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The VS 9/VS 8/VS 8A Vital Signs Monitors are intended for monitoring, displaying, storing, alarming, and transfering of multiple physiological parameters including Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon Dioxide (CO2). All the parameters can be monitored on single adult, pediatric, and neonatal patients.

The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The VS 9/VS 8/VS 8A Vital Signs Monitor are not intended for helicopter transport, hospital ambulance, or home use.

The subject VS series Vital Signs Monitors includes three monitors:

• VS 9 Vital Signs Monitor
• VS 8 Vital Signs Monitor
• VS 8A Vital Signs Monitor .

The VS series Vital Signs Monitors are for use for adult, pediatric, and neonatal patients. The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. The monitors should only be used by persons who have received adequate training in their use.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

Device: Mindray VS Series Vital Signs Monitors (VS 9/VS 8/VS 8A)
Parameter for Analysis: Temperature (Temp) measurement using the new Mindray Temp Module (TrueTemp) in Predictive mode.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for temperature measurement are based on the requirements of ISO 80601-2-56:2017/Amd.1:2018(E). The summary provides statistical results from a clinical investigation.

Note: The document states that the performance of the TrueTemp module "meets the requirements of ISO 80601-2-56:2017/ Amd.1:2018(E) for temperature measurement and meets the acceptance criteria in clinical protocol." While the specific numerical acceptance criteria from the ISO standard are not explicitly listed in the table, the reported performance metrics are the results of testing against those criteria. The predicate device's performance is also included in the table in the full submission, showing similar statistical results.

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

• Sample Size for Test Set:
  • 106 valid cases for oral temperature.
  • 110 valid cases for axillary temperature.
  • 109 valid cases for rectal temperature.
• Data Provenance: The study was a clinical investigation conducted by Mindray. The country of origin is not explicitly stated in the provided abstract, but Mindray is a Chinese company (Shenzhen, Guangdong, P.R. China), suggesting the study likely took place in China. It was a prospective clinical investigation as it aimed to meet specific requirements for validity and accuracy of the new module.
• Subject Demographics: The study included subjects in three age groups: infants (newborn to one year), children (greater than one to five years), and adults (greater than five years old). The age of subjects ranged from 4 days to 67 years old. The total number of febrile subjects constituted not less than 30% and not greater than 50% of all subjects in each selected age group and body site.

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

This information is not explicitly provided in the summary. The ground truth (reference temperature) was established by comparing the TrueTemp module's measurements to the "direct mode of WelchAllyn SureTemp PLUS 690." It's likely that a trained clinical professional operated the reference thermometer, but the specific number and qualifications of experts involved in establishing the "ground truth" are not detailed.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated. Given that the ground truth was established by a comparative measurement against a reference device (WelchAllyn SureTemp PLUS 690), it implies a direct comparison rather than an expert consensus requiring an adjudication process.

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

This is not applicable. The device is a vital signs monitor that directly measures physiological parameters like temperature. It is not an AI-assisted diagnostic tool that involves human readers or interpretation of medical images/data in a way that would necessitate an MRMC comparative effectiveness study to assess human improvement with AI assistance.

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

Yes, a standalone performance evaluation was done for the temperature measurement function. The clinical investigation directly assessed the accuracy and validity of the "new Mindray Temp Module (TrueTemp)" in its predictive mode compared to a reference standard (WelchAllyn SureTemp PLUS 690). This evaluation focused on the device's intrinsic measurement capabilities without assessing human interaction or interpretation as part of the core performance metrics discussed here.

7. The Type of Ground Truth Used

The ground truth used was comparison to a legally marketed reference device: the "direct mode of WelchAllyn SureTemp PLUS 690," which is itself a clinical thermometer. This is a form of comparative measurement against a recognized standard in the field.

8. The Sample Size for the Training Set

The document does not provide information regarding a separate training set for the Mindray TrueTemp module's temperature measurement function. Given that this is a hardware module (thermal resistance technique) with associated algorithms for predictive mode, its development and calibration would typically involve internal technical specifications and potentially laboratory testing, but "training set" in the context of machine learning is not directly applicable or reported for this type of device in the provided summary.

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

As no training set information is provided, how its ground truth was established is not discussed in this document.

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The MedWand™ Device, in combination with the MedWand™ Software Application installed on an attached mobile device or computing system, is an intermittent vital sign measuring and examination system intended to collect, record, and display the following information:

• · Oxygen saturation (SpO2),
• · Pulse rate (PR),
• · Infrared body temperature (TEMP)
• · Amplified auscultation sounds filtered for heart, lungs, and abdomen (STETH)
• · Photographs of areas needing assessment (CAMERA)

The device is intended for use by adult lay users independently or guided by a health care professional (HCP) in home and non-acute clinical environments.

The MedWand™ Device is intended for use by trained adults only who can use smart phones, tablets, or computers proficiently.

Collected information is not intended for self-diagnosis. Interpretation and assessment of results should be performed by an HCP. Collected information can be provided to a HCP when used as a standalone device.

Additionally, the MedWand™ Device can integrate with external data communications systems (not part of the MedWand™ Device) through a programming interface. This integration will facilitate interactions between the lay user and HCP for telemedicine. The device is intended for spot-checking and does not have continuous monitoring capability or alarm features.

The MedWand™ Device is a handheld telemedicine device that allows measurement of SpO2. pulse rate, and stethoscope along with a camera. The device is intended to be used by lay people or clinical personnel. The patient applies their finger to the sensor on the top of the device designed for measuring SpO2 and pulse rate. The thermometer is a non-contact IR thermometer that is pointed to the patient's forehead. The camera can be pointed to the particular body part at the (remote) Health Care Professional's (HCP) direction. The stethoscope is contacted directly to the patient's chest or abdomen to provide auscultation sounds to the (remote) HCP.

