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The MICROLET®NEXT 2 Lancing Device is used with the disposable MICROLET®NEXT Lancet to obtain capillary blood samples.

The proposed MICROLET®NEXT 2 Lancing Device falls under multiple Use Blood Lancet for Single Patient Use Only category. The proposed MICROLET®NEXT 2 Lancing Device is a pen-like instruments to be used with the compatible MICROLET® NEXT Lancets (28 G) for the controlled puncture of the skin to obtain the capillary blood droplet sample for testing.

The provided FDA 510(k) clearance letter and summary for the MICROLET®NEXT 2 Lancing Device (K250813) addresses the device's technical characteristics, regulatory classification, and substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria or detailed study results (like numerical performance metrics) typically found in a clinical study report for AI/ML-based medical devices or diagnostics.

The document describes a usability study rather than a performance study focused on specific numerical criteria for the lancing device's function (e.g., depth of penetration accuracy, blood sample volume consistency). The "acceptance criteria" in this context appear to be related to the usability and safety of the device by lay users.

Based on the provided text, here's a breakdown of the requested information, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance for MICROLET®NEXT 2 Lancing Device (K250813)

Note: The provided document describes a lancing device and its clearance based on substantial equivalence, primarily focusing on usability and safety. It does not contain quantitative performance metrics or specific "acceptance criteria" (e.g., sensitivity, specificity, accuracy percentages) typically seen for diagnostic devices or AI algorithms. The "performance" here refers to the device's ability to be used effectively and safely by lay persons.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Sample Size for Test Set:
  • Enrolled: 131 lay persons with diabetes.
  • Completed Study: 120 lay persons with diabetes.
• Data Provenance:
  • Country of Origin: Not explicitly stated but implied to be within the US given the FDA submission and contact information.
  • Retrospective or Prospective: Prospective ("enrolled into the study at a single clinical site").

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This was a usability study with lay users, not an expert-driven validation of a diagnostic ground truth. The "ground truth" was the ability of the lay person to successfully use the device to obtain a blood sample.

4. Adjudication Method for the Test Set

• Not Applicable. No expert adjudication of results was mentioned as the study was about user proficiency and device function in obtaining a sample, rather than interpretation of diagnostic results.

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

• No. This type of study is typically performed for AI-assisted image interpretation or diagnostic systems to evaluate how AI improves human reader performance. The device in question is a lancing device, which provides a blood sample, not an interpretation tool.

6. Standalone (Algorithm Only) Performance

• Not Applicable. This is a mechanical lancing device, not a software algorithm.

7. Type of Ground Truth Used

• Functional Success / User Proficiency: The ground truth was whether the enrolled lay users could successfully operate the device to "obtain adequate blood volume from fingertip and palm lancing to obtain a numerical or non-numerical result on the BGMS."

8. Sample Size for the Training Set

• Not Applicable. This device is hardware (a lancing device), not an AI/ML algorithm that requires a training set. The "training" for the users in the study was reading the Instructions for Use (IFU).

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

• Not Applicable. See point 8.

Summary Limitations of this Document:

This document is a regulatory clearance letter and 510(k) summary, specifically for a mechanical lancing device. It is not a document for an AI/ML-based diagnostic device. Therefore, it lacks the detailed performance metrics (like sensitivity, specificity, AUC), expert read studies, and training/test set data provenance typically associated with the evaluation of AI/ML algorithms. The "clinical study" described is a usability and safety study for the physical device, demonstrating that lay users can operate it safely and effectively.

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The CONTOUR® NEXT GEN Blood Glucose Monitoring System consists of the CONTOUR® NEXT GEN meter, CONTOUR® NEXT blood glucose test strips and the CONTOUR® Diabetes app.

The CONTOUR® NEXT GEN Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The CONTOUR® NEXT GEN Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® NEXT GEN 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 in monitoring the effectiveness of a diabetes control program.

The CONTOUR® NEXT GEN Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use.

