(228 days)
The V20, V20a, AVSM3 SNF are intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR) and temperature (TEMP) in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V20 and V20a are for adult, pediatric and neonatal patients and the AVSM3 SNF is for adult patients only. Also, the V20 is only suitable for single measurement but V20a and AVSM3 SNF are suitable for single as well as continuous measurement.
The V20, V20a, AVSM3 SNF are intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR) and temperature (TEMP) in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V20 and V20a are for adult, pediatric and neonatal patients and the AVSM3 SNF is for adult patients only. Also, the V20 is only suitable for single measurement but V20a and AVSM3 SNF are suitable for single as well as continuous measurement.
The Mediana V20, V20a, AVSM3 SNF vital signs monitors are a lightweight and compact device (249 x 211 x 176 (mm) (W×H×D) and 3.1 kg for Standard configuration) powered by AC mains (100-240VAC, 50Hz/60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on 8″ TFT-LCD screen.
Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance for the Mediana V20, V20a, AVSM3 SNF vital signs monitors.
Important Note: The provided document is an FDA 510(k) clearance letter and an accompanying 510(k) summary. These documents primarily focus on demonstrating substantial equivalence to predicate devices rather than providing detailed, standalone clinical study results for the new device. As such, direct answers to some of your specific questions (like sample sizes for specific new studies, number of experts for ground truth, or MRMC studies) are not explicitly present. The manufacturer is leveraging data from previously cleared devices and relying on the substantial equivalence principle.
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria for the new devices (V20, V20a, AVSM3 SNF) with corresponding reported performance. Instead, it relies on the concept of substantial equivalence to predicate devices. The implicit acceptance criterion is that the new devices should perform equivalently to the cleared predicate devices according to established standards.
The performance characteristics are stated as:
- Non-Invasive Blood Pressure (NIBP), Pulse Rate (PR), Pulse Oximetry (SpO2), and Temperature (TEMP): The device's specifications and performance for these parameters are stated to be equivalent to the respective predicate devices.
Table of Acceptance Criteria (Inferred from Substantial Equivalence to Predicates):
| Parameter | Inferred Acceptance Criteria | Reported Device Performance (V20, V20a, AVSM3 SNF) |
|---|---|---|
| Non-Invasive Blood Pressure (NIBP) | Performance equivalent to Mediana Co., Ltd. V10 vital signs monitors, SunTech LifeWindow LW8 Lite, and AND NIBP modules (supported by their original 510(k) submissions and clinical studies). This implies meeting the performance standards that these predicate devices met. | "The Non-Invasive Blood Pressure (NIBP) measurement specifications and performance are equivalent to Mediana Co., Ltd. vital signs monitors V10 and SunTech LifeWindow LW8 Lite. The clinical studies which were carried out by SunTech and AND companies were used to support different NIBP modules of the subject device under their original 510(k) submissions, and that Mediana has licensed the two NIBP modules for use in the subject device." |
| Pulse Rate (PR) | Performance equivalent to Mediana Co., Ltd. V10 vital signs monitors, SunTech LifeWindow LW8 Lite, and Covidien Nellcor™ Bedside Respiratory Patient Monitoring System. This implies meeting the performance standards that these predicate devices met. | "The Pulse rate specifications and performance derived from either Non-Invasive Blood Pressure (NIBP) or Pulse Oximetry (SpO2) are equivalent to Mediana Co., Ltd. vital signs monitors V10, SunTech LifeWindow LW8 Lite and Covidien Nellcor™ Bedside Respiratory Patient Monitoring System." |
| Pulse Oximetry (SpO2) | Performance equivalent to Mediana V10 vital signs monitor and Covidien Nellcor™ Bedside Respiratory Patient Monitoring System. This implies meeting the performance standards that these predicate devices met. | "The Pulse Oximetry (SpO2) specifications and performance are equivalent to Mediana V10 vital signs monitor and Covidien Nellcor™ Bedside Respiratory Patient Monitoring System." |
| Temperature (TEMP) | Performance equivalent to Covidien Genius 2 thermometer, Covidien Filac 3000 thermometer, and Exergen thermometer. This implies meeting the performance standards that these predicate devices met. | "The Temperature specifications and performance are equivalent to Covidien Genius 2 thermometer, Covidien Filac 3000 thermometer and Exergen thermometer." |
| Safety and Effectiveness | Substantially equivalent to predicates. | "The Mediana vital signs monitor, Model V20, V20a, AVSM3 SNF substantially has been tested in accordance with the system V & V plan #MDR-EG160311-01 included with the submission using production equivalent units prior to release to market." |
| Bench Testing | Compliance with relevant standards (Electrical Safety, EMC, Environmental, ISTA 2A). | "The bench testing (electrical safety testing, EMC testing, IEC60068-2-27, IEC60068-2-64, IEC60068-2-1/2-2/2-30 and ISTA 2A test) has been performed and the results all tests demonstrate that the subject device is substantially equivalent to the predicated device." |
Study Details:
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Sample size used for the test set and the data provenance:
- The document does not provide specific sample sizes for new clinical test sets for the V20, V20a, AVSM3 SNF devices.
- It states that for NIBP, "The clinical studies which were carried out by SunTech and AND companies were used to support different NIBP modules of the subject device under their original 510(k) submissions, and that Mediana has licensed the two NIBP modules for use in the subject device." This indicates that clinical data from the original predicate device manufacturers (SunTech and AND) are being leveraged. The provenance of that data would be tied to those original submissions, but it's not detailed here. For other parameters (SpO2, PR, Temp), it simply states equivalence, implying reliance on the predicate device's performance data without necessarily conducting new clinical trials for the Mediana V20 series.
- The document mentions "system V & V plan #MDR-EG160311-01" for performance testing, which is likely a combination of bench and possibly some limited clinical testing, but specifics are absent.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. Given the reliance on predicate device data and bench testing, direct ground truth establishment for a new clinical test set (as would be typical for an AI/algorithm-focused submission) doesn't seem to be the primary method for this 510(k).
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided as there's no detailed description of a new clinical test where expert adjudication would be relevant for these types of vital signs measurements.
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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:
- No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic imaging devices. The devices in this submission (vital signs monitors) measure physiological parameters directly and do not involve "human readers" interpreting an AI output in this context.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The devices perform automated measurements (NIBP, SpO2, PR, TEMP). The "performance" described is inherently standalone, as the device calculates and displays these values. However, "standalone performance" in the context of AI usually refers to the algorithm's output before human review. For these vital signs monitors, the measurement algorithm's performance is the device's performance. The document states the "specifications and performance are equivalent" to predicates, implying their algorithms produce comparable results.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For such vital signs monitors, the "ground truth" for NIBP, SpO2, PR, and TEMP typically involves direct, invasive, or highly accurate reference measurements (e.g., invasive arterial line for NIBP, co-oximetry for SpO2, EKG for PR, highly accurate reference thermometers for TEMP). The document doesn't explicitly detail the ground truth methods used for the predicate studies it references.
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The sample size for the training set:
- This information is not provided and is generally not applicable in the same way it would be for AI/ML-based devices. Vital signs monitors often rely on traditional signal processing algorithms rather than machine learning models that require distinct training sets. Even if there were some adaptive algorithms, training set details are not mentioned.
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How the ground truth for the training set was established:
- This information is not provided, as details about a "training set" in the context of this device are absent.
§ 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).