(211 days)
The Mercury Airway Pressure Manometer is a disposable manometer intended to measure airway pressure up to 80 cm H2O. It is designed to be attached by flexible tubing to the Mercury CPR bag or other devices providing expiratory pressure.
The Mercury Airway Pressure Manometer is a disposable manometer intended to measure airway pressure up to 80 cm H2O.
The provided text is a 510(k) summary for the Mercury Airway Pressure Manometer. It describes the device, its intended use, and states that bench testing was performed. However, the text does not contain the detailed information required to answer your questions about acceptance criteria and a study proving device performance.
Specifically, the document omits the following crucial information:
- A table of acceptance criteria and the reported device performance: The text states the device "measures airway pressures up to 80 cm H2O in a manner consistent with the Dwver Magnahelic Gauge". This is a very high-level statement and does not provide specific acceptance criteria (e.g., accuracy, precision, bias within a defined range) or detailed performance results.
- Sample size used for the test set and the data provenance: No information about the sample size (number of measurements, number of devices tested) or the origin of the data is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no mention of expert-established ground truth.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is typically for image-based diagnostic devices comparing human readers with and without AI assistance. This device is a manometer, so an MRMC study is not relevant here.
- Standalone performance: The text mentions "Bench testing has determined that the Mercury Airway Pressure Manometer measures airway pressures...", which implies standalone performance, but no details of this test are provided.
- Type of ground truth used: The ground truth appears to be comparison with a "Dwver Magnahelic Gauge, a pre-amendment device." However, no details on how this comparison was carried out (e.g., what constitutes "consistent") are given.
- Sample size for the training set: Not applicable as this is not an AI/machine learning device requiring a training set in the conventional sense.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided 510(k) summary is very brief and only states that bench testing was done and the device is consistent with a predicate device. It lacks the specific details required to complete your comprehensive request regarding acceptance criteria and study methodology.
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Image /page/0/Picture/0 description: The image shows a black and white drawing of two figures. One figure is standing behind the other, with their arms around the seated figure. Both figures have a heart shape on their chest. There is also a registered trademark symbol in the image.
Image /page/0/Picture/1 description: The image shows the logo for Mercury Medical. The word "MERCURY" is in large, bold, sans-serif font, with a line underneath it. Below the line, the word "MEDICAL" is in a smaller, sans-serif font, with the registered trademark symbol to the right of the word.
ENCLOSURE I
510(k) SUMMARY
- Mercury Airway Pressure Manometer .
- Airway Pressure Manometer (gauge) .
- monitor, airway pressure (includes gauge) .
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act 1990 and 21CFR 807.92.
The Mercury Airway Pressure Manometer is a disposable manometer intended to measure airway pressure up to 80 cm H2O. It is designed to be attached by flexible tubing to the Mercury CPR bag or other devices providing expiratory pressure. Bench testing has determined that the Mercury Airway Pressure Manometer measures airway pressures up to 80 cm H2O in a mannner consistent with the Dwver Magnahelic Gauge, a pre-amendment device.
Kathy L. Hann
Kathy L. Hann
9/22/95
Date
Se
§ 868.2600 Airway pressure monitor.
(a)
Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.(b)
Classification. Class II (performance standards).