The system is intended for in vitro diagnostic use only.

The CONTOUR® PLUS BLUE Blood Glucose Monitoring System consists of the CONTOUR® PLUS BLUE meter, the CONTOUR® PLUS blood qlucose test strips, and the CONTOUR® Diabetes app.

The CONTOUR® PLUS BLUE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® PLUS BLUE 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 in monitoring the effectiveness of a diabetes control program.

The CONTOUR® PLUS BLUE Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The CONTOUR® PLUS blood glucose test strips are for use with the CONTOUR® PLUS BLUE meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips.

The system is intended for in vitro diagnostic use only.

CONTOUR® NEXT GEN and CONTOUR® PLUS BLUE Blood Glucose Meters have Bluetooth Low Energy technology built in so that the meters can communicate wirelessly to smart phones and tablets. The CONTOUR® NEXT GEN meter uses the CONTOUR® NEXT blood glucose test strips and CONTOUR® NEXT control solution and CONTOUR® PLUS BLUE meter uses CONTOUR® PLUS blood glucose test strips and CONTOUR® PLUS control solution respectively. The meters can be connected to the CONTOUR® Diabetes app. Both the meters use two replaceable coin cell batteries. Both the meters' shape is a traditional oval form factor. The CONTOUR® NEXT GEN and CONTOUR® PLUS BLUE meters have smartLIGHT® and smartCOLOR® indicator features respectively to see if a glucose result is above, within, or below target range.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CONTOUR® PLUS BLUE and CONTOUR® NEXT GEN Blood Glucose Monitoring Systems.

It's important to note that the provided FDA 510(k) clearance letter and summary primarily focus on demonstrating substantial equivalence to a predicate device, specifically for a minor modification (change in Bluetooth Low Energy microprocessor). As such, the documentation does not contain exhaustive details about the initial validation studies that established the device's fundamental accuracy and performance. Instead, it leverages previous clearances and focuses on showing that the change doesn't negatively impact performance.

Therefore, for several points requested in the prompt, the information is not available in the provided text, as the submission is for a modification rather than an entirely new device's initial clearance.

Acceptance Criteria and Device Performance

The document states that "Bench testing showed that the CONTOUR® NEXT GEN Blood Glucose Monitoring System and CONTOUR® PLUS BLUE Blood Glucose Monitoring System performed as intended and met the relevant standards (ANSI IEEE C63.27-2021, IEEE UL Std 2621.2-2022, IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION), performance testing and software testing applicable to this change."

While specific numerical acceptance criteria (e.g., accuracy percentages) and detailed reported performance metrics are not explicitly listed in this 510(k) summary, the mention of "relevant standards" and "performance testing" implies that the device met the established performance requirements for blood glucose monitoring systems. For the purpose of this specific modification submission, the critical acceptance criterion was demonstrating that the measurement function was not impacted by the change.

Given the nature of the submission (a change in microprocessor), the primary 'acceptance criteria' in this context are:

Note: For a full, initial clearance of a blood glucose meter, specific accuracy criteria (e.g., ISO 15197) would be provided, often specifying percentages of readings within a certain deviation from a reference method (e.g., laboratory analyzer) for different glucose ranges. These details are not in the provided modification summary.

Study Details

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

   • Sample Size: Not specified for this particular submission's testing. The document states "Bench testing including reliability testing, software verification and validation, and confirmation of no impacts to BGM measurement was conducted." This type of testing typically involves a set number of meters and strips, and controlled blood samples, but the exact quantities are not detailed in this summary.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The testing described is "bench testing," implying laboratory-based evaluation. The document also states "The modified devices also relied on previously conducted analytical testing to support substantial equivalence." This suggests some data would be retrospective from prior clearances. The "clinical testing was leveraged from the previous clearances," meaning no new clinical trials were conducted for this specific modification.

