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Glucose Meter-Check Solution for TaiDoc is intended for in vitro diagnostic use (i.e., for external use only) to assess the performance of blood glucose meters and test strips manufactured by TaiDoc Technology Corporation by healthcare professionals and in the home by people with diabetes mellitus. For In Vitro Diagnostic Use

The control solutions are comprised of buffered aqueous liquid glucose control solution with viscosity modifiers to simulate certain properties of blood on the test strip and colored red to help users see the solution while dispensing onto a test strip. The control solutions are formulated to have performance comparable to those currently manufactured by TaiDoc Technology Corporation. The product is packaged in plastic bottles with dropper tips for dispensing the control solutions for use with test strips. This is a non-hazardous aqueous glucose control solution containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation.

Here's a breakdown of the acceptance criteria and the study details for the Glucose Meter-Check® Solution for TaiDoc, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Glucose Meter-Check Solution are derived from its intended use as a quality control material to assess the performance of TaiDoc blood glucose meters and test strips. The "performance" in this context refers to its ability to consistently produce glucose measurements within specified target ranges when tested on the intended meters and strips.

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Glucose Meter-Check Solution Roche ACCU-CHEK is intended to assess the performance of the following Roche ACCU-CHEK blood glucose monitoring systems:

· Roche ACCU-CHEK Nano SmartView® using SmartView® test strips

• · Roche ACCU-CHEK Aviva® and ACCU-CHEK Aviva Combo® using Aviva Plus® test strips
• · Roche ACCU-CHEK Active® using ACCU-CHEK Active test strips
• Roche ACCU-CHEK Compact® and ACCU-CHEK Compact Plus® using ACCU-CHEK Compact test strips.
• · Roche ACCU-CHEK Advantage using Comfort Curve® test strips

Glucose Meter-Check Solution for Roche ACCU-CHEK is intended for use by healthcare professionals and people with diabetes mellitus at home.

For In Vitro Diagnostic Use

Glucose Meter-Check Solution is a single-level, viscosity-adjusted, aqueous liquid glucose control solution. Glucose Meter-Check Solution is intended for use to verify the performance of the Roche ACCU-CHEK brand BGM Systems listed in the package insert at recover glucose values within the interval recommended in ISO 15197:2003 In vitro diagnostic test systems - Requirements for blood glucose monitoring systems for selftesting in managing diabetes mellitus for most meter types (Aviva, SmartView, Advantage), and comparable to solutions currently marketed by Roche for others (Active, Compact). This mid-level glucose concentration will complement the current, low and high glucose concentrations available in quality control products distributed by Roche Diagnostics for these same BGM systems. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. The control has a red color to help users see the solution while dispensing onto a test strip.

Glucose Meter-Check Solution is a non-hazardous aqueous solution glucose control solution containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation.

This material consists of viscosity-adjusted, aqueous glucose control solution prepared with a single concentration of D-glucose and has been optimized to simulate the response of whole blood on the Roche ACCU-CHEK blood glucose monitoring systems. The solution contains no hazardous, human or animal derived components. The solution is recognized as a control automatically by the ACCU-CHEK Aviva and Nano SmartView meters to perform consistently as the Roche branded products.

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

Device: Glucose Meter-Check® Solution for Roche ACCU-CHEK

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Value Assignment: For each meter type and for 3 lots of test strips, 8 measurements of the Glucose Meter-Check Solution were taken on each of 5 meters. This results in 120 measurements per meter type (3 lots x 8 measurements/lot x 5 meters/lot).
• Sample Size for Method Comparison/Equivalence: For each meter brand, 2 meters were used. For each meter, 1 measurement of Glucose Meter Check Solution was followed by 1 measurement of the Roche ACCU-CHEK branded control solution. This sequence was repeated until 25 sets of pairs were recorded per meter (25 measurements for the candidate device and 25 for the predicate device, per meter).
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing described appears to be retrospective laboratory testing performed by Bionostics, Inc. to characterize the new control solution and compare it to existing solutions. It is not patient-derived data.

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

N/A. This device is a quality control solution for glucose meters, not a diagnostic algorithm that interprets medical images or patient data. The "ground truth" here refers to the known glucose concentration of the control solution itself and the expected performance ranges of the glucose meters. The "ground truth" for the control solution's glucose level is established through analytical methods (YSI 2300 calibrated with N.I.S.T. 917 traceable materials), not expert interpretation.

