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510(k) Data Aggregation
(228 days)
The FreeStyle Precision Neo Blood Glucose Monitoring System is for use outside the body only (in vitro diagnostic use) in the quantitative measurement of glucose in fresh whole blood for self-testing by lay users from the fingers. It is not intended to be used for testing neonatal blood samples or the diagnosis or screening of diabetes.
The FreeStyle Precision Neo System is indicated for home (lay user) in the management of patients with diabetes. It is intended to be used by a single person and should not be shared.
The FreeStyle Precision Neo Blood Glucose Test Strips are for use with theFreeStyle Precision Neo Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The FreeStyle Precision Neo Meter is for the quantitative measurement of glucose in capillary whole blood samples. The FreeStyle Precision Neo Meter, in conjunction with the FreeStyle Precision Neo Blood Glucose Test Strips, 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 System is compatible with the following components and accessories:
- . FreeStyle Precision Neo Blood Glucose Test Strips (available separately)
- MediSense Glucose and Ketone Control Solutions (available separately)
- . USB Cable (available separately)
- FreeStyle Lancing Device II ●
- Thin Lancets ●
The provided text describes the FreeStyle Precision Neo Blood Glucose Monitoring System and its substantial equivalence to a predicate device. It includes performance study information for glucose measurements.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text details the performance of the FreeStyle Precision Neo Blood Glucose Monitoring System against specific criteria. The key performance metrics revolve around the accuracy of glucose measurements.
Acceptance Criteria for Blood Glucose Monitoring Systems (as per ISO 15197:2003, which is commonly referenced for such devices):
- For glucose concentrations < 75 mg/dL (4.2 mmol/L): Minimum of 95% of results must be within ±15 mg/dL (±0.83 mmol/L) of the reference method.
- For glucose concentrations ≥ 75 mg/dL (4.2 mmol/L): Minimum of 95% of results must be within ±20% of the reference method.
- Overall: 99% of all individual glucose measurement results shall fall within zones A and B of the Consensus Error Grid (CEG) for type 1 diabetes.
Reported Device Performance (based on the provided text, specifically the self-testing accuracy study):
The document presents data in the following format:
A total of 152 lay users and 912 results were used for this study.
| Reference Range (mg/dL) | n | FreeStyle Precision Neo Range (mg/dL) | % Within Range |
|---|---|---|---|
| For Glucose values < 75 mg/dL | |||
| 50-75 mg/dL | 22 | within + 15 mg/dL | 100% |
| For Glucose values 75 mg/dL | |||
| 75-100 mg/dL | 167 | within + 20% | 100% |
| 101-150 mg/dL | 306 | within + 20% | 100% |
| 151-250 mg/dL | 266 | within + 20% | 99% |
| 251-400 mg/dL | 149 | within + 20% | 99% |
| Overall | 910 | 99.7% | |
| All results in Consensus Error Grid Zones A and B | 100% |
Summary Table of Acceptance Criteria and Performance:
| Performance Metric | Acceptance Criteria (e.g., ISO 15197:2003) | FreeStyle Precision Neo Performance | Evaluation |
|---|---|---|---|
| Accuracy for Glucose < 75 mg/dL | ≥ 95% of results within ±15 mg/dL of reference | 100% of 22 results within ±15 mg/dL (for 50-75 mg/dL range) | Meets Criteria (and exceeds for the specified sub-range) |
| Accuracy for Glucose ≥ 75 mg/dL | ≥ 95% of results within ±20% of reference | 100% (167 results for 75-100 mg/dL), 100% (306 results for 101-150 mg/dL), 99% (266 results for 151-250 mg/dL), 99% (149 results for 251-400 mg/dL) | Meets Criteria for the specified sub-ranges |
| Overall Accuracy (Consensus Error Grid Zones A & B) | 99% of all individual glucose measurement results in Zones A and B of CEG | 100% of all results in Consensus Error Grid Zones A and B | Meets Criteria (and exceeds) |
| Overall Agreement Rate | Not explicitly defined as a single percentage by ISO 15197 for all ranges combined | 99.7% (overall for 910 results when measured against the ±15 mg/dL / ±20% criteria) | Excellent Performance |
2. Sample Size and Data Provenance
- Sample Size for Test Set: A total of 152 lay users participated in the study, generating 912 results.
- Data Provenance: The document does not explicitly state the country of origin. It indicates Abbott Diabetes Care Inc. is based in Alameda, CA, and the legal manufacturer is Abbott Diabetes Care Ltd. in the UK, but this doesn't specify where the clinical study itself was conducted. The study is prospective, involving lay users performing self-testing.
3. Number of Experts and Qualifications for Ground Truth
The document does not provide details on the number of experts used or their qualifications for establishing ground truth. Blood glucose monitoring system studies typically use a laboratory reference method (e.g., YSI analyzer) as the ground truth, calibrated and operated by trained laboratory personnel, rather than clinical experts for ground truth establishment.
4. Adjudication Method
The document does not mention any adjudication method for the test set. For blood glucose measurements, where the ground truth is typically a precise laboratory reference method, adjudication by multiple human experts is generally not performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human interpretation is a key component, comparing human readers with and without AI assistance. This device is a quantitative measurement system for self-testing, so the performance is assessed against a reference measurement, not human interpretation.
6. Standalone Performance Study
Yes, a standalone performance study was done. The precision and accuracy data presented (e.g., the table under point 1) directly reflect the algorithm's (device's) performance compared to a reference method, without human-in-the-loop assistance influencing the measurement outcome. Lay users operated the device as intended for self-testing, but their interaction is part of the intended use, not "human-in-the-loop" for interpretation or decision-making beyond operating the device.
7. Type of Ground Truth Used
The ground truth used for the accuracy study is a reference method, likely a laboratory analyzer (e.g., YSI glucose analyzer), which is the standard for blood glucose measurement studies. This is inferred from the context of "Reference Range (mg/dL)" in the performance table.
8. Sample Size for the Training Set
The document does not specify a separate training set size or methodology. For in vitro diagnostic devices like blood glucose meters, the development process involves extensive internal validation and verification using various samples, but these are typically not referred to as "training sets" in the same way machine learning models are. The reported performance data is from a clinical study for validation.
9. How Ground Truth for the Training Set Was Established
As no specific "training set" is mentioned in the context of typical machine learning model training, the document does not describe how ground truth for such a set was established. Device development and calibration involve rigorous testing against reference methods using known glucose concentrations.
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