(88 days)
Circon's Rigid Operative Culdoscopy Accessories are intended to be used with Circon's Rigid Culdoscope and Accessories for viewing pelvic organs endoscopically via a posterior vaginal fornix entry for the purpose of performing diagnostic and operative procedures on the female genital organs. Indications for use are:
- Unexplained pelvic pain (acute, chronic)
- Menstrual abnormalities
- Infertility and sterility
- Indefinite pelvic mass
- Ectopic pregnancy
- Pelvic endometriosis
- Polycystic ovaries
- Pelvic inflammatory disease (PID)
- Pain mapping
- Congenital anomalies of the pelvic organs
- Lysis of adhesions
- Cytology sampling
- Biopsy
Circon's Rigid Operative Culdoscopy Accessories consist of several tubular stainless steel components. During culdoscopy, light from a high intensity light source is transmitted to a rigid culdoscope by a fiber optic light guide that is detachably connected to a light post on the body of the scope. The light is carried by the illumination fibers to the target. A distal lens focuses an image of the target onto the rod lens train. The image is transmitted to the proximal end of the scope, where it is magnified and focused by an eyepiece ocular. The image may be viewed directly through the evepiece, or the scope may be connected to a video system via a standard endoscopic video coupler. In order to perform operative procedures, the operative cannula of the subject system replaces the smaller diagnostic cannula of the predicate system, and an operative sheath replaces the smaller diagnostic sheath of the predicate system. A channel is formed between the culdoscope and the operative sheath, thereby allowing passage of small instruments for a variety of operative procedures.
The provided text is a 510(k) Summary for "Circon's Rigid Operative Culdoscopy Accessories". The document describes the device, its intended use, and compares it to predicate devices. However, it does not contain information on acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The 510(k) submission process for this type of device (medical instruments) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with specific performance metrics and acceptance criteria as might be expected for novel diagnostic algorithms or AI-driven systems.
Therefore, I cannot populate the requested information from the provided text.
Here's the structure of the answer I would provide if the information were available:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| (e.g., Accuracy, Sensitivity, Specificity, Precision, Image Quality, Functionality) | (e.g., >90% accuracy, Sensitivity > 85%, etc.) | (e.g., 92% accuracy, Sensitivity = 88%) |
| ... | ... | ... |
2. Sample Size and Data Provenance for Test Set
- Sample Size for Test Set: [Number]
- Data Provenance: [e.g., Country(ies) of origin, Retrospective/Prospective, (if applicable) specific institutions/databases]
3. Number and Qualifications of Experts for Ground Truth (Test Set)
- Number of Experts: [Number]
- Qualifications of Experts: [e.g., Board-certified Radiologist with X years of experience in Y subspecialty, Pathologist, etc.]
4. Adjudication Method for Test Set
- [e.g., 2+1 (two experts, third for tie-breaking), 3+1 (three experts, fourth for tie-breaking), Majority vote, Consensus meeting without formal tie-breaker, None (single expert review)]
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? [Yes/No]
- If Yes:
- Effect size (improvement with AI vs. without AI assistance): [e.g., increase in AUC, sensitivity, specificity, reduction in reading time, etc., with specific values or ranges]
6. Standalone (Algorithm Only) Performance Study
- Was a standalone performance study done? [Yes/No]
- If Yes:
- Performance metrics: [e.g., Accuracy, Sensitivity, Specificity, AUC, F1-Score, etc., with specific values]
7. Type of Ground Truth Used
- [e.g., Expert Consensus (as described above), Histopathology/Pathology, Long-term patient outcomes, Clinical follow-up, Surgical findings, Reference standard device output]
8. Sample Size for Training Set
- Sample Size for Training Set: [Number]
9. How Ground Truth for Training Set Was Established
- [e.g., Expert annotation (similar to test set, or different process/number of experts), Pathology reports linked to images, Pre-existing clinical labels, etc., describe the process in detail]
§ 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.