(83 days)
The StarTrack Infant Graphics Monitor's intended use is the measurement and display of breathing flow, volume and pressure as delivered trough the patient's endotracheal tube. The intended patient population comprises neonatal and pediatric patients requiring an endotracheal tube
The StarTrack Infant Graphics Monitor, StarTrack is contained in a rectangular metal enclosure measuring 9.25 inches wide by 6 inches high by 5.7 inches deep and weighing 7.2 Ibs. A front panel LCD screen enables the presentation of graphics, numeric breath data and alarm settings. User-selectable graphics screens present Flow and Volume vs Time. Pressure and Volume vs Time, Flow and Pressure vs Time, Flow / Volume Loop and Pressure / Volume Loop. Numeric breath data are Expiratory Tidal Volume, Expiratory Minute Volume, ET Tube Leak, Breath Rate and Dynamic Compliance. Alarm Settings are High Minute Volume, Low Minute Volume, High ET Tube Leak, High Breath Rate and Breath Interval. StarTrack also provides visual and audible indicators. Alarms are divided into two categories: patient-related alams and system-related alarms. A patient alarm causes a flashing bell to display next to the violated alarm setting. This is accompanied by an audible sound and the flashing Patient-Related Alarm LED. When the alarm condition is corrected, the audible sound ceases and the bell and LED stop flashing. These displays will turn off when the operator presses the Visual Reset button. Patient-related alarms can be silenced for sixty seconds by pressing the Alarm Silence button. System-related alarms concem problems with the hardware, such as the sensor, sensor cable and the StarTrack electronics. System-related alarms have both visual and audible indicators. The audible indicators cannot be silenced. The System-Related alarms are Sensor Disconnect, Sensor Defect, Sensor Contaminated, AC Power Loss and System Failure.
The provided document is a 510(k) summary for the StarTrack Infant Graphics Monitor, a device intended for measuring and displaying breathing flow, volume, and pressure in neonatal and pediatric patients.
Based on the provided text, the following information can be extracted regarding acceptance criteria and the study conducted:
1. A table of acceptance criteria and the reported device performance:
The document states: "Safety and environmental testing to accepted industry standards has been conducted as well as in-vitro testing to confirm the accuracy of StarTrack." However, specific numerical acceptance criteria for accuracy (e.g., ±X% accuracy for flow or volume) and the reported device performance against these criteria are not detailed in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions "in-vitro testing," which implies that the testing was performed in a laboratory setting, not on human subjects. No information is provided regarding the specific sample size for the in-vitro test set, data provenance (country of origin), or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Since the testing was "in-vitro," there would typically be no human experts involved in establishing a "ground truth" in the way a clinical study would. Ground truth in this context would likely be established by a reference standard measurement device. The document does not specify the type or number of reference devices used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
As it was an in-vitro study, adjudication methods typically used in clinical trials involving expert interpretation are not applicable.
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:
The document describes a physical medical device (monitoring spirometer), not an AI-powered diagnostic imaging or interpretation system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not conducted or is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document states that the StarTrack uses "substantially the same software algorithm for determining airway flow values as used on the predicate device." While this confirms an algorithm is involved, the primary study mentioned is "in-vitro testing to confirm the accuracy of StarTrack," which represents standalone performance of the device itself (including its integrated algorithm and hardware) against a reference standard. There is no explicit mention of an "algorithm only" test separate from the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For "in-vitro testing," the ground truth would typically be established by a highly accurate and calibrated reference measurement instrument or system (e.g., a highly precise flow and volume simulator or standard). The document does not specify the exact type of reference ground truth used.
8. The sample size for the training set:
The document indicates that the StarTrack's embedded software contains "substantially the same software algorithm for determining airway flow values as used on the predicate device, the Bear Medical Systems Neonatal Volume Monitor, model NVM-1, K890724." This suggests that the algorithm was likely developed and "trained" (if machine learning was involved, which is unlikely for a 1998 device measuring basic physiological parameters) in conjunction with the predicate device. However, no information on the sample size for a training set is provided. Given the device's function, it's more probable that the algorithm is based on physiological principles and calibrated parameters rather than a machine learning training set in the modern sense.
9. How the ground truth for the training set was established:
As above, without a specific "training set" being described, the method for establishing ground truth for training is not available. If the algorithm is based on the predicate device, the initial development and validation of that predicate device would have established its internal ground truth and calibration methods.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and mentions "in-vitro testing" for accuracy. However, it lacks granular details regarding the specific acceptance criteria, quantitative performance results, sample sizes, and detailed methodology typically found in comprehensive study reports for device validation. This is common for 510(k) summaries, which aim to provide a high-level overview rather than a full study protocol and results.
§ 868.1850 Monitoring spirometer.
(a)
Identification. A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.(b)
Classification. Class II (performance standards).