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510(k) Data Aggregation
(540 days)
The AP-3000 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, upper arm, calf, and thigh) for self testing by persons with diabetes at home. The AP-3000 Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for use by lay users and should only be used by a single patient as an aid to monitor the effectiveness of diabetes control. It is intended to be used by a single person and should not be shared. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-3000multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, calf, and thigh) for self testing by persons with diabetes. The AP-3000multi Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. This system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or diabetes mellitus, and is not intended for use on neonates.
The AP-3000 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-3000 test strips and MAJOR control solution with the AP-3000 Blood Glucose Monitoring System.
The AP-3000multi Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-3000multi test strips and MAJOR control solution with the AP-3000multi Blood Glucose Monitoring System.
Here's a summary 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 provided 510(k) summary does not explicitly state numerical acceptance criteria for accuracy or performance metrics. Instead, it makes a general statement about meeting intended use. The table below outlines the performance characteristics mentioned, but without specific numerical targets, it's impossible to directly compare to 'acceptance criteria' in the traditional sense of a specific threshold.
| Performance Characteristic | Acceptance Criteria (Implicit from "Intended Use") | Reported Device Performance |
|---|---|---|
| Glucose Test Range | Quantitative measurement in whole blood for diabetes monitoring | 20-600 mg/dL |
| Temperature Range | Operable for glucose measurement | 50 ~ 104°F (10 ~ 40°C) |
| Humidity Range | Operable for glucose measurement |
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(509 days)
The AP-2000 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2000 Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter) [OTC] by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2000multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2000multi Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2010 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2010 Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter) [OTC] by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2010multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2010multi Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2020 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2020 Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter) (OTC) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2020multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2020multi Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2000 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-2000 test strips and MAJOR control solution with the AP-2000 Blood Glucose Monitoring System.
The AP-2010multi Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-2010multi test strips and MAJOR control solution with the AP-2010multi Blood Glucose Monitoring System.
The AP-2010 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-2010 test strips and MAJOR control solution with the AP-2010 Blood Glucose Monitoring System.
The AP-2010multi Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-2010multi test strips and MAJOR control solution with the AP-2010multi Blood Glucose Monitoring System.
The AP-2020 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-2020 test strips and MAJOR control solution with the AP-2020 Blood Glucose Monitoring System.
The AP-2020multi Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-2020multi test strips and MAJOR control solution with the AP-2020multi Blood Glucose Monitoring System.
This 510(k) summary does not contain sufficient information to directly answer all components of your request, specifically regarding detailed acceptance criteria, the study design, and sample sizes for training and testing as typically found in comprehensive clinical/performance studies.
The document is a 510(k) summary for new glucose monitoring systems (AP-2000, AP-2000multi, AP-2010, AP-2010multi, AP-2020, and AP-2020multi), stating their substantial equivalence to a predicate device (AP-1000 Blood Glucose Monitoring System, K090389). It emphasizes that the new devices have the "same performance characteristics as the predicate device" and that "A comparison of system accuracy performance demonstrated that... [new devices]... are substantially equivalent." This implies that the acceptance criteria and performance data for the new devices are considered to be met by virtue of their equivalence to the predicate device, for which performance data presumably exists elsewhere.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document states that the "AP-2000, AP-2000multi, AP-2010, AP-2010multi, AP-2020, and AP-2020multi Blood Glucose Monitoring System has the same performance characteristics as the predicate device." It also states, "A comparison of system accuracy performance demonstrated that... [the new devices]... are substantially equivalent."
Since no explicit acceptance criteria or detailed performance results are provided in this 510(k) summary for the new devices beyond this statement of equivalence, we must infer that the acceptance criteria and reported performance would be those met by the predicate device (AP-1000). Without the predicate's performance data, specific numbers are unavailable from this document.
| Acceptance Criteria (Inferred from Substantial Equivalence to Predicate) | Reported Device Performance (Inferred as equivalent to Predicate) |
|---|---|
| (Not explicitly stated in this document; assumed to be equivalent to the predicate AP-1000's criteria, likely following ISO 15197 or similar standards for glucose meters) | "Same performance characteristics as the predicate device" (AP-1000). "System accuracy performance demonstrated... [new devices]... are substantially equivalent." |
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 this document. The submission relies on demonstrating "substantial equivalence" to a predicate device rather than presenting new detailed performance study data for the new devices themselves.
- Data Provenance: Not specified.