The MedWand™ Device works as part of the MedWand™ Ecosystem. The MedWand™ Ecosystem consists for following elements:

• 1. MedWand™ Device including its embedded firmware This device is provided to the patient or other user who is physically present with the patient.
• 2. USB-C cable provided with the device. This cable physically connects the MedWand™ Device to the mobile device or computing platform to provide power, communications, and control for the MedWand™ Device
• 3. Client App Software Proprietary software that is provided to the patient or user to run on their mobile device or computing platform (MCP). This software is available for both Windows-based and Android-based devices. This software supports the local operation of the MedWand™ Device and the use of the device in the context of a telemedicine system. This software contains the user interface to the MedWand™ Device. This software provides the user with the concept of a session in which the user activates one or more sensors, collects readings for temperature and pulse oximeter, photos from the camera, and recordings from the stethoscope.
• 4. Device Communications Module (DCM) The DCM runs on the MCP incorporated as a library in the Client App. The DCM manages the serial communications between the MedWand™ Device and MCP. The DCM is also known as the Software Developer's Kit (SDK), as it provides a controlled programming interface to enable integration with thirdparty telemedicine systems.
• 5. A mobile device (e.g., laptop, tablet or smartphone) or computing platform (laptop or computer) (collectively Mobile Computing Platform (MCP)) – The MCP is supplied by the patient or user, not by MedWand. The Client App proprietary software runs the MCP. The MCP is not part of the medical device.
• 6. A clinician receiving platform located in a clinical environment (e.g., a PC at the clinic, not supplied by MedWand and not part of the medical device). As described in the cited FDA guidance, this platform and any clinician interface are not part of the medical device.
• 7. Commercial Telemedicine systems provides real-time voice and video communications between the HCP and the MedWand™ Device user (as patient) in a virtual live visit. These external software systems would be classified as Medical Device Data Systems, which FDA no longer considers medical devices.

Here's a breakdown of the acceptance criteria and study information for the MedWand™ Device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document provides performance details for individual functions (SpO2, Pulse Rate, Temperature) but explicitly states that the MedWand™ Device met "the more stringent required acceptance criteria from the FDA guidance for reflectance pulse oximeters" and that thermometer results are "similar to other published temperature data for IR thermometers." The exact numerical acceptance criteria from the FDA guidance or standards are not fully specified for all metrics in this document, but the device's performance against them is confirmed.

2. Sample Sizes and Data Provenance

For SpO2 Accuracy Study (Controlled Hypoxia):

• Sample Size: 14 healthy volunteer subjects
• Test Set Description: Ages 21-40; 6/14 male (42%); range of ethnicities, including at least 28% (4/14) with dark skin tones.
• Data Provenance: Not explicitly stated, but the nature of a "controlled hypoxia" study strongly suggests prospective clinical data collected specifically for this validation in a controlled environment. Country of origin not specified.

For Thermometer & Additional SpO2/PR Clinical Agreement Study:

• Sample Size: 158 subjects
• Test Set Description: Patients from an outpatient health clinic; ages 18-81 (median 35, mean 37); 64/158 male (41%); skin tones 1-6 (dark) with median 2; 59/158 (37%) presented febrile symptoms.
• Data Provenance: Not explicitly stated, but implies prospective clinical data collected from an outpatient health clinic. Country of origin not specified.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number or specific qualifications of experts used to establish ground truth for the test sets. However, it references established methods:

• For SpO2: Arterial blood samples were measured for SaO2 on a cooximeter, which is a highly accurate reference method. This implicitly relies on the calibration and proper operation of the cooximeter.
• For Temperature: A "well-established reference clinical thermometer" was used, specifically mentioning the Exergen TAT thermometer (K011291) as a reference predicate in the comparison table, which uses rectal as the reference body site.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1) for the test sets. The ground truth was established using objective, established reference methods (cooximetry for SpO2, reference clinical thermometer for temperature).

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

No MRMC comparative effectiveness study is mentioned. The studies described are device performance studies against reference standards.

6. Standalone Performance Study

Yes, the clinical studies evaluate the performance of the MedWand™ Device in a standalone manner against established reference methods. For example, the SpO2 data from the MedWand™ pulse oximeter was compared directly to SaO2 results from a cooximeter. Similarly, MedWand™ temperature readings were compared to a reference clinical thermometer.

7. Type of Ground Truth Used

• For SpO2: Physiological ground truth established by arterial blood gas analysis (SaO2 measured by cooximeter).
• For Temperature: Physiological ground truth established by a reference clinical thermometer (Exergen TAT thermometer, K011291, with rectal as the reference body site).

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size for the device's algorithms. The clinical studies described are explicitly for validation of the finished device.

9. How Ground Truth for Training Set Was Established

Since a separate "training set" with ground truth establishment is not described in the context of machine learning (which might use such a set for model development), this information is not provided. The performance data presented is from validation studies comparing the device to accepted medical reference standards.

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The device is intended to be used for measuring, storing, and to generate prompts for, multiple physiological parameters of adults and pediatrics. The device is intended for use by trained healthcare professionals in hospital environments.

Parameters include: NIBP, SpO2, PR (pulse rate), TEMP.

The F3000 Quick TEMP module is not intended for neonates.

The device is not intended for MRI environments.

The iM3s series vital signs monitors including iM3s\iM3As\iM3Bs\ iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults, pediatrics and neonates.

Here's an analysis of the provided text regarding the acceptance criteria and study data for the Vital Signs Monitor (iM3s, iM3As, iM3Bs, iHM3s).

