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510(k) Data Aggregation
(192 days)
The TD-4140 Smart Dongle Blood Glucose plus [-ketone Monitoring System consists of the Smart Dongle blood glucose test strips, Smart Dongle {}-ketone test strips, and the Procheck mobile application as the display component of the system. This system is intended to be used for the quantitative measurement of glucose (sugar) and fketone in fresh capillary whole blood from the finger.
This system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is intended to be used by a single person and should not be shared. This system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.
The TD-4140 Smart Dongle Blood Glucose plus ß-ketone Monitoring System consists of the Smart Dongle meter, Smart Dongle blood glucose test strips, Smart Dongle 0-ketone test strips, and the Procheck mobile application as the display component of the system.
This system is compatible to iPhone series, including iPhone 4/4s, 5/5s, 6/6 plus, and iPod touch 5. These products have been designed, tested, and proven to work together as a system to produce accurate test results. The Smart Dongle meter should only be used with the Smart Dongle Blood Glucose test strips and the Smart Dongle ß-ketone test strips.
The provided text describes the TD-4140 Smart Dongle Blood Glucose plus ß-ketone Monitoring System, but only offers limited information on specific acceptance criteria for blood glucose and ß-ketone measurements. It reports accuracy and precision performance. The study described is a submission for 510(k) clearance, which typically involves demonstrating substantial equivalence to a predicate device through various performance characteristics, not necessarily a comparative effectiveness study with human readers.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state "acceptance criteria" but rather presents performance results against implicit standards for glucose and ß-ketone meters. The ranges below are derived from the reported accuracy tables for blood glucose and ß-ketone.
| Measurement Parameter | Acceptance Criteria (Implied from Performance Tables) | Reported Device Performance |
|---|---|---|
| Blood Glucose | ||
| Accuracy: | For glucose < 75 mg/dL: - Within 5 mg/dL (target of 100%) - Within 10 mg/dL (target of 100%) - Within 15 mg/dL (target of 100%) | Glucose < 75 mg/dL (N=78): - Within 5 mg/dL: 57 (73.1%) - Within 10 mg/dL: 78 (100%) - Within 15 mg/dL: 78 (100%) Glucose ≥ 75 mg/dL (N=402): - Within 5%: 272 (67.7%) - Within 10%: 386 (96.0%) - Within 15%: 402 (100%) - Within 20%: 402 (100%) (This implies stricter criteria are being met fully) |
| For glucose ≥ 75 mg/dL: - Within 5% (target of 100%) - Within 10% (target of 100%) - Within 15% (target of 100%) - Within 20% (target of 100%) | Intermediate Precision (Blood Glucose): - Level 1 (49.6 mg/dL): CV 4.38%- Level 2 (139.4 mg/dL): CV 3.13%- Level 3 (335.4 mg/dL): CV 3.01%Repeatability (Blood Samples - Glucose): - Level 1 (49.7 mg/dL): CV 4.39%- Level 2 (91.2 mg/dL): CV 3.23%- Level 3 (128.3 mg/dL): CV 3.16%- Level 4 (227.8 mg/dL): CV 3.15%- Level 5 (390.2 mg/dL): CV 3.09% | |
| Precision (CV%) | (Generally, CV% < 5% for glucose measurements is considered good, but specific criteria are not stated) | |
| ß-ketone | ||
| Accuracy: | For ketone < 2 mmol/L: - Within ±0.3 mmol/L (target of 100%) - Within ±0.5 mmol/L (target of 100%) | Ketone < 2 mmol/L (N=89): - Within ±0.3 mmol/L: 84 (94.4%) - Within ±0.5 mmol/L: 89 (100%) Ketone ≥ 2 mmol/L (N=31): - Within 5%: 14 (45.2%) - Within 10%: 26 (83.9%) - Within 15%: 29 (93.5%) - Within 20%: 31 (100%) - Within 25%: 31 (100%) (This implies stricter criteria are being met fully) |
| For ketone ≥ 2 mmol/L: - Within 5% (target of 100%) - Within 10% (target of 100%) - Within 15% (target of 100%) - Within 20% (target of 100%) - Within 25% (target of 100%) | Repeatability Precision (ß-ketone - Venous Blood): - Level 1 (0.520 mmol/L): CV 10.59%- Level 2 (2.887 mmol/L): CV 3.12%- Level 3 (5.030 mmol/L): CV 3.05%Intermediate Precision (ß-ketone - Control Solution): - Level 1 (0.593 mmol/L): CV 6.15%- Level 2 (2.583 mmol/L): CV 2.71% | |
| Precision (CV%) | (Generally, CV% < 10% for ketone measurements is often a benchmark, but specific criteria are not stated) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Blood Glucose Accuracy:
- For glucose < 75 mg/dL: N = 78
- For glucose ≥ 75 mg/dL: N = 402
- Total N for glucose accuracy: 480
- ß-ketone Accuracy: N = 120 (capillary blood sampling subjects)
- Ketone < 2 mmol/L: N = 89
- Ketone ≥ 2 mmol/L: N = 31
- Precision Tests (Glucose & ß-ketone): The document doesn't specify the exact number of samples or subjects for precision tests, only the "levels" of control solutions/blood samples tested.
- Data Provenance: Not specified. The document states the applicant company is in Taiwan, but it does not specify the country of origin for the clinical study data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not specified. The document describes electrochemical biosensor technology being used, and the "ground truth" for glucose and ß-ketone measurements would typically be established by a reference laboratory method (e.g., YSI for glucose, or a high-performance liquid chromatography (HPLC) method for ketones), not by human experts for this type of quantitative measurement.
4. Adjudication Method
Not applicable. For quantitative measurements by a device, ground truth is typically established by laboratory reference methods, not by expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not mention an MRMC comparative effectiveness study. This type of study is more common for diagnostic imaging or interpretation tasks, not for quantitative blood glucose and ß-ketone monitoring systems. The study presented focuses on the device's standalone analytical performance and substantially equivalence to a predicate device.
6. Standalone Performance
Yes, the studies reported are standalone performance studies of the algorithm/device. The tables provided show the accuracy and precision of the TD-4140 Smart Dongle Blood Glucose plus ß-ketone Monitoring System relative to reference measurements, without human intervention in the measurement process. The mobile application acts as a display component, but the core measurement and algorithmic analysis for glucose and ß-ketone are intrinsic to the dongle and test strips.
7. Type of Ground Truth Used
The ground truth for both glucose and ß-ketone measurements is implied to be based on laboratory reference methods. The document states, "The test strip is calibrated to display the equivalent of plasma glucose values to allow comparison of results with laboratory methods," strongly suggesting that such methods were used as the gold standard for comparison in accuracy studies.
8. Sample Size for the Training Set
Not specified. The document focuses on performance studies for regulatory submission (510(k)) and does not detail the internal development and training of any algorithms within the device. For electrochemical biosensors, "training" might refer to the calibration of the strips and meter rather than machine learning algorithm training.
9. How the Ground Truth for the Training Set Was Established
Not specified. As mentioned above, the concept of a "training set" and "ground truth establishment" in the context of machine learning is not explicitly addressed in this document. If algorithmic calibration was involved, it would likely use well-characterized reference solutions and laboratory methods, similar to the ground truth used for validation.
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