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510(k) Data Aggregation
(260 days)
GlucoDr.S Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip. Glucose Monitoring System is intended to be used by a single person and should not be shared. It 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.
GlucoDr.S Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoDr.S Blood Glucose Monitoring System is not for use in neonates.
GlucoDr.S Blood Glucose Test Strips are for use with GlucoDr.S Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
GlucoDr.S BLE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip. GlucoDr.S BLE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It 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.
GlucoDr.S BLE Blood Glucose Monitoring System should not be used for the diagnosis of or diabetes. GlucoDr.S BLE Blood Glucose Monitoring System is not for use in neonates.
GlucoDr.S BLE Blood Glucose Test Strips are for use with GlucoDr.S BLE Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
GlucoDr.S NFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip. GlucoDr.S NFC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It 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.
GlucoDr.S NFC Blood Glucose Monitoring System should not be used for the diagnosis of or diabetes. GlucoDr.S NFC Blood Glucose Monitoring System is not for use in neonates.
GlucoDr.S NFC Blood Glucose Test Strips are for use with GlucoDr.S NFC Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The subject systems are to measure and display glucose test results. The subject meters are portable devices using a battery with capability to store 500 test results in memory, and can search the stored test results with 7, 14, 30, 60, or 90-day average value of test results. This system provides beep, hypo/hyper warning limit, date/time setting, average period, and test reminder alarms settings.
The three systems which are GlucoDr.STM, GlucoDr.STM BLE, and GlucoDr.STM NFC are exactly the same devices except the data transfer features. The GlucoDr.S™ can transfer test results to a PC or to a smart device via a USB cable only, and the GlucoDr.S™M BLE offers Bluetooth data transfer features in addition to the USB cable port. The GlucoDr.S™ NFC offers NFC data transfer features in addition to the USB cable port.
The provided text describes the performance data for the GlucoDr.S Blood Glucose Monitoring System, including acceptance criteria and study results.
Here's the breakdown as requested:
1. A table of acceptance criteria and the reported device performance
The document provides performance data primarily for Precision Evaluation and Linearity Evaluation.
Precision Evaluation Study (Measured mg/dL)
| Samples | Acceptance Criteria (Pooled STD or CV) | Reported Pooled STD (mg/dL) | Reported Pooled CV (%) |
|---|---|---|---|
| Repeatability | |||
| Level 1 (39.1 mg/dL) | STD < 4 mg/dL | 2.7 | 6.3 |
| Level 2 (85.5 mg/dL) | STD < 4 mg/dL | 3.2 | 3.9 |
| Level 3 (121 mg/dL) | CV < 4% | 4.2 | 3.7 |
| Level 4 (205 mg/dL) | CV < 4% | 6.3 | 3.4 |
| Level 5 (352 mg/dL) | CV < 4% | 11.7 | 3.7 |
| Intermediate Precision | |||
| Level 1 (37.2 mg/dL) | STD < 4 mg/dL | 1.4 | 3.7 |
| Level 2 (80.4 mg/dL) | STD < 4 mg/dL | 1.8 | 2.2 |
| Level 3 (118 mg/dL) | CV < 4% | 2.6 | 2.2 |
| Level 4 (200 mg/dL) | CV < 4% | 3.5 | 1.7 |
| Level 5 (353 mg/dL) | CV < 4% | 7.4 | 2.1 |
Linearity Evaluation Study
| Metric | Acceptance Criteria (Implied by equivalence, usually R^2 close to 1, slope close to 1) | Reported Performance (Range across 3 lots) |
|---|---|---|
| Slope | Not explicitly stated but implied linearity acceptance | 0.97622 to 0.99754 |
| R^2 | Not explicitly stated but implied linearity acceptance | 0.99827 to 0.99951 |
| Claimed Linear Range | 20 to 600 mg/dL (supported by results) | Data supports 20 to 600 mg/dL |
Accuracy Studies (Lay User Study - Capillary Blood Samples vs. YSI Model 2300 STAT Plus Glucose Analyzer)
For glucose concentration < 75 mg/dL:
| Performance Metric | Site 1 | Site 2 | Site 3 | Total |
|---|---|---|---|---|
| Within ± 5 mg/dL | 0/1 (0%) | 7/7 (100%) | 5/7 (71.4%) | 12/15 (80%) |
| Within ± 10 mg/dL | 1/1 (100%) | 7/7 (100%) | 7/7 (100%) | 15/15 (100%) |
| Within ± 15 mg/dL | 1/1 (100%) | 7/7 (100%) | 7/7 (100%) | 15/15 (100%) |
For glucose concentration ≥ 75 mg/dL:
