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The DINAMAP MPS* Select* Portable 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 Portable Monitor networking capabilities are identical to the predicate device (K955113) and include connection to the OBSERVER* Central Station via VHF, spread spectrum or hardwire communication; host communications for use on the auxiliary serial port or RS-232 serial port; and remote view protocol over Ethernet enabling communication with other devices such as currently-marketed DINAMAP* Monitors, remote display, data collection or hospital information system, or remote alarm. In addition, the Portable Monitor may be operated from internal NiMH batteries making the device portable. This device is intended for use by qualified healthcare personnel trained in its use.

The DINAMAP MPS Portable Monitor 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 portable and/or transport 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, operating room, and same-day surgery. Using this monitor, the clinician can view, record and recall clinical data derived from the user-selectable monitoring parameter modules. This clinical data includes heart rate, ECG waveforms, oxygen saturation (SpO2), invasive pressure, noninvasive pressure (systolic, diastolic, mean), endtidal carbon dioxide (CO2), respiration rate and temperature. These are the same modules utilized in the currently-marketed Johnson & Johnson Medical, Inc. (JJMI) DINAMAP MPS* Select* Monitor which received marketing clearance August 15, 1996, via 510(k) premarket notification K955113: • ECG (3 lead)/Respiration/Heart Rate/Continuous Temperature • ECG (6 lead)/Respiration/Heart Rate/Continuous Temperature • Noninvasive Blood Pressure/Heart Rate • Invasive Pressure/Heart Rate • Pulse Oximetry (Oxygen Saturation)/Heart Rate • Endtidal Carbon Dioxide/Respiration • Recorder (double wide) The Portable Monitor accepts modules in any combination and the waveforms and parameter measurements on the screen vary according to the modules that are in the Monitor. The Monitor will detect module type and will disable modules as appropriate (e.g. duplicates) to prevent the system from operating improperly. Modules can be inserted or removed, as necessary, while the Monitor is operating. When a module is inserted, the Monitor automatically detects it. When a module is removed, the patient can continue to be monitored with any of the remaining modules. The Portable Monitor is self-contained and has a carrying handle. It can be operated from internal battery or AC (via an in-line DC power supply). At the side of the Monitor are six slots for modules. All patient connectors are on the modules. On the front of the Monitor are three indicators that let the user know when the backup battery is being charged or if the Monitor is operating on AC or battery power. The internal battery is capable of powering the Portable Monitor for 60 minutes (+ 10 minutes). The two optional user-replaceable batteries are capable of adding 60 minutes each to the operating time. On the back of the monitor are the on/off button, power supply connection, optional user-replaceable Nickel Metal Hydride (NiMH) batteries, network and device connections, and an optional pullout hanging bracket. On the bottom of the Monitor is the mounting plate. The Portable Monitor provides connections for the currently-marketed JJMI OBSERVER* Central Station (K933404; hardwire, digital spread spectrum or VHF communication); other monitoring devices, such as the currently-marketed JJMI DINAMAP PLUS Monitors (K943709 & K912188); a remote monitor (display); a full-page printer; data collection or hospital information system; remote alarm and/or Ethernet network. If the Portable is networked, the user may observe vital signs data from other devices by using the Remote View feature. As with the monitoring parameter modules, communications protocols for the Portable Monitor are the same as the currently-marketed DINAMAP MPS* Select* Monitor.

The provided text describes a 510(k) submission for the DINAMAP MPS Portable Monitor. This document does not contain acceptance criteria or a study proving that a device meets acceptance criteria, as it is a premarket notification for a vital signs monitor, not a diagnostic AI device.

The document primarily focuses on establishing substantial equivalence to a predicate device (DINAMAP MPS Select Monitor), device description, classification, and indications for use. It mentions that "Several bench studies were conducted which demonstrate safety and effectiveness of the DINAMAP MPS Portable Monitor: • Environmental • Electromagnetic Compatibility • Battery Life". However, it does not provide details of these studies, nor does it list specific acceptance criteria or performance metrics.

Therefore, I cannot provide the requested information for acceptance criteria and study details based on the provided text.

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The DINAMAP Compact Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside. Vital signs parameters include noninvasive blood pressure (systolic, diastolic and mean arterial pressure), pulse rate, temperature and/or oxygen saturation (pulse oximetry). The portable device is designed for use in numerous clinical settings, primarily in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor & delivery, endoscopy, cardiac step-down, etc. and can also be used during many specialized procedures in satellite areas, or in ambulatory surgery centers, physicians' offices or alternate care settings.

