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The HCK - 2000 (health station) is an automated system intended to be used by the general adult public, in public environments, so that the user can measure his/her own health parameters such as blood pressure, heart rate, Body Mass Index (BMI) and body weight. It is not a diagnostic device and only furnishes data so that users can consult their personal physicians or other healthcare professional. For personal reference purposes, the user can also choose to print or store their data on the HealthChek network's database.

The HealthChek Network Health Station, Model HCK - 2000 is a kiosk designed for use by the general adult public in public locations to measure the user's health parameters such as blood pressure, heart rate, Body Mass Index (BMI) and body weight. The HealthChek Network Health Station kiosk is not a diagnostic device. It does not introduce any novel modes of operational theory.

The HealthChek Network Health Station, Model HCK-2000, is an automated system intended for use by the general adult public in public environments to measure health parameters such as blood pressure, heart rate, Body Mass Index (BMI), and body weight. It is not a diagnostic device and only provides data for users to consult with their personal physicians or other healthcare professionals.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in a quantitative table format with corresponding device performance for each metric. Instead, it relies on a Substantial Equivalence Comparison to a predicate device (StayHealthy HealthCENTER Biometric Screening Kiosk) and compliance with recognized consensus standards.

However, based on the information provided, particularly for the regulated component (Noninvasive Blood Pressure Measurement System), the device's performance is expected to meet the requirements of relevant standards.

Implicit Acceptance Criteria (based on standards compliance and predicate comparison):

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

The document explicitly states: "Because of the long-established use of health monitoring kiosks, no clinical trial was performed." (Page 4). Therefore, there is no specific sample size for a test set involving human subjects for performance evaluation mentioned in this submission. The evaluation relies on bench testing and comparison to a predicate device.

The data provenance for the bench testing is not specified beyond "Bench Testing was conducted on a unit...". It's implied this was conducted in a laboratory setting by the manufacturer (GMI Solutions) or a testing facility working with them.

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

Since no clinical trial or test set involving human subjects for performance evaluation was conducted, there are no experts mentioned as establishing ground truth in this context. The "ground truth" for the device's technical specifications and safety is derived from compliance with recognized international and national standards.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was performed.

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

No. The document states "no clinical trial was performed." Therefore, there was no MRMC comparative effectiveness study to assess improvement with or without AI assistance. The device is a "health station" for self-measurement, not an AI-assisted diagnostic tool for human readers.

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

The document describes the device as an "automated system" for self-measurement, which inherently functions in a standalone capacity without "human-in-the-loop" performance as typically understood in AI/imaging diagnostics. Its performance is demonstrated through compliance with technical standards and equivalence to a predicate device, rather than a standalone performance study as would be conducted for a diagnostic algorithm.

7. Type of Ground Truth Used

The "ground truth" for the device's acceptable performance is established through:

• Compliance with recognized consensus standards: (e.g., IEC 80601-2-30 for non-invasive sphygmomanometers, IEC 60601-1 for electrical safety).
• Bench testing: Verifying the device's technical specifications against these standards.
• Substantial equivalence to a legally marketed predicate device: Demonstrating that its design, intended use, and technological characteristics are similar to a device already cleared by the FDA.

8. Sample Size for the Training Set

Not applicable. This device is a measurement kiosk and does not involve AI or machine learning algorithms that require a "training set" in the context of diagnostic image analysis or similar applications. The BMI calculation uses "NIH's algorithms," which are established formulas, not a learned model requiring a training set.

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

Not applicable, as there is no training set for the reasons stated above.

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The Mercy TAPE device (2D and 3D models) is intended to estimate the body weight of pediatric patients between the ages of 2 months and 16 years, using linear measurements from specific anatomical landmarks made with the Mercy TAPE device for humeral length (HL, for the 2D model) or half-humeral length (HHL, for the 3D model) and the mid-upper arm circumference (MUAC).

The Mercy TAPE device may be less reliable for use in children with known or apparent limb deformities, or abnormal body proportions caused by conditions such as edema or severe malnutrition.

The Mercy TAPE Device (2D and 3D Models) consists of semi-durable or disposable flexible strips of coated paper, fabric or plastic tape printed with numbered bins proportional to fractional body weight of pediatric patients. The markings correspond to the validated Mercy Method (calculation algorithm) for determining pediatric body weight using humeral length and mid-upper arm circumference.

The Mercy TAPE Device 2D Model consists of a single strip of tape that is used in two (2) stages to measure humeral length and mid-upper arm circumference. For the Mercy TAPE Device 3D Model, two (2) perpendicular strips of tape are designed to be joined into a sliding "T" shape so that humeral length and mid-upper arm circumference can be measured.

The provided text describes the Mercy TAPE device, which estimates pediatric patient body weight using linear measurements. While the document mentions clinical studies and a human factors/usability study, it does not explicitly define acceptance criteria in a quantifiable manner (e.g., "The device must achieve an accuracy of X% within Y kg"). Instead, it broadly states that "the device shows acceptably small variability from true weight with minimal bias" and that "the estimated weights generated by the Mercy TAPE Device (2D and 3D Models) are more accurate than the weights returned with existing weight estimation strategies."

It also states that the device was "validated against a mechanical scale to demonstrate equivalent performance," but the specific metrics and thresholds for this equivalence are not provided.

Therefore, I will extrapolate the "acceptance criteria" based on the general statements of acceptable performance and the study's conclusions, and then provide the reported performance based on the descriptions of the clinical studies.

Here's the information structured as requested, with details extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: As explicit quantitative acceptance criteria were not stated, these are inferred from the study's conclusions regarding acceptable performance and equivalence.

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

The document describes several clinical studies. It seems the "clinical studies" mentioned in Section H encompass both the algorithm development/validation and a separate human factors study.

