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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® PLUS BLUE Blood Glucose Monitoring System consists of the CONTOUR® PLUS BLUE meter, the CONTOUR® PLUS blood glucose 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® PLUS BLUE Blood Glucose Monitoring System is a blood glucose monitoring system with Bluetooth Low Energy technology built in so that the meter can communicate wirelessly to smart phones and tablets. The meter uses the CONTOUR® PLUS blood glucose test strips and CONTOUR® PLUS control solution. The meter can be connected to the Contour® Diabetes app. It utilizes a similar algorithm as the one used in the CONTOUR® NEXT GEN Blood Glucose Monitoring System. It uses two replaceable coin cell batteries. The meter's shape is a traditional oval form factor and it includes an on-screen arrow that points to the color indicating if a glucose result is above, within, or below target range.

This document describes the CONTOUR® PLUS BLUE Blood Glucose Monitoring System, a medical device for quantitative measurement of glucose in fresh capillary whole blood. The submission aims to demonstrate substantial equivalence to a predicate device (CONTOUR® NEXT GEN Blood Glucose Monitoring System (K193407)).

Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text generally states that the device "met the system specifications" and "performed as intended." However, it does not provide specific numerical acceptance criteria or detailed performance data in a tabular format as requested. Therefore, the table below provides what can be inferred from the text, but lacks the specific quantitative details typically found in such a table.

Important Note: The current document lacks the detailed numerical acceptance criteria (e.g., specific accuracy ranges, precision limits, interference limits) and the corresponding measured performance data. For a complete answer, this information would be required from a more detailed study report.

2. Sample Size and Data Provenance

The document states that "clinical testing showed that the CONTOUR® PLUS BLUE Blood Glucose Monitoring System performed as intended and met the system specifications." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study).

3. Number of Experts and Qualifications for Ground Truth

The document does not provide any information regarding the number of experts used to establish the ground truth for the test set or their qualifications. This information is typically relevant for studies involving human interpretation (e.g., interpretation of medical images), which is not directly applicable to a blood glucose monitoring system that provides a quantitative reading. The "ground truth" for a device measuring glucose would likely be a highly accurate laboratory reference method.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method. This is usually relevant in studies where multiple human readers or experts are involved in assessing data, and their disagreements need to be resolved. For a blood glucose monitoring system, the "adjudication" would refer to the process by which the reference method's result is established, which is typically a standardized laboratory procedure rather than expert consensus on interpretation.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to a blood glucose monitoring system. This type of study evaluates the effect of AI assistance on human reader performance, typically in diagnostic imaging. The CONTOUR® PLUS BLUE system directly measures glucose and provides a reading, without human interpretation in the same way an imaging study would require. Therefore, no such study was performed or needed.

6. Standalone Performance (Algorithm Only)

The document focuses on the overall system performance, which includes the meter, test strips, and app. It states that the system "met the system specifications." While the device uses "a similar algorithm as the one used in the CONTOUR® NEXT GEN Blood Glucose Monitoring System," the document does not provide separate standalone (algorithm-only) performance data. The performance described encompasses the integrated device.

7. Type of Ground Truth Used

While not explicitly stated, for a blood glucose monitoring system, the ground truth is typically established using a highly accurate laboratory reference method for glucose measurement (e.g., a YSI analyzer, or a certified clinical laboratory method). This is the gold standard against which the device's measurements are compared. The document states "clinical testing showed that the CONTOUR® PLUS BLUE Blood Glucose Monitoring System performed as intended and met the system specifications," implying comparison to a reference.

8. Sample Size for the Training Set

The document does not provide any information about the sample size for the training set. The device utilizes "a similar algorithm as the one used in the CONTOUR® NEXT GEN Blood Glucose Monitoring System," which suggests that the core algorithm may have been trained previously, and this submission focuses on validating the integrated system.

9. How Ground Truth for Training Set Was Established

The document does not provide any information on how the ground truth for the training set was established. Given it states the algorithm is "similar" to a previously approved device, it's possible the training data and ground truth protocols for the original algorithm are foundational, but the specific details are not present in this submission summary. As with the test set, it would expectedly involve comparison to a laboratory reference method.

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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 GEN Blood Glucose Monitoring System contour® next GEN meter, Contour® next 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 test strips and Contour® next control solution. The meter can be connected to the Contour® Diabetes app. It utilizes a similar algorithm as the one used in the Contour® next ONE blood glucose meter. It uses two replaceable CR2032 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 document provides information on the Contour® next GEN Blood Glucose Monitoring System, a medical device for quantitative measurement of glucose in fresh capillary whole blood. The device has been reviewed by the FDA and determined to be substantially equivalent to a legally marketed predicate device.

