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510(k) Data Aggregation
(146 days)
The Assure Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (In Vitro Diagnostic Use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Assure® Pro Blood Glucose Meter:
The Assure Pro Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (In Vitro Diagnostic Use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Assure® Pro Blood Glucose Test Strips:
Assure Pro Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood when used with the Assure Pro Blood Glucose Meter. Testing is done outside the body (In Vitro Diagnostic Use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Assure® Pro Control Solution:
For use with Assure Pro Blood Glucose Meter and Assure Pro Test Strips as a quality control check to verify the accuracy of blood glucose test results.
The Assure Pro Blood Glucose Monitoring System consists of a meter, test strips, and control solution. It is intended for over-the-counter, home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by health care professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument designed for use with Assure Pro Blood Glucose Test Strips.
The provided 510(k) summary for the Assure Pro Blood Glucose Monitoring System is a premarket notification for a modification to an existing device, not a new device. Therefore, the study details are primarily focused on demonstrating that the modifications did not negatively impact the performance, rather than establishing initial performance criteria from scratch.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. However, the overarching acceptance criterion is "appropriate performance" and "substantially equivalent to that of the unmodified version."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Performance (general) | "Appropriate performance" |
| Precision | Confirmed |
| Hematocrit Range | Confirmed |
| Interferences | Confirmed |
| Minimum Sample Volume | Successful testing confirmed reduced minimum sample volume claim |
| Overall Equivalence | "Substantially equivalent to that of the unmodified version" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the numerical sample size used for the test set. It broadly states, "Test strips were tested with fresh capillary whole blood."
- Data Provenance: Fresh capillary whole blood was used, implying prospective data collection during the testing phase. The country of origin is not specified but is presumably the USA, where the company and FDA are located.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. For blood glucose monitoring systems, the "ground truth" is typically established by comparative measurements against a laboratory reference method, not by human experts interpreting results.
4. Adjudication Method for the Test Set
Not applicable in the typical sense for a blood glucose meter. Ground truth is established through quantitative comparison to a reference method, not through consensus of human interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks where multiple human readers assess cases, and AI assistance is evaluated for its impact on their performance. A blood glucose meter provides a direct quantitative measurement, not an interpretation task for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence, the testing performed on the device (meter and test strips) is standalone performance. The device itself generates the blood glucose reading without human interpretation of the result. The clinical and non-clinical testing assesses the accuracy and reliability of these direct measurements.
7. The Type of Ground Truth Used
The document implies that the ground truth for performance verification would be established by comparison to a recognized laboratory reference method for blood glucose measurement. While not explicitly stated, this is standard practice for blood glucose meter validation.
8. The Sample Size for the Training Set
No training set is mentioned or applicable in the AI sense. This device is a traditional electrochemical blood glucose meter, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no AI/ML training set was involved.
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(118 days)
The Assure Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (In Vitro Diagnostic Use). It is indicated for use in clinical settings by healthcare professionals, or at home (over the counter [OTC]) by persons with diabetes, as an aid to monitor the effectiveness of diabetes control.
The Assure® Pro Blood Glucose Monitoring System consists of a meter, test strips, and control solution. It is intended for over-the-counter, home use by persons with diabetes to monitor their blood glucose levels, or for use in a clinical setting by health care professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument designed for use with Assure® Pro Test Strips.
The provided 510(k) summary for the Assure® Pro Blood Glucose Monitoring System describes a clinical study to demonstrate its accuracy. However, specific acceptance criteria and detailed performance metrics are not explicitly stated in the provided text. The summary generally claims "good correlation" without quantifying it against pre-defined thresholds.
Here's a breakdown of the requested information based on the provided text, highlighting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document mentions "good correlation" but doesn't provide numerical thresholds for accuracy (e.g., % within +/- X mg/dL, or accuracy metrics against a reference standard). | Linear regression statistics showed "good correlation between participant, clinician and reference results." Tested blood glucose values encompassed the 61-383 mg/dL glucose range. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "participants with diabetes" but does not quantify the number of individuals or the number of samples collected.
