(243 days)
The HealthTracker is a software accessory for use with a blood pressure monitor with data transmission capabilities. This software is able to transfer data from the device's memory to a computer.
The HealthTracker is intended for use at home and clinical settings as an aid for users and their healthcare professionals to review, analyze and manage the historical results.
The HealthTracker is intended for use with BestShape Blood Pressure Monitoring System.
The HealthTracker is an optional software accessory for use with a blood pressure monitoring system with data management capabilities. The HealthTracker transfers data from the device's memory to a computer for enhanced data management.
The proposed software includes functions of managing personal account information on computer and data upload from blood pressure monitor to a personal computer or Health Vault.
The HealthTracker is for use with BestShape Blood Pressure Monitoring System. The HealthTracker can control BestShape Blood Pressure Monitoring System in its recording of blood pressure measurements and transmitting of the data to a computer with the subject software.
The provided document describes the HealthTracker software, an accessory for blood pressure monitoring systems. However, it does not contain the level of detail typically found in a study proving a device meets specific acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy, etc.) for a diagnostic or AI-driven decision support tool.
The document primarily focuses on:
- Device Description: The HealthTracker transfers blood pressure data from the monitor to a computer for management.
- Intended Use: Aid users and healthcare professionals to review, analyze, and manage historical blood pressure results.
- Comparison to Predicate Device: States both use cable connection and data cannot be modified.
- Performance Studies: A generic statement that "Risk analysis and software validation was performed to verify and validate the HealthTracker works functionally."
Therefore, based solely on the provided text, I cannot generate a comprehensive table of acceptance criteria and reported device performance, nor can I provide information about sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The document does not describe a study in the sense of a clinical trial or performance evaluation with quantitative metrics.
Below is a response outlining what can be extracted or inferred and explicitly stating what cannot.
This document (K110770) describes the HealthTracker software, an accessory for blood pressure monitoring systems. The "Performance Studies" section states that "Risk analysis and software validation was performed to verify and validate the HealthTracker works functionally." This indicates that the validation focused on the software's functionality and safety, rather than a clinical performance study measuring diagnostic accuracy or clinical outcomes.
Given the nature of the device as a data transfer and management software, detailed performance metrics (like sensitivity, specificity, or AUC) typically associated with diagnostic AI systems are not relevant or reported in this submission. The acceptance criteria would likely be related to successful data transfer, data integrity, user interface functionality, and compliance with software design specifications.
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from "functional" validation) | Reported Device Performance (Inferred from "functional" validation) |
|---|---|---|
| Data Transfer | Successful transmission of blood pressure data from monitor to computer. | Verified to transfer data successfully. |
| Data Integrity | Data transferred without modification or corruption. | Data transferred cannot be changed or modified in any way. |
| Account Management | Ability to manage personal account information on the computer. | Works functionally for managing personal account information. |
| Compatibility | Works with BestShape Blood Pressure Monitoring System. | Intended for use with BestShape Blood Pressure Monitoring System. |
| Risk Management | Risks associated with software usage are identified and mitigated. | Risk analysis was performed. |
| Software Validation | Software meets its specifications and intended use. | Software validation was performed to verify functionality. |
2. Sample size used for the test set and the data provenance:
Not specified in the provided document. The validation appears to be a functional software validation rather than a clinical test with a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/Not specified. For a diagnostic or AI device, ground truth would refer to expert-verified diagnoses or pathology results. For this data transfer software, "ground truth" would relate to the correctness of data transfer and software functions, which would be verified by software testers and quality assurance personnel against requirements, rather than medical experts.
4. Adjudication method for the test set:
Not applicable/Not specified. Adjudication methods (like 2+1) are common in clinical studies where expert consensus is needed to establish ground truth for ambiguous cases. This is not described for this software validation.
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. The HealthTracker is software for data management, not an AI-driven diagnostic or decision support tool that assists human readers in interpreting medical cases. No MRMC study was conducted or is relevant for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not directly applicable in the typical sense of a diagnostic algorithm. The software's "standalone" function is to transfer and display data, which was validated functionally. Its performance is in data handling and display, not in making clinical determinations that would be compared to human performance.
7. The type of ground truth used:
For the software validation, the "ground truth" would be the predefined functional and performance requirements for the software (e.g., "data must transfer accurately," "interface must respond within X milliseconds," "all specified fields must be present after transfer"). Verification would compare the software's behavior against these requirements. It does not involve medical ground truth like pathology or expert consensus on patient conditions.
8. The sample size for the training set:
Not applicable. The HealthTracker is not an AI/machine learning device that requires a "training set" of data. It is a deterministic software for data transfer and management.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of software.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).