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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. It is indicated for ECG (3 or 5 leadwire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), non-invasive 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 a central station through wireless 802.11 communication.

The ViSi Mobile Monitoring System is a lightweight, portable patient vital signs monitor featuring a high resolution, full color touch screen display, with visual and audible alarms and alerts. The ViSi Mobile Monitor is body-worn and designed to continuously measure ECG, heart rate, SpO2, pulse rate, respiration rate, and temperature. The ECG, SpO2, and Respiration waveforms are viewable on demand. NIBP can be measured as a onetime measurement, or it can be measured automatically at predefined intervals.

The provided document (510(k) Summary for the ViSi Mobile Monitoring System) does not contain detailed information about specific acceptance criteria, a comprehensive study outline proving these criteria, or specific performance metrics with sample sizes, ground truth establishment, or expert qualifications for the device's various parameters.

The document primarily focuses on describing the device, its indications for use, and a general statement about its safety and effectiveness based on compliance with recognized standards and similarities to predicate devices. It also mentions "verification and validation activities performed based on the FDA's draft guidance on Radio-Frequency Wireless Technology in Medical Devices provides assurance of a more reliable wireless connection." However, it does not provide the specifics of these verification and validation activities in terms of acceptance criteria and study details.

Therefore, I cannot populate the requested table and answer the specific questions about the study design, sample sizes, ground truth, and expert involvement based solely on the provided text.

The information that is available from the document is:

• Device Name: ViSi Mobile Monitoring System
• Intended Use: Single or multi-parameter vital signs monitoring of adult patients in hospital-based facilities (general medical-surgical floors, intermediate care floors, and emergency departments) for ECG (3 or 5 leadwire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP).
• General Claim: "The ViSi System has been tested and complies with recognized performance, safety, and electromagnetic compatibility standards for medical devices. The verification and validation activities performed based on the FDA's draft guidance on Radio-Frequency Wireless Technology in Medical Devices provides assurance of a more reliable wireless connection. These results demonstrate that the ViSi System is safe, as effective, and based on the similarities with the predicate devices, substantially equivalent."

To answer your request, a more detailed study report or clinical trial summary would be necessary, which is typically a separate document from the 510(k) summary itself.

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The Propaq LT 802 series monitors are highly portable devices intended to be used by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of ambulatory and non-ambulatory neonate, pediatric and adult patients. These monitors are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by this device are hospital general medical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services and other healthcare applications. The monitors may be used as standalone devices or as devices networked to an Acuity " central station through wireless communication over Welch Allyn's FlexNet™ network.

This device is available for sale only upon the order of a physician or licensed health care professional.

The Propaq LT 802 Series of monitors are small, lightweight patient monitoring devices intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive Interious bo adou by cirite, ECG, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2) in ambulatory, non-ambulatory and transport environments

This document is a 510(k) summary for the Welch Allyn Propaq LT 802 Series vital signs monitor. It describes the device, its intended use, and provides a statement of its substantial equivalence to predicate devices. However, it does not contain the detailed performance study results, acceptance criteria, or ground truth information typical for an AI/ML device submission.

Therefore, I cannot fully complete the requested table and sections based on the provided text.

Here's what I can infer and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific numerical acceptance criteria for each vital sign parameter (ECG, NIBP, Respiration, SpO2).
• Quantified performance results (e.g., mean absolute difference for NIBP, accuracy percentages for heart rate, SpO2 accuracy over specific ranges).

Study Related Information (Based on what can be inferred/is missing):

• Study That Proves the Device Meets Acceptance Criteria: The document mentions that the device "will be tested in accordance with the [test methods mentioned elsewhere in the submission] using production equivalent units prior to release to market." This indicates that verification and validation testing was planned or executed, but the details of these studies are not present in this summary. The summary focuses on regulatory compliance and substantial equivalence rather than detailed performance study reports.

• 2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

  • Not specified in the document. The document does not provide details on specific test sets, sample sizes, or data provenance.

• 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 applicable/Not specified. For a vital signs monitor, ground truth is typically established by reference devices (e.g., a highly accurate NIBP simulator, a SpO2 simulator, or a known ECG waveform generator) rather than expert consensus on medical images or diagnoses. The document does not mention experts for ground truth establishment.

• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

  • Not applicable/Not specified. Adjudication methods are typically used in studies involving subjective interpretation (e.g., image reading). For vital sign measurements, accuracy is usually determined against a validated reference.

• 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:

  • No. This is a vital signs monitor, not an AI-powered diagnostic device. MRMC studies are not relevant in this context.

• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

  • Yes, implicitly. The device itself is a standalone vital signs monitor. Its performance would be evaluated as an algorithm/device-only performance against reference standards. This is the primary mode of evaluation for such devices.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

  • Likely a combination of physical simulators and clinical studies against reference devices. While not explicitly stated, for vital signs monitors, ground truth typically comes from:
    • For NIBP: Cuff inflation measurements against a reference manometer or invasive arterial pressure measurements.
    • For ECG: Standardized ECG waveforms, or simultaneous recordings with a highly accurate reference ECG device.
    • For SpO2: Controlled hypoxia studies against a CO-oximeter, or testing with calibrated SpO2 simulators.
  • The document mentions "production equivalent units," implying testing against established standards.

