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The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm and/or forearm. Testing is done outside of the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, as an aid to monitor the effectiveness of diabetes control.

The WaveSense Jazz Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, lancing device lancets, control solution and instructions for use. Test Strips are necessary for testing but are sold separately.

The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertips, palm or forearm. The WaveSense Jazz Test Strips are for in vitro diagnostic (outside of the body) use only. The WaveSense Jazz System is not intended for use with neonates.

The provided text describes a 510(k) premarket notification for the WaveSense Jazz Blood Glucose Monitoring System. The document focuses on establishing substantial equivalence to a predicate device (K072413), rather than presenting a de novo clinical study with detailed acceptance criteria and performance data as typically seen for novel devices, especially those incorporating AI.

Therefore, the information required to fully answer the request regarding acceptance criteria and a study proving device performance (especially for an AI/ML context) is largely absent from this specific 510(k) summary. The document primarily discusses the intended use, technological comparison to a predicate, and the modifications made (new colors, new data management feature), implying that much of the performance data would have been established for the original predicate device.

However, I can extract the relevant information that is present and indicate where information is not available from the provided text.

Here's an attempt to answer based on the provided document, acknowledging its limitations for an AI/ML-centric request:

Acceptance Criteria and Device Performance (based on the provided 510(k) Summary for a Glucose Monitoring System)

It's crucial to understand that this 510(k) pertains to a Blood Glucose Monitoring System, which is a hardware-based diagnostic device, not an AI/ML-powered software or imaging device. Therefore, many of the typical questions regarding AI/ML clinical studies (MRMC, expert consensus for ground truth, training set details, etc.) are not applicable to this type of submission.

The "study" referenced in the provided text is primarily focused on verification and validation (V&V) of the modifications made to an existing predicate device, rather than a large-scale clinical trial to establish novel performance.

1. Table of Acceptance Criteria and Reported Device Performance

For a Blood Glucose Monitoring System, acceptance criteria usually relate to accuracy standards (e.g., ISO 15197 for point-of-care testing), precision, and other analytical performance characteristics. The provided 510(k) summary does not explicitly list these numerical acceptance criteria or the specific performance results in a table. It instead states that "verification and validation results" were sufficient to establish substantial equivalence.

However, based on typical FDA requirements for Blood Glucose Monitoring Systems, the implicit acceptance criteria would relate to:

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The One Drop Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose (sugar) levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The One Drop Blood Glucose Monitoring System is intended for self-testing outside the body (In vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The One Drop Blood Glucose Monitoring System is not for the diagnosis of, or diabetes, and is not intended for use with neonates.

The One Drop Blood Glucose Test Strips:

The One Drop Blood Glucose Test Strips are for use with the One Drop Blood Glucose Meter to quantitatively measure blood glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

The One Drop Blood Glucose Monitoring System (BGMS) is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The One Drop BGMS is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.

The system measures the concentration of glucose in a drop of blood obtained from the fingertip. The test strip is inserted into the meter and the blood is then introduced to the tip of the test strip. The blood reacts with chemicals on the test strip and this reaction generates an electrical current which is measured by the meter. The magnitude of the current is related to the blood glucose concentration. The fundamental scientific technology and the electronics that sends the electrical signals to the assay algorithm are all the same as the predicate device AgaMatrix Jazz Wireless 2 BGMS (K152365). The unit of measure displayed on the meter screen is fixed in mg/dL and cannot be modified by the user.

The One Drop Blood Glucose Monitoring System (BGMS) consists of:

• 1 One Drop Blood Glucose Meter ●
• 1 One Drop Owner's Guide ●
• 1 Carry Case
• 1 Lancing Device
• 10 Lancets
• 100 One Drop Glucose Test Strips ●
• AgaMatrix Glucose Control Solution (available separately) ●

The provided text describes the One Drop Blood Glucose Monitoring System (BGMS) and its submission for FDA 510(k) clearance. The document focuses on demonstrating substantial equivalence to a predicate device, the AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System (K152365).

