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OneTouch® Reveal™ is indicated for use by individuals or health care professionals in the home or health care facilities for transmitting data from home monitoring devices such as glucose meters and insulin pumps to a server database to support diabetes management. The device is indicated for professional use and over-the-counter sales.

OneTouch® Reveal™ is a Web-based Diabetes management system. The application is designed to assist health care professionals and people with diabetes to track blood glucose levels and insulin doses. The application identifies patterns to help patients manage glycemic control. OneTouch® Reveal™ includes pattern recognition messages, reports, and the ability to view patient data remotely.

Here's an analysis of the acceptance criteria and study information for the LifeScan OneTouch® Reveal™ device, based on the provided text:

Device: OneTouch® Reveal™ (Web-based Diabetes management system)

The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance acceptance criteria for a new clinical study. For software devices like OneTouch® Reveal™, "performance" often refers to software verification and validation, and usability, rather than a clinical accuracy study directly analogous to a blood glucose meter.

Based on the available information, here's what can be extracted and what is not explicitly stated:

Acceptance Criteria and Reported Device Performance

Important Note: The document does not provide specific numerical acceptance criteria (e.g., minimum accuracy percentages, specific error rates) that are typical for diagnostic devices, as this is a software system for data management. The "performance data" section broadly states that the device "meets its required specifications and performs as intended."

Study Information

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated. The document mentions "software verification and validation testing" and "Human Factors Usability Studies," but does not provide specific sample sizes (e.g., number of test cases for software, number of participants for usability).
   • Data Provenance: Not explicitly stated. For software testing, this would typically involve synthetic data, simulated data, and potentially real patient data for validation. For Human Factors, this would involve participants simulating real-world use. The location of these activities is not mentioned.

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

   • Not explicitly stated. For software verification, "ground truth" would be the expected output based on specifications, which is established by software engineers and subject matter experts. For usability, "truth" is often observed user behavior against defined tasks. No specific number or qualifications of such experts are provided.

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

   • Not explicitly stated. Adjudication methods like 2+1 or 3+1 are typically used for clinical endpoints where expert consensus is needed on a subjective interpretation (e.g., image reading). For software functionality and usability testing, this type of adjudication is generally not directly applicable.

4. 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. This device is a data management system, not an AI-assisted diagnostic tool that would be evaluated with human readers. Its primary function is to track, identify patterns, and display data for users, not to provide interpretations that human readers would then review or be assisted by.

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

   • Yes, in essence, the "software verification and validation testing" evaluates the algorithm's performance in a standalone manner against its specifications (i.e., does the software correctly process data, identify patterns, and generate reports as designed). The document implies this was done when it states the device "meets its required specifications and performs as intended."

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

   • For software verification: The "ground truth" would be the expected outcomes and behaviors defined by the software requirements and design specifications. This is derived from scientific principles of glucose monitoring and diabetes management.
   • For human factors: The "ground truth" would be the successful completion of tasks by users, adherence to usability principles, and user satisfaction metrics.

7. The sample size for the training set:

   • Not applicable as this is not a machine learning/AI device in the sense of requiring a "training set" for model development. It's a rules-based software system for data management and pattern recognition. The "patterns" it identifies are likely based on predefined clinical rules or thresholds, not derived from a machine learning training dataset.

8. How the ground truth for the training set was established:

   • Not applicable for the same reason as point 7. The "ground truth" for the system's logic (e.g., what constitutes a "pattern" or "high glucose event") would be established by clinical experts and engineers based on established medical guidelines for diabetes management, not through a machine learning training process with labeled data.

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The OneTouch® Reveal Diabetes Management Application is a software accessory to the OneTouch® Verio Sync Blood Glucose Monitoring System, and is intended for use in the home setting by people with diabetes. It is intended to aid in the review, analysis, and evaluation of patient data to support diabetes management. The OneTouch® Reveal Diabetes Management Application receives (from both manual entry and wireless transmission), stores, and sends patient data for display and reporting. The OneTouch® Reveal Diabetes Management Application also communicates with web-based applications. The OneTouch® Reveal Diabetes Management Application is available for use on commercially-available mobile devices and uses generally-available networks and communication protocols.