- Data Provenance: The study was a prospective clinical testing, comparing results obtained by participants with diabetes against clinician results and reference methods. The country of origin for the data is not specified, but the submission is from Hypoguard USA, Inc. in Minneapolis, MN, USA, suggesting a US-based study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: The document refers to "clinician results" as part of the comparison. It does not specify the number of clinicians involved or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, given the context of a blood glucose monitor, these would likely be healthcare professionals, potentially nurses, phlebotomists, or laboratory technicians who are trained in blood drawing and glucose measurement.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- The document describes comparing results among "participants with diabetes," "clinician results," and "reference method results." This implies a comparison against a gold standard (reference method) and potentially other professional measurements. However, it does not describe an adjudication method in the sense of resolving discrepancies between human readers or experts (e.g., 2+1, 3+1). The "reference method" itself acts as the de facto "ground truth" against which all other measurements are compared.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done in the context typically understood for AI/imaging devices (i.e., assessing human performance with vs. without AI assistance). This study focuses on the accuracy of a standalone device (blood glucose monitor) compared to reference methods and clinician measurements.
6. Standalone Performance Study
- Yes, a standalone study was done. The "Accuracy/method correlation testing" directly evaluated the performance of the Assure® Pro Blood Glucose Monitoring System itself by comparing its readings to a recognized reference method and clinician results. This is a direct measure of the algorithm/device's accuracy.
7. Type of Ground Truth Used
- The type of ground truth used was a reference method. For blood glucose monitoring systems, this typically involves a laboratory-based, highly accurate method (e.g., using a YSI glucose analyzer or a similar clinical chemistry analyzer) that is considered the gold standard for glucose measurement. The document states "reference method results."
8. Sample Size for the Training Set
- The document does not specify a training set sample size. This k-summary describes the device validation (clinical testing) to support substantial equivalence, not the development or training of an algorithm in the modern AI sense. Blood glucose meters do not typically involve "training sets" in the same way machine learning models do. Their calibration is usually established during manufacturing and validated through rigorous testing.
9. How Ground Truth for the Training Set Was Established
- As there is no mention of a "training set" in the context of an AI/machine learning model, this question is not applicable based on the provided document. The device operates based on electrochemical principles, and its internal calibration would be set during manufacturing and validated through testing, not through a "training set" in the sense of supervised learning.
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(256 days)
The Advance Micro-draw™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Advance Micro-draw™ Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. Advance Micro-draw™ Test Strips must be used with the Advance Microdraw™ Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
For use with Advance Micro-draw™ Blood Glucose Meter and Advance Microdraw™ Test Strips as a quality control check to verify the accuracy of blood qlucose test results.
The Advance Micro-draw™ Blood Glucose Monitoring System consists of a meter, test strips, and control solution. It is intended for over-the-counter, home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by health care professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument designed for use with Advance Micro-draw™ Blood Glucose Test Strips.
The provided document is a 510(k) summary for the Advance Micro-draw™ Blood Glucose Monitoring System, seeking clearance for an expanded indication to include palm testing in addition to fingertip testing. It does not provide detailed acceptance criteria or a comprehensive study report with the level of detail requested for an AI/device performance study.
Based on the information provided, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy percentages, bias limits) that the device must meet. It only states that "Linear regression statistics showed good correlation between fingertip and alternate site results."
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (from "7. CLINICAL TESTING") |
|---|---|
| Not provided in the document | Linear regression statistics showed good correlation between fingertip and alternate site (palm) results. |
| Tested blood glucose values encompassed the 51-435 mg/dL glucose range. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: "Testing included both men and women, both Type 1 and Type 2 diabetes, ages from twenty to seventy-eight." A specific number of participants or samples is not provided.
- Data Provenance: The document does not specify the country of origin of the data. It implies a prospective study as it describes "testing was done comparing fingertip results obtained by clinicians with alternate site results obtained by participants with diabetes."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The "ground truth" in this context would likely be the fingertip blood glucose measurement, which is considered the standard for comparison.