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):
This information is not applicable as the device is a Blood Glucose Monitoring System, which measures a quantitative biochemical marker. The "ground truth" for glucose measurements would typically be established by a laboratory reference method (e.g., hexokinase method) rather than expert human consensus on image or clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable for a quantitative blood glucose measurement device. Adjudication methods are relevant for subjective interpretations (e.g., radiology reads) that require consensus among experts.
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:
This is not applicable. An MRMC study is relevant for imaging or diagnostic interpretation tasks involving human readers, typically in conjunction with AI assistance. This device is a standalone in-vitro diagnostic device for quantitative glucose measurement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The performance characteristics mentioned are for the "AP-2000, AP-2000multi, AP-2010, AP-2010multi, AP-2020, and AP-2020multi Blood Glucose Monitoring System," which is an integrated system (meter, test strips, control solutions). The "system accuracy performance" mentioned implies a standalone performance evaluation of the device itself. No human-in-the-loop interaction for interpretation (like with AI tools) is suggested, as it provides a direct quantitative reading.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
While not explicitly stated in this document, for blood glucose monitoring systems, the "ground truth" would almost certainly be established by a highly accurate laboratory reference method (e.g., hexokinase or glucose oxidase methods using a central lab analyzer), not expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
- Sample Size for Training Set: Not specified. This submission focuses on "substantial equivalence" to a predicate, not on a de novo device with an explicit training dataset. The device is a hardware/software system, and "training set" would typically refer to data used to develop or calibrate the algorithm, which is not detailed here.
9. How the ground truth for the training set was established:
- This information is not specified in the provided document. If a training set was used for algorithmic development, the ground truth would similarly be established by a laboratory reference method, as mentioned in point 7.
Ask a specific question about this device
(484 days)
The AP-1010 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1010 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AP-1010 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-1010 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP-1010 Blood Glucose Test Strips must be used with the AP-1010 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
AP-1010multi Blood Glucose Monitoring System
The AP-1010multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1010multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multi-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-1010multi Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP-1010multi Blood Glucose Test Strips must be used with the AP-1010multi Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). This system should only be used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
AP-1020 Blood Glucose Monitoring System
The AP-1020 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1020 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AP-1020 Blood Glucose Monitoring Systems is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-1020 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP-1020 Blood Glucose Test Strips must be used with the AP-1020 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
AP-1020multi Blood Glucose Monitoring System
The AP-1020multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1020multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multi-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-1020multi Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP-1020multi Blood Glucose Test Strips must be used with the AP-1020multi Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). This system is only used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-1010 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-1010 test strips and MAJOR control solution with the AP-1010 Blood Glucose Monitoring System.
The AP-1010multi Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-1010multi test strips and MAJOR control solution with the AP-1010multi Blood Glucose Monitoring System.
The AP-1020 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-1020 test strips and MAJOR control solution with the AP-1020 Blood Glucose Monitoring System.
The AP-1020multi Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-1020multi test strips and MAJOR control solution with the AP-1020multi Blood Glucose Monitoring System.
The provided text is a 510(k) summary for the AP-1010, AP-1010multi, AP-1020, and AP-1020multi Blood Glucose Monitoring Systems. This document focuses on demonstrating substantial equivalence to a predicate device (AP-1000 Blood Glucose Monitoring System, K090389), rather than presenting a detailed de novo study with specific acceptance criteria and performance data for the current device.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this specific 510(k) summary because the submission relies on the established performance of the predicate device.
Here's a breakdown of the available and unavailable information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated for this device in the provided document. The submission hinges on "substantial equivalence" to the predicate device. | The document states: "AP-1010, AP-1010multi, AP-1020, and AP-1020multi Blood Glucose Monitoring System has the same performance characteristics as the predicate device." |
| Performance of the predicate device (AP-1000) would contain the relevant acceptance criteria and performance data. | Software verification and validation testing confirmed that the performance, safety and effectiveness of the AP-1010, AP-1010multi, AP-1020, and AP-1020multi Blood Glucose Monitoring System are equivalent to the predicate device. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in this 510(k) summary. The submission asserts equivalence to a predicate device, implying that the performance data for the predicate device forms the basis of performance.
- Data Provenance: Not specified for any new testing for these specific devices. The previous 510(k) for the AP-1000 (K090389) would contain this information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. Blood glucose monitoring systems typically use a laboratory reference method (e.g., YSI analyzer) as the ground truth, not expert consensus/adjudication.
