(66 days)
The Glucotrend Basic System is designed for testing glucose by persons with diabetes or by health care professionals in the home or in health care facilities.
Instrument Operating Principle -- photometric
Reagent Test Principle -- glucose deoxy reductase
The provided text describes the Glucotrend™ Basic System, a self-monitoring blood glucose test system. It focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific acceptance criteria for performance and then proving that the device meets those criteria.
However, the "Performance Characteristics" section provides data that would typically be used to assess accuracy and precision, which can be interpreted as the device's reported performance against implicit expectations for a blood glucose monitor.
Here's an attempt to structure the information based on your request, understanding that explicit acceptance criteria are not stated.
Interpretation of "Acceptance Criteria" from the provided text:
Since explicit acceptance criteria are not given, we can infer that the device's performance is being benchmarked against the predicate device (Accu-Chek Advantage System) and generally accepted standards for blood glucose monitors at the time of submission (1997), particularly in terms of accuracy (correlation with reference methods) and precision (reproducibility). Regulatory bodies typically have guidance documents outlining acceptable performance ranges for such devices, even if not explicitly stated in this summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | "Acceptance Criteria" (Inferred/Benchmark) | Reported Device Performance (Glucotrend™ Basic System) |
|---|---|---|
| Accuracy | (Implicitly similar to predicate and within acceptable clinical deviation from reference method) | |
| Trained HCP vs. Reference (Capillary Blood) | Correlation (r) > 0.973, Slope (y) approx. 0.99x-1.0x, Intercept (b) approx. 5.0 (based on predicate) | N = 202 |
| y = 1.02x + 2.6 | ||
| r = 0.989 | ||
| range = 51 to 490 mg/dL | ||
| Trained HCP vs. Reference (Venous Blood) | Correlation (r) > 0.990, Slope (y) approx. 1.05x-1.0x, Intercept (b) approx. -0.6 (based on predicate) | N = 104 |
| y = 1.029x + 2.7 | ||
| r = 0.995 | ||
| range = 35 to 483 mg/dL | ||
| Consumers vs. Reference | Comparable performance to trained health care professionals, supporting OTC use. (Predicate did not perform this study, relying on existing data for its glucose oxidase strips) | N = 134 |
| y = 1.082x - 2.9 | ||
| r = 0.976 | ||
| range = 58 to 357 mg/dL | ||
| Precision | (Implicitly similar or better than predicate, and low standard deviation) | |
| Control Level 1 (Mean ± SD) | Approx. 42.0 ± 4.2 mg/dL (based on predicate) | Mean: 84.0 mg/dL |
| SD: 2.0 | ||
| Control Level 2 (Mean ± SD) | Approx. 104.0 ± 3.0 mg/dL (based on predicate) | Mean: 196.4 mg/dL |
| SD: 2.5 | ||
| Venous Blood Level 1 (Mean ± SD) | Approx. 53.0 ± 3.9 mg/dL (based on predicate) | Mean: 28.7 mg/dL |
| SD: 1.2 | ||
| Venous Blood Level 2 (Mean ± SD) | Not applicable for predicate | Mean: 87.3 mg/dL |
| SD: 2.6 | ||
| Venous Blood Level 3 (Mean ± SD) | Not applicable for predicate | Mean: 129.4 mg/dL |
| SD: 3.0 | ||
| Venous Blood Level 4 (Mean ± SD) | Approx. 233.0 ± 2.9 mg/dL (based on predicate) | Mean: 229.2 mg/dL |
| SD: 2.8 | ||
| Venous Blood Level 5 (Mean ± SD) | Approx. 490.0 ± 3.6 mg/dL (based on predicate) | Mean: 335.0 mg/dL |
| SD: 3.4 |
2. Sample Size Used for the Test Set and Data Provenance
- Trained health care professional versus reference (Capillary blood): N = 202
- Trained health care professional versus reference (Venous blood): N = 104
- Consumers versus reference: N = 134
- Precision (Control levels): N = 20/Level (for 2 levels)
- Precision (Venous Blood levels): N refers to the samples run for precision, but the exact number for blood levels isn't explicitly stated as "N = X" in the same way as controls, only mean and SD are provided per level. However, precision studies typically involve multiple replicates.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, given the context of a 510(k) submission, these would typically be prospective studies conducted in a clinical or laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing ground truth. The "reference" is mentioned, which implies a laboratory reference method (e.g., a YSI analyzer), not human expert consensus, for determining blood glucose levels. The "Trained health care professional" refers to the user of the device, not an expert establishing ground truth.
4. Adjudication Method for the Test Set
Not applicable. Blood glucose measurements typically use a reference laboratory method as the ground truth, not human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, this type of study was not conducted as this is a blood glucose monitoring device, not an imaging device requiring human interpretation. The study involved comparison of the device's readings against a reference method, with different types of users (trained healthcare professionals, consumers).
6. Standalone (Algorithm Only) Performance
Yes, the accuracy and precision studies described represent standalone performance of the device without human-in-the-loop assistance influencing the measurement itself. The human interaction is limited to operating the device (e.g., applying the blood sample) in the intended use case (self-monitoring or healthcare professional use).
7. Type of Ground Truth Used
The ground truth used was a reference method (implied to be a laboratory standard for blood glucose measurement). This is evident from phrases like "Trained health care professional versus reference" and "Consumers versus reference."
8. Sample Size for the Training Set
The document does not provide information on a specific "training set" for an algorithm. This is a medical device, and the performance data presented are for validation/testing, not for training a machine learning model. If any calibration or development was done using data, it is not detailed here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a discrete "training set" in the context of an algorithm's development is not discussed in this device's 510(k) summary.
§ 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.