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510(k) Data Aggregation
(121 days)
The Livongo Blood Glucose Monitoring System (BG1000) is composed of the Livongo Blood Glucose Meter (BG1000) and Livongo Blood Glucose Test Strips (BG1000).
The system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. The system is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control programs. The Livongo Blood Glucose Monitoring System (BG1000) is intended for single-patient use and should not be shared.
The system is for in vitro diagnostic use and is not intended for the diagnosis of or diabetes, nor intended for use on neonates.
The Livongo Blood Glucose Monitoring System (BG1000) is an Over-The-Counter (OTC) system designed for the self-monitoring of blood glucose by persons with diabetes in home settings to aid in their diabetes management. The system consists of the following components:
- Livongo Blood Glucose Meter (BG1000) ("Livongo meter")
- Livongo Blood Glucose Test Strips (BG1000) ("Livongo test strips")
- Livongo Lancing Device - class I accessory
- Livongo Lancets
- Livongo Level 1 Control Solution
- Livongo Level 2 Control Solution
- AC Adapter (wall charger) and USB Charger Set
- Carrying Case
The Livongo meter is a cellular-connected handheld device that monitors glucose in the blood to help with the management and treatment of diabetes. The meter also incorporates additional features to aid in self-monitoring of blood glucose including tables and logs, graphs. The blood glucose levels are displayed on the screen and stored in the meter's memory, and may also be transmitted over a cellular network to a secure server.
The Livongo test strips will be packaged in 50 count of strips in sealed vials.
The Livongo Control Solutions consist of an aqueous based mixture prepared with a known amount of glucose concentration. It is available in two levels, Level 1 and Level 2.
The Livongo Blood Glucose Monitoring System (BG1000) underwent extensive testing to establish its performance and demonstrate substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and supporting study details:
1. Table of Acceptance Criteria & Reported Device Performance
The acceptance criteria for blood glucose monitoring systems typically align with ISO 15197 standards. While specific acceptance criteria are not explicitly enumerated with numerical targets for each performance metric in the provided text, the qualitative statements and the nature of the tests performed (precision, linearity, interference, user evaluation) imply adherence to recognized standards for accuracy and reliability in blood glucose measurement. The "Discussion of Substantial Equivalence" explicitly states that testing demonstrated the candidate device is substantially equivalent, which implies meeting performance benchmarks comparable to predicate devices and relevant standards.
To infer the implied acceptance criteria from the reported performance, we look for statements confirming the results were "within" acceptable ranges or demonstrated "accurate readings."
| Acceptance Criteria (Inferred from Performance Statements) | Reported Device Performance (Summary from provided K200277) |
|---|---|
| Precision: Glucose readings are consistent within acceptable ranges. | Within-Run Precision: SD or %CV values reported are low (e.g., 1.49 mg/dL to 2.33 mg/dL for lower concentrations, 2.5% to 2.7% for higher concentrations). |
| Intermediate Precision: SD or %CV values reported are low (e.g., 1.41 mg/dL to 2.30 mg/dL for lower concentrations, 2.2% to 2.9% for higher concentrations). | |
| Linearity: Device accurately measures glucose across its specified testing range. | Linear regression analysis results show high R² values (0.9968 to 0.9984) and slopes close to 1, with small y-intercepts. This "support[s] the glucose measurement range of 40-600 mg/dL." |
| Interference (Hematocrit): Glucose measurement is not significantly affected by varying hematocrit levels. | Bias of measurement was within ±10 mg/dL for glucose concentration level 1, and within ±8% for glucose concentration levels 2-6, with no individual value having a bias greater than 15%. This confirms "accurate readings for the specified hematocrit range of 10%-70%." |
| Robustness (Flex Studies): System maintains performance under various environmental and operational stresses. | "System operated within its specified operating ranges even under stress conditions, and errors were correctly displayed when outside the meter's operating ranges." This includes mechanical vibration and shock, operating conditions (temperature/humidity), altitude, stability, samples outside range, short sample detection, sample perturbation, intermittent sampling, and used strips. |
| Electromagnetic Interference (EMI) & Electrical Safety: Device complies with relevant safety and EMI standards. | System "passed electrical and safety testing according to national and international standards including IEC 61010-1, IEC 61010-2-101, IEC 61000-3-2, IEC 61000-3-3, IEC 61000-4-2, and IEC 61000-4-8." Also passed EMC testing to "IEC 60601-1-2, FCC 47 CFR 15 Part B, and PTCRB." |
| Software: Software functionality meets design requirements and safety standards. | "Testing and documentation for Moderate level of concern software was completed" per FDA guidance. |
| Clinical Performance (User Evaluation): Lay users can operate the device accurately and are satisfied with ease of use. | Study results indicated that "non-professional, inexperienced lay persons were able to obtain blood glucose readings... comparable to the comparator YSI 2300 obtained by trained technicians." Furthermore, "participating lay persons were questioned and responded as satisfied with the ease of operation... and the overall performance." |
2. Sample Size Used for the Test Set and Data Provenance
- Precision Evaluation (Within-Run & Intermediate):
- Sample Size: Ten replicate assays were run on ten Livongo meters using three strip lots for each of six glucose concentration levels.
- Data Provenance: The study used "heparinized venous blood samples." The document does not specify the country of origin, but it is a non-clinical/laboratory study.
- Linearity Evaluation:
- Sample Size: Blood samples were prepared at eleven glucose concentration levels and run on 10 meters using test strips from three lots.
- Data Provenance: The document does not specify the country of origin. It is a non-clinical/laboratory study using prepared blood samples.
- Interference – Hematocrit:
- Sample Size: Whole blood samples were prepared to hematocrit levels across the claimed range at 5% intervals with six glucose concentration levels. Test strips from three lots were used.
- Data Provenance: The document does not specify the country of origin. It is a non-clinical/laboratory study using prepared blood samples.
- Clinical (User Evaluation) Study:
- Sample Size: Not explicitly stated but implied to be a cohort of "lay persons."
