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The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, 48 hour, or longer period. These measurements are recorded in the monitor and may be transferred to Spacelabs ABP analysis systems.

The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor (Model 90217A) is a small, lightweight unit designed to take non-invasive blood pressure (NIBP) and heart rate (HR) measurements for a 24 hour, 48 hour, or longer period. These measurements are recorded in the monitor and may be transferred to Spacelabs ABP analysis systems.

The Model 90217A allows the use of an automated or manual inflation system, and utilizes the oscillometric NIBP measurement method. The pressure sensor signal is amplified, digitized by an analog to digital converter (ADC), and supplied to a microprocessor which has control of the pump and vent valve. Measurements are made during the stepwise deflation of the cuff. The Model 90217A NIBP and HR algorithms are identical to that of the predicate. Additionally, the NIBP patient cuffs used with the Model 90217A are the same as those used with the predicate. A block diagram of the Model 90217A is presented in Figure 2.

The Model 90217A is powered by three (3) "AA" alkaline or rechargeable NiCad batteries; there is no capability to connect the Model 90217A to AC mains power. A lithium battery is used to provide backup power for the Model 90217A memory. Both battery types need to be periodically replaced.

The Model 90217A is carried in a pouch that is strapped and/or belted to the side of the patient. NIPB and HR measurements are taken using a blood pressure cuff attached to the patients arm. This information is recorded in the monitor, and can be transferred over a modem link, or by direct connection, between the Model 90217A and one of the ABP analysis systems.

The provided text describes the Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor and its 510(k) premarket notification. However, it does not contain the specific details required to fully address all components of your request, particularly regarding acceptance criteria, the study design (sample sizes, ground truth establishment, expert qualifications), or comparative effectiveness studies.

The document indicates that "Performance Testing" was conducted in accordance with applicable standards and that the device "complies with its predetermined specification." This implies that acceptance criteria were met, but the specific criteria and the detailed performance results are not provided in the summary.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Information Missing: The document states that performance testing was done and that the device "complies with its predetermined specification." However, it does not provide a table specifying the acceptance criteria (e.g., accuracy, precision targets) or the detailed reported device performance against these criteria.

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

Information Missing: The document states that "Performance Testing" was conducted, but it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data).

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

Information Missing: This device is a blood pressure monitor, and the ground truth for blood pressure measurements is typically established by another, often invasive or highly calibrated, measurement method, not usually by "experts" in the sense of image interpretation. The document does not specify how ground truth was established for performance testing, nor does it mention any experts involved in defining ground truth.

4. Adjudication Method for the Test Set

Information Missing: As there is no mention of "experts" or a consensus process for ground truth establishment for a blood pressure monitor, an adjudication method is not applicable and is not mentioned.

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

No: The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more common for diagnostic imaging AI devices where human interpretation is a primary component. The device is an automated blood pressure monitor.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes (Implied): The device is an "Ambulatory Blood Pressure (ABP) Monitor" that "takes non-invasive blood pressure (NIBP) and heart rate (HR) measurements" and records them. It utilizes "oscillometric NIBP measurement method" and its "NIBP and HR algorithms are identical to that of the predicate." This description strongly suggests that the device operates in a standalone manner, with the algorithm performing the measurements without human intervention during the measurement process. The "Performance Testing" mentioned would assess this standalone performance.

7. Type of Ground Truth Used

Information Missing (Specifics): While not explicitly stated, for a non-invasive blood pressure measurement device, the implied ground truth for performance testing would typically be simultaneous measurements from a highly accurate reference standard, such as an intra-arterial blood pressure monitor or another highly validated non-invasive reference device. The document does not explicitly state the specific type of ground truth used.

8. Sample Size for the Training Set

Information Missing: The document states that the "NIBP and HR algorithms are identical to that of the predicate." This suggests that the algorithms themselves might not have undergone new "training" for this specific device, but rather are adopted from the predicate. If any new training was done, the sample size for the training set is not mentioned.