Based on the information provided, here is the breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list "acceptance criteria" for the device's performance in a table format with corresponding "reported device performance." Instead, it establishes substantial equivalence by demonstrating that the One Drop BGMS has the same performance characteristics as the predicate device. The performance characteristics are implicitly considered "acceptance criteria" because they mirror those of the already-cleared predicate.

The document explicitly states: "The fundamental scientific technology and the electronics that sends the electrical signals to the assay algorithm are all the same as the predicate device AgaMatrix Jazz Wireless 2 BGMS (K152365)." And "The device modifications described in this premarket notification do not affect or alter the fundamental scientific technology of the predicate device, the AgaMatrix Jazz Wireless 2 Blood Glucose Monitor." This implies that the device's performance is expected to be identical to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify the sample size used for any performance testing of the One Drop BGMS, nor does it provide information on data provenance (e.g., country of origin, retrospective or prospective). The document relies on demonstrating substantial equivalence to the predicate device, implying that extensive de novo testing that would require such details might not have been included in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since this is a submission for a blood glucose monitoring system, the "ground truth" for glucose measurements is typically established through a laboratory reference method (e.g., YSI analyzer) performed by trained laboratory technicians, not clinical "experts" in the sense of radiologists.

The document does not provide details on the number of laboratory personnel or their specific qualifications for establishing the ground truth for any testing conducted for the One Drop BGMS.

4. Adjudication Method for the Test Set

As the "ground truth" for blood glucose measurements is generally an objective laboratory reference method, an "adjudication method" involving multiple human readers as described (e.g., 2+1, 3+1) is not applicable to this type of device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study is relevant for devices where human interpretation plays a significant role in diagnosis or decision-making (e.g., imaging studies). For a blood glucose monitoring system, which provides a direct numerical reading, an MRMC study comparing human readers with and without AI assistance is not applicable. The device is intended for self-testing by individuals with diabetes, not for interpretation by multiple clinical experts.

6. Standalone Performance Study

The provided document does not explicitly describe a standalone (algorithm only) performance study for the One Drop BGMS with detailed metrics. The submission focuses on establishing substantial equivalence to a predicate device, which implies that the underlying technology's standalone performance characteristics were already validated with the predicate. The document states that the fundamental scientific technology and electronics are the same as the predicate.

7. Type of Ground Truth Used

For blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method for glucose measurement, such as a YSI glucose analyzer, which provides highly accurate and precise glucose values in blood samples. Details of this are not explicitly stated for the One Drop BGMS but would be standard for this type of device.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for any training set. Given the focus on substantial equivalence, if machine learning or AI was used in the development (which is not explicitly stated beyond "assay algorithm"), the training details are not disclosed in this summary.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for any training set was established. As with testing, if a training set were used for an algorithm, the ground truth would typically be established by a laboratory reference method.

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The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose (sugar) levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The AgaMatrix Jazz ™ Wireless 2 Blood Glucose Monitoring System is intended for selftesting outside the body (In vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.

The AgaMatrix Jazz™ Blood Glucose Test Strips are for use with the AgaMatrix Jazz™ Wireless 2 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.

The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System includes the AgaMatrix Jazz™ Wireless 2 Blood Glucose Meter and the AgaMatrix Jazz™ Blood Glucose Test Strips. The apply blood symbol is displayed for the user to apply blood to the test strip until the meter begins the test. When enough blood has been applied to the strip electrodes the meter detects trigger current from the test strip initiating the test countdown. When the countdown is complete a test result is displayed on the meter screen. The unit of measure displayed on the meter screen is fixed in mg/dL and cannot be modified by the user.