- Data Provenance: "Simulated home environment." The document does not specify the country of origin or whether it was retrospective or prospective, but a "user evaluation" implies a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- All Non-Clinical Studies (Precision, Linearity, Hematocrit): The ground truth was established by a "YSI (Model 2300 STAT PLUS) Glucose Analyzer reference instrument, which is traceable to NIST reference standard." This is an analytical reference method, not human experts.
- Clinical (User Evaluation) Study: The ground truth for comparative blood glucose readings was obtained by "trained technicians" using the YSI 2300 Stat Plus Glucose Analyzer. The number and specific qualifications of these technicians are not provided.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. The ground truth was established by a reference analytical instrument or trained technicians using a reference instrument, not by expert consensus requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The clinical study was a user evaluation demonstrating the ability of lay persons to use the device accurately, not a comparative study of human readers with vs. without AI assistance. The device itself is a standalone measurement system, not an AI-assisted diagnostic tool for human interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance
Yes, the device's performance in the non-clinical studies (precision, linearity, interference, flex studies) directly demonstrates its standalone (algorithm only) performance when measuring glucose. The "user evaluation" study then assessed the ability of lay users to successfully operate this standalone system.
7. Type of Ground Truth Used
- Non-Clinical Studies (Precision, Linearity, Hematocrit): The ground truth was established using an analytical reference instrument, specifically the "YSI (Model 2300 STAT PLUS) Glucose Analyzer," which is traceable to the NIST reference standard.
- Clinical (User Evaluation) Study: The ground truth was established by trained technicians using the "YSI 2300 Stat Plus Glucose Analyzer."
8. Sample Size for the Training Set
The document does not provide information about a "training set" in the context of machine learning or AI. This device is a blood glucose meter, and its performance is typically evaluated through analytical and clinical validation studies, not by training a machine learning model on a distinct training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for a machine learning model is mentioned in the context of this device.
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(114 days)
The On Call Sure Blood Glucose Monitoring System is comprised of the On Call Sure Blood Glucose Meter and On Call Sure Blood Glucose Test Strips. The On Call Sure Blood Glucose Monitoring System is intended to the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm. The On Call Sure Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. The On Call Sure Blood Glucose Monitoring System is intended for single-patient use and should not be shared.
The On Call Sure Blood Glucose Monitoring System is for in vitro diagnostic use. The On Call Sure Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The On Call Sure Sync Blood Glucose Monitoring System is comprised of the On Call Sure Sync Blood Glucose Meter and On Call Sure Blood Glucose Test Strips. The On Call Sure Sync Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm. The On Call Sure Sync Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. The On Call Sure Sync Blood Glucose Monitoring System is intended for single-patient use and should not be shared.
The On Call Sure Sync Blood Glucose Monitoring System is for in vitro diagnostic use. The On Call Sure Sync Blood Glucose Monitoring System is not intended for the diagnosis of or diabetes, nor intended for use on neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The On Call Sure Blood Glucose Monitoring System and On Call Sure Sync Blood Glucose Monitoring System are designed for the quantitative measurement of glucose in fresh capillary whole blood samples obtained from the fingertip, forearm, and/or palm.
Both systems have almost the same meter design and use the same strip and control solution. The only difference is that On Call Sure Sync Blood Glucose meter is embedded with a Bluetooth module which results in an additional Bluetooth data transfer feature for this meter. Thus, the On Call Sure Blood Glucose Monitoring System and On Call Sure Sync Blood Glucose Monitoring System can be considered equivalent for the performance of glucose testing.
Both systems share the same On Call Sure Blood Glucose test strip. It has a reagent system that includes glucose dehydrogenase (FAD-GDH) and a mediator that reacts with the glucose in the whole blood sample to produce an electrical current signal. This current is measured using an amperometric detection method. The meter then calculates and displays the blood glucose concentration reading, calibrated to plasma reference. The On Call Sure / On Call Sure Sync Blood Glucose Meters are auto-coding.
Both systems consist of the On Call Sure / On Call Sure Sync Blood Glucose Meter, On Call Sure Blood Glucose Test Strips, and On Call Sure Clucose Control Solutions. Kits may be marketed with various combinations and quantities of the system components, or each of the components may be sold separately. All meter kits include a Carrying Case, User's Manual, Ouick Reference Guide, Warranty Card and Logbook. Materials needed but not provided include a single user lancing device and sterile lancets.
The On Call Sure Glucose Control Solutions are used to confirm that the meter and test strips are working properly. Glucose control solution(s) is/are viscosity-adjusted, buffered aqueous control solutions that contain known concentrations of d-glucose. Two control solution levels are available (Level 1 and Level 2). Level 1 is provided with the system. Level 2 is sold separately.
Both meters have a USB data transfer function that is inactive, pending validation with the On Call Diabetes Management Software (K131469). Only the On Call Sure Sync Blood Glucose Meter is equipped with Bluetooth.
The On Call Sure Sync Blood Glucose Meter is designed with a Bluetooth module which can send glucose test results to a mobile device if the glucose meter and the mobile device are paired and within range.
The acceptance criteria and study proving the device meets them are detailed below based on the provided FDA 510(k) summary. The device in question is the ACON Laboratories, Inc. On Call Sure Blood Glucose Monitoring System and On Call Sure Sync Blood Glucose Monitoring System.
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is compared against the FDA Guidance for Industry and Food and Drug Administration Staff - Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (2016) regarding accuracy. The acceptance criteria for glucose meters typically follow an established standard, in this case, a combination of ISO 15197:2015 and FDA guidance.
