(76 days)
The DINAMAP® Pro 1000 V3 Monitor is intended to monitor oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), heart/pulse rate, respiration rate, ECG, oxygen saturation (SpO2) by non-invasive pulse oximetry, and predictive temperature with an electronic thermometer in the adult, pediatric and neonate populations. An additional feature is the detection of three lethal arrhythmias- asystole, ventricular tachycardia (v-tach), and ventricular fibrillation (v-fib). The Pro 1000 V3 Monitor also detects alarm limit conditions and is capable of recording up to two waveforms. Using this monitor a clinician can view, record and recall clinical data derived from each parameter.
The DINAMAP® Pro 1000 V3 Monitor is intended to monitor a single patient's vital signs in the hospital, outpatient surgery and healthcare practitioner facilities. The patient populations include adult, pediatric, and neonatal. The device's networking capabilities include connection to a central station via VHF, 900 MHz or hardwire communication; host communications for use with other devices. In addition, the DINAMAP Pro 1000 Monitor may be operated from internal batteries making the device portable and suitable for intra-hospital transport.
Here's an analysis of the provided text regarding the DINAMAP® PRO 1000 V3 Monitor, focusing on acceptance criteria and supporting studies:
Based on the provided document (K031376), it is not possible to describe the acceptance criteria and the study that proves the device meets them in detail as requested. The document primarily focuses on the regulatory submission process and establishing substantial equivalence to a predicate device.
Specifically, the document states:
- "Several bench studies were conducted which demonstrate safety and effectiveness of the DINAMAP® PRO 1000 V3 Monitor:
- Electromagnetic Compatibility
- Electrical Safety
- Mechanical and Environmental"
However, it does not provide any details on:
- Specific quantitative acceptance criteria for any of these studies.
- The reported performance of the device against any such criteria.
- The methodology, sample sizes, data provenance, ground truth establishment, or any other specifics of these studies.
- Any clinical studies, standalone algorithm performance, or multi-reader multi-case studies.
Therefore, many of the requested elements cannot be completed from the provided text.
Here's a table attempting to fill in what can be inferred from the provided text, along with a clear indication where information is not available (N/A):
Table of Acceptance Criteria and Reported Device Performance
| Parameter/Characteristic | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|---|
| Electromagnetic Compatibility | N/A (Presumed to meet relevant standards) | N/A |
| Electrical Safety | N/A (Presumed to meet relevant standards) | N/A |
| Mechanical Safety | N/A (Presumed to meet relevant standards) | N/A |
| Environmental Performance | N/A (Presumed to meet relevant standards) | N/A |
| Oscillometric Non-Invasive Blood Pressure | N/A | N/A |
| Heart/Pulse Rate | N/A | N/A |
| Respiration Rate | N/A | N/A |
| ECG Performance | N/A | N/A |
| SpO2 by Non-Invasive Pulse Oximetry | N/A | N/A |
| Predictive Temperature | N/A | N/A |
| Lethal Arrhythmia Detection (Asystole, V-Tach, V-Fib) | N/A | N/A |
Study Details (Based on available information)
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: N/A. The document mentions "bench studies" (Electromagnetic Compatibility, Electrical Safety, Mechanical and Environmental) but does not provide any sample sizes or details about data used.
- Data Provenance: N/A. No information is given about the origin or nature of any data used in these bench studies. They are mentioned as general engineering tests.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Given that the described studies are "bench studies" related to engineering compliance (EMC, electrical, mechanical, environmental), expert input for "ground truth" in a clinical sense would not typically be applicable or detailed in such a summary. No clinical ground truth establishment is mentioned for these engineering tests.
-
Adjudication method for the test set:
- N/A. No information provided, and not typically relevant for the type of bench studies mentioned.
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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:
- N/A. The document describes a traditional physiological monitor, not an AI-assisted device. Therefore, no MRMC study or AI-related effectiveness analysis would have been performed or reported here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device is a physiological monitor, not a standalone algorithm. Performance validation would typically involve the device itself (hardware and embedded software) against reference standards or clinical measurements. The document does not detail such performance studies.
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The type of ground truth used:
- N/A. For the mentioned "bench studies," the "ground truth" would likely be established by international standards (e.g., for electrical safety, EMC limits) or engineering specifications. No clinical ground truth (e.g., pathology, outcomes data, expert consensus) is discussed for proving the device's functional performance in a clinical setting. The document focuses on substantial equivalence to a predicate device, implying that the predicate's established performance serves as a benchmark rather than new extensive clinical validation.
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The sample size for the training set:
- N/A. This device is not described as having an AI component that would require a "training set" in the context of machine learning.
-
How the ground truth for the training set was established:
- N/A. Not applicable as there is no mention of a "training set" for an AI component.
Conclusion:
The provided document is a 510(k) summary focused on establishing substantial equivalence for a medical device. While it mentions "bench studies" for safety and effectiveness, it lacks the detailed information required to answer most of the questions regarding specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or clinical performance data. The regulatory submission emphasizes that "The DINAMAP® PRO 1000 V3 Monitor has the same technological characteristics as the predicate device, the DINAMAP® PRO 1000 V2 Monitor. There are no new technologies used on the DINAMAP® PRO 1000 V3 Monitor," which is the primary argument for its safety and effectiveness without needing extensive new clinical trials.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.