(78 days)
The Clever Chek Health Care System Software is an optional software accessory for use with the following models with data management capabilities: a) Clever Chek blood glucose meters, b) Clever Chek blood glucose plus blood pressure monitors, and c) Clever blood pressure monitors. When use with one of these meters, Clever Chek Health Care System Software transfers data from the device's memory into a computer for enhanced data management.
The Clever Chek Health Care System Software is intended for use in home and clinical settings as an aid for users and their health care professionals to review, analyze and evaluate the historical test results to support health management effectively.
The Clever Chek Health Care System Software is an optional software accessory for use with the following models with data management capabilities: a)Clever Chek blood glucose meters, b) Clever Chek blood glucose plus blood pressure monitors, and c) Clever blood pressure monitors. When use with one of these meters, Clever Chek Health Care System Software transfers data from the device's memory into a computer for enhanced data management.
Here's a breakdown of the acceptance criteria and study information for the Clever Chek Health Care System Software (K070941), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use Fulfillment: The system should meet its intended use | Demonstrated: Testing (hardware validation, software validation, user evaluation) demonstrated that the system meets its intended use. |
| Data Integrity: Data transferred from the device cannot be changed or modified in any way. | The device meets this criterion as it's explicitly stated as a feature of both the proposed device and its predicate, contributing to substantial equivalence. |
| Satisfactory Performance: | Demonstrated: The device demonstrated "satisfactory performance." |
| Suitability for Intended Use: | Demonstrated: The device is "suitable for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It vaguely refers to "Testing... included validation of hardware (data transfer through the cable) software and user evaluation."
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. Given the nature of the device (data management software for blood glucose and blood pressure monitors), the "ground truth" would likely be the raw, accurate readings from the meters themselves, rather than interpretations by medical experts.
4. Adjudication Method
The document does not describe an adjudication method. This is likely because the "ground truth" for this type of device would be the direct data from the connected medical devices, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The device is software for data management, not an interpretive diagnostic tool that human readers would use to assess cases for improved effectiveness.
6. Standalone Performance Study
A standalone performance study was done. The "Performance Studies" section states, "Testing of Clever Chek Health Care System Software included validation of hardware (data transfer through the cable) software and user evaluation. It demonstrated that the system meets its intended use." This indicates the software was tested on its own to confirm its functionality and adherence to its intended purpose.
7. Type of Ground Truth Used
The type of ground truth used was the raw data generated by the associated medical devices (blood glucose meters and blood pressure monitors). The software's function is to transfer and display this data accurately, without modification.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. Given that this is a data management software, it's unlikely to rely on traditional machine learning models that require a separate training set. Its validation would focus on data transfer accuracy, software functionality, and user interface.
9. How the Ground Truth for the Training Set Was Established
As there's no mention of a traditional "training set" in the context of machine learning, the document does not describe how ground truth for a training set was established. The "ground truth" pertinent to this device's function would be the accurate transmission and display of data from the aformentioned medical devices.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.