| Acceptance Criteria (FDA Guidance 2016) | Reported Device Performance (On Call Sure Sync BGMS) - User Evaluation Study (All 3 Lots Combined Capillary Blood Samples) | Reported Device Performance (On Call Sure Sync BGMS) - Accuracy at Extreme Glucose Values Study (All 3 Lots Combined Capillary Blood Samples) |
|---|---|---|
| **For glucose concentrations 95% of results within ± 15 mg/dL of comparator | 100.0% within ± 15 mg/dL (264/264) | |
| >99% of results within ± 20 mg/dL of comparator | 100.0% within ± 20 mg/dL (264/264) | |
| For glucose concentrations ≥ 80 mg/dL: | High Glucose Level (250-600 mg/dL): | |
| >95% of results within ± 15% of comparator | Fingertip: 99.5% within ± 15% (364/366) | |
| Palm: 98.9% within ± 15% (362/366) | ||
| Forearm: 98.1% within ± 15% (359/366) | 93.4% within ± 10% (171/183) | |
| 100.0% within ± 15% (183/183) | ||
| >99% of results within ± 20% of comparator | Fingertip: 100.0% within ± 20% (366/366) | |
| Palm: 100.0% within ± 20% (366/366) | ||
| Forearm: 100.0% within ± 20% (366/366) | 100.0% within ± 20% (183/183) | |
| Overall Acceptance Criteria: 95% of all SMBG results are within 15% (or 15 mg/dL for 250 mg/dL. Each contrived sample was measured in duplicate for each of the 3 lots, resulting in: |
* Low Glucose: 88 samples * 3 lots = 264 measurements
* High Glucose: 61 samples * 3 lots = 183 measurements
- Data Provenance: The studies were conducted as part of a premarket notification (510(k)) submission to the FDA, implying they were performed for regulatory approval purposes. While the specific country of origin for the study participants is not explicitly stated, the submission is from ACON Laboratories, Inc., located in San Diego, California, USA, and follows FDA guidance, suggesting the studies were likely conducted in the United States or under similar clinical regulatory standards. The studies were prospective in nature, involving active recruitment of subjects to use the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- The ground truth reference method used was the YSI Model 2300 STAT PLUS Glucose Analyzer (K913806).
- The document states that the YSI 2300 glucose measurement results were obtained by trained technicians. No specific number of experts (technicians) is provided, nor are their detailed qualifications (e.g., years of experience). The YSI 2300 STAT PLUS is a laboratory-grade reference instrument often used for establishing ground truth in glucose monitoring studies.
4. Adjudication Method for the Test Set
- For the user evaluation study, the trained technician collected capillary blood samples in microtainer tubes (with heparin anticoagulant) to be measured on the YSI 2300 Stat Plus Glucose Analyzer in duplicate. This duplicate measurement likely served as an internal check for the reference method, but there is no explicit mention of an adjudication method used to resolve discrepancies between device readings and the reference, or between multiple reference measurements, beyond the duplicate testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size (Human Readers Improve with AI vs. Without AI Assistance)
- This device is a blood glucose monitoring system intended for self-testing by individuals with diabetes. It is a standalone analytical instrument and does not involve "human readers" interpreting medical images or data assisted by AI for diagnosis. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device. The studies focused on the accuracy of the device itself when used by lay persons compared to a laboratory reference.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, a standalone performance evaluation (algorithm only, in the sense of the device's internal measurement and calculation) was a core component of the non-clinical testing. This included:
- Precision/Reproducibility: Repeatability and Intermediate Precision studies were conducted using the device on venous blood samples and control solutions.
- Linearity/Assay Reportable Range: Evaluated the device's ability to accurately measure glucose across its claimed range using prepared blood samples.
- Analytical Specificity (Interference): Tested the device's accuracy in the presence of various interfering substances.
- Stability, Detection Limit, Hematocrit Effect, Temperature Effect, Altitude Effect, Sample Volume, Humidity Effect, etc.: These are all tests of the device's inherent analytical performance without direct human interpretation of results beyond performing the test procedure.
- The "User Evaluation Study" involved lay persons operating the device, but the focus was on the system accuracy (device + user) compared to the reference, rather than an "algorithm-only" performance in isolation from user impact.
7. The Type of Ground Truth Used
- The ground truth used for both the user evaluation study and the accuracy at extreme glucose values study was a laboratory reference method: the YSI Model 2300 STAT PLUS Glucose Analyzer. This is a widely accepted standard for determining glucose concentrations in blood samples.
8. The Sample Size for the Training Set
- This document is a 510(k) summary for a traditional blood glucose meter, not an AI/ML-driven device that typically relies on large "training sets" in the same way. The device's measurement principles are based on established electrochemical enzymatic assays. Any internal calibration or algorithm development would likely have been performed using laboratory data during the device's development phase, but specific "training set" sizes are not applicable/provided in the context of this traditional device submission.
9. How the Ground Truth for the Training Set Was Established
- As noted above, a distinct "training set" in the context of AI/ML is not applicable here. For the device's internal calibration and analytical performance development (if a similar term were to be used), the ground truth for establishing values (e.g., for control solutions) was determined by an in-house procedure using the YSI reference method. The On Call Sure and On Call Sure Sync Blood Glucose Monitoring System is also stated to be traceable to the NIST SRM 917b reference material.
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(450 days)
VivaChek™ Ino Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Blood Glucose Meter and the VivaChek™ Ino Blood Glucose Test Strips. The VivaChek™ Ino Blood Glucose Monitoring System (Meter Model: VGM01) is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. It allows diabetics to take blood samples from the fingertip, forearm, or palm. It is used at home as a way to monitor the effectiveness of diabetes control programs. Alternate testing sites (forearm and palm) should be used only during steady-state times (when blood glucose level is not changing rapidly). This system is intended to be used by a single patient and should not be shared.
The VivaChek™ Ino Blood Glucose Monitoring System is not used for the diagnosis of or screening of diabetes or for neonatal use.
The VivaChek™ Ino Blood Glucose Control Solution is for use with the VivaChek™ Ino Blood Glucose Meter and Strips as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly.
The VivaChek™ Ino Blood Glucose Monitoring System (Meter Model: VGM01) is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. The glucose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose enzyme and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed. The meter is calibrated to display plasma-like concentration results.
All 3 levels control solution consists of glucose in water with buffers and a preservative, and a dye. The device is formulated to provide low, normal and high ducose values representative of low, normal and high blood glucose values in subjects. The active ingredient, glucose, is the same analyte measured in blood specimens by the relevant blood glucose test systems. The proprietary characteristics of the solution have been modified to mimic the measurement of blood specimens with this non - biological, non - toxic, aqueous solution. The product does not contain red blood cells, and so, cannot be used to assess hematocrit effects on glucose measurement. The solution has a red color to enhance its visibility.
