(56 days)
For endometrial sampling for histologic biopsy of the uterine mucosal lining including post menopausal patients.
The RI. MOS. s.r.l. curette operates manually by applied vacuum suction and is a sterile single-use disposable device.
The provided text describes a 510(k) summary for the RI. MOS. s.r.l. GINRAM® Endocic device, an endometrial suction curette. Based on the provided sections, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sufficient amount of tissue collection | Results showed sufficient amount of tissue collection |
| Sufficient grade of tissue collection | Results showed sufficient grade of tissue collection |
| No perforations | No perforations occurred |
| No adverse events | No adverse events were reported |
| Safe and effective collection of endometrial tissue samples by aspiration | Clinical sampling study conducted to evaluate Endocic's design for safe and effective collection. |
| Biocompatibility | Safety tests were conducted and passed in accordance with the relevant sections of ISO 10993. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "A clinical sampling study was conducted" but does not specify the sample size used for this study. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information regarding the number of experts used or their qualifications for establishing ground truth. The nature of the study (tissue collection) implies pathology experts would be involved in assessing tissue grade, but this is not stated.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a clinical sampling study to evaluate the device's design.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device is a manual medical instrument (curette), not an AI algorithm. Therefore, no standalone algorithm performance study was done as it's not applicable.
7. The Type of Ground Truth Used
The ground truth used would implicitly be histologic biopsy results to assess the "amount and grade of tissue collection."
8. The Sample Size for the Training Set
This device is a manual instrument; therefore, there is no "training set" in the context of an algorithm or AI. The clinical sampling study served as the evaluation or test set for the device's performance.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for a manual device, this question is not applicable. The "ground truth" for the device's performance on the clinical sampling study would have been established by histopathological examination of the collected endometrial tissue.
§ 884.1175 Endometrial suction curette and accessories.
(a)
Identification. An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.(b)
Classification. Class II (performance standards).