The following items are included in the AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System:

• 1 AgaMatrix Jazz™ Wireless 2 Glucose Meter .
• . 1 Owner's Guide
• . 1 Carry Case
• 1 AgaMatrix Lancing Device .
• . 10 AgaMatrix Lancets
• AgaMatrix Jazz™ Blood Glucose Test Strips -
• -1 Meter Pairing & Syncing Guide

The following items are compatible with the AgaMatrix Jazz™ Wireless 2 Glucose Monitoring System and are available separately:

• . AgaMatrix Glucose Control Solutions (cleared in K103544)
• AgaMatrix Diabetes Manager Mobile Application (cleared in K132821) -

Here's a summary of the acceptance criteria and the study details for the AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System, extracted from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a single consolidated table with corresponding performance. However, based on the Performance Characteristics section, the implicit acceptance criteria are derived from standard deviations, coefficients of variation (CV%), and percentages of agreement within certain error ranges when compared to a reference method (YSI 2300 Glucose Analyzer).

Analytical Performance (Precision/Reproducibility):

Method Comparison (System Accuracy) with YSI Reference:

This part of the study is crucial for demonstrating device accuracy against a recognized standard. The acceptance criteria for blood glucose monitoring systems are typically based on ISO 15197:2013, which specifies accuracy requirements. Although the document doesn't explicitly refer to ISO 15197, the presentation of results in terms of percentage agreement within specific limits (e.g., ±5 mg/dL, ±15%) aligns with these standards.

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The AgaMatrix Health Manager is intended for single patient use. It is an accessory to blood glucose monitoring systems to assist in the review, analysis and evaluation of glucose results to aid in diabetes and health management. The AgaMatrix Health Manager collects data from AgaMatrix manufactured glucose meters and allows adding, editing, and viewing additional health data. The AgaMatrix Health Manager is not intended to provide automated treatment guidance or decisions, nor is it to be used as a substitute for professional healthcare advice.

The AgaMatrix Health Manager (app) is an optional software accessory for blood glucose meters manufactured by AgaMatrix. It is a digital logbook and diabetes tool designed to operate using an iPhone or iPod touch. An individual can manually enter blood glucose readings or can download readings directly to the app installed on an iPhone or iPod touch from the AgaMatrix meter by using the AgaMatrix Cable to connect the meter to the connector of the iPhone or iPod touch. The app will allow the user to manually enter carbohydrate, insulin, and weight information. Users will have the ability to have their data from the AgaMatrix Health Manager automatically uploaded to the AgaMatrix Health Manager cloud portal for back-up. The cloud portal will enable access to the health information in a web browser. Users will have the ability to create and edit their profile, set goals, and download their information as a .csv file.

The AgaMatrix Health Manager (app) is an optional software accessory for blood glucose meters manufactured by AgaMatrix. It functions as a digital logbook and diabetes tool designed to operate using an iPhone or iPod touch. Users can manually enter blood glucose readings or download readings directly from an AgaMatrix meter via a connecting cable. The app also allows for manual entry of carbohydrate, insulin, and weight information. Data can be automatically uploaded to the AgaMatrix Health Manager cloud portal for backup and web browser access, enabling users to create/edit profiles, set goals, and download data as a .csv file. This device is intended for use in the home to aid individuals with diabetes and their healthcare professionals in reviewing, analyzing, and evaluating blood glucose test results to support effective diabetes management. It is not intended to provide automated treatment guidance or decisions, nor to substitute for professional healthcare judgment.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not explicitly state a specific numerical sample size for the usability study participants. It generally refers to "Users."
• Data Provenance: Not explicitly stated, though the context of an FDA submission for a US market suggests the study was likely conducted in the USA. The study appears to be prospective as it involved users actively performing tasks with the device during the study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• This information is not provided in the document. The "ground truth" for data accuracy was established by user confirmation (meter to app) and study evaluators' confirmation (app to cloud). The qualifications of these evaluators are not mentioned.

4. Adjudication Method for the Test Set:

• The document describes a method of confirmation rather than an adjudication method. For the meter-to-app data transmission, "Users had to confirm that 100% of the readings downloaded." For the app-to-cloud data transmission, "study evaluators confirmed that 100% of the readings uploaded." There is no mention of a multi-reader or multi-reviewer adjudication process.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a data management software, not an AI-powered diagnostic tool requiring human interpretation comparison.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• The study described focuses on the usability and data integrity of the software when used by an "intended population" (i.e., human users). It specifically tests aspects like data transmission from a physical meter to the app, and from the app to a cloud portal, which inherently involves the human user interacting with the system. While the "accuracy" figures refer to the software's ability to transfer data correctly, the overall evaluation is of the human-in-the-loop performance for these tasks rather than a purely standalone algorithm's performance on a dataset.