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

   • Not Applicable / Not Specified. For a blood glucose meter, "ground truth" for accuracy is typically established by comparative measurements against a laboratory reference method (e.g., a YSI Glucose Analyzer) using blood samples with known glucose concentrations, not by expert consensus on visual review as might be the case for imaging devices. The document does not describe the specific ground truth establishment method for the bench testing beyond stating "confirmation of no impacts to BGM measurement." For the leveraged clinical testing (from previous submissions), the ground truth would have been established using a laboratory reference method, but the details are not provided here.

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

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation of data (e.g., radiology reads) to resolve discrepancies. This document describes bench testing for a physical/electrical device modification and leveraging prior clinical data, neither of which involves such adjudication processes.

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. This is a blood glucose monitoring system, not an AI-powered image analysis or diagnostic tool involving human readers. Therefore, an MRMC study is not relevant or performed for this device.

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

   • Partially Applicable. Blood glucose meters are essentially standalone algorithms (or systems) that provide a numerical output. The "bench testing" and "confirmation of no impacts to BGM measurement" assessed the device's performance directly, independent of a human "in the loop" for the measurement itself, beyond the act of sampling. The focus was on the performance of the meter and strips, and the impact of the new microprocessor on that performance.

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

   • Analytical Reference Method. For blood glucose meters, the ground truth for accuracy is established by a highly accurate laboratory reference method (e.g., YSI Glucose Analyzer) that measures glucose concentration in blood samples. This is a scientific, analytical measurement, not based on expert consensus or pathology. While not explicitly detailed for this submission's testing, it would have been the ground truth for the "previously conducted analytical testing" and "clinical testing leveraged from the previous clearances."

7. The sample size for the training set:

   • Not Applicable / Not Specified. This document describes a modification to an existing, cleared device, not the development of a new device or an AI/machine learning model that would have a traditional "training set." The performance assessments are validation efforts, not model training.

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

   • Not Applicable. See point 7.

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The disposable MICROLET®NEXT Lancet is used for capillary blood collection.

The disposable MICROLET®NEXT Lancet is used for capillary blood collection. The device comprises of a stainless needle encapsulated with a plastic and protective cap; the protective cap is twisted off to expose the needle for use. The device is sterilized by radiation. The needle body and protective cap form a sterile barrier to maintain the needle sterile.

The provided text describes a 510(k) premarket notification for a medical device, the MICROLET®NEXT Lancet, which is used for capillary blood collection. It is a Class II device. The document mostly focuses on demonstrating substantial equivalence to a predicate device (STERILANCE DISPOSABLE BLOOD LANCET, K221507) and regulatory compliance.

However, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for an AI/Software as a Medical Device (SaMD).

The document discusses non-clinical and clinical tests, but these are related to the physical performance of a lancet (biocompatibility, usability, shelf life, and the ability to obtain adequate blood volume for a blood glucose monitor), not the performance of an AI or software algorithm.

Therefore, I cannot extract the following information that would be relevant to an AI/SaMD study:

1. A table of acceptance criteria and the reported device performance (for an AI/SaMD): Not present, as this is not an AI/SaMD.
2. Sample sizes used for the test set and the data provenance: A clinical study "enrolled 131 lay persons with diabetes" and "120 completed the study." This is a sample size for a human-use study of a physical device, not an AI test set. Data provenance is not specified beyond "a single clinical site."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a lancet isn't established by experts in the same way it is for an AI interpreting medical images. The "ground truth" here is whether the lancet can obtain a sufficient blood sample for a BGMS.
4. Adjudication method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is for evaluating human performance with and without AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the lancet's performance is the ability to obtain "adequate blood volume from fingertip and palm lancing to obtain a numerical result on the BGMS."
8. The sample size for the training set: Not applicable, as this is not an AI.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is for a physical medical device (a lancet) and not an AI/SaMD. Therefore, the specific details regarding acceptance criteria, test set, ground truth, and study design relevant to an AI/SaMD are not present.

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The Contour® next GEN Blood Glucose Monitoring System consists of the Contour® next GEN meter, Contour® next blood glucose test strips and the Contour® Diabetes app.