The OneTouch® Reveal Diabetes Management Application (App) is a diabetes management tool that can help you determine what your blood glucose test results mean. This allows you and your health care professional to better monitor and adjust your diabetes care plan. The App is designed to work in conjunction with the OneTouch® Verio™ Sync Meter. Using the Bluetooth® feature on your meter and Apple® device, blood sugar test results can be sent directly from your meter to the App. Once a blood sugar result is sent to the App you can: Tag the blood sugar result with a meal flag, Receive Low and High Pattern messages, Add carbs, activity, medication data and Notes about your activities, Manually enter other blood sugar test results, Review results on graphs, Share your blood sugar results with others for review and follow-up, and Set reminders to prompt you to complete certain tasks.

The OneTouch® Reveal Diabetes Management Application is a software accessory designed to aid in the review, analysis, and evaluation of patient data to support diabetes management. The device works in conjunction with the OneTouch® Verio™ Sync Meter, receiving blood sugar test results via Bluetooth, and allowing users to tag results, receive pattern messages, add data (carbs, activity, medication, notes), and review/share results.

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided summary does not explicitly list quantitative acceptance criteria with corresponding performance metrics in a defined table format. Instead, it describes general validation activities and concludes with substantial equivalence. The "Summary of Performance Characteristics" section indicates:

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

The provided 510(k) summary does not specify the sample size used for the user performance evaluation study or the human factors usability studies.

The data provenance is not explicitly stated. Given it's a submission for the US FDA, it's likely that at least some of the testing involved participants in a US-equivalent demographic or was overseen by US regulatory standards. However, the sponsor is LifeScan Europe, a Division of Cilag GmbH International (Switzerland), so testing could have occurred internationally. The summary does not indicate whether data was retrospective or prospective.

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

The document does not mention the use of experts to establish ground truth for the test set in the context of blood glucose pattern recognition or other analytical features. The validation focuses on software functionality and user interaction rather than diagnostic accuracy requiring expert consensus on specific cases.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method like 2+1 or 3+1. This type of adjudication is typically used for image-based diagnostics where multiple experts' opinions are combined to form a ground truth, which is not directly applicable to the described functionalities of this diabetes management application (e.g., displaying data, identifying patterns based on predefined algorithms).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No MRMC comparative effectiveness study was mentioned in the provided summary. The device's primary function is to process and display blood glucose data, not to perform interpretations that typically require multiple human readers. The summary focuses on comparing the device's functionality to a predicate device and validating its software and usability.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, a form of standalone evaluation was conducted as part of the "Full verification and validation testing of the OneTouch® Reveal™ Diabetes Management Application software." This validation would inherently involve testing the software's algorithms and functionalities (e.g., pattern recognition, data storage, display accuracy) in a standalone manner, separate from human-in-the-loop performance, to ensure they meet design specifications before user performance studies. The "user performance evaluation study" and "Human Factors Formative Usability studies" assessed the human-in-the-loop aspects.

7. The Type of Ground Truth Used

For the software validation, the "ground truth" would be established by the predefined software specifications and functional requirements. For example:

• Data Storage and Transmission: The ground truth would be that the data received, stored, and sent accurately matches the input data from the OneTouch® Verio™ Sync Meter or manual entry.
• Pattern Recognition: The ground truth would be the predefined rules or algorithms for identifying "Low patterns" and "Before-Meal High patterns." The algorithm's output (identification of a pattern) would be compared against the expected output based on these rules.
• Calculations/Display: The ground truth would be accurate mathematical calculations and correct display of data as per design.

No mention of pathology, outcomes data, or expert consensus specific to establishing the "correctness" of interpreted medical findings is made, as the device's main role is data management and simple pattern alerts based on pre-set thresholds.

