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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 ABL90 FLEX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, and oximetry in heparinised whole blood. The ABL90 FLEX analyzer is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order.

pH, pO2 and pCO2: pH, pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Potassium (cKT): potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

Sodium (cNa*): sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.

Calcium (cCart): calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

Chloride (cCI¯): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.

Glucose (cGlu): glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Lactate (cLac): The lactate measurements measure the concentration of lactate in plasma. Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood.)

Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.

sO2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoqlobin.

FO2Hb: oxyhemoglobin as a fraction of total hemoglobin.

FCOHb: carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.

FMetHb: methemoglobin as a fraction of total hemoglobin.

FHHb: reduced hemoglobin as a fraction of total hemoglobin.

Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin. FHbF is seldom used clinically.

The ABL90 FLEX is a portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2 , pCO2, potassium, sodium, chloride, glucose, lactate, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, F MetHb, FHHb and FHbF).

The implementation of the WiFi option allows wireless functionality for establishing network connectivity; all of which is supported by wired LAN connection in the existing application.

Here's an analysis of the provided text regarding the ABL90 Flex device modification for WiFi, structured to address your specific questions.

Acceptance Criteria and Study for ABL90 Flex - WiFi Modification

The submission pertains to a Special 510(k) for a device modification, specifically adding WiFi functionality to the existing ABL90 Flex. A key assertion in such submissions is that the modification does not affect the core performance characteristics of the previously cleared device. Therefore, the "acceptance criteria" and "device performance" in this context refer to the performance characteristics of the original ABL90 Flex, which the modified device is claimed to still meet.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a special 510(k) for a modification (WiFi functionality), the acceptance criteria are implicitly that the addition of WiFi does not degrade or alter the performance characteristics of the existing device's measurements. The reported device performance is that these performance characteristics remain unchanged.

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

The document explicitly states: "No performance characteristics are affected by the change. The performance data submitted in the original submission (K092686) still apply."

This indicates that no new performance studies were conducted specifically for the WiFi modification to generate a new "test set" for measurement performance. The evidence relies on the existing performance data of the predicate device (K092686).

• Sample Size for Test Set: Not applicable for new performance data related to the WiFi modification, as existing data is referenced. The sample size for the original ABL90 Flex (K092686) performance studies would be relevant but is not provided in this submission summary.
• Data Provenance: Not applicable for new performance data related to the WiFi modification. The provenance for the original ABL90 Flex performance data (K092686) is not detailed in this submission summary.

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

Again, because no new performance studies are detailed for the WiFi modification, this information is not provided in the submission. The ground truth for the original ABL90 Flex (K092686) performance studies would have been established, but details are not present here.

4. Adjudication Method for the Test Set

Not applicable, as no new performance studies with specific test sets requiring adjudication were conducted for the WiFi modification.

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

No. This type of study is typically performed for diagnostic imaging devices where human interpretation plays a significant role. The ABL90 Flex is an automated analytical instrument where the output is numerical measurements, not subjective human interpretation.

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

Yes, in essence. The ABL90 Flex is an automated analytical device. Its performance, as referenced from the original 510(k) (K092686), is inherently "standalone" in that it performs measurements without real-time human intervention affecting the measurement process itself. The modification (WiFi) is a connectivity feature and does not alter the core analytical algorithm or measurement capabilities.

7. The type of Ground Truth Used

For the core analytical measurements of the ABL90 Flex (pH, pO₂, electrolytes, glucose, etc.), the ground truth would typically be established through:

• Reference Methods: Highly accurate and precise laboratory methods considered the "gold standard" for specific analytes.
• Calibrated Reference Materials: Using certified reference materials or calibrators with known concentrations.
• Interlaboratory Comparison: Comparing results against other established and validated analytical devices or laboratories.

However, the specific details for the original ABL90 Flex (K092686) are not provided in this document.

8. The Sample Size for the Training Set

Not applicable. The ABL90 Flex is a chemical analyzer, not a machine learning or AI-based device that requires a "training set" in the conventional sense. Its "training" or calibration involves using specific calibrant solutions according to established protocols.

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

Not applicable, as there is no "training set" in the context of machine learning for this device. The calibration process involves using commercially available or internally prepared calibrants with known, traceable values (ground truth) to adjust the instrument's response.

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