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The DINAMAP® Pro Series 100, 200, 300, 400 Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital or ground transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate and/or oxygen saturation (pulse oximetry). The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor and delivery, endoscopy, cardiac step-down. It can also be used in satellite areas, physicians' offices, or alternate care settings.

The DINAMAP Pro Monitor, Series 100, 200, 300, 400 is a prescription device intended for use only by health care professionals. Four configurations of the monitor - all with an integrated printer - will offer the following vital signs parameters: . DINAMAP Pro Series 100: Non-Invasive Blood Pressure and Pulse Rate - DINAMAP Pro Series 200: Non-Invasive Blood Pressure and Monitor/Predictive Oral/Rectal . Temperature - . DINAMAP Pro Series 300: Non-Invasive Blood Pressure and Nellcor® Pulse Oximetry and Pulse Rate - . DINAMAP Pro Series 400: Non-Invasive Blood Pressure and Pulse Rate; Monitor/Predictive Oral/Rectal Temperature; and Nellcor® Oxygen Saturation and Pulse Rate (Pulse Oximetry) This portable device includes an integrated printer and is capable of operation from an external AC mains power source or an internal lead-acid rechargeable battery. The device uses the same technology and materials as the predicate devices, the DINAMAP MPS™ Select™ Multiparameter System (K955113 cleared 8/15/96); the DINAMAP MPS™ Select™ Portable Monitor (K971569 cleared 9/19/97); and the DINAMAP® Compact Monitor (K970182 cleared 8/18/97).

Here's a breakdown of the acceptance criteria and study information for the DINAMAP® Pro Monitor, Series 100, 200, 300, 400, based on the provided text:

Acceptance Criteria and Device Performance for DINAMAP® Pro Monitor

1. Table of Acceptance Criteria and Reported Device Performance

This device combines multiple physiological monitoring functionalities. The acceptance criteria and performance are detailed for each major component: Non-Invasive Blood Pressure (NIBP), Oxygen Saturation (SpO2), and Temperature.

2. Sample Size and Data Provenance

• NIBP:

  • Clinical Study for Accuracy (predicate device): The text states accuracy was established in "adult, pediatric, and neonatal populations." It references the DINAMAP MPS Select NIBP Module, but does not provide specific sample sizes for these populations in the current document.
  • Data Provenance: Not explicitly stated, but the studies were for a U.S. market device, so likely at U.S. clinical sites. The studies for the predicate device would have been prospective clinical trials.

• SpO2:

  • Co-Oximeter Correlation Study: 3 healthy subjects.
  • Non-Invasive Controlled Hypoxia Study: 35 subjects.
  • Data Provenance: Not explicitly stated, but conducted by Nellcor Puritan Bennett, Inc. (NPB), a U.S. company. Likely prospective studies.

• Temperature:

  • Clinical Study: 78 subjects (adult and pediatric).
  • Data Provenance: In-house study conducted by Critikon. Likely prospective.

3. Number of Experts and Qualifications for Ground Truth

• The document primarily references standards (ANSI/AAMI, ASTM) and reference devices (co-oximeter, mercury-in-glass thermometer, IVAC 2080 Measurement System) for establishing ground truth, rather than human experts making subjective assessments for the purpose of algorithm validation directly.
• For NIBP, the ground truth would have been established by invasive arterial blood pressure measurements (gold standard for NIBP validation) during the predicate device trials. The document doesn't specify the number or qualifications of clinicians involved in those ground truth measurements, but it would have been standard clinical practice.
• For SpO2, arterial blood oxygen saturation co-oximeter measurements serve as the ground truth. These are objective measurements; no human experts are mentioned for establishing this ground truth.
• For Temperature, mercury-in-glass thermometers and the Alaris Medical Systems IVAC® 2080 Measurement System served as the reference standards for ground truth. Again, these are objective measurement devices, not subjective assessments by human experts.

4. Adjudication Method

• NIBP, SpO2, Temperature: The validation relies on comparisons against established objective reference standards and devices (e.g., co-oximeters, mercury thermometers, invasive BP for NIBP in predicate). Therefore, there is no mention of an adjudication method involving multiple human experts for subjective assessment as would be common in image interpretation studies. The "adjudication" is inherent in the comparison of the device reading to the objective reference standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a MRMC comparative effectiveness study was not explicitly mentioned or performed for this device. The studies described are focused on standalone device accuracy against objective standards, not on how human readers interact with or improve using AI assistance, as this is a vital signs monitor, not an AI-driven interpretive system.

