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For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. For symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The ALEVE® Direct Therapy® device is a battery powered transcutaneous electrical nerve stimulator (TENS) device for relieving lower back pain. The device is comprised of a TENS generator with integral electrodes, two replaceable "AAA" size batteries, replaceable electroconductive hydrogel pads (Gel Pads), and a Mobile App to control the TENS device via Bluetooth® connection, which installs to Apple® iOS® 9.0 or higher or Android® 4.4 or higher smartphone platforms. Additionally, the TENS intensity may be increased or decreased using onboard mechanical buttons on the TENS unit enclosure. The TENS device offers an optional handheld, wireless remote control via Radio Frequency (RF) connection which is sold separate and comes with one replaceable CR2032 Lithium-ion coin battery.

The provided text is a 510(k) summary for the ALEVE® Direct Therapy® medical device, which is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief.

Based on the provided document, the device is a TENS unit, and the acceptance criteria and study proving it meets these criteria are related to its safety and performance based on engineering and laboratory testing, rather than clinical efficacy studies for AI/ML performance.

Therefore, I cannot provide information on AI/ML specific criteria such as:

• A table of acceptance criteria and reported device performance related to AI/ML metrics (e.g., sensitivity, specificity, AUC).
• Sample sizes for test sets in an AI/ML context.
• Number of experts and their qualifications for ground truth establishment for an AI/ML test set.
• Adjudication methods for an AI/ML test set.
• MRMC comparative effectiveness studies.
• Standalone (algorithm-only) performance.
• Type of ground truth used in an AI/ML context.
• Sample size for a training set (AI/ML).
• How ground truth for a training set was established (AI/ML).

Here's a breakdown of what can be extracted from the document regarding the device's acceptance criteria and the study that proves it meets them, framed in the context of a medical device submission (Premarket Notification 510(k)) that relies on substantial equivalence to predicate devices:

Device: ALEVE® Direct Therapy® (Second Generation) - Transcutaneous Electrical Nerve Stimulator (TENS) for Pain Relief

1. Table of Acceptance Criteria and Reported Device Performance (Based on Substantial Equivalence and Non-Clinical Testing):

The document does not present a formal table of explicit acceptance criteria with numerical performance targets for a new device. Instead, it demonstrates substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if the device performs as safely and effectively as the predicates through a series of non-clinical tests and shows comparable technological characteristics.

• Unit level testing
• System testing
• Software verification and validation |
  | Usability Engineering | Testing performed and results contributed to meeting established specifications. |
  | Biocompatibility | Met requirements per ISO 10993-1. |
  | Electrical Safety | IEC 60601-1:2005 Ed. 3 + C1:2009 + A1:2012 (FDA Recognition Number 19-4) compliant. |
  | Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014 Ed. 4 (FDA Recognition 19-8) compliant. |
  | Home Healthcare Environment | IEC 60601-1-11 Edition 2.0 2015-01 (FDA Recognition Number 19-14) compliant. |
  | TENS Specific Safety | IEC 60601-2-10 Edition 2.0 2012.06 (FDA Recognition Number 17-11) compliant. |
  | Risk Management | ISO 14971 Second edition 2007-03-01 (FDA Recognition Number 5-40) compliant. |
  | Software Life Cycle Processes | IEC 62304 Edition 1.1 2015-06 (FDA Recognition Number 13-79) compliant. |
  | Chemical Characterization (Materials) | AAMI/ANSI/ISO 10993-10:2010 (FDA Recognition Number 2-173) compliant (implied by biocompatibility). |

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

• Sample Size: The document does not specify a "sample size" in the conventional sense of a clinical trial or a machine learning test set. The validation is based on non-clinical bench and safety testing of the device itself (e.g., electrical safety, software validation, biocompatibility), not a dataset of patient data or clinical images. Therefore, the "test set" would refer to the physical units of the device tested in the laboratory. The document does not specify how many units were tested.
• Data Provenance: Not applicable in the context of patient data. The data provenance is from laboratory testing performed by the manufacturer, Bayer HealthCare LLC. The document does not specify the country where these tests were conducted, but the company is based in Whippany, New Jersey, USA. The testing is retrospectively reported as part of the 510(k) submission.

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

• Not applicable. Ground truth for a TENS device's safety and performance in the context of a 510(k) is established through adherence to recognized international and national standards (e.g., IEC, ISO, ANSI/AAMI) verified by laboratory testing, not by expert consensus on clinical data or images.

4. Adjudication Method for the Test Set:

• Not applicable. There is no human adjudication process involved in verifying the compliance of a TENS device with electrical safety, EMC, or biocompatibility standards.

