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The Nonin Bluetooth® - enabled Model 4100 Patient Oximeter Module is indicated for use in measuring and transmitting functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and plethysmographic data to a compatible Bluetooth - enabled device.

Nonin's Model 4100 Bluetooth® - enabled wrist-worn Patient Oximeter Module measures and transmits SpO2, pulse rate, and plethysmographic data to a compatible Bluetooth - enabled device. The patient module includes a class II Bluetooth radio with a range of approximately 30 feet (spherical range). The 4100 Patient Oximeter Module is powered with two AA batteries, which last for approximately 120 hours when used continuously.

The provided text is a 510(k) summary for the Nonin Model 4100 Patient Oximeter Module. It states that the device has undergone "both bench and clinical testing in order to demonstrate that it has appropriate functional features and is substantially equivalent to the predicate device." However, the document does not provide specific details about the acceptance criteria or the specific study results proving the device meets those criteria.

Therefore, many of the requested details cannot be extracted from this document.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what cannot:

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

The document does not specify any quantitative acceptance criteria for device performance, nor does it present reported device performance in a table. It only states that functional and safety testing was performed and that the device is "substantially equivalent" to a predicate.

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

This information is not provided in the document. It only mentions "clinical testing."

3. 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)

This information is not provided in the document.

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

This information is not provided in the document.

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

This is not applicable as the device is an oximeter, not an AI-powered diagnostic tool requiring human reader interpretation improvements. The document describes a traditional medical device (pulse oximeter).

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

This is not applicable as the device is an oximeter, not an AI algorithm. Its performance is inherent to its function of measuring SpO2 and pulse rate.

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

This information is not explicitly provided. For pulse oximeters, the ground truth for SpO2 measurements typically involves co-oximetry blood gas analysis, but the document does not confirm this.

8. The sample size for the training set

This is not applicable as the device is a hardware medical device (pulse oximeter) and does not inherently involve a "training set" in the context of machine learning or AI.

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

This is not applicable for the same reasons as point 8.

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The RTX3320 device is for use by patients at home. It is intended to be used in combination with a variety of patient monitors upon the prescription of a licensed physician or other authorized healthcare provider. RTX3320 serves as the remote communication link between compatible patient monitors, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management center, or with the healthcare/wellness provider or other out-of-hospital caregivers.

The purpose is to transmit selected medical information (such as weight, blood pressure, blood glucose) over a normal residential telephone line.

RTX3320 is a "black box" device – it is not connected to the patient and not operated by the patient. The installation must be performed by or under supervision of an authorized professional healthcare company.

This device does not measure, interpret or make any decisions on the vital data that it conveys.

The RTX3320 telemedicine device perform transmission of physiological patient information to and from wireless patient monitors, and a remote data server healthcare facility using standard digital communication technologies and protocols.

The RTX3320, with its build-in modem, transmits data using the public switched telephone network. It is designed not to interfere with the normal use of phones on the same telephone line.

The RTX3320 device is not operated by, or used directly on a patient, and poses no significant risk to the patient or other people within the patient's home.

The RTX3320 device is a "black box" telemedicine device designed to transmit physiological patient information from wireless patient monitors to a remote healthcare facility using standard digital communication technologies and protocols. It uses a built-in modem to transmit data over the public switched telephone network. The device is not operated by or used directly on a patient and is not intended for emergency calls or time-critical data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify a distinct "test set" sample size or data provenance in terms of patient data or clinical cases for the RTX3320 device. The focus of the substantiation is on:

• Conformance to standards: This involves testing the device against specific technical and safety standards (IEC, FCC). These tests typically involve laboratory setups and simulated environments, not patient data sets.
• Comparison to a predicate device (K023749): The assessment largely relies on demonstrating substantial equivalence by comparing the technical characteristics, intended use, and safety profiles with an already cleared device.
• Verification and internal validation: The document states that "Verification and validation testing activities [were] conducted to establish performance and reliability characteristics of the device." This implies internal testing of the device's hardware, software, and communication capabilities, likely through engineering tests and non-clinical scenarios rather than a clinical "test set" with patient data.

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

Given that the substantiation is primarily based on standards conformance, risk management, and comparison to a predicate device, and not on the evaluation of medical images or diagnostic outputs from a clinical test set, there is no mention of experts establishing a "ground truth" for a test set in the traditional sense of clinical studies.

The "ground truth" in this context is established by:

• Regulatory bodies and standards organizations: The standards (IEC, FCC, ISO) themselves represent a form of "ground truth" for device safety and performance.
• Engineering and quality assurance personnel: Internal experts at RTX Healthcare would have conducted the verification and validation tests against these standards.
• The predicate device's established safety and effectiveness: The predicate device (Philips M3810A) serves as a benchmark for equivalence.

4. Adjudication Method for the Test Set

As there is no specific clinical "test set" involving human interpretation of medical data, there is no mention of an adjudication method (like 2+1 or 3+1). The "adjudication" is implicitly handled by the adherence to established engineering standards and regulatory requirements.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed and is not applicable to this device. The RTX3320 is a communication gateway, not a diagnostic or interpretive device. It explicitly states: "This device does not measure, interpret or make any decisions on the vital data that it conveys." Therefore, there is no human-in-the-loop performance to improve with or without AI assistance, and no effect size regarding human reader improvement is relevant.

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

A standalone performance study in the context of an algorithm's diagnostic accuracy was not performed and is not applicable. The device's primary function is data transmission, not data analysis or diagnosis. Its "performance" is assessed by its ability to reliably transmit data according to communication standards and safety requirements.

7. Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

• Compliance with recognized international and national standards (IEC, FCC): These standards define acceptable levels of safety, electromagnetic compatibility, and communication performance.
• Risk management principles (ISO 14971:2000): Ensures that identified risks are mitigated to acceptable levels.
• Substantial equivalence to a legally marketed predicate device: The functional and safety characteristics of the predicate device (Philips M3810A) serve as a benchmark for the RTX3320.
• Verification and internal validation testing: This involves engineering tests to confirm the device meets its design specifications and performs reliably in its intended environment.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. The RTX3320 is a hardware device designed for data transmission, not for machine learning or AI models that require training data.

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

Since there is no training set, this question is not applicable.

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