4. Adjudication Method for the Test Set

N/A. No human interpretation (such as radiological reads) is involved, so no adjudication method is applicable. The evaluation criteria are quantitative and based on instrument readings.

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

No, an MRMC study was not done. This study pertains to the performance of a quality control solution with blood glucose meters, not an AI-assisted diagnostic tool that involves human readers.

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

Yes, in a sense. The core "performance" of the Glucose Meter-Check Solution is its ability to produce expected glucose values when tested on various blood glucose monitoring systems. The studies evaluated the control solution itself and its interaction with the meters, which are standalone devices. There is no human-in-the-loop aspect for the control solution's function or the meter's measurement.

7. The Type of Ground Truth Used

The ground truth used is analytical measurement of glucose concentration traceable to a recognized standard:

• N.I.S.T. SRM 917 (National Institute of Standards and Technology Standard Reference Material 917)
• Measurements were performed using a YSI 2300 (a glucose analyzer).
• For the meter performance, the "ground truth" is defined by the expected assay ranges provided by Roche for their test strips and the assigned range for the Glucose Meter-Check solution (±15% of the grand mean).

8. The Sample Size for the Training Set

N/A. This is a quality control solution, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML. The device's formulation and performance specifications are developed through R&D and analytical testing, not supervised learning.

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

N/A. As there is no training set for a machine learning model, this question is not applicable.

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Glucose Meter-Check Solution for Bayer is intended to assess the performance of the following Bayer blood glucose test systems:

• Bayer Contour Next blood glucose monitoring systems
• Bayer Breeze 2 blood glucose monitoring systems
• Bayer Contour and Contour TS blood glucose monitoring systems
  Glucose Meter-Check Solution for Bayer is intended for use by healthcare professionals and people with diabetes mellitus at home.
  For In Vitro Diagnostic Use

Glucose Meter-Check Control Solution is a viscosity-adjusted, aqueous liquid glucose control solution containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation. Glucose Meter-Check Control Solution is intended for use to verify the performance of the Bayer BGM systems listed in the package insert and is intended for use by healthcare professionals and people with diabetes mellitus at home. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. The control has a red color to help users see the solution while dispensing onto a test strip. Glucose Meter-Check Solution is a non-hazardous aqueous solution glucose control solution containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation.

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

Device: Glucose Meter-Check® Solution for Bayer

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific numerical sample size for the test set. However, it mentions:

• "a series of measurements" were performed.
• Glucose Meter-Check Solution and mid-level Bayer quality control solution were tested "for each strip/meter type."
• The table "Evaluation of Equivalence of Control Solutions" presents data for various test strip and meter brands (Breeze 2, Contour, Contour TS, Contour Next EZ). Each row represents a "Control Brand" (Bayer's own control, Current Meter-Check, New Meter-Check) with "Pooled Mean," "Pooled SD," "Pooled CV%" implying multiple measurements were pooled for each combination.

Data Provenance:

• The document states: "Current version blood glucose meters, test strips and quality control solutions were purchased through retail outlets for Bayer blood glucose monitoring systems." This suggests the data was collected from commercially available products, likely in the country where the testing was conducted (not specified, but presumably the US where the submission was made).
• The study appears to be prospective as it involved testing the performance of the new device against existing ones.

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

This type of study does not typically involve human experts establishing a "ground truth" in the diagnostic sense (e.g., radiologists interpreting images).

For this device (a quality control solution for blood glucose meters), the ground truth is based on:

• Value assignment ranges: These ranges are established by the test strip manufacturers (Bayer in this case) and Bionostics for their Meter-Check solutions.
• Measurement against reference methods: The document mentions "determined by analysis of glucose on commercial lots of glucose test strips qualified for proper measurement using manufacturer recommended control solution" and "Traceability: N.I.S.T. SRM 917." This indicates a reliance on standardized laboratory methods and reference materials, rather than expert interpretation.

4. Adjudication Method for the Test Set

No explicit adjudication method (like 2+1 or 3+1) is mentioned, as this is not a study relying on human interpretation of subjective data. The assessment is objective, based on whether numerical results fall within predefined ranges.

