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The 9303 Neonatal/ Adult Vital Signs monitor is indicated for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adult, pediatric and neonatal patients in the care of health care professionals.

The 9303 Neonatal / Adult Vital Signs Monitor is a prescription device intended for use only by health care professionals.

The monitor is designed to monitor and spot check adult, pediatric and neonatal patients for blood pressure, oxygen saturation, pulse and temperature noninvasively in a variety of clinical settings.

The monitor is portable, lightweight, and durable. The user selects either the adult or neonatal application for NIBP. Power is supplied by an internal lead acid rechargeable battery. The battery is charged by plugging monitor to an AC power source. Information is displayed in an easy to read LED display. NIBP Readings may be taken manually, or at automatic, operator selected intervals. A STAT mode is available for a rapid series of NIBP measurements. A message center display provides system alarm messages, operating modes, battery state and troubleshooting prompts. A history mode displays previous NIBP and Sp02 readings which can be sent to an optional printer. The monitor can operate in one of four languages which the operator may change. There are NIBP and Sp02 patient alarms to warn the user of any measurement parameter outside the range of a user set or factory default value. A test mode may be activated to test for pneumatic leaks and calibration. The predictive temperature function may be either oral, axillary or rectal with appropriate probe.

The 9303 monitor is year 2000 compatible. The monitor includes a time stamp function for the printout of NIBP values and a history function in non-volatile memory. The history function is a short term (hours) storage and is not effected by yearly changes. The monitor will show the year 2000 as "00". Accounting for leap year is not a problem.

Here's an analysis of the provided 510(k) summary regarding the CAS Medical Systems, Inc. 9303 Neonatal/Adult Vital Signs Monitor, structured to answer your questions.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary provides a high-level overview of clinical performance criteria met, rather than detailed numerical acceptance criteria and reported device performance for each parameter. However, based on the information provided, we can infer the following:

Important Note: The document does not provide the specific numerical thresholds for "meeting clinical performance criteria" or "passing clinical accuracy testing." These standards (AAMI/ANSI SP10, etc.) would contain those detailed metrics.

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

The 510(k) summary does not explicitly state the sample sizes used for the clinical tests for NIBP, Pulse Oximetry, or Predictive Thermometer.

Regarding data provenance:

• The document implies that the clinical testing for the NIBP component was conducted on the 9303 device itself.
• For Pulse Oximetry (Nonin®) and Predictive Thermometer (SureTemp®), the document states that these "components" have passed clinical testing, suggesting that the clinical data supporting these components may have originated from the manufacturers of those specific technologies (Nonin Medical, Inc. and Welch Allyn, Inc.), likely from their own regulatory submissions. It does not state if new clinical tests were performed on the integrated 9303 device specifically for these components beyond what their original manufacturers may have provided.
• The provenance (e.g., country of origin, retrospective/prospective) for any of these clinical tests is not specified.

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

The 510(k) summary does not provide information on the number of experts or their qualifications used to establish ground truth for any of the clinical tests mentioned.

4. Adjudication Method for the Test Set

The 510(k) summary does not provide information on any adjudication method used for the clinical tests.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the 510(k) summary. This type of study is typically associated with imaging devices where human interpretation is a primary outcome, which is not the case for a vital signs monitor.

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

The device itself is a standalone system for measuring vital signs. The clinical tests described (meeting AAMI/ANSI SP10, SpO2 accuracy, thermometer accuracy) are inherently assessments of the algorithm/device-only performance without human intervention during the measurement process, other than a healthcare professional initiating the measurement. So, in essence, the "standalone" performance is what was tested.

7. The Type of Ground Truth Used

Based on the nature of vital signs monitoring devices:

• Non-invasive Blood Pressure (NIBP): For AAMI/ANSI SP10 compliance, ground truth is typically established by invasive arterial blood pressure measurements (for accuracy testing) or by reference oscillometric devices that themselves have been validated against invasive methods.
• Pulse Oximetry (SpO2): Ground truth for SpO2 accuracy testing is traditionally established using co-oximetry (blood gas analysis) on arterial blood samples, with induced hypoxemia in human volunteers.
• Predictive Thermometer: Ground truth for thermometer accuracy is established by continuous core body temperature measurements (e.g., rectal, esophageal, or pulmonary artery catheter) using highly accurate reference thermometers.

The document only states that the components "passed clinical accuracy testing" or "meets clinical performance criteria," implying the use of established ground truth methods for these physiological parameters.

8. The Sample Size for the Training Set

The 510(k) summary does not mention any "training set." This term is usually relevant for machine learning or AI-driven devices. As this device predates widespread AI in medical devices (1998) and relies on established physiological measurement technologies (oscillometry, oximetry, thermistors), there would not typically be a distinct "training set" in the modern sense. The "training" of such devices would be inherent in their engineering design, calibration, and validation against physical and physiological models.

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

Since no training set is mentioned in the context of machine learning/AI, this question is not applicable based on the provided document. The device's underlying technologies (oscillometry, oximetry, thermistors) are based on well-understood physical principles and established calibration standards, rather than statistical models trained on large datasets.

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