6. Standalone Performance Study

• Yes, standalone performance studies were done for all parameters.
  • NIBP: Accuracy was established for the NIBP algorithm itself, which is incorporated into the device. The clinical study for accuracy, although done on a predicate, validates the algorithm in a standalone manner.
  • SpO2: Clinical and bench tests directly evaluated the accuracy of the oxygen saturation parameter of the new device against reference standards.
  • Temperature: Both monitor and predictive modes were tested for accuracy against reference standards in liquid baths and clinically against a mercury-in-glass thermometer.

7. Type of Ground Truth Used

• NIBP: For the predicate device studies, the ground truth for NIBP accuracy would have been invasive arterial blood pressure measurements.
• SpO2: Arterial blood oxygen saturation co-oximeter measurements (objective laboratory measurements).
• Temperature: Mercury-in-glass thermometer and the Alaris Medical Systems IVAC® 2080 Measurement System (objective reference devices/standards).

8. Sample Size for the Training Set

• This device is a traditional physiological monitor, not an AI/machine learning device in the modern sense that typically relies on "training sets." The NIBP algorithm is based on established oscillometric principles. Therefore, there is no specific "training set" sample size mentioned or applicable in the context of an AI/ML model for this type of device. The algorithm and device were likely developed and refined using R&D data, but not in the format of a distinct "training set" for an AI model.

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

• As there is no explicit "training set" in the AI/ML sense, this question is not directly applicable. The underlying principles and algorithms for NIBP, SpO2, and temperature are based on well-understood physiological measurements and engineering principles, validated against established medical standards and reference measurements. Development of these algorithms would involve extensive testing and refinement against known accurate measurements, but not in a "ground truth for training set" paradigm.

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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 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 modified DINAMAP MPS® Select® Portable Monitor device description is identical to the currently-marketed device. The difference between the two devices lies only in the electromagnetic compatibility (EMC) emissions classification. The modified Portable Monitor meets CISPR 11 Class A emissions requirements; the original Portable Monitor met CISPR 11 Class B emissions requirements. All other EMC specifications remain unchanged.

The provided text describes a 510(k) premarket notification for a medical device, the DINAMAP MPS® Select® Portable Monitor. This submission primarily focuses on demonstrating substantial equivalence to a predicate device, with the key difference being a change in electromagnetic compatibility (EMC) emissions classification.

Therefore, the information traditionally associated with acceptance criteria performance studies for novel medical devices (like those involving clinical trials, statistical performance metrics, or ground truth establishment) is not present in this document. The "study" here is specifically related to EMC testing.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this specific 510(k) submission are related to electromagnetic compatibility (EMC) emissions.

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

• Sample Size: A "fully configured modified DINAMAP MPS® Select® Portable Monitor" was tested. This indicates a single or a small number of physical units, not a patient sample size in a clinical sense.
• Data Provenance: The testing was performed by an "ANSI-certified test facility." The country of origin of the data is not specified beyond that. The data is prospective for this specific modification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This concept is not applicable here. EMC testing involves objective measurements against established technical standards (CISPR 11 Class A), not qualitative assessment by human experts.

4. Adjudication Method for the Test Set

Not applicable. EMC testing is based on engineering measurements, not expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. The submission is for an updated version of an existing vital signs monitor, with the only change being an EMC classification, not a change in clinical algorithms or human-machine interface that would warrant such a study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is a monitor, and its "performance" in this context is its adherence to EMC standards, not an algorithm's diagnostic or predictive capability. Its function is to display vital signs, which inherently involves human interpretation.

7. The Type of Ground Truth Used

The "ground truth" for this submission is adherence to the technical standard CISPR 11 Class A for electromagnetic emissions.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device requiring a training set. The device's functionality is based on established physiological monitoring principles and electrical engineering.

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

Not applicable, as there is no training set for this type of device modification.

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The OBSERVER Central Station with ST-segment measurement is a prescription device intended for use only by health care professionals. The device is used for the remote monitoring of physiological parameters, including non-invasive and invasive blood pressure; invasive hemodynamic and intracranial pressures; oxygen saturation via pulse oximetry; temperature; ECG ; and pulse/heart rate of adult, pediatric and neonatal patients. The device is located at a distance from the patient but within the same facility, including settings such as hospital and outpatient services, including general medical/surgical, critical care, intermediate/step-down care, emergency room, radiology, labor and delivery, operating and recovery room, cardiac catheterization lab, endoscopy and same-day surgery.