The VivaChek™ Ino Blood Glucose Monitoring System underwent various tests to demonstrate its accuracy and establish substantial equivalence to predicate devices. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text references compliance with EN ISO 15197:2013, which specifies accuracy requirements for blood glucose monitoring systems. While the exact performance metrics from the VivaChek Ino study are not explicitly listed in a direct comparison table within this document, the overall conclusion states that the device "meets the accuracy requirements per EN ISO 15197."
For blood glucose monitoring systems, EN ISO 15197:2013 typically sets the following accuracy criteria against a laboratory reference method (e.g., YSI):
| Acceptance Criteria (EN ISO 15197:2013) | Reported Device Performance (VivaChek™ Ino) |
|---|---|
| **For glucose concentrations |
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(85 days)
YSI Model 2300 STAT PLUS (K913806)
The On Call® Express Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm. The On Call Express Pro Blood Glucose Monitoring System is intended for multiple patient use by health care professionals in health care facilities as an aid to monitoring the effectiveness of diabetes control programs. The system should only be used with single-use, auto disabling lancing devices.
The On Call Express Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates. Alternative site testing (AST) testing should only be done during steady-state times (when glucose is not changing rapidly).
The On Call Express Pro Blood Glucose Test Strips are used with the On Call Express Pro Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm. The On Call Express Pro Blood Glucose Control Solution is for use with the On Call® Express Pro Blood Glucose Meter and Strips as a quality control check to verify the accuracy of blood glucose test results.
The On Call Express Pro Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip, palm and forearm. The glucose measurement is achieved by using the amperometric detection method.
The test strip has a reagent system including glucose oxidase and a mediator that reacts with glucose in the whole blood sample to produce an electrical current is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed on the meter display, calibrated to a plasma reference.
The On Call Express Pro Blood Glucose Monitoring System contains a blood glucose meter and On Call Express Pro blood glucose test strips. This is a no code meter. The On Call Express Pro Blood Glucose Monitoring System consists of the On Call Express Pro Blood Glucose Meter, On Call Express Pro Blood Glucose control solutions (Level 1 and Level 2), Carrying Case, User's Manual, Warranty Card and Logbook. Materials needed but not provided are the On Call Express Pro Blood Glucose Test strips and disposable, single use lancing devices.
Control solution(s) is/are viscosity-adjusted, buffered aqueous control solutions that contain known concentrations of d-glucose. The products are intended for use to verify the performance of the On Call Express Pro Blood Glucose Monitoring System
On Call Express Pro Blood Glucose Monitoring System has a data transfer function.
Data Port sends information to a computer via an optional data transfer cable. It allows users to view, analyze and print stored data in the meter. The data transfer cable is available for order as an optional add-on. The meter can transfer stored test results to a Windows-based personal computer (PC) using an optional data transfer cable and the On Call® Diabetes Management Software (K131469). The software has been validated for use with On Call Express meter (K132086) which is the exact same device as On Call Express Pro meter.
Here's a summary of the acceptance criteria and the study details for the On Call® Express Pro Blood Glucose Monitoring System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for blood glucose monitoring systems are generally outlined in ISO 15197:2013. While the document doesn't explicitly state the acceptance criteria thresholds (e.g., specific percentages for each glucose range), it reports the device's performance against typical accuracy categories. The FDA guidance mentioned ("FDA Guidance for Industry In-Vitro Diagnostic Glucose Test System") would also refer to these standards.
Below is a combined table showing the reported device performance for both the Method Comparison Study (Healthcare Professionals) and the User Performance Study (Lay Persons). The implicit acceptance criteria are that the device performance meets or exceeds these reported percentages, aligning with regulatory standards for glucose meters.
Method Comparison Study (Healthcare Professionals)
| Glucose Level Range | Acceptance Criteria (Implicit) | Reported Device Performance (Fingertip) | Reported Device Performance (Forearm) | Reported Device Performance (Palm) |
|---|---|---|---|---|
| **Glucose |
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(318 days)
The On Call Sharp Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative site testing should be done only during steady-state times (when blood glucose level is not changing rapidly). The On Call Sharp Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only.
The On Call Sharp Blood Glucose Monitoring System in not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates.
The On Call Sharp Blood Glucose Test Strips are used with the On Call Sharp Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm."
The On Call Sharp Blood Glucose Control Solutions are for use with the On Call Sharp Blood Glucose Meter and On Call Sharp Blood Glucose Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.
For In Vitro Diagnostic Use
The On Call Sharp Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip, palm and forearm. The glucose measurement is achieved by using the amperometric detection method.
The test strip has a reagent system including flavin adenine dinucleotide-glucose dehydrogenase (GDH-FAD) enzyme chemistry and a mediator that reacts with glucose in the whole blood sample to produce an electrical current. This current is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed on the meter display, calibrated to a plasma reference.
The provided text describes the "On Call Sharp Blood Glucose Monitoring System" and its performance evaluation. Here's a summary of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The submission mentions compliance with EN ISO 15197:2003 "In vitro diagnostic test systems - Requirements for in vitro whole blood glucose monitoring systems intended for use by patients for self testing in management of diabetes mellitus." This standard typically sets the accuracy requirements for blood glucose monitoring systems. While the exact numerical criteria from ISO 15197 are not explicitly stated in the provided text, the conclusion affirms that the device "meets the accuracy requirements per EN ISO 15197."
Based on the information provided, a table detailing specific acceptance criteria and reported device performance from the clinical study, particularly regarding accuracy, would typically present comparisons between device readings and a reference method (like YSI Model 2300 STAT PLUS). However, the document only broadly states that the device "meets the accuracy requirements per EN ISO 15197."