4. Adjudication method for the test set
- Not applicable and not provided. Blood glucose measurements are quantitative and compared directly to a 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
- Not applicable. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device that involves human readers interpreting results.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device is a standalone blood glucose monitoring system. Its performance is evaluated based on the accuracy of its glucose measurements compared to a laboratory reference. The submission explicitly states "Software verification and validation testing confirmed that the performance, safety and effectiveness... are equivalent to the predicate device." This implicitly refers to standalone performance.
7. The type of ground truth used
- While not explicitly stated for these specific modified devices in this document, for blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method, such as a YSI glucose analyzer, which is highly accurate and traceable to certified standards.
8. The sample size for the training set
- Not applicable and not provided. This is a medical device based on electrochemical biosensor technology, not an AI/ML model that requires a "training set" in the conventional sense. Software validation is mentioned, but not "training set."
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:
The study that "proves the device meets acceptance criteria" is implicitly the original 510(k) submission for the predicate device, AP-1000 Blood Glucose Monitoring System (K090389).
For the current submission (K103044), Bestgen Biotech Corporation performed testing (including "Software verification and validation testing") to demonstrate that the modifications to the AP-1010, AP-1010multi, AP-1020, and AP-1020multi systems did not change the "performance characteristics" of the device from its predicate. The modifications primarily involved "engineering change in the mechanical appearance of the device and name change."
The conclusion of this 510(k) states: "Based on the information provided in this submission, the AP-1010, AP-1010multi, AP-1020, and AP-1020multi Blood Glucose Monitoring System is substantially equivalent to the predicate AP-1000 Blood Glucose Monitoring System." This means that the original performance data and acceptance criteria established for the AP-1000 are deemed sufficient to cover these modified devices due to their substantial equivalence. The document does not elaborate on new performance studies for these specific models.
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(694 days)
The AP-1000 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, upper arm, calf, and thigh) for self testing by persons with diabetes. The AP-1000 Blood Glucose Monitoring Systems is intended to be used by a single person and should not be shared. The AP-1000 Blood Glucose Monitoring Systems is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-1000multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, upper arm, calf, and thigh). The AP-1000multi Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use) and is intended for multi-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system is only used with single-use, auto-disabling lancing device. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-1000 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-1000 test strips and MAJOR control solution with the AP-1000 Blood Glucose Monitoring System.
The AP-1000multi Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-1000multi test strips and MAJOR control solution with the AP-1000multi Blood Glucose Monitoring System.
The provided document describes the AP-1000 and AP-1000multi Blood Glucose Monitoring Systems. While it mentions "Performance Studies" that demonstrated the system's suitability for its intended use, it does not provide detailed acceptance criteria or the specific results of these studies.
The document primarily focuses on:
- Submitting entity and device identification.
- Device description (meter, test strip, control solutions).
- Intended use (quantitative measurement of glucose in capillary whole blood for self-testing by persons with diabetes and multi-patient use in professional healthcare settings).
- Comparison to a predicate device (K090389), stating "There are no any changes between the two devices" other than the new added AST function of K100437 device that is based K090389 device to re-test (this statement seems contradictory, as K100437 IS the new device with AST, and the predicate is K090389 which has no AST).
- A general conclusion that the system "demonstrates satisfactory performance."
Therefore, I cannot provide the requested information regarding specific acceptance criteria, reported device performance, sample sizes, ground truth establishment, or expert details, as these are not present in the provided text.
The document is a 510(k) summary, which often provides general statements about performance but refers to more detailed studies (which are usually proprietary and not included in the public summary) for the actual data.
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(147 days)
The AP-1000 Blood Glucose Monitoring System (BGMS) is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Viro 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. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-1000 Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. AP-1000 Blood Glucose Test Strips must be used with the AP-1000 Meter. 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.
The AP-1000 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. AP-1000 Blood Glucose Test Strips must be used with the AP-1000 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.
MAJOR Level I/Level II Control Solutions are for use with the AP-1000 meter and AP-1000 Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.
Based on an electrochemical biosensor technology and the principle of capillary action, AP-1000 Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 6 seconds.
The provided text describes the AP-1000 Blood Glucose Monitoring System and mentions pre-clinical and clinical data without detailing the specifics of the study, acceptance criteria, or performance against specific metrics. Therefore, a comprehensive answer to all points of your request cannot be fully extracted from the provided document.