Arrhythmia detection and ST-segment measurement are optional ECG features limited to the adult population. ST-segment measurement is contraindicated in paced patients. The ST-segment feature of the OBSERVER Central Station provides for the measurement of the ST-segment level and slope of the ECG waveform, alerting the clinician to ST-segment changes. The significance of ST-segment changes must be determined by a clinician. The device is not designed, sold or intended for use except as indicated.

The OBSERVER Central Station with ST-segment measurement is an optional feature of the OBSERVER Central Station with arrhythmia analysis. This feature allows for the measurement of the ST-segment level and slope and the issuance of alarms for ST elevations and depressions. The clinician may adjust certain waveform points and alarm priority and limits or rely on default settings for each patient to be analyzed.

The OBSERVER Central Station (K933404) is a PC-based monitoring system designed to provide remote surveillance with alarms, trending and retrieval of wave-form and numeric physiological data for up to 8 patients who are monitored via various DINAMAP* Physiological Monitors or other appropriate bedside/patient monitors.

The OBSERVER Central Station displays, records and stores physiological data including ECG, non-invasive and invasive blood pressure, heart rate, temperature and pulse oximetry. The system is designed to be used with a hardwire interface using RS 232; wireless connectivity using 900 MHz spread spectrum or fixed frequency; or VHF (174-216 MHz, TV channels 7 through 13), including patient-worn telemetry. Monitors that may be networked with the OBSERVER Central Station for ECG include members of the Johnson & Johnson Medical Inc. DINAMAP* family of monitors, such as the DINAMAP MPS* Select* Monitor (K955113) and the DINAMAP* PLUS Monitor (K943709 and K912188), and patient-worn ECG VHF telemetry (VitalCom, Inc. K942147). The OBSERVER Central Station uses a Pentium PC with an SVGA, touch or non-touch, color monitor. Recordings can be made on either the built-in two-channel thermal recorder or with an optional HP LaserJet* Printer. Also optional is full disclosure (history) of all waveforms.

The OBSERVER* Central Station with ST-segment measurement is a continuous monitoring device. The device was found to be substantially equivalent to the currently marketed OBSERVER Central Station with arrhythmia analysis (K933404) and the ST-segment measurement feature of the VitalCom, Inc. VCOM Central Monitor (K942147).

1. Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical acceptance criteria for each performance metric. It mentions that the software was "tested against" databases to "measure" the algorithm's performance. The conclusion states that the modified device is "safe, effective and substantially equivalent" to predicate devices.

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

• Sample Size: Not explicitly stated, as the document refers to "AHA and MIT databases" and the "European ST-T database." These are established public databases containing numerous ECG recordings.
• Data Provenance: The databases used are:
  • AHA (American Heart Association) database
  • MIT (Massachusetts Institute of Technology) database
  • European ST-T database
    These are generally retrospective, publicly available datasets for ECG algorithm testing, often compiled from various clinical sources. The specific country of origin for each sample within these databases is not detailed in this summary, but they are recognized international benchmarks.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not specify the number of experts or their qualifications for establishing the ground truth within the AHA, MIT, or European ST-T databases. These databases are typically curated with expert-validated annotations, but the details of that validation process are external to this 510(k) summary.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for the test set as part of this submission. The ground truth for the databases is assumed to be established by the curators of those databases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned for this device. The regulatory submission focuses on the algorithm's performance against standard databases and its substantial equivalence to predicate devices, not on human-in-the-loop performance improvement.

6. Standalone (Algorithm Only) Performance:

Yes, a standalone performance evaluation was done. The "Performance" section explicitly states that "The ST-enabled arrhythmia analysis software was tested against the AHA and MIT databases" and "The algorithm was also tested against the European ST-T database." This indicates an algorithm-only performance evaluation.

7. Type of Ground Truth Used:

The ground truth used is implied to be expert-annotated ECG waveforms from established public databases (AHA, MIT, European ST-T). These databases typically provide reference annotations for QRS complexes, arrhythmias, and ST-segment changes, which are considered the ground truth for evaluating such algorithms.

8. Sample Size for the Training Set:

The document does not specify the sample size for the training set. It focuses on the validation of the algorithm against known test databases.

9. How the Ground Truth for the Training Set Was Established:

The document does not describe how the ground truth for any training set was established. Given that the software was developed by VitalCom, Inc. (who also developed the ST-segment software for a predicate device), it's likely they used proprietary or established datasets for training, with ground truth established through expert review, but this is not detailed in the 510(k) summary.

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