(91 days)
The FreeStyle Precision Neo Blood Glucose Test Strips are for use outside the body only (in vitro diagnostic use) with the FreeStyle Libre Reader's built-in meter as components of the Flash Glucose Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. They are not intended to be used for testing neonatal blood samples or screening of diabetes.
The FreeStyle Precision Neo Blood Glucose Test Strips are indicated for home (lay) user in the management of patients with diabetes. They are intended to be used by a single person and should not be shared.
The FreeStyle Precision Neo Blood Glucose Test Strips are used for the quantitative measurement of glucose in capillary whole blood samples. The FreeStyle Precision Neo Blood Glucose Test Strips, in conjunction with the FreeStyle Libre Reader's built-in meter, works on the principal of amperometric technology, measuring glucose by its reaction with Glucose Dehydrogenase (GDH) in blood samples or control solutions through electrical mediation.
The FreeStyle Precision Neo Blood Glucose Test Strips are compatible with the FreeStyle Precision Neo Blood Glucose Meter (cleared under K140371) or the FreeStyle Libre Reader's built-in meter.
The provided document is a 510(k) premarket notification for a medical device: FreeStyle Precision Neo Blood Glucose Test Strips. The submission seeks to expand the indications for use of existing test strips to include compatibility with the FreeStyle Libre Reader's built-in meter.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that a clinical study was performed to assess device accuracy compared to a YSI reference method, and "all performance characteristics were met." However, it does not explicitly list specific numerical acceptance criteria (e.g., accuracy percentages within certain glucose ranges) or the detailed reported performance values against those criteria. The general statement is that the device "is safe and effective for its intended use and technological characteristics when used with the FreeStyle Libre Reader's built-in meter."
| Acceptance Criteria Category | Specific Acceptance Criteria (Not Explicitly Stated in Detail) | Reported Device Performance |
|---|---|---|
| Accuracy (Clinical Study) | Implicit: Device accuracy compared to YSI reference. Detailed statistical metrics (e.g., % within +/-15 mg/dL or +/-15% of reference for different glucose ranges, Mean Absolute Relative Difference (MARD)) are not provided in this summary. | "All performance characteristics were met." (Implies satisfactory accuracy against YSI reference). |
| Precision | Implicit: Acceptable levels of variability in repeated measurements. | "All performance characteristics were met." |
| Linearity | Implicit: Accurate measurement across the specified glucose operating range (20-500 mg/dL). | "All performance characteristics were met." |
| Detection Limits | Implicit: Ability to accurately detect glucose at the low and high ends of the operating range. | "All performance characteristics were met." |
| Interference | Implicit: Robustness to common interfering substances. | "All performance characteristics were met." |
| Environmental Conditions | Implicit: Performance within specified operating temperature (59-104°F) and humidity (10-90%). | "All performance characteristics were met." |
| Sample Volume | Implicit: Accurate performance with the specified sample volume (0.6 microliters). | "All performance characteristics were met." |
| Infection Control | Implicit: Satisfactory infection control measures/design. | "All performance characteristics were met." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "a clinical study was performed" but does not specify the sample size used for this clinical study (the test set).
Regarding data provenance:
- Country of Origin: Not explicitly stated for the clinical study. However, the legal manufacturer establishment is Abbott Diabetes Care Ltd., located in Witney, Oxon, UK. This suggests the study might have been conducted in the UK or under their oversight, but this is an inference, not a direct statement about the study itself.
- Retrospective or Prospective: Not explicitly stated. Clinical studies for device accuracy are typically prospective to control variables and collect fresh samples, but this is an assumption based on common practice, not directly from the text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states that the ground truth for the clinical study was established by comparison to a YSI reference method.
- Number of Experts: Not applicable, as YSI is an automated laboratory analyzer, not human experts.
- Qualifications of Experts: Not applicable. The YSI reference method is a gold standard laboratory method for glucose measurement, operated by trained laboratory personnel.
4. Adjudication Method for the Test Set
Not applicable, as the ground truth was established by an automated YSI reference method, not by human expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not conducted. This type of study is more common for diagnostic imaging devices where human readers interpret images. For a blood glucose test strip, the "reader" is the device itself (the FreeStyle Libre Reader's built-in meter), and the primary assessment is standalone analytical and clinical accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, a standalone performance assessment was conducted. The "performance testing" and "clinical study" described assess the FreeStyle Precision Neo Blood Glucose Test Strips in conjunction with the FreeStyle Libre Reader's built-in meter as a complete system, without human interpretation as a variable affecting the glucose measurement outcome. The accuracy is directly compared to a reference method (YSI), reflecting the device's intrinsic performance.
7. The Type of Ground Truth Used
The ground truth used was a YSI reference method. This is a highly accurate laboratory method commonly considered the gold standard for glucose measurement in clinical studies of blood glucose monitoring systems.
8. The Sample Size for the Training Set
The document does not provide information on a "training set" sample size. For in vitro diagnostic devices like blood glucose test strips, the development process might involve initial analytical verification and validation studies during device design and iterative refinement. However, the "clinical study" mentioned typically refers to the final validation conducted on a separate, independent "test set" population. The concept of a distinct 'training set' as used in machine learning models is not typically applied or reported in the same way for these types of IVDs.
9. How the Ground Truth for the Training Set Was Established
Since no information about a distinct "training set" is provided, how its ground truth was established is also not stated. The document focuses on the testing and validation of the device, where the YSI reference method serves as the ground truth for comparison.
§ 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.