7. The Type of Ground Truth Used:

• The ground truth for the test set was based on direct comparison and confirmation:
  • For meter-to-application data transmission: User confirmation that 100% of readings downloaded.
  • For application-to-cloud data transmission: Study evaluator confirmation that 100% of readings uploaded, comparing downloaded CSV files.

8. The Sample Size for the Training Set:

• This information is not provided. The AgaMatrix Health Manager is described as software, and the document focuses on its verification and validation testing, not on a machine learning model that would typically require a training set. If there were any internal development and testing, details about such a "training set" are not disclosed here.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as details about a training set for a machine learning model are not provided or implied by the information given.

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The iBGStar™ Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels from fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. It is intended to be used by a single patient and should not be shared. The iBGStar™ Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iBGStar™ Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.

The iBGStar Diabetes Manager Application is intended for use in the home with the capability of sending glucose readings through email to an individual's healthcare professional in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the iBGStar Blood Glucose Monitoring System.

The iBGStar Blood Glucose Monitoring System (BGMS) consists of:

• iBGStar Blood Glucose Meter .
• . BGStar Test Strips
• BGStar Control Solution .

The iBGStar. Diabetes Manager Application (DMA) is an optional software accessory for the iBGStar Blood Glucose Monitoring System. It is a digital logbook and diabetes tool designed to operate using an iPhone or iPod touch. An individual can manually enter blood glucose readings or can download readings directly to the DMA installed on an iPhone or iPod touch from the iBGStar meter.

Here's an analysis of the provided text regarding the AgaMatrix iBGStar Blood Glucose Monitoring System and iBGStar Diabetes Manager Application, focusing on acceptance criteria and supporting studies.

Based on the provided 510(k) summary, the device under review (K130535) is an update to an existing device (predicate K103544) to ensure compatibility with newer Apple devices (iPhone 5, iPod touch 5th generation) using a Lightning adapter. Crucially, the document states that there were no changes to the fundamental scientific technology of the Blood Glucose Monitoring System (meter, strips, controls) or the Diabetes Manager Application itself. The improvements are primarily related to connectivity and physical compatibility with new phone models.

Therefore, the performance data presented is focused on demonstrating that these new connectivity components (Lightning adapters) do not negatively impact the previously established performance, and that the updated system as a whole remains substantially equivalent to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the submission (compatibility update, not a new sensing technology), the acceptance criteria mentioned are related to:

• Disinfection and Robustness of the new adapter hardware and associated Apple devices.
• Verification and Validation that the new adapters facilitate data transfer as intended.
• Human Factors to ensure users can correctly use the new adapters with the system.

The original performance characteristics for the blood glucose monitoring system (e.g., accuracy of glucose measurement) are assumed to be met as they were established for the predicate device, which remains unchanged in its core technology.

Performance: Disinfection testing with PDI® Super Sani-Cloth® Germicidal Disposable Wipes (EPA number 9480-4) demonstrated complete inactivation of live virus. |
| Robustness | Criterion: Ensure the new components maintain performance and material integrity after repeated cleaning/disinfection cycles.

Performance: Robustness testing involved 260 cleaning/disinfection cycles (simulating 5 years of use) with the PDI® Super Sani-Cloth® Germicidal Disposable Wipes. Results showed no change in performance or material of the tested devices. |
| Verification and Validation (of new adapters/connectivity) | Criterion: Demonstrate that the Apple Lightning to 30-pin Adapter and the Apple Lightning to 30-pin Adapter (0.2m) cable correctly enable the iBGStar DMA to function as intended (i.e., transfer glucose readings).

Performance: Verification and validation protocols were successfully executed, and results demonstrated "substantial equivalence to the predicate system" regarding the use of these adapters. |
| Human Factors | Criterion: Ensure users can successfully connect and transfer readings via the new Apple Lightning to 30-pin Adapter and cable.

