Search Results
Found 1 results
510(k) Data Aggregation
(321 days)
TSX PRM PULMONARY RESUSCITATION MONITOR
The TDx PRM is intended to be used as an accessory to emergency resuscitators to monitor vontilatory functions including peak inspiratory pressure, respiratory rate, positive end expiratory pressure, and inspiratory/expiratory time ratio.
The TDx PRM is intended to be used as an accessory to emergency resuscitators to monitor ventilatory functions. It is a small, portable battery operated device that attaches to bag mask resuscitators, oxygen powered demand valve resuscitators or automatic transport ventilators, which may not be equipped with pressure gauges for the purpose of patient airway monitoring. The TDx PRM monitors the following patient parameters: peak inspiratory pressure, breath frequency, inspiratory and expiratory times, positive end expiratory pressure ("PEEP"). The TDx PRM also offers a cardiopulmonary resuscitation metronome to assist in the pacing of cardiopulmonary resuscitation efforts. The TDx PRM performs no diagnostic or therapeutic functions; it functions solely as a patient monitor and does not provide any patient alarms. Moreover, the TDx PRM has no direct patient contact; transmission of airborne pathogens is prevented by means of standard bacterial filters such as are routinely used with emergency resuscitation equipment. The TDx PRM is a microprocessor-controlled device that utilizes a electronic pressure transducer.
Here's an analysis of the acceptance criteria and study information for the Spiracle Technology TDx PRM Pulmonary Resuscitation Monitor, based on the provided text:
Device: Spiracle Technology TDx PRM Pulmonary Resuscitation Monitor
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific numerical acceptance criteria for the device's performance parameters (e.g., peak inspiratory pressure accuracy within X mmHg, respiratory rate accuracy within Y breaths/min).
Instead, it broadly states that the device "meets its performance objectives." Without explicit criteria, the "reported device performance" can only be a confirmation that the device functions as intended.
| Performance Characteristic | Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Ventilatory function monitoring | Not explicitly stated | "demonstrated that it meets its performance objectives" |
| Peak inspiratory pressure | Not explicitly stated | Functions as intended, part of "performance objectives" |
| Respiratory rate | Not explicitly stated | Functions as intended, part of "performance objectives" |
| Positive end expiratory pressure | Not explicitly stated | Functions as intended, part of "performance objectives" |
| Inspiratory/expiratory time ratio | Not explicitly stated | Functions as intended, part of "performance objectives" |
| Cardiopulmonary resuscitation metronome accuracy | Not explicitly stated | Functions to "assist in the pacing of cardiopulmonary resuscitation efforts" |
| Environmental conditions (impact/drop, storage temp, EMI, ESD, spill resistance, surface temp) | Not explicitly stated | "demonstrated that it meets its performance objectives and complies with applicable FDA guidelines" |
| Power supply (battery life, low power icon) | Not explicitly stated | "demonstrated that it meets its performance objectives" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any of the performance tests. It refers to "Extensive functional testing" and "testing... performed under various environmental conditions."
The data provenance is not explicitly stated, but given the context of a 510(k) submission, it would be internal company testing conducted for regulatory approval.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of external experts to establish ground truth for the device's performance. The testing described appears to be internal validation by the manufacturer.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for establishing ground truth, as no external experts or consensus process is mentioned. The testing relies on the device itself and its ability to monitor specified parameters.
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 device is a monitor, not a diagnostic imaging tool that would typically involve human readers interpreting results. Its function is to display physiological parameters.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone monitor. Its performance evaluation would inherently be a standalone assessment of its accuracy in measuring the ventilatory functions it's designed to monitor. The phrase "standalone performance" isn't explicitly used, but the testing described (functional, environmental, power supply) is an evaluation of the device's inherent capabilities without human intervention for its primary function of measurement.
7. The Type of Ground Truth Used
The type of ground truth used would be measurement standards or reference devices/methods. For example, to verify the accuracy of peak inspiratory pressure, the TDx PRM's readings would be compared against a calibrated, highly accurate pressure gauge. Similarly, respiratory rate would be validated against precise timing mechanisms. The document doesn't explicitly state what reference methods were used, but rather that the device "meets its performance objectives."
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. The TDx PRM is a hardware-based monitor with a microprocessor calculating parameters from transducer inputs. It does not use machine learning or AI algorithms that require a training set to learn patterns or make predictions. Its "logic" is programmed, not learned.
9. How the Ground Truth for the Training Set Was Established
As stated above, a "training set" and associated ground truth establishment for such a set are not applicable to this device.
Ask a specific question about this device
Page 1 of 1