Please note: The provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It primarily presents performance specifications and shows that the new device meets those, often by referencing existing standards or previous clearances. It does not typically include detailed experimental setups for clinical or performance studies in the way a research paper would. Therefore, some information requested (like sample size for training sets, specific adjudication methods, MRMC studies, or detailed ground truth establishment for training data) is not present in this type of regulatory document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the predicate device's specifications and compliance with relevant ISO/IEC standards. The "Reported Device Performance" for the subject device is stated as meeting these same specifications.

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

• Sample Size for Test Set: Not specified in the document. The performance is validated through "functional and system level testing" and compliance with standards, not a clinical trial with a specified patient sample size for device comparison.
• Data Provenance: The studies are described as "non-clinical data" and "bench testing." No country of origin is mentioned for patient data, as no clinical studies with human subjects are detailed. The nature of the testing implies it's retrospective, based on existing standards and validation procedures, rather than prospective clinical data.

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

• This information is not provided in the document. The "ground truth" for these performance tests would typically be established by highly calibrated reference instruments or simulated physiological signals according to the requirements of the cited ISO/IEC standards, rather than expert human interpretation in a clinical context.

4. Adjudication Method for the Test Set

• This information is not applicable and not provided. As no clinical studies with human subjects or interpretation tasks are described, there is no need for an adjudication method. The assessment is against technical specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical data: Not applicable." The focus is on the device's standalone performance against engineering and international standards.

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

• Yes, the performance reported is essentially standalone. The "bench testing" and "software verification and validation testing" assess the device's accuracy and functionality in isolation, without an explicit human-in-the-loop component for interpreting outputs in the context of the device's core physiological measurements (NIBP, SpO2, PR, TEMP).

7. The Type of Ground Truth Used

• The ground truth for the performance testing is based on:
  • Reference measurements from calibrated equipment: For parameters like SpO2, NIBP, and TEMP, the "ground truth" would be simulated physiological signals or measurements from highly accurate, traceable reference devices as mandated by the respective ISO/IEC standards.
  • Compliance with international standards: The device is tested against the specific requirements and accuracy tolerances defined in standards such as IEC 80601-2-30 (NIBP), ISO 80601-2-56 (thermometers), and ISO 80601-2-61 (pulse oximeters).

8. The Sample Size for the Training Set

• This information is not provided and is not applicable in the context of this device and document. This device is a vital signs monitor, not typically an AI/machine learning diagnostic device that relies on "training sets" in the conventional sense of machine learning algorithms. Its parameters are measured directly through hardware and firmware, validated against physical standards.

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

• This information is not provided and is not applicable as there is no "training set" for an AI algorithm described for this device. The device's fundamental operational principles are based on established physiological measurement techniques, not on learning from a dataset.

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The Infrared Body Thermometer, Model: HTD8823US, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead in people of all ages for home setting use.

Infrared (IR) Body Thermometer, model: HTD8823US, is a hand-held, battery powered, infrared thermometer that measures human body temperature from forehead. The reference body site is oral. The device can measure temperature with two modes, forehead mode and forehead scan mode, and both modes measure forehead temperature. The forehead mode measures temperature from center of the forehead. Forehead scan mode measures temperature by gently positioning the probe flush (flat) on the center of the forehead, midway between the eyebrow and the hairline, press and hold the On/Scan button. Lightly slide the thermometer across the forehead keeping the sensor flat and in contact with the skin until reaching the right hairline, release the On/Scan button and remove the thermometer from the forehead, then the temperature will display on the screen, the whole process takes 3~10 seconds.

The provided document is a 510(k) Summary for the HeTaiDa Technology Co., Ltd. Infrared Body Thermometer, Model: HTD8823US. It outlines the device's characteristics and its substantial equivalence to predicate devices, supported by non-clinical and clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document references two primary performance standards for the Infrared Body Thermometer: ASTM E1965-98 (2016) and ISO 80601-2-56: 2017. While it states that the device "Meets" these standards, specific quantitative acceptance criteria from these standards and the device's reported performance against each of those specific numerical criteria (e.g., maximum permissible error at different temperature ranges) are not explicitly itemized in a table within the provided text.

However, the "Summary of technological characteristics of device compared to the predicate devices" (Pages 5-7) includes some key performance characteristics that imply acceptance criteria and performance, mostly by stating "Same" or "Similar" to predicates which are presumed to meet equivalent criteria.

Here's a curated table based on the available information, inferring acceptance criteria from the predicates and performance against those:

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

• Sample size for the test set: 140 subjects.
• Data provenance: The document does not explicitly state the country of origin of the data. It also does not explicitly state if the study was retrospective or prospective, but clinical accuracy studies for new devices are typically prospective. The text mentions "Each model was evaluated in 0 up to 3 months, 3 months up to one year, older than 1 year and younger than 5 years, and older than 5 years age groups," indicating a structured, likely prospective clinical trial.

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

This information is not provided in the document. For a clinical thermometer, the "ground truth" for temperature measurement is typically established by using a highly accurate reference thermometer (e.g., laboratory-grade thermometer or a rectal/oral thermometer considered the gold standard in a clinical setting by trained medical professionals). The document only states "The clinical accuracy test report and data analysis followed the requirements of the ASTM E 1965-98 (2016)," which is a standard for infrared thermometers. It doesn't detail the personnel involved in supervised measurements.

4. Adjudication method for the test set

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typical for subjective interpretations (e.g., radiology reads). For quantitative measurements like temperature, the ground truth is usually established by direct measurement with a reference standard, not typically through expert adjudication of images or subjective findings.