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

• No. This type of study is relevant for AI/ML diagnostic devices where human readers interpret medical images. This device is a therapeutic TENS unit.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• Not applicable in the context of an AI/ML algorithm. The "standalone" performance here refers to the device's ability to operate according to its specifications (e.g., output electrical pulses within specified parameters) without human intervention during its operational cycle, which is verified through bench testing. The mobile app controls the device, but the "performance" validated is of the TENS output, not the app's diagnostic or interpretive capabilities.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's acceptance is its compliance with pre-defined technical specifications, safety standards, and performance characteristics as demonstrated through non-clinical bench testing, software verification/validation, and adherence to recognized standards (e.g., electrical safety, EMC, biocompatibility, risk management). It is essentially engineering and regulatory standard compliance.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a training set of data.

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

• Not applicable. As above, this is not an AI/ML device.

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Temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

The ALEVE Direct Therapy device is a battery powered transcutaneous electrical nerve stimulator (TENS) for applying an electrical current to electrodes on a patient's skin to relieve pain. The device reduces the perception of pain by electrically stimulating peripheral nerves across the skin. The design of the device limits the application for use to the anatomical site of the back.

The device is comprised of a TENS unit with integral electrodes, one pair of replaceable electroconductive hydrogel pads, batteries for the remote and TENS unit, and a remote control. The user can turn the device on/off by pressing a button on the TENS unit. The hydrogel pads are adhesive and gently adhere the TENS unit to the user's skin on the lower back. There is also a remote control for the device, which the user turns on/off, and by which the user adjusts the intensity of stimulation.

This document is a 510(k) summary for the ALEVE Direct Therapy TENS device, claiming substantial equivalence to a predicate device (Pain Pilot™ / WiTouch® K120500). As such, it focuses on demonstrating similarity rather than presenting a detailed de novo study with specific acceptance criteria and performance against those criteria in the way a novel device might.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of acceptance criteria and the reported device performance

The document does not present a formal "acceptance criteria" table with specific quantitative thresholds for the device's clinical performance (e.g., pain reduction scores). Instead, it relies on demonstrating substantial equivalence to a predicate device, meaning its performance is expected to be similar or identical.

The performance data primarily focuses on engineering and safety standards, and a single usability study.

• ISO 14971:2007 (risk management)
• AAMI/ANSI ES60601-1:2005/(R)2012 (general basic safety and essential performance)
• IEC 60601-1-2 Ed 4.0 2014-02 (EMC)
• IEC 60601-1-11 Ed 1.0 2010-04 (home healthcare environment)
• IEC 60601-2-10 Ed 2.0 2012-06 (nerve and muscle stimulators) |
  | Biocompatibility Standards Compliance | Conformance with ISO standards:
• AAMI/ANSI/ISO 10993-1:2009/(R) 2013 (biological evaluation, risk management)
• AAMI/ANSI/ISO 10993-5:2009/(R) 2014 (in vitro cytotoxicity)
• AAMI/ANSI/ISO 10993-10:2010 (irritation and skin sensitization)
  (Note: The document states "The safety of this colorant has been demonstrated (Section 12, Biocompatibility).") |
  | Software Verification and Validation (Moderate Level Concern) | Software verification and validation testing conducted, documentation provided in accordance with FDA's guidance for "Moderate level concern device." |
  | Device Output Characteristics | Data in support of the device waveform and verification of output characteristics provided. (The specific characteristics are listed in the "Basic Unit Characteristics Comparison" table on page 5, which are all "IDENTICAL" or "Substantially Equivalent" to the predicate, implying conformity to the predicate's established performance). |
  | Usability | A 15-subject usability study was conducted for the predicate device (K120500) and reported to the FDA. The submitter (Bayer HealthCare, LLC) references this study due to the devices and labeling being "sufficiently similar." This implies the predicate device met usability criteria, and by extension, the new device is considered to meet them. |
  | Substantial Equivalence | The overall acceptance criterion is "substantial equivalence" to the predicate device (Pain Pilot™ / WiTouch® K120500). The document concludes: "The electrical safety, EMC, biocompatibility, software verification and validation, basic unit characteristics, and output specifications information provided in the 510(k) submission is sufficient to demonstrate substantial equivalence to the predicate device. As the ALEVE Direct Therapy TENS device is nearly identical to the predicate device, with identical indications for use and essentially identical technological characteristics, the ALEVE Direct Therapy TENS device is substantially equivalent to the predicate device." |

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

• Test Set Sample Size:
  • For the usability study (which is the only human-based performance data mentioned), the sample size was 15 subjects.
  • No other human clinical "test set" data is explicitly described for performance on the primary indication (pain relief). The submission relies on the predicate device's established effectiveness.
• Data Provenance: The usability study was conducted by Hollywog (the original manufacturer of the predicate device). The document doesn't specify the country of origin for this study, nor does it explicitly state if it was retrospective or prospective, though usability studies are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a TENS unit for pain relief, not an AI/imaging diagnostic device. Ground truth, in the sense of expert annotation, is not relevant to the usability study or the engineering/safety tests described. Pain relief, if directly measured in a clinical trial, would typically rely on patient-reported outcomes, not expert-established ground truth.

