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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.

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The Textronics™ ECG Electrode is intended for use in general electrocardiograph monitoring and recording procedures.

The Textronics™ ECG Electrode is indicated for use with most ECG instruments on the market. It is indicated for applications including resting ECGs, exercise ECGs, and/or ambulatory monitoring. The device is indicated for both prescription and over-the-counter use.

The Textronics ™ ECG Electrode consists of electrodes, an exterior housing for the electrodes that makes contact with the patient, and a means of connecting the device to an ECG instrument. The Textronics™ ECG Electrode has textilebased electrodes made of electrically conductive yarns knitted together with electrically non-conductive yarns. The conductive yarns are silver coated polyamide (nylon). The non-conductive yarns can include cotton, spandex, polyester, and/or nylon. The Textronics™ ECG Electrode's textile-based electrodes have an exterior housing made of fabric, which can be made out of common textile materials, including polypropylene, nylon, Lycra® Spandex, polyester, and/or cotton. This fabric exterior housing can take the shape of a variety of garments, such as chest straps, wrist bands, shirts, bras, or vests. The Textronics™ ECG Electrode connects to ECG instruments via a conductive snap.

Here's an analysis of the provided information regarding the Textronics™ ECG Electrode's acceptance criteria and substantiating study:

This 510(k) summary does not provide explicit acceptance criteria in the typical sense of quantitative thresholds (e.g., minimum sensitivity, PPV). Instead, the "acceptance criteria" are implied to be "functional as intended" and "clarity and resolution of the tracings were observed to be substantially equivalent to the commercially available electrodes."

The study is a comparative performance study against commercially available ECG electrodes.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document mentions "ECGs were recorded," implying multiple recordings, but no specific number of patients or recordings is provided.
• Data Provenance: Not explicitly stated, but the study was conducted "in the lab." This suggests a controlled environment, likely in the US where Textronics, Inc. is located. It is a prospective study as the device was tested against existing commercial electrodes.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not stated.
• Qualifications of Experts: Not stated.

The evaluation of "clarity and resolution" would typically involve expert interpretation, but the document does not specify who performed this assessment or their qualifications.

4. Adjudication Method for the Test Set

• Adjudication Method: Not stated. Given the qualitative nature of the performance assessment ("observed to be substantially equivalent"), it's possible a formal adjudication process was not used, or at least not described.

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

• MRMC Study: No. This type of study is not described. The assessment focuses on the device's technical performance in generating ECG tracings, not on human reader performance with or without AI assistance.

6. Standalone Performance Study (Algorithm Only)

• Standalone Performance Study: Yes, in the sense that the performance data presented is for the device itself.
  • The Textronics™ ECG Electrode was "tested in the lab using ECG recording devices with the commercially available ECG electrodes and the Textronics ™ ECG Electrode used simultaneously."
  • "ECGs were recorded, and the tracings were compared."
  • The device's output (ECG tracings) was directly assessed for functionality, clarity, and resolution.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device's performance is effectively concurrent comparison to commercially available, predicate ECG electrodes. The "ground truth" for what constitutes a "functional" and "clear, resolute" ECG tracing is established by the accepted performance of these predicate devices. It is based on expert observation/interpretation of these comparative tracings, rather than pathology or long-term clinical outcomes.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The Textronics™ ECG Electrode is a hardware device (electrode), not an AI algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this hardware device.

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