Here's an analysis of the provided text, addressing your specific questions about acceptance criteria and the study proving the device meets these criteria:

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

The document does not explicitly provide a table of acceptance criteria for glucose measurement accuracy with specific numerical targets (e.g., % of readings within +/- X mg/dL or %). However, it states that "Clinical trials and bench testing showed that the Contour® next GEN Blood Glucose Monitoring System performed as intended and met the system specifications."

For glucose meters, the generally accepted accuracy standards are often based on ISO 15197 (or similar national standards). The FDA might have specific internal or guidance-based acceptance criteria for substantial equivalence claims. Given the context of a 510(k) submission, the device is being compared to a predicate, implying that its performance is equivalent to, or better than, the predicate device which presumably met relevant accuracy standards at its time of clearance.

Without direct quantitative performance data in this specific document, a table cannot be fully constructed. However, the qualitative "reported device performance" is that it "performed as intended and met the system specifications."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "Clinical trials and bench testing" and "Usability testing" but does not specify the sample sizes used for these test sets.
Similarly, data provenance (country of origin, retrospective or prospective) is not detailed in this summary. These details would typically be found in the full submission, which is not provided here.

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)

For a blood glucose monitoring system, the "ground truth" for glucose concentration is typically established by laboratory reference methods (e.g., using a YSI glucose analyzer) rather than expert radiographic review. The document does not specify details about the personnel or their qualifications involved in establishing this reference ground truth.

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

Adjudication methods like 2+1 or 3+1 are typically for human reader studies involving subjective interpretations (e.g., radiology). For a blood glucose meter, the "ground truth" is a quantitative measurement from a reference laboratory instrument, which doesn't involve human interpretation directly or require adjudication in the same way. Therefore, this concept is not applicable in the context of a glucose meter's accuracy testing, and no adjudication method is mentioned.

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

An MRMC study is relevant for AI-assisted diagnostic imaging, where human readers interpret cases with or without AI assistance. This is not applicable to a blood glucose monitoring system, which provides a direct numerical measurement and is used by individuals for self-monitoring. The device itself is not an AI system assisting human interpretation of images. Consequently, no MRMC study or effect size for human reader improvement is mentioned or expected.

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

For a blood glucose meter, the "standalone performance" is essentially the device's accuracy in measuring glucose values against a reference method. The document states that "Clinical trials and bench testing showed that the Contour® next GEN Blood Glucose Monitoring System performed as intended and met the system specifications." This implies that the device's ability to measure glucose values accurately was assessed, which is its standalone performance. The system's algorithm (mentioned as "similar algorithm as the one used in the Contour® next ONE blood glucose meter" and having "Modified terms in the equations") is intrinsic to its measurement process.

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

The ground truth for a blood glucose monitoring system is established by highly accurate laboratory reference methods for glucose measurement, typically performed on venous blood samples. These reference methods are considered the gold standard for quantifying glucose concentration. The document does not explicitly state "laboratory reference method" but this is the standard practice for such devices.

8. The sample size for the training set

The document does not provide information on the sample size for the training set. Blood glucose meters typically use algorithms (the document mentions "similar algorithm as the one used in the Contour® next ONE" and "Modified terms in the equations"), which might be developed using extensive calibration data. Details about this data (size, characteristics) are not available in this summary.

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

Similar to the test set, the ground truth for any data used in training/calibration of the glucose meter's algorithm would have been established by highly accurate laboratory reference methods for glucose measurement. The document does not provide specifics on how this was established for the training data.

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The CONTOUR® NEXT ONE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The CONTOUR® NEXT ONE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® NEXT ONE 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 ONE Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when gluosse is not changing rapidly). The CONTOUR® NEXT test strips are for use with the CONTOUR® NEXT ONE blood glucose meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or palm.

The system is intended for in vitro diagnostic use only.

CONTOUR® NEXT ONE Blood Glucose Monitoring System is a blood glucose meter with Bluetooth Low Energy technology built in so that the meter can communicate wirelessly to a mobile smart device. The meter has a 7-segment display and icons in the display to aid the user with the features of the meter. It uses two replaceable CR2032 coin cell batteries. The associated CONTOUR Diabetes app is compatible with Apple iOS operating system and the Android operating system. The app communicates with the CONTOUR® NEXT ONE blood glucose meter using Bluetooth Low Energy wireless technology. Blood glucose test results are automatically sent to the mobile device for viewing and editing, and settings on the meter can be modified using the app. The meter remains unchanged.

The CONTOUR® NEXT Blood Glucose Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL. The CONTOUR® NEXT Blood Glucose Test Strips are to be used with an over the counter (OTC) device utilized by lay-users with diabetes in home settings for the measurement of glucose in whole blood. There is no change in either intended use or indications for use. CONTOUR® NEXT Blood Glucose Test Strips remain the same.