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 was not done, nor would it be relevant for this type of device. This device is an infrared thermometer, not an AI-assisted diagnostic tool that involves human "readers" or interpretation of complex cases. Therefore, there's no mention of AI assistance or its effect size on human performance.

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

The device itself is a standalone algorithm, in the sense that it automatically measures and displays temperature without requiring human interpretation of an output from an underlying AI (beyond reading the numerical display). The "clinical accuracy testing" evaluates the device's performance in this standalone capacity.

7. The type of ground truth used

The ground truth for the clinical accuracy testing was established by comparing the device's measurements against a reference standard of body temperature measurement, as specified by ASTM E1965-98 (2016). While not explicitly stated, this usually involves a core body temperature measurement method (e.g., rectal, oral, or an equivalent highly accurate reference thermometry system) performed by trained personnel.

8. The sample size for the training set

This information is not applicable and therefore not provided. Infrared thermometers like the HTD8823US are hardware-based measurement devices that employ fixed algorithms and calibrations, not machine learning or AI models that require "training sets" in the conventional sense. Any "training" would refer to internal calibration and validation data used during the device design and manufacturing process, which is distinct from a machine learning training set.

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

As inferred above, this information is not applicable as the device does not utilize a machine learning model that requires an external "training set" with established ground truth. The device is calibrated and validated against physical temperature standards and clinical performance requirements.

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LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healtheare professionals. It consists of a hosted web server, a hosted database server and two types of client interfaces - one that is provided by Windows client and one that is provided by a web client interface.

LifeStream software's intended use is to retrospectively receive, display and store monitored vital signs parameters and related data. Such data includes patient blood pressure (NIBP), oxygen saturation (SpO2), weight, blood glucose, temperature, dispensed medicine, ECG, peak flow, prothrombin time and retrospective PERS messages.

LifeStream retrospectively displays the data, user-defined data alerts for review and interpretation by a healthcare professional. LifeStream is not intended for emergency use or real-time monitoring.

LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healthcare professionals. It consists of a hosted web server and two types of client interfaces, one that is provided by Windows client and one that is provided by a web client interface. LifeStream 5, like the predicate LifeStream 4.0, is configured to accept patient data that is acquired periodically and displayed retrospectively from Honeywell HomMed Patient Monitors (e.g. Genesis Touch). LifeStream 5 can also interface with 3nd party compatible medical device data systems (e.g. Govsphere TV). LifeStream 5 has the same intended use as the predicate, LifeStream 4.0. LifeStream 5, like LifeStream 4.0 is not intended for emergency use or real-time monitoring. Both are designed to retrospectively receive, display and store scheduled vital sign parameters and related data. Such data includes patient blood pressure (NIBP), oxygen saturation (SpO2), weight, blood glucose, temperature, ECG, peak flow, prothrombin time and retrospective PERS messages.

The Honeywell HomMed LifeStream™ 5 is a software program designed to retrospectively receive, display, and store monitored vital signs parameters and related data for review and interpretation by healthcare professionals. It is not intended for emergency use or real-time monitoring.

Here's an analysis of its acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific quantitative acceptance criteria for performance. The "acceptance criteria" here are implied by the claim of substantial equivalence in intended use, users, use environment, technological characteristics, and safety to the predicate device, LifeStream™ 4.0.

The performance reported is qualitative, stating that LifeStream 5 is substantially equivalent to LifeStream 4.0 and that differences "do not affect the relative safety and/or effectiveness."

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

The document does not specify a "test set" in the context of clinical performance evaluation using patient data. This 510(k) submission primarily relies on demonstrating substantial equivalence through non-clinical performance testing (bench testing) and comparison of technological characteristics with a predicate device.

Therefore, there is:

• No specific sample size for a test set of patient data mentioned.
• No data provenance (country of origin, retrospective/prospective) related to a clinical test set.

The "validation testing of complete systems" and "black box testing" likely used simulated data or internal test cases, but no details on their size or origin are provided.

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

Since there is no mention of a clinical test set requiring expert ground truth, this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set

As there is no clinical test set with expert ground truth mentioned, no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on technical and functional comparison to a predicate device and non-clinical testing, not on comparative effectiveness with human readers.

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

The device itself is a "standalone, prescription-based software program" for retrospective display and storage of vital signs, intended for use by healthcare professionals for review and interpretation. The "Performance / Bench Testing" section describes functional, validation, automated regression, black box, localization, and deployment testing, along with "External evaluation by Honeywell clinical team." This evaluation represents the standalone performance of the software in its intended function of receiving, displaying, and storing data correctly, as it is a device intended to assist human professionals, not to make diagnoses autonomously. However, these are engineering/software tests, not clinical performance studies measuring diagnostic accuracy of an algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance/bench testing, the "ground truth" would be established by the expected behavior and output defined in the software's functional specifications and requirements. For example:

• Functional Testing: The "ground truth" is that the software correctly performs its intended function (e.g., displaying specific vital sign data accurately, registering alerts based on defined thresholds).
• Validation Testing: The "ground truth" is that the complete system meets all specified requirements.
• Automated Regression Testing: The "ground truth" is that previously corrected defects remain fixed and new changes haven't introduced new errors.

There is no mention of pathology, outcomes data, or expert consensus serving as ground truth for a clinical dataset in this submission.

8. The Sample Size for the Training Set

Not applicable. This submission describes a medical device, LifeStream™ 5, which is a software system for managing vital signs data. It is not an AI/Machine Learning algorithm that typically requires a "training set" of data to learn patterns or make predictions. The software's functionality is pre-programmed based on defined rules and specifications.

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

Not applicable, as there is no training set for an AI/Machine Learning algorithm. The software's "ground truth" for its development would be its functional and system requirements.

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The SureSigns VS3 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSignsVS3 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.

