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The Connex Spot Monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in normal and axillary modes of neonatal, pediatric, and adult patients. Monitoring respiration rate from photoplethysmogram (Masimo RRp®) is indicated for adult and pediatric patients greater than two years old. The most likely locations for patients to be monitored are general medical or surgical floors and general hospital and alternate care environments.

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

Welch Allyn Connex® Spot Monitor (CSM) is an integrated, configurable vital signs monitor. CSM is intended to be used by clinicians and medically qualified personnel for measuring or monitoring patient vital signs. The specific vital sign measurements available are determined by the sensor/processing technology integrated into the base unit including:

• · Noninvasive blood pressure (NIBP) provides measurements of noninvasive blood pressure and pulse rate
• · Spo2 provides pulse rate, respiration rate, and noninvasive functional oxygen saturation of arteriolar hemoglobin
• · Thermometer measures temperature in neonatal, pediatric, and adult patients
• · Respiration rate from photoplethysmogram (RRp)
• The custom scores option provides custom calculations based on patient vital sign values and modifiers determined by the user

The CSM 1.53, in the same manner as the CSM predicate device, can display and transmit patient data that is electronically or manually entered from external and accessory devices, including weight and height data, manually entered respiration rate, barcode scanned patient and clinician data, and other patient or facility information to a connected Host system. Data is transmitted electronically via USB, Wi-Fi, Bluetooth or ethernet communications to electronic record systems, and for remote display and alarming (e.g., at a central station).

This FDA 510(k) summary provides information for the Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM), which is receiving an update to include Masimo RRp® (respiration rate from photoplethysmogram). However, the document does not contain a specific table of acceptance criteria for this new feature nor detailed results of a study proving the device meets said criteria.

Instead, the document states:

• "Non-clinical testing was performed on the CSM to verify safety and efficacy of the device."
• "All updates were implemented through the design control process and verified to not impact safety and efficacy of the device."
• "The non-clinical tests performed confirm that the subject CSM device is substantially equivalent to the legally marketed predicate CSM (K142356)."

Therefore, I cannot provide the specific details requested in your prompt as they are not present in the provided text. The document focuses on regulatory compliance through substantial equivalence, listing general standards applied, rather than specific performance metrics and a detailed study report for the RRp feature.

To answer your request based only on the provided text, the following information is unavailable:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: Not provided. The testing is referred to as "non-clinical testing," but no specifics on test data are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not conducted, as this is a medical device for vital sign monitoring, not an AI-assisted diagnostic imaging device requiring human reader improvement studies.
6. If a standalone performance study was done: "Non-clinical testing" was performed, indicating testing of the algorithm/device itself, but specific details of a standalone study (like methodologies, results, and metrics) are not provided.
7. The type of ground truth used: Not provided.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

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The iExaminer system with PanOptic Plus, consisting of PanOptic Plus, SmartClip, iExaminer application, and one of the following: iPhone 11 Pro, iPhone 11 Pro Max, iPhone 12 Pro, is intended to be used to capture images as an aid to clinicians in the evaluation, and documentation of ocular health. The images from the iExaminer System with PanOptic Plus are not intended to be used as a sole means of diagnosis.

The iExaminer System with PanOptic Plus is a medical device that allows the user to capture images through the use of a PanOptic Plus ophthalmoscope and a smart device. The iExaminer System with PanOptic Plus consists of (also see Figure 1):

1. PanOptic Plus Ophthalmoscope:
   a. Ophthalmoscope Head
   b. Compatible energy sources (i.e. battery handles or wall units)
   c. Optional Patient Eyecup
2. Smart device attachment instrument (made of SmartBracket and SmartClip);
3. Compatible smart device (iPhone X, iPhone 11 Pro, iPhone 11 Pro Max, iPhone 12 Pro).
4. iExaminer Pro Software Application.
   The iExaminer system with PanOptic Plus is intended to take photographs of the eye and surrounding area.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The document states that a non-clinical and clinical (image comparison) study was performed to demonstrate that the iExaminer System with PanOptic Plus images are substantially equivalent to the predicate device images in their usefulness for documentation and clinical referrals. The acceptance criteria themselves are not explicitly detailed in a table with specific numerical thresholds for metrics like sensitivity, specificity, or accuracy. Instead, the general acceptance criterion for the clinical study was that the new device's images are "substantially equivalent" in usefulness for documentation and clinical referrals compared to the predicate device.

Given that no specific performance metrics like sensitivity or specificity were reported for the device itself against a ground truth, it's not possible to create a table of acceptance criteria and reported device performance in those terms. The study focuses on comparative usefulness.

However, based on the conclusion, the device did meet the established acceptance criteria:
"The results of the image comparison study demonstrate that the iExaminer System with PanOptic Plus has passed all established acceptance criteria and is as safe and effective as the predicate device for its intended use."

Study Details:

1. A table of acceptance criteria and the reported device performance
   As noted above, explicit numerical acceptance criteria for performance metrics (sensitivity, specificity) are not provided. The acceptance criterion was "substantially equivalent" usefulness of images for documentation and clinical referrals compared to the predicate device. The study concluded this criterion was met.

2. Sample size 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 for the test set (number of images or patients). It also does not mention the country of origin of the data or whether it was 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 describe the establishment of a "ground truth" by experts for specific pathologies. Instead, the study was an "image comparison study" where the new device's images were compared to the predicate device's images for "usefulness for documentation and clinical referrals." The number and qualifications of experts (if any specific graders were involved in comparing image usefulness) are not detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
   The document does not provide details on any adjudication method used for comparing images or establishing usefulness.