- Number of experts: The document mentions "clinicians" obtained fingertip results, but does not specify the number or qualifications of these clinicians.
- Qualifications of experts: Not provided.
4. Adjudication method for the test set
- There is no information on any adjudication method. For a blood glucose meter, the "ground truth" or reference method is typically another validated glucose measurement method (e.g., a laboratory analyzer), and the device's readings are compared directly to that. Differences are usually handled statistically without a need for expert adjudication in the same way an imaging study might.
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
- No, this is not applicable. The device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging or interpretation device that human readers would use. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, this was effectively a standalone performance study. The Advance Micro-draw™ Blood Glucose Monitoring System is a device that provides a direct numerical output. The study compared the device's readings from the palm (new indication) against its readings from the fingertip (established method), both of which are "algorithm-only" outputs from the device itself. The primary objective was to show the equivalence of the device's performance at the alternate site.
7. The type of ground truth used
- The "ground truth" or reference method for the alternate site (palm) measurements was the fingertip blood glucose results obtained by clinicians. While not explicitly stated, clinical practice for blood glucose meter validation typically involves comparison to a highly accurate laboratory reference method (e.g., hexokinase or glucose oxidase methods) for the initial validation of the fingertip readings, and then the fingertip reading can serve as the "clinical ground truth" for comparing alternate sites. The document implies the fingertip results were the standard against which the palm results were compared.
8. The sample size for the training set
- This document describes a clinical validation study for an expanded indication. It does not provide information about a "training set" as it would for a machine learning model. Blood glucose meters are typically developed and calibrated in a different manner, involving engineering and chemistry, rather than machine learning training sets in the AI sense.
9. How the ground truth for the training set was established
- As a training set is not explicitly mentioned or relevant to the traditional development of a blood glucose meter, no information is provided on how its "ground truth" was established.
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(82 days)
DiaScreen® Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative measurement of glucose in urine. These measurements are used in the screening and diagnosis of glucose metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.
DiaScreen® Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative measurement of ketones in urine. Identification of ketones is used in the qualitative measurement of acidosis or ketosis and for monitoring patients on ketogenic diets and patients with diabetes.
Testing can be done by dipping the Reagent Strips into a specimen container or by holding them directly in the urine stream.
The glucose and ketone strips are intended for both professional and over-the-counter use.
DiaScreen® Reagent Strips for Urinalysis are plastic strips coated with one or more dry reagents. Each reagent is specific for a particular analyte. Reagent areas are spaced along the test strip, with a physical gap between reagent areas. Three configurations are designed for both professional and home use: detecting one or both of the following analytes: glucose, ketone. The dry reagents change color in reaction to the presence, and concentration, of their associated analyte. The strips are read visually against a color chart.
The provided 510(k) summary for the DiaScreen® Reagent Strips for Urinalysis does not contain detailed information about specific acceptance criteria or a comprehensive study report with quantitative data to definitively prove the device meets those criteria.
However, based on the available text, we can infer some aspects and highlight what is missing.
Here's an attempt to answer your questions based on the provided text, along with notes about information that is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria (Inferred/Not Stated) | Reported Device Performance | Notes/Missing Information |
|---|---|---|---|
| Accuracy (Home Use) | Not explicitly stated (e.g., specific sensitivity/specificity thresholds) | "home users can obtain accuracy which is substantially equivalent to that obtained by professional users." | This is a qualitative statement of equivalence. No numerical accuracy metrics (e.g., percent agreement, sensitivity, specificity, PPV, NPV) are provided for either home users or professional users, nor are the specific acceptance thresholds for these metrics. |
| Precision/Reproducibility | Not explicitly stated | Not reported | No data on the variability of results within or between users, or over time. |
| Interfering Substances | Not explicitly stated | Not reported | No information on potential interferences from common urine components, medications, or other substances that might affect test results. |
| Stability (Shelf-life) | Not explicitly stated | Not reported | No data on the stability of the reagent strips over their shelf-life under various storage conditions. |
| Readability of Color Chart | Not explicitly stated (e.g., clear distinction between color blocks) | Implied to be sufficient for visual reading. | No specific validation of the color chart's clarity or ease of interpretation for untrained users. |
| Equivalence to Predicate Device | Substantial equivalence to the existing "DiaScreen® Reagent Strips for Urinalysis" | Implied by the FDA's 510(k) clearance: "device is substantially equivalent" | While the FDA has determined substantial equivalence, the specific performance metrics used to support this for the new labeling for OTC use are not detailed here. The primary claim for this submission seems to be the change in intended use/labeling to include OTC home use. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not specified. The document only mentions "Clinical data" and "Testing demonstrated," but provides no numbers for participants or urine samples for any clinical study.