• 8. The sample size for the training set:

  • Not applicable/Not specified. This is not an AI/ML device that requires a "training set" in the conventional sense. The device's algorithms for processing vital signs are likely based on established physiological principles and signal processing, not statistical learning from a large training dataset.

• 9. How the ground truth for the training set was established:

  • Not applicable/Not specified. As it's not an AI/ML device relying on a training set, this question is not relevant.

Summary of Device and Regulatory Context:

This 510(k) summary is for a traditional medical device (vital signs monitor). The regulatory pathway focuses on demonstrating "substantial equivalence" to existing legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness compared to the predicate. The performance data, while crucial for the submission, is usually summarized or referenced rather than detailed in the public 510(k) summary.

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The Acuity system is intended to be used by skilled clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities. The Acuity system consists of the Acuity® Central Monitoring Station. Acuity software, FlexNet™ communications network and Welch Allyn vital signs monitors. The vital signs monitors can operate standalone (according to their individual Intended Use Statement) or be networked to the Acuity central monitoring station through the Acuity FlexNet communication network.

In addition to the central monitoring of patient data, waveforms, alarms and alerts, the Acuity software can include optional modules to provide extended recording of patient data (Full Disclosure), arrhythmia monitoring and ST analysis.

• . Full Disclosure stores patient data for up to 96 hours.
• Arrhythmia monitoring module provides real-time monitoring and alarms for specific . changes in cardiac rhythms. The clinician is responsible for determining the clinical significance of each detected arrhythmia event or alarm. The arrhythmia module is not intended for use with neonatal patients.
• ST analysis module provides real-time monitoring and alarms for ST segment deviations, . from a reference beat, for patients with suspected heart disease and anomalies. The clinician is responsible for determining the clinical significance of each detected ST segment deviation or alarm. The ST analysis module is not intended for use with neonatal patients.

The most likely locations for patients monitored by an Acuity system are step-down units, telemetry departments, general med/surg floors and emergency departments. The Acuity system is available for sale only upon the order of a physician or licensed health care professional.

The Acuity system comprises four components: the Acuity Central Monitoring Station, Acuity software, the FlexNet™ communications network, and Welch Allyn vital signs monitors. The Acuity Central Monitoring Station is the heart of the system, using hardware provided by Sun Microsystems, Inc. The Acaity Central Monitation Station, Shippetwork devices on the FlexNet Betweek uring hardwired Ethernet connections (IEEE 802.3-compliant) or wireless Ethernet connections (IEEE 802.11compliant).

The Acuity software operating system is Solaris™, the Unix®-based operating system from Sun Microsystems. Welch Allyn Protocol's application software provides the routines and services required to accomplish the tasks associated with central patient monitoring. These tasks include the user interface, communication with patient monitors, management of alarms and settings, and recording and review of patient data.

The Archythmia Analysis and ST Analysis options are being replaced with Mortara Instrument's arrhythmia algorithm software module. Mortara Instrument's arrhythmia software will now provide the data analysis for both the Arrhythmia Analysis and the ST Analysis options.

The Acuity application software receives the output from the Mortara software module and records the results in the same manner as the previous version of Acuity software. There are only a few minor changes to the user interface as described in the Acuity Directions For Use.

The Acuity hardware and software operating system are not changed.

Here's an analysis of the acceptance criteria and study detailed in the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a formal table with pass/fail thresholds. However, it implicitly sets performance expectations by comparing the new software module to the previous one and by presenting specific performance metrics from a standalone test.

Implicit Acceptance Criteria and Reported Performance:

Study Details

The document describes performance testing conducted to evaluate the new Mortara arrhythmia software module within the Acuity system.

2. Sample Size and Data Provenance:

• Test Set Sample Size: "one test case, which included 1600 beats". This refers to the specific instance where 3 ventricular beats were mislabeled. The document also mentions "playback files" being used, suggesting a standardized set of ECG recordings.
• Data Provenance: Not specified, but the use of "playback files" implies pre-recorded data, likely retrospective. There is no mention of country of origin.

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document does not describe how the ground truth for the test playback files was established or who established it.

4. Adjudication Method:

• Adjudication Method: Not specified.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

• Was it done?: No. The study focuses on the performance of the algorithm itself and mentions the improvement of the Mortara software module over the prior Acuity software module. It does not describe human readers using the AI-assisted system and comparing their performance to human readers without AI assistance.

6. Standalone (Algorithm Only) Performance:

• Was it done?: Yes. The text explicitly states: "A standalone (non-networked) Acuity system with a single patient monitor connected was also tested with the same playback files." This represents a standalone evaluation of the algorithm's performance.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not explicitly stated, but based on the context of "playback files" and evaluating arrhythmia detection and labeling, the ground truth would most likely be expert consensus on ECG interpretations or potentially derived from established, adjudicated databases of ECG recordings. The document doesn't provide enough detail to definitively confirm this, but it is implied by the nature of arrhythmia analysis.

8. Sample Size for the Training Set:

• Sample Size: Not specified. The document focuses on the testing of the Mortara module within the Acuity system, not on the development or training of the Mortara algorithm itself.

9. How Ground Truth for the Training Set Was Established:

• How Established: Not specified. As with the training set size, this information pertains to the development of the Mortara algorithm, which is not detailed in this submission.

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