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, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with or without AI assistance was not conducted or reported. The study was an "image comparison study" between two devices to show substantial equivalence. The device itself is an image capture system, not an AI-powered diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
   No, a standalone algorithm performance study was not done. The device is a system for capturing images for human clinicians to evaluate, not an automated diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
   The study did not use a traditional "ground truth" in the sense of confirmed diseases (e.g., pathology, outcomes data, or expert consensus on diagnosis). Instead, it focused on the "usefulness for documentation and clinical referrals" of images captured by the proposed device compared to images from the predicate device. The predicate device's images are assumed to be a sufficient and already accepted reference point for "usefulness."

8. The sample size for the training set
   This information is not applicable. The device is an image capture system, not an AI model that requires a training set.

9. How the ground truth for the training set was established
   This information is not applicable, as there is no training set for an AI model.

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The Connex Central Station is intended to be used by clinicians for the central monitoring of neonatal, pediatric and adult patients in health care facilities. In addition to the central monitoring of patient data and alarms, the Connex software can include optional modules to provide extended recording of patient data, including full disclosure.

Both the Welch Allyn primary predicate and subject Connex Central Station devices are software devices for a Windows-based operating system that provide clinicians with a means to remotely monitor the health of several patients simultaneously.

This document is a 510(k) summary for the Welch Allyn Connex Central Station (v.1.8.5). It primarily focuses on demonstrating substantial equivalence to a predicate device, not on presenting a detailed study proving performance against specific acceptance criteria for a new AI/ML device.

Therefore, many of the requested details regarding acceptance criteria, study design, expert qualifications, and ground truth establishment for an AI/ML model are not present in this document. The document states "No clinical studies were utilized for the purpose of obtaining safety and effectiveness data." and refers to software verification and validation, and adherence to various medical device standards.

However, based on the provided text, I can infer and extract some relevant information as best as possible, particularly regarding the non-clinical testing performed and the nature of the device.

Here's an attempt to answer your questions based on the provided text, noting where information is explicitly not available for an AI/ML context:

Acceptance Criteria and Device Performance (Inferred)

Since this is a submission for substantial equivalence based on a predicate device and not a new AI/ML algorithm requiring performance metrics like sensitivity/specificity against a ground truth, the "acceptance criteria" here are primarily met through software verification and validation testing and adherence to recognized medical device standards. The performance is not reported as specific clinical metrics but rather as meeting the functional and safety requirements for a central patient monitoring station.

The key change is the addition of ECG parameter display from another cleared device (Welch Allyn CVSM, K171621), and the acceptance is that this integration does not introduce new safety or effectiveness concerns.

2. Sample size used for the test set and the data provenance:

• Test Set: Not applicable in the context of an AI/ML test set with patient data. The "testing" here refers to software verification and validation activities and compliance with standards. There's no mention of a "test set" of patient data for performance evaluation in the way an AI/ML algorithm would use it.
• Data Provenance: Not applicable. The document refers to "well-established, scientific methods" for evaluating new ECG parameter features, but this is about the display of parameters already collected by another cleared device (CVSM, K171621), not new data analysis or inference from a patient data set by the Connex Central Station itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This submission does not involve establishing ground truth for an AI/ML algorithm's clinical performance. The ground truth for the ECG parameters themselves would have been established during the clearance of the Welch Allyn CVSM (K171621), but that's not detailed here.

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

• Not applicable. This is not an AI/ML study involving human readers and adjudicated ground truth.

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. The document explicitly states: "No clinical studies were utilized for the purpose of obtaining safety and effectiveness data."

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

• Not applicable. This device integrates and displays data from other cleared devices; it's a central monitoring station, not an AI/ML algorithm that operates "standalone" to produce a diagnostic or prognostic output from raw data. Its "performance" is based on its ability to accurately receive, process, and display parameters from connected devices and manage alarms, complying with relevant standards.

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

• Not applicable in the context of an AI/ML performance study for this submission. The "ground truth" for the displayed ECG parameters originates from the cleared Welch Allyn CVSM device (K171621), which would have undergone its own validation. For the central station itself, the "ground truth" lies in its adherence to functional specifications, risk management, and the standards listed (e.g., IEC 62304 for software, IEC 60601-2-27 for ECG monitoring equipment safety aspects relevant to its display).

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that undergoes a training phase with a dataset.

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

• Not applicable. (See point 8).

Summary of what the document DOES tell us about the "study":

The "study" or evaluation performed was primarily:

• Software Verification and Validation (V&V): This involved testing the software against its design requirements and functional specifications. The "level of concern" for the software was "Major" (meaning a failure could result in serious injury or death).
• Compliance with Recognized Standards: The device was tested to evaluate its performance based on various international standards for medical devices, specifically:
  • IEC 62366-1:2015 (Usability Engineering)
  • IEC 60601-1-8:2012 (Basic Safety and Essential Performance)
  • IEC 62304:2015 (Medical Device Software - Software Life Cycle Processes)
  • IEC 60601-2-27:2011 (Electrocardiographic Monitoring Equipment Safety)
  • ISO 14971:2019 (Risk Management)
  • AAMI 80001-1:2010 (Risk Management for IT networks with medical devices)
  • ISO 15223-1:2016 (Symbols for labeling)
  • FDA Special Controls Guidance for Arrhythmia Detector and Alarm (October 28, 2003).