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

Not applicable, as described in point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic or interpretation device that would involve human readers or MRMC studies.

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

Not applicable. This is a physical medical device (TENS unit), not a software algorithm or AI.

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

For the usability study, the "ground truth" would be the direct experience and feedback of the 15 subjects regarding the device's ease of use and functionality. For the safety and engineering tests, the "ground truth" is compliance with recognized standards or objective measurements of electrical characteristics. For the primary indication (pain relief), the justification relies on the predicate device's established clinical effectiveness, which would have been based on patient outcomes data (e.g., pain scores) in its original approval.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI that would require a "training set."

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

Not applicable, as described in point 8.

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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 single-patient 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 USB 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 USB 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.

This document is a 510(k) premarket notification for the Contour Next USB Blood Glucose Monitoring System, which primarily describes modifications to an existing predicate device (K121087) rather than providing a detailed study of the modified device's performance against specific acceptance criteria. The modifications focus on improved error detection capabilities.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth for a full performance study is not explicitly detailed in the provided text. The submission focuses on demonstrating substantial equivalence to the predicate device due to specific enhancements.

Here's an attempt to extract the available information based on your request, with noted limitations where data is not provided:

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

The document does not explicitly state numerical acceptance criteria in a table format for blood glucose measurement accuracy for the modified device. Instead, it describes functional improvements related to error detection. The "reported device performance" focuses on the functionality of these new error checks and equivalency to the predicate device.

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

• Test Set Sample Size: Not specified. The document mentions "bench testing" and an "internal user study" but does not give sample sizes for either.
• Data Provenance: Not specified, but likely proprietary internal data from Bayer Healthcare. It doesn't specify country of origin or whether it's retrospective or prospective. Given the context of 510(k) submissions, such studies are typically prospective tests conducted by the manufacturer.

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 or not specified. This type of submission for a blood glucose meter does not typically involve expert consensus to establish ground truth in the same way an imaging or diagnostic AI device would. The "ground truth" for a blood glucose meter is usually established by a laboratory reference method. The document mentions "internal user study," suggesting lay users may have been involved in some testing, but no details on expert involvement for ground truth are provided.

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

Not applicable or not specified. Adjudication methods like 2+1 are typically used for subjective assessments (e.g., image interpretation) where multiple experts review and reconcile differences. For a quantitative device like a blood glucose meter, ground truth is established by a reference method, not by expert adjudication.

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. MRMC studies are relevant for devices that assist human readers (e.g., AI for medical imaging). This is a standalone diagnostic device. The study mentions an "internal user study" but not in the context of an MRMC design or comparing human performance with/without AI assistance.

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

Yes, in essence. The bench testing and software verification of the error detection mechanisms would fall under "standalone" algorithm testing to ensure the meter correctly identifies errors and does not misclassify good results. The equivalency testing would also implicitly assess the algorithm's accuracy compared to the predicate.

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

For blood glucose meters, the ground truth for accuracy studies is typically established by a laboratory reference method (e.g., YSI glucose analyzer) for whole blood glucose concentration. While not explicitly stated for this specific submission, this is the standard for blood glucose meter validation. The text focuses on the functional correctness of its new error checks rather than primary accuracy data against a reference method, as it's demonstrating equivalence to an already cleared device.

8. The sample size for the training set

Not applicable. As a medical device (blood glucose meter) and not an AI/ML algorithm that requires a "training set" in the conventional sense, this information is not relevant or provided. The "training" for such a device is its design and manufacturing process, and its performance is validated through testing.

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

Not applicable, as there is no "training set" in the context of AI/ML for this device.

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CONTOUR®NEXT control solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check to ensure that the Contour Next Blood Glucose Monitoring Systems are working properly.

Contour Next Control Solution is used as a quality control check to assure the customer that their Bayer Contour Next blood glucose monitoring system is reading accurately. The control solution has a very controlled amount of glucose in it. The bottles of Contour Next test strips have a range of acceptable values on every bottle that is used to compare the result obtained when the control solution is applied to the test strip. When the reading from the control solution is within the range on the bottle, the system has been quality control checked and shown to be accurate. If the reading from the control solution is outside the stated range, then the customer is instructed by the user guide to not use the system until trouble-shooting can be done and/or customer service is called for help.

The Solution is a prescribed amount of glucose in water and includes a buffer, red dye, and a thickening agent. The control solution comes in a 2.5mL plastic bottle with an applicator tip. It comes in two glucose levels, Level 1 (about 45mg/dL) and Level 2 (about 125mg/dL).