General Features and Specifications (as acceptance criteria for technical characteristics):
| Feature | Acceptance Criteria (Specification) | Reported Device Performance (as per specification) |
|---|---|---|
| Measurement Range | 20 to 600 mg/dL (1.1-33.3 mmol/L) | 20 to 600 mg/dL (1.1-33.3 mmol/L) |
| Result Calibration | Plasma-equivalent | Plasma-equivalent |
| Sample | Fresh capillary whole blood | Fresh capillary whole blood |
| Minimum Sample Size | 0.8 µL | 0.8 µL |
| Test Time | 5 seconds | 5 seconds |
| Battery Life | Minimum of 1,000 measurements | Minimum of 1,000 measurements |
| Hematocrit Range | 25-70% | 25-70% |
| Operating Temperature | 10-45°C (50-113°F) | 10-45°C (50-113°F) |
| Operating Relative Humidity | 10-90% (non-condensing) | 10-90% (non-condensing) |
| Coding | Auto Coding by meter automatic recognition | Auto Coding by meter automatic recognition |
| Meter Memory | Up to 500 records with time and date | Up to 500 records with time and date |
| User Satisfaction | Users satisfied with ease of operation and overall performance | Acknowledged via lay person questionnaire |
The specific accuracy data (e.g., mean bias, percentage of readings within certain error margins) required by ISO 15197 is not detailed in this summary. The summary only concludes that the device meets these requirements.
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact numerical sample size (number of participants or measurements) used in the clinical studies for the test set. It mentions studies were conducted with "lay persons and trained laboratory technicians."
- Data Provenance: The document does not explicitly state the country of origin. It indicates that the studies were performed using the ACON Clinical Study Protocol for the Blood Glucose Monitoring System, implying an internal or sponsored study. The clinical studies were performed to evaluate system accuracy compared to a reference method. It's a prospective study as it involves conducting clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: The document mentions "trained laboratory technicians" performed comparative readings. It does not specify the number of technicians involved.
- Qualifications of Experts: The experts are described as "trained laboratory technicians." Specific qualifications (e.g., years of experience, certifications) are not provided.
4. Adjudication method for the test set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "trained laboratory technicians" used the YSI Model 2300 STAT PLUS as a reference method. The comparison was between the device readings by lay persons and the results obtained by these technicians using the reference device.
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
There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed, nor is there any mention of AI assistance. This device is a standalone blood glucose monitoring system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone system for measuring blood glucose. The performance evaluation includes both its internal accuracy (laboratory testing) and its use by "lay persons" (human-in-the-loop). The "algorithm only" performance would be equivalent to the device's accuracy when operated correctly, which is implied by the laboratory testing and comparison to the YSI reference. The clinical study also involved assessing accuracy when used by lay persons, which is a key aspect of real-world "human-in-the-loop" performance for a self-monitoring device.
7. The type of ground truth used
The ground truth for the accuracy evaluation was established using a reference method, specifically the YSI Model 2300 STAT PLUS (K913806), which is a laboratory-grade analyzer for glucose measurement.
8. The sample size for the training set
The document does not provide information about a separate "training set" or its sample size. For medical devices like this, performance is typically evaluated against established standards and reference methods in validation studies, rather than a machine learning training/test set paradigm.
9. How the ground truth for the training set was established
As no specific "training set" for a machine learning algorithm is mentioned, information on how its ground truth was established is not applicable or provided. The device relies on established electrochemical principles and calibration against reference methods.
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(167 days)
The On Call® Express Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative should be done only during steady-state times (when blocd glucose level is not changing rapidly).
The On Callo Express Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only.
The On Call® Express Blood Glucose Monitoring System in not intended for the diagnosis of or diabetes, nor intended for use on neonates. The On Call® Express Blood Glucose Test Strips are used with the On Call Express Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.
The On Call® Express Blood Glucose Control Solutions are for use with the On Call® Express Blood Glucose Meter and On Call® Express Blood Glucose Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.
The On Call Express Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip, palm and forearm. The glucose measurement is achieved by using the amperometric detection method.
The test strip has a reagent system including glucose oxidase and a mediator that reacts with glucose in the whole blood sample to produce an electrical current. This current is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed on the meter display, calibrated to a plasma reference.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the On Call Express Blood Glucose Monitoring System are based on the EN ISO 15197:2003 standard. The document states that the device "meets the accuracy requirements per EN ISO 15197:2003." Unfortunately, the specific numerical acceptance criteria from EN ISO 15197:2003 and the exact corresponding reported device performance values (e.g., % of results within ±15% or ±20% of reference for specific glucose ranges) are not detailed within the provided text. The text only provides a list of performance characteristics tested.
Therefore, the table below will list the relevant performance characteristics mentioned as being evaluated against the ISO standard in the "Laboratory Testing" section, and indicate that the exact reported performance values are not provided, but that the device meets the ISO standard.
| Acceptance Criteria Category (from ISO 15197:2003) | Reported Device Performance (as stated in document) |
|---|---|
| Repeatability precision | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Intermediate precision | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Accuracy evaluation | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 (compared to YSI Model 2300 STAT PLUS) |
| User performance | Evaluated (lay persons obtained comparable readings to trained technicians); device meets accuracy requirements per EN ISO 15197:2003 |
| Linearity | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Interfering agents | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Altitude effect | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| System traceability | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Validation of calibration control materials | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Hematocrit effect | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Temperature effect evaluation (blood & control solution) | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Low battery effect evaluation | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Sample volume | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Humidity effect | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Simulated shipping studies (test strip & control solution) | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Accelerated Use Life (control & strip) | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| 65° Accelerated Stability (Strip & Control) | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Packaging, vibration, drop tests, temperature exposure, humidity exposure | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Control value assignment | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Virucidal, efficacy validation | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Meter cleaning and disinfection | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Meter testing | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Software validation testing | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Electromagnetic compatibility and electrical safety testing (per EN/IEC 61010-1 & 61010-2-101) | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the sample size (number of patients or measurements) for the clinical studies involving lay persons and trained laboratory technicians. It simply mentions "clinical studies were conducted with lay persons and trained laboratory technicians."
- Data Provenance: The document does not specify the country of origin for the data. The study involved "lay persons" and "trained technicians" using the device. It is a prospective study as it involved conducting clinical studies and laboratory testing for the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: One "expert" device was used: the YSI Model 2300 STAT PLUS. The document does not specify a number of human experts involved in establishing the ground truth, but rather refers to readings obtained by "trained technicians."
