(77 days)
The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (18 years or older). It is indicated for ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP), continuous noninvasive blood pressure (cNIBP), noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including, general medical-surgical floors, intermediate care floors, and emergency departments.
The ViSi Mobile Monitoring System may be used as standalone devices or networked to ViSi Mobile Remote Viewers through wireless 802.11 communication.
The ViSi Mobile Monitoring System is a lightweight, body-worn vital signs monitor featuring a high resolution, full color touch screen display, with visual and audible alarms and alerts. The ViSi Mobile Monitor is designed to continuously non-invasively measure ECG, heart rate, SpO2, blood pressure, pulse rate, respiration rate, and temperature. The ECG, SpO2, and Respiration waveforms are viewable on demand. The ViSi Mobile Monitoring System is capable of one-time and continuous NIBP measurements.
This document describes the ViSi Mobile Monitoring System, a vital signs monitor. However, the provided text does not contain the detailed study information required to fully answer all aspects of your request regarding acceptance criteria and performance study specifics. Specifically, it lacks quantitative performance data, sample sizes for test sets, details on expert panels, adjudication methods, or MRMC study results.
Based on the available information, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document mentions that acceptance criteria were met, but it does not provide specific numerical criteria or reported device performance metrics in a table format. It states: "The results demonstrated that all acceptance criteria were met, and therefore conforms to expected device performance and intended use."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test set, nor does it provide information on data provenance (country of origin, 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)
The document does not mention the number or qualifications of experts used to establish ground truth for the test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for the test set.
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 does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a vital signs monitor, not an AI-assisted diagnostic tool for human readers, so such a study would likely not be applicable in this context. The modifications are related to posture tracking and associated alarms.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document implies that standalone performance testing of the algorithms was conducted, specifically:
- "SVT-000061 - Walking Algorithm Software Verification"
- "SVT-000062 Undesirable Posture, Immobility and Fall Detection . Software verification"
- "TP-670 – Undesirable Posture Alarms Validation"
- "TP-671 Immobility Alarms Validation"
- "TP-672 Patient Fall Alarm Validation"
- ". TP-673 - Posture Definitions and Walking Validation"
These tests suggest evaluating the algorithms' accuracy in detecting posture, immobility, and falls. However, the specific metrics or acceptance criteria for these standalone tests are not provided in the summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the type of ground truth used for the posture, immobility, and fall detection features. Given the nature of these features, ground truth would likely involve:
- Direct observation: Human observers physically verifying the patient's posture, movement, or fall event.
- Reference sensors/equipment: Other validated sensors (e.g., accelerometers, video analysis) used as a gold standard to establish true states.
8. The sample size for the training set
The document does not provide any information regarding the sample size for the training set.
9. How the ground truth for the training set was established
The document does not provide any information on how the ground truth for the training set was established.
Summary of available information regarding acceptance criteria and performance study:
The device under review is the ViSi Mobile Monitoring System, which added new posture alarm features (undesirable posture, immobility, patient fall) and the ability to display if a patient is walking.
Acceptance Criteria and Reported Performance:
- Acceptance Criteria for new features: The document generally states that "all acceptance criteria were met." However, the specific, quantitative acceptance criteria for each new feature (undesirable posture alarm, immobility alarm, patient fall alarm, walking detection) are not detailed.
- Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, precision) are provided for these features within this document. The statement is qualitative: "The results demonstrated that all acceptance criteria were met, and therefore conforms to expected device performance and intended use."
Study Information (Inferred/Partial):
- Type of Study: Non-clinical performance (verification and validation) testing.
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified.
- Experts for Ground Truth: Not specified.
- Adjudication Method: Not specified.
- MRMC Study: Not applicable/not performed for this type of device modification.
- Standalone Performance: Yes, algorithm-only performance was evaluated through various software verification and validation tests related to walking, undesirable posture, immobility, and fall detection.
- Ground Truth Type: Not explicitly stated but likely involved direct observation or comparison with reference sensors for posture and movement.
- Training Set Sample Size: Not specified.
- Training Set Ground Truth Establishment: Not specified.
In conclusion, while the document confirms that verification and validation testing was conducted and acceptance criteria were met for the new posture features, it lacks the granular detail about the studies themselves, including specific performance metrics, sample sizes, and ground truth methodologies.
§ 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).