8. The Sample Size for the Training Set

The document does not specify a sample size for a "training set." This type of application (diabetes management software) typically does not involve machine learning models that require explicit training data in the same way an AI diagnostic algorithm would. Its functionalities are rule-based and deterministic (e.g., displaying data, recognizing patterns based on pre-defined thresholds, calculating averages). Therefore, the concept of a "training set" is not applicable in the context usually addressed by such questions for AI/ML devices.

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

As there's no mention of a traditional machine learning "training set," the concept of establishing ground truth for it is not applicable here. The "ground truth" for the device's functions (e.g., correct data processing, accurate pattern identification) would be established by its design specifications and the underlying mathematical or logical rules programmed into the software.

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The OneTouch® Verio" Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The OneTouch® Verio" Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.

The OneTouch® Verio" 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 OneTouch® Verio™ Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidlv).

The OneTouch® Verio™ Test Strips are for use with the OneTouch® Verio" Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The OneTouch® Verio" Control Solutions are for use with the OneTouch® Verio" Blood Glucose Meter and Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

The OneTouch® Verio" Blood Glucose Monitoring System consists of the OneTouch® Verio" Meter, OneTouch® Verio™ Test Strips, OneTouch® Verio" Control Solutions (mid and high levels), the Lancing Device, Sterile Lancets and Clear Cap (sold separately). The OneTouch® Verio" System measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.

Here's a breakdown of the acceptance criteria and study information for the OneTouch® Verio™ Blood Glucose Monitoring System, as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to testing being done in accordance with ISO 15197:2003(E). While explicit numerical acceptance criteria for each category are not always stated outright, the results presented are the reported device performance and implicitly demonstrate that the device meets the standards of ISO 15197:2003(E).

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The Symphony Meter Remote is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood, and as a wireless (RF) remote control to deliver insulin from the Symphony Pump. The Symphony Meter Remote is intended for use for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The Symphony Meter Remote is specifically indicated for use on the finger, forearm or palm. It should not be used for the diagnosis of diabetes or testing of newborns.

The Symphony Meter Remote is designed to function both as an in vitro diagnostic device for self-monitoring blood glucose (measure blood glucose concentrations) and as a remote controller of a Symphony Pump for insulin delivery through an infusion set placed subcutaneously.

The Symphony Meter Remote is a reusable handheld-battery operated device supplied clean and non-sterile to primarily function as a stand-alone blood glucose meter. With user activation of RF communication between a specific Symphony Meter Remote and specific Symphony Pump, the Symphony Meter Remote also becomes a remote controller of certain features of the Symphony Pump. When paired through radio frequency (RF) communication the Symphony Meter Remote can be used to control bolus insulin delivery, review the status of the Symphony Pump and view and confirm selected pump alerts and warnings.

The Symphony Meter Remote incorporates other design features that utilize glucose test data, insulin delivery data, and information important to overall diabetes management, as well as provide interface capability with a personal computer (PC) via data management software.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Symphony Meter Remote, based on the requested information.

Note: The provided text is a 510(k) summary for a remote control device with integrated blood glucose meter. It focuses heavily on regulatory equivalence and does not contain detailed technical performance studies or acceptance criteria for the blood glucose measurement component itself. The document states: "Performance evaluations, both bench and clinical, of the Symphony Meter Remote were completed and did not raise any new issues of safety and effectiveness." This implies that the specific performance criteria and studies for the glucose meter are assumed to be covered by the predicate device (Symphony Glucose Management System K080639), and this submission is primarily for the remote control functionality. Therefore, I will synthesize what can be inferred or directly stated from the text.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria or performance metrics for the Symphony Meter Remote beyond its function as a remote control. It relies on the substantial equivalence to a predicate device (Symphony Glucose Management System, K080639).

However, as the device incorporates a glucose test system, general performance expectations for blood glucose meters typically involve accuracy metrics (e.g., ISO 15197 standards). Since the document claims: "Performance evaluations, both bench and clinical, of the Symphony Meter Remote were completed and did not raise any new issues of safety and effectiveness," this suggests the blood glucose monitoring function met relevant established performance standards.