- Qualifications of Experts: The ground truth was established by comparing the On Call Express Blood Glucose Monitoring System's readings to those from the YSI Model 2300 STAT PLUS (K913806), which is a laboratory reference method. The text mentions that "trained technicians" were involved in obtaining readings, implying they are qualified to operate such equipment and conduct these tests accurately. There is no mention of specific medical qualifications (e.g., radiologist with X years of experience) as this is a blood glucose monitoring device.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method in the traditional sense (e.g., 2+1, 3+1 consensus). Instead, the method involved direct comparison of the test device's readings with a recognized laboratory reference method (YSI Model 2300 STAT PLUS). The goal was to establish accuracy by demonstrating concordance, not to resolve discrepancies between multiple human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. This type of study typically involves assessing the performance of multiple human readers on multiple cases, often with and without AI assistance. The study described focuses on the accuracy of the device itself and its usability by lay persons compared to trained technicians using a reference method. It does not evaluate human reader improvement with AI assistance. The device itself is a standalone glucose monitor, not an AI assistant to human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was conducted. The "Laboratory Testing" section lists numerous tests (repeatability, precision, accuracy, linearity, interfering agents, etc.) that evaluate the system's performance independently. The "clinical studies" also assess the device's ability to provide accurate blood glucose readings on its own, with lay persons simply operating it according to instructions. The comparison to the YSI Model 2300 STAT PLUS explicitly assesses the algorithm's (and integrated system's) accuracy against a gold standard.
7. The Type of Ground Truth Used
The ground truth used was reference laboratory measurement. Specifically, the On Call Express Blood Glucose Monitoring System's results were compared to those obtained from the YSI Model 2300 STAT PLUS (K913806), which is a widely accepted laboratory reference instrument for glucose measurement.
8. The Sample Size for the Training Set
The document does not provide information regarding a specific training set or its sample size. This device is a blood glucose monitoring system, not a machine learning model that typically undergoes explicit "training" on a separate dataset in the way an AI diagnostic algorithm would. The development and calibration of such devices usually involve internal studies by the manufacturer, but the specific details of these are not disclosed as "training set" information in this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" is mentioned in the context of a machine learning model, this question is not directly applicable. For the device's internal calibration and development, it's highly probable that similar reference laboratory methods (like YSI) would have been used, but the document does not elaborate on this.
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The On Call® Vivid Pro Blood Glucose Monitoring System is an electrochemical enzymatic assay. It is used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip. The On Call® Vivid Pro Blood Glucose Monitoring System is intended for multiple patient use by health care professionals in health care facilities as an aid to monitoring the effectiveness of diabetes control programs. The system should only be used with single-use, autodisabling lancing devices.
The On Call® Vivid Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates.
The On Call® Vivid Pro Blood Glucose Test Strips are used with the On Call Vivid Pro Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the finger.
The On Call® Vivid Pro Blood Glucose Control Solutions are for use with the On Call® Vivid Pro Blood Glucose Meter and Strips as a quality control check to verify the accuracy of blood glucose test results.
The On Call" Vivid Pro Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip. The glucose measurement is achieved by using the amperometric detection method.
The test strip has a reagent system including glucose oxidase and a mediator that reacts with glucose in the whole blood sample to produce an electrical current. This current is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed on the meter display, calibrated to a plasma reference.
The quality control of the On Call Vivid Pro Blood Glucose Monitoring System is performed by testing the test strip on meter with glucose control solution to confirm that the test strip and meter are working together properly. The glucose control solution contains a known concentration of glucose with preservatives in an aqueous based mixture. The control solution test result should fall within the predetermined control solution range for the given strip lot to confirm the accuracy of the On Call Vivid Pro Blood Glucose Monitoring System.
Here's an analysis of the On Call Vivid Pro Blood Glucose Monitoring System's acceptance criteria and the study proving it meets them, based on the provided text:
Acceptance Criteria and Device Performance for On Call Vivid Pro Blood Glucose Monitoring System
1. Table of Acceptance Criteria and Reported Device Performance
The provided document indicates that the device's accuracy was evaluated against the requirements of EN ISO 15197:2003 "In vitro diagnostic test systems - Requirements for in vitro whole blood glucose monitoring systems intended for use by patients for self testing in management of diabetes mellitus."
The key performance criterion mentioned in the conclusion is "accuracy requirements per EN ISO 15197". While the document doesn't explicitly list the detailed accuracy thresholds from this standard, it states that the system meets these requirements.
Table: Acceptance Criteria (Referenced Standard) and Device Performance (Study Conclusion)
| Performance Metric | Acceptance Criteria (from EN ISO 15197:2003) | Reported Device Performance |
|---|---|---|
| Accuracy | Meets requirements of EN ISO 15197:2003 | Meets the accuracy requirements per EN ISO 15197 and is comparable to a YSI Model 2300 STAT PLUS reference. It demonstrated comparable blood glucose readings between lay persons and trained laboratory technicians. |
Note: The specific numerical accuracy criteria (e.g., error grid analysis outcomes, percentage of results within a certain margin of a reference method) for EN ISO 15197:2003 are not provided in this summary but are the underlying benchmark mentioned.
Other performance characteristics evaluated as part of non-clinical tests (though specific acceptance values aren't typically stated as "acceptance criteria" but rather as "specifications" for these types of devices in 510k summaries):
- Repeatability precision
- Intermediate precision
- Linearity
- Interfering agents
- Hematocrit effect
- Temperature effect evaluation (blood & control solution)
- Low battery effect
- Altitude effect
- Sample volume
- Humidity effect
- Simulated shipping study (test strip & control solution)
- Control value assignment
- Meter testing
- Software validation testing
- Electromagnetic compatibility and electrical safety testing
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Tests: The document states "Clinical studies were conducted with lay persons and trained laboratory technicians". It does not specify the exact number of participants (sample size) for these clinical studies.
- Data Provenance: The document does not explicitly state the country of origin of the data. However, as it's a 510(k) submission to the US FDA, and the company is based in San Diego, California, it's highly probable the clinical studies were conducted in the United States. The study is prospective, as it explicitly mentions "Clinical studies were conducted" to evaluate the system's accuracy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Reference Method: The ground truth was established by the YSI Model 2300 STAT PLUS (K913806). This is a laboratory-grade reference instrument for glucose measurement, widely considered a "gold standard" in blood glucose monitoring studies.