The key finding from this "study" or evaluation was that even with the new feature (displaying ECG parameters), the device continues to meet these standards and its design requirements, and therefore remains substantially equivalent to its predicate, raising no new questions of safety or effectiveness.

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The Welch Allyn® Diagnostic Cardiology Suite™ is a prescription device intended for use by physicians, other licensed health care practitioners, and trained personnel who are acting on the orders of a physician. Welch Allyn Diagnostic Cardiology Suite is intended for use in medical clinics, physician offices and hospital settings to acquire, analyze, display, transmit and print certain physiological signals identified below and provide the data for consideration by a physician.

Welch Allyn Diagnostic Cardiology Suite utilizes a software platform to support 12-lead diagnostic resting ECG and diagnostic Spirometry applications and is designed to operate within the inherent capabilities of an off-the-shelf laptop or PC Windows operating system. Welch Allyn Diagnostic Cardiology Suite also provides functions related to patient data management including communication with electronic medical records systems. Welch Allyn Diagnostic Cardiology Suite Resting ECG's are intended to be taken with the patient in the supine position and offer VERITAS™ resting ECG algorithm to generate measurements and advisory statements for review and interpretation by the physician.

Welch Allyn Diagnostic Cardiology Suite is not intended to be used as a physiological vital signs monitor, not intended to be used in a mobile medical environment (e.g. ambulance, helicopter), in magnetic resonance (MR) environments, in operating theaters, nor in conjunction with high frequency surgical equipment.

Indications for Welch Allyn Diagnostic Cardiology Suite ECG range from routine screening of cardiac health in the physician office environment to directed diagnostic differentiation in a hospital cardiology department. Welch Allyn Diagnostic Cardiology Suite ECG is indicated for patients of all ages. There are no known contraindications for resting ECG.

Welch Allyn Diagnostic Cardiology Suite Spirometry is indicated for pulmonary function testing, providing forced expiratory flow-volume and time measurements. The device is intended to be a general assessment tool assisting the clinician in the diagnosis of pulmonary function. These devices are commonly used on patients with occupational exposure to dust or chemicals; presenting with symptoms such as chronic cough, shortness of breath and wheezing; disorders such as interstitial lung disease, bronchitis, asthma, and COPD; or other patients where the clinician determines these pulmonary function measurements are needed. Welch Allyn Diagnostic Cardiology Suite with Spirometry is indicated for adult and pediatric patients age 6 years and older and should only be used with patients able to understand the instructions for performing the test.

The Welch Allyn Diagnostic Cardiology Suite is a PC-based software device. Section 16 details the software technology including its requirements, architecture, detailed design, development environment, verification and validation and lifecycle management plan. Medical device software development and management is characterized in IEC 62304 Medical device software – Software life cycle processes.

The technology of the hardware accessories are:

• For diagnostic ECG, the technology involves applying surface electrodes to the patient's skin to obtain signals of the heart's electrical activity. The electrical signals are then amplified, analyzed (VERITAS algorithms) and displayed on Welch Allyn Diagnostic Cardiology Suite ECG module user interface. Clinical Users can evaluate these ECGs, store them, save them or send them via the technological characteristics provided by the Welch Allyn Diagnostic Cardiology Suite. The diagnostic ECG technology is characterized in IEC 60601-2-25 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs. The Welch Allyn RScribe K120865 utilizes the same VERITAS algorithms as Welch Allyn Diagnostic Cardiology Suite ECG and therefore is being cited herein as a reference device.
• For diagnostic Spirometry, a pneumotach air flow sensor obtains signals of a patient's forced expiratory breathing maneuvers, called "efforts", that are then analyzed against norms contained within Welch Allyn Diagnostic Cardiology Suite Spirometry module. Patient breathing efforts are displayed on the Welch Allyn Diagnostic Cardiology Suite Spirometry user interface. Clinical Users can evaluate these Spirometry efforts, store them, save them or send them via the technological characteristics provided by the Welch Allyn Diagnostic Cardiology Suite. The diagnostic Spirometry technology is characterized in ISO 26782 Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans and follows ATS 2005 Standardization of Spirometry quidelines.

This document describes the regulatory submission for the Welch Allyn® Diagnostic Cardiology Suite™ 2.X.X with Spirometry option 901128 CARDIOPULMONARY ECG SYSTEM (K191013). This submission aims to demonstrate substantial equivalence to a predicate device, Welch Allyn CardioPerfect®Workstation Software™ (CPWS) 901047 (K082478), with the addition of diagnostic spirometry capabilities.

Based on the provided information, no specific acceptance criteria or detailed study results for the device's performance are explicitly stated in terms of metrics like sensitivity, specificity, or accuracy thresholds. The submission focuses on demonstrating substantial equivalence primarily through non-clinical performance data and comparison to a predicate device and a reference device (Welch Allyn® RScribe™ K120865) that shares the same ECG algorithms.