• Algorithm Validation (Test Set):

  • Sample size: 1,938 datasets
  • Data Provenance: Not explicitly stated for the validation set, but the underlying algorithm was developed using data from the National Health and Nutrition Examination Survey (NHANES) database. NHANES data is collected in the United States, so the provenance is likely United States.
  • Retrospective/Prospective: The use of "datasets" from NHANES suggests a retrospective analysis of existing data for algorithm development and validation.

• Human Factors/Usability Study (Test Set):

  • Sample size: 1,412 assessments (performed by healthcare providers). This implies that a number of pediatric patients were assessed multiple times. The exact number of unique "patients" in this study is not specified, but the number of "assessments" is 1,412.
  • Data Provenance: Not specified, but given the context of Children's Mercy Hospital in Kansas City, MO, it is likely United States.
  • Retrospective/Prospective: These were active "assessments" comparing the device to other strategies, so this was likely a prospective study.

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

• The document does not specify the number or qualifications of experts used to establish ground truth for either the algorithm validation or the human factors study.
• The ground truth for weight was established using "scales that use mechanical strain or balance methods" for comparison, which implies a direct measurement, not an expert consensus for the "true weight."

4. Adjudication Method for the Test Set

• The document does not describe any adjudication method for the test set. The ground truth appears to be based on objective measurements (mechanical scales), removing the need for expert adjudication.

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

• Yes, a MRMC-like study was done in the context of the human factors/usability study.
• The human factors study evaluated "front-line" healthcare providers (ED nurses and first responders) comparing the Mercy TAPE device against five other weight estimation strategies. This involves multiple "readers" (healthcare providers) evaluating cases (presumably pediatric patients).
• Effect size of how much human readers improve with AI vs without AI assistance: The document states that the Mercy TAPE device yielded "more accurate" estimated weights than existing strategies, even when factoring in errors and close-calls. However, it does not provide a specific quantitative effect size (e.g., percentage improvement in accuracy, reduction in error margin) for this improvement.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance evaluation was done. The "clinical studies" section states: "Clinical studies were conducted to evaluate the predictive performance of the Mercy TAPE Device (2D and 3D Models) and their equivalence to the underlying Mercy Tape method algorithm." This primarily refers to the algorithm's performance in estimating weight.
• This performance was described as showing "acceptably small variability from true weight with minimal bias."

7. Type of Ground Truth Used

• The ground truth used for weight estimation was direct measurement from mechanical scales (e.g., "scales that use mechanical strain or balance methods"). This is an objective measurement, not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

• The Mercy Tape method algorithm was developed using "demographic and anthropometric data on 17,328 individual children." This represents the training/development set.

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

• The ground truth for the training set (17,328 children) was established using data from the National Health and Nutrition Examination Survey (NHANES) database. NHANES collects comprehensive health and nutrition data, which includes anthropometric measurements and likely objective weight measurements, establishing the ground truth for algorithm development.

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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® and accessories are indicated for the continuous noninvasive monitoring of total hemoglobin concentration of 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.

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

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

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

The CVSM 6000 Series is 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), Total Hemoglobin (SpHb and SpHbv), and body temperature in normal and axillary modes of neonatal, pediatric, and adult patients. The CVSM can also display and transfer patient data that is electronically or manually entered from external and accessory devices, e.g., weight and height data, barcode, IR temperature, and other patient or facility information. Data can be transferred electronically via USB, wired Ethernet, or wireless communications.

The monitor has an enclosure constructed of engineering plastics with internal steel members for strengthening. A silicone light bar is prominent in a carry handle on the top of the device and illuminates for different alarm conditions. A power button is located on the side of the device. A touch screen display is prominent on the front of the device and provides the primary interface for the user to interact with the device. Internal and external communications are primarily by USB. External host USB connections for accessories are tool accessible. A USB connection for data transfer is on the side of the device, as is a connection to an internal relay for use with nurse call systems. The device contains an internal AC power supply for operating the device and charging the internal Lithium Ion battery.

The monitor can be configured for use in different workflows including desktop, affixed to a mobile stand, or on a wall mount.

The Welch Allyn Connex® Vital Signs Monitor 6000 Series is a physiological monitor. The provided text indicates that no clinical studies were performed, but rather verification and validation were conducted to ensure expected performance based on relevant international standards. Therefore, some of the requested information regarding clinical studies and ground truth cannot be extracted.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states that "No clinical studies were utilized for the purpose of obtaining safety or effectiveness data." Therefore, there is no information on a 'test set' in the context of clinical data, its sample size, or data provenance. The testing appears to have been focused on engineering verification and validation against standards.

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 human expert ground truth were conducted.

4. Adjudication method for the test set

Not applicable, as no clinical studies with human expert adjudication were conducted.

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. The device is a vital signs monitor and does not involve AI or human readers interpreting data in a comparative effectiveness study as described.

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

The entire submission focuses on the standalone performance of the device itself (the "algorithm only" in the sense of the device's inherent functionality). The device's performance was evaluated by confirming its compliance with various international standards through "Verification and validation," rather than through a clinical study where its output would be compared to a human interpretation.

7. The type of ground truth used

The "ground truth" used for this device's evaluation was primarily based on compliance with established international engineering and medical device standards. For example, the device was tested to ensure it met the requirements for basic safety, essential performance, electromagnetic compatibility, alarm systems, sphygmomanometers, and pulse oximeters as defined by the listed IEC and ISO standards.

8. The sample size for the training set

Not applicable, as the document does not describe an AI/ML model that would require a training set. The device is a physiological monitor whose performance was validated against established engineering and medical device standards.

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

Not applicable, as there was no training set for an AI/ML model.

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