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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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(125 days)
The LinkDr 2.0 Diabetes Management Software is a PC-based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results for effective diabetes management. It is intended for use as an accessory to compatible All Medicus brand blood glucose monitoring systems such as the GlucoDr Supersensor blood glucose meter, GlucoDr Plus blood glucose meter and GlucoDr auto blood glucose meter.
The LinkDr 2.0 Diabetes Management Software is optional data management software for use with All Medicus brand blood glucose meters: GlucoDr Supersensor(K050985), GlucoDr Plus(K082328), and GlucoDr auto(K083628). The subject device consists of a LinkDr USB cable and software (provided in a CD). The LinkDr 2.0 Diabetes Management Software allows the transfer of data from the mentioned blood glucose meters to a personal computer (PC) for enhanced data management using graphic displays and analysis tools.
Here's a summary of the acceptance criteria and study details for the LinkDr 2.0 Diabetes Management Software, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
| Acceptance Criteria Requirement | Reported Device Performance |
|---|---|
| Data Accuracy Transmission | Bench Testing: All glucose values, flags (control solution, post-meal, pre-meal, exercise, stress), date, and time properly downloaded from the meters to the software. |
| Memory Data Rollover | Bench Testing: Memory data rollover functioned properly, with new glucose values replacing the oldest glucose values in meters that were pre-loaded with full memory (tested by adding 5 data points). |
| User Ease of Use | User Study: 100% of personal lay users and professional healthcare users rated the LinkDr 2.0 Diabetes Management Software as "easy or somewhat easy" for overall program setup and use. No users rated it as "somewhat difficult or difficult." |
| User Satisfaction | User Study: 100% of personal lay users and professional healthcare users reported satisfaction with the LinkDr 2.0 Diabetes Management Software and its manual. |
| Data Integrity | Stated Feature: Data transferred from the meter cannot be changed or modified in any way. (This is a design feature common to both the subject and predicate devices, confirmed by the general statement: "data transferred from the meter cannot be changed or modified in any way" when comparing to the predicate). Although not explicitly a "test result" in the performance section, it's a critical assurance for data management software. The performance tests regarding data accuracy transmission implicitly confirm this by verifying proper download of values, flags, date, and time, indicating data wasn't altered during transfer. |
Study Details
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Sample Size and Data Provenance (Test Set):
- Data Accuracy Transmission & Memory Rollover: The exact numerical sample size for "bench testing" is not specified but it involved testing with "each meter" (GlucoDr Supersensor, GlucoDr Plus, and GlucoDr auto). The data provenance is not explicitly stated in terms of country of origin but implies laboratory/bench testing conducted by All Medicus Co., Ltd. The data is prospective as it describes tests conducted specifically for this submission.
- User Study: The sample size for the user study (personal lay users and professional healthcare users) is not specified. The provenance is not explicitly stated, but it would have been conducted by All Medicus Co, Ltd., likely in their local region (Republic of Korea). The data is prospective.
-
Number of Experts and Qualifications (Ground Truth for Test Set):
- For Data Accuracy Transmission & Memory Rollover: No external experts are mentioned. The ground truth would have been based on the expected values directly from the blood glucose meters and the known behavior of memory rollover, assessed by the company's internal testing personnel.
- For User Study: No external experts are mentioned for establishing ground truth for the "ease of use" and "satisfaction" metrics. The ground truth was based on the direct responses and ratings of the study participants themselves, acting as the subjective "ground truth" for their own experience.
-
Adjudication Method (Test Set):
- For Data Accuracy Transmission & Memory Rollover: No adjudication method is described. Bench testing typically involves direct comparison of transferred data against source data or expected system behavior, likely with pass/fail criteria.
- For User Study: No adjudication method is described. User feedback was collected directly.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done. This device is a data management software, not an AI diagnostic tool where human reader performance with/without AI assistance would be relevant.
-
Standalone (Algorithm Only) Performance Study:
- Yes, the performance data presented (data accuracy transmission, memory rollover) pertains to the standalone performance of the software and its interaction with the meters, demonstrating its functionality without direct human interpretation of the output data for diagnostic purposes (though humans interact with the software interface). The user study also assesses the standalone user experience.
-
Type of Ground Truth Used:
- For Data Accuracy Transmission & Memory Rollover: The ground truth was based on the objective data values and flags directly from the compatible blood glucose meters and the designed functionality of memory management.
- For User Study: The ground truth was subjective user feedback and ratings (ease of use, satisfaction).
-
Sample Size for the Training Set:
- This document does not describe the use of machine learning or AI algorithms with "training sets" in the conventional sense. The software functions as a data transfer and display tool, not a predictive or interpretive algorithm that requires a training set. Therefore, no training set sample size is mentioned.
-
How Ground Truth for the Training Set Was Established:
- Not applicable, as no training set (for machine learning) is relevant to the description of this device. The software's development would have been based on specifications and requirements for data handling and user interface, rather than a labeled training dataset.