Given the lack of explicit data in this specific document, I will present the information based on the typical requirements for such devices, acknowledging that the specific numerical values are not present here.

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

The 510(k) summary for K082570 provides no specific details regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for the "Performance evaluations, both bench and clinical." The statement indicates these evaluations were completed but does not provide their specifics. Since it refers to "no new issues" compared to the predicate (K080639), it implies reliance on the studies performed for the predicate 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 510(k) summary. For blood glucose meters, ground truth is typically established by laboratory reference methods (e.g., YSI analyzer) performed by trained lab personnel, not necessarily "experts" in the clinical review sense.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Given the nature of blood glucose measurement, "adjudication" in the sense of reconciling divergent expert opinions is not typically applicable. Ground truth for blood glucose is established by validated laboratory instruments.

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 mentioned. MRMC studies are typically used for diagnostic imaging devices where human interpretation varies. This device is a blood glucose meter and a remote control, which does not involve "reading" cases in that context.

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

The "Performance evaluations, both bench and clinical" would encompass standalone performance of the blood glucose meter component. The phrase "did not raise any new issues of safety and effectiveness" suggests that the standalone performance as a blood glucose meter was sufficient and comparable to the predicate. However, detailed results of this standalone testing are not provided in this summary.

7. The Type of Ground Truth Used

For the blood glucose measurement function, the ground truth would typically be established using laboratory reference methods (e.g., a YSI Glucose Analyzer). The document does not explicitly state this, but it is the standard for blood glucose meter validation. For the remote control functionality, the ground truth would involve successful and accurate control commands being transmitted and executed by the insulin pump, which would be assessed through functional testing.

8. The Sample Size for the Training Set

The 510(k) summary does not provide any information regarding a training set sample size. This type of detail is more common for devices employing machine learning algorithms, which is not suggested to be the primary mechanism for the blood glucose measurement in this device generation. For a blood glucose meter, "training" in the ML sense is not typically applicable in the same way; calibration and robustness testing are usually performed.

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

As no training set is described or implied for an AI/ML context, this information is not applicable in the context of this 510(k) summary. If a "training set" refers to samples used for device calibration, the ground truth would be established using laboratory reference methods, similar to the test set.

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The OneTouch® Vita™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch® Vita™ System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch Vita™ Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.

The OneTouch® Vita™ Blood Glucose Monitoring System consists of the OneTouch® Vita™ Meter; OneTouch® Vita™ Test Strips (provided separately); OneTouch® Vita™ Control Solution and OneTouch® Vita™ High Control Solution (provided separately); either the OneTouch® UltraSoft® Adjustable Blood Sampler with OneTouch® UltraClear® Cap or the OneTouch® Lancing Device with OneTouch® AST ClearCap; and OneTouch® UltraSoft Sterile Lancets.

The OneTouch® Vita™ Blood Glucose Monitoring System is a modification of existing predicate devices (OneTouch® Select™ and OneTouch® Ultra®2 meters and OneTouch® Ultra® test strip). The acceptance criteria and performance are based on the ISO 15197:2003(E) standard for in vitro diagnostic test systems for self-testing in managing diabetes mellitus.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text only explicitly mentions that the device was tested in accordance with ISO 15197:2003(E). It does not provide a detailed table of specific acceptance criteria values (e.g., specific percentage agreement within a certain range) or the exact reported performance metrics from the study. Therefore, the table below will list the categories of performance characteristics evaluated based on the ISO standard and the general statement of performance presented in the summary.

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 or the data provenance (e.g., country of origin, retrospective/prospective). It generally states that "analytical performance testing included system accuracy, repeatability and intermediate precision testing" and "A user performance evaluation assessed usability of the device (human factors) in the hands of intended users."

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

The document does not specify the number of experts used or their qualifications for establishing ground truth. For blood glucose monitoring systems, the "ground truth" for system accuracy is typically established by comparative measurements against a laboratory reference method, which is itself calibrated and controlled rather than relying on expert consensus in the same way an imaging device might.