The provided text is a 510(k) Summary for the Bayer Contour Next Control Solution. It describes the device, its intended use, and compares it to a predicate device. However, the document does not contain the specific details required to answer all parts of your request about acceptance criteria and a study proving those criteria are met, especially concerning numerical performance data, sample sizes, expert involvement, and ground truth methodologies.

This document is a regulatory submission demonstrating substantial equivalence, not a detailed scientific study report with raw performance data. It summarizes testing done but does not provide the granular information you're asking for.

Here's an attempt to answer based on the available information, with significant limitations and explicit mentions of missing data:

Acceptance Criteria and Device Performance

The document states that "Bench testing conducted showed that the modified Contour Next Control Solution performed as intended and met the system specifications." However, specific numerical acceptance criteria for performance (e.g., accuracy ranges for control solutions) and the detailed results demonstrating those are not provided in this document. It generally claims the device met specifications.

The provided differences table suggests implicit performance targets related to glucose concentration levels. For example, Level 1 is about 45 mg/dL for the predicate and 0.03% (equivalent to 30 mg/dL if 1% is 1000 mg/dL, which is unusual for glucose concentrations in this context, 0.03% is more likely a weight/volume percentage meaning 30 mg/mL, not mg/dL), and Level 2 about 125 mg/dL for the predicate and 0.07% for the modified. The exact equivalence or acceptance criteria for these specific concentrations are not detailed.

Given the nature of a control solution, the primary performance acceptance criteria would usually revolve around:

• Stability: Maintaining glucose concentration within specified ranges over shelf-life and use-life.
• Accuracy: When tested with the blood glucose meter, the control solution results fall within the expected range printed on the test strip vial.
• Usability: End-users can successfully perform a control test.

The document claims these were met, but without numerical specifics.

Study Details

Due to the limited information in the 510(k) Summary, many of your questions cannot be fully answered.

1. Table of Acceptance Criteria and Reported Device Performance:

   Feature / Test Category	Acceptance Criteria	Reported Device Performance
   Bench Testing	"Met system specifications" (details not provided)	"Performed as intended and met the system specifications"
   Stability Testing	Preservation of "shelf-life or use-life claims" (specific parameters not provided)	"No impact to the claimed shelf-life or use-life"
   Usability Testing	Ability of end-users to "perform a control test" (specific metrics not provided)	"No impact in the ability of end users to perform control tests"
   Glucose Concentration (Level 1)	Implicit: New nominal concentration of 0.03%	Modified: 0.03%
   Glucose Concentration (Level 2)	Implicit: New nominal concentration of 0.07%	Modified: 0.07%
   Impact of Surfactant	Implicit: No negative impact on performance	Surfactant added, assumed to not negatively impact performance, as overall conclusion is substantial equivalence.
   Control Test Temperature Range	Implicit: Functional within 15C-35C	Modified: 15C-35C

   Note: The "acceptance criteria" column is largely inferred from the "reported device performance" due to the lack of explicit, detailed criteria in the document. The exact numerical ranges that define "met system specifications" or "no impact" are not provided.

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

   • Sample Size: Not specified. The document does not mention the number of units tested for bench, stability, or usability testing.
   • Data Provenance: Not specified. It's a Bayer Healthcare LLC internal study, but the geographical origin of the data (e.g., country of testing, participants in usability study) is not mentioned. It is an internal, retrospective summary of performance testing for a regulatory submission.

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

   • Not applicable/Not specified. This device is a control solution for a blood glucose monitor. Performance testing would likely involve laboratory equipment, chemical analysis, and potentially human factors testing, but not typically "experts establishing ground truth" in the sense of clinical interpretation (e.g., radiologists reviewing images). The accuracy of glucose concentration is determined by analytical methods.

4. Adjudication Method for the Test Set:

   • Not applicable/Not specified. Adjudication is typically for resolving discrepancies in expert interpretation. Given the nature of performance testing for a control solution, this wouldn't be relevant.

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

   • No. An MRMC study is relevant for diagnostic devices requiring human interpretation (e.g., imaging devices). This is a quality control material.

6. Standalone Performance:

   • Yes, to an extent. The "bench testing" and "stability testing" sections refer to the performance of the control solution itself, independent of a human operator, in terms of its chemical properties and stability. "Usability testing" does involve human interaction, but its goal is to ensure the control solution's design doesn't hinder the user, not to assess human interpretation of outputs.

7. Type of Ground Truth Used:

   • For glucose concentration and stability: Likely analytical measurements against certified standards or reference methods. The "ground truth" for a control solution's glucose level is its actual chemical concentration determined by precise laboratory techniques.
   • For usability: Ground truth for successful control testing would be the successful completion of the test and obtaining a result within the expected range, often observed or reported by test participants.

8. Sample Size for the Training Set:

   • Not applicable. This device is a chemical control solution, not an AI/machine learning algorithm that requires a "training set."