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

Information Missing: Given the statement that the algorithms are identical to the predicate, detailed information on how ground truth was established for the original training of those algorithms (if applicable) is not provided. If new training was performed for this device, then the method for establishing ground truth for the training set is not mentioned.

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The Spacelabs Medical Ultraview Digital Telemetry System, when used in conjunction with a Spacelabs Medical PCMS Patient Monitor or Ultraview Care Network, provides a means for the continuous monitoring of electrocardiographic signals in order to detect abnormal cardiac rhythms, including life-threatening events such as high and low heart rates, asystole, and ventricular fibrillation. Optionally, on adult patients, additional abnormal cardiac rhythms, such as ventricular runs, tachycardia, and ST segment deviations are detected.

The Ultraview Digital Telemetry System also provides a means for the episodic monitoring of noninvasive blood pressure (NIBP) signals to detect abnormal events such as high and low blood pressure. The System also provides a means for both continuous and episodic monitoring of pulse blood oxygen saturation signals in order to detect desaturation caused by abnormal pulmonary/circulatory functions.

The Spacelabs Medical Ultraview Digital Telemetry System Models 90343 and 90347 are intended for use with either adult or neonatal patient populations in a hospital environment. When the NIBP option is selected in the Model 90343 configuration, the NIBP feature is to be used with adult patient populations only.

The Ultraview Digital Telemetry System is a multiple parameter system which provides the capability for wireless central station monitoring of patients within hospitals or medical center facilities. This telecommunications feature converts bedside monitors to telemetry operation and works with a portable monitor for the transport of telemetricallymonitored patients to allow for the remote programming and data retrieval of clinical parameters specific to patient populations, clinical protocols, or operating preferences. Physiological parameters supported by the System are the acquisition and monitoring of electrocardiographic signals (ECG), pulse oximetric oxygen saturation (SpO2) and noninvasive blood pressure (NIBP) parameters, based upon the System configuration options selected by the clinician.

The devices subject to this submission are the Models 90343, 90347, and 90478. Each Ultraview Digital Telemetry System configuration consists of a battery-operated Telemetry Transmitter, a Receiver Module, and an antenna system. The Ultraview Digital Telemetry Multi-Parameter Transmitter Model 90343 is a wideband VHF unit that provides 5electrode ECG and continuous or episodic SpO2 monitoring capabilities, with an optional noninvasive blood pressure (NIBP) interface when connected to a Spacelabs Medical Model 90217Ambulatory Blood Pressure (ABP) Monitor (K855127). The Ultraview Digital Telemetry ECG Transmitter Model 90347 is identical to the Model 90343 with the SpO2 measurement function and ABP communications capabilities removed.

The Ultraview Digital Telemetry System interfaces to a patient using standard accessories including ECG electrodes and lead wires, NIBP hoses and cuffs, SpO2 cables and sensors, and adapter cables to connect these accessories to the Transmitter. The telemetry system sends raw ECG vectors or preprocessed SpO2 and NIBP data, based upon the capability of the selected Transmitter, to the VHF version of the Model 90478 Modular Receiver via a diversity antenna system.

The Modular Receiver collects and processes parameter specific physiologic data for alarm generation and display of numeric values and waveforms on a Spacelabs Medical Patient Care Management System (PCMS) Monitor or Ultraview Care Network via SDLC communications. The monitor provides the display, review, editing and analysis capabilities for the care provider. Hard copy records may be provided by the wide variety of Spacelabs Medical printers and recorders that can be interfaced by either Ethernet or SDLC communications.

Here's an analysis of the provided text regarding the Spacelabs Medical Ultraview™ Digital Telemetry System, focusing on acceptance criteria and study information:

Based on the provided text, a detailed breakdown of acceptance criteria and a study proving device performance is not explicitly present in the format requested. This document is a 510(k) Safety and Effectiveness Summary, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics against a ground truth.

However, I can extract the information that is available and highlight what is missing based on your request.