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

No. An MRMC comparative effectiveness study is designed to evaluate the performance of human readers (e.g., radiologists, pathologists) with and without AI assistance on a set of cases. This study is for a quality control solution used to verify the performance of blood glucose meters, not for an AI algorithm assisting human interpretation. Therefore, it does not involve human readers or assess an effect size of AI assistance.

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

While the device (quality control solution) doesn't have an "algorithm" in the typical AI sense, the performance testing described is analogous to a standalone performance evaluation. The device (control solution) is used directly with blood glucose meters, and its functionality is assessed based on whether the meter/strip system produces results within established ranges when the control solution is used. There is no human intervention required to interpret the control solution's performance; the meter provides a reading, and that reading is objectively compared to the expected range.

7. The Type of Ground Truth Used

The ground truth used is based on:

• Manufacturer-recommended value assignment ranges: These are the expected glucose values for a given meter/test strip/control solution combination.
• Traceability to N.I.S.T. SRM 917: This refers to the National Institute of Standards and Technology Standard Reference Material 917, which is a certified glucose standard, ensuring the accuracy of the glucose concentration.
• YSI analysis: The stability section mentions "percent glucose recovery on YSI," indicating that a YSI (Yellow Springs Instruments) analyzer, a highly accurate laboratory instrument, was used for reference measurements.

This type of ground truth is analogous to analytical reference methods or certified reference materials.

8. The Sample Size for the Training Set

Not applicable. This device is a quality control solution, not an AI algorithm that requires a "training set." The product's performance is driven by its chemical formulation and manufacturing processes, not by machine learning from a dataset.

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

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

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Glucose Meter-Check Solution for Infopia is intended for use to verify the performance and correct operation of Infopia blood glucose monitoring test systems utilizing Infopia glucose test strips. Glucose Meter-Check Solution for Infopia is intended for use by healthcare professionals and people with diabetes mellitus at home.

For In Vitro Diagnostic Use

Glucose Meter-Check Solution for Infopia is a buffered aqueous solution with glucose containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation. The Glucose Meter-Check Solution is formulated for optimal performance on Infopia glucose meters using Infopia test strips.

This material consists of viscosity-adjusted, aqueous glucose control solution prepared with a single concentration of D-glucose with recovery on the test systems in the range corresponding to Interval 2 of the glucose contration intervals for evalution of intermediate precision in ISO 151972 (96 to 144 mg/dL). This solution has been optimized to simulate the response of whole blood on the blood glucose test systems manufactured by Infopia using Infopia blood glucose test strips. The solution contains no hazardous, human or animal derived components.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Glucose Meter-Check Solution for Infopia:

The submission K113764 is for a control solution, not an AI device, and therefore the majority of the requested information regarding AI device evaluation (such as sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document. This document describes the equivalence of a new control solution to an existing one.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a control solution are typically defined as its ability to produce glucose readings within a specified target range when tested with the intended blood glucose monitoring system. The predicate device's established target range serves as the basis for substantial equivalence.

Note: The new device's target range (88 – 132 mg/dL) falls within the established performance window for glucose concentration intervals for evaluation of intermediate precision in ISO 15197 (96 to 144 mg/dL), and is deemed substantially equivalent to the predicate.

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

This information is not applicable as this is a medical device submission for a control solution, and not an AI device undergoing a performance study with a test set of data. The "tests conducted" section lists stability and response tests, but does not detail sample sizes as would be relevant for an AI model's test set.

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

This information is not applicable. Ground truth, in the context of an AI device, refers to expertly curated data for model comparison. For a control solution, the "truth" is its certified glucose concentration, which is established through analytical chemistry, not expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations, which is not pertinent to the evaluation of a glucose control solution.

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

This information is not applicable. MRMC studies are used to evaluate the impact of AI on human reader performance, which doesn't apply to a control solution.

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

This information is not applicable. There is no algorithm or AI component in this control solution.

7. The Type of Ground Truth Used

For the Glucose Meter-Check Solution, the "ground truth" implicitly refers to the analytical concentration of D-glucose in the buffered aqueous solution, established through chemical manufacturing and quality control processes. This is confirmed by the statement: "Glucose Meter-Check Solution for Infopia is a buffered aqueous solution with glucose..." and its formulation "with a single concentration of D-glucose".