The Contour® next GEN Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The Contour® next GEN Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Contour® next GEN 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 in monitoring the effectiveness of a diabetes control program.

The Contour® next GEN Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use.

The system is intended for in vitro diagnostic use only.

CONTOUR® NEXT GEN Blood Glucose Monitoring System is a blood glucose meter with Bluetooth Low Energy technology built in so that the meter can communicate wirelessly to smart phones and tablets. The meter uses the CONTOUR® NEXT blood glucose test strips and CONTOUR® NEXT control solution. The meter can be connected to the CONTOUR® Diabetes app. It uses two replaceable CR2032 or DL2032 coin cell batteries. The meter's shape is a traditional oval form factor, and it includes an illuminated strip port with colors indicating if a glucose result is above, within, or below target.

The provided text describes a 510(k) summary for the CONTOUR® next GEN Blood Glucose Monitoring System. This submission focuses on demonstrating substantial equivalence to a predicate device due to minor modifications (e.g., changes to internal meter circuitry due to component end-of-life, changes to packaging, user guide format, and test strip packaging from bottled to foil-packed).

The information provided is typical for a 510(k) submission of a blood glucose monitoring system, which primarily relies on analytical performance data (accuracy of glucose measurements) to demonstrate that the device performs as intended and is substantially equivalent to a predicate. This type of device does not involve an AI algorithm with a training or test set, nor does it involve expert reviews, ground truth establishment through consensus, or MRMC studies.

Therefore, the requested information regarding AI acceptance criteria and study details (sample sizes for training/test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable to this specific device submission. The device described is a physical medical device (blood glucose meter and test strips), not an AI-powered diagnostic system.

However, I can extract information related to the performance testing mentioned, even if it's not structured around AI-specific criteria.

Key takeaway: This document does not describe an AI medical device.

Information applicable to the device (even without AI context):

1. A table of acceptance criteria and the reported device performance:
   The document states: "Verification testing against well-established methods showed that the modified CONTOUR® NEXT GEN Blood Glucose Monitoring System, with the proposed changes outlined herein, performed as intended and met the system specifications."
   It also mentions: "Validation testing with the proposed black and white pamphlet User Guide demonstrated that the CONTOUR® NEXT GEN Blood Glucose Monitoring System continued to be easy to use by typical customers."
   However, the specific numerical acceptance criteria and reported performance data are not detailed in this 510(k) summary. For a blood glucose meter, this would typically involve accuracy metrics (e.g., % of results within ±X% of reference, ISO 15197 compliance). This summary only states that they were met.

2. Sample sizes used for the test set and the data provenance:
   Not explicitly stated in the provided text. For a blood glucose meter, validation studies would involve a sufficient number of blood samples (from various glucose concentrations) and potentially human subject testing for usability/accuracy. The provenance would likely be from clinical sites where these tests were performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
   Not applicable, as this is not an AI diagnostic device. Ground truth for blood glucose meters is established by reference laboratory methods (e.g., YSI or hexokinase method) on the same blood samples.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   Not applicable, as this is not an AI diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable, as this is not an AI algorithm. The device itself is the "standalone" entity that performs the glucose measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For a blood glucose monitoring system, the ground truth for glucose levels is established using a highly accurate and precise laboratory reference method (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer, or a hexokinase enzymatic method).

8. The sample size for the training set:
   Not applicable, as this is not an AI device with a training set.

9. How the ground truth for the training set was established:
   Not applicable, as this is not an AI device.

In summary, the provided document is a 510(k) premarket notification for a blood glucose monitoring system, which is a physical diagnostic device. It does not contain information about AI algorithm development, training, or testing, and therefore, most of the requested details are not relevant to this specific submission.

