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The Dash 3000/4000 Patient Monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash is designed as a bedside, portable, and transport monitor that can operate in all professional medical facilities and medical transport modes including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities, intra-hospital patient transport, interhospital patient transport via ground vehicles (i.e., ambulance, etc.) and fixed and rotary winged aircraft, and pre-hospital emergency response.

Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, oxygen, and anesthetic agents as summarized in the operator's manual.

The Dash 3000/4000 Patient Monitor is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital data at the point-of-care.

This information can be displayed, trended, stored, and printed.

The Dash 3000/4000 Patient Monitor was developed to interface with non-proprietary third party peripheral devices that support serial data outputs.

The Dash 3000/4000 Patient Monitor is a device that is designed to be used to monitor, display, and print a patient's basic physiological parameters including: electrocardiography (ECG), invasive blood pressure, non-invasive blood pressure, oxygen saturation, temperature, impedance respiration, end-tidal carbon dioxide, oxygen, nitrous oxide and anesthetic agents. Other features include arrhythmia, cardiac output, cardiac and pulmonary calculations, dose calculations. PA wedge. ST analysis, and interpretive 12 lead ECG analysis (12SL).

Additionally, the network interface allows for the display and transfer of network available patient data.

This document describes a 510(k) submission for a medical device and, as such, focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria in a clinical study for a novel AI algorithm. Therefore, many of the requested points, particularly those related to detailed study design, ground truth establishment, expert review, sample sizes for training/test sets, and comparative effectiveness studies with AI, are not applicable or cannot be extracted from this type of regulatory submission.

The submission primarily states that the device is "as safe, as effective, and performs as well as the predicate devices" based on compliance with voluntary standards and internal quality assurance measures.

Here's an attempt to answer the questions based on the provided text, noting where information is not available:

Acceptance Criteria and Device Performance (Based on available information)

Study Details

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: Not specified.
   • Data Provenance: Not specified. The document states "The Dash 3000/4000 Patient Monitor complies with the voluntary standards as detailed in Section 9 of this submission" and lists quality assurance measures, which would typically involve testing, but no details on specific test sets or study types (e.g., patient data, simulated data) are provided.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable. This is a traditional medical device (patient monitor) regulatory submission based on substantial equivalence to predicate devices and compliance with performance standards, not a specific AI/machine learning algorithm requiring expert-established ground truth for a test set in the same manner.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable for the reasons stated above.

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

   • Not applicable. The device is a physiological patient monitor, not an AI-assisted diagnostic tool that would typically undergo an MRMC study.

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

   • Not applicable. This is not an algorithm-only device; it's a patient monitor system. Its performance is inherent to the system's design and functionality in monitoring physiological parameters.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • Not explicitly stated in terms of a "ground truth" as it would be for an AI diagnostic device. The "ground truth" for a patient monitor's accuracy would typically be established through validation against validated reference devices or established physiological measurement standards during product testing, as implied by "compliance with voluntary standards" and "safety testing."

7. The sample size for the training set

   • Not applicable. This is not an AI/machine learning device that involves a "training set" in the conventional sense.

8. How the ground truth for the training set was established

   • Not applicable for the reasons stated above.

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The XRE Collimator with spectral filter is designed to be the primary X-ray beam limiting device as part of an angiographic imaging system and is controllable manually and automatically. It also provides a means of manual or automatic selection of filtration designed to reduce the xray dose applied to the patient while still providing high quality images. It is designed to be operated by professional medical personnel only.

Not Found

This document is a 510(k) clearance letter from the FDA for the "XRE Collimator with Spectral Filter" and an "Indications for Use Statement". It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth, or adjudication methods.

Therefore, I cannot provide the requested information based on the input text. The provided text only confirms that the device has received FDA clearance for marketing based on substantial equivalence to a predicate device.

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