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The Acuity® Central Monitoring System, in all configurations including the hardwired and wireless Acuity LT and Mobile Acuity LT System configurations, is intended to be used by clinicians for the central monitoring of neonatal, pediatric and adult patients in healthcare facilities.

In addition to the central monitoring of patient data, waveforms, and alarms and alerts, Acuity System software can include optional modules to provide extended recording and analysis of patient data. Acuity System software can include the following optional modules:

• . The Full Disclosure module stores patient data for up to 96 hours (24 hours with Acuity LT and . Mobile Acuity LT).
• . The Arrhythmia Analysis 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 Analysis module is not intended for use with neonatal patients.
• . The ST Analysis module provides real-time monitoring and alarms for ST segment deviations for patients with suspected heart disease and anomalies. The clinician is responsible for determining the clinical significance of each selected ST segment deviation or alarm. The ST Analysis option is not intended for use with neonatal patients.
• . The Welch Allyn Connectivity Server (WACS) module consists of a server platform on which one or more of the following software options are installed: Link To Acuity (Acuity System patient information delivered to mobile devices running Clinician Notifier software), Web Server (Acuty System patient printout files available on Web browsers) and HL7 options.

The Acuity® Central Monitoring System, in all configurations including the hardwired and wireless Acuity LT and Mobile Acuity LT System configurations, is intended to be used by clinicians for the central monitoring of neonatal, pediatric and adult patients in healthcare facilities.

In addition to the central monitoring of patient data, waveforms, and alarms and alerts, Acuity System software can include optional modules to provide extended recording and analysis of patient data. Acuity System software can include the following optional modules:

• The Full Disclosure module stores patient data for up to 96 hours (24 hours with Acuity LT and . Mobile Acuity LT).
• . The Arrhythmia Analysis 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 Analysis module is not intended for use with neonatal patients.
• . The ST Analysis module provides real-time monitoring and alarms for ST segment deviations for patients with suspected heart disease and anomalies. The clinician is responsible for determining the clinical significance of each selected ST segment deviation or alarm. The ST Analysis option is not intended for use with neonatal patients.
• . The Welch Allyn Connectivity Server (WACS) module consists of a server platform on which one or more of the following software options are installed: Link To Acuity (Acuity System patient information delivered to mobile devices running Clinician Notifier software), Web Server (Acuty System patient printout files available on Web browsers) and HL7 options.

The Link To Acuity option is Welch Allyn's mobile alarm management solution. It consists of Clinician Notifier software for non-proprietary mobile devices and administrative software for the Welch Allyn Connectivity Server (WACS).

Mobile devices running the Clinician Notifier software deliver patient alarm information and real-time waveforms gathered from patient monitors connected to the Acuity Central Monitoring System. The devices are not intended for use as primary alarm notification devices. Devices running Clinician Notifier software are not directly connected to patients.

The Link To Acuity option is designed to extend the patient monitoring functions of the Acuity Central Monitoring System. The software enables administrators to track the status of clinician-patient assignments, and it enables clinicians to track, respond to and view Acuity System patient alarms, view historical alarm details and waveforms, and view real-time patient waveforms. The mobile devices can be used for barcode scanning to enter patient ID and room number.

The Link To Acuity option is to be used by authorized health care professionals using standard institutional procedures and good clinical practice guidelines for patient monitoring. Staff training in the operation of the Link To Acuity option is essential for optimal use. Users should be skilled at the level of a technician, nurse, physician, health care provider or medical specialist, with the knowledge and experience to acquire and interpret patients' vital signs data.

Individuals using the Link To Acuity option should be familiar with its operation as described in the directions for use manual, and they should understand all warnings and cautions in the directions for use manual.

This document, a Special 510(k) Premarket Notification for the "Link To Acuity® Clinician Notifier Option (Modification to Acuity® Central Monitoring System)", describes a software modification to an existing central monitoring system. The focus is on a mobile alarm management solution, and as such, the performance data presented is related to software testing and clinical entry testing for the specific Clinician Notifier component, rather than broad physiological monitoring accuracy.

