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The medical Vital Signs Analyzer seca mVSA 535 is a Spot-Check device used for non-invasive, discontinuous measurement and display of NIBP (blood pressure), SpO2 (oxygen saturation of arterial hemoglobin), TEMP (body temperature) and PR (pulse rate).

The vital signs monitor model seca mVSA 535 is mainly used in inpatient facilities (hospitals, medical practices and care facilities) in accordance with nations and is intended to be used on adult and pediatric individuals (3 years of age or older).

The seca mVSA 535 can be used in conjunction with an optional PC software accessory for data management, calculations and display of information.

If used in conjunction with seca medical weight measurement devices the seca mVSA 535 can receive and display weight and height values.

The seca mVSA 535 is a portable, non-invasive, reusable microprocessor-controlled, AC or DC-powered Vital Signs Analyzer providing discontinuous Spot-Check measurements of vital sign parameters of a patient (adult and pediatric individuals >3 years) in a clinical settings (hospitals, medical practices and care facilities). The vital sign data help clinicians to manage and monitor health conditions of patients.

The seca mVSA 535 is used by a health care provider (HCP) in a clinical setting, only. During the start the seca mVSA 535 performs a self-check. The user is not required to perform any special maintenance and/or calibration activities. Users do not require any special training other than the provided instructions for use.

The seca mVSA 535 does not include alarms or arrhythmia detection.

The following vital signs are measured:

• . Blood pressure (NIBP),
• . Oxygen saturation of arterial hemoglobin (SpO₂)
• . Body temperature (TEMP) (oral/axillary/rectal)
• . Pulse rate (PR) – this parameter is not measured but determined while measuring blood pressure or SpO2

The provided document describes the seca mVSA 535, a vital signs analyzer intended for non-invasive, discontinuous measurement and display of NIBP (blood pressure), SpO2 (oxygen saturation), TEMP (body temperature), and PR (pulse rate). The study described is a non-clinical performance evaluation to demonstrate substantial equivalence to a predicate device, not a study demonstrating the device meets specific acceptance criteria in a clinical setting in the way a diagnostic AI would. Therefore, much of the requested information (like ground truth, expert qualifications, adjudication, MRMC studies, standalone performance with AI, training set details) is not applicable or cannot be extracted from this summary.

However, I can provide the available information regarding the performance data and acceptance criteria based on the regulatory submission.

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

The document states that the seca mVSA 535 "meets all the requirements" and "PASSED all testing" for various standards. It does not provide specific numerical acceptance criteria or reported device performance values for each vital sign parameter, but rather confirms compliance with the general requirements of the referenced standards.

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

The document does not specify the sample sizes used for the "test set" for the non-clinical performance data. It describes tests against standards, which typically involve specific test setups and reference devices rather than a patient-based "test set" in the context of clinical accuracy claims for an AI. The data provenance is also not detailed, as these are engineering and safety tests rather than clinical studies with patient data.

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

Not applicable. The non-clinical performance data relies on compliance with established technical standards, not expert-established ground truth from clinical readings.

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

Not applicable. This is a non-clinical performance evaluation focused on device functionality and safety against technical standards.

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 seca mVSA 535 is a vital signs measurement device, not an AI-assisted diagnostic tool for human readers. No MRMC study was mentioned.

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

This is not an AI algorithm. The device performs automated, non-invasive measurements. Its performance is assessed against the requirements of the standards for such medical devices, which is essentially a "standalone" assessment of its measurement accuracy and safety.

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

The "ground truth" for the non-clinical performance data is defined by the reference standards and calibrated instruments used in the testing outlined by ISO 80601-2-30 (sphygmomanometers), ISO 80601-2-56 (clinical thermometers), and ISO 80601-2-61 (pulse oximeters). These standards specify the methods and acceptable deviations for accuracy, rather than clinical ground truth from patient outcomes or expert consensus.

8. The sample size for the training set

Not applicable. This device does not employ a machine learning algorithm that requires a training set.