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The MICROLET®NEXT lancing device is intended for collecting capillary blood from the fingertip or palm for blood glucose testing or other testing utilizing small amounts of blood. The MICROLET NEXT lancing device is for singlepatient use. The MICROLET NEXT lancing device is used with disposable, sterile MICROLET® lancets. The MICROLET NEXT lancing device with the MICROLET lancet are intended for collecting fingertip capillary blood from persons age two years and older. The alternative site testing endcap is intended for collecting capillary blood from the palm in adults only.

Ascensia's blood lancets consists of two components. First component is a re-usable base which is referred as MICROLET® NEXT lancing device and the second component is a sterile single use blade which is referred as MICROLET® Lancet. The subject MICROLET® NEXT Lancing Device is a pen-like instruments to be used with the compatible subject MICROLET® NEXT Lancets (28 G) for the controlled puncture of the skin to obtain the capillary blood droplet sample for testing. The MICROLET® NEXT Lancing Device is available with two endcaps: the Black/White cap for fingertip sampling and the Clear Alternative Site Testing (AST) for palm sampling. The Black/White cap has a dial control that allows the user to adjust the blade penetration depth for comfort when obtaining the blood droplet. The subject MICROLET® Lancet is a disposable single-use sterile device intended for drawing a blood sample. It is intended to be used with compatible lancing devices. The lancets are sterile, single-use devices. They must be discarded after each use. The lancet comprises the following elements: a steel needle body with a protective cap. The lancet remains sterile until the cap is removed. The product is sterilized with gamma radiation. They are available with 28G (0.36mm) diameter lancets. Together, they are intended for obtaining a capillary blood sample for blood glucose testing or other testing utilizing small amounts of blood. The lancet needle consists of stainless steel which is coated with medical grade silicone for smooth penetration of the skin. The lancet needle is siliconized. This is encased in a plastic cover. The proposed MICROLET® Lancets are offered in a variety of colors. Figure-2 shows different colored lancets (seven colors-Yellow. Orange, Red, Green, Blue, Purple and Pink). The needle tip is hidden by a protective cap, which has to be removed before usage and creates the sterile barrier. After usage the lancet can be placed back into the protective cap for disposal. thereby protecting users from unintended injuries. The proposed MICROLET® Lancet can be stored for 5 years without losing its function or sterility if the protective cap is not removed. The MICROLET® Lancet is a disposable single-use sterile device intended for drawing a blood sample. It is Intended to be used with compatible lancing device. The lancet comprises the following elements: a steel needle, needle body with a protective cap. The lancet remains sterile until the cap is removed. The product is sterilized with gamma radiation. The product can be stored for 5 years without losing its function or sterility if the protective cap is not removed. The MICROLET® NEXT lancing device is used for obtaining capillary blood samples from the fingertip. Capillary samples can be obtained from the palm as well The lancing device is for use only on a single patient.

Ascensia Diabetes Care's MICROLET® NEXT Lancing Device and MICROLET® Lancet were evaluated through a clinical study and extensive non-clinical performance testing to demonstrate their safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria for the clinical study with specific quantitative targets (e.g., "X% of subjects must obtain sufficient blood volume"). However, the study aims and conclusions implicitly serve as the acceptance criteria for clinical performance related to blood collection, while non-clinical tests have pass/fail criteria.

Here's a summary:

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

• Sample Size for Test Set (Clinical Study): 119 lay persons.
• Data Provenance: The study was conducted at the "Mishawaka site," which generally refers to a clinical study location within the country where the submission is made (USA in this case, given the FDA filing). The document doesn't explicitly state the country for the clinical study, but it is implied to be within the US. The study appears to be prospective as participants were enrolled and tested with the device.