The SureSigns VS4 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.

The subject devices are SureSigns VS3 and SureSigns VS4 multi-parameter patient monitors. Modifications include adding connectivity to IntelliVue GuardianSoftware (IGS), adding Temporal Temperature measurement to VS3, and other enhancements such as additional title bar indicators, expanded patient records pane, display patient name or primary ID, expanded QuickCapture entries, default CO2 setting alignment (VS4 only), temperature high and low alarms color change, increased SpO2 alarm delay defaults, option to prevent inadvertently clearing NBP programs, and RFID patient ID entry.

This document describes the Philips SureSigns VS3 and VS4 Vital Signs Monitors, which are multi-parameter patient monitors. The submission is a 510(k) premarket notification for modifications to previously cleared devices.

Here's an analysis of the acceptance criteria and study information provided, focusing on what can be extracted from the text:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that "Pass/Fail criteria were based on the specifications cleared for the subject device." However, it does not explicitly list specific numerical acceptance criteria for performance metrics (e.g., accuracy ranges for NBP, SpO2, Temperature, CO2). Instead, it confirms that the device reportedly meets these implicit criteria.

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

The document does not provide details on the sample size used for the test set.
It also does not specify the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be internal validation by Philips Medical Systems.

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 testing described is verification, validation, and performance testing, which typically involves comparing device outputs to a known reference standard (e.g., calibration equipment, established measurement methods) rather than human expert-established ground truth in a clinical scenario.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the device (monitoring physiological parameters), "adjudication" in the sense of resolving discrepancies between human experts for a diagnostic task is unlikely to be relevant here. The testing would involve comparing device readings against a gold standard or reference measurement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically for diagnostic imaging devices where human readers interpret images with and without AI assistance. The SureSigns VS3 and VS4 are vital signs monitors, not diagnostic imaging devices designed for human interpretation of complex data patterns in the same way. The modifications focus on software connectivity, a new temperature measurement accessory, and feature enhancements.

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

The document describes "system level tests, performance tests, and safety testing from hazard analysis." This strongly implies that standalone performance testing was done for the device's functions (e.g., accuracy of NBP, SpO2, Temperature measurements). The software verification and validation, along with compliance to specific standards for temperature measurement, suggest testing of the algorithms and hardware in a standalone capacity against reference standards. However, "standalone" in the context of an AI algorithm is typically for diagnostic or predictive AI, which this device, in its described modifications, does not appear to be. It's a measurement device.

7. The Type of Ground Truth Used

The ground truth used for these types of physiological parameter monitors would typically involve:

• Reference standard instruments: Highly accurate and calibrated devices used to establish the true value of parameters like NBP, SpO2, and Temperature.
• Known physical inputs: For example, precise temperature probes, blood pressure simulators, or SpO2 simulators with defined oxygen saturation levels.
• Compliance with industry standards: The mention of ISO 80601-2-56 for temperature indicates that the ground truth for temperature measurement accuracy would be established by following the specific protocols and reference measurements outlined in that standard.

The document does not explicitly state "expert consensus" or "pathology" as ground truth, which are more relevant for diagnostic AI applications.

8. The Sample Size for the Training Set

The document does not describe any "training set." This is because the device, based on the provided information, is a vital signs monitor and not an AI/ML-based diagnostic or predictive system that requires a training set for model development. The focus is on measurement accuracy and software functionality.

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

Since there is no mention of a training set, this information is not applicable/provided.

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The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on adult, pediatric, and neonatal patients in healthcare facilities when used by clinical physicians or appropriate medical staff under the direction of physicians.

The SmartLinx Vitals Plus Patient Monitoring System consists of the SmartLinx Vitals Plus mobile medical application and externally integrated vital signs modules operating on the SmartLinx Neuron 2 mobile platform. The application controls the modules at the point of care through interfaces on the SmartLinx Neuron 2 mobile platform and presents this to the monitoring purposes. The supported physiological parameters are: non-invasive blood pressure (systolic, diastolic, mean arterial pressure (MAP)), pulse rate, functional arterial oxygen saturation (SpO2), and temperature.

The SmartLinx Vitals Plus Patient Monitoring System is composed of multiple products:

• The SmartLinx Vitals Plus mobile medical application
• The SmartLinx Vitals Plus NIBP Module with SunTech Medical cuffs and hoses
• The Masimo SET uSpO2 Pulse Oximetry Cable
• The Exergen TAT-5000S infrared thermometer
• The SmartLinx Neuron 2 Mobile Platform
• The SmartLinx Vitals Plus Roll Stand

The provided document details the 510(k) premarket notification for the SmartLinx Vitals Plus Patient Monitoring System. It describes the device, its intended use, and a comparison to a predicate device, focusing on functional equivalence. However, the document does not contain detailed acceptance criteria for specific performance metrics (like accuracy or precision for NIBP, SpO2, or temperature) nor does it provide a study report proving the device meets said criteria with specific quantitative results.

Instead, the document generally states that the device "complies with its predetermined specification" based on various types of testing, often referencing compliance with established electrical safety, EMC, and software standards, as well as a clinical performance standard for NIBP (ISO 81060-2:2013).

Therefore, I cannot populate the table or answer all the requested questions with specific data from the provided text. I will indicate where information is not available.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Details:

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

   • Test Set Sample Size: Not specified in the document. For clinical performance testing (referencing ISO 81060-2:2013), this standard typically requires a certain number of subjects (e.g., 85 subjects for NIBP accuracy) and measurements, but the document does not report the actual sample size used for this specific device's clinical performance trial.
   • Data Provenance: Not specified. The document does not indicate the country of origin, nor whether the data was retrospective or prospective.

