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Confidant 2.6 is intended for personal use by out-of-hospital patients as a means to retrospectively collect and record physiologic measurements from home monitoring devices (including blood glucose meters, blood pressure cuffs and weight scales). The data is transmitted to a database server where customized messages are generated by the system and returned to the patient. The returned messages contain objective observations and motivational information intended to help the patient better understand and manage their health.

Confidant 2.6 is an accessory device that collects data from a range of supported home-monitoring devices. The data is collected from the supported devices and sent to a central database server, using standard communication technologies. Upon receipt of newly submitted patient data, the Confidant Server software will generate and send one or more feedback messages directly to the patient, via cell-phone or personal computer. The feedback messages are selected by the system based on the patient's currently submitted and recent historic data.

Confidant 2.6 does not provide diagnosis of any disease or medical condition.

Confidant 2.6 is not intended to provide automated treatment decisions, or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

Confidant 2.6 is not intended for emergency calls or for transmission or indication of any real-time alarms or time-critical data. This device is not intended as a substitute for direct medical supervision or emergency intervention.

Confidant 2.6 is intended for over-the-counter use.

Confidant 2.6 is an accessory device that collects data from a range of supported home-monitoring devices. The data is collected from the supported devices and sent to a central database server, using standard communication technologies. Upon receipt of newly submitted patient data, the Confidant Server software will generate and send one or more feedback messages directly to the patient, via cell-phone or personal computer. The feedback messages are selected by the system based on the patient's currently submitted and recent historic data. Confidant 2.6 currently supports several models of glucose meters, a non-invasive blood pressure cuffs and a weight scale.

Here's an analysis of the provided text regarding the Confidant 2.6 System, focusing on acceptance criteria and supporting studies:

The provided 510(k) summary for the Confidant 2.6 System primarily focuses on demonstrating substantial equivalence to a predicate device (Confidant 2.5, K072698) rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel AI/algorithm.

Therefore, much of the requested information (like specific performance metrics for an AI, sample sizes for training/test sets, expert qualifications, MRMC studies, stand-alone performance, and detailed ground truth establishment) is not present in this document because the device is a data collection and messaging system, not an AI for diagnosis or interpretation of medical images/signals.

However, I will extract what is available and indicate when information is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

• Performance within specifications and functional requirements. | "The test results demonstrate that Confidant 2.6 is in compliance with the applied standards and that it performed within its specifications and functional requirements." |
  | Device Compatibility | - Compatibility with supported home monitoring devices (glucose meters, blood pressure cuffs, weight scales), including new devices like the OMNIS glucose meter. | "low-level, device compatibility verification for the OMNIS glucose meter."
  "Confidant 2.6 currently supports several models of glucose meters, a non-invasive blood pressure cuffs and a weight scale." |
  | Technological Equivalence| - Same types of supported monitoring devices as predicate.
• Same operational features as predicate.
• Same fundamental technology as predicate. | "Confidant 2.6 utilizes the same technology as the predicate device (Confidant 2.5, K072698) including: The same types of supported monitoring devices, The same operational features, The same fundamental technology." |
  | Safety and Effectiveness | - As safe and effective as the legally marketed predicate device. | "it is our conclusion that Confidant 2.6 is as safe, as effective and performs as well as the legally marketed predicate device." |

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

The document does not specify a distinct "test set" sample size in the context of typical AI/algorithm evaluation (e.g., number of patients, images, or data points). The testing described is "functional performance testing of the new PC Interface software component, and low-level, device compatibility verification for the OMNIS glucose meter." This suggests hardware/software integration and basic functionality checks rather than a clinical performance study with a patient data test set.

• Sample size for test set: Not specified beyond general "testing" of the PC Interface and OMNIS glucose meter.
• Data provenance: Not specified. Given the nature of the device (collects data from home monitoring devices and sends messages), the "data" being tested would likely be simulated or actual readings from these monitoring devices to verify correct transmission and message generation. It's not a study on patient outcomes or disease detection.

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

Not applicable/Not provided. The Confidant 2.6 System is not an AI diagnostic device that requires expert-established ground truth for medical conditions. Its function is to collect data, transmit it, and generate pre-defined motivational messages based on that data. The "ground truth" for its testing would involve verifying that the data is transmitted correctly and that the appropriate messages are triggered under specific data conditions, which does not require medical experts for truth establishment in the traditional sense.