Performance: A human factors study was conducted, and results demonstrated "substantial equivalence to the predicate system" in relation to users' ability to connect and transfer readings using the new adapters. |
| (Implied) Blood Glucose Measurement Accuracy/Performance | Criterion: (Inherited from predicate) The iBGStar BGMS performs quantitative measurements of blood glucose levels in fresh capillary whole blood with acceptable accuracy and precision.

Performance: The document explicitly states: "There have been no modifications to the iBGStar BGMS to allow it to operate with the iPhone 5 and iPod touch 5th generation. The Meter, Test Strips and Control Solution are identical to the previously cleared system. The iBGStar BGMS has all the same technological and performance characteristics as the predicate." Therefore, the previous performance data for K103544 is considered applicable and sufficient. No new studies on the core blood glucose measurement accuracy are reported here. |

2. Sample Size Used for the Test Set and Data Provenance

Due to the nature of this 510(k) submission being an update for compatibility with new accessories rather than a new core device, detailed sample sizes for the "test set" (in the typical sense of clinical performance) are not provided in this summary.

• Disinfection and Robustness Test Set: This involved the physical components: iPhone 5, iPod touch 5th generation, Apple Lightning to 30-pin Adapter, and Apple Lightning to 30-pin Adapter (0.2m) cable. The "sample size" here refers to the number of individual devices/adapters tested, which is not specified but implicitly sufficient for the tests performed (e.g., "the tested devices").
• Verification and Validation: The number of tests/data points for validating the data transfer via the new adapters is not specified.
• Human Factors Study: The sample size for the human factors study is not specified in this summary.
• Data Provenance: Not specified for these specific tests in this summary. The manufacturer is US-based. These tests are prospective, conducted for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is not applicable (N/A) for this submission.

The studies described (disinfection, robustness, verification/validation of connectivity, human factors for adapter connection) do not involve establishing a clinical "ground truth" using medical experts like radiologists. They are engineering and usability tests. The "ground truth" for the disinfection study was the complete inactivation of live virus, observed directly (laboratory result). For robustness, it was the maintenance of performance and material integrity. For verification/validation and human factors, it was the successful connection and data transfer by users, assessed against functional requirements.

4. Adjudication Method for the Test Set

This section is N/A for this submission.

The studies described do not involve a medical diagnosis or interpretation that would require an adjudication method (like 2+1 or 3+1 consensus). The outcomes are objective measurements or functional verifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This section is N/A for this submission.

An MRMC study is typically for evaluating the diagnostic performance of a system (often AI-based) and comparing human readers with and without AI assistance. This submission is for an updated blood glucose monitoring system and its associated data management app's compatibility with new phone accessories. It does not involve a diagnostic AI component in the sense of image interpretation or similar tasks.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The "iBGStar Diabetes Manager Application" is a standalone software accessory in that it collects and displays data. This submission is about ensuring its connectivity with newer hardware accessories. The core 'standalone' performance (data logging, trend charting) of the application itself was likely established in the predicate 510(k) (K103544).

The described verification and validation protocols for K130535 specifically tested the standalone functionality of data transfer via the new adapters.

7. The Type of Ground Truth Used

• Disinfection Study: Laboratory-confirmed complete inactivation of live virus.
• Robustness Testing: Objective measurements of device performance and material integrity before and after simulated use cycles.
• Verification and Validation: Successful data transfer and system functionality, verified against predefined technical specifications.
• Human Factors Study: Observation and measurement of user success in connecting and transferring readings, likely against criteria for ease of use and error rates.

None of these studies utilized medical "gold standards" such as pathology, expert consensus on images, or long-term outcomes data, as they are not clinical performance studies for a new diagnostic capability.

8. The Sample Size for the Training Set

This section is N/A for this submission.

The device itself is a blood glucose monitor and a data management application. It is not described as an AI/Machine Learning device that requires a "training set" in the context of developing an algorithm for diagnostic or predictive tasks. The tests reported here are for hardware compatibility and usability, not algorithm development.