- Number of "Experts" for Ground Truth: While the YSI 2300 STAT PLUS is an automated instrument, its operation and validation would typically be performed by trained laboratory technicians. The document implicitly refers to these "trained laboratory technicians" as performing the reference measurements, stating "compared to the YSI Model 2300 STAT PLUS... per the ACON Clinical Study Protocol for the Blood Glucose Monitoring System." The number of these technicians isn't specified, but their qualification is "trained laboratory technicians."
4. Adjudication Method for the Test Set
- No explicit adjudication method is mentioned. The comparison is directly between the result from the On Call Vivid Pro system and the established reference device (YSI Model 2300 STAT PLUS).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a typical MRMC comparative effectiveness study, as understood in the context of radiology or image interpretation where human readers interpret cases with and without AI assistance, was not conducted.
- Instead, this study compared the device's performance against a reference standard (YSI Model 2300 STAT PLUS) and evaluated the comparable results between "lay persons" (users of the device) and "trained laboratory technicians" (who often run the reference method). The focus was on the device's accuracy and ease of use for its intended users, not on improving human reader performance with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, the accuracy study comparing the On Call Vivid Pro Blood Glucose Monitoring System to the YSI Model 2300 STAT PLUS effectively represents a standalone performance evaluation of the device.
- The device, an electrochemical enzymatic assay, inherently provides an algorithmic output (the glucose reading) based on the electrochemical reaction on the test strip and the meter's calculation. Its performance is assessed independently of further human interpretation or intervention to correct its reading beyond its basic operation. The study evaluated "the system accuracy of the On Call Vivid Pro Blood Glucose Monitoring System."
7. Type of Ground Truth Used
- The ground truth used was a reference laboratory instrument's measurement (YSI Model 2300 STAT PLUS). This is a highly accurate and established method for quantifiable analyte measurement.
8. Sample Size for the Training Set
- The document does not specify a separate "training set" sample size or discuss how a training set was used. For a blood glucose monitoring system like this, the "development" or "training" of the system would typically involve extensive engineering, chemical formulation, and calibration efforts during the design phase, rather than a distinct "training set" of patient data as might be seen for AI/ML algorithms that learn from data. The clinical studies described are for validation (test set), not training.
9. How the Ground Truth for the Training Set Was Established
- Given that a specific "training set" for an AI/ML algorithm isn't described for this device, a method for establishing its ground truth is not applicable in this context. The development of the system's internal algorithms (e.g., for converting electrical current to glucose concentration) would be based on fundamental electrochemical principles, extensive laboratory testing with known glucose concentrations, and calibration against reference methods during the device's engineering and manufacturing process.
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(143 days)
The On Call® Chosen Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in fresh capillary whole blood from the fingertip by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternate (forearm and palm) testing sites should be used only when blood glucose level is not changing rapidly. The On Call® Chosen Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only.
The On Call Chosen Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes mellitus, or use on neonates.
The On Call Chosen Blood Glucose Test Strips are used with the On Call Chosen Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertip, forearm and palm.
The On Call Chosen Blood Glucose Control Solution is for use with the On Call Chosen Blood Glucose Meter and Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.
The On Call "Chosen Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip, palm, and forearm. The glucose measurement is achieved by using the amperometric detection method.
The test strip has a reagent system including glucose oxidase and a mediator that reacts with glucose in the whole blood sample to produce an electrical current. This current is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed on the meter display, calibrated to a plasma reference.
This document describes the acceptance criteria and the study performed for the On Call Chosen Blood Glucose Monitoring System.
1. Table of Acceptance Criteria and Reported Device Performance
The submission references compliance with EN ISO 15197:2003 for accuracy requirements. Based on the "Discussion of Clinical Tests Performed" section, it states that the system meets these accuracy requirements. No specific performance metrics (e.g., bias, CV, or percentages within zones of an error grid) are numerically presented in the provided text as 'acceptance criteria' vs. 'reported performance' in a direct comparison table. However, the overall conclusion states that the device meets the accuracy requirements per EN ISO 15197.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text. The document mentions "clinical studies were conducted with lay persons and trained laboratory technicians," but does not provide the number of participants or samples collected.
- Data Provenance: Not explicitly stated. Given ACON Laboratories, Inc. is located in San Diego, California, it's likely the studies were conducted in the US, but this is not confirmed. The study was conducted according to the "ACON Clinical Study Protocol for the Blood Glucose Monitoring System," implying a prospective study design.
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)
- Number of Experts/Ground Truth Method: The reference method for establishing ground truth was the YSI Model 2300 STAT PLUS (K913806). This is a laboratory-grade analyzer for glucose measurement, not an expert human assessment.
- Qualifications of Experts: Not applicable, as the ground truth was established by an analytical instrument. However, the study involved "trained laboratory technicians" who operated the YSI device, implying they were qualified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. The ground truth was established by a reference instrument (YSI Model 2300 STAT PLUS). No human adjudication process is mentioned for the reference method.
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
- MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not done. This device is a blood glucose monitoring system, and the study focused on its accuracy compared to an established laboratory reference, and ease of use by lay persons, rather than assessing improvements in human reader performance with AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, in essence, the "system accuracy" evaluation of the On Call Chosen Blood Glucose Monitoring System compared to the YSI Model 2300 STAT PLUS constitutes a standalone performance evaluation of the device itself (though humans are involved in using both systems). The study specifically aimed to show that "nonprofessional, inexperienced lay persons were able to obtain comparable blood glucose readings" to those obtained by trained technicians using the reference, implying the device's inherent accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth was established using a reference laboratory instrument, specifically the YSI Model 2300 STAT PLUS (K913806).
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device is a blood glucose monitoring system, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The studies performed were for verification and validation of the device's performance, not for training an algorithm.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of device mentioned.
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(90 days)
The On-Call® Plus Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in capillary whole blood from the fingertip, forearm, and/or palm by people with diabetes at home and by healthcare professionals as an aid in the monitoring the effectiveness of diabetes control programs.
The On-Call® Plus Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates.
The On-Call® Plus Blood Glucose control solution is for use with the On-Call® Plus Blood Glucose meter and strips as a quality control check to verify the accuracy of blood glucose test results.
The On-Call® Plus Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip, palm, and/or forearm. The glucose, measurement is achieved by using the amperometric detection method.