4. Adjudication Method for the Test Set

The concept of an adjudication method (like 2+1 or 3+1) is not applicable here as the ground truth for blood glucose measurements is established through a laboratory reference method, not through consensus read by experts.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human interpretation of images or data is involved. For a blood glucose monitoring system, the performance is measured by the device's accuracy in autonomously measuring glucose levels.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the primary performance evaluation for the OneTouch® Vita™ Blood Glucose Monitoring System is inherently a "standalone" evaluation. The device (meter and test strip) itself measures glucose concentration independently of human interpretation of the reading. The "user performance evaluation" described is to assess usability and comprehension by human users, not to assess human interpretation of the device's output.

7. The Type of Ground Truth Used

The ground truth for system accuracy is established through comparison to a laboratory reference method. The document states that "A comparison of system accuracy performance demonstrated that the OneTouch Vita™ Blood Glucose Monitoring System is substantially equivalent to the currently marketed OneTouch® Select™ and OneTouch® Ultra®2 Blood Glucose Monitoring Systems." This implies that the device's measurements were compared against highly accurate laboratory glucose measurements.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. For medical devices like blood glucose monitors, the development process involves extensive testing and refinement rather than a distinct "training set" in the machine learning sense. The performance characteristics described are from verification and validation testing, which would involve a test set.

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

As there is no explicit mention of a "training set" in the context of this device's regulatory submission, the establishment of ground truth for a training set is not described. The ground truth for the performance evaluation (test set) is established via a laboratory reference method.

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The ONE Touch® Zoom™ Diabetes Management Program is intended for use in home and clinical settings to aid people with diabetes and healthcare professionals in the review, analysis, and evaluation of historical blood glucose test results to support effective diabetes management. It is intended for use as an accessory to LifeScan blood glucose monitoring systems with data management capabilities.

The OneTouch® Zoom™ Diabetes Management Program is a web-based application that is designed to retrieve blood glucose data from the Microsoft® HealthVault™ and provide trending and reports in order to assist people with diabetes management. The program also includes a stand-alone software driver, branded as OneTouch® Meter Drivers for use with Microsoft® HealthVault™ that downloads blood glucose data from Lifescan Brand blood glucose meters with data management capabilities to Microsoft® HealthVault™ Connection Center, which subsequently upload the data to the user's online Microsoft® HealthVault™ account. The OneTouch® Zoom™ Diabetes Management Program is a .NET based client/server application that runs on Windows 2003 server and supports Internet Explorer 6.0 and higher on the client side. The OneTouch® Meter Drivers for use with Microsoft® HealthVault™ run on Windows XP Service Pack 2 and Windows Vista platforms.

Here's an analysis of the provided text regarding the acceptance criteria and study for the OneTouch® Zoom™ Diabetes Management Program:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the provided text. The document refers to "Design Verification testing" but does not give specific numbers for test cases or datasets.
• Data Provenance: Not explicitly stated. The testing is described as design verification and software verification/validation, implying internal testing, but details on the origin of data used for this testing (e.g., country, retrospective/prospective) are absent.

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

Not applicable. The device is a software program for diabetes management data analysis; there is no mention of human expert-established ground truth in the context of diagnostic accuracy for the device itself. The "ground truth" would likely relate to the accuracy of data retrieval, processing, and display, rather than clinical diagnosis.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this type of adjudication is typically for diagnostic accuracy studies with human readers, which is not the nature of this device's testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No. An MRMC comparative effectiveness study was not performed. The device is a data management program, not an AI-assisted diagnostic tool for human readers.

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

Yes, implicitly. The "Design Verification testing (including software verification and validation testing)" would assess the standalone performance of the software in its intended functions (data retrieval, trending, reporting). The focus is on the software's ability to accurately process and present the blood glucose data.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device would be established by:

• Conformance to requirements: Ensuring the software correctly implements its specified functions (e.g., retrieves data accurately, generates reports as defined, performs calculations correctly).
• Predicate device equivalence: The primary "ground truth" or benchmark is the predicate device. The testing aimed to confirm that the new device's performance characteristics were equivalent to the already approved predicate.
• The accuracy of the blood glucose data itself, which originates from LifeScan blood glucose meters, is assumed as established by the prior approval of those meters.