Missing Information/Why it's not present:

• Detailed Acceptance Criteria Table: The document describes the intended function of the device (detecting abnormal cardiac rhythms, NIBP events, SpO2 desaturation), but it does not specify quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy percentages) that the device must meet for each function.
• Reported Device Performance (Quantitative): Since quantitative acceptance criteria are not stated, reported performance metrics are also absent. The document asserts that the device will be subject to extensive testing and will meet functional requirements and specifications, but it doesn't provide the results of such tests here.
• Sample Size for Test Set, Data Provenance, Ground Truth Establishment for Test Set: There is no mention of a specific test set, its size, the origin of data, or how ground truth was established for this device. The document relies on substantial equivalence to predicate devices which presumably have undergone such testing.
• Number of Experts, Adjudication Method, MRMC Study, Standalone Performance, Type of Ground Truth (Test Set): These are all related to a specific clinical or performance study that is not detailed in this 510(k) summary. The document does not describe such studies for the Ultraview Digital Telemetry System.
• Sample Size for Training Set, Ground Truth Establishment for Training Set: As this is a traditional medical device (not explicitly AI/ML software), the concept of a "training set" in the context of machine learning is not applicable here. Even if it involved some algorithms, the document does not elaborate on a training phase or 'training data' in the modern AI sense.

Information that can be extracted or inferred:

1. A Table of Acceptance Criteria and the Reported Device Performance

Explanation: The "acceptance criteria" listed above are inferred from the stated "Indications for Use" and the "Testing" section. The document does not provide specific quantitative thresholds (e.g., "detect with 90% sensitivity"). The "Reported Device Performance" column reflects the statements made in the document about the device's design and planned testing, not actual performance data for this submission.

2. Sample size used for the test set and the data provenance:

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified. This document emphasizes substantial equivalence to existing predicate devices rather than presenting data from a new, specific clinical trial for this device.

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

• Not specified. (No specific test set or ground truth establishment described for this device in the provided text).

4. Adjudication method for the test set:

• Not specified.

5. 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:

• Not mentioned. This document describes a medical device, not a diagnostic AI system for medical image interpretation or a system that "assists human readers" in an interpretable way in the context of MRMC studies.

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

• The device is a "multiple parameter system which provides the capability for wireless central station monitoring." It performs automated detection of physiological events. Its intended use implies "standalone" detection for the parameters it monitors, but no specific "standalone performance study" in the modern sense (e.g., comparing algorithm output to human interpretation) is described as part of this submission. The device itself is the "standalone" component doing the monitoring and detection.

7. The type of ground truth used:

• Not explicitly stated for the new device. For predicate devices, it would typically involve clinical diagnosis, validated reference measurements, or expert clinical review for arrhythmia detection. This document implies that the device's functional integrity will ensure it aligns with the expected physiological measurements, rather than comparing its diagnostic output against a 'ground truth' in a clinical study for this 510(k).

8. The sample size for the training set:

• Not applicable/Not specified. This document describes a hardware/software system for physiological monitoring, not an AI/Machine Learning model that undergoes a training phase in the typical sense.

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

• Not applicable/Not specified. (See point 8).

Summary of the Study (Based on 510(k) statement):

The "study" described in the 510(k) summary is not a detailed clinical trial with quantified results, but rather a declaration of planned and ongoing testing.

• Device Under Review: Spacelabs Medical Ultraview™ Digital Telemetry System (Models 90343, 90347, 90478).
• Purpose of Testing: To ensure the device meets all its functional requirements and performance specifications, and complies with applicable industry and safety standards (e.g., ANSI/AAMI EC13 and AAMI ECAR-1987).
• Nature of Testing: "Extensive safety and performance testing prior to release," including "various performance tests" and "safety testing... performed by third party agencies."
• Conclusion: The submission concludes that the device "is as safe and effective as its predicate devices and raises no new issues," implying that the planned testing will confirm this.

In essence, this 510(k) submission primarily leverages the concept of substantial equivalence to predicate devices. It describes the device's functional capabilities and the commitment to conduct testing to ensure it performs as intended and meets relevant safety standards, rather than presenting the results of a specific, comprehensive clinical study.

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