Based on the provided text, the document does not contain detailed acceptance criteria and reported device performance in a tabulated format as typically expected for medical device performance studies, especially those involving diagnostic accuracy or clinical outcomes. Instead, it refers to internal testing documents.

Here's an analysis of the information available and what is not provided, broken down into your requested categories:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with corresponding reported device performance values. It lists internal Welch Allyn documents that describe testing activities:

• 830-1423-00: Test Plan, Acuity V7.00
• 831-1285-00: Pre-Validation Clinical Entry Test Report Clinician Notifier 2.35/WACS 2.10.00
• 830-1472-00: Welch Allyn Link to Acuity® - Simulated Clinical Engineering Test Protocol
• 831-1248-00: Link To Acuity® Simulated Clinical Testing Report

These documents, which are not included, would contain the specific acceptance criteria and detailed performance results. The narrative only states that the device was tested "in accordance with the following Welch Allyn documents using production equivalent units prior to market release." The nature of the device (alarm notification and information viewing) suggests that acceptance criteria would likely focus on:

• Reliability: Successful delivery of alarms and real-time data to mobile devices.
• Timeliness: Latency of alarm delivery.
• Accuracy: Correct display of patient information and waveforms as transmitted from the central system.
• Functionality: Proper operation of features like patient assignment, alarm response, and security (login/logout).
• Usability/Human Factors: (Likely covered by the "Pre-Validation Clinical Entry Test Report" to some extent).

Since these detailed performance metrics are not explicitly stated, a table cannot be constructed from the provided text.

The following questions relate to specific types of studies, and the document largely indicates that these types of clinical performance studies (e.g., diagnostic accuracy, comparative effectiveness with human readers) were not performed or are not detailed in this 510(k) summary. This is consistent with a "Special 510(k)" for a software modification that extends the functionality of an already cleared central monitoring system for notification purposes, rather than a novel diagnostic AI algorithm.

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 refers to a "Pre-Validation Clinical Entry Test Report Clinician Notifier 2.35/WACS 2.10.00" and a "Link To Acuity® Simulated Clinical Testing Report".

• Sample Size: Not specified in the provided text for either clinical entry or simulated testing.
• Data Provenance: Not specified. Given the nature of a "Special 510(k)" for a software modification, extensive novel clinical data from external sources is less common. "Simulated Clinical Testing" implies controlled, non-patient data or scenarios. "Clinical Entry Test Report" suggests some form of testing in a clinical environment, but details are absent.
• Retrospective/Prospective: Not specified.

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 is not applicable as the device is not performing a diagnostic or interpretive task that requires expert-established ground truth in the traditional sense of a diagnostic AI study. The "ground truth" for an alarm notification system would be the alarm generated by the central monitoring system and the accuracy of its delivery and display on the mobile device. The internal testing would verify the software's correct function. The "Pre-Validation Clinical Entry Test Report" would likely involve clinical users (nurses, physicians) evaluating the system's usability and functionality, but not establishing a diagnostic ground truth.

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

Not applicable for the reasons stated in point 3. There is no diagnostic ground truth established by multiple experts requiring an adjudication method.

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, an MRMC comparative effectiveness study was not done or is not reported in this document. This type of study is relevant for AI algorithms that perform diagnostic tasks that human readers also perform, to show improvement in diagnostic accuracy or efficiency with AI assistance. The "Link To Acuity Clinician Notifier" is a notification and information display system, not a diagnostic AI.

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

The "Link To Acuity Clinician Notifier" is inherently a "human-in-the-loop" device, as its purpose is to deliver information to a human clinician for action. The underlying "Arrhythmia Analysis module" and "ST Analysis module" of the main Acuity system do perform standalone algorithmic analysis (e.g., detecting arrhythmias, ST segment deviations), and their performance would have been established in previous 510(k) submissions (e.g., K052160 for the Acuity® Central Monitoring Station). This current submission is for the notifier component, which relays the results of those analyses. Therefore, its performance is measured by its ability to deliver existing data, not by its own standalone diagnostic accuracy. The "Simulated Clinical Engineering Test Protocol" and "Simulated Clinical Testing Report" would likely cover the standalone software function of the notifier (e.g., proper routing, display), but not diagnostic performance.