4. Adjudication Method for the Test Set

Not applicable/Not provided. Since there's no expert clinical ground truth being established for diagnostic accuracy, there's no need for an adjudication method. Testing would involve engineering validations (e.g., does data transfer correctly, are messages generated as expected).

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

No. An MRMC study is used to assess the diagnostic performance of a system (often an imaging CADx system) by comparing multiple human readers with and without AI assistance on multiple cases. The Confidant 2.6 is a data collection and messaging system, not a diagnostic AI that assists human readers.

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

The device's core functionality is standalone in terms of data collection and message generation. However, it's not an "algorithm only" device in the sense of making diagnostic or treatment decisions. It automates information flow and feedback messages, but explicitly states: "Confidant 2.6 does not provide diagnosis of any disease or medical condition." and "Confidant 2.6 is not intended to provide automated treatment decisions, or to be used as a substitute for professional healthcare judgment."

The performance evaluation described ("functional performance testing of the new PC Interface software component, and low-level, device compatibility verification for the OMNIS glucose meter") is essentially a standalone test of its stated functions.

7. The Type of Ground Truth Used

For the described testing, the "ground truth" would be:

• Expected data transmission: Verification that data from home monitors is accurately received by the server.
• Expected message generation: Verification that the system generates the correct pre-defined feedback messages based on the received data, according to its internal logic.
• Compatibility verification: That the device successfully interfaces with and collects data from specified home monitoring devices (e.g., OMNIS glucose meter).

This is a form of functional/technical validation rather than medical ground truth (e.g., pathology, outcomes).

8. The Sample Size for the Training Set

Not applicable/Not provided. The Confidant 2.6 is not an AI device developed using machine learning that requires a "training set" in the conventional sense. It's a rules-based system that processes data and generates messages based on pre-programmed logic rather than learning from data.

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

Not applicable/Not provided. As there is no training set mentioned, this information is not relevant to the described device.

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Confidant 2.5 is intended for personal use by out-of-hospital patients as a means to retrospectively collect and record physiologic measurements from home monitoring devices (including blood glucose meters, blood pressure cuffs and weight scales). The data is transmitted to a database server where customized messages are generated by the system and returned to the patient. The returned messages contain objective observations and motivational information intended to help the patient better understand and manage their health.

Confidant 2.5 is an accessory device that collects data from a range of supported home-monitoring devices. The data is collected from the supported devices and sent to a central database server, using standard wireless technologies. Upon receipt of newly submitted patient data, the Confidant Server software will generate and send one or more feedback messages directly to the patient's cell-phone. The feedback messages are selected by the system based on the patient's currently submitted and recent historic data.

Confidant 2.5 does not provide diagnosis of any disease or medical condition.

Confidant 2.5 is not intended to provide automated treatment decisions, or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

Confidant 2.5 is not intended for emergency calls or for transmission of any real-time alarms or timecritical data. This device is not intended as a substitute for direct medical supervision or emergency intervention.

Confidant 2.5 is intended for over-the-counter use.

Confidant 2.5 is an accessory device that collects data from a range of supported home-monitoring devices. The data is collected from the supported devices and sent to a central database server, using standard wireless technologies. Upon receipt of newly submitted patient data, the Confidant Server software will generate and send one or more feedback messages directly to the patient's cell-phone. The feedback messages are selected by the system based on the patient's currently submitted and recent historic data.

Confidant 2.5 currently supports several models of glucose meters, noninvasive blood pressure cuffs and weight scales.

The provided text describes the Confidant 2.5 system, its intended use, and its equivalence to predicate devices, but it does not contain information about specific acceptance criteria or an explicit study proving performance against those criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on:

• Same supported monitoring devices
• Same operating features
• Same fundamental technology

The "Discussion of functional and safety testing" section (page 2) states:
"Testing of Confidant 2.5 included electrical safety and EMC testing of the Confidant Connector component; software testing of the Confidant Collector and Confidant Server components; and low-level, device compatibility testing with each of the supported monitoring devices. The test results demonstrate that Confidant 2.5 is in compliance with the applied standards and that it performed within its specifications and functional requirements."

This general statement asserts that the device met its specifications and functional requirements, but it does not define what those specifications or functional requirements were (i.e., the acceptance criteria), nor does it provide details about the study methodology, sample sizes, or outcome metrics.

Therefore, I cannot populate the requested table or answer most of the questions as the specific details are not present in the provided text.

Here's what can be inferred or explicitly stated based on the text, with the understanding that key details for many points are missing:

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

2. Sample sized used for the test set and the data provenance

• Sample size for test set: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective).

