(171 days)
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.
| Parameter | Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1, 5, 10 | PASSED all testing |
| Electrical Safety | ANSI/AAMI ES60601-1, IEC 60601-1-6 | PASSED required testing |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | PASSED required testing |
| Usability Engineering | IEC 62366 | PASSED required testing |
| Software Verification & Validation | IEC 62304 / FDA Guidance (Moderate Level of Concern) | PASSED required testing |
| Non-Invasive Sphygmomanometers (NIBP) | ISO 80601-2-30 | PASSED required testing |
| Clinical Thermometers (TEMP) | ISO 80601-2-56 | PASSED required testing |
| Pulse Oximeter Equipment (SpO2) | ISO 80601-2-61 | PASSED required testing |
| Risk Management | ISO 14971, EN ISO 14971 | All requirements met, risks reduced as far as possible |
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.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).