8. The Sample Size for the Training Set

This information is not applicable, as there is no AI model or training set associated with this control solution.

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

This information is not applicable, as there is no AI model or training set associated with this control solution.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria for this control solution primarily focuses on non-clinical tests comparing its characteristics and performance to a legally marketed predicate device (Infopia Control Solution K0572369).

The key aspects of the study demonstrating substantial equivalence include:

• Comparison of Technological Characteristics: A direct comparison table is provided, showing the new device shares fundamental characteristics with the predicate, such as:
  • Name (Infopia Control Solution vs. Glucose Meter-Check Control Solution for Infopia)
  • Number of levels (1, typical fasting glucose)
  • Analytes (glucose)
  • Container (6 mL LDPE vial with dispensing tip and cap)
  • Fill volume (4 mL)
  • Color (red)
  • Matrix (Buffered, aqueous solution of D-Glucose, viscosity modifier, preservatives and other, non-reactive ingredients)
• Target Ranges: The new device's target range (88 – 132 mg/dL) was established and deemed acceptable when compared to the predicate's range (94 – 140 mg/dL). This range is also stated to correspond to Interval 2 of the glucose concentration intervals for the evaluation of intermediate precision in ISO 15197 (96 to 144 mg/dL), implying it meets recognized standards for control solution performance.
• Non-Clinical Performance Tests: The submission states that tests were conducted to verify specific performance requirements:
  • Closed bottle stability (Shelf-life)
  • Stability after opening (Use-life)
  • Transport Stability
  • Test response (This implicitly confirms that the solution provides readings within its specified range on the target glucose meters).

Conclusion drawn from these tests: "Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence." This means the new Glucose Meter-Check Solution for Infopia performs comparably to the predicate control solution, within acceptable parameters, ensuring it can effectively verify the performance of Infopia blood glucose monitoring test systems as intended.

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Glucose Meter-Check Control Solution for NIPRO TRUEresult is intended for use to verify the performance and correct operation of the NIPRO TRUEresult Glucose Test Systems. Glucose Meter-Check Control Solution for NIPRO TRUEresult is intended for use by healthcare professionals and people with diabetes mellitus at home.

Glucose Meter-Check Control Solution for NIPRO TRUEresult is a buffered aqueous solution with glucose containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation. The Glucose Meter-Check Control Solution is formulated for optimal performance on NIPRO TRUEresult glucose meters. The product is provided in 2 levels, 1 representing hypoglycemia (low blood glucose) and 2, representing typical fasting blood glucose levels in non-diabetic persons.

The provided text is a 510(k) summary for a medical device called "Glucose Meter-Check Control Solution for NIPRO TRUEresult." This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain detailed acceptance criteria, specific study designs, or performance results in the format requested.

Therefore, I cannot populate the requested tables and sections regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. These details are typically found in more comprehensive study reports or clinical trial data, which are not present in this 510(k) summary.

The document does include the following limited information relevant to non-clinical tests:

Summary of Non-Clinical Tests (b) (1):

• Tests Conducted to Verify Specific Performance Requirements:
  • Closed bottle stability (Shelf-life)
  • Stability after opening (Use-life)
  • Transport Stability
  • Test response

Summary of Clinical Tests (b) (2):

• N/A (No clinical tests submitted with the premarket notification)

Conclusions (b) (3):

• "Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence."

In conclusion, the document's purpose is to demonstrate substantial equivalence, and it does not provide the specific data points needed to fill out the detailed tables and sections you've requested regarding acceptance criteria and performance evaluation studies.

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The Glucose Meter-Check Control Solution for AgaMatrix is intended for use to verify the performance and correct operation of the AgaMatrix blood glucose monitoring test systems utilizing the WaveSense family of blood glucose test strips. Glucose Meter-Check Control Solution for AgaMatrix is intended for use by healthcare professionals and people with diabetes mellitus at home.

Glucose Meter-Check Control Solution for AgaMatrix is a buffered aqueous solution with glucose containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation. The Glucose Meter-Check Control Solution is formulated for optimal performance on AgaMatrix glucose meters utilizing the WaveSense family of test strips.

The provided text describes a 510(k) summary for the Glucose Meter-Check Control Solution for AgaMatrix. It details the device's characteristics, intended use, and comparison to a predicate device for substantial equivalence. However, it does not contain detailed information about specific acceptance criteria or the results of a study designed to prove the device meets these criteria.