The DINAMAP Compact Monitor is a prescription device intended for use only by health care professionals. Three configurations of the monitor with the following vital signs parameters will be available: Noninvasive Blood Pressure and Heart Rate, Noninvasive Blood Pressure and Heart Rate, and Predictive Oral/Rectal Thermometry Noninvasive Blood Pressure and Heart Rate, Predictive Thermometry, and Nellcor® Pulse Oximetry and Heart Rate In addition, the currently-marketed Sherwood Medical Inc. FirstTemp™ Genius™ Infrared Tympanic Thermometry Unit (K920713) may be physically attached to the side of (but not electrically integrated with) the DINAMAP Compact Monitor. The device is designed for monitoring adult, pediatric and neonatal patients in hospital, outpatient surgery center, physician office and/or alternate healthcare settings. It is portable and capable of operation from an external AC mains power source or an internal lead-acid rechargeable battery. An optional printer is also available. The Compact Monitor provides connection for the currently marketed Johnson & Johnson Medical, Inc. (JJMI, formerly Critikon, Inc.) OBSERVER* Central Station (K933404), other monitoring devices, a remote display, data collection system, remote alarm and/or host information system.

The DINAMAP Compact Monitor is a prescription device intended for use by healthcare professionals for monitoring vital signs (noninvasive blood pressure, pulse rate, temperature, and/or oxygen saturation) in adult, pediatric, and neonatal patients in various clinical settings.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text for the K970182 submission does not explicitly state numerical acceptance criteria for each vital sign parameter (e.g., specific accuracy ranges for blood pressure or temperature). Instead, it states that "Several clinical studies were conducted which demonstrate safety and effectiveness" for:

• Predictive Thermometry Accuracy
• Adult Noninvasive Blood Pressure Accuracy
• Pediatric Noninvasive Blood Pressure Accuracy
• Neonatal Noninvasive Blood Pressure Accuracy
• Pulse Oximetry (implicitly covering accuracy for this parameter, though "accuracy" isn't explicitly listed next to it as for the others)

The document concludes that the device is "safe, effective and substantially equivalent to the predicate devices." This implies that the performance in these clinical studies met the expected safety and effectiveness benchmarks, likely derived from the predicate devices or relevant standards at the time (though these specific benchmarks are not detailed).

Therefore, a table with specific numerical acceptance criteria and reported performance cannot be fully constructed from the provided text.

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

The document mentions "Several clinical studies" for predictive thermometry accuracy, and adult, pediatric, and neonatal noninvasive blood pressure accuracy. However, no specific sample sizes for these test sets are provided in the current document. The data provenance (e.g., country of origin, retrospective or prospective nature) is also not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth for any of the clinical studies mentioned.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test sets.

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

This device is a vital signs monitor, not an AI-assisted diagnostic imaging device. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed. The device itself performs the measurements; it does not assist human interpretation of complex cases in the same way AI might for medical imaging.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

The device is inherently a "standalone" system in its measurement function, as it provides direct readings of vital signs. The clinical studies mentioned (e.g., "Predictive Thermometry Accuracy," "Adult Noninvasive Blood Pressure Accuracy") would inherently assess the algorithm's performance in generating these measurements independently. There isn't a "human-in-the-loop" for the initial measurement generation itself; humans then interpret and act upon the device's numerical output. Therefore, yes, standalone performance (algorithm only) was assessed for each vital sign parameter.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for each parameter. However, for a vital signs monitor:

• Noninvasive Blood Pressure: Ground truth would typically be established by invasive blood pressure measurements (e.g., arterial line) or a highly accurate non-invasive reference standard (e.g., mercury sphygmomanometer with auscultation by trained observers), often performed simultaneously or sequentially with the device under test.
• Pulse Oximetry: Ground truth would typically involve co-oximetry of arterial blood samples.
• Predictive Temperature: Ground truth would likely be established by a continuous core body temperature measurement device or a highly accurate traditional thermometer (e.g., rectal probe for a set duration) against which the "predictive" algorithm's output is compared.

8. The Sample Size for the Training Set

The document does not specify any sample sizes for a "training set." This type of conventional "training set" concept is more common in modern machine learning-based devices. For this device, developed in the mid-1990s, the development process would have involved engineering design, calibration, and verification testing, rather than a distinct "training set" in the AI sense. The clinical studies mentioned serve as the validation evidence.

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

As no specific "training set" is described in the context of modern AI/ML development, the method for establishing ground truth for such a set is not applicable/described. The device's algorithms were likely developed and refined through engineering principles, calibration studies, and internal testing, with the clinical studies serving as external validation against observed clinical states (ground truth as described in point 7).

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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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