The modification discussed in this Special 510K consists of the following:

1. Replacing the current CONTOUR NEXT Blood Glucose test strips in the CONTOUR NEXT ONE Blood Glucose Monitoring System packaging from CONTOUR NEXT glucose Test strips in a bottle to CONTOUR NEXT glucose test strips in foiled packaging ("Foiled Strips"). The Foiled Strips were cleared under K191286 for a retail box package. This new, alternative packaging configuration consists of the Foiled Strips (without a retail box) placed in a wallet with the other system components.
2. Replacing the current CONTOUR NEXT ONE color, booklet User Guide with a black and white pamphlet User Guide. In addition, some format and minor content labeling changes to the User Guide and Quick Reference Guide have occurred with this transformation. Please see Volume 012 for proposed labeling changes.
3. Replacing the current CONTOUR NEXT ONE Blood Glucose Monitoring System packaging with a smaller outer carton.

This modification represents an alternative labeling and packaging configuration.

The provided text is a 510(k) Summary for the CONTOUR® NEXT ONE Blood Glucose Monitoring System. This document describes modifications made to an existing device (predicate device K191286) and seeks to demonstrate substantial equivalence to the predicate.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a detailed table of device performance results against specific criteria. It broadly states that "Verification and validation testing against well-established methods showed that the CONTOUR® NEXT ONE Blood Glucose Monitoring System, with the proposed changes outlined herein, performed as intended and met the system specifications."

The core of this 510(k) is about packaging and labeling changes, not fundamental performance changes of the blood glucose measurement technology itself. The performance of the underlying blood glucose test strips (CONTOUR® NEXT Blood Glucose Test Strips) is implicitly covered by their prior clearance (K191286) and the statement "CONTOUR® NEXT Blood Glucose Test Strips remain the same."

The key performance assessment mentioned is:

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

The document does not specify the sample size for the usability test set(s) or the provenance (country of origin, retrospective/prospective) of the data.

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

This information is not provided. The usability testing likely involved "typical customers" (lay users with diabetes), not necessarily experts in establishing a ground truth for a medical device's performance, but rather experts in using the device.

4. Adjudication method for the test set

This information is not provided.

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

An MRMC study is not relevant here as the device is a Blood Glucose Monitoring System, not an imaging device with human readers or AI assistance in interpretation. The context is self-testing for glucose levels.

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

This concept is not directly applicable. The device measures glucose (an "algorithm" in itself to convert electrical signals to glucose values), and the performance of this measurement system is covered by prior clearances. The current submission focuses on packaging and labeling updates.

7. The type of ground truth used

For the usability testing, the "ground truth" would be the ability of typical users to correctly and safely operate the device following the new pamphlet guide. This is typically assessed through observational studies, task completion success rates, and user feedback. No specific "ground truth" method (like pathology or outcomes data) is described in this summary.

For the measurement accuracy of the blood glucose system itself, the ground truth would typically be established against a laboratory reference method (e.g., YSI analyzer). However, this submission relies on the established performance of the CONTOUR® NEXT Test Strips and meter from the predicate device (K191286), rather than presenting new accuracy data for the measurement component.

8. The sample size for the training set

This information is not provided and is not applicable for a traditional ML/AI "training set" as this is not an AI/ML device per se. If "training set" refers to samples used for initial development and validation of the (non-AI) blood glucose measurement algorithm, that data would have been part of the predicate device's submission and is not detailed here.

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

Not applicable as this is not an AI/ML device. For the predicate device, the ground truth for the glucose measurement accuracy would have been established against a laboratory reference method.

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The CONTOUR® NEXT EZ Blood Glucose Monitoring System is an over the counter (OTC) device utilized for selftesting 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 be used as an aid 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 EX 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 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 test strips and 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 its 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 be used 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.

The CONTOUR® NEXT ONE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The CONTOUR® NEXT ONE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® NEXT ONE 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 ONE Blood Glucose Monitoring System should be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). The CONTOUR® NEXT test strips are for use with the CONTOUR® NEXT ONE blood glucose meter to quantitatively measure glucose in fresh capillary whole blood draw from the fingertips or palm.

The system is intended for in vitro diagnostic use only.

The CONTOUR® NEXT USB 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 consists of a CONTOUR® NEXT USB blood glucose meter, CONTOUR® NEXT test strips and CONTOUR® NEXT control solutions.

The CONTOUR® NEXT USB 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 CONTOUR® NEXT USB 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 USB Blood Glucose Monitoring System for the quantitative measurement of glucose in whole blood.

