpose of regulatory submission. The document refers to "non-clinical testing."
4. Adjudication method for the test set:
Not applicable. No expert adjudication process was described for this type of device 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 device is a colposcope, an optical instrument for direct viewing, not an AI or CADe system. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used:
For the technical specifications, the "ground truth" was derived from measurements against engineering and performance standards (e.g., USAG Chart NBS 1963A for resolution, direct measurements for depth of field, distortion, and illumination properties). For regulatory purposes, the primary "ground truth" for substantial equivalence was the performance and characteristics of the predicate devices.
8. The sample size for the training set:
Not applicable. This device does not involve a training set as it is not an AI/machine learning system.
9. How the ground truth for the training set was established:
Not applicable. No training set was used.
§ 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.