(8 days)
The Trio™ monitor is intended for use in healthcare settings under the direct supervision of a licensed healthcare practitioner. The intended use of the monitor is to monitor physiologic parameter data on adult and pediatric patients. Physiologic data includes: electrocardiogram, invasive blood pressure, non-invasive blood pressure (NIBP), pulse oximetry, heart rate (derived from ECG, SpO2 or NIBP), respiration and temperature as summarized in the operating instructions manual. The information can be displayed, stored, trended and printed.
The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor
The Trio monitor is a three or four trace patient monitor that can be mounted on a rolling stand, wall mount bracket, bed rail, or operated as a tabletop device. The patient parameters that can be monitored on the Trio are: ECG (3-lead or 5- lead selectable), Temperature, SpO2, Invasive Blood Pressure, Respiration and Non-Invasive Blood Pressure. Digital displays are provided for Heart Rate, Pulse Rate, Pulse Oximetry, Non-Invasive Blood Pressure, Respiration Rate, Invasive Blood Pressure (optional) and Temperature. Waveform displays are provided for ECG, Pleth, Invasive Blood Pressure (optional) and Respiration. The optional built-in thermal recorder provides hard copies of all digital data and waveforms, as well as Tabular and Graphic Trend information.
The provided text for K041907 focuses on establishing substantial equivalence for the Trio Monitor, particularly regarding its expanded capability to derive Heart Rate from Non-Invasive Blood Pressure (NIBP). While it mentions testing, it does not offer the detailed acceptance criteria and study results in the structured format requested. The document primarily references previous submissions and states that the device is "as safe, as effective and performs as well, as the predicate devices."
Therefore, I cannot fulfill all sections of your request based solely on the provided text. I will, however, extract what information is present and indicate where details are missing.
Acceptance Criteria and Study for K041907 (Trio Monitor - NIBP Derived Heart Rate)
The provided submission does not explicitly state detailed, quantitative acceptance criteria or present a full study report with specific performance metrics for the NIBP-derived heart rate functionality. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to voluntary standards.
The document indicates that testing and documentation related to the ability of the Trio monitor to derive Heart Rate from Non-Invasive Blood Pressure were included in sections five, seven, and eight of the original 510(k) submission K032338, as well as in the current submission. However, these sections are not provided in the input text.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Not explicitly stated in provided text) | Reported Device Performance (Not explicitly stated in provided text) |
|---|---|---|
| Accuracy of NIBP-derived Heart Rate vs. Reference Heart Rate | Presumed to meet AAMI standards or predicate performance | Stated as "performs as well as predicate devices" |
| Bias (Mean Difference) | Not provided | Not provided |
| Precision (Standard Deviation) | Not provided | Not provided |
| Agreement Limits (e.g., Bland-Altman) | Not provided | Not provided |
Note: The submission states that "The results of these measurements demonstrated that the Trio monitor is as safe, as effective and performs as well, as the predicate devices." This is a general statement of equivalency rather than specific numerical performance data or explicit acceptance criteria.
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. This would typically include information about the patient population, site of data collection (e.g., country of origin), and whether the data was collected retrospectively or prospectively.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, this type of study is not relevant for a physiological monitoring device that produces objective measurements like heart rate. MRMC studies are typically used to evaluate diagnostic imaging algorithms where human readers interpret images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
- Standalone Study: Yes, the evaluation of the NIBP-derived Heart Rate would inherently be a standalone performance assessment of the algorithm against a reference standard (e.g., ECG-derived Heart Rate). However, specific details of this study (e.g., its design, results) are not provided in the text. The statement "The ability to derive Heart Rate from the Non-Invasive Blood Pressure parameter is the subject of this 510(k) submission" and "Testing and documentation, related to the ability of the Trio monitor to derive Heart Rate from Non-Invasive Blood Pressure, is included in this 510(k) submission" implies such benchmarking was performed algorithmically.
7. The Type of Ground Truth Used
- Type of Ground Truth: While not explicitly stated, for a physiological parameter like heart rate derived from NIBP, the ground truth would most likely be a well-established and highly accurate reference method, such as Heart Rate derived from Electrocardiogram (ECG). The document mentions that in the previous submission, heart rate was derived from ECG and SpO2, suggesting ECG as a primary reference.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not specified in the provided text. The document refers to "development process" and "testing and documentation," but does not detail the training set used for the NIBP-derived heart rate algorithm if machine learning was involved in its development. However, NIBP-derived heart rate typically relies on signal processing algorithms rather than complex machine learning models requiring large "training sets" in the modern AI sense.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not specified. If the algorithm is based on signal processing principles rather than machine learning, a "ground truth for a training set" in the typical sense would not be applicable. The algorithm would be built upon known physiological relationships and signal characteristics where fundamental reference measurements (like those from ECG) are implicitly the gold standard.
In summary, the provided document K041907 serves as a 510(k) summary for a modification, referencing a previous submission (K032338). It states that testing was performed to demonstrate the safety and effectiveness of the NIBP-derived heart rate, concluding that it performs "as well as predicate devices." However, it lacks the detailed quantitative data, sample sizes, and methodological specifics typically found in full study reports when evaluating novel algorithms or device performance against explicit acceptance criteria.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).