Search Results

The MediCompass® Connect serves as an interface or a gateway between personal monitoring devices and a general-purpose personal health management database. The MediCompass Connect collects physiologic measurements and retrospectively monitors vital signs from defined personal monitoring devices and transmits the data to a central database server, using standard communication technologies. MediCompass Connect is designed for professional, personal and home use.

MediCompass Connect is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment.

MediCompass® Connect is a telehealth gateway to upload biometric data from personal health monitoring devices, including glucose monitors, insulin pumps, blood pressure monitors, digital spirometers, pulse oximeter, PT/INR meter, activity monitor/pedometer, and weight scales. The system conveniently transfers data via a standard phone line or Internet-enabled personal computer using the MetrikLink® connectivity hub, or connection directly to mobile devices via wireless technology.

After connectivity is activated by a health care professional, patients can connect their monitoring device to MediCompass Connect using MetrikLink, adapters or compatible cables provided for their specific medical device and model. The data captured from the personal monitoring medical devices is transferred securely to the MediCompass database or other secure online database, then to the health care provider's remote general purpose health management database.

MediCompass Connect does not provide diagnosis of any disease or medical condition, nor is it 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.

MediCompass Connect is not intended for emergency use 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.

The provided text describes the MediCompass® Connect, a telehealth gateway. However, it does not include specific acceptance criteria or a detailed study proving the device meets particular performance metrics.

The document mainly focuses on:

• Regulatory information: Device classification, predicate devices, and FDA substantial equivalence determination.
• Device description: How it functions as an interface to transfer biometric data.
• Indications for Use: The intended purpose of the device.
• Performance Testing (High-level): A brief statement saying "Verification and validation testing activities were conducted to establish the performance, functionality and reliability characteristics of MediCompass Connect... The results of all performance testing were acceptable and demonstrated performance as intended."

Therefore, most of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth, and expert involvement for a specific study proving device performance cannot be extracted from this document.

Here's how to address each point 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)

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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 as the document does not describe a study involving expert-established ground truth for diagnostic or clinical performance. The device is a data transfer gateway, not a diagnostic tool.

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

• Not applicable; no clinical study or diagnostic performance evaluation 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 MRMC study was done. This device is not an AI diagnostic tool and does not involve human readers for interpretation.

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

• A "standalone" performance testing for the device's function as a data gateway was done, as stated: "Verification and validation testing activities were conducted to establish the performance, functionality and reliability characteristics of MediCompass Connect... The results of all performance testing were acceptable and demonstrated performance as intended." However, no quantitative standalone performance metrics (e.g., accuracy of data transfer, speed, error rate) are provided.

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

• The concept of "ground truth" as typically used in diagnostic or AI studies is not directly applicable here. The device's function is data transfer. Its "ground truth" would likely involve successful transfer of data identical to the source, without corruption or loss. The text does not detail how this "ground truth" for data integrity was established during testing.

8. The sample size for the training set

• Not applicable. This device is a hardware/software system for data transfer, not an AI model that requires a "training set" in the machine learning sense.

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

• Not applicable. (See #8)

Ask a specific question about this device

MediCompass Connect serves as an interface or a gateway between personal monitoring devices and a general purpose personal health management database. Monitoring devices that can interface to the MediCompass Connect include, but are not limited to:

• Blood glucose monitor
• Blood pressure cuffs I
• Insulin pumps
• Spirometers
• . Scales

MediCompass Connect is designed for professional healthcare settings and home use.

MediCompass Connect is a system that transmits data from personal monitoring devices using standard communication methods such as telephone lines or wireless, or transmits data by using a PC that has a connection to the Internet. MediCompass Connect transmits the data from a personal monitoring devices, such as a blood pressure cuff, to a remote general-purpose personal health management database.

• Blood pressure cuffs .
• . Blood glucose meters
• Insulin pumps .
• Spirometers .
• . Scales

This document is a 510(k) premarket notification for the MediCompass Connect device, which is a data transfer system for personal monitoring devices. It outlines the regulatory classification, a comparison to a predicate device, and the list of devices it is validated to work with. However, it does not contain the specific acceptance criteria or the results of a study that prove the device meets such criteria.

Therefore, I cannot populate the table or provide details for most of your questions based only on the provided text. The document is primarily a regulatory submission for substantial equivalence rather than a detailed performance study report.

Here's what I can infer and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not specified in this document. This document focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific quantitative performance criteria related to accuracy or clinical effectiveness.
• Reported Device Performance: Not provided. The document lists which devices MediCompass Connect is validated for use with, implying functional compatibility, but does not present data on its performance (e.g., data transfer success rate, speed, or accuracy of data transmission) against any set criteria.

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

• Sample Size: Not specified.
• Data Provenance: Not specified.

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

• Not applicable as no specific test set or ground truth establishment relevant to device performance is described.

4. Adjudication method for the test set:

• 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:

• Not applicable. This device is a data transfer system, not an AI-powered diagnostic tool involving human readers.

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

• Not explicitly stated. The "validation for use with" section (page 4) suggests functional testing for compatibility, but not a standalone performance study in the sense of an algorithm's diagnostic accuracy.

7. The type of ground truth used:

• Not applicable as no specific ground truth for performance evaluation is mentioned. The ground truth for this type of device would likely be accurate data transfer, which would be verified through functional testing rather than expert-established ground truth.

8. The sample size for the training set:

• Not applicable, as this device does not appear to involve machine learning or AI that would require a training set in the typical sense. It is a data transfer system.

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

• Not applicable.

What information is provided regarding the device's assessment:

• Predicate Device: Health Buddy® with BuddyLink (K040086) (Page 3).
• Comparison: MediCompass Connect is stated to be "substantially equivalent" to the predicate device for general-purpose personal health management information communication (Page 4).
• Validated Devices: A list of 27 personal monitoring devices (blood glucose monitors, blood pressure monitors, insulin pumps, spirometers) from various brands (Roche, Bayer, Abbott, LifeScan, Becton, Dickinson, and Company, HDI, A&D Medical, Omron Healthcare) that MediCompass Connect is validated to work with (Page 4). This indicates functional compatibility testing, but the details of this testing (e.g., how many tests per device, success rate, specific metrics) are not included in this summary.

Ask a specific question about this device