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

   • Not applicable. (See point 8).

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

The CONTOUR® NEXT EZ blood glucose monitoring system is indicated for use with fresh fingertip capillary whole blood samples. The clinical utility of this device is to aid in monitoring the effectiveness of your diabetes control program.

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

The CONTOUR® NEXT 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 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.

Here's a breakdown of the acceptance criteria and study information for the Contour Next EZ Blood Glucose Meter (K130265):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Contour Next EZ Blood Glucose Monitoring System are based on ISO 15197:2003 standards for accuracy, repeatability, linearity, and intermediate precision. The provided document details the performance of the Contour Plus System as a proxy for the Contour Next EZ system, along with specific additional testing for the modified Contour Next EZ meter.

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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 measurement of glucose in whole blood, and is for single-patient use only and should not be shared. 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.

Contour NEXT 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 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 Paradigm REAL-TIME Insulin Pumps or Medtronic MiniMed 530G Insulin Pumps or Guardian REAL-TIME Monitor 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 LINK Wireless Blood Glucose Monitoring System consists of a blood glucose meter, dry test strips and liquid controls to be used for the measurement of glucose in capillary whole blood by persons with diabetes. The System has the same automatic calibration as the predicate device. Blood glucose results are displayed on the meter window and stored in the meter's memory. The System also contains radio frequency (RF) functions for sending BGM 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 management software.

This 510(k) summary (K122370) describes Bayer Healthcare's Contour® NEXT LINK Wireless Blood Glucose Monitoring System. The submission is to add the Medtronic MiniMed 530G insulin pump to the list of compatible devices in the Indications for Use, meaning the device itself (the blood glucose meter) remains essentially the same as the predicate (K110894).

Therefore, the performance of the updated device is considered substantially equivalent to the predicate device. The submission explicitly states: "The performance of the Contour NEXT LINK Wireless Blood Glucose Monitoring System is substantially equivalent to the performance of the previously cleared Contour NEXT LINK Wireless Blood Glucose Monitoring System (K110894)." This implies that the acceptance criteria and performance data for the predicate device are referenced.

Acceptance Criteria and Reported Device Performance:

The document refers to a PMA submission (P120010) for verification reports on the performance of the Contour NEXT Link Wireless Blood Glucose Meter with the Medtronic MiniMed 530G Insulin Pump. Without access to P120010, the specific acceptance criteria and detailed performance of the device cannot be explicitly extracted from this 510(k) summary. However, for blood glucose meters, typical acceptance criteria would involve accuracy standards (e.g., ISO 15197 for clinical accuracy) which define the permissible deviation of meter readings from laboratory reference values within certain error grids (e.g., Consensus Error Grid or Clarke Error Grid).

Given the statement of substantial equivalence, the device is expected to meet the same performance criteria as the predicate device (K110894).

Study Information (Based on the provided 510(k) summary and inferring from BGM regulatory practices):

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

   • The 510(k) summary does not explicitly state the sample size for the test set. It refers to "VERIFICATION AND VALIDATION DATA" in PMA submission P120010.
   • Data provenance: Not specified in this 510(k) document. Typically, accuracy studies for blood glucose meters involve prospective clinical studies with human subjects.

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

   • Not applicable in the conventional sense for a blood glucose meter accuracy study. The "ground truth" for blood glucose measurements is established by a laboratory reference method (e.g., YSI 2300 STAT PLUS Glucose & Lactate Analyzer), not by expert consensus. This method is operated by trained laboratory personnel, not "experts" in the context of medical imaging or diagnosis.

3. Adjudication method for the test set:

   • Not applicable. Blood glucose meter accuracy studies compare meter readings directly against a highly accurate laboratory reference method, not against an adjudicated ground truth from multiple observers.

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, a MRMC study was not done. This is a blood glucose meter, an in-vitro diagnostic device, not an AI-assisted diagnostic imaging device.

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

   • Yes, the accuracy studies for blood glucose meters fundamentally assess the standalone performance of the device (meter + test strip) against a laboratory reference. The user interaction is typically part of human factors validation, ensuring correct operation, but the core accuracy is an "algorithm only" measurement.

6. The type of ground truth used:

   • Laboratory Reference Method: For blood glucose meters, the ground truth is established by a highly accurate and precise laboratory reference instrument, such as a YSI glucose analyzer, which measures glucose concentrations in blood samples.

7. The sample size for the training set:

   • This is not relevant for a blood glucose meter in the context of this 510(k). The device uses a "Multi-pulse algorithm" which is established during the device's original development (likely for K110894) and does not typically involve additional "training sets" in the AI/machine learning sense for each submission unless the algorithm itself is being changed, which it isn't here. This submission is for compatibility with a new insulin pump, not a new algorithm.

