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The DINAMAP Select MPS is intended to monitor a single patient's vital signs at the bedside. The patient populations include adult, pediatric and neonatal. Remote monitoring is available if a network of monitors exists.

The DINAMAP Select Multi Parameter System (MPS) is a prescription device intended for use only by health care professionals. It can be used in hospital and/or outpatient surgery center settings and functions as a patient bedside multiparameter monitoring unit. It is designed for monitoring adult, pediatric and neonatal patients in acute care settings such as critical care, emergency room, radiology, labor and delivery, and operating room. Using this monitoring system, the clinician can view, record and recall clinical data derived from the user-selectable modules/monitoring parameters. This clinical data includes heart rate, ECG waveforms, oxygen saturation (SpO2), invasive pressure, noninvasive pressure (systolic, diastolic, mean), entidal carbon dioxide (CO2), respiration rate and temperature.

The DINAMAP Select MPS functions as a single-patient monitor or as part of an Ethernet network. Patient data may be viewed in graphical or text form and is stored for twenty-four hours. If the MPS is networked, the user may observe vital signs data from other devices by using the Remote View feature. The MPS is modular and monitors multiple parameters simultaneously. When necessary, the user can temporarily suspend all activity of the monitor while in Standby mode. The MPS consists of the mainframe, modules and monitor (display).

The mainframe provides a single rack with nine slots for modules. All patient connectors are on the front of the mainframe. All network and device connectors are on the back. The indicators, on the right side of the mainframe, informs the user when the battery is being charged and when the MPS is operating on AC or battery power. The mainframe provides connection for the currently marketed Johnson & Johnson Medical, Inc. (JJMI, formerly Critikon, Inc.) OBSERVER* Central Station (K933404), other monitoring devices, such as the currently marketed Johnson & Johnson Medical, Inc., DINAMAP PLUS Monitors (K943709 & K912188), a remote monitor, a full-page printer, data collection system, remote alarm and/or host information system.

Modules measure patient vital signs and patient airway gases, and provide thermal paper strip records. The MPS accepts two types of modules: parameter modules and recorder modules. Parameter modules process data from transducers to generate waveforms and numeric data on the display screen. The waveforms and parameter measurements on the screen vary according to the modules inserted into the mainframe. The user can continue to monitor a patient with any of the remaining modules while inserting or removing other modules.

Currently, the Select MPS will offer the following modules:

• ECG (3 lead)/Respiration/Heart Rate/Continuous Temperature .
• ECG (6 lead)/Respiration/Heart Rate/Continuous Temperature .
• Noninvasive Blood Pressure (single wide)/Heart Rate .
• Noninvasive Blood Pressure (double wide)/Heart Rate ●
• Invasive Pressure/Heart Rate .
• Pulse Oximetry (Oxygen Saturation)/Heart Rate .
• Endtidal Carbon Dioxide/Respiration ●
• Recorder (double wide) ●

Here's an analysis of the provided text regarding the DINAMAP Select Multi-Parameter System (MPS) and its acceptance criteria and supporting studies:

Important Note: The provided text is a 510(k) summary from 1995. Medical device regulatory practices and the level of detail required in summaries have evolved significantly since then. This summary provides high-level information but lacks the granular detail often found in more recent submissions concerning acceptance criteria and study methodologies.

Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state specific quantitative acceptance criteria (e.g., accuracy percentages, precision ranges) for the DINAMAP Select MPS or its individual modules. Instead, it relies on demonstrating substantial equivalence to predicate devices, implying that if the new device performs similarly or meets the standards of the predicate, it is acceptable.

However, the summary indicates that "Several bench studies were conducted which demonstrate safety and effectiveness" and "Several clinical studies were conducted which demonstrate safety and effectiveness." These studies implicitly aimed to show the device's performance met an unstated standard, likely mirroring the performance of the predicate devices.

Table 1: Acceptance Criteria and Reported Device Performance (Inferred)

Detailed Study Information:

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: The summary does not specify the sample sizes for any of the clinical studies. It only states "Several clinical studies were conducted which demonstrate safety and effectiveness," specifically mentioning "Noninvasive Blood Pressure in the adult, pedicatric and neonatal populations" and "Pulse Oximetry."
   • Data Provenance: The summary does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission in the US, it's highly probable the studies were conducted in the US. Clinical studies mentioned would typically be prospective to evaluate a new device, but this is not explicitly stated.

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

   • The summary provides no information on the number or qualifications of experts used to establish ground truth for any clinical studies mentioned. For vital signs monitors, ground truth is typically established by well-established reference methods and trained clinical staff, rather than a panel of "experts" in the sense of image interpretation.

3. Adjudication method for the test set:

   • The summary provides no information on any adjudication method. This type of detail is more common in studies involving subjective assessments (e.g., image interpretation) than in objective physiological measurements where ground truth is typically measured directly.

4. 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 device is a vital signs monitor, not an AI-assisted diagnostic tool for human "readers" (e.g., radiologists interpreting images). Therefore, this question is not applicable to the DINAMAP Select MPS. The concept of "AI assistance" or "human reader improvement" does not apply to this type of medical device as described in the 1995 submission.

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

   • This question is also not directly applicable in the modern sense of "standalone AI performance." The DINAMAP Select MPS itself is a "standalone" device in the sense that its algorithms process physiological signals and display results without requiring continuous real-time human interpretation of raw data for every output. Its performance, as demonstrated in the bench and clinical studies, is the "algorithm-only" performance as it provides direct numerical and waveform output. The human "in-the-loop" is the healthcare professional using the data for patient care.

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

   • For Noninvasive Blood Pressure and Pulse Oximetry, ground truth would typically be established using simultaneous measurements from a recognized gold standard invasive method (e.g., arterial line for NIBP in some studies, or co-oximetry for SpO2) or highly accurate non-invasive reference devices, under controlled clinical conditions.
   • For other parameters like ECG, Respiration, Temperature, CO2, and Invasive Pressure, the ground truth would similarly involve validated reference equipment and methodologies known for their accuracy in measuring those specific physiological parameters (e.g., precision thermometers, capnographs, direct-reading transducers). The summary does not specify the exact methods.

7. The sample size for the training set:

   • The summary does not mention a training set. This is consistent with the era and the nature of the device. While the device contains algorithms, it's unlikely they used "training sets" in the modern machine learning sense. More likely, algorithms were developed and calibrated by engineering teams using physiologically relevant data from various sources (simulators, animal models, limited human data) which are not detailed in a 510(k) summary.

8. How the ground truth for the training set was established:

   • As no "training set" in the modern sense is mentioned, there is no information on how its ground truth would have been established. Any "ground truth" used for internal algorithm development would have been established through a combination of engineering principles, established physiological models, and data from laboratory or early clinical testing, likely against established reference methods.

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