- Data Provenance: Not specified (e.g., country of origin). The study is simply referred to as "Clinical testing." It is implied to be prospective, as it involves home users obtaining results, likely comparing them to professional users.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document refers to "professional users," implying healthcare professionals, but their specific titles, years of experience, or training for interpreting these strips are not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. It is unclear how discrepancies between home user results and professional user results (or any other ground truth) were resolved, or if any formal adjudication process was used.
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. This device is a visual dipstick test, not an AI-powered diagnostic imaging or interpretation system. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a manual, visually interpreted test strip. There is no "algorithm only" performance to evaluate. The performance is inherently tied to human visual interpretation.
7. The Type of Ground Truth Used
- Type of Ground Truth: The document implies that the ground truth for home user performance was based on the results obtained by "professional users." This suggests a comparison to a referent standard performed by trained personnel, likely using the same DiaScreen® Reagent Strips or a laboratory reference method. However, the exact nature of this "ground truth" (e.g., whether professional user results were cross-referenced with a lab analyzer, pathology, or confirmed clinical outcomes) is not specified.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is not an AI/machine learning device that requires a training set. The device's performance relies on the inherent chemical reactions on the strip and visual interpretation against a color chart.
9. How the Ground Truth for the Training Set was Established
- Training Set Ground Truth: Not applicable, as there is no training set for this type of device.
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(20 days)
The Hypoquard Advance Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
The Hypoquard Advance Blood Glucose Monitoring System consists of a meter, test strips, and control solution. It is intended for over-the-counter, home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by health care professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument designed for use with Hypoguard Advance Blood Glucose Test Strips.
This 510(k) submission (K031388) describes a modification to the Hypoguard Advance Blood Glucose Monitoring System. The acceptance criteria and supporting studies are presented as relating to this modification, rather than the initial predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "Acceptance criteria were met" for all described tests, but does not explicitly list the quantitative acceptance criteria. Therefore, the table below will reflect the reported outcome.
| Acceptance Criteria Category | Reported Device Performance | Specifics (if available) |
|---|---|---|
| Precision | Acceptance criteria were met. | Within run, between run, and total CV% were calculated identically to the original 510(k) and met acceptance criteria. |
| Dynamic Range | Validated. | Acceptance criteria were met. |
| Minimum Sample Volume | Validated. | Acceptance criteria were met. |
| Accuracy/Method Correlation | Acceptance criteria were met. | Compared against the original Hypoguard Advance System and the YSI 2300 analyzer. Clarke Error Grid Analysis acceptance criteria were met. |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not specify the exact sample size for the clinical accuracy/method correlation testing or the precision studies.
- Data Provenance: The document does not explicitly state the country of origin.
- Retrospective or Prospective: Not specified. However, the nature of the "accuracy/method correlation testing" against a predicate and a reference method suggests a prospective study for data collection on the modified device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. This device measures glucose quantitatively using a reference analyzer (YSI 2300), not through expert interpretation of images or clinical assessments.
4. Adjudication Method for the Test Set:
Not applicable, as ground truth is established by a reference analyzer (YSI 2300), not expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a blood glucose monitoring system, and its performance is evaluated against a reference method, not through human reader interpretation or comparison with human readers' diagnostic accuracy.
6. Standalone Performance Study:
Yes, a standalone performance study was conducted. The accuracy/method correlation testing directly evaluated the algorithm/device's performance by comparing its glucose measurements against a reference standard (YSI 2300 analyzer) and the original Hypoguard Advance system.
