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510(k) Data Aggregation
(263 days)
The ACCU-CHEK Performa Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in venous whole blood or fresh capillary whole blood from the fingertips. The ACCU-CHEK Performa Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid in monitoring the effectiveness of glucose control. This system should only be used with single-use, auto-disabling lancing devices.
The ACCU-CHEK Performa Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. This system is also not for neonatal use.
The ACCU-CHEK Performa test strips are for use with the ACCU-CHEK Performa meter to quantitatively measure glucose (sugar) in venous whole blood or fresh capillary whole blood samples from the fingertips.
The ACCU-CHEK Performa blood glucose monitoring system is a blood glucose monitoring system that makes use of the ACCU-CHEK Performa test strips, the ACCU-CHEK Performa meter, the ACCU-CHEK Inform II Control Solutions (cleared under K121679), and the ACCU-CHEK Inform II Linearity Test Kit (cleared under K121679). This system is a multi-patient use blood glucose monitoring system intended to be used in a professional environment to quantitatively measure glucose in venous whole blood and fresh capillary whole blood samples drawn from the fingertips.
The ACCU-CHEK Performa Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in venous or fresh capillary whole blood. The system is for in vitro diagnostic use in professional healthcare settings and should only be used with single-use, auto-disabling lancing devices. It is not for the diagnosis or screening of diabetes, nor for neonatal use.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated as criteria, but inferred from data presentation as performance targets) | Reported Device Performance (ACCU-CHEK Performa System) |
|---|---|
| Method Comparison (vs. YSI Glucose Analyzer): | |
| For glucose concentrations < 75 mg/dL: | |
| Within ±5 mg/dL | 17/19 (89.5%) |
| Within ±10 mg/dL | 18/19 (94.7%) |
| Within ±15 mg/dL | 19/19 (100%) |
| For glucose concentrations ≥ 75 mg/dL: | |
| Within ±5 % | 50/86 (58.1%) |
| Within ±10 % | 78/86 (90.7%) |
| Within ±15 % | 84/86 (97.7%) |
| Within ±20 % | 85/86 (98.8%) |
| Repeatability (Within Lot) Precision: | |
| For targets < 75 mg/dL: SD ≤ 5.0 mg/dL | All reported SDs for means < 75 mg/dL (37.1 mg/dL) are 1.7 mg/dL, which is ≤ 5.0 mg/dL. |
| For targets ≥ 75 mg/dL: CV ≤ 5.0% | All reported CVs for means ≥ 75 mg/dL (81.1, 134.6, 216.2, 345.3 mg/dL) are 4.7%, 3.4%, 3.3%, 3.6%, 3.0% respectively, all are ≤ 5.0%. |
| Reproducibility (Intermediate/Day-to-Day) Precision: | |
| (No specific criteria provided, but data is presented for comparison) | For control solutions: |
| Low mean (45.8 mg/dL): SD 1.5 mg/dL, CV 3.2% | |
| Mid mean (118.8 mg/dL): SD 2.7 mg/dL, CV 2.3% | |
| High mean (310.8 mg/dL): SD 6.6 mg/dL, CV 2.1% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Method Comparison (Test Set):
- For glucose concentrations < 75 mg/dL: 19 samples.
- For glucose concentrations ≥ 75 mg/dL: 86 samples.
- Sample Size for Repeatability Precision: 100 measurements per blood level (5 blood levels), totaling 500 measurements.
- Sample Size for Reproducibility Precision: 100 measurements per control solution level (3 control levels), totaling 300 measurements.
- Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. It is implied to be prospective clinical and laboratory testing conducted in support of the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts, their qualifications, or their involvement in establishing ground truth for the test set. For blood glucose monitoring systems, the "ground truth" or reference method is typically a laboratory-based analyzer (e.g., YSI Glucose Analyzer), not expert consensus.
4. Adjudication Method for the Test Set
Not applicable. For blood glucose measurement, the comparison is typically against a highly accurate laboratory reference method, not an adjudicated clinical assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is a blood glucose monitoring system, which typically involves a single user and an automated reading, not a multi-reader visual interpretation task. There is no AI component described in the context of improving human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, the performance data presented (method comparison, repeatability, reproducibility) represents the standalone performance of the device (ACCU-CHEK Performa Blood Glucose Monitoring System) against a laboratory reference standard (YSI Glucose Analyzer) and its own internal precision metrics. The device is designed for automated glucose measurement.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the method comparison study was established using a "reference method" instrument, likely a YSI Glucose Analyzer, as is standard practice for blood glucose monitoring systems. Although not explicitly named in the results table, it's mentioned under "Results for glucose concentrations less than 75 mg/dL" and "Results for glucose concentrations greater than or equal to 75 mg/dL," implying comparison to a highly accurate laboratory analyzer.
8. The Sample Size for the Training Set
The document does not provide information on the sample size used for the training set. For blood glucose meters, "training" often refers to the calibration and algorithm development process by the manufacturer, which utilizes extensive internal data, but this data is not typically disclosed in 510(k) summaries in terms of sample size.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly detail how the ground truth for any "training set" was established. However, for blood glucose meters, the development and calibration of the device's algorithms (which could be considered analogous to "training") would typically involve:
- Measuring glucose levels in various blood samples using a highly accurate laboratory reference method (like a YSI Glucose Analyzer).
- Using these reference values to calibrate the meter's internal algorithm to accurately translate the electrochemical signal from the test strip into a glucose concentration reading.
- Extensive testing across various glucose ranges, hematocrit levels, and interfering substances.
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