Here's an analysis of the provided information regarding acceptance criteria and performance studies, addressing each of your points:

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

The document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy) or reported numerical performance data from a clinical study for the subject device. The clearance is based on:

• Substantial Equivalence: The primary "acceptance criteria" here is satisfying the FDA's "substantial equivalence" requirements. This means demonstrating that the new device is as safe and effective as a legally marketed predicate device.
• Non-Clinical Performance Data: The reported performance is implicitly covered by successful adherence to various international and national standards for medical devices, particularly for electrical safety, software lifecycle, usability, and specific requirements for electrocardiographs and spirometers. The document states: "Non-clinical performance tests were conducted and submitted to demonstrate that the Welch Allyn Diagnostic Cardiology Suite performs similarly 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)

The document explicitly states: "No clinical studies were utilized for the purpose of showing substantial equivalence." Therefore, there is no clinical test set sample size, data provenance, or information on retrospective/prospective data for a clinical performance study of the subject device itself. The evidence relies on:

• Predicate Device Performance (K082478): The predicate device has established performance.
• Reference Device Performance (K120865): The shared VERITAS algorithms with the reference device, which has been in clinical use since 2012, serve as indirect evidence of performance for the ECG component.
• Non-clinical testing: This includes compliance with standards (e.g., ISO 26782 for spirometers, IEC 60601-2-25 for ECGs). The sample sizes for these engineering or bench tests are not specified here but would typically involve controlled testing environments rather than patient data.

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)

Since no clinical studies were performed for this submission to show substantial equivalence, there were no experts establishing ground truth for a clinical test set in the context of a new performance study. The existing "ground truth" is implied by the predicate device's established performance and the established standards for spirometry and ECG interpretation (e.g., ATS 2005 Standardization of Spirometry guidelines, VERITAS algorithms).

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

Not applicable, as no clinical test set requiring ground truth adjudication was used for this submission.

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. This submission does not mention an MRMC study or any AI components that assist human readers requiring a comparative effectiveness study. The device is a "CARDIOPULMONARY ECG SYSTEM" and a "Diagnostic Spirometer" which acquires, analyzes, displays, transmits, and prints physiological signals, and offers "VERITAS™ resting ECG algorithm to generate measurements and advisory statements for review and interpretation by the physician." This suggests an algorithmic interpretation, but not necessarily one that assists a human reader in an MRMC comparative study context.

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

The device incorporates algorithms ("VERITAS™ resting ECG algorithm" and analysis against "norms contained within Welch Allyn Diagnostic Cardiology Suite Spirometry module"). The performance of these algorithms is implicitly demonstrated through the non-clinical testing against relevant standards (e.g., IEC 60601-2-25 for ECG, ISO 26782 and ATS 2005 for spirometry) and the substantial equivalence argument to predicate/reference devices that also use such algorithms. However, a separate, specific standalone performance study (e.g., reporting sensitivity/specificity of the algorithm diagnosis) is not presented in this document. The description implies that the algorithm generates "measurements and advisory statements for review and interpretation by the physician," indicating a human-in-the-loop for final interpretation.

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

For the non-clinical performance and substantial equivalence argument, the "ground truth" for the device's function is established by:

• Adherence to recognized standards: ISO 26782 (Spirometers), ATS 2005 Standardization of Spirometry, IEC 60601-2-25 (Electrocardiographs). These standards define acceptable levels of performance and accuracy in a controlled, non-clinical environment.
• Comparison to predicate/reference devices: The predicate (K082478) and reference (K120865) devices have already been found substantially equivalent to establish their safety and effectiveness. The current submission argues that the new device performs similarly.

8. The sample size for the training set

Not applicable. Since no new clinical performance study was conducted for this submission (which would typically involve machine learning or AI models with training sets), there is no specified training set for the subject device. The VERITAS algorithm is pre-existing and its development "training" data is not discussed in this document.

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

Not applicable, as no new training set or associated ground truth establishment is described in this document. The "VERITAS algorithms" are mentioned as existing technology, implying their ground truth was established during their initial development and clearance.

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The Welch Allyn RetinaVue Network is a web-based software system application intended for use in storing, managing, and displaying patient data, diagnostic data, and images from computerized diagnostic instruments. Original and enhanced images can be viewed by trained healthcare professionals.

The RetinaVue Network software enables providers to transfer eye images.

1. Transfer images via the Client or Customer portal to the database for storage and/or to the Over-read (Physician) Portal for interpretation.
2. Allow for the enhancement and interpretation of images and report generation at the Over-read (Physician) Portal.
3. Transfer reports from the Over-read (Physician) Portal to the Customer Portal for download.

The provided document is a 510(k) summary for the Welch Allyn RetinaVue Network. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device's performance against detailed acceptance criteria through a clinical study for a new intended use.

Specifically, the document states:

• "PERFORMANCE DATA: RetinaVue Network is a software-only device and was designed and tested within the framework as defined by ISO 14971:2007 Medical devices - application of risk management to medical devices, FDA Guidance dated October 2, 2014 Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, FDA Guidance dated January 11, 2002 General Principles of Software Validation and IEC 62304:2006 Medical device software - software life cycle processes. Usability engineering/human factors testing and was performed in accordance with FDA Guidance dated February 3, 2016 Applying Human Factors and Usability Engineering to Medical Devices and IEC 62366-1:2015-02 incl. Corr. (2016) Application of Usability Engineering to Medical Devices. RetinaVue Network is DICOM compliant as stipulated in its DICOM Conformance Statement. Performance testing confirmed that RetinaVue Network performs as intended, supports the indications for use statement, demonstrates that the device is substantially equivalent to the predicate, and does not raise new questions regarding safety and effectiveness."
• "CLINICAL PERFORMANCE DATA: None required nor submitted."

This explicitly states that no clinical performance data was required or submitted, and the performance testing conducted was focused on demonstrating substantial equivalence and compliance with relevant standards and guidance documents for a PACS medical image system, not on proving a specific clinical acceptance criteria (like diagnostic accuracy, sensitivity, specificity, etc.) with a test set involving human experts.

