Search Results

The DynoSense Vital Sign Measuring System is intended to record, transfer, store and display of single lead electrocardiography (ECG), heart rate (HR), functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), respiration rate (RR), and oral body temperature (TEMP). The device comes in contact with the patient for approximately 60 seconds at each use. This system is for spot checking and does not have continuous monitoring capability or any alarm features.

This system is intended for patients 18 years and older in the home environment. It is intended for use with patients who are well perfused and during no motion condition.

This system makes no specific diagnosis. The device is for single patient use.

Users with implanted pacemakers and/or implanted cardio-defibrillators (ICDs) are not recommended to use the device.

The DynoSense Vital Sign Measuring System is a battery-powered, handheld, personalized single patient use vital sign measuring apparatus. The user must hold the Device with their left hand. Functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements are based on transmittance of light through the index finger. Respiration rate (RR) measurements are based on pressure change at the aperture opening during breathing. Oral temperature (TEMP) is measured via sublingual and lingual contact with the thermometer tip. ECG and heart rate (HR) measurements are obtained via completing an electrical path across the left side of the chest. Vital sign data are communicated to a Bluetooth-capable mobile platform for forwarding to the cloud application for processing and storage.

Here's a breakdown of the acceptance criteria and the study details for the DynoSense Vital Sign Measuring System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria & Reported Device Performance

The document provides performance data for several vital signs, primarily referencing compliance with ISO standards and clinical/bench agreement studies, rather than explicit numerical acceptance criteria for each measurement. However, accuracy claims are stated for some parameters.

2. Sample Size and Data Provenance for Test Set

• Sample Size: The document does not explicitly state the numerical sample size for the test set for any of the studies (clinical agreement or bench agreement). It generally refers to "a clinical agreement study" or "bench agreement testing."
• Data Provenance: Not specified. It's unclear if the data was collected nationally or internationally, or if it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

• The document does not mention the use of experts to establish ground truth.
• The ground truth for most vital sign measurements in these types of studies is typically established by comparing the device's readings against a highly accurate reference standard (e.g., a calibrated simulator for bench tests, or established clinical methods/devices for clinical studies).

4. Adjudication Method for Test Set

• Not applicable. The document describes direct performance testing against standards or reference devices, not a scenario requiring expert adjudication of qualitative data.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device measures vital signs directly and is not an imaging AI diagnostic aid that would typically involve human readers interpreting AI results.

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

• Yes, the performance studies described are essentially standalone (algorithm only) performance studies. The device measures vital signs automatically. The studies validate the device's ability to accurately measure ECG, HR, SpO2, PR, RR, and TEMP against established standards or reference methods. The usability study is about a human interacting with the system, but the core vital sign measurement performance is standalone.

7. Type of Ground Truth Used

• For Bench Agreement Studies (ECG, HR, Pulse Rate): The ground truth was established using bench agreement testing as per ISO 60601-2-47:2012 and comparison against a pulse rate simulator (for PR). This implies highly controlled, synthetic data or precise physical models.
• For Clinical Agreement Studies (SpO2, Pulse Rate, Respiration Rate, Temperature): The ground truth was established through a clinical agreement study for each parameter, adhering to relevant ISO standards (e.g., ISO 80601-2-61:2011 for SpO2/PR, ISO 80601-2-56:2012 for Temperature). This means the device's measurements were compared against accepted clinical reference methods/devices for those vital signs, usually involves real patient data.
• For Usability Study: The ground truth was the successful simulation of normal use by laypeople based on instructions for use.

8. Sample Size for Training Set

• The document does not explicitly mention the sample size for a training set. For vital signs monitoring devices, the "training" (development and calibration) might involve iterative testing and refinement, but it's not typically described in terms of a distinct, formalized "training set" as it would be for deep learning AI models. The standards compliance and clinical/bench studies primarily focus on validation/testing.

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

• Since a distinct "training set" and its ground truth establishment are not detailed in the provided document, this information is not available. Device development and calibration would typically involve laboratory measurements and comparisons to known standards, which effectively serve as the "ground truth" for the device's internal algorithms during its design and optimization phases.

Ask a specific question about this device

The oCare Wrist Pulse Oximeter, Model Pro 100, is a wrist-worn device indicated for use in noninvasive measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate (PR). The intended measuring site of this device is the wrist skin surface. It is intended for spot-checking or continuous monitoring of adult patients during no motion conditions, in hospital-type facilities, and home environments.