9. How the Ground Truth for the Training Set Was Established

This section is N/A for this submission, as there is no mention of an algorithm training set in the AI/ML sense.

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The iBGStar™ Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. It is intended to be used by a single patient and should not be used for testing multiple patients. The iBGStar™ Blood Glucose Monitoring System is intended for self testing outside the body (In vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iBGstar Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.

BGStar™ Test Strips are for use with the iBGStar™ Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. Palm and foream testing (Alternative Site Testing) should be done only during steady-state times (when glucose is not changing rapidly).

BGStar Control Solutions are for use with the iBGStar™ Blood Glucose Meter and BGStar Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

The iBGStar Diabetes Manager Application is intended for use in the capability of sending glucose readings through email to an individual's healthcare professional in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the iBGStar Blood Glucose Monitoring System.

The iBGStar Blood Glucose Monitoring System consists of: iBGStar Blood Glucose Meter, BGStar Test Strips, BGStar Control Solution.

The iBGStar Diabetes Manager Application is an optional data management software accessory for use with the iBGStar Blood Glucose Monitoring System.

Here's a breakdown of the acceptance criteria and supporting study details for the AgaMatrix iBGStar Blood Glucose Monitoring System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in a numerical format that would commonly be seen with diagnostic performance metrics (e.g., sensitivity, specificity, accuracy within a certain percentage). Instead, it focuses on demonstrating substantial equivalence to predicate devices.

However, the "Assessment of Performance" section implicitly identifies the core acceptance criteria as demonstrating ease of operating and performance equivalent to predicate devices for both the iBGStar Blood Glucose Monitoring System (BGMS) and the iBGStar Diabetes Manager Application.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size used for the test set in a clinical study. It generally states a "clinical setting by person with diabetes." It does not provide information on the country of origin or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For a blood glucose monitoring system, the "ground truth" would typically come from a laboratory reference method, not expert consensus.

4. Adjudication Method for the Test Set

This information is not provided in the document, as the "ground truth" for a blood glucose device would not typically involve expert adjudication in the same way as, for instance, imaging interpretation.

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 done or at least not described in this document. This type of study is more common for diagnostic imaging or interpretation tasks where human readers' performance is being evaluated with and without AI assistance. This submission is for a blood glucose meter and accompanying software, not an interpretive AI system for diagnosis.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The primary device (iBGStar Blood Glucose Monitoring System) is a standalone device that measures blood glucose. The iBGStar Diabetes Manager Application is software that processes and displays data from the blood glucose meter. The "Assessment of Performance" states that "An evaluation of the iBGStar BGMS and iBGStar Diabetes Manager Application were studied in house and in a clinical setting," implying that the performance of the device (BGMS) and the application (Diabetes Manager) were evaluated. The BGMS itself performs "algorithm only" measurements.

7. The Type of Ground Truth Used

While not explicitly stated, for a blood glucose monitoring system, the ground truth for performance evaluation is almost always established through comparison to a laboratory reference method (e.g., a YSI analyzer) for blood glucose measurement. The document implies this by focusing on "quantitative measurement of blood glucose levels."

8. The Sample Size for the Training Set

This information is not provided. Blood glucose meters typically do not use a "training set" in the same machine learning sense, but undergo extensive calibration and verification during manufacturing. If an algorithm is involved in the measurement, its development would involve data, but it's not described here.

9. How the Ground Truth for the Training Set Was Established

This information is not provided. As mentioned above, typical blood glucose meter development involves calibration against reference methods.

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The WaveSense Diabetes Manager (WDM) application (app) is intended for use in the home and professional settings to aid individuals with diabetes and their healthcare professionals; in the review, analysis and evaluation of blood glucose readings to support an effective diabetes management program. The WaveSense Diabetes Manager application is a digital logbook and diabetes management tool designed to operate using the iPhone Operating System platform. The application can be used alone or with the WaveSense Direct Connect Cable and a WaveSense-enabled blood glucose meter (BGM) with a mini-USB port.