Therefore, most of the information requested in your prompt regarding clinical acceptance criteria and related study details (e.g., sample size for test set, expert ground truth, MRMC study, standalone performance, training set details) is not applicable to this 510(k) submission for the Welch Allyn RetinaVue Network.

Here's a breakdown of what can be answered based on the provided document:

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

• Acceptance Criteria: The document primarily focuses on demonstrating substantial equivalence to the predicate device (Zeiss FORUM® FORUM Archive, FORUM Viewer (K122938)) in terms of intended use, technological characteristics, and performance for a PACS medical image system. Specific quantitative clinical performance acceptance criteria (e.g., specific accuracy, sensitivity, or specificity thresholds for disease detection) are not stated or required for this type of device.
• Reported Device Performance: The document states that "Performance testing confirmed that RetinaVue Network performs as intended, supports the indications for use statement, demonstrates that the device is substantially equivalent to the predicate, and does not raise new questions regarding safety and effectiveness." This implies the system functions correctly as a PACS for storing, managing, and displaying medical images, including image enhancement features. Specific metrics beyond functional conformity and compliance with standards are not provided.

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

• Not applicable as no clinical test set for performance evaluation (e.g., diagnostic accuracy) was required or submitted. The testing referenced is software verification and validation, usability testing, and compliance with standards like DICOM, ISO, and IEC.

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; no clinical ground truth establishment was conducted for a clinical performance study. The "trained healthcare professionals" mentioned in the indications for use are expected to interpret the images.

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

• Not applicable.

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 study was not done. The device is described as a PACS system, not an AI-assisted diagnostic tool for humans, and explicitly states "CLINICAL PERFORMANCE DATA: None required nor submitted."

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

• No, a standalone diagnostic performance analysis was not done. The device is a PACS, displaying images for human review. It is not an algorithm that outputs a diagnostic result on its own.

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

• Not applicable for a clinical performance study. For software validation, the "ground truth" would be the expected functional behavior based on specifications and regulatory requirements.

8. The sample size for the training set

• Not applicable; this is a PACS system, not a machine learning model that requires a training set for clinical diagnostic performance.

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

• Not applicable.

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The VSM 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for:

• noninvasive blood pressure,
• pulse rate.
• noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and
• body temperature in normal and axillary modes.

The most likely locations for patients to be monitored are general medical floors, general hospital, and alternate care environments.

The optional Masimo Rainbow SET® Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, total hemoglobin concentration (SpHb), and/or respiration rate (RRa). The Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

The optional Oridion module and accessories are intended for the continuous non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate. It is intended for use with neonatal, pediatric and adult patients in hospitals and hospital type facilities.

The optional Oridion module also provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor; end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pentilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.

The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

Optional compatible weight scales (e.g., Health o meter®) can be used for height, weight, and BMI input.

The Welch Allyn Connex® Vital Signs Monitor (CVSM) 6000 Series also contains the Welch Allyn Applications Framework ("Framework"). The Framework is general purpose software that allows medical device and non-medical device software applications to be run on the CVSM independently of, and isolated from, the CVSM's vital signs monitoring functionality. All such applications are intended to be used on the CVSM by trained professionals in a health care setting.

The EarlySense (Everon) module is intended for continuous measurement of respiration rate, heart rate and movement. in an automatic contact-less manner, in a hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EarlySense has been studied in children (weight > 10 Kg) and adults (weight

The Welch Allyn Connex® Vital Signs Monitor 6000 Series (CVSM) is designed to provide a scalable, modular system of components which can be configured to address the needs for vital signs spot checking and continuous monitoring.

The Welch Allyn Connex® Vital Signs Monitor 6000 Series monitor is intended to be used by clinicians and medically qualified personnel for measuring or monitoring patient vital signs. The particular vital sign measurements available are determined by the sensor/processing modules installed into the base unit including;

• NIBP Module provides measurements of noninvasive blood pressure and pulse rate,
• SpO2 Modules from Nellcor and Masimo provide pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin,
• The Masimo SpO2 Module can also provide hemoglobin measurements (SpHb, SpHbv) and acoustic ● respiration rate (RRa),
• . The SureTemp Temperature Module measures body temperature in normal and axillary modes of neonatal, pediatric, and adult patients. Temperature can also be measured IR ear thermometer.
• . The Oridion Capnography Module equipped systems are also capable of carbon dioxide (CO2), respiration rate (RR) and calculation of Integrated Pulmonary Index (IPI) measurements,
• The EarlySense Module provide users the option of continuous and contact-less monitoring of respiration rate, heart rate and patient movement.
• The Global Instruments module provides 3 -5 lead ECG/Impedance Respiration. The ECG modules is for continuous measurement of respiration rate, heart rate and detection of cardiac standstill (asystole), ventricular tachycardia and ventricular fibrillation of this Global Instruments Module is the subject of this 510(k)

The CVSM can also display and transmit patient data that is electronically or manually entered from external and accessory devices, e.g., weight and height data, barcode scanner, IR temperature, and other patient or facility information. Data can be transmitted electronically via USB, wired Ethernet, or wireless communications, including, for example, to electronic record systems and for remote display and alarming (e.g., central station).

This document is a 510(k) premarket notification for the Welch Allyn Connex® Vital Signs Monitor 6000 Series, specifically addressing the integration and display of signals from the Global Instruments ECG module. The filing asserts substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and a study report as would be typical for proving performance de novo.