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

   • Not specified. The document indicates clinical performance testing was done "in accordance with ISO 81060-2:2013". For NIBP validation studies, ground truth (reference measurements) are typically established by trained technicians using a reference device (e.g., auscultation with mercury sphygmomanometer), but the number and qualifications of these individuals are not detailed in this submission.

3. Adjudication method for the test set:

   • Not specified. If ground truth involved multiple measurements or experts, an adjudication method would typically be used, but this information is absent.

4. 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 device is a vital signs monitor, not an AI-assisted diagnostic imaging device that involves "human readers" or "AI assistance" in that context. Therefore, an MRMC study and AI improvement effect size is not applicable to this type of device and was not conducted.

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

   • Yes, to an extent. The performance testing described (Software Testing, Electrical Safety, EMC Testing, Bench Performance Testing, and Clinical Performance Testing conforming to standards like ISO 81060-2:2013) essentially evaluates the device's inherent performance. While the device is intended for use by healthcare providers, these tests assess the accuracy and reliability of the device's measurements and functions independent of a human's interpretation of those measurements in a diagnostic workflow (which is the typical context for "standalone AI performance"). The software and hardware perform their functions (measuring NIBP, SpO2, temp) without direct "human-in-the-loop" assistance for the measurement process itself.

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

   • For NIBP, the ground truth would typically be established by simultaneous auscultatory measurements by trained observers using a reference device, as per the methodology specified in ISO 81060-2.
   • For SpO2, ground truth is usually established by CO-oximetry of arterial blood samples.
   • For temperature, ground truth would be from a precisely calibrated reference thermometer or other established method.
   • The document does not explicitly state the ground truth methodology beyond referencing the ISO standards, but these standards define the accepted methods for ground truth establishment.

7. The sample size for the training set:

   • Not applicable. This document describes a traditional medical device (a vital signs monitor) and its validation. It does not refer to an AI/Machine Learning model that requires a "training set" in the conventional sense. The software development process mentioned is likely for deterministic software, not a learned model.

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

   • Not applicable, as there is no "training set" for an AI/ML model described in this document.

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The SureSigns VS3 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSignsVS3 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.

The SureSigns VS4 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.

The subject devices are multi-parameter patient monitors, specifically the SureSigns VS3 and SureSigns VS4. Modifications to the VS4 include the addition of CO2, SpHb, Respiratory Rate RRa, and Masimo SpO2 measurements. Both VS3 and VS4 have the QuickNBP mode added.

This is a 510(k) summary for Philips SureSigns VS3 and VS4 vital signs monitors, describing modifications to add additional measurement capabilities. The provided text, however, does not contain information about specific acceptance criteria or a detailed study proving the device meets said acceptance criteria with numerical performance data. It broadly states that "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject device. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the subject device and test results showed substantial equivalence."

Therefore, I cannot fulfill all parts of your request with the provided information.

However, based on the information available, here's what can be extracted:

• Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in a table or numerical format. The document states that "Pass/Fail criteria were based on the specifications cleared for the subject device and test results showed substantial equivalence," implying that the devices met pre-defined specifications. However, the exact criteria and corresponding performance metrics are not detailed.

• Sample Size for Test Set and Data Provenance: This information is not explicitly stated in the provided text.

• Number of Experts and Qualifications: This information is not mentioned in the provided text.

• Adjudication Method: This information is not mentioned in the provided text.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no indication that an MRMC study was done. The device is a vital signs monitor, which typically involves direct measurement rather than interpretation by multiple human readers in the way an AI-assisted diagnostic tool might.

• Standalone (Algorithm Only) Performance Study: The document mentions that the new features are achieved by using OEM modules that are "FDA cleared under Kxxxxxx." This implies that the performance of these modules as standalone components was already established in their respective clearances. For instance, for CO2 measurement, the Oridion microMediCO2 OEM module was cleared under K094012; for SpHb, RRa, and Masimo SpO2, the Masimo Rainbow SET Radical 7R CO-Oximeter was cleared under K100428; and for Temporal Temperature, the Exergen TemporalScanner Thermometer was cleared under K011291. The QuickNBP mode is described as based on the "same algorithm that provides the regular NBP measurements" in the existing devices. Therefore, while not explicitly called a "standalone study," the reliance on previously cleared, established technologies suggests that their standalone performance has been demonstrated.

• Type of Ground Truth Used: Not explicitly stated for the overall device's performance. However, for the OEM modules incorporated, their original clearances would have involved appropriate ground truth methods for each physiological parameter (e.g., direct measurement for temperature, arterial blood gas analysis for SpO2 calibration, etc.).

• Sample Size for Training Set: This information is not applicable as the document describes hardware modifications incorporating existing, cleared OEM modules and leveraging existing algorithms. It does not mention the development or training of new algorithms that would require a distinct training set.

• How Ground Truth for Training Set Was Established: Not applicable given the nature of the device modifications.

In summary, the provided text primarily focuses on the substantial equivalence argument for modifications to existing vital signs monitors by integrating previously cleared OEM modules and leveraging existing algorithms. It does not contain the detailed performance study information with specific acceptance criteria, sample sizes, expert involvement, or adjudication methods that your request entails for a newly developed AI/diagnostic device.

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The VL40xx is a Non-Invasive diagnostic system designed to detect peripheral vascular pathology in adults. In all cases the intended use is for spot checking and attended use by trained medical professionals in a hospital or medical facility by the order of a medical doctor.

The VL40xx is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.

The VL40xx is a family of products designed for non-invasive peripheral vascular diagnostic systems. The VL40 indicates the family of products that are all made from the same parts with the only differences being that some parts are not installed or some features are not enabled. The "xx" will be used to indicate the family of products. Options of what Doppler or PPG probes are installed do not qualify for a specific model number because there is no physical change to the device to add them. Different air channels require a model number because the valves require a physical change to the device that can only be done at the factory. Specifically the following models are used.