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

For the "Link To Acuity Clinician Notifier," the "ground truth" would be the accurate and timely transmission and display of patient data (waveforms, alarms, alerts, patient info) as generated by the already-cleared Acuity Central Monitoring System. It's about data fidelity and system functionality, not diagnostic accuracy requiring pathology or outcomes data.

8. The sample size for the training set

Not applicable. The "Link To Acuity Clinician Notifier" is a software application designed for alarm management and information display. It is not an AI/ML algorithm that is "trained" on a dataset to learn patterns or make predictions in that sense. It processes and transmits data based on predefined rules and algorithms.

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

Not applicable for the reasons stated in point 8. The device does not involve a training set for an AI/ML model.

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The VSM series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, body temperature, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in normal and axillary modes of neonatal, pediatric and adult patients. The most likely locations for patients to be monitored are general medical and surgical floors, general hospital and alternate care environments. This device is available for sale only upon the order of a physician or licensed health care professional.

The VSM, Vital Signs Monitor, Model 53000 Series, (VSM 300) provides real time monitoring and display of noninvasive blood pressure (NIBP), pulse rate, body temperature and nominvasive oxygen saturation of arteriolar hemoglobin (SpO2).

• NIBP - Noninvasive Blood Pressure is intended to noninvasively measure systolic, diastolic and mean arterial pressures (MAP).
• Temperature -- Intermittent thermometer takes patient temperature in oral, axillary or rectal mode.
• SpO2 - Pulse Oximetry channel is intended to noninvasively measure oxygen saturation of arteriolar hemoglobin at a peripheral measurement site.
  The subject device is a modified version of the Model 53000 Series vital signs monitor, which was cleared for marketing under 510(k) K031740. The Model 53000 Series vital signs monitor has been changed to incorporate a modified NIBP module. The modified and existing NIBP modules are similar in their basic functionality. The modified NIBP module contains an updated safety processor, which replaces a discontinued safety processor. Both safety processors belong to the same microcontroller family. The modified NIBP module also incorporates other minor software and hardware changes, including the addition of a Resistor-Capacitor network to reduce sensitivity to external vibration. The modified Vital Signs Monitor, Model 53000 Series (VSM 300) monitor communicates to the user the same basic information as the Model 53000 Series vital signs monitor, specifically:
• Saturation,
• Pulse rate,
• Pleth waveform,
• Trigger waveform for audible beep, and
• Status information (e.g., sensor type, board integrity).
  In addition, the user display of the above information (e.g., saturation, pulse rate, error codes) remains unchanged.

The Welch Allyn Vital Signs Monitor, Model 53000 Series (VSM 300), underwent a modification involving its noninvasive blood pressure (NIBP) module. The K063419 submission primarily focuses on demonstrating that these changes are minor and do not alter the substantial equivalence of the device to its predicate. Therefore, the "acceptance criteria" discussed here relate to internal testing and adherence to standards rather than showing a new level of clinical performance for a novel function.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list specific acceptance criteria in terms of numerical performance thresholds for the NIBP module, nor does it provide detailed performance data against such criteria in the typical format of sensitivity, specificity, or accuracy for a diagnostic device. Instead, the "Performance Data" section references a series of internal Welch Allyn test reports that demonstrate compliance with relevant standards and internal verification.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the NIBP performance testing (e.g., number of patients or measurement points). The studies referenced (e.g., ANSI/AAMI SP10:2002 test reports) are inherently designed to use defined sample sizes specified by those standards, but the specific numbers are not detailed in this summary.