7. Type of Ground Truth Used:
The ground truth for the clinical accuracy/method correlation study was established using the YSI 2300 analyzer, which is a widely accepted laboratory reference method for glucose measurement.
8. Sample Size for the Training Set:
This information is not provided. Given that this submission is for a modification to an existing device, it's possible that earlier versions of the device were trained on specific datasets, but this document does not detail training data for the modified system.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided.
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(88 days)
The Express Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in a clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.
Express Control Solution is intended for use with the Express as a quality control check to verify the accuracy of blood glucose test results. Use the Express Control Solution to verify that the Express System is functioning properly.
The Express Blood Glucose Monitoring System includes a disposable meter containing 100 biosensors (test strips) plus control solution. It is intended for over-the-counter, home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by healthcare professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument.
Here's an analysis of the provided text regarding the Express Blood Glucose Monitoring System, formatted to address your specific points:
Since this is a blood glucose monitoring system, the "acceptance criteria" are typically related to the accuracy and precision of glucose measurements, often compared against a reference method (like a YSI analyzer) or a predicate device. The "device performance" refers to the results obtained from the non-clinical and clinical testing sections.
Acceptance Criteria and Reported Device Performance
| Criteria Type | Acceptance Criteria (Implied) | Reported Device Performance and Evidence |
|---|---|---|
| Precision | Within-run and between-run precision values should be substantially equivalent to the predicate device and meet FDA Guidance Document recommendations. | Within-run Precision: Twenty replicates at six glucose concentrations across the performance range for six spiked venous whole blood samples. Performed within four hours of blood collection. Between-run Precision: Twenty replicates per day at six glucose concentrations using six tests with six different blood donors. Result: "The within-run and between-run precision values were substantially equivalent to that of the predicate." |
| Hematocrit Effect | Acceptable accuracy within the tested hematocrit range. | Study Design: Evaluated at a range of hematocrit levels from 30% to 55%. YSI plasma-referenced data used for comparison. Result: "Results showed acceptable accuracy within this hematocrit range." |
| Altitude Effect | No significant effect on performance due to high elevation. | Study Design: Tested using two control solutions and capillary whole blood spiked to three different levels. Performed at 800-feet and 40,000-feet elevations. Result: "Evaluation of mean values and CVs indicated no significant effect of high elevation on performance. The Express Blood Glucose Monitoring System is qualified at altitudes up to 10,000 ft. above sea level." (It's important to note the device is qualified to 10,000 ft, even though testing went up to 40,000 ft, suggesting that the 40,000 ft test might have demonstrated the lack of effect up to the qualified altitude). |
| Dynamic Range / Linearity | Good performance across the specified dynamic range (20-600 mg/dL). | Study Design: Testing conducted using venous blood spiked with D-glucose to provide samples across the 20-600 mg/dL dynamic range. Used Express Strip Readers and one YSI glucose analyzer. Result: "The results demonstrated good performance across the 20-600 mg/dL range." |
| Accuracy / Method Correlation | Good correlation with the YSI plasma reference method, and substantially equivalent regression statistics to the predicate device. | Study Design: Compared Express Strip Reader against the predicate and the YSI 2300 analyzer (reference method). Included men and women, Type 1 and Type 2 diabetes, ages 18-80s, and a wide range of educational levels. Blood glucose values encompassed 30-90 mg/dL (low end) to over 250 mg/dL (high end). Result: "Linear regressions statistics showed good correlation between Express Strip Reader results and the YSI plasma reference method, whether testing was carried out by the clinician or the patient. Regression statistics were substantially equivalent to those obtained for the predicate device." |
Additional Information Addressing Your Request:
-
Sample size used for the test set and the data provenance:
- Precision Study:
- Within-run: Twenty replicates.
- Between-run: Twenty replicates per day.
- Blood Donors: Six different blood donors (for between-run).
- Hematocrit Study: Not specified how many samples or donors were used for the hematocrit range evaluation, only the range of hematocrit (30-55%).
