(94 days)
The Passport Series Patient Monitors(Passport 12), are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead, or 12-lead selectable), arrhythmia detection and ST Segment analysis, QT analysis, heart rate (HR), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), and anesthetic gas (AG).
All the parameters can be applied to single adult, pediatric and neonatal patients with the following:
- ·C.O. monitoring is restricted to adult patients only;
· PAWP monitoring is not intended for neonatal patients;
· The Mortara ECG Algorithm arrhythmia detection and ST Segment analysis is intended for adult and pediatric patients. The Mindray ECG Algorithm arrhythmia detection is intended for adult and pediatric patients, and the Mindray ECG Algorithm ST Segment analysis is intended for adult patients only.
· 12-lead monitoring and AG monitoring are available for Passport 12 Patient Monitor only.
The monitors are to be used in healthcare facilities by clinical physiciate medical staff under the direction of physicians.
The subject Passport Series Patient Monitors includes two monitors:
- Passport 8 Patient Monitor ●
- Passport 12 Patient Monitor ●
All of the devices in the family are multiparameter monitors indicated for monitoring, displaying. reviewing, alarming, and transferring multiple physiological parameters. The Passport 8 and Passport 12 Patient monitors provide patient monitoring capabilities based on the user selected modules that are plugged into the main monitor.
This document is a 510(k) premarket notification for the Passport Series Patient Monitors (Passport 8 and Passport 12), not a study report. It states that "Mindray conducted functional and system level testing on the subject devices. The testing provided an evaluation of the performance of the device relevant to each of the modifications to the subject devices since their previous clearance. The functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate."
Therefore, most of the information required to answer the question is not present in the provided text. The document refers to "Mindray conducted functional and system level testing" and "testing to ensure the subject devices meet relevant consensus standards" but does not detail the specific studies, sample sizes, or ground truth methodologies that would typically be found in a clinical study report.
However, based on the provided text, here is what can be inferred or explicitly stated regarding acceptance criteria and performance:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly present a table of "acceptance criteria" alongside "reported device performance" like a typical study report. Instead, it compares the "Subject Devices" (Passport 8 and Passport 12) with a "Predicate Device (K132662)" and notes changes and additions in features. The "Performance Data" section broadly states that testing showed the devices "continue to meet specifications and the performance of the device is equivalent to the predicate."
For features where "Same" is indicated, the "Predicate Device" rows effectively represent the performance (specifications) that the current devices are expected to meet. For new or modified features, the stated capabilities in the "Subject Devices" row serve as the claimed performance.
Let's extract an example for a specific parameter based on the device comparison table:
| Feature/Parameter | Acceptance Criteria (Implied from Predicate/New Feature) | Reported Device Performance (Implied from Subject Device Row) |
|---|---|---|
| ECG (Mindray Algorithm) | - 3-lead, 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, Pace detection and heart rate (HR) | - Added QT analysis |
- Added an additional Pace detection channel to enhance the Pace detection function
- Added ECG J-point auto detection
- Added adjustable QRS Detection Threshold |
| Arrhythmia Analysis (Mindray Algorithm) | - Asystole, VFib/VTac, Vtac, Vent. Brady, Extreme Tachy, Extreme Brady, PVC, Couplet, Bigeminy, Trigeminy, R on T, VT>2, PVCs, Tachy, Brady, Missed Beats, Vent. Rhythm, PNP, PNC, Multif. PVC, Nonsus. Vtac, Pause, Irr. Rhythm | - Added AFib |
Crucially, the document does NOT provide quantitative performance metrics (e.g., sensitivity, specificity, accuracy, error margins) that would typically serve as acceptance criteria or reported performance figures from a clinical study for these algorithms. It only lists the features that the device supports and how they compare to the predicate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not provided. The document states "Mindray conducted functional and system level testing," but no details about the sample size of the test set or the provenance of the data (e.g., patient demographics, country, retrospective/prospective nature) are given.
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)
- Not provided. The document does not mention the use of experts for establishing ground truth for any testing performed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not provided. No information regarding adjudication methods is mentioned.
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 / Not provided. This device is a patient monitor, not an AI-assisted diagnostic imaging device requiring human-in-the-loop comparison. The document focuses on the device's technical specifications and equivalence to predicate devices, not on improving human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Implied, but details are not provided. The document states that "Mindray conducted functional and system level testing on the subject devices." This implies standalone testing of the algorithms (e.g., for arrhythmia detection, ST segment analysis, QT analysis, NIBP accuracy) as part of ensuring they "meet specifications and the performance of the device is equivalent to the predicate." However, specific details of these standalone performance studies (metrics, methodologies) are not included.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not provided. The document doesn't specify how ground truth was established for the "functional and system level testing." For vital sign monitors, ground truth often involves comparison to established reference standards or expert-derived measurements.
8. The sample size for the training set
- Not applicable / Not provided. This document describes a medical device's premarket notification, not the development or validation of a machine learning algorithm where a distinct "training set" would typically be discussed. While the algorithms within the monitor (e.g., ECG algorithms) would have been developed and "trained," this document does not provide details of that process or associated training set sizes.
9. How the ground truth for the training set was established
- Not applicable / Not provided. (See point 8).
In summary, the provided FDA 510(k) document is a regulatory submission for substantial equivalence, not a detailed scientific study report. It asserts that the device "meets specifications and the performance of the device is equivalent to the predicate" based on internal testing, but it does not provide the specific, granular data (sample sizes, expert qualifications, quantitative performance metrics, ground truth methodologies) that would be required to fully answer your questions about acceptance criteria and study particulars.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.