The data provenance is internal to Welch Allyn, as indicated by the "Welch Allyn documents" for the test reports. It is implied these were prospective tests carried out on production-equivalent units. No information is provided regarding the country of origin of the data or if it was retrospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. For NIBP validation, ground truth is typically established by invasive arterial pressure measurements or calibrated reference devices as per standards like ANSI/AAMI SP10. The summary does not detail the personnel or their qualifications involved in establishing this reference.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of NIBP validation, it's unlikely a human adjudication method (like 2+1, 3+1) would be directly applicable; rather, the "ground truth" would be objective measurements from a highly accurate reference method.

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 MRMC study was performed. This submission is for modifications to a vital signs monitor, not an AI-assisted diagnostic device requiring human interpretation. The device provides objective vital sign measurements.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a standalone vital signs monitor. The performance studies referenced (e.g., NIBP accuracy against a standard) are inherently "algorithm only" in the sense that they assess the device's measurement capabilities independent of a human interpretation loop beyond reading the displayed values.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For NIBP measurements, the ground truth would typically be established through highly accurate, direct arterial pressure measurements or comparison against a validated reference monitor, as specified in the ANSI/AAMI SP10 standard. This is a form of objective, direct measurement rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The VSM 300 is a hardware device with associated software/firmware for acquiring and processing vital signs. It is not an AI/ML device that requires a "training set" in the conventional sense for learning patterns. The "training" for such a device would be its engineering design, calibration, and validation against established medical device standards.

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

This information is not applicable for the reasons stated above (not an AI/ML device requiring a training set).

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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 VSM series of monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, body temperature. noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in normal and axillary modes of neonatal, pediatric and adult patients.

The most likely locations for patients to be monitored are general med/surg, floors, general hospital and alternate care environments. This device is available for sale only upon the order of a physician or licensed health care professional.

The model 53000 Series of monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, body temperature, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpOz), and body temperature in normal and axillary modes of neonatal, pediatric and adult patients.

The most likely locations for patients to be monitored are general med/surg. floors, general hospital and alternate care environments. This device is available for sale only upon the order of a physician or licensed health care professional.

The provided text is a 510(k) summary for a medical device cleared through substantial equivalence, not a detailed study report with specific acceptance criteria and performance metrics. Therefore, much of the requested information (such as specific performance criteria, sample sizes for test and training sets, expert qualifications, and adjudication methods) is not explicitly stated in this document.

However, based on the available text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the 510(k) summary. The document states that the device "will be tested in accordance with the Test Plan / Report, #831-0719-00, and Clinical Validation Report #831-0752-00 included with the submission," but the content of these reports, including specific acceptance criteria and performance data, is not summarized here. Instead, it relies on substantial equivalence to predicate devices, implying that its performance should be comparable.

2. Sample Size Used for the Test Set and Data Provenance

This information is not explicitly provided. The document mentions a "Clinical Validation Report #831-0752-00," which would contain this data, but the summary does not detail it.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not explicitly provided.

4. Adjudication Method for the Test Set

This information is not explicitly provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size

This information is not explicitly provided. The document focuses on substantial equivalence based on technical specifications and performance compared to predicate devices, not on a comparative study with human readers for improved effectiveness.

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

This information is not explicitly provided. Given the device is a vital signs monitor, its core function is to produce readings directly, which implies a standalone performance would be inherent. However, specific details about such testing are not in this summary.

7. The Type of Ground Truth Used

This information is not explicitly provided. For vital signs monitors, ground truth would typically come from reference standards for each measurement (e.g., arterial line measurements for NIBP, co-oximetry for SpO2, calibrated thermometers for temperature), but this is not detailed in the summary.

8. The Sample Size for the Training Set

This information is not applicable/provided. This device is a vital signs monitor that likely uses established algorithms and hardware for measurement, not a machine learning or AI-based device requiring a "training set" in the typical sense.

9. How the Ground Truth for the Training Set was Established

This information is not applicable/provided for the same reasons as point 8.