8. The Sample Size for the Training Set

Not applicable. This device is a data management program, not a machine learning model that undergoes a training phase.

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

Not applicable, as there is no training set for this type of software device.

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The OneTouch® UltraLink™ Blood Glucose Monitoring System is intended to be used for self-testing outside the body (in vitro diagnostic use) for the quantitative measurement of glucose in fresh capillary whole blood obtained from the finger, forearm or palm. The OneTouch® UltraLink™ System is intended for use by people with diabetes in a home setting and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.

The OneTouch® UltraLink™ Blood Glucose monitor may be used to transmit glucose values to appropriate MiniMed Paradigm® and Guardian® REAL Time devices using radio frequency communication.

The OneTouch® UltraLink Blood Glucose Monitoring System is a modification to the OneTouch® Ultra® 2 Blood Glucose Monitoring System, retaining the features, functions, and user interface of the OneTouch® Ultra® 2 meter while introducing a feature allowing Radio-Frequency transmission of blood glucose results to compatible Medtronic MiniMed, Inc. devices. The OneTouch® UltraLink™ Blood Glucose Monitoring System is composed of the OneTouch® UltraLink™ Blood Glucose meter, OneTouch® Ultra® Test Strips, OneTouch® Ultra® Control Solution, OneTouch® Lancing device, OneTouch® UltraSoft® Lancets, and meter carrying case. System modifications were made only to the blood glucose meter, carrying case, and instructions for use.

Here's a breakdown of the acceptance criteria and the study information for the OneTouch® UltraLink™ Blood Glucose Monitoring System, based on the provided text:

Acceptance Criteria and Device Performance

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The OneTouch® Select™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch® Select™ System is intended for self-testing outside the body (in vitro diagnostic use) by pcople with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch® Select™ Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.

The OneTouch® Select™ Blood Glucose Monitoring System consists of the OneTouch® Select™ Meter, OneTouch® Select™ Test Strips (provided separately), OneTouch® Select™ Control Solution (provided separately), OneTouch® Select™ High Control Solution (provided separately), either the OneTouch® UltraSoft® Adjustable Blood Sampler with OneTouch® UltraClear® Cap or the OneTouch® Lancing Device with Onc Touch® AST ClearCap and OneTouch® UltraSoft Sterile Lancets.

The OneTouch® Select™ meter, test strip and high control solution are modifications of the OneTouch Ultra 2® meter, test strip and normal control solution, respectively.

There are no changes to other system testing components compared to the currently marketed product.

The OneTouch® Select™ Blood Glucose Monitoring System was tested and found to be substantially equivalent to the predicate OneTouch Ultra 2 Blood Glucose Monitoring System.

Here's a breakdown of the requested information, although some details (like specific sample sizes for training sets and the exact number/qualifications of experts) are not explicitly provided in the summary:

1. Table of Acceptance Criteria and Reported Device Performance

The summary states that the modified blood glucose monitoring system was tested in accordance with ISO 15197:2003(E). This standard outlines acceptance criteria for the accuracy of blood glucose monitoring systems. While the exact numerical criteria from ISO 15197:2003(E) are not listed in this summary, the document asserts that the "System accuracy performance demonstrated that the OneTouch® Select™ Blood Glucose Monitoring System and the currently marketed OneTouch Ultra 2 Blood Glucose Monitoring System are substantially equivalent."

Therefore, the acceptance criteria would be those defined by ISO 15197:2003(E), and the performance reported is that it met these criteria as being substantially equivalent to the predicate device.

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

• Sample Size for Test Set: The document does not explicitly state the sample size used for the analytical performance testing (system accuracy, repeatability, intermediate precision) or the user performance evaluation.
• Data Provenance: Not explicitly stated, but the testing would typically be prospective for such performance studies. Given LifeScan's global presence, the data would likely be collected in a controlled clinical or laboratory setting as part of the design verification process.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: For ground truth in blood glucose measurements, this would typically involve laboratory reference methods and highly trained medical laboratory professionals rather than "experts" in the sense of radiologists. The "User performance evaluation" would assess accuracy by intended users (people with diabetes and healthcare professionals), but the ground truth for glucose values would be established by a reference laboratory method.

