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510(k) Data Aggregation
(87 days)
The Hystero CO2-Pneu is designed for dilating the cavum uteri with CO2 gas during diagnostic and operative hysteroscopy.
They Hystero-CO2-Pneu 2221 supplies CO2 gas from cylinders or central gas supplies to dilate the cavum uteri by the CO2 gas insufflation.
The gas pressure and flow rate are controlled according to the instructions by the device user.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|
| Intrauterine pressure adjustable between 0 mmHg and 150 mmHg. | Preselected values are in accordance with measured values within specified deviations. |
| Flow rate adjustable between 0 ml/min and 99 ml/min. | Preselected values are in accordance with measured values within specified deviations. |
| Pressure and flow values checked by microprocessor control. | Verified through microprocessor control. |
| Independent safety devices to guarantee safe insufflation. | Present and functioning as described. |
| Ability to display pressure, flow, and gas consumption on-screen. | Data can be displayed on-screen. |
| Ability to display user-defined text on-screen. | User-defined text can be displayed. |
| Ability to transmit measuring data to a printer via a serial interface. | Relevant measuring data can be transmitted to a printer. |
2. Sample Size and Data Provenance
According to the provided text, no clinical tests were performed. The "bench data" refers to measurements performed on the device itself. Therefore, a sample size for a test set in the traditional sense (e.g., patient data) is not applicable, nor is the concept of data provenance in terms of country of origin or retrospective/prospective for patient data. The "bench data" would have been generated from the device in a laboratory setting.
3. Number of Experts and Qualifications
Not applicable. No clinical tests were performed, and the evaluation was based on "bench data." Therefore, no experts were used to establish ground truth from patient data.
4. Adjudication Method
Not applicable. No clinical tests were performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The device's evaluation was based on bench data, not human interpretation of medical images or data.
6. Standalone (Algorithm Only) Performance
Not applicable in the context of an algorithm. This device is a medical instrument (insufflator), not an AI algorithm. The performance described is its inherent mechanical and electronic functionality.
7. Type of Ground Truth Used
The ground truth for the device's performance was established through direct measurement of the device's output (pressure and flow rates) against its preselected settings in a laboratory or bench setting. This is a form of empirical measurement against design specifications.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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