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

   • Not applicable, as there is no mention of a "training set" in the context of this 510(k) for the reasons mentioned above. The algorithm's parameters would have been set based on extensive testing and calibration during its initial development, using blood samples with known glucose concentrations verified by a laboratory reference.

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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 measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The CONTOUR®NEXT Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only.

CONTOUR®NEXT 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 Control Solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check.

The CONTOUR®NEXT 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 Blood Glucose Monitoring System consists of a small handheld blood glucose meter that utilizes dry reagent test strips and liquid controls for the measurement of glucose in capillary whole blood by persons with diabetes. The meter together with the test strips and control solutions is referred to as the CONTOUR® NEXT Blood Glucose Monitoring System.

The CONTOUR® NEXT Blood Glucose Monitoring System underwent various verification and validation activities to demonstrate its substantial equivalence to the predicate device. Details regarding acceptance criteria and study results are provided below based on the information extracted:

Acceptance Criteria and Device Performance

• Meter shall not experience permanent damage or present hazard such as excessive temperature or heat due to overvoltage. | - All blood glucose tests attempted while connected to PC generated "Do not Test, Connected" error screen.
• All results maintained correct voltage regulation within limits and did not present temperature hazard near or above the specified limit. |
  | Biocontamination – exposure to blood-borne pathogens via device | - Must meet requirements set forth in IEC 61010-1:2001 (2nd Edition).
• No residual blood or control solution to be observed on any of the meters after cleaning.
• No virus must be detected on any surface after 60s of cleaning with specified wipes. | - Compliance with IEC 61010-1:2001 requirements confirmed via testing by an external lab.
• There was no residual blood or control solution observed on any of the meters after soiling and cleaning.
• The specified disinfectant passed the virus elimination effectiveness test for all tested meter device surfaces. |
  | Material degradation due to cleaning and disinfection | - Plastic parts were not to exhibit any cracking, glazing, discoloration or expansion after being exposed to cleaning agents.
• Metallic parts were to exhibit little or no corrosion (evaluated as low, medium, or high). | - All results for plastic and metallic parts met the specified criteria for each solution tested. |
  | Choking/toxicity dangers from small parts (batteries) | - Reagent insert shall warn users of accidental swallowing of test strip.
• User Guide shall warn users of accidental swallowing of assembly components.
• Assembly components are not required to be unscrewed for any reason.
• Design will utilize a non-ordinary screw and require uncommon tools to remove. | - Test strip insert already warns against swallowing test strips.
• System User Guide warns: "Keep out of reach of children. This kit contains small parts which could cause suffocation if accidentally swallowed." and "Keep batteries away from children. Lithium batteries are poisonous. If swallowed, immediately contact your poison..."
• Device designed so that no hazardous assembly parts are easily accessible to user. |
  | Meter malfunction - incorrect reading or does not function properly | - The accuracy of the test strip driving voltage of the Analog Front End at operating temperature range shall be assessed under various test temperatures.
• The CONTOUR®NEXT meter data port shall withstand multiple cycles (insertions/removals).
• The meter shall perform an electronics self test to verify proper function of the meter electronics. | - All results for each test temperature were within the required mV range set forth in the testing.
• All results for the meter data port were within the specified limits after multiple test strip insertion/removal cycles.
• All software test conditions in validation testing passed acceptance criteria. |
  | Erroneous data transfer from meter to PC | - The CONTOUR®NEXT meter's computer interface shall detect and correct communication errors. | - All software test conditions in validation testing passed acceptance criteria. |
  | User unable to properly use meter or follow its instructions for use | - Product labeling for proper instrument operation shall be validated through customer focus study (summative usability study) for 2 critical tasks: 1) completing initial setup and 2) running a mock blood glucose test and marking the result. | - Completing initial setup task was successful.
• Study subjects successfully completed a mock blood glucose test and marked the reading. |
  | User misinterprets meter readings | - Product labeling for proper instrument operation shall be validated through customer focus study (summative usability study) for 2 critical tasks: 1) completing initial setup and 2) running a mock blood glucose test and marking the result. | - Completing initial setup task was successful.
• Study subjects successfully completed a mock blood glucose test and marked the reading. |
  | User mishandles meter (i.e., drops meter, spills liquid on meter) | - Meter must be designed to withstand drop and show no signs of damage to any components.
• Meter must also be designed to withstand Spill Test after exposure to various test solutions. | - All results withstood the stated Drop test and Spill challenges. |

Study Details

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

   • Biocontamination: "One set of meters were soiled with CONTOUR®NEXT liquid control and another set of meters were soiled with 5 uL of venous blood." "Test meters received contact with an EPA-approved surrogate for a human virus for 24 hours on various test surfaces." The exact number of meters in each set is not specified.
   • Usability Study: The document refers to a "customer focus study (summative usability study)" but does not specify the number of participants.
   • Other tests: For other technical performance tests (e.g., electrical safety, material degradation, meter malfunction, data transfer, drop/spill), the sample size of meters or components tested is not explicitly stated, but the results indicate "All results" for the tested items met criteria.
   • Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." The studies appear to be internal verification and validation tests conducted by the manufacturer as part of the device development and submission process.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The studies described are engineering and usability focused, not involving expert interpretation of medical images or diagnostic results. The "ground truth" for these tests are objective engineering specifications or direct observation of user behavior (for usability).