Therefore, the information traditionally found under "acceptance criteria and the study that proves the device meets the acceptance criteria" (as per new device development) is not explicitly present in the provided text. Instead, the document focuses on demonstrating that the modified device (CVSM with integrated ECG module) remains as safe and effective as its predicate devices.

However, I can extract the closest equivalents to the requested information based on the provided text, particularly from the "Non-Clinical Tests" and "Device Comparison Table" sections.

Acceptance Criteria and Device Performance (based on "Non-Clinical Tests" and "Device Comparison Table"):

Given that this is a 510(k) submission for a software modification to integrate an already cleared ECG module into an already cleared vital signs monitor, the "acceptance criteria" are primarily related to maintaining the safety and effectiveness of the existing device and ensuring proper integration of the new module, without introducing new risks or compromising existing performance. The "performance" is demonstrated through compliance with recognized standards and successful completion of various engineering and functional tests.

Here's a table summarizing the "acceptance criteria" (implied through standards compliance and comparative performance) and "reported device performance" (via test results and stated equivalence):

Detailed Study Information:

It's important to reiterate that this is a 510(k) submission, relying on substantial equivalence to existing devices. As such, it does not describe a de novo clinical study proving the ECG module's performance, but rather the integration of an already cleared module.

1. A table of acceptance criteria and the reported device performance:
   See table above. The "acceptance criteria" are implied by compliance with various IEC/ISO standards and the claimed substantial equivalence to predicate devices, meaning the new configuration must perform "as well as" the existing cleared devices. The "reported device performance" is documented as "Pass" for all listed non-clinical tests and as "Same" when compared to the performance characteristics of the predicate devices for each vital sign parameter.

2. Sample sizes used for the test set and the data provenance:
   The document does not specify "sample sizes" in terms of patient data for clinical studies, as "No clinical studies were utilized for the purpose of obtaining safety and effectiveness data." (page 12). The testing mentioned (e.g., thermal shock, functional drop, abuse testing) are engineering and bench tests performed on the device itself.

   • Data Provenance: Not applicable as no clinical study data is presented. The tests are non-clinical/bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable, as no clinical studies with expert-adjudicated ground truth were performed for this submission. The "ground truth" for the non-clinical tests would be the established engineering specifications and regulatory standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as no clinical studies requiring expert adjudication were performed.

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 done, nor is AI assistance mentioned as a feature of this device. This device is a vital signs monitor, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   The document does not describe standalone algorithm performance in the context of this 510(k). The ECG module itself (Global Instruments ECG module, K152701) would have had its own performance data for its 510(k) clearance, but that data is not detailed here, only referenced. The current submission focuses on integrating this cleared module into another cleared system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the non-clinical bench testing, the "ground truth" would be the established engineering specifications, design requirements, and the pass/fail criteria derived from the referenced IEC and ISO standards. For the performance characteristics of the various vital sign modules, the "ground truth" refers to the validated performance of the predicate devices to which the current device claims substantial equivalence.

8. The sample size for the training set:
   Not applicable. The device is not an AI/ML device that requires a training set in the conventional sense. The "training" in this context would be the engineering and software development process leading to the integration of the ECG module.

9. How the ground truth for the training set was established:
   Not applicable. See point 8.

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The Connex Spot monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, 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.

The Welch Allyn Connex® Spot Monitor (CSM) is an integrated, configurable monitor designed to facilitate the workflows of its users. The Welch Allyn Connex® Spot Monitor is intended to be used by clinicians and medically qualified personnel for measuring or monitoring patient vital signs. The particular vital sign measurements available are determined by the sensor/processing technology integrated into the base unit including; NIBP, provides measurements of noninvasive blood pressure and pulse rate, SpO2 , provides pulse rate and noninvasive functional oxygen saturation of arteriolar hemoglobin, Thermometer measures temperature, e.g., in neonatal, pediatric, and adult patients. The Custom Scores option provides custom calculations based on patient vital sign values and modifiers determined by the user. The CSM can also display and transmit patient data that is electronically or manually entered from external and accessory devices, e.g., weight and height data, barcode scanner, and other patient or facility information. Data can be transmitted electronically via USB, wired Ethernet, or wireless communications including Bluetooth, for example, to electronic record systems and for remote display and alarming (e.g., central station).

The Welch Allyn Connex® Spot Monitor (CSM) has undergone various tests to demonstrate its safety and effectiveness, leading to its classification as substantially equivalent to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes several non-clinical tests performed on the Welch Allyn Connex® Spot Monitor. The acceptance criteria are implicitly defined by the standards and guidance documents against which the device was tested. The reported device performance for these tests is simply "Pass."

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

The document does not explicitly state the specific sample sizes for each non-clinical test (e.g., number of units tested for shipping, number of subjects for SpO2 accuracy). It refers to testing against established standards and guidance documents, which typically dictate sample size requirements.

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective, as the studies are described as non-clinical and bench testing.

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

The document does not mention the use of experts to establish ground truth for the non-clinical tests described. These tests primarily rely on established engineering standards and technical measurements rather than expert human interpretation. For the SpO2 Functional Accuracy testing, the ground truth would be against a reference oximeter or validated physiological measurements as per the FDA guidance. For Formative Usability Testing, user feedback would be gathered, but the number and qualifications of "experts" are not detailed.

4. Adjudication Method for the Test Set

No adjudication method is described, as the tests are non-clinical and the results are performance against established metrics or standards (resulting in a "Pass").