The document mentions "Tests were conducted to verify specific performance requirements" in section (b)(1) within part {1}, listing categories like "Closed bottle stability (Shelf-life)," "Stability after opening (Use-life)," "Transport Stability," and "Test response." However, it does not provide the actual acceptance criteria for these tests or the reported performance data from these tests.

Therefore, I cannot populate the table or answer most of the specific questions as the required information is not present in the provided text.

Here is a summary of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states that tests were conducted for stability and test response, but it does not specify the acceptance criteria (e.g., "glucose concentration should be within X% of target") or the actual results obtained from these tests.

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

Not available in the provided text. There is no mention of sample sizes or data provenance (country of origin, retrospective/prospective) for any testing.

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

Not applicable/available. This device is a control solution for glucose meters, not an AI/diagnostic imaging device requiring expert ground truth for interpretation of complex data. The "ground truth" for a control solution would typically be its known glucose concentration, established through a traceable analytical method rather than expert consensus on images or clinical cases.

4. Adjudication method for the test set

Not applicable/available. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in diagnostic imaging studies. This is not relevant for a glucose control solution.

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 device is a control solution for glucose meters, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI effect sizes are not relevant.

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

Not applicable. This device is a control solution, not an algorithm.

7. The type of ground truth used

For a control solution, the ground truth would be the known, analytically determined concentration of glucose within the solution. While the document doesn't explicitly state "analytically determined glucose concentration was used as ground truth," this is the standard for such products.

8. The sample size for the training set

Not applicable. This is a control solution, not a machine learning model, so there is no "training set."

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

Not applicable. As there is no training set.

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LifeScan OneTouch Ultra Control Solution is intended for use to verify the performance of the LifeScan OneTouch Ultra Family and the OneTouch Ping™ Meter Remote blood glucose monitoring test systems at a glucose level printed on the test strip vial. The LifeScan OneTouch Ultra Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home.

LifeScan OneTouch Select Control Solution is intended for use to verify the performance of the LifeScan OneTouch Select blood glucose monitoring test system at a glucose level printed on the test strip vial. The LifeScan OneTouch Select Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home.

LifeScan OneTouch Vita Control Solution is intended for use to verify the performance of the LifeScan OneTouch Vita blood glucose monitoring test system at a glucose level printed on the test strip vial. The LifeScan OneTouch Vita Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home.

For In Vitro Diagnostic Use

The control solution is a buffered aqueous solution with glucose containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation. The primary differences in the composition of the OneTouch Select, Ultra and Vita branded Control Solutions to that of the current, OneTouch Ultra Control are the type and relative content of buffer system, type and relative content of the viscosity adjusting agent, type and relative content of the preservative system, a lower concentration of dye, and a relative reduction in the content of water. The OneTouch Ultra control is currently in use with all LifeScan blood glucose test systems under the OneTouch Ultra, OneTouch Select and OneTouch Vita brands. The new control solution is reformulated for optimized performance across these various brands of test strips, and will be distributed under the same brands as the current Ultra control.

This material consists of viscosity-adjusted, aqueous glucose control solution prepared with a single concentration of D-glucose with recovery on the test systems in the range typically considered normal, fasting glucose for a non-diabetic person. This solution has been optimized to simulate the response of whole blood on the LifeScan OneTouch Ultra, Select and Vita branded blood glucose test systems. The solution contains no hazardous, human or animal derived components.

The provided text describes a 510(k) summary for LifeScan OneTouch Select, Ultra, and Vita Control Solutions. This document outlines the control solutions' characteristics and intended use, comparing them to a predicate device to establish substantial equivalence. However, it does not contain detailed information about acceptance criteria or specific studies proving device performance against those criteria in the format requested.

The document states that "Tests were conducted to verify specific performance requirements" and lists

• a) Closed bottle stability (Shelf-life)
• b) Stability after opening (Use-life)
• c) Transport Stability
• d) Test response

But it does not provide the acceptance criteria for these tests, nor the results of these tests, therefore it is not possible to complete the table or the rest of the requested information.