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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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The Micropaq monitor is intended to be used by clinicians for single or multiparameter vital signs montoring of ambulatory and non-ambulatory pediatric and adult patients in health care facilities. It is also intended for patient transport. Micropaq is intended to operate with an Acuity® central station through wireless communication over Welch Allyn Protocol's FlexNet™ network. FlexNet connects multiple devices through hardwired Ethernet networks and Wireless Local Area Networks (WLANs) to an Acuity® central station. If the Micropaq is moved out of range or loses communication with the FlexNet network, it continues to monitor the patient, display patient data, and generate local patient alarms or alert messages.
The ECG channel is intended for five-lead ECG monitoring.
The Pulse Oximetry channel is intended for continuous noninvasive monitoring of functional oxygen saturation of arteriolar hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
The most likely locations for patients monitored by this device are step-down units, telemetry departments, general med/surg floors, emergency departments, and in-hospital transport. This device is available for sale only upon the order of a physician or licensed health care professional.

The Micropaq is a patient wearable device that provides real time monitoring and display of ECG and SpO2. The Micropaq is powered by a rechargeable battery and has a liquid crystal display (LCD) that displays both waveforms and numerics. The Micropag communicates with Welch Allyn Protocol's Acuity® central station through a wireless local area network (WLAN) operating in the ISM 2.4 GHz band. The communication link is bi-directional, providing monitoring at the Acuity central station and remote control of the Micropaq from the Acuity central station.

The provided 510(k) summary for the Welch Allyn Micropaq vital signs monitor (K021681) does not contain the detailed information requested regarding specific acceptance criteria, device performance metrics, and the study methodology for proving those criteria.

Instead, the summary focuses on establishing substantial equivalence to predicate devices and adherence to general medical device standards. It mentions:

• Substantial Equivalence: The Micropaq 400 series monitors are considered substantially equivalent to the Micropaq 400 series monitors cleared under K002725. The SpO2 channel in model 404 is substantially equivalent to the SpO2 channel in the Nellcor Puritan Bennett, Inc. N-595 Pulse Oximeter cleared under K019821.
• Compliance with Standards: The device and accessories "have been tested and found to comply with the recognized, national and international, performance, safety, and electromagnetic compatibility standards for medical devices and product specifications listed in the Micropaq labeling."
• Risk Analysis: A risk analysis was developed, verified, and validated.
• Quality System: The manufacturer's Quality System conforms to 21CFR820 and is certified to ISO 9001 and EN46001.

Without access to the full submission or specific test reports referenced, it's impossible to provide the detailed table of acceptance criteria and associated performance metrics, sample sizes, ground truth establishment, or multi-reader study information.

Here's a breakdown of what cannot be extracted from the provided text and why:

1. Table of Acceptance Criteria and Reported Device Performance: No specific performance metrics (e.g., accuracy, precision, sensitivity, specificity for ECG or SpO2) are listed, nor are the thresholds for acceptance defined. The document only states compliance with "recognized... performance... standards."
2. Sample Size and Data Provenance for Test Set: No information is given about the number of patients or recordings used in any performance testing, nor their origin (country, retrospective/prospective).
3. Number of Experts and Qualifications for Ground Truth: The document does not describe any human expert review process for establishing ground truth for performance testing. Medical devices like vital signs monitors often rely on established reference devices or physical simulators for validation, rather than expert human interpretation in the same way an AI diagnostic tool might.
4. Adjudication Method: Not applicable as no expert review for ground truth is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is explicitly not mentioned. MRMC studies are typically for AI-assisted diagnostic tools where human reader performance is a key metric. This device is a vital signs monitor, not typically subject to this type of study for its primary function.
6. Standalone (Algorithm Only) Performance: While the device monitors and displays, the "performance testing" described is likely for the accuracy of parameters (ECG, SpO2) compared to a reference, not necessarily an "algorithm-only" performance in the sense of a diagnostic AI. The document doesn't provide such details.
7. Type of Ground Truth Used: Given the nature of a vital signs monitor, ground truth would typically come from:
   • Reference Devices: Highly accurate, calibrated medical instruments used simultaneously with the device under test (e.g., a laboratory oximeter or a 12-lead ECG system).
   • Simulators: Bio-simulators that accurately reproduce physiological signals.
   • Clinical Data (Comparative): Comparing readings to established clinical methods, often in a controlled environment.
     However, the document does not specify which type was used.
8. Sample Size for Training Set: This device is not described as an AI/ML device that requires a "training set" in the modern sense. It's an electronic monitoring device.
9. How Ground Truth for Training Set was Established: Not applicable, as there's no mention of a "training set."

