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The RTX3370 is for use in non-clinical settings (such as the home), as an accessory device that is intended to be a communication tool to enable health care providers to receive historical patient information. It is intended to be used in combination with a variety of external devices. The RTX3370 serves as the remote communication link between compatible external devices, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management centre or with the healthcare/wellness provider or other out of hospital caregivers. The purpose is to collect and transmit selected medical information (such as weight, blood pressure, blood glucose) over a normal residential telephone line.

The RTX3370 does not measure, interpret or make any decisions on the vital data that it conveys.

The RTX3370 telemedicine device performs transmission of physiological patient information to and from wireless, infrared and cabled patient monitors, and a remote data server healthcare facility using standard digital communication technologies and protocols. The RTX3370, with its build-in modem, transmits data using the public switched telephone network.

The RTX3370 screen, displays the information or questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons

The RTX3370 device is not used directly on a patient, and poses no significant risk to the patient or other people within the patient's home.

The provided text describes a 510(k) submission for the RTX3370 telemedicine device and its substantial equivalence to a predicate device (DLM112 Daylink Monitor, K062304). The submission focuses on demonstrating that the new device meets the same safety and effectiveness criteria as the predicate device, primarily through verification and validation activities guided by relevant standards, rather than a clinical trial with specific performance metrics.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

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

The document does not detail specific sample sizes for a "test set" in the context of a clinical performance study. The evaluation focused on verification and internal validation in contrast to "large scale validation in form of clinical investigation." Therefore, it's highly likely that the testing involved laboratory-based verification of compliance with established standards and internal validation protocols conducted by the manufacturer.

• Sample size: Not specified, as it was not a traditional clinical study but rather engineering verification and validation.
• Data provenance: Not explicitly stated, but given it's manufacturer-conducted verification and validation, it would be internal data from the company (RTX Healthcare, Denmark). The tests would be prospective in nature, as they are conducted on the device to prove compliance.

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 applicable and not provided in the document. The device is a physiological signal transmitter and receiver, a communication tool, and not a diagnostic device that interprets medical data or requires expert-established ground truth for its performance assessment in the way a diagnostic AI would. Its "performance" is assessed against technical standards and its ability to accurately transmit data, not against clinical expert interpretations of medical conditions.

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

Not applicable. This type of adjudication method is used in clinical studies, particularly in radiology or pathology, where human expert disagreement needs to be resolved for ground truth establishment. This is not relevant for the type of device and testing described.

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:

No, an MRMC comparative effectiveness study was not performed. This type of study would be relevant for AI-powered diagnostic or assistive tools where human performance is being evaluated and potentially augmented by AI. The RTX3370 is a communication device and does not involve "human readers" or "AI assistance" in the diagnostic sense.

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

The device itself is a "standalone" communication device in the sense that its primary function (data transmission) does not involve a human-in-the-loop for its direct operation. However, its purpose is to transmit data to healthcare providers. The performance data discussed relates to its compliance with technical standards (e.g., electrical safety, EMC, radio frequency emissions, telephone network connectivity) and internal validation of its communication functions. It's not an algorithm that performs a diagnostic task, so the concept of "standalone" performance for an algorithm isn't directly applicable in the same way as for AI.

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

The concept of "ground truth" for this device's performance relies on compliance with established technical and safety standards (e.g., IEC 60601-1, FCC Part 15, etc.) and successful execution of its intended communication functions as verified by internal testing. There is no biological or clinical "ground truth" (like pathology or outcomes data) involved for this specific type of device, as it does not make diagnostic or treatment decisions.

8. The sample size for the training set:

Not applicable. The RTX3370 is not an AI/ML device, so there is no "training set" in the context of machine learning.

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

Not applicable, as there is no training set.

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The Daylink 112 Monitor ("DLM112") is for use in non-clinical settings (such as the home), as an accessory device that is intended to be a communication tool to enable health care providers to receive historical patient information. It is intended to be used in combination with a variety of external devices. The DLM112 serves as the remote communication link between compatible external devices, 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 collect and transmit selected medical information (such as weight, blood pressure, blood glucose) over a normal residential telephone line.

The DLM112 Monitor does not measure, interpret or make any decisions on the vital data that it conveys.

The DLM112 telemedicine device performs transmission of physiological patient information to and from wireless, infrared and cabled patient monitors, and a remote data server healthcare facility using standard digital communication technologies and protocols. The DLM112, with its build-in modem, transmits data using the public switched telephone network.

The DLM112 screen, displays the information or questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons

The DLM112 device is not used directly on a patient, and poses no significant risk to the patient or other people within the patient's home.

Here's an analysis of the provided 510(k) summary regarding the DLM112 Daylink Monitor, focusing on acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance for DLM112 Daylink Monitor

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "Based on the fact that the performance comparison of the predicate device and the submission device show that the differences are minor and causes no harm to the user, and the fact that the intended use and indication for use is the same, it was early in the project decided to focus on verification and internal validation instead of large scale validation in form of clinical investigation."

Therefore, there was no "test set" in the context of a clinical study or a dataset of patient information as would be used for evaluating an AI/algorithm-driven device. The validation focused on engineering verification and internal functional testing of the device against established technical standards.

• Sample Size: Not applicable in the context of patient data. The "sample" would be the device itself and its components undergoing engineering and functional tests.
• Data Provenance: Not applicable. The validation was based on testing the hardware and software against technical standards, not on patient data.

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

Not applicable. As there was no clinical test set involving patient data for which "ground truth" (e.g., disease presence, measurement accuracy) needed to be established by experts, this information is not provided. The "ground truth" here is the adherence to technical specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

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

No. This device is a communication hub, not an AI/algorithm that assists human readers in interpreting medical images or data. Therefore, an MRMC study is not relevant and was not performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a conceptual sense, the "performance" described is standalone algorithm/device performance against technical specifications. However, it's crucial to understand that the DLM112 is a data transmission device, not an AI or diagnostic algorithm. Its "standalone performance" refers to its ability to reliably transmit data according to its design and industry standards, entirely without human intervention in the transmission process itself. The document states: "The DLM112 Monitor does not measure, interpret or make any decisions on the vital data that it conveys."

7. The Type of Ground Truth Used

The "ground truth" for the DLM112's performance is adherence to recognized engineering standards and regulatory requirements. This includes:

• IEC 60601-1 (general safety of medical electrical equipment)
• IEC 60601-1-2 (electromagnetic compatibility)
• FCC Part 15 (radio frequency emissions)
• FCC Part 68 (telecom network connections)
• ISO 14971:2000 (risk management processes)

The device's functionality (data transmission) was verified against these established technical benchmarks.

8. The Sample Size for the Training Set

Not applicable. The DLM112 is a hardware communication device with embedded software, not an AI model that requires a "training set" of data in the machine learning sense. Its functionality is based on programmed logic and communication protocols, not learned patterns from a dataset.

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

Not applicable. As there is no training set for an AI model, there is no ground truth established for it.

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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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