• . Model 4000: full system, twelve channel air
• Model 4010: full system, two channel air portable .
• Model 4030: ABI (Ankle Brachial Index), six channel air .

The base unit has the same main printed circuit board (PCB), battery, speaker, software, and power supply.

Adding the PPG option requires installing a PCB module to the main PCB and attaching the PPG sensors to the outside of the case.

Adding the Doppler requires attaching the desired frequency probe (4 or 8 MHz) to the case. All Doppler frequency probes use the same PCB logic. This means that any probe frequency can be added without any changes to the main PCB or the connectors. The universal Doppler probe is possible because all the Doppler electronics are in the probe. The device PCB for the Doppler only has the logic to turn on the probe and read the data. The Doppler probe has all the electronics to control the IQ signal separation and power output of the probe.

Adding the temperature reading requires purchasing a cleared FDA IR temperature probe from a 3rd party (example Exergen model TAT 5000, K011291). The IR device is a complete standalone product with its own FDA clearance. The VL40xx simply provides a method in software for the operator to record the temperature samples in a table for convenience of reporting. The temperature tests protocols do not care about the absolute temperature readings but do care about the differential readings. What is important is the temperature difference of before and after readings.

For the above features there are no changes to the case and the changes can be made at any time.

The following features require changes to the back panel of the case to support the number of air hoses. The number of air hoses installed is 2, 6, or 12. Internally only the required valves, pressure sensors, and pumps will be installed. Adding air hoses later would require a new case and the appropriate valves, pressure sensors, and pumps to be added. It is much easier to install all the valves and manage the air connectors by choosing what air hoses are attached externally. Unless weight / portability are an issue the easiest solution will always be to choose the 12 air hose system and manage the external air hoses. The external air hoses can be changed at any time to create a system that has 2-12 air hoses as needed. The VL4000 is the model with all air hoses enabled internally.

The air hoses are color coded to help the user attach them to the correct blood pressure cuff. Each air hose has a Red for Right and Lemon for Left code in addition to another color (white, black. orange, yellow, blue, and green) to help identify the location of the software always displays the color of the side (Red or Lemon) and the color of the location that it intends to use. The system has no way to determine that the user connects the air hose to the correct cuff at the correct location.

The software for all models is exactly the same. The software automatically detects what features are installed. All models have the following software features: patient history, comments, storage, printing, print preview, configuration, and online help. Optional software features include Modality Work List (MWL), exporting of data using DICOM Images / Structured Reporting, email, native PDF, long term data storage, data mirroring, and online support.

The VL4030 ABI system will have all tests disabled in software except for the ABI specific tests.

One of the main measurements of the system is segmental systolic blood pressures. In general, the measurement is conducted by applying an appropriately sized cuff to the measured segment, obtaining a reference PPG or a Doppler signal in a location distal to the cuff placement, and then inflating the cuff to such a pressure that will occlude the blood vessels and prevent blood flow distal to the cuff location, which will result in disappearance of the reference signal. Then, a slow cuff deflation begins, and the instantaneous cuff pressure at which the reference signal reappears is typically defined as the segmental systolic blood pressure. While the software automatically places a cursor at the time location which is suspected as being the systolic pressure, it is the total responsibility of the system operator and the medical staff to modify the cursor location according to their medical training, and define the correct segmental pressure.

Based on the segmental pressures, the pressure indices are calculated, as the ratio between the systolic segmental pressure, and the higher of the 2 brachial systolic pressures that does not exceed a noncompressible limit (usually 240 mmHg). The ABI index is a commonly used index, which is a specific case of the above, calculated as the systolic right or left ankle pressure, divided by the hight or left brachial systolic pressure.

The other main measurement of the system is recording a wave that represents the flow of blood for each heartbeat. The three main modalities for this are the Doppler, PPG, and PVR wave forms. All three of these modalities produce a wave form that has a systolic up stroke, a diastolic down stroke, a pause, and a repeat. Researchers have shown that the shape of these waveforms is a great indicator of disease and that the actual measurement of the wave is not as important.

The system has a wireless remote control. Everything that the remote can do can also be done with the keyboard. The advantage of the remote is that it provides the most common functions needed to perform the measurement without requiring the operator to reach for the keyboard.

If the IR remote is not available then the user will access the VL40xx using a directly wired keyboard, mouse, or touchscreen.

The scientific principal of CW Doppler in very high level terms is as follows. A crystal is cut in half. One half of the crystal has a 4 or 8 MHz sine wave applied. When the acoustic output of the crystal is focused into human tissue it will bounce back and be absorbed by the remaining crystal. Any Doppler effect caused by moving blood can be detected in the phase shift when the transmitted signal is compared with the echoed signal. The phase shift for blood in humans is usually less than 6 kHz and therefore makes for a nice audio signal that can easily be heard. Most modern CW Doppler systems will use IQ modulation and FFT to detect the spectral of the audio signal returned. Tracing the envelope of the spectral will provide the familiar heart beat trace. The CW Doppler can measure the velocity of blood in a specific artery.

The scientific principal of PPG in very high level terms is as follows. An Infra-Red pulse is provided by an LED and applied to the skin. The blood and tissue will absorb and reflect the IR signal. The amount of blood in the capillaries will determine how much IR signal is absorbed or reflected. An LED sensor is applied that measures the reflected IR signal. Displaying the LED sensor output will provide the familiar heart beat trace. The PPG can measure the change in blood flow in the skin.

