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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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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 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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