The document explicitly states "Summary of clinical tests submitted with the premarket notification for the device. (b) (2) N/A", indicating that no clinical tests were submitted. Therefore, it is impossible to extract information about sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance. The ground truth for training also cannot be determined from this document.

In summary, the provided text is a 510(k) summary focused on demonstrating substantial equivalence of control solutions, not on providing detailed performance study results against specific acceptance criteria.

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Enterix InSure FIT FOBT Controls are for in vitro diagnostic use only and include a positive control containing stabilized human hemoglobin and a negative control containing a buffer. This is an assayed positive and negative control and intended for the qualitative test determinations of Enterix InSure FIT product. Enterix InSure FIT FOBT Controls are for exclusive use with Enterix InSure FIT product. These controls can be used to independently verify the functionality and performance of the InSure FIT test by laboratories and other professional medical institutions as part of a comprehensive quality assurance program.

Enterix InSure FIT FOBT Controls is a two-level, aqueous control solution. Enterix InSure FIT FOBT Controls is intended for use to verify the performance of Enterix InSure FIT product. The Enterix InSure FIT Test method is based on the detection of human hemoglobin (hHb). Human hemoglobin indicates the presence of blood in the stool. The test detects the globin (protein) portion of the hHb molecule. Because globin does not survive passage through the upper gastrointestinal (GI) tract, any globin in the stool indicates that there is bleeding in the lower colon or rectum, the region where colorectal cancers originate. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips.

Enterix InSure FIT FOBT Controls is a non-hazardous aqueous solution containing bovine albumin, salts, buffers preservatives and in addition contains human hemoglobin in the positive control.

Here's the breakdown of the acceptance criteria and study information for the Enterix® InSure® FIT™ FOBT Controls, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document describes the device as a quality control solution for the Enterix InSure FIT product. Its primary function is to verify the performance of the InSure FIT test. Therefore, the acceptance criteria are directly tied to how the control solutions behave when tested with the InSure FIT Kit.

Table of Acceptance Criteria and Reported Device Performance

Study Information

The provided document is a 510(k) summary for a control solution, not the primary diagnostic test itself. Therefore, the studies primarily focus on the performance and stability of the control solution rather than extensive clinical validation of a diagnostic algorithm.

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

   • The document does not specify explicit sample sizes (e.g., number of runs, number of vials) for the stability or test response studies. It only states that "Tests were conducted to verify specific performance requirements."
   • Data Provenance: Not specified as being from a particular country. These are likely internal laboratory studies conducted by Bionostics, Inc. The studies are non-clinical tests as explicitly stated ("Summary of non-clinical tests submitted with the premarket notification for the device.").

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

   • This is not applicable to this submission. The "ground truth" for a control solution's performance is its expected reactivity with the intended diagnostic kit (e.g., negative control should be negative, positive control should be positive). The evaluation of these controls would be based on the instrument/kit's reading, not expert interpretation.

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

   • Not applicable. The evaluation of control solution performance on an in vitro diagnostic test typically involves observing the expected reaction (e.g., appearance of a line) on the test strip, rather than expert adjudication of complex clinical images or diagnoses.

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 MRMC study was done (or is applicable). This device is a control solution for an IVD kit, not an AI-powered diagnostic tool requiring human reader interpretation or assistance.

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

   • Not applicable as this is a control solution for an in vitro diagnostic test, not an algorithm or AI device. The "performance" is whether the control solution produces the expected result on the test kit.

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

   • The "ground truth" is intrinsic to the design of the control solutions:
     • Negative Control: Designed to lack human hemoglobin, thus expected to yield a negative result on the InSure FIT test.
     • Positive Control: Designed to contain stabilized human hemoglobin, thus expected to yield a positive result on the InSure FIT test.
   • The verification of this ground truth is done by testing the controls with the InSure FIT Kit and observing the qualitative outcome (presence/absence of test lines, presence of control line).

7. The sample size for the training set:

   • Not applicable for this type of device (control solution). There is no "training set" in the context of machine learning or AI models. The controls are manufactured to specified formulations.

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

   • Not applicable, as there is no training set. The "ground truth" for the performance of the control solutions is established by their intended chemical composition and expected reactivity with the InSure FIT test.

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OMNIS Health Embrace Glucose Control Solution is intended for in vitro diagnostic use to assess the performance of the OMNIS Health Embrace blood glucose test systems by healthcare professionals and in the home by people with diabetes mellitus.

