(93 days)
The LT-300 HD digital video 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.
LT-300 HD digital video colposcope is a digital video colposcope intended to provide magnified viewing of the vagina, cervix and external genitalia. LT-300 HD digital video colposcope is used to diagnose abnormalities and select areas for biopsy. LT-300 HD digital video colposcope acquires and displays high-resolution still and sequentially captured images and videos.
LT-300 HD digital video colposcope offers non-patient contact, fully digital and highresolution 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.
The provided text is a 510(k) summary for the LT-300 HD digital video colposcope. It describes the device, its intended use, and a comparison to a predicate device (LT-300 Digital Colposcope, K143119). However, it does not contain a detailed study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.
The document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and adherence to performance standards. It explicitly states that "These differences do not raise different questions of safety or effectiveness, and accepted test methods were used to assess the effects of these differences on device performance."
Therefore, I cannot populate most of the requested fields as the information is not present in the provided text. The document refers to "nonclinical tests" on image quality but does not provide specific acceptance criteria or results from studies involving human readers or ground truth for diagnostic accuracy.
Here's what can be extracted based on the provided text, and where information is missing:
1. A table of acceptance criteria and the reported device performance
The document lists performance standards the device meets, but these are general engineering and optical standards, not specific acceptance criteria for diagnostic performance (e.g., sensitivity, specificity for disease detection).
| Acceptance Criteria (from standards) | Reported Device Performance (from standards) |
|---|---|
| Optical Performance (Met general standards) | Met general optical standards |
| Field of View (ISO 8600-3:1997) | Conforms to standard |
| Optical Resolution (ISO 8600-5:2005) | Conforms to standard |
| Electrical Safety & EMC (Met general standards) | Met general electrical safety & EMC standards |
| Medical Electrical Equipment Safety (IEC 60601-1:2005) | Conforms to standard |
| Electromagnetic Compatibility (IEC 60601-1-2:2007) | Conforms to standard |
| Other Nonclinical Tests | Met as tested |
| Thermal Safety Test | Met |
| Image Distortion Test | Met |
| Field of View Test | Met |
| Illuminance (≥ 2000Lux at 300mm working distance) | ≥ 2000Lux |
| Field of View (min mag > Φ 60mm & max mag > Φ 10mm) | > Φ 60mm & > Φ 10mm |
| Depth of Field (min mag > 120mm; max mag ≥5mm) | > 120mm & ≥5mm |
Missing information: Acceptance criteria for clinical performance (e.g., diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value) are not provided, as this is a 510(k) summary focusing on substantial equivalence through technical characteristics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing from text: No information provided regarding a test set for clinical performance. The "tests" mentioned are non-clinical engineering and performance standard tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Missing from text: No information provided, as there is no described test set for diagnostic accuracy with a stated ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing from text: No information provided, as there is no described test set for diagnostic accuracy.
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
- Missing from text: No MRMC study or AI assistance is mentioned. This device is a colposcope, not an AI-powered diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing from text: Not applicable, as this is a medical device (colposcope) that is used by a human operator, not an algorithm, and no standalone algorithm performance is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Missing from text: No information about ground truth for diagnostic accuracy is provided. The tests described are engineering and compliance tests, not clinical performance evaluations against a diagnostic ground truth.
8. The sample size for the training set
- Missing from text: Not applicable. This is not a machine learning or AI-driven device requiring a training set in the conventional sense.
9. How the ground truth for the training set was established
- Missing from text: Not applicable.
§ 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.