| Performance Metric | Site 1 | Site 2 | Site 3 | Total |
|---|---|---|---|---|
| Within ± 5 % | 103/142 (72.5%) | 118/161 (73.3%) | 71/87 (81.6%) | 292/390 (74.9%) |
| Within ± 10 % | 137/142 (96.5%) | 156/161 (96.9%) | 87/87 (100%) | 380/390 (97.4%) |
| Within ± 15 % | 142/142 (100%) | 161/161 (100%) | 87/87 (100%) | 390/390 (100%) |
Note: The document states "Study results indicate that the measurements of the GlucoDr.S™ meter were within acceptance criteria for the entire HCT range of 20-65%." but does not provide the specific numeric acceptance criteria for hematocrit or interferences.
2. Sample size used for the test set and the data provenance
- Precision Evaluation:
- Repeatability: 5 venous blood samples, 10 replicates each, with 3 test strip lots and 10 meters.
- Intermediate Precision: 5 glucose control solutions, 10 replicates each, with 3 test strip lots and 10 meters.
- Linearity Evaluation: 15 levels of glucose concentrations, 3 lots of test strips.
- Interference Testing: 30 potential interfering substances, 3 lots of test strips, 3 glucose concentrations of venous blood samples, 10 replicates each.
- Hematocrit Interference: 6 glucose concentration levels of venous blood samples, 10 replicates each, 3 lots of test strips.
- Sample Volume: 4 glucose concentration levels, 3 sample volumes, 3 lots of blood glucose test strips.
- Temperature and Humidity Effects: 4 concentrations of blood samples, 10 replicates each, 3 test strip lots.
- Altitude Effects: 4 concentrations of venous blood samples.
- Lay User Study (Accuracy): 405 patients for capillary blood samples.
- Data Provenance: Not explicitly stated regarding country of origin for patient data. Often, such studies are conducted by the manufacturer, in this case, All Medicus Co., Ltd. (Republic of Korea). The studies appear to be prospective, specifically designed to test the device performance as part of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The ground truth for glucose measurements in the performance studies (precision, linearity, accuracy, interferences, hematocrit, environmental effects) was established using a YSI Model 2300 STAT Plus Glucose Analyzer as the reference method. This is an automated laboratory analyzer, not human experts. Therefore, the concept of "experts establishing ground truth" as it applies to image interpretation or clinical diagnosis by human readers is not directly applicable here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The ground truth was established by an objective, automated laboratory reference method (YSI 2300 STAT Plus Glucose Analyzer), not through human interpretation requiring adjudication.
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 device is a blood glucose monitoring system, not an AI-powered diagnostic imaging tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The performance evaluations for the GlucoDr.S Blood Glucose Monitoring System were effectively "standalone" in the sense that the device's measurements were compared directly against the reference method (YSI 2300) without human interpretation being part of the primary measurement loop. The "Lay User Study" evaluates user performance, which includes human interaction, but the core measurement is still by the device itself, not by a human interpreting device output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for quantitative glucose measurements was established using an objective, laboratory-based reference method: the YSI Model 2300 STAT Plus Glucose Analyzer. This is considered a highly accurate and precise method for determining glucose concentration.
8. The sample size for the training set
The document does not explicitly mention a "training set" in the context of machine learning. This is a traditional medical device submission for an in vitro diagnostic device, not an AI/ML-based device that typically undergoes separate training and test phases. The studies described are performance validation studies.
9. How the ground truth for the training set was established
As there is no mention of a "training set" for an AI/ML model, this question is not applicable in the context of this device's submission. The described studies focus on validation of the device's performance against established laboratory standards.
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