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, as this device primarily involves data collection and messaging, not interpretation requiring expert ground truth in the traditional sense (e.g., for image analysis or diagnosis). The testing described is functional and safety-oriented.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set

• Not applicable, as the testing described is functional and safety-oriented, not involving subjective interpretation requiring adjudication.

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 done. The device is a data collection and messaging system, not an AI-assisted diagnostic tool for human readers.

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

• The software testing of the Confidant Collector and Confidant Server components could be considered a form of standalone performance evaluation for the algorithmic aspects (e.g., data processing, message generation). However, specific metrics, methodology, and results for "standalone performance" in a quantitative sense (like accuracy, sensitivity, specificity) are not provided. The conclusion statement vaguely refers to "performance testing."

7. The type of ground truth used

• For electrical safety, EMC, and device compatibility, the "ground truth" would be established by relevant engineering standards and physical verification methods. For software, it would be its design specifications and functional requirements. There is no mention of expert consensus, pathology, or outcomes data in the context of this device's testing.

8. The sample size for the training set

• Not applicable. This document describes a traditional medical device (data collector/messenger) and its testing for 510(k) clearance, not an AI/ML-based diagnostic device that typically involves training data sets. While it selects messages based on "currently submitted and recent historic data," this refers to patient data for operational use, not a separate "training set" for model development in the context of a performance study.

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

• Not applicable, as no training set (in the AI/ML context) is described.

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Confidant 2.0 is intended to be used by out-of-hospital patients as a means to collect and transmit medical measurements (such as blood glucose level, weight, and blood pressure) to their healthcare provider and to receive returned educational and motivational messages to help them better understand and manage their chronic condition. Confidant 2.0 is to be used only upon prescription of a licensed physician or other authorized healthcare provider.

Confidant 2.0 is not intended for emergency calls or for transmission or indication of any real-time alarms or time-critical data. This device is not intended as a substitute for direct medical supervision or emergency intervention.

Confidant 2.0 is not intended to provide automated treatment decisions, or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

Confidant 2.0 is an accessory device that collects data from a range of supported measurement devices. The data is collected and sent using standard wireless technologies and maintained on an associated database server located within the healthcare facility. Based on patient specific parameters set by the healthcare provider, educational and motivational messages are returned to the patient. Confidant 2.0 currently supports several models of glucose meters, non-invasive blood pressure cuffs and weight scales.

The Confidant 2.0 device is a physiological transmitter and receiver that collects and transmits medical measurements to a healthcare provider and provides educational and motivational messages to the patient.

Here's an analysis of the acceptance criteria and study information based on the provided text:

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

The provided text does not explicitly state specific, quantifiable acceptance criteria such as accuracy thresholds, sensitivity, or specificity. Instead, the evaluation focuses on "substantial equivalence" to a predicate device.

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 mentions "usability and pilot studies" and "software unit, integration, system and load/performance testing," but it does not specify the sample size for any test set or provide details on the data provenance (e.g., country of origin, retrospective or prospective nature).

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)

The document does not mention the use of experts to establish ground truth for a test set. This type of device (physiological transmitter and receiver) primarily focuses on data collection and transmission functionality, rather than diagnostic interpretation that would typically require expert ground truth.

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

Since the document does not describe a clinical study or a test set requiring interpretation, there is no mention of an adjudication method.

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

There is no indication of an MRMC comparative effectiveness study being conducted. The device is not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases.

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

The "stand-alone" performance of the Confidant 2.0 device itself was implicitly evaluated through "software unit, integration, system and load/performance testing." This testing would assess the device's functionality (data collection, transmission, message delivery) without direct human intervention in the core operational loop. However, the exact methodology and results are not detailed beyond "successfully completed."

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

Given the nature of the device, the "ground truth" for the functional and safety testing would likely involve:

• Successful transmission and reception of data: Verifying that measurements are accurately collected from supported devices and transmitted to the database server.
• Correct message delivery: Confirming that educational and motivational messages are delivered to the patient as intended based on configured parameters.
• System stability and performance: Ensuring the device operates reliably under various conditions.

The document does not explicitly state "ground truth" based on expert consensus, pathology, or outcomes data, as these are typically associated with diagnostic or prognostic devices.

8. The sample size for the training set

The document does not mention a training set or its sample size. The device functions as a data collection and transmission system, not a machine learning model that typically requires a distinct training set.

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

As there is no mention of a training set, there is no information on how its ground truth would have been established.

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