- Altitude Study: Not specified, only mentions "two control solutions and capillary whole blood spiked to three different levels."
- Dynamic Range/Linearity: Not specified how many samples/replicates were used, only that venous blood was spiked to cover the range.
- Accuracy/Method Correlation: Not explicitly stated, but implies a diverse group of "both men and women, both Type 1 and Type 2 diabetes, ages from eighteen to eighties, and a wide range of educational levels" was included.
- Data Provenance: Not explicitly stated, but typically clinical studies for 510(k) submissions in the US are conducted in the US. The reference to "YSI plasma-referenced data" suggests a well-established laboratory method for comparison. The studies appear to be prospective as they describe specific testing protocols.
- Precision Study:
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is an in-vitro diagnostic device measuring a quantitative analyte (glucose). The "ground truth" is established by a highly accurate reference instrument (YSI 2300 analyzer) or by comparing against the predicate device. No human expert consensus for image interpretation is involved.
-
Adjudication method for the test set:
- Not applicable. The "ground truth" (reference method) for glucose measurement doesn't involve subjective human adjudication. It's an objective measurement compared against another objective measurement.
-
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 is not an imaging AI device requiring human reader interpretation or assistance. The study evaluates the device's accuracy in measuring glucose, which is a standalone quantitative measurement. The "patient use" aspect of the accuracy study implies that both clinicians and patients used the device, suggesting a form of usability/performance evaluation for different user groups, but not an MRMC study in the typical AI sense.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this entire study is effectively a standalone performance evaluation of the device (Express Strip Reader) itself. While patients and clinicians used the device, their role was as the users performing the test, not as "human-in-the-loop" for an algorithm's decision-making process. The system provides a direct blood glucose measurement.
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The type of ground truth used:
- Reference Method: YSI 2300 analyzer (for accuracy/method correlation, hematocrit, and dynamic range).
- Predicate Device: Hypoguard Advance™ Blood Glucose Monitoring System (for substantial equivalence claims in precision and accuracy).
- Spiked Samples: Used in precision, altitude, and dynamic range studies where known concentrations of glucose were introduced into blood samples or control solutions.
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The sample size for the training set:
- This is a traditional medical device (blood glucose meter), not an AI/machine learning product. Therefore, there is no "training set" in the context of machine learning model development. The device relies on a pre-programmed electrochemical or optical methodology, not a learned algorithm.
-
How the ground truth for the training set was established:
- Not applicable for the same reason as point 7.
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(71 days)
GlucoBalance™ Data Management Software is an optional accessory for use with Hypoguard blood glucose meters with data management capabilities. GlucoBalance transfers data from the meter's memory into a computer for enhanced data management. GlucoBalance is intended for use in home and clinical settings to assist people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support diabetes management.
The GlucoBalance Data Management Software is an optional accessory for use with Hypoguard blood glucose meters with data management capabilities. The subject device consists of a data transfer cable and software. The system allows the user to download blood glucose results from their glucose meter to their computer, maintain a history of their glucose test results, and convert them into graphs, charts and reports. It should be noted that the software does not recommend any medical treatment or medication dosage level.
The provided text describes the 510(k) submission for the GlucoBalance Data Management Software. However, it does not contain the detailed information required to fill out all sections of your request regarding acceptance criteria and a definitive study proving the device meets those criteria.
Here's what can be extracted and what is missing:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document generally refers to "appropriate functional characteristics" and "ease of operation by in-home users." | "demonstrate appropriate functional characteristics" "demonstrated the systems ability to be easily operated by in-home users." |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The document mentions "consumer studies" but does not give a sample size.
- Data provenance: Not specified. It's unclear if the data was retrospective or prospective, or the country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is data management software, not a diagnostic tool where expert ground truth would typically be established for classification tasks. The "ground truth" here would likely be the accurate transfer and display of blood glucose data, validated against the meter's internal memory or direct meter readings.
4. Adjudication method for the test set
- Not applicable/Not specified. Given the nature of the device (data management software), an adjudication method as typically applied in diagnostic image analysis or similar fields is unlikely to be relevant or detailed here.