3. Adjudication method for the test set: Not applicable. The tests performed are objective, involving mechanical stress, electrical measurement, or direct observation of adherence to instructions. There is no mention of a need for adjudication.

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: Not applicable. This device is a blood glucose monitoring system, not an AI-based diagnostic imaging tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is standalone in terms of its glucose measurement algorithm. The various tests described assess the device's standalone performance across different parameters (electrical, mechanical, software, etc.). The usability studies indirectly evaluate human-in-the-loop performance in terms of whether users can operate the device correctly.

6. The type of ground truth used:

   • Objective Engineering Specifications: For risks like electric shock, material degradation, meter malfunction, erroneous data transfer, and user mishandling, "ground truth" is defined by established engineering standards (e.g., IEC 61010-1:2001, specified mV ranges, withstand limits for drop/spill).
   • Direct Observation/Absence of Failure: For biocontamination, the ground truth is the absence of observed residual blood/control solution or detected virus.
   • Successful Task Completion: For user inability to use the meter or misinterpreting readings, the ground truth is the successful completion of specific tasks by study participants as observed in the usability study.

7. The sample size for the training set: Not applicable based on the provided document. The document describes validation and verification studies for a medical device (blood glucose meter), not an AI algorithm requiring a training set. The device utilizes a "blood glucose measurement algorithm and automatic calibration," but details about the development or training of this algorithm are not provided in this 510(k) summary.

8. How the ground truth for the training set was established: Not applicable, as no training set for an AI algorithm is described.

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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 single-patient use only and should not be shared. 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. The CONTOUR® NEXT USB Blood Glucose Monitoring System may be used as an aid to monitor the effectiveness of a diabetes control program and 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 Controls are for use with the CONTOUR® NEXT USB Blood Glucose Monitoring System to check that the meter and test strips are working properly.

Glucofacts® Deluxe Diabetes Management Software is an over-the-counter software program intended for use by health care professionals and patients with diabetes for viewing and printing reports that display blood sugar readings from Baver's Contour and Breeze families of meters.

The Contour NEXT USB Blood Glucose Monitoring System consists of a small handheld blood glucose meter that is substantially equivalent in look and feel to the predicate system. Contour Next Wireless Blood Glucose Meter, (K110894). The system also consists of dry reagent test strips used for the measurement of glucose in capillary whole blood and includes liquid controls to check the performance of the system.

The chemical principle of the system 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.

The Bayer Contour NEXT USB Blood Glucose Monitoring System was tested and found to meet the system accuracy requirements of ISO 15197:2003 through analytical performance testing and a user performance evaluation.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from ISO 15197:2003 for system accuracy.

**System Accuracy - Glucose Concentrations

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The CONTOUR® LINK Wireless Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The CONTOUR® LINK Wireless Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip only.

CONTOUR® 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® 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 through use of radio frequency communication.

The CONTOUR® 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 LINK Wireless Blood Glucose Monitoring System features the CONTOUR LINK Wireless Blood Glucose Monitor and the currently marketed CONTOUR Blood Glucose Test Strips, among other components (e.g., lancing device, lancets and control solution)