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No MRMC study was done. The document explicitly states: "No clinical studies were conducted as part of submission to prove substantial equivalence." This is a device for measuring vital signs, and the substantial equivalence is primarily based on technological similarity and non-clinical performance to an existing predicate device.

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

The performance tests described are inherently standalone in nature, as they evaluate the device's technical specifications and adherence to standards (e.g., accuracy of NIBP, SpO2, Temperature, communication capabilities). There isn't an "algorithm only" component presented distinctly from the device's integrated functionality. The software verification and validation would fall under this category as an evaluation of the device's core processing independent of human interaction during the test.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests is based on:

• Established engineering standards and regulatory guidance: For safety (IEC 60601-1), EMC (IEC 60601-1-2), alarm systems (IEC 60601-1-8), specific vital sign measurements (IEC 80601-2-30 for NIBP, ISO 80601-2-61 for SpO2, ISO 80601-2-56 for temperature), and risk management (EN/ISO 14971).
• Reference measurements/equipment: For functional accuracy of SpO2, it would be compared against a 'gold standard' or reference pulse oximeter as per FDA guidance.
• Specifications: For wireless/Bluetooth communication, the ground truth is successful communication within defined parameters.
• User feedback: For formative usability testing, user needs and expectations serve as a form of ground truth.

8. The Sample Size for the Training Set

The document does not mention a "training set" as it relates to machine learning or AI algorithms. The device's vital sign algorithms (NIBP, SpO2, Temperature) are stated to be "unchanged from CVSM" (the predicate device). Therefore, any "training" (if applicable to these types of algorithms, which often rely on established physiological models rather than machine learning training sets) would have been conducted for the predicate device. For this submission, no new training data or process is described.

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

Since no training set for new algorithms is described for the CSM (as the algorithms are carried over from the predicate device), the method for establishing ground truth for a training set is not applicable to this submission.

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The Connex Central Station (CS) is intended to be used by clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities. In addition to the central monitoring of patient data and alarms, the Connex software can include optional modules to provide extended recording of patient data, including full disclosure.

Connex Central Station, also known as Monitoring Station, is a Windows-based product that provides clinicians with a means to remotely monitor the health of several patients simultaneously. The Monitoring Station receives patient vital signs and alarm data from patient monitors and spot check devices over a network, then displays the data and sounds audio alarms in a centralized location.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Welch Allyn Monitoring Station (Connex Central Station), K132807.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It primarily details non-clinical verification and validation testing, rather than a traditional clinical study with defined acceptance criteria and detailed performance metrics as one might see for a diagnostic AI device. Therefore, some of the requested information (like specific performance metrics, sample sizes for test/training sets with provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone performance) is not explicitly present or isn't applicable in the context of this type of submission for a patient monitoring central station.

1. Table of Acceptance Criteria and Reported Device Performance

For each "Test Objective" below, the implicit acceptance criteria is that the test objective is met and the explicit reported performance is "Pass".

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

• Sample Size: Not specified in terms of number of patients or specific data points. The testing describes functional, performance, and usability tests on the device and its various new features.
• Data Provenance: The document does not mention specific clinical data or patient data being used for these non-clinical tests. It implies simulated environments or direct device-to-device communication for testing functionalities like alarm delivery or data display. The tests are "Non-Clinical Tests."

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

• Number of Experts: Not applicable. The "ground truth" for these tests relates to the expected functional behavior of the software and hardware according to design specifications and standards.
• Qualifications of Experts: Not applicable. These were verification and validation tests against pre-defined specifications rather than expert interpretation of clinical data.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The tests are pass/fail based on whether the system performs as expected, not on subjective interpretations requiring adjudication.

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

• Was it done? No. The document explicitly states: "No clinical studies were utilized for the purpose of obtaining safety or effectiveness data." This submission is for a central monitoring station, not a diagnostic AI device requiring MRMC studies.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was it done? In a sense, yes, for specific functionalities. The tests described are primarily standalone device performance tests, verifying the software and hardware functions as designed, independent of human interaction within the test (though human users were involved in usability testing). However, this is not a "standalone algorithm" in the context of typical AI device evaluation. The device itself is designed for human-in-the-loop operation by clinicians.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for these non-clinical tests is established by the device's design specifications, relevant industry standards (IEC, ISO), and functional requirements for the software and hardware features. For usability testing, it would be adherence to pre-defined usability requirements.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This is a traditional software/hardware medical device, not an AI/ML device that requires a training set in the typical sense.

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

• Ground Truth Establishment: Not applicable, as there is no "training set." The device's functionality is based on deterministic programming and hardware design, not machine learning from a data set.

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The VSM 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for:

• noninvasive blood pressure,
• pulse rate,
• noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and
• body temperature in normal and axillary modes.

The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments.

The optional Masimo Rainbow SET® Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, total hemoglobin concentration (SpHb), and/or respiration rate (RRa). The Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

The optional Oridion module and accessories are intended for the continuous non invasive measurement and monitoring of carbon dioxide concentration of the expired breath and respiration rate. It is intended for use with neonatal, pediatric and adult patients in hospitals and hospital type facilities.

The optional Oridion module also provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.

The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

Optional compatible weight scales (e.g., Health o meter") can be used for height, and BMI input.

The Welch Allyn Connex® Vital Signs Monitor (CVSM) 6000 Series also contains the Welch Allyn Applications Framework ("Framework"). The Framework is general purpose software that allows medical device and non-medical device software applications to be run on the CVSM independently of, and isolated from, the CVSM's vital signs monitoring functionality. All such applications are intended to be used on the CVSM by trained professionals in a health care setting.