The CONTOUR® NEXT Blood Glucose Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL. The Blood Glucose Test Strips are to be used with an over the counter (OTC) device utilized by lay-users with diabetes in home settings for the measurement of glucose in whole blood. There is no change in either intended use or indications for use. The strips remain the same; and the only change is the new alternative packaging.

The modification discussed in this Special 510K consists a new, alternative packaging configuration of a desiccated-lined foil pouch, with each pouch containing five individually sealed, test strips in comparison to the existing blood glucose test strips in a desiccated-lined bottle.

The CONTOUR® NEXT Blood Glucose Test Strips are for use with the following CONTOUR® NEXT Blood Glucose Monitoring Systems:

CONTOUR® NEXT
CONTOUR® NEXT USB
CONTOUR® NEXT ONE
CONTOUR® NEXT EZ
CONTOUR® NEXT LINK Wireless

This document describes the FDA's 510(k) clearance for several CONTOUR® NEXT Blood Glucose Monitoring Systems, specifically focusing on a change to the packaging of the test strips. The core of the submission is to demonstrate that the new packaging, a desiccated-lined foil pouch containing five individually sealed test strips, performs equivalently to the existing desiccated-lined bottle packaging.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria defined by specific performance metrics for glucose measurement accuracy (e.g., ISO 15197:2013 standards for accuracy, precision). Instead, it states:

"Verification and validation testing against well-established methods showed that the CONTOUR® NEXT test Strips with the proposed, alternative foiled packaging, performed as intended and met the system specifications."

This implies that the acceptance criteria are the "system specifications" and "well-established methods" for glucose measurement devices. The reported device performance is that the new packaging met these specifications. However, no specific numerical data or thresholds are provided in this summary.

Given the nature of the device (blood glucose monitoring system) and the regulatory context (FDA 510(k) summary), the implicit acceptance criteria would relate to the accuracy, precision, and clinical usability of the blood glucose measurements compared to a reference method, typically governed by standards like ISO 15197. The document asserts that these were met.

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

The document does not specify the sample size used for the performance testing (the "test set") or the data provenance (e.g., country of origin, retrospective or prospective). It simply mentions "Verification and validation testing."

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

The document does not specify the number of experts used or their qualifications for establishing ground truth, as this type of device (blood glucose meter) typically uses laboratory reference methods for ground truth, not expert human interpretation of images.

4. Adjudication Method for the Test Set

The concept of "adjudication" (e.g., 2+1, 3+1) is typically associated with studies involving human readers or interpretation of complex data (like medical images) where there can be disagreement among experts. For a blood glucose monitoring system, the ground truth is established through a laboratory reference method, so no adjudication method as described would be applicable.

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

An MRMC study is relevant for imaging devices or AI tools that assist human interpretation. Since this device is a blood glucose meter, which provides a quantitative measurement, an MRMC study is not applicable or described. The device does not assist human readers in diagnosing or interpreting images, but rather provides a direct numerical measurement.

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

This device is an in-vitro diagnostic device that provides a direct measurement, not an AI algorithm for interpretation. Therefore, the concept of "standalone performance" in the context of an algorithm without human-in-the-loop is not applicable. The device itself is the "standalone" measurement system.

7. Type of Ground Truth Used

While not explicitly stated in this summary, for blood glucose monitoring systems, the ground truth for performance evaluation is typically established using a laboratory reference method (e.g., a YSI STAT 2300 Glucose & Lactate Analyzer or similar highly accurate laboratory instrument) that measures glucose concentration in blood samples. This provides a gold standard against which the device's measurements are compared. The phrase "well-established methods" strongly implies the use of such a reference standard.

8. Sample Size for the Training Set

This document describes a 510(k) submission for a change in packaging for an existing device. It does not indicate that this submission involves a "training set" in the context of machine learning. Blood glucose meters are electrochemical or optical devices, not machine learning algorithms that require training data. Therefore, the concept of a "training set" as it pertains to AI/ML is not applicable here.

9. How Ground Truth for the Training Set Was Established

As there is no "training set" in the context of AI/ML for this device, this question is not applicable.

Summary of what the document implies about the study:

The document indicates that the study performed was a verification and validation of the new packaging's effect on the performance of the existing CONTOUR® NEXT test strips. The key finding is that the test strips in the new foil pouch packaging deliver performance that "met the system specifications" when tested against "well-established methods" (likely laboratory reference methods). Additionally, "Usability testing was conducted on the proposed foiled packaging to ensure that the packaging was easy to use and labeling understood by typical customers." This suggests that the study primarily focused on ensuring the new packaging did not negatively impact the established analytical performance of the test trips, and that it was still user-friendly.

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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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