However, based on the information available, here's what can be gathered regarding the study and acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state the acceptance criteria for specific performance metrics (e.g., accuracy percentages within certain glucose ranges) or fully report the device's performance against such criteria. It only indicates that "Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/ FDA." This implies that the study was conducted to meet the requirements outlined in the FDA guidance for in vitro diagnostic test systems, but the specific numerical acceptance criteria and a table of reported performance against these criteria are not included in this document.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not mention an MRMC comparative effectiveness study or any effect size of AI assistance on human readers, as the device is a standalone blood glucose monitoring system and not an AI-assisted diagnostic tool for image interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The AP-1000 Blood Glucose Monitoring System is a standalone device intended for quantitative measurement of glucose. Its performance would inherently be evaluated in a standalone manner (algorithm/device only) without a "human-in-the-loop" as it's a direct measurement device rather than an interpretive aid. The document implies a standalone evaluation was performed by stating "Pre-clinical and clinical data are employed," but details are missing.
7. The Type of Ground Truth Used
For a blood glucose monitoring system, the "ground truth" for accuracy studies would typically be established by comparing the device's readings to laboratory reference methods (e.g., YSI analyzer) known for their high accuracy. The document does not explicitly state the specific type of ground truth used but it would be expected to be a laboratory reference method.
8. The Sample Size for the Training Set
The document does not specify any training set sample size. For a blood glucose monitoring system based on electrochemical biosensor technology, the development would involve calibration and optimization using blood samples, but these are generally not referred to as "training sets" in the same way as machine learning models.
9. How the Ground Truth for the Training Set Was Established
Not applicable as a distinct "training set" in the context of machine learning is not mentioned or relevant for this type of device. The calibration and development would have been based on comparison to laboratory reference methods.
In summary, while the document indicates that pre-clinical and clinical data were used to demonstrate safety and effectiveness in accordance with FDA guidance, it lacks the detailed information requested regarding specific acceptance criteria, study sizes, ground truth establishment, and expert involvement.
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(198 days)
The MAJOR III 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 person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.
Based on an electrochemical biosensor technology and the principle of capillary action, MAJOR III Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 8 seconds.
The provided text does not contain detailed acceptance criteria or a study that explicitly demonstrates the device meets such criteria. It primarily focuses on the device's substantial equivalence to a predicate device and its intended use. However, based on the information provided, here's an attempt to answer your questions, highlighting where information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., accuracy percentages, sensitivity, specificity) for the MAJOR III Blood Glucose Monitoring System. Instead, the "Synopsis of Test Methods and Results" section broadly states:
"Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/FDA."
This indicates that some form of testing was done, but the specific performance results or acceptance thresholds are not detailed in this summary. The substantial equivalence claim is based on the device having the "same working principle and technologies" as the predicate device. Therefore, the "acceptance criteria" here implicitly revolve around demonstrating that the new device performs comparably to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance comparable to EASY CHECK Blood Glucose Monitoring System (K062538) in terms of safety and effectiveness. | "Both of them have the same working principle and technologies." |
| "The differences are due to the feature design aspects, not relating to the safety or effectiveness aspects. They are substantially equivalent." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. There is no mention of specific sample sizes for any test sets, data provenance, or whether the studies were retrospective or prospective.
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)
This information is not provided in the given text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given text.
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
This information is not applicable and not provided. This document pertains to a blood glucose monitoring system, which is an in vitro diagnostic device, not an imaging device that would typically involve human "readers" or AI assistance in the way described for MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not explicitly stated in the provided text. However, blood glucose monitoring systems like the MAJOR III are inherently "standalone" in that they provide a direct measurement result without human interpretation of complex outputs in the way an AI algorithm for image analysis might require. The device itself is the "algorithm" giving the quantitative measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document mentions "fresh capillary whole blood" for glucose measurement. For a blood glucose monitoring system, the "ground truth" would typically be established by a reference method for glucose measurement (e.g., a laboratory-grade analyzer using enzymatic methods) against which the device's readings are compared. This information is not explicitly detailed but is implied by the nature of the device (quantitative measurement of glucose).
8. The sample size for the training set
This information is not provided in the given text. The term "training set" is also typically associated with machine learning models, which is not clearly the primary focus for this type of electrochemical biosensor.
9. How the ground truth for the training set was established
This information is not provided in the given text, and also not directly applicable in the context of what is presented.
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