The WaveSense Diabetes Manager (WDM) application (app) is a digital logbook and diabetes management tool for the iPhone operating system platform. The application can be used alone or with the WaveSense Direct Connect Cable and a WaveSense-enabled Blood Glucose Meter (BGM) with a mini-USB port.

Here's an analysis of the provided text regarding the acceptance criteria and study for the AgaMatrix WaveSense Diabetes Manager application:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to a predicate device rather than explicitly defining and meeting specific analytical or clinical performance acceptance criteria for the WaveSense Diabetes Manager application itself. The study's focus was on the ease of use and functional equivalence as a data management tool.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The text mentions "Clinical setting by persons with diabetes," but does not provide a number for the participants in this evaluation.
• Data Provenance: The study was conducted "in house and in a Clinical setting." The country of origin is not specified but is presumed to be the USA, given the submission to the FDA. The study appears to be prospective in nature, as it involved actively evaluating the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The study primarily focused on user experience and functional equivalence rather than a diagnostic performance evaluation requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the study (ease of use and functional equivalence), a formal adjudication method for diagnostic accuracy would likely not be relevant or necessary.

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, an MRMC comparative effectiveness study was not done. The WaveSense Diabetes Manager application is a data management tool, not an AI-powered diagnostic device, and therefore this type of study is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a standalone application in the sense that it collects and displays data. However, it's not an "algorithm-only" device for diagnostic or predictive purposes without human interaction. Its function is to facilitate human review and analysis of blood glucose data. The performance assessment was based on its operational ease and functional equivalence.

7. The Type of Ground Truth Used

The concept of "ground truth" as it applies to diagnostic accuracy (e.g., pathology, expert consensus) is not applicable to this device. The "ground truth" for this application would be the accurate transfer and display of blood glucose readings, which are generated by an external BGM, and the user's ability to easily navigate and utilize the app's features. The study implicitly evaluated the functional correctness and user experience as its "ground truth."

8. The Sample Size for the Training Set

This information is not applicable/not provided. The WaveSense Diabetes Manager is an application for data management, not a machine learning or AI model that requires a "training set" in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As stated above, this device does not utilize a "training set" in the context of an AI/ML model.

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AgaMatrix JAZZ Wireless™ 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.

AgaMatrix JAZZ Wireless™ Blood Glucose Meter is intended for use with AgaMatrix JAZZ 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.

AgaMatrix JAZZ Blood Glucose Test Strips are intended for use with AgaMatrix JAZZ Wireless 110 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.

AgaMatrix WaveSense™ Control Solution is intended for use with the AgaMatrix JAZZ Wireless M Meter and AgaMatrix JAZZ Wireless " Test Strips as a quality control check to verify the accuracy of blood glucose test results.

The AgaMatrix Jazz Wireless™ Blood Glucose Monitoring System which is codeless, includes a meter with batteries, compact carrying case, lancing device, lancets, control solution and owner's booklet. Test Strips and control solution are sold separately.

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.

The modification of Jazz Wireless™ blood glucose system allows users to upload glucose readings from the meter to a blue tooth enabled PC without the use of a USB cable.

The provided document describes a 510(k) summary for the AgaMatrix Jazz Wireless™ Blood Glucose Monitoring System. The modification pertains to the wireless upload of glucose readings; therefore, the core performance of the glucose measurement itself likely relies on previously established data or adherence to recognized standards.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the manufacturer certifies the device complies with ISO 15197:2003 "In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus." This standard outlines performance requirements for blood glucose meters.

While the document states compliance with ISO 15197:2003, it does not provide a specific table of acceptance criteria from ISO 15197 or the detailed reported device performance against those criteria. It merely makes a general declaration of compliance. To fully answer this, the specific ISO 15197:2003 criteria (e.g., accuracy within certain percentage or mg/dL for different glucose ranges) and the AgaMatrix Jazz Wireless™ device's performance data against those criteria would be needed, but they are not included in this document.