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

Not applicable. This device does not employ a machine learning algorithm that requires a training set.

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The seca mBCA 514 measures body Weight and records body Height for calculation of Body Mass Index (BMI), Resting Energy Expenditure (REE) and Total Energy Expenditure (TEE) to monitor growth process and weight changes in individuals of all ages.

In healthy individuals aged 18 years and older the device also measures body impedance (Reactance Xc and Resistance R) for estimation of body composition. Estimation of body composition includes Total Body Water (TBW), Intra Cellular Water (ICW), Extra Cellular Water (ECW), Lean Soft Tissue (LST), Fat-Free Mass (FFM), Fat Mass (FM), Fat Mass Indices (FMI and FMMI), Skeletal Muscle Mass (SMM), Bioelectrical Impedance Vector Analysis (BIVA), Energy stored in body (Ebody) and Phase Angle (Φ).

The seca mBCA 514 can be used in conjunction with the optional PC software accessory seca analytics 115 for data management, calculations and display of information.

The seca mBCA 514 is a scale and impedance plethysmograph body composition analyzer for estimation of the body composition of individuals based on the Bioelectrical Impedance Analysis (BIA). The device measures bioelectrical impedance values by means of multi frequency, segmental measurements (right arm, trunk, right leg, left leg, right body side and left body side).

The seca mBCA 514 is a body composition analyzer that uses bioelectrical impedance analysis (BIA) to estimate body composition. The device's performance was evaluated through bench and clinical testing to demonstrate its safety and effectiveness compared to a predicate device, the BioSpace InBody 720 (K052646), and other established methods for specific body composition parameters.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in terms of specific thresholds (e.g., a certain percentage of agreement or a specific correlation coefficient). Instead, it states that the results of the testing "demonstrate that the seca mBCA 514 is as safe and effective as the predicate device" and that the "differences with the predicate devices and methods are sufficiently minor to establish substantial equivalence." This implies that the acceptance criteria were met by demonstrating comparable performance to established methods.

Here's a summary of the comparisons:

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

The document does not explicitly state the specific sample size used for the test set in the clinical trials, nor does it specify the country of origin of the data or whether it was retrospective or prospective. It only broadly refers to "clinical testing."

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

The document does not specify the number of experts or their qualifications for establishing the ground truth. The ground truth for different parameters was established using established scientific methods (e.g., deuterium oxide dilution, sodium bromide dilution, DXA, BOD POD), rather than solely expert consensus on interpretations of device outputs.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by reference methods, not by expert adjudication of device outputs.

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

No. The study described is a comparison of the device's measurements against established methods and a predicate device, not a human reader study with or without AI assistance.

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

Yes, the studies described are standalone performance evaluations of the seca mBCA 514's ability to measure or estimate various body composition parameters compared to established reference methods and a predicate device. The device's output (measurements and estimations) is directly compared.

7. The Type of Ground Truth Used

The ground truth for the device's performance was established using established scientific methods considered gold standards for body composition measurement:

• Deuterium oxide dilution method: For Total Body Water (TBW)
• Sodium bromide dilution method: For Extra Cellular Water (ECW)
• GE Lunar iDXA Bone Densitometer (K052581): For Lean Soft Tissue (LST)
• Four compartment model (incorporating GE Lunar iDXA, BOD POD Sonamet Body Composition Analyzer (K060848), and deuterium oxide dilution method): For Fat-Free Mass (FFM)
• Biospace InBody 720 (K052646): As a predicate device for Impedance raw data and Weight.

8. The Sample Size for the Training Set

The document does not provide information about a specific training set size. Body composition analyzers typically use pre-developed algorithms and regression equations, which are often derived from large historical datasets, but no details are given here regarding the specific training set for seca's algorithms.

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

The document does not provide information on how the ground truth for any potential training set was established. It only describes the methods used for the comparative clinical testing to establish substantial equivalence.

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