(37 days)
The Ascensia BRIO™ Blood Glucose Monitoring System is for the Self-Monitoring of Blood Glucose as an adjunct to the care of person with diabetes.
The Ascensia BRIO™ Blood Glucose Meter is used with Ascensia® EASYFILL™ Blood Glucose Test Strips and ASCENSIA® EASYFILL™ CONTROL SOLUTIONS (Low, Normal, and High) for the measurement of glucose in whole blood. The Ascensia BRIO™ Blood Glucose Monitoring System is an Over-the-Counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities.
The Ascensia® Brio™ Blood Glucose Monitoring System is indicated for use with fingertip capillary whole blood specimens.
The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
The Ascensia BRIO™ Blood Glucose Monitoring System consists of an electrochemical method-based meter and reagent sensor (test strips) designed for testing glucose by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
The Ascensia BRIOTM Blood Glucose Monitoring System test is based on the measurement of electrical current caused by the reaction of glucose with the reagents (glucose oxidase) on the electrode of the test strip. It is conceptually the same as other blood glucose monitoring products available for blood glucose testing. There are 50 test strips in a plastic bottle. The system is specific for glucose and has been referenced to plasma glucose values from fingerstick capillary samples. The System has a linear response to glucose from 30-550 mg/dL.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Ascensia BRIO™ Blood Glucose Monitoring System:
The provided documents are a 510(k) Safety and Effectiveness Summary and the FDA clearance letter for the Ascensia BRIO™ Blood Glucose Monitoring System. These documents are primarily focused on demonstrating substantial equivalence to a predicate device for market clearance, rather than detailing specific, quantified acceptance criteria and study results in the manner typically found in comprehensive medical device validation reports or peer-reviewed publications. As such, some of the requested information (like specific effect sizes for MRMC studies, training set details, or highly granular expert qualifications) is not present in these specific documents.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
The provided documents do not explicitly state numerical acceptance criteria in a detailed table format. Instead, the assessment of performance relies on demonstrating "substantial equivalence" to predicate devices. The key performance indicator mentioned is the system's ability to measure glucose within a specified linear range.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Substantial equivalence to current methods for blood glucose monitoring. | "The studies demonstrated that users can obtain blood glucose results that are substantially equivalent to current methods for blood glucose." |
| "The results of clinical evaluations... demonstrate that the device is equivalent in performance to the predicate devices and suitable for its intended use." | |
| Specificity for glucose. | "The system is specific for glucose." |
| Linear response for glucose. | "The System has a linear response to glucose from 30-550 mg/dL." |
| Use by persons with diabetes or healthcare professionals. | "studied both internally and externally in a clinical setting by persons with diabetes." |
| Referenced to plasma glucose values. | "The system... has been referenced to plasma glucose values from fingerstick capillary samples." |
Note: For blood glucose meters, typical acceptance criteria often refer to accuracy within specific ranges (e.g., ±15% or ±20% of a reference method for certain glucose concentrations, or error grid analysis like Clarke Error Grid). These specific numerical targets are not provided in this summary.
Study Details
2. Sample size for the test set and data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "An evaluation... was studied both internally and externally in a clinical setting by persons with diabetes." However, the exact number of participants or samples is not specified.
- Data Provenance: The studies were conducted "internally and externally in a clinical setting." The country of origin for the data is not explicitly stated, but given the submitter's address (Elkhart, IN, USA) and FDA regulatory submission, it is highly likely that at least a significant portion, if not all, of the clinical data was generated in the United States. The studies were likely prospective given they involved clinical settings and persons with diabetes using the device.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. However, the ground truth for blood glucose meters typically involves a laboratory reference method performed by trained laboratory personnel.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable/not specified. For blood glucose meters, the "ground truth" is typically established by comparing the device's reading to a laboratory reference method, not by expert adjudication of human interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging or interpretation tasks where multiple human readers assess cases. Blood glucose monitoring systems primarily measure a physiological value, and their performance is assessed against a reference measurement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the fundamental performance of the device itself (the meter and test strip system) represents "standalone" performance. The clinical studies evaluated how users operate the device and how accurately the device measures glucose. The "algorithm" in this context is the electrochemical measurement process and the meter's internal calculations. The statement "The studies demonstrated that users can obtain blood glucose results..." confirms evaluation of the device's final output.
7. The type of ground truth used:
- Ground Truth Type: The ground truth for the test set was based on plasma glucose values from fingerstick capillary samples as measured by current reference methods. The document states, "The system is specific for glucose and has been referenced to plasma glucose values from fingerstick capillary samples."
8. The sample size for the training set:
- Training Set Sample Size: Not specified. For this type of device (electrochemical sensor), there isn't typically a "training set" in the machine learning sense. The device's calibration and algorithm development would be based on internal development data, not necessarily a distinct "training set" as defined in AI studies.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set (if applicable): Not explicitly detailed in the provided documents. The calibration and development of such systems usually involve controlled laboratory experiments comparing the device's readings to highly accurate laboratory reference instruments using known glucose concentrations or patient samples tested by those reference methods.
§ 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.