What is present in the document:

2. Sample size used for the test set and the data provenance

The document states "Based upon the testing and comparison to the predicate device". However, it does not specify the sample size used for the test set, the country of origin of the data, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide any information regarding the number of experts, their qualifications, or their role in establishing ground truth for any test set. For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods, not expert consensus in the way image analysis or clinical diagnosis might use.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not specify any adjudication method for a test set.

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 device is a blood glucose monitoring system, not an AI-powered diagnostic imaging tool that would typically involve human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device and was not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The document indicates that the device itself performs the measurement. The "testing" mentioned implies standalone performance studies were conducted to demonstrate compliance with ISO 15197:2003. However, specific details of such standalone testing (e.g., protocol, metrics, results) are not provided, beyond the general statement of compliance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For blood glucose monitoring systems, the ground truth is typically established by laboratory reference methods (e.g., YSI analyzer). The document does not explicitly state the type of ground truth used, but this is the standard practice for demonstrating accuracy of blood glucose meters against a known, highly accurate method.

8. The sample size for the training set

The document does not provide any information about a "training set." This term is typically associated with machine learning or AI algorithms. While the device likely has internal algorithms for glucose measurement, the document does not discuss a separate training phase or associated sample sizes.

9. How the ground truth for the training set was established

As no training set is discussed, no information is provided on how its ground truth might have been established.

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AgaMatrix WaveSense™ KeyNote Codeless Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm, and/or forearm. 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 AgaMatrix WaveSense™ KeyNote Codeless Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, lancing device, lancets, control solution and owner's booklet. Test Strips are sold separately. The meter is a portable, battery-operated instrument.

The provided text describes the AgaMatrix WaveSense™ KeyNote Codeless Blood Glucose Monitoring System, which states that it complies with ISO 15197:2003. This standard specifies the requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. While the summary states compliance, it does not explicitly provide a table of acceptance criteria or reported device performance against specific targets from ISO 15197. Therefore, the following information is based on the general understanding of ISO 15197 for blood glucose meters, as the specific performance data is not detailed in the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

As specific performance data against ISO 15197:2003 criteria is not provided in the document, a general representation based on the standard's requirements for accuracy is used.

| Performance Characteristic | Acceptance Criteria (from ISO 15197:2003 for glucose values ≥ 4.2 mmol/L (75 mg/dL) and

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AgaMatrix JAZZ™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm, and/or forearm. 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.

AgaMatrix JAZZ™ Blood Glucose Meter is intended for use with AgaMatrix JAZZ™ Blood Glucose Test Strips for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm, and/or forearm. 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.

AgaMatrix JAZZ™ Blood Glucose Test Strips are intended for use with AgaMatrix JAZZ™ Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm and/or forearm. 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.

AgaMatrix JAZZ™ Control Solutions are intended for use with the AgaMatrix JAZZ™ Meter and AgaMatrix JAZZ™ Test Strips as a quality control check to verify the accuracy of blood glucose test results.

The AgaMatrix WaveSense JAZZ™ Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, Lancing device, lancets, control solution and owner's booklet. Test Strips are sold separately. 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.

The provided text is a 510(k) Summary for the AgaMatrix WaveSense JAZZ™ Blood Glucose Monitoring System, dated August 17, 2007. It states the device's intended use and that it complies with ISO 15197:2003, but it does not contain information about specific acceptance criteria or a study proving the device directly meets acceptance criteria for accuracy with detailed performance metrics.

The document discusses the device's modification (no coding required), intended use, and compliance with various international standards, including ISO 15197:2003 ("In vitro diagnostic test systems- Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus"). While compliance with ISO 15197 generally implies meeting certain accuracy standards, the specific performance data (e.g., mean absolute relative difference (MARD), percentages within certain error grids) are not present in this summary.

Therefore, I cannot fulfill all parts of your request based solely on the provided text.

Here's what I can provide based on the given information, along with explanations for the missing elements:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The document states compliance with ISO 15197:2003. This standard sets performance requirements for blood glucose monitoring systems.
  • ISO 15197:2003 Acceptance Criteria (generally, not explicitly stated in the document, but implied by compliance):
    • For glucose concentrations

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