The EarlySense (Everon) module is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner, in a hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EarlySense has been studied in children (weight ≥ 10 Kg) and adults (weight

The Welch Allyn Connex® Vital Signs Monitor 6000 Series (CVSM) is designed to provide a scalable, modular system of components which can be configured to address the needs for vital signs spot checking and continuous monitoring.

The Welch Allyn Connex® Vital Signs Monitor 6000 Series monitor is intended to be used by clinicians and medically qualified personnel for measuring or monitoring patient vital signs. The particular vital sign measurements available are determined by the sensor/processing modules installed into the base unit including;

• NIBP Module provides measurements of noninvasive blood pressure and pulse rate.
• SpO2 Modules from Nellcor and Masimo provide pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin.
• The Masimo SpO2 Module can also provide hemoglobin measurements (SpHb, SpHbv) and acoustic respiration rate (RRa),
• The Temperature Module measures body temperature in normal and axillary modes of neonatal, pediatric, and adult patients.
• The Oridion Capnography Module equipped systems are also capable of carbon dioxide (CO2), respiration rate (RR) and calculation of Integrated Pulmonary Index (IPI) measurements,
• The EarlySense Module provide users the option of continuous and contact-less monitoring of respiration rate, heart rate and patient movement. The addition of this Module is the subject of this 510(k).

The CVSM can also display and transmit patient data that is electronically or manually entered from external and accessory devices, e.g., weight and height data, barcode scanner. IR temperature, and other patient or facility information. Data can be transmitted electronically via USB, wired Ethernet, or wireless communications, including, for example, to electronic record systems and for remote display and alarming (e.g., central station).

This looks like a 510(k) summary for the Welch Allyn Connex® Vital Signs Monitor 6000 Series (CVSM) that focuses on the addition of the EarlySense module. The submission claims substantial equivalence to a previously cleared device (K121013), not necessarily claiming novel performance that requires significant clinical studies.

Here's an analysis of the provided text regarding acceptance criteria and studies:

Key Takeaway from the Document:

The document explicitly states: "No clinical studies were utilized for the purpose of obtaining safety and effectiveness data." (Page 8). This means that for the subject device (the CVSM with the integrated EarlySense module), there wasn't a new clinical study to establish its performance. Instead, it relies on substantial equivalence to a predicate device and bench testing for the integration of the EarlySense module. The EarlySense module itself was previously cleared in a separate 510(k) (K120465), and the performance claims for respiration rate, heart rate, and patient movement from that clearance are what are being incorporated.

Therefore, the acceptance criteria and performance data for the overall device are generally based on the predicate device's performance, as well as the previously cleared EarlySense module's performance, and the current submission primarily addresses the safety and effectiveness of the integration via non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since no new clinical studies were performed for this specific 510(k), the "reported device performance" for the subject device (CVSM with EarlySense module) relies on the performance characteristics inherited from the predicate device and the previously cleared EarlySense module.

Note: The acceptance criteria for the EarlySense module's measurements (Respiration Rate, Heart Rate, Patient Movement) are those from its original 510(k) clearance (K120465), which are being appended to the CVSM's indications for use.

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

As explicitly stated: "No clinical studies were utilized for the purpose of obtaining safety and effectiveness data."

Therefore, there is no "test set" in the context of new clinical performance data generated for this 510(k) submission.

The section "Clinical Performance Data" directly states this lack of new clinical studies. The performance of the EarlySense module for respiration rate, heart rate, and patient movement was established in its prior 510(k) (K120465), and the current submission is for the integration of this already-cleared module into the CVSM.

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

Not applicable, as no new clinical studies were conducted for this submission that would require establishing a ground truth with experts. The performance data for the EarlySense module itself would have been established during its original K120465 clearance process.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical studies were conducted for this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done as part of this 510(k) submission. The submission explicitly states "No clinical studies were utilized for the purpose of obtaining safety and effectiveness data." This type of study would be classified as a clinical study.

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

The document indicates that the "EarlySense (Everon) module is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner." This implies a standalone algorithm for these measurements. However, no new standalone performance study was done for this submission. The performance characteristics of the EarlySense module were presumably established during its original K120465 clearance. This 510(k) focuses on the integration of this already-cleared module into the Welch Allyn CVSM.

The "Non-Clinical Tests" section lists several bench tests (e.g., Electromagnetic Compatibility, Shock and Vibration, Thermal Shock, Operating Environmental Test, Battery Use Cycles, Electrical Safety, Industrial Design Specification Analysis, Shipping Container Labeling, BOM Verification, Design Validation, Directions For Use Validation). These are engineering and usability tests to ensure the integrated system functions safely and effectively, but they are not standalone performance studies of the measurement algorithms themselves.

7. The type of ground truth used

Not applicable for this 510(k) submission, as no new clinical studies were conducted. The ground truth for the EarlySense module's measurements (Respiration Rate, Heart Rate, Patient Movement) would have been established during its original K120465 clearance, likely using reference methods or gold standards for vital sign measurement.

8. The sample size for the training set

Not applicable for this 510(k) submission, as no new clinical studies were conducted. Any training data for the EarlySense algorithms would have been part of its original development and clearance (K120465).

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

Not applicable for this 510(k) submission. This information would pertain to the original development and clearance of the EarlySense module (K120465).

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