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Repeatability Test: 10 meters, 10 replicates per meter. Total n=100.
  • Data Provenance: Not explicitly stated, but likely in-house lab testing (prospective).
• Intermediate Precision Test: 10 meters tested over 10 days, one measurement per meter per lot per control solution per day.
  • Data Provenance: Not explicitly stated, but likely in-house lab testing (prospective).
• System Accuracy Evaluation (ISO 15197): 100 fresh capillary blood samples tested using 2 test strip lots on 2 CONTOUR LINK meters. Total of 400 readings.
  • Data Provenance: Fresh capillary blood samples (prospective). Country of origin not specified, but typically conducted in the submitting company's R&D facilities or contracted labs.
• Linearity/Assay Reportable Range (Predicate K062058 data cited):
  • Study 1: Blood with 40% hematocrit, 5 glucose concentrations, 3 CONTOUR lots, 24 sensors per lot.
  • Study 2: 8 meters, 3 sensors per lot tested on each.
  • Data Provenance: Unspecified, but derived from the predicate device's 510(k) submission (K062058), so likely both in-house lab testing (prospective) and potentially some clinical data.
• Detection Limit: 3 production lots of CONTOUR sensors, 24 sensors per sample for manipulated blood samples.
  • Data Provenance: Not explicitly stated, likely in-house lab testing (prospective).
• Analytical Specificity (Interferences): Not explicitly stated how many samples or replicates were performed for each compound.
  • Data Provenance: Not explicitly stated, likely in-house lab testing (prospective).
• Method Comparison with Predicate Device (Linearity/Assay Reportable Range comparison): 444 paired readings collected.
  • Data Provenance: Fresh venous blood; likely prospective in-house lab testing.
• Method Comparison with Predicate Device (CONTOUR LINK vs. CONTOUR meters): 111 subjects (fingerstick study). Two lots of CONTOUR sensors, four CONTOUR meters. RF function of CONTOUR LINK left on.
  • Data Provenance: Fresh capillary blood samples from 111 subjects. Likely prospective clinical or usability study. Country unspecified.
• Clinical Study (Usability and Accuracy - New Device): 77 adults.
  • Data Provenance: Adults aged 20-85 (fresh capillary blood, self-test and HCP-test results). Likely prospective clinical or usability study. Country unspecified.
• Clinical Study (Usability and Accuracy - Predicate K062058 cited): 109 adults.
  • Data Provenance: Adults aged 20-75 (self-testing). Derived from predicate device's 510(k) submission (K062058). Likely prospective clinical or usability study. Country unspecified.

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

• No human experts were used for establishing ground truth. The ground truth in these studies was established using a high-precision laboratory reference method.

4. Adjudication Method for the Test Set

• Not applicable. Since the ground truth was established by a laboratory reference instrument (YSI 2300 STAT PLUS glucose analyzer) rather than human experts, there was no need for an adjudication method.

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

• No, an MRMC comparative effectiveness study was not done in the context of comparing human readers (interpreting images/cases) with and without AI assistance. This device is a blood glucose meter, and its performance is assessed against a laboratory reference standard, not against human interpretation of images.
• A comparative performance study was done between the new device (CONTOUR LINK) and the predicate device (CONTOUR) using blood samples, showing equivalence.

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

• Yes, the device's accuracy tests (Precision, System Accuracy, Linearity, Detection Limit, Analytical Specificity) represent standalone performance, as these evaluate the device's ability to measure glucose values compared to a reference method, without human intervention in the measurement process itself beyond standard operation. The clinical study also included "HCP-test results" which implies professional use, which would also be standalone.
• The clinical usability studies involved human users (self-testers and HCPs) operating the device, but the accuracy assessment within these studies is still primarily evaluating the device's standalone measurement capability under real-world usage conditions.

7. The Type of Ground Truth Used

• Laboratory Reference Method: The primary and most frequently cited ground truth was the YSI 2300 STAT PLUS glucose analyzer.
• Traceability: The YSI analyzer is traceable to the hexokinase method, which was developed collaboratively by the FDA, CDC, NIST, and AACC. This method utilizes NIST Standard Reference Material 917, dry D-glucose.

8. The Sample Size for the Training Set

• The document does not explicitly state the sample size for a training set. Blood glucose meters typically do not involve "training sets" in the same way AI algorithms do unless specific machine learning components are involved (which is not described here). The development and calibration of such devices usually rely on extensive internal R&D test data and validated chemical/electrical principles, rather than a publicly reported "training set."

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

• As the document does not explicitly mention a training set in the context of an AI/ML model, it also does not describe how ground truth for such a set was established. Device calibration and internal validation would rely on the same laboratory reference methods described for the performance studies (e.g., YSI 2300 STAT PLUS traceable to hexokinase method).

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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 measurement of glucose in whole blood, and is for single-patient use only and should not be shared. 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. The system consists of a Contour NEXT LINK Wireless 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 from 20 to 600 mg/dL.

The CONTOUR® NEXT Control Solutions are aqueous glucose solutions intended for use in selftesting by people with diabetes as a quality control check.

The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is intended to be used to transmit dlucose values to Medtronic MiniMed Paradigm Insulin pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps or Medtronic MiniMed Paradigm® REAL-TIME Insulin Pumps or Guardian REAL-TIME Monitor 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 LINK Wireless Blood Glucose Monitoring System consists of a small handheld electronic device is substantially equivalent in look and feel to the Contour® USB predicate system (K091820). The System also contains dry reagent strips and liquid controls to be used for the measurement of glucose in capillary whole blood by persons with diabetes. The System has the same automatic calibration as the predicate device. Blood glucose results are displayed on the meter window and stored in the meter's memory. The System is intended to transmit 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 management software.

Here's a breakdown of the acceptance criteria and study information for the Contour® NEXT LINK Wireless Blood Glucose Meter, extracted from the provided 510(k) summary:

Acceptance Criteria and Device Performance

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