The test strip has a reagent system including glucose oxidase and a mediator that reacts with glucose in the whole blood sample to produce an electrical current is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed on the meter display, calibrated to a plasma reference.
The provided text describes the "On-Call® Plus Blood Glucose Monitoring System" and its substantial equivalence to a predicate device, the "One Touch Ultra Blood Glucose Monitoring System". The information primarily focuses on non-clinical and clinical performance to establish this equivalence.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The text explicitly mentions compliance with EN ISO 15197:2003 "In vitro diagnostic test systems - Requirements for in vitro whole blood glucose monitoring systems intended for use by patients for self testing in management of diabetes mellitus" as the primary standard for accuracy requirements. While the document states the device meets these accuracy requirements, it does not provide a direct table detailing the specific accuracy acceptance criteria from ISO 15197:2003 (e.g. percentage of readings within ±15% or ±20% of reference measurements) nor does it report specific performance metrics against these criteria.
However, it does list several performance characteristics that were evaluated:
| Feature/Test | Acceptance Criteria (Implicit from ISO 15197:2003, though not explicitly detailed with thresholds) | Reported Device Performance (Summary) |
|---|---|---|
| System Accuracy (Clinical Studies) | Meets accuracy requirements per ISO 15197:2003. (Specific thresholds of % within ±X% or ±Y mg/dL not provided in the text). | Non-professional, inexperienced lay persons were able to obtain comparable blood glucose readings when using the On-Call® Plus Blood Glucose Monitoring System as compared to results obtained by trained technicians. |
| Repeatability Precision | Not explicitly stated, implied to meet appropriate precision standards. | Evaluated (details not given). |
| Intermediate Precision | Not explicitly stated, implied to meet appropriate precision standards. | Evaluated (details not given). |
| Linearity | Not explicitly stated, implied to meet appropriate linearity standards. | Evaluated (details not given). |
| Interfering Agents | Not explicitly stated, implied to meet appropriate standards for common interfering substances. | Evaluated (details not given). |
| Hematocrit Effect | Not explicitly stated, implied to meet appropriate standards for varying hematocrit levels. | Evaluated (details not given). |
| Temperature Effect (Blood & Control) | Not explicitly stated, implied to meet appropriate standards across operative temperature range. | Evaluated (details not given). |
| Low Battery Effect | Not explicitly stated, implied to maintain accuracy under low battery conditions. | Evaluated (details not given). |
| Altitude Effect | Not explicitly stated, implied to maintain accuracy across various altitudes. | Evaluated (details not given). |
| Sample Volume | Not explicitly stated, implied to perform accurately with specified minimum volume. | Evaluated (details not given). |
| Software Validation | Not explicitly stated, implied to meet software quality and safety standards. | Evaluated (details not given). |
| Electromagnetic Compatibility (EMC) | Not explicitly stated, implied to meet relevant EMC standards. | Evaluated (details not given). |
| Electrical Safety | Not explicitly stated, implied to meet relevant electrical safety standards. | Evaluated (details not given). |
2. Sample Size Used for the Test Set and Data Provenance
The text states: "Clinical studies were conducted with lay persons and trained laboratory technicians using the On-Call® Plus Blood Glucose Monitoring System."
- Sample Size: The exact sample size for the clinical test set is not provided in the given text.
- Data Provenance: The text does not explicitly state the country of origin. It can be inferred that the studies were likely conducted in the US, given the submission is to the FDA and references US regulatory documents. The studies are prospective clinical studies involving both lay persons and trained technicians.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Ground Truth Establishment: The ground truth for the clinical studies was established by comparison to the YSI Model 2300 STAT PLUS (K913806). The YSI is a commonly accepted laboratory reference method for glucose measurement.
- Number of Experts/Qualifications: The text mentions "trained laboratory technicians" used the predicate device, but it does not specify the number or specific qualifications (e.g., years of experience) of these technicians. The YSI machine itself serves as the reference, not human interpreters in this context.
4. Adjudication Method for the Test Set
Not applicable in the conventional sense for a blood glucose monitoring system. The accuracy is determined by direct comparison of the device's readings against a laboratory reference standard (YSI Model 2300 STAT PLUS), rather than human adjudication of interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was one done? No, a MRMC comparative effectiveness study was not done in the context of human readers improving with or without AI assistance. This device is a blood glucose meter, and the comparison is between the device's reading and a laboratory reference, not between human interpretations.
- Effect Size of Human Readers with/without AI: Not applicable, as there is no AI component for interpretation by human readers. The clinical study did compare readings obtained by "lay persons" (users at home) to "trained technicians" using the same device, but this isn't a human-reader-with-AI vs. human-reader-without-AI scenario. The conclusion was that lay persons obtained "comparable" readings.
6. Standalone (Algorithm Only) Performance
- Was one done? Yes, the entire evaluation of the "On-Call® Plus Blood Glucose Monitoring System" is a standalone performance evaluation of the device as an algorithm/system. The device itself (meter and test strip) is the "algorithm" that measures glucose. Its performance is directly compared to the YSI reference. The clinical study specifically assesses the device's ability to provide accurate readings on its own when used by both lay persons and professionals.
7. Type of Ground Truth Used
The type of ground truth used for the clinical performance evaluation was a laboratory reference method: the YSI Model 2300 STAT PLUS (K913806).
8. Sample Size for the Training Set
The text does not specify the sample size for any training set. Given the time period (2009) and the nature of the device (blood glucose meter), it is highly likely that empirical calibration and validation methods were used rather than a large-scale "training set" in the modern machine learning sense. The "laboratory testing" mentioned (linearity, precision, etc.) would have involved various samples to characterize the device's inherent performance.
9. How the Ground Truth for the Training Set was Established
As discussed above, the concept of a separate "training set" with ground truth in the AI/ML sense is not explicitly presented or likely for this device. The development and calibration of such a device generally involve using reference methods (like YSI) to establish the accuracy of the electrochemical enzymatic assay at various glucose concentrations, across different hematocrit levels, temperatures, etc. This would have involved numerous laboratory samples where the true glucose concentration was known through the reference method. However, the specific details or distinction between "training" and "testing" samples in this context are not provided in the document.
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