(168 days)
The POPS!® one Blood Glucose Monitoring System is comprised of the POPS!® one blood glucose meter, the POPS!® one blood glucose sensor modules, and the POPS!® mobile application as the display component.
The POPS!® one Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood taken from the finger. It is intended to be used by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program.
The POPS!® one Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is not intended for the diagnosis of, or screening of diabetes. It is not intended for use on neonates.
The POPS!® one Blood Glucose Monitoring System is designed to make blood glucose testing and diabetes management easier and more convenient. The traditional test kit is replaced by a low-profile meter that contains everything needed for testing and requires no assembly. The meter pairs with a mobile app installed on the user's phone via Bluetooth, allowing the meter to perform glucose testing and send the results to the app where they are communicated to the user and automatically stored.
The POPS!® one Blood Glucose Monitoring System contains the following:
- . POPS!® one blood glucose meter works directly with the POPS!® app installed on the user's mobile phone. The meter performs a blood glucose test and sends the result to the POPS!" app.
- . POPS!® one blood glucose sensor module is individually packed and sterile. It contains 3 test sites with separate foil covers; each containing a lancet and test strip. The user inserts the sensor module in the meter and replaces a used sensor module with a new once all 3 test sites have been used. The sensor module not only provides all components for performing a glucose test to the user in a convenient, self-contained format but it also provides a new lancet for each test; preventing lancet re-use.
- . POPS!® mobile application acts as the primary interface with users; enabling them to test, communicating blood glucose results and messages, and allowing them to monitor trends on their phone.
The document describes the POPS!® one Blood Glucose Monitoring System and its substantial equivalence to a predicate device (TD-4277 Blood Glucose Monitoring System).
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the POPS!® one Blood Glucose Monitoring System met all performance criteria as assessed by non-clinical and clinical studies. However, specific acceptance criteria values (e.g., accuracy percentages for various glucose ranges as per ISO 15197 or FDA guidance) are NOT explicitly listed in the provided text. The document generally refers to "performance criteria" being met, implying compliance with the FDA Guidance issued on October 11, 2016: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.
Without the specific numerical acceptance criteria from that guidance, a table comparing them to reported device performance cannot be fully constructed from the provided text. The document only mentions that the system accuracy was "confirmed."
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Clinical Testing Summary: A user evaluation confirmed the system accuracy, operation according to design, and ease of use to support the intended use as described in the proposed labeling." However, the specific sample size used for the test set (number of participants, number of samples) and the data provenance (e.g., country of origin, retrospective or prospective) are NOT provided in the text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications used to establish ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document describes a blood glucose monitoring system, which typically involves a single user taking a measurement and is not generally subject to MRMC studies designed for image interpretation or diagnosis by multiple readers. Therefore, an MRMC comparative effectiveness study was not done in the context of this device's evaluation as described.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
The device is a "Blood Glucose Monitoring System" intended for "Self-Monitoring." Its core function is the quantitative measurement of glucose from a blood sample using a meter and sensor module, with results displayed via a mobile app. This inherently involves human interaction (blood sampling, operating the device). Therefore, a purely "standalone" algorithm-only study, without human interaction, is not applicable or described for this type of medical device. The "system accuracy" would be evaluated with human users.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for performance evaluation (e.g., reference lab method, YSI analyzer). For blood glucose monitoring systems, ground truth is typically established by comparing device readings to a highly accurate laboratory reference method.
8. Sample Size for the Training Set
The document does not mention a "training set" or its sample size. This type of information is typically relevant for AI/ML-driven devices that learn from data, and while the device uses software (for display and storage), it's not described as having a learning algorithm in the context of its glucose measurement. The "non-clinical testing" likely involved engineering and analytical validation with simulated or controlled samples, but not a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, this information is not applicable or provided.
§ 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.