In summary, the provided 510(k) summary is typical for a medical device seeking substantial equivalence based on engineering and safety standards, rather than the detailed performance and ground truth studies often available for AI/ML-driven diagnostic devices. The document confirms that performance testing was done in accordance with applicable standards, but it does not disclose the specific criteria or the results of those tests.

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The Propaq 200 Series monitors are intended to be used by skilled clinicians for multiparameter vital signs monitoring of neonatal, pediatric, and adult patients in health care facility bedside applications; as well as for intrafacility and interfacility transport.

The Propaq 200 Series monitors are small, light weight, portable, multi-parameter patient monitors equipped with either a monochrome or color display. The monitors provide real time monitoring and display of ECG, respiration, invasive blood pressure, noninvasive blood pressure, temperature, CO2 and SpO22. Rechargeable batteries power the monitors. The Propaq 200 Series monitors can communicate with Welch Allyn Protocol's Acuity® central station through a local area network. The communication link is bi-directional, ventral station and one a louity central station and remote control of the Propaq from the Acuity central station.

This 510(k) summary provides limited information regarding specific acceptance criteria and detailed study results. Based on the provided text, here’s a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantifiable acceptance criteria for the Propaq 200 Series Monitors' overall performance or for the improved SpO2 channel in a clear table format. The performance section states:

For the improved SpO2 channel, the device is considered "substantially equivalent to the SpO2 channel in the Nellcor model N-395 Pulse Oximeter," which was previously cleared. This implies that the performance of the improved SpO2 channel is expected to meet the same standards demonstrated by the predicate Nellcor N-395.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only generally states that testing was performed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. The type of testing mentioned relates to compliance with standards, not performance against expert-established ground truth for diagnostic accuracy in a clinical setting.

4. Adjudication Method 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, and its effect size

No MRMC comparative effectiveness study is mentioned. This 510(k) relies on substantial equivalence to predicate devices and compliance with recognized standards, not a comparative study demonstrating improvement with AI assistance (as AI is not explicitly mentioned as a component here).

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

The Propaq 200 Series monitors are patient monitors intended for use by "skilled clinicians." The document does not describe standalone algorithm performance without human intervention. The testing described appears to be for the device's adherence to engineering and safety standards.

7. The Type of Ground Truth Used

For the overall device, the "ground truth" seems to be compliance with "recognized national and international, performance, safety, and electromagnetic compatibility standards for medical devices and product specifications listed in the Propaq labeling."

For the improved SpO2 channel, the "ground truth" for substantial equivalence is implied to be the performance characteristics of the predicate Nellcor N-395 Pulse Oximeter, which presumably met its own set of performance standards at the time of its clearance. No specific clinical ground truth data (e.g., pathology, outcomes data, or expert consensus on clinical readings) is mentioned as being used for the Propaq 200 Series in this summary.

8. The Sample Size for the Training Set

This information is not provided. The development of the Propaq 200 Series monitors and its SpO2 channel would have involved development and verification processes, but specific "training set" sample sizes, as might be relevant for machine learning algorithms, are not discussed.

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

This information is not provided. Given the nature of medical device standards compliance and substantial equivalence claims for patient monitors, the concept of a "training set" and "ground truth establishment" in the context of diagnostic accuracy (as would be typical for AI/CAD devices) is not explicitly applicable or discussed in this document. The "ground truth" for development and verification would be derived from engineering specifications, established physiological principles, and compliance with recognized standards.

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