(85 days)
This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor.
The monitored parameters are:
- ECG
- Noninvasive Blood Pressure (NIBP)
- Invasive Blood Pressure (IBP)
- Temperature
- Respiratory Gases
- Anesthetic Agent Gases
- Respiratory Rate
- Pulse Oximetry (SpO2)
- Arrhythmia and ST Analysis of the ECG waveforms
The 9100 monitor measures and displays real time physiological data of the patient, including a graphical plethysmogram and numerical data. The 9100 is a modular system and can be used to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), Invasive BP, Temperature, Respiratory Gases, Anesthetic Agent Gases and SpO2. Arrhythmia and ST Segment analysis of the ECG waveforms is also offered. For all these vital parameters, the 9100 will be capable of limit alarms and alerts, printing of strip chart recordings and storing trends for retrospective review.
The provided text does not contain specific acceptance criteria or a study detailing the device's numerical performance against such criteria. The document is a 510(k) summary for the Criticare Systems Inc. Model 9100 Family Vital Signs Monitor, which primarily asserts substantial equivalence to predicate devices and compliance with various performance and safety standards.
Therefore, many of the requested details, such as specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods, are not present in this document.
Here's an overview of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific numerical acceptance criteria and reported device performance. Instead, it broadly states: "The 9100 monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device." It also lists various performance standards that the device complies with, implying that meeting these standards constitutes the acceptance criteria.
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Overall Device | Equivalent to predicate device (8100/8500 Vital Signs Monitor K012059; 8100 w/Arrhythmia & ST Analysis Vital Signs Monitor K030613; 9100 Vital Signs Monitor K091050) | Confirmed to be equivalent to the predicate device. |
| Specific Modalities | Compliance with relevant performance standards: | Compliance confirmed for all listed standards. |
| NIBP | - IEC 60601-2-30 NIBP Safety | |
- EN 1060-1 NIBP Performance | ||
- EN 1060-3 NIBP Performance | ||
- AAMI SP-10 NIBP Performance | Implicitly meets the performance standards by stating compliance. | |
| Oximetry (SpO2) | - ISO 9919 Oximetry Performance | Implicitly meets the performance standards by stating compliance. |
| ECG | - IEC 60601-2-27 ECG Safety | |
- AAMI EC-13 Basic ECG Performance | ||
- AAMI EC-57 Performance of Cardiac Rhythm and ST Segment Measurement Algorithms | Implicitly meets the performance standards by stating compliance. | |
| Invasive BP | - IEC 60601-2-34 Invasive Blood Pressure Safety | Implicitly meets the performance standards by stating compliance. |
| Gas Monitor | - ISO 21647 Gas Monitor Performance | Implicitly meets the performance standards by stating compliance. |
| Temperature | - EN 12470-4 Temperature Performance | Implicitly meets the performance standards by stating compliance. |
| Safety | - IEC 60601-1 Medical Electrical Safety | |
- IEC 60601-1-2 EMC Compliance | ||
- IEC 60601-1-8 Alarms | ||
- IEC 60601-2-49 Multi-parameter Monitor Safety | ||
- ISO 10993-5,10-11 Biocompatibility | Compliance confirmed for all listed standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The filing focuses on substantial equivalence and standard compliance rather than detailed study results.
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)
This information is not provided in the document. Given that the main claim is equivalence to predicate devices and compliance with engineering standards, direct human interpretation of a test set with expert ground truth establishment is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
An MRMC comparative effectiveness study is not mentioned in the document. The device is a vital signs monitor, and the filing describes its standalone performance and equivalence, not its role in assisting human interpretation or diagnostic efficacy in a reader study. There is no AI component mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the filing implicitly describes a standalone performance evaluation by stating "The 9100 monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device" and listing compliance with various performance standards (e.g., for NIBP, oximetry, ECG, etc.). These standards typically involve objective testing of the device's accuracy and functionality without human intervention in the loop of the measurement and display process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance evaluations mentioned (compliance with standards like AAMI SP-10 for NIBP or ISO 9919 for Oximetry), the ground truth would typically be established through scientific reference methods, calibrated instruments, and standardized test protocols as defined by those specific engineering and performance standards. It is not expert consensus, pathology, or outcomes data in the clinical sense, but rather "technical ground truth" established by the standards themselves.
8. The sample size for the training set
This information is not provided in the document. The document references "existing core technologies from the predicate 8100 monitor" and "CSI's field experience with these modalities in the predicate devices has been satisfactory." This suggests that the development likely leveraged historical data and experience from previous products, but specific training set sizes are not disclosed.
9. How the ground truth for the training set was established
This information is not explicitly provided. Given the reliance on "existing core technologies" and "field experience," the ground truth for any underlying algorithms (e.g., for arrhythmia detection or ST segment analysis) would have been established during the development and validation of those predicate technologies, likely through a combination of clinical data and expert review, but the specifics are not detailed here.
§ 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.