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

• The document refers to "study staff testing the blood on a Contour next family of blood glucose meters" to determine the acceptability of capillary blood volume.
• It does not specify the number or qualifications of these "study staff" experts. It also doesn't mention expert review of images or specific clinical diagnoses by independent experts to establish ground truth in the way one might see for diagnostic AI. In this context, "acceptability" refers to whether enough blood was collected for a meter reading, which is a functional assessment rather than a diagnostic one requiring expert consensus on a disease state.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method for the clinical study results in the traditional sense of resolving discrepancies between multiple readers or systems. The determination of "sufficient capillary blood volume" was made by "study staff testing the blood on a Contour next family of blood glucose meters." This implies a direct, objective assessment by the meters and observation by staff, rather than a subjective interpretation requiring adjudication among 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 (comparing human readers with and without AI assistance) is not applicable here as the device is a lancing device and lancet, not an AI diagnostic tool. The clinical study focused on the device's ability to collect blood and its safe usage by lay persons.

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

• No, a standalone algorithm-only performance study was not done. The device is a physical medical device (lancing device and lancet), not a software algorithm. Its performance is assessed through mechanical, biological, and user experience testing, not algorithmic accuracy.

7. The Type of Ground Truth Used

• For the clinical study, the "ground truth" for success was defined by the ability to obtain sufficient capillary blood volume as determined by a blood glucose meter ("Contour next family of blood glucose meters"). This is a form of outcomes data pertaining to device functionality (i.e., whether the device successfully facilitates blood collection for testing).
• For non-clinical tests, the ground truth was adherence to predetermined acceptable ranges or conditions (e.g., "no external damage or deterioration," "results were within the acceptance range," "no corrosion," "all devices met min 1.3 mm needle tip distance").

8. The Sample Size for the Training Set

• The document is for a physical medical device (lancing device and lancets), not an AI/ML algorithm. Therefore, the concept of a "training set" for an algorithm is not applicable.

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

• As the device is not an AI/ML algorithm, there is no training set and thus no ground truth established for a training set. The development of the device would have involved engineering specifications, materials science, and usability design, leading to the device submitted for testing.

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The CONTOUR®NEXT EZ blood glucose monitoring system is an over the counter (OTC) device utilized for self-testing by persons with diabetes at home for the quantitative measurement of glucose in whole blood, is for single-patient use only, and should not be shared.

The system is intended for self testing outside the body (in vitro diagnostic use) and is to monitor the effectiveness of diabetes control. The CONTOUR® NEXT EZ blood glucose monitoring system is indicated for use with fresh fingertip capillary whole blood samples.

The CONTOUR® NEXT EZ blood glucose monitoring system is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

The CONTOUR® NEXT test strips are for use with the CONTOUR® NEXT EZ blood glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

The Contour Next EZ Blood Glucose Meter consists of a small handheld blood glucose meter that utilizes dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes. Liquid control solution is used to check the performance of the system. The meter, together with the test strips and control solutions, is referred to as the Contour Next EZ Blood Glucose Monitoring System.

The chemical principle utilized for both the predicate and modified devices is based on measurement of electrical current caused by the reaction of glucose in the blood with chemicals on the reagent strip. The blood sample is drawn into the tip of the reagent strip through capillary action. Glucose in the sample reacts with FAD glucose dehydrogenase (FAD-GDH) enzyme on the reagent strip. The electrons generated by this reaction are shuttled to an electrode by a mediator chemical, producing a current that is proportional to the glucose in the sample. After a fixed reaction time, the glucose concentration in the sample is calculated and displayed.

The provided text describes modifications made to the Contour Next EZ Blood Glucose Monitoring System (K162336) compared to its predicate device (K130265). It outlines the new features and the testing conducted to demonstrate substantial equivalence, but it does not explicitly state specific acceptance criteria or provide detailed study results in numerical form. It describes the type of studies performed and what they aimed to confirm.

However, based on the information provided, I can infer the general acceptance criteria and describe the studies conducted.

Here's an analysis structured around your request:

Acceptance Criteria and Device Performance for Contour Next EZ Blood Glucose Monitoring System (K162336)

The documentation provided focuses on demonstrating substantial equivalence of the modified device (K162336) to its predicate (K130265) by highlighting improved error detection capabilities and confirming that fundamental performance remains unchanged. While explicit numerical acceptance criteria are not detailed, the underlying goal for a blood glucose monitoring system is generally accuracy and reliability, particularly in identifying and preventing erroneous results.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify numerical sample sizes for any of the test sets (bench testing, equivalency testing, software verification, control testing).