OMNIS Health Embrace Glucose Control Solution is a two-level, viscosity-adjusted, aqueous liquid glucose control solution. OMNIS Health Embrace Glucose Control Solution is intended for use to verify the performance of OMNIS Health Embrace blood glucose test systems at glucose levels within the normal fasting blood glucose range for non-diabetic persons, and at elevated ranges consistent with hyperglycemia. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. The control has a red color to help users see the solution while dispensing onto a test strip. OMNIS Health Embrace Glucose Control Solution is a non-hazardous aqueous solution containing no human or animal-derived materials.

The provided 510(k) summary for the “OMNIS Health Embrace Glucose Control Solution” describes a quality control product for a blood glucose test system, not a diagnostic device that performs analysis or makes a diagnosis. Therefore, the typical acceptance criteria and study designs applicable to diagnostic devices with human subject data (e.g., sensitivity, specificity, MRMC studies, expert ground truth) are not relevant here.

Instead, the study presented focuses on the performance and stability of the control solution itself, ensuring it functions correctly to verify the performance of the glucose test system it's designed for.

Here is an analysis based on the information provided, tailored to the nature of this device:

Acceptance Criteria and Device Performance for OMNIS Health Embrace Glucose Control Solution

The OMNIS Health Embrace Glucose Control Solution is a two-level, viscosity-adjusted, aqueous liquid glucose control solution intended to verify the performance of OMNIS Health Embrace blood glucose test systems. The acceptance criteria for such a product relate to its stability and its ability to consistently provide a known glucose value for quality control.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly list quantitative acceptance criteria values for each test. However, it indicates types of performance requirements that were met, which imply underlying acceptance criteria (e.g., stability within a defined range, consistent mean response).

Note on "Mid Assigned Value": The comparison table with predicate devices lists "Mid Assigned Value*" for L1 (low) and L2 (high) levels as 114 mg/dL and 229 mg/dL respectively. This is not a performance result of the control solution itself when tested, but rather the target value (mid-point of assigned ranges on OMNIS Health glucose test strips) that the control solution is calibrated to represent. The "test mean response and precision data" likely confirmed that when the control solution was tested with the OMNIS Health Embrace system, the results fell within the expected range around these assigned values with acceptable precision.

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

The 510(k) summary does not specify the sample sizes (number of samples, replicates, or batches) used for each of the non-clinical tests (shelf-life, use-life, transport stability, preservative efficacy, mean response, and precision).

The data provenance is implied to be retrospective from internal non-clinical testing conducted by Bionostics, Inc. The country of origin of the data is USA, where Bionostics, Inc. is located.

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

Not applicable for this type of device and study. The "ground truth" for a control solution is typically established through analytical chemistry methods to determine the precise concentration of the analyte (D-glucose) and then verified through rigorous testing on the target device. It does not involve human expert interpretation of a diagnostic output in the same way clinical diagnostic devices do.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation of results or images. For a control solution, the "ground truth" (the known glucose concentration) is analytically determined, and the device's performance is assessed against this known value using objective, quantitative metrics.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are typically reserved for diagnostic imaging or interpretation devices where human readers play a critical role in the diagnostic process and the effectiveness of AI assistance needs to be evaluated. This device is a quality control solution and does not involve human interpretation in its primary function.

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

While the term "standalone study" usually refers to diagnostic algorithms, the non-clinical tests described (stability, mean response, precision) function as an "algorithm only" equivalent in verifying the intrinsic properties and performance of the control solution itself. These studies assess the chemical and physical characteristics of the control solution independently of a human user's interpretation of its results. The OMNIS Health Embrace Glucose Control Solution's performance is measured by how consistently it produces expected results on the OMNIS Health Embrace blood glucose test systems, rather than by its own diagnostic output.

7. The Type of Ground Truth Used

The ground truth for this device is based on analytical chemistry standards and established reference values for glucose concentration. The "Mid Assigned Values" (e.g., 114 mg/dL and 229 mg/dL) represent the target, known concentrations that the control solution is designed to mimic when tested by the OMNIS Health Embrace blood glucose test system. The control solution itself is the ground truth for the system it's meant to evaluate.

