(198 days)
Is intended to measure airway pressure when used with positive pressure devices. The device alarms when the airway pressure falls outside of the user selected high and low alarm limits and displays peak pressure and real-time airway pressures. It may be used with positive pressure devices which do not include pressure measurement capabilities, e.g. resuscitation bags or basic ventilators, or as an independent backup pressure monitor for devices with pressure measurement capability. Environment of use is hospital, home, and sub-acute institutions. The device has been designed for stationary and intra-institution transport only.
The Criterion 40 is a microprocessor controlled device that measures and monitor patient airway pressure. produces continuous positive airway pressure. It measures low and high pressures and advises the user if the pressure fall outside the user-set ranges. It operates on AC / DC power and provides digital and graphically readouts of the pressure - real-time and peak pressures. It connects into the patient circuit with the use of a pressure tubing with integral in-line filter and a connector.
The provided text describes the PROMEDIC INC Criterion 40 Airway Pressure Monitor, a microprocessor-controlled device designed to measure and monitor patient airway pressure. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics.
However, based on the information provided, we can infer some "acceptance criteria" through comparison with the predicate device and the stated functionalities. The reported device performance is directly drawn from the device's specifications.
Here's an analysis of the requested information:
1. Table of Acceptance Criteria (Inferred from comparison with predicate) and Reported Device Performance
| Feature/Criterion | Acceptance Criteria (Inferred from Predicate/Function) | Reported Device Performance (Criterion 40) |
|---|---|---|
| Intended Use | Measurement and monitoring of patient airway pressure (high & low alarms) with positive pressure devices. | Is intended to measure airway pressure when used with positive pressure devices. Alarms when pressure falls outside user-set limits. Displays peak and real-time pressures. |
| Environment of Use | Hospital, sub-acute institutions, home care. Stationary and intra-institution transport. | Hospital, sub-acute institutions, home care. Stationary and intra-institution transport only. |
| Device Size | Comparable to predicate (7.5" x 6" x 4") | 6.5" x 3.4" x 5" |
| Device Weight | Comparable to predicate (approx. 1 lb) | approx. 2 lb. |
| Controls | Solid-state pressure transducer, DC adaptable controls. | Microprocessor controlled, solid-state pressure transducer, AC/DC adaptable. |
| Power Specifications | 9 V DC. | 120 V AC, 60 Hz, 20 W or 230 V AC, 50 Hz, 60 mA, 12 V DC. |
| Output | Analog readout of pressures. | Digital readout of pressures. |
| Patient Interface Materials | PVC, K-resin for pressure tubing and airway connector tee. | PVC, K-resin for the pressure tubing and airway connector tee. |
| Patient Interface Method | Airway adapter in circuit or connection to face mask. | Airway adapter placed in the circuit or connection to a face mask. |
| Display of Information | Low/high pressure alarm setting, inadvertent off alarm, pressure gauge shows values (peak/real-time), power status alarm. | Low/high pressure alarm setting, status of alarm silence and time remaining, peak pressure, real-time pressure (bar graph), power source and status, audible and visual alarm. |
| Low Pressure Alarm Range | 2 - 50 cm H2O (resolution not specified). | 1 - 20 cm H2O, 1 cm H2O resolution. |
| High Pressure Alarm Range | 2 - 100 cm H2O (resolution not specified). | 5 - 99 cm H2O, 1 cm H2O resolution. |
| Peak Pressure Display | Determined by visual observation. | Displayed as value. |
| Real-time Pressure Display | Determined by visual observation only. | Displayed as bar graph. |
| Alarm Delay | Yes - 2 - 60 seconds. | Yes - 1 - 20 seconds. |
| AC/DC Operation | 9 V DC, no AC capabilities. | 120 V AC / 230 V AC and 12 V DC. |
| Accuracy of Pressure Alarm | +/- 3 cm H2O. | +/- (1 + 3% of reading) rounded up to nearest cm H2O. |
| Accuracy of Display (Peak/Bar Graph) | Not specified. | +/- (1 + 3% of reading) rounded up to nearest 0.5 cm H2O. |
| Alarms | Low pressure, high pressure, inadvertent off, low battery. | Low pressure, high pressure, loss of power, low battery. |
| Operating Temp/Humidity | 16 °C - 34 °C, 20 - 90% RH. | 5 °C to 45 °C, 15 - 95% RH. |
| Storage Temperatures | Not specified. | -40 °C to 60 °C @ 95% RH. |
| Battery Life | up to 2 months. | up to 24 hours for backup and transport use (primary power AC). |
| Zero Calibration | Yes. | Yes. |
| Pressure Tubing with In-line Filter & Airway Connector | Yes. | Yes. |
| Pole Mount | Yes. | Yes. |
| AC Power Supply | Not applicable. | Yes. |
| Electrical Safety Standards | CSA C22.2 No. 125 Risk Class 2, UL 260 / IEC 601-1. | IEC 601-1-2, UL 260 / IEC 601-1. |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of clinical or performance data for the Criterion 40. The submission is a 510(k) Pre-Market Notification, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing de novo clinical study data. The "study" here is a comparison of specifications and intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set is described.
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
Not applicable. This device is an airway pressure monitor, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself operates as a standalone monitor of airway pressure. The document describes its functional capabilities and comparison to a predicate device, which implies its direct performance without human interpretation being the primary measure. However, it's not an "algorithm-only" performance study in the AI sense. It's an electro-mechanical device performance evaluation based on specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for demonstrating substantial equivalence is based on:
- Predicate Device Specifications: The established (and legally marketed) characteristics, intended uses, and performance of the Monaghan CM 5000 Airway Pressure Monitor (K871083) and its modifications.
- Engineering and Design Standards: Compliance with electrical safety standards (IEC 601-1-2, UL 260 / IEC 601-1).
- Internal Testing/Validation (Implied): While not detailed, the accuracy claims for pressure alarm and display (+/- (1 + 3% of reading)) would have been established through internal testing against calibrated reference standards.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that uses a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this device.
§ 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).