The data provenance is not explicitly stated (e.g., country of origin). Given the FDA submission, it is assumed to be from studies conducted under US regulatory standards, though the specific location of the study subjects or samples is not mentioned. The studies appear to be prospective insofar as they were designed specifically to evaluate the modifications before market clearance.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide any information regarding the use of experts, their number, or qualifications for establishing ground truth. The nature of the device (blood glucose monitor) generally relies on laboratory reference methods (e.g., YSI glucose analyzer) for ground truth, rather than expert interpretation of images or clinical data.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1). This is typical for objective diagnostic devices like blood glucose monitors where results are compared directly against a reference method, rather than subjective interpretations needing consensus.

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

No MRMC comparative effectiveness study was done or mentioned. This type of study is not applicable to a blood glucose monitoring system, which provides objective numerical results and does not involve human readers interpreting cases (like radiology or pathology). The assessment is about the device's accuracy compared to a reference standard or its predicate.

6. Standalone (Algorithm Only) Performance

The studies described, particularly "Equivalency testing" and "Control testing," assess the device's performance directly, implying a standalone performance assessment. The device's modifications are primarily related to error detection algorithms and communication protocols, which are inherent to the algorithm and system's standalone operation. The comparison is between the modified device and the predicate device's performance, which itself is a standalone measurement.

7. Type of Ground Truth Used

While not explicitly named, the ground truth for blood glucose monitoring systems like this is typically established using laboratory reference methods, such as a YSI glucose analyzer, which are considered highly accurate. The phrase "equivalency testing was conducted to ensure the performance of the modified and predicate meters was not statistically different" implies comparison against a reliable standard.

8. Sample Size for the Training Set

The document does not provide any information about a specific "training set" or its sample size. For an electrochemical blood glucose meter, the "training" (calibration) is typically done during manufacturing using known glucose concentrations and the system's inherent design, rather than a machine learning training set in the conventional sense. The "Contour Next Test Strips are for use with the Contour Next EZ blood glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips," indicating that the system is pre-calibrated to the strips.

9. How Ground Truth for the Training Set Was Established

As no specific "training set" in the machine learning sense is described, the method for establishing its ground truth is not applicable or mentioned. The device operates based on a determined chemical reaction and electrical current measurement, where the relationship between current and glucose concentration is established through engineering and chemical principles, likely validated against laboratory reference methods during the device's development and manufacturing calibration process.

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The Contour Next blood glucose monitoring system is an over-the-counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for single-patient use only, and should not be shared. The system is intended for self-testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control.

The Contour Next blood glucose monitoring system is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).

The system consists of a Contour Next blood glucose meter. Contour Next control solutions.

Contour Next test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples.

The Contour Next blood glucose monitoring system is not intended for the diagnosis or screening for diabetes mellitus and is not intended for use on neonates.

The Contour Next Link Wireless Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for singlepatient use only and should not be shared. The System is intended for self-testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control.

The Contour Next Link Wireless Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).

Contour Next Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples.

The Contour Next Link Wireless Blood Glucose Monitoring System is intended to transmit glucose values to Medtronic MiniMed Paradigm Insulin Pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps or Medtronic MiniMed 530G Insulin Pumps and facilitate transfer of information to Medtronic MiniMed Carelink Therapy Management Software through use of radio frequency communication.

The Contour Next Link Wireless Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

Contour Next Link Wireless Blood Glucose Meter:
The Contour Next Link Wireless Blood Glucose Meter consists of a small handheld blood glucose meter that utilizes dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes. Liquid control solution is used to check the performance of the system. The meter, together with the test strips and control solutions, is referred to as the Contour Next Link Wireless Blood Glucose Monitoring System.