The oCare™ Wrist Pulse Oximeter, Model Pro 100 is a wrist-worn device for noninvasive measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate. The intended measuring site of this device is the lateral side of wrist and slightly above the wrist bone (ulnar styloid processus).

The oCare™ Wrist Pulse Oximeter, Model Pro 100 is a watch-like device with a reflectance pulse oximetry sensor located at the bottom of the watch case and on top of the wrist. The reflectance pulse oximetry sensor includes three light emitting diodes (LEDs) of red, infrared and green wavelength and one photodiode light detector placed next to each other. Light beams are emitted from LEDs through the skin to the arteriolar bed of the tissue. Changes in light absorption during the pulsing cycle are measured by the photodiode light detector as scattered lights are reflected back from the pulsating arteriolar bed. The functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate are measured by the well-established non-invasive pulse oximetry technology where the red and infrared light is absorbed in different amounts depending on the oxygenation of the blood during the arterial pulsing. The maximum optical output power is less than 2 mW.

The oCare™ Wrist Pulse Oximeter, Model Pro 100 is a single-patient use, non-sterile pulse oximeter. It is available in one configuration as a standalone device with a wrist pulse oximeter and a detachable watchband for wearing the pulse oximeter on the wrist.

The oCare™ Wrist Pulse Oximeter, Model Pro 100 is a compact and light weight device which consists of a reflectance pulse oximetry sensor, a color graphic OLED display, a lithium ion polymer rechargeable battery, a memory, an analog and digital unit, a microprocessor and an operating software.

The provided text describes the performance data for the oCare™ Wrist Pulse Oximeter, Model Pro 100, focusing on its accuracy in measuring functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate (PR).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The exact number of human subjects is not explicitly stated. The text mentions "human subjects screened for this testing" and "each human subject," implying multiple individuals, but a specific number (e.g., n=X) is not provided.
• Data Provenance: The study was conducted at an "independent research university hospital." The subjects were "health, male, female, no-smoking and light to dark-skinned adult subjects of 20-40 years of age."
  • Country of Origin: Not explicitly stated, but the submission is from Taiwan Biophotonic Corporation, suggesting the study might have been conducted in Taiwan or an affiliated institution.
  • Retrospective or Prospective: Prospective. The study "was designed in accordance with ISO 80601-2-61" to "verify the SpO2 accuracy" where hypoxia was induced in a "stair-stepped manner" and arterial blood samples were taken simultaneously. This indicates a pre-planned, forward-looking study.

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

The text does not indicate that human experts were used to establish ground truth for the device's performance. The ground truth for SpO2 was established invasively using co-oximetry with arterial blood samples. Therefore, this section is not applicable in the context of expert review for ground truth.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for SpO2 accuracy was established through direct
invasive measurement (co-oximetry) of arterial blood samples, not through human
adjudication of medical images or observations.

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

No, an MRMC comparative effectiveness study was not conducted. This study focused on the standalone accuracy of the pulse oximeter device against an invasive gold standard (co-oximetry), not on evaluating how human readers (e.g., clinicians) perform with or without AI assistance. The device is a diagnostic tool, not an AI-assisted diagnostic aid for clinicians.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone study was performed. The "Clinical Studies" section describes a study testing the oCare™ Wrist Pulse Oximeter's accuracy in measuring SpO2 directly against a gold standard (co-oximetry with arterial blood samples). This is a purely algorithmic/device performance evaluation without any human interpretation of the device's output being part of the primary performance metric.

7. The Type of Ground Truth Used

The ground truth used for SpO2 accuracy was invasive functional oxygen saturation of arterial hemoglobin (% SaO2) analyzed by the co-oximetry method with arterial blood samples taken simultaneously.

8. The Sample Size for the Training Set

Not applicable. The device is a pulse oximeter that uses well-established non-invasive pulse oximetry technology (based on light absorption by hemoglobin) and does not appear to employ machine learning that would require a "training set" in the conventional sense (e.g., for AI model development). Its operation is based on physiological principles and signal processing, not a data-driven learning algorithm.

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

Not applicable, as there is no mention or indication of a "training set" for this
device's underlying technology.

Ask a specific question about this device