8. The Sample Size for the Training Set

Not applicable. The OMNIS Health Embrace Glucose Control Solution is a manufactured chemical product, not an algorithm that requires a training set. The "development" and "optimization" mentioned in the description ("optimized to simulate the response of whole blood") refer to formulation adjustments and testing during product development, not machine learning model training.

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

Not applicable. As stated above, this is a chemical product, not an algorithm.

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RNA Medical® Brand Glucose and ß-Ketone Calibration Verification Controls are assayed materials for confirming the calibration and linearity of glucose and ß-ketone at the upper and lower limits of the reportable range and at three (3) points within the range. This product is for use with the Precision Xceed Pro Blood Glucose and ß-ketone Monitoring System, which uses Precision Xceed Pro Blood Glucose Test Strips and Precision Xceed Pro Blood B-Ketone Test Strips. It is not for use with the Precision PCx System or the i-STAT® 1 Analyzer, which use Precision PCx Test Strips, Precision PCx Plus Test Strips, or i-STAT 1 glucose cartridges.

RNA Medical Glucose and ß-Ketone Calibration Verification Controls is intended for use by healthcare professionals.

For In Vitro Diagnostic Use

RNA Medical Glucose and ß-Ketone Calibration Verification Controls is a five-level. viscosity-adjusted, aqueous liquid glucose and ß-ketone control linearity set optimized for use with the Abbott Diabetes Care Precision Xceed Pro™ Blood Glucose and B-Ketone Monitoring System using Precision Xceed Pro Blood Glucose Test Strips and Precision Xceed Pro Blood β-Ketone Test Strips. RNA Medical Glucose and β-Ketone Calibration Verification Controls provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as part of their quality assurance program. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. The control has a red color to help users see the solution while dispensing onto a test strip.

RNA Medical Glucose and β-Ketone Calibration Verification Controls contains glucose and ketone values at the lower and upper limits of reportable range as well as three points within the range and therefore, may be used to assess the linearity and calibration, or verify performance of the blood glucose and blood ketone systems listed on the package insert.

This material is comprised of an aqueous solution of glucose (0.03% - 0.40%), β-hydroxybutyrate (0.01% - 0.12%), and non-reactive ingredients (viscosity enhancing agent, dye, buffer, and preservative) prepared in five specific glucose and ketone concentrations. These controls contain no hazardous or human biological materials.

Acceptance Criteria and Study for RNA Medical Glucose and ß-Ketone Calibration Verification Controls

Based on the provided document, the "RNA Medical Glucose and ß-Ketone Calibration Verification Controls" is a control product used to assess the performance of a blood glucose and β-ketone monitoring system, not an AI device. As such, the typical metrics and study designs applicable to AI/ML medical devices (e.g., sensitivity, specificity, MRMC studies, standalone performance) are not relevant here.

Instead, the acceptance criteria and supporting studies focus on the stability and accuracy of the control solution itself, ensuring it provides reliable and consistent reference points for calibration verification and linearity testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a quantitative table format for performance metrics. Instead, it describes "specific performance requirements" that were verified. The reported device performance is presented as the intended target values for the different levels of the control.

Here's an interpretation of the implied acceptance criteria and the device's reported performance (target values):

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

• Sample Size for Test Set: The document does not specify a "test set" sample size in terms of patient data or clinical samples, as this is a control solution, not a diagnostic device directly analyzing patient samples. The testing involved multiple measurements of the control solution itself. The exact number of runs or samples per stability or precision study is not detailed in this summary.
• Data Provenance: Not applicable in the context of patient data for a control solution. The data would originate from laboratory testing performed internally by the manufacturer (Bionostics, Inc.) during product development and validation. The country of origin for the testing would presumably be the USA (Devens, MA), where the company is located. The studies would be prospective in nature, as they involve testing the newly developed control solution.

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

• Number of Experts: Not applicable. For a control solution like this, the "ground truth" for the test set is established by precise chemical formulation and analytical testing, not by expert interpretation of images or clinical cases.
• Qualifications of Experts: N/A. The "experts" involved would be analytical chemists, quality control specialists, and metrologists responsible for formulating the controls and verifying their concentrations using established laboratory methods and traceable standards.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication typically refers to resolving discrepancies between multiple human readers or between human readers and an AI system for clinical assessments. For a chemical control, the "truth" is determined by objective analytical measurements