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The REACH Access Telemedicine Dose Calculator is designed for used by trained clinicians to calculate any individual patient's dose for a given agent based on a weight determined by the clinician. Drug dosing for a patient must be made only after careful consideration of the full clinical status of the patient by the ordering clinician and the software provides no validation as to the appropriateness of the entered weight-based dose. The REACH Access Telemedicine Dose Calculator is a convenience feature for trained clinicians based upon accurately entered data. No medical decision should be based solely upon the results provided by this software program. The REACH Access Telemedicine Dose Calculator is intended to be used as an aid in the consultative process and does not overrule or replace physician judgment or diagnosis.

REACH Access is a highly integrated Telemedicine solution that combines workflow, video conferencing, electronic clinical documentation, and medical imaging into a comprehensive and secure internet-based service. It enables healthcare organizations to form virtual collaborative care teams which are created based on patient need rather than availability of specialists. With a flexible, template-based design tool, REACH Access can build template sets which support clinician workflow and documentation relevant to numerous protocols. REACH Access templates support a specific point-in-time consult. This means the workflow processes and clinical content is captured and coordinated with the integrated audio/video conference to allow a remote provider to collaborate with caregivers at a different location in the care of a patient.

The normal process is the patient is assessed and treated in the Emergency Department (ED) by ED staff and the video conference support of a specialist consultant. After reviewing key patient data and assessing the patient, the remote consultant renders an impression, recommends the treatment order as indicated, and helps determine the appropriate disposition. This usually concludes the consultant's part in the session. The ED continues to render care by completing the recommended treatment order and monitoring patient vital signs and other assessments. The disposition commonly consists of transferring the originating hospital to the Hub with which the consultant is associated. However, if there is adequate local support, the decision may be made to admit the patient to the local facility.

This process/workflow is similar to what may be required for other point-in-time consults needed to provide additional remote assistance to caregivers for other patient problems or conditions at the patient point of care. A protocol/template can be part of a coordinated collection of toolsets. The flexible template design process in REACH Access addresses the need for multiple protocols to support the various phases of care. The flexibility of the tool allows for the unique presentation of data for a specific condition; e.g., stroke, in the format most relevant to the patient's current need/condition. This flexibility can be replicated to address similar capability. This can be handled through a combination of both individual and a series of protocols arranged in clinically logical groups.

This document is a 510(k) premarket notification decision letter from the FDA for the "REACH Access Telemedicine Dose Calculator." It focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria and results from an independent test set.

Therefore, most of the information requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not present in this document. This typically wouldn't be included in a 510(k) summary for devices like a dose calculator where the primary demonstration of safety and effectiveness relies on software verification and validation, and comparison to a predicate device with similar operational principles.

Here's what can be extracted and what cannot be from the provided text:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated as formal, quantitative acceptance criteria for a performance study. The core "acceptance" for this device is "substantial equivalence" to the predicate, based on its intended use, technological characteristics, and principles of operation, and that it raises "no issues of safety or effectiveness."
• Reported Device Performance: Instead of performance metrics from a clinical study, the document reports "Validation and Verification" was done. The conclusion states "The performance of the REACH Access Telemedicine Dose Calculator is substantially equivalent to that of the Picis Weight Based Dose Converter and raises no safety or effectiveness issues and performs as well or better than the predicate device."
  • Implication: For a dose calculator, "performance" would primarily relate to the accuracy of its mathematical calculations. The mention of "Validation and Verification" suggests that the software was tested to ensure it correctly computes doses based on the input weight and dose rate, as per its simple mathematical equation. However, no specific numerical performance results (e.g., error rates, precision) are provided.

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

• Sample Size (Test Set): Not mentioned. "Validation and Verification" for a software like a dose calculator typically involves testing a defined set of inputs and expected outputs, not a "sample size" in the sense of patient data in a clinical trial.
• Data Provenance: Not applicable in the context of this device type and the information provided. The "data" being processed is clinician-entered weight.

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

• Number of Experts: Not applicable. Ground truth for a mathematical calculation is the correct mathematical result, not expert interpretation.
• Qualifications of Experts: N/A

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

• Adjudication Method: Not applicable.

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:

• MRMC Study: No. This is not an AI-assisted diagnostic imaging device. It's a simple dose calculator.

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

• Standalone Performance: For a dose calculator, the "standalone performance" refers to its mathematical accuracy. While "Validation and Verification" implies such testing was done, no specific results or methods are detailed in this summary. The device's function is purely algorithmic: "Uses simple mathematical equation to calculate dosing based on patient weight."

7. The type of ground truth used:

• Ground Truth: For a drug dose calculator, the ground truth would be the quantitatively correct mathematical dose calculation based on the entered weight and the specified drug dose per unit weight (which the clinician determines). This ground truth is derived from the fundamental mathematical operations the calculator performs.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This device is not an AI/ML model that requires a training set. It is a rule-based software performing a direct calculation.

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

• Ground Truth for Training Set: Not applicable as there is no training set for this type of device.

Summary of what is present in the document relevant to your query:

• The device is a "REACH Access Telemedicine Dose Calculator."
• Its purpose is to "calculate any individual patient's dose for a given agent based on a weight determined by the clinician."
• The calculation "Uses simple mathematical equation to calculate dosing based on patient weight."
• The study done was "Validation and Verification" (which for such a device implies testing the accuracy of the calculation).
• The primary method of demonstrating legitimacy was to show "Substantial Equivalence" to a predicate device (Picis Weight Based Dose Converter, K121542), meaning it has the "same intended uses, technological characteristics and principles of operation."

This document does not describe the kind of performance study one would expect for an AI/ML diagnostic or prognostic device, but rather a software validation process for a simple calculation tool.

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