The scientific principal of VPR in very high level terms is as follows. A cuff is placed around an arm or leg and inflated to 60 mmHg. The higher the pressure without occluding the blood flow (below systolic blood pressure) will produce the best pressure change in the cuff for each heartbeat will cause a pressure change in the cuff ranging from 0.01 – 0.5 mmHg. Displaying the pressure sensor output will provide the familiar heart beat trace. The VPR can measure the change in blood flow for a network of arteries.

The speaker is located on the front of the VL40xx and all other connectors (Doppler, PPG, VPR, USB, power supply, and status LEDs) are on the back.

The provided document, K131860, is a 510(k) Summary for the VascuLab VL40xx, VL4000, VL4010, VL4030 non-invasive peripheral vascular diagnostic systems.

It is important to note that this document describes a traditional medical device (a piece of hardware with associated software), not an AI/ML-driven device. Therefore, many of the typical acceptance criteria and study designs associated with AI/ML devices (such as ground truth establishment with experts, MRMC studies, or standalone algorithm performance) are not applicable or described in this submission.

The acceptance criteria discussed primarily relate to regulatory compliance, general safety, and functional equivalence to a predicate device.

Acceptance Criteria and Reported Device Performance

Given that this is not an AI/ML device, the "acceptance criteria" are not framed in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) against a ground truth dataset, but rather in terms of engineering, safety, and functional requirements.

Study Details (Applicable to Non-AI/ML Devices)

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

   • The document describes non-clinical testing primarily focused on engineering validation, safety, and functional performance rather than diagnostic accuracy on patient data.
   • There is no mention of a "test set" of patient data for diagnostic performance evaluation or data provenance (country of origin, retrospective/prospective).
   • The testing mentioned includes Bio-Compatibility, Electrical Safety, Mechanical Safety, Acoustic Output, EMC emissions and immunity, and internal unit/verification/performance/validation testing. These typically involve laboratory setups, phantoms, or specific test equipment, not patient data in the context of diagnostic accuracy.

2. 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 as there is no diagnostic "test set" or ground truth based on expert consensus described for evaluating diagnostic performance. The device is a measurement tool, where the operator interprets the data.

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

   • Not applicable as there is no diagnostic "test set" requiring adjudication.

4. 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 is not an AI/ML device, and no MRMC study is described. The device provides measurements and waveforms which are then interpreted by a "trained medical professional."

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

   • Not applicable. This is not an AI/ML device relying on an algorithm to make diagnostic interpretations. It's a measurement device.

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

   • For the safety and functional testing described, the "ground truth" would be established engineering specifications, recognized standards, and physical laws (e.g., accuracy of pressure readings against calibrated instruments, acoustic output measurements according to standards). There is no "ground truth" in the diagnostic sense from patient data.

7. The sample size for the training set

   • Not applicable. This is not an AI/ML device that requires a training set.

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

   • Not applicable.

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Valeo VT-601 Series IR Thermometer, (Model no.: VT-601D, VT-601E, VT-601F) is infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.

The Valeo VT-601 Series IR Thermometer, (Model no.: VT-601D, VT-601E . VT-601F) is hand-held, non-sterile, reusable, battery operated device that can measure human body temperature. The Valeo VT-601D IR Forehead/ Ear Thermometer can measure human body temperature in 2 ways: (1) The temporal artery over forehead. (2) Tympanic temperature via the human ear. The Valeo VT-601E IR Ear Thermometer measures human body temperature natural thermal infrared radiation emitted from the ear tympanic. The Valeo VT-601F IR Forehead Thermometer measure human body temperature by the temporal artery over forehead. Operation is based on the measuring of the natural thermal infrared radiation emitted from the surface of the skin over the temporal artery or from the ear tympanic.

Here's a breakdown of the acceptance criteria and study information for the Valeo VT-601 Series IR Thermometer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified directly in the provided text. The document mentions "A Clinical Test Report conducted according to ASTM E 1965: 1998 (2009)" but does not detail the number of subjects or measurements.
• Data Provenance: The study was "performed by the manufacturer." The country of origin is not explicitly stated for the study data itself, but the manufacturer (VALEO Corporation) is based in Taipei, Taiwan. The study is retrospective in terms of being a report of past activity, but the study itself (the clinical test) would have been prospective to gather the data.

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 text. As this is a medical device for measuring temperature, the "ground truth" would likely be established by a reference thermometer or highly accurate clinical measurement standards, rather than expert judgment in the human-reader sense.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. Temperature measurements are typically compared directly to a "gold standard" reference, without the need for human adjudication between multiple readers of the device's output.

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:

This is not applicable. The device is an infrared thermometer, not an AI-powered diagnostic imaging tool that assists human readers.

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

The device is a standalone algorithm/device. Its performance is evaluated on its own ability to measure temperature. The accuracy criteria listed above define its standalone performance.

7. The Type of Ground Truth Used:

The ground truth used for assessing accuracy was based on the "method recommended in ASTM E1965 standard." This standard specifies methods for determining the accuracy of clinical thermometers, which typically involves comparing the device's readings against a reference thermometer (a highly accurate and calibrated device) in a controlled environment, and/or against a subject's core body temperature measured by an invasive "gold standard" method in clinical trials. Therefore, the ground truth is derived from a standardized clinical measurement method.

8. The Sample Size for the Training Set:

This information is not applicable and therefore not provided. The Valeo VT-601 Series IR Thermometer is a physical device based on infrared sensing technology, not a machine learning model that requires a training set.

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

This information is not applicable and therefore not provided. As stated above, the device does not use a "training set" in the context of machine learning. The device's design and calibration would be based on engineering principles and physical laws of infrared radiation, validated against established measurement standards like ASTM E1965.

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