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(144 days)
The GlucoDr™ auto blood glucose monitoring system is intended for in vitro diagnostic use (i.e., for external use only) for quantitative measurement of glucose in venous, arterial and capillary whole blood. Testing sites include traditional fingertip site along with palm, upper arm, forearm, thigh, and calf.
The GlucoDr" auto blood glucose monitoring system may be used by healthcare professionals or for self testing by diabetic lay users in the mellitus at home as aid in monitoring the effectiveness of diabetes control program.
The GlucoDr" auto blood glucose monitoring system is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates.
The GlucoDr" auto control solution is for use with the GlucoDr™ auto test meters and strips as a quality control check to verify the accuracy of blood glucose test results.
The GlucoDr™ auto blood glucose monitoring system consists of GlucoDr™ auto Test Meter, GlucoDr™ auto Test strips and GlucoDr™ auto control solution.
The GlucoDr™ auto blood glucose monitoring system is based on measurement of electrical currents caused by the reaction of glucose with reagents on the gold electrode strip. Glucose in the sample reacts with glucose dehydrogenase and mediators. This reaction creates electrical currents. The subsequent electrical currents are proportional to the glucose concentration in the blood and converted to the equivalent glucose concentration by the algorithm programmed in the GlucoDr™ auto test meter.
The provided text is a 510(k) summary for the GlucoDr™ auto Blood Glucose Monitoring System. It describes the device's intended use, comparison to a predicate device, and conclusion of substantial equivalence. However, it does not contain the detailed study information requested, such as acceptance criteria, reported device performance, sample sizes, ground truth establishment, or any information about multi-reader multi-case studies or standalone performance.
Therefore, I cannot fulfill your request for this specific device based on the provided text. The document is a regulatory submission summary, not a detailed technical study report.
If you have a study report that contains this information, please provide it, and I will be happy to extract the requested details.
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(197 days)
The GlucoDr™ Plus system is intended for in vitro diagnostic use (i.e., for external use only) for quantitative measurement of glucose in venous whole blood and capillary whole blood. Testing sites include traditional fingertip site along with palm, arm and thigh.
The GlucoDr "1" Plus system may be used by healthcare professionals or for self testing by diabetic lay users with diabetes mellitus at home as aid in monitoring the effectiveness of diabetes control program.
The GlucoDr The Plus system is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates.
The GlucoDr™ Plus control solution is for use with the The GlucoDr™ Plus meters and strips as a quality control check to verify the accuracy of blood glucose test results.
The GlucoDr™ Plus system consists of GlucoDr™ Plus Test Meter, GlucoDr™ Plus Test strips and GlucoDr™ Plus control solution.
The GlucoDr™ Plus system is based on measurement of electrical currents caused by the reaction of glucose with reagents on the gold electrode strip. Glucose in the sample reacts with glucose dehydrogenase and mediators. This reaction creates electrical currents. The subsequent electrical currents are proportional to the glucose concentration in the blood and converted to the equivalent glucose concentration by the algorithm programmed in the GlucoDr™ Plus test meter.
The provided text is a 510(k) summary for the GlucoDr™ Plus System. However, it does not contain the acceptance criteria or a detailed study description proving the device meets acceptance criteria. The document primarily focuses on establishing substantial equivalence to a predicate device, device description, and intended use.
Therefore, I cannot provide the requested information from the given text. A typical 510(k) summary might refer to an internal report for validation studies, but the provided excerpts do not include that level of detail.
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(171 days)
The GlucoDr™ SuperSensor system is intended for in vitro diagnostic use (i. e., for external use only) for quantitative measurement of glucose in venous whole blood and capillary whole blood from the fingertip.
The GlucoDr™ SuperSensor system may be used by healthcare professionals or for self testing by diabetic lay users in the home.
The GlucoDr"M SuperSensor system is not intended for the diagnosis of or screening for diabetes mellitus.
The GlucoDr™ SuperSensor system is not intended for use on neonates.
The GlucoDr™ SuperSensor system consists of the GlucoDr™ SuperSensor Test Meter, GlucoDr™ SuperSensor Test strips and GlucoDr™ SuperSensor control solution. The GlucoDr™ SuperSensor system is based on measurement of electrical currents caused by the reaction of glucose with the regents on the glod electrode strip. Glucose in the sample reacts with glucose dehydrogenase and mediators. This reaction creates electrical currents. The subsequent electrical currents is proportional to the glucose concentration in the blood and converted to the equivalent glucose concentration by the algorithm programmed in the GlucoDr™ SuperSensor test meter.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The text provided is a 510(k) summary and related FDA correspondence for a medical device called the GlucoDr™ SuperSensor System, which primarily focuses on its substantial equivalence to a predicate device and its intended use. There are no details regarding specific performance metrics, test methodologies, sample sizes, or expert adjudication as requested in your prompt.
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