4. Adjudication Method for the Test Set

• Not applicable as the ground truth for blood glucose measurements is typically established by precisely calibrated and traceable laboratory reference methods, not subjective interpretation requiring adjudication among multiple human readers.

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

• No, an MRMC study was not done. This type of study is relevant for medical imaging where human readers interpret cases. For a blood glucose monitoring system, the primary evaluation is the accuracy of the device's measurement compared to a reference method, rather than human interpretation of device output.

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

• Yes, a standalone performance study was done. "Analytical performance testing included system accuracy, repeatability and intermediate precision testing." This refers to the device's inherent ability to measure glucose values accurately and precisely, independently of user interaction for the measurement itself (though user interaction is a separate usability test).

7. The Type of Ground Truth Used

• The ground truth for blood glucose measurement studies is typically established by laboratory reference methods. These are highly accurate and precise methods (e.g., hexokinase method) performed in a clinical laboratory to determine the true blood glucose concentration against which the device's readings are compared.

8. The Sample Size for the Training Set

• The document does not provide information regarding a specific "training set" or its size. For a blood glucose meter, the "training" (calibration) is inherent in its design and manufacturing. Any iterative development might involve internal testing, but a distinct "training set" like in machine learning is not typically detailed in 510(k) summaries for these devices.

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

• As a "training set" is not explicitly mentioned in the context of this device's regulatory submission, the method for establishing its ground truth is not provided. The ground truth for the device's validation (test set) is established using laboratory reference methods.

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The OneTouch Ultra Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch Ultra System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch Ultra Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.

The OneTouch Ultra Blood Glucose Monitoring System consists of the OneTouch Ultra Meter, OneTouch Ultra Test Strips (provided separately), OneTouch Ultra Control Solution, OneTouch UltraSoft Blood Sampler with OneTouch ClearCap and OneTouch UltraSoft Sterile Lancets. The predicate OneTouch® Ultra® meter hardware and software has been modified. There are no changes to other system testing components compared to the currently marketed product.

This document describes the OneTouch® Ultra® Blood Glucose Monitoring System, which measures glucose in fresh capillary whole blood. The system is intended for use by people with diabetes at home and/or by healthcare professionals in a clinical setting to monitor diabetes control. It is specifically indicated for use on the finger, forearm, or palm.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria for glucose measurement accuracy. Instead, it refers to compliance with the ISO 15197:2003(E) standard. For blood glucose monitoring systems, ISO 15197:2003(E) typically sets accuracy criteria, often related to the percentage of results falling within specific ranges compared to a reference method (e.g., within ±15% or ±20%).

Since specific numerical criteria are not provided, we can only state the overall performance claim made in the document.

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

The document does not provide details on:

• The sample size used for the test set in the system accuracy study.
• The country of origin for the data.
• Whether the study was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not provide information on:

• The number of experts used to establish ground truth.
• The qualifications of those experts.

Given that this is a blood glucose monitoring system, the "ground truth" would typically be established by a laboratory reference method, not by an expert consensus on interpreting images or clinical data.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. This is understandable as the "ground truth" in this context would likely be a precise numerical measurement from a laboratory reference instrument, not a subjective interpretation requiring adjudication.

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. MRMC studies are typically used for diagnostic imaging devices where human readers interpret medical images. This device is a blood glucose monitor, not an imaging device.

6. If a Standalone Performance Study Was Done

Yes, a standalone performance assessment (algorithm only without human-in-the-loop performance) was done. The "system accuracy study" and "Design Verification (including software verification and validation testing)" are examples of standalone performance evaluations for a medical device. The device's performance is measured directly against a reference.