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
- No MRMC comparative effectiveness study was done or reported. This device is data management software, not an AI-powered diagnostic tool, so this type of study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The "performance testing to demonstrate appropriate functional characteristics" and "validation of the systems hardware (the data transfer cable) and software" likely represent standalone testing of the device's ability to transfer, store, and display data correctly. The "consumer studies" for ease of operation would involve human interaction but not in the sense of "human-in-the-loop performance" for a diagnostic algorithm.
7. The type of ground truth used
- The ground truth would be the accurate representation of blood glucose data as recorded by the blood glucose meters. This would involve comparing the data downloaded and displayed by the GlucoBalance software against the raw data stored in the connected blood glucose meters, or potentially against manual readings/logs. This is an accuracy assessment of data transfer and display, not a clinical outcome or pathology ground truth.
8. The sample size for the training set
- Not applicable/Not specified. This is software for data management, not a machine learning model that requires a training set in the conventional sense. Software development involves testing, but not typically "training sets" as understood in AI/ML contexts.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):
The document states that the device underwent "Safety Testing: performance testing to demonstrate appropriate functional characteristics." This included:
- Validation of the system's hardware (the data transfer cable).
- Validation of the software.
- Consumer studies "that demonstrated the systems ability to be easily operated by in-home users."
The conclusion drawn from this testing was that "The GlucoBalance Data Management Software is substantially equivalent to the Camit Data Management System from Roche Diagnostics Corp. (K001907)." This implies that the performance in these unspecified tests was deemed sufficient to meet the FDA's requirements for substantial equivalence.
In essence, the provided document offers a high-level summary of testing but lacks the granular details typically present in a full study report to address all your specific questions.
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(29 days)
The Hypoguard ADVANCE™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
The Hypoguard ADVANCE™ Blood Glucose Meter is intended for use with Hypoguard ADVANCE™ Blood Glucose Test Strips for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
The Hypoguard ADVANCE™ Blood Glucose Test Strips are intended for use with Hypoguard ADVANCE™ Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Hypoguard ADVANCE™ Control Solution is intended for use with the Hypoguard ADVANCE™ Meter and Hypoguard ADVANCE™ Test Strips as a quality control check to verify the accuracy of blood glucose test results.
Not Found
The provided text is a U.S. FDA 510(k) clearance letter for the Hypoguard ADVANCE™ Blood Glucose Monitoring System. This document does not contain the detailed study information required to answer your prompt thoroughly.
Specifically, the letter states that the device is "substantially equivalent" to legally marketed predicate devices, which implies that its performance is comparable to existing glucose monitoring systems. However, it does not provide the acceptance criteria, the results of specific studies, sample sizes, expert qualifications, or ground truth methods related to the device's performance.
The letter confirms the "Indications For Use" for the Hypoguard ADVANCE™ system, meter, test strips, and control solution, which is that it's for quantitative measurement of glucose in fresh capillary whole blood for in vitro diagnostic use, both at home and in clinical settings, as an aid to monitor diabetes control.
To answer your specific questions, information about performance criteria and study details would typically be found in the 510(k) submission summary or in a separate study report, which is not part of this clearance letter.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: Not present.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method: Not present.
- Multi Reader Multi Case (MRMC) comparative effectiveness study, including effect size: Not present. Glucose meters are generally standalone, so an MRMC study with human readers would be exceptionally rare for this type of device.
- Standalone (algorithm only) performance study: While the device is a standalone system, the details of its standalone performance study (e.g., accuracy metrics vs. a reference method) are not provided here.
- Type of ground truth used: Not present, but for blood glucose meters, the ground truth is typically a laboratory reference method (e.g., YSI analyzer).
- Sample size for the training set: Not applicable/not present. For a device like a blood glucose meter, the "training set" in an AI/algorithm sense is less relevant than the design, calibration, and validation against a reference method.
- How the ground truth for the training set was established: Not applicable/not present.
In summary, the provided document is an FDA clearance letter and does not contain the detailed study results needed to answer your questions.
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(162 days)
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