The System also contains radio frequency (RF) functions for sending blood glucose results to compatible Medtronic MiniMed insulin pumps. The RF function can also serve as a pass through for data being transmitted from Medtronic MiniMed insulin pumps to Medtronic's MiniMed PC-based data manaqement software.

The chemical principle utilized for both the predicate and modified devices is based on measurement of electrical current caused by the reaction of glucose in the blood with chemicals on the reagent strip. The blood sample is drawn into the tip of the reagent strip through capillary action. Glucose in the sample reacts with FAD qlucose dehydrogenase (FAD-GDH) enzyme on the reagent strip. The electrons generated by this reaction are shuttled to an electrode by a mediator chemical, producing a current that is proportional to the glucose in the sample. After a fixed reaction time, the glucose concentration in the sample is calculated and displayed.

Contour Next Blood Glucose Meter:
The Contour Next Blood Glucose Meter consists of a small handheld blood glucose meter that utilizes dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes. Liquid control solution is used to check the performance of the system. The meter, together with the test strips and control solutions, is referred to as the Contour Next Blood Glucose Monitoring System.

The chemical principle utilized for both the predicate and modified devices is based on measurement of electrical current caused by the reaction of glucose in the blood with chemicals on the reagent strip. The blood sample is drawn into the tip of the reagent strip through capillary action. Glucose in the sample reacts with FAD qlucose dehydrogenase (FAD-GDH) enzyme on the reagent strip. The electrons generated by this reaction are shuttled to an electrode by a mediator chemical, producing a current that is proportional to the glucose in the sample. After a fixed reaction time, the glucose concentration in the sample is calculated and displayed.

Ascensia Diabetes Care US Inc. developed the Contour Next Link Wireless Blood Glucose Monitoring System and Contour Next Blood Glucose Monitoring System. The acceptance criteria and supporting studies are described below:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. However, based on the provided information, the acceptance criteria implicitly involve the proper functioning of new error detection features and comparable performance to predicate devices. The reported device performance indicates that these criteria were met.

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

The document indicates that studies were performed, but does not specify the sample sizes used for the test sets in any of the described performance evaluations (bench testing, software verification, equivalency testing, internal user study).

The data provenance is not explicitly stated regarding country of origin or whether the data was retrospective or prospective. It can be inferred that the internal user study and bench testing were prospective studies conducted by Ascensia Diabetes Care US Inc., likely within the US, given the FDA submission.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test sets. For blood glucose monitoring systems, ground truth is typically established using a laboratory reference method (e.g., YSI analyzer) rather than expert consensus on subjective interpretation.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. Given the nature of blood glucose measurement, where accuracy is assessed against a laboratory reference standard, a traditional adjudication method for subjective interpretations (like 2+1 or 3+1) would not be applicable.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The document describes an "internal user study" for the Contour Next Link Wireless system to ensure accuracy, but this is distinct from an MRMC study comparing human readers with and without AI assistance. The device is a standalone blood glucose meter and does not involve AI assistance for human readers in interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The primary evaluations described are effectively standalone performance studies of the device's algorithm and hardware. Bench testing, software verification testing, and equivalency testing assess the device's inherent performance characteristics, including the new error detection algorithms ("improved detection"). The "internal user study" assesses accuracy when used by individuals, but the core performance criteria focus on the device's ability to accurately measure glucose and detect errors independently.

7. Type of Ground Truth Used

The ground truth used for such blood glucose monitoring systems is typically established using a laboratory reference method, such as a YSI glucose analyzer, which provides a highly accurate and precise measurement of glucose concentration. While not explicitly stated, this is the standard practice for validating blood glucose meters. The document mentions "blood glucose result accuracy," reinforcing the use of an objective, high-precision reference.

8. Sample Size for the Training Set

The document does not specify the sample size for any training set. As the device involves improvements to existing algorithms (e.g., error detection), it's possible that data was used for refining these algorithms, but no details are provided about this "training" data.

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

The document does not provide information on how ground truth for any potential training set was established.

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