7. The Type of Ground Truth Used

The document implies that the ground truth used for the system accuracy study would be a laboratory reference method for glucose measurement. While not explicitly stated, this is standard practice for blood glucose meters to ensure accuracy. The ISO 15197:2003(E) standard inherently requires comparison to a highly accurate reference method.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for a training set. For in vitro diagnostic devices like blood glucose meters, the development often involves analytical studies, calibration, and verification rather than "training sets" in the machine learning sense, although internal data is used during development.

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

The document does not provide information on how ground truth for a training set was established. As mentioned above, the concept of a "training set" with established ground truth, as used in machine learning, is not explicitly discussed for this type of device. The development process would rely on precise chemical and analytical methods to calibrate and verify the device's measurement capabilities.

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The OneTouch UltraMini Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch UltraMini System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch UltraMini Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.

The OneTouch UltraMini Blood Glucose Monitoring System consists of the OneTouch UltraMini Meter, OneTouch Ultra Test Strips (provided separately), OneTouch Ultra Control Solution, OneTouch Lancing Device with AST Clear Cap or OneTouch UltraSoft Blood Sampler with OneTouch UltraClear Cap and OneTouch UltraSoft Sterile Lancets. The predicate OneTouch® Ultra® Meter has been modified to produce the OneTouch UltraMini Meter. The OneTouch Lancing Device with AST Clear Cap is a modification (smaller size) of the existing OneTouch UltraSoft Blood Sampler with OneTouch UltraClear Cap (class I, exempt device). There are no changes to any of the other system testing components compared to the currently marketed product.

The submitter for the K061118 device is LifeScan, Inc. The device is the OneTouch® UltraMini™ Blood Glucose Monitoring System which is a modification of the predicate device, the OneTouch Ultra Blood Glucose Monitoring System. The claim for the device is substantial equivalence to the predicate. The performance characteristics of the new device are the same as the predicate since there has been no change to the fundamental scientific technology.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text states: "The modified meter was tested in accordance with ISO 15197:2003(E) including System Accuracy, Clinical Accuracy, and Consumer Evaluation to assess ease of use (human factors and user acceptance)."

However, specific numerical acceptance criteria (e.g., accuracy percentages, bias limits) and the detailed study results for these criteria are not explicitly provided in the given summary. It only states that the testing was performed and confirmed equivalence.

Therefore, a table with specific numbers cannot be generated from the provided text.

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

The summary mentions a "meter equivalence study" and "Design Verification (including software verification and validation) testing." It also states "The modified meter was tested in accordance with ISO 15197:2003(E)."

• Sample Size for Test Set: The document does not specify the sample size used for the test set in any of the studies (meter equivalence, design verification, or ISO 15197 testing).
• Data Provenance (Country of Origin, Retrospective/Prospective): The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide any information regarding the number or qualifications of experts used to establish ground truth for any of the testing mentioned.

4. Adjudication Method for the Test Set

The document does not provide any information regarding the adjudication method used for the test set.

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

The provided summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on demonstrating equivalence to the predicate device, not on human reader performance improvement with AI assistance.

6. Standalone (Algorithm Only) Performance Study

The device is a blood glucose monitoring system, which inherently involves human interaction for obtaining a blood sample and reading the meter. Therefore, a purely standalone "algorithm only" performance study in the context of AI is not applicable to this type of medical device as described. The performance studies would naturally involve the device being used as intended.

7. Type of Ground Truth Used

While the document doesn't explicitly state "ground truth," for blood glucose monitoring systems, the generally accepted "ground truth" for assessing accuracy is the comparison of device readings to a laboratory reference method (e.g., YSI analyzer) performed on the same blood sample. Given the reference to ISO 15197:2003(E), which directly addresses accuracy against reference methods, it can be inferred that a laboratory reference method would have been used.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. This is consistent with a device that does not employ machine learning or AI in a way that requires a separate "training set" in the conventional sense for algorithm development. The device is a modification of an existing system, and the studies focus on verifying its equivalence.

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

As no training set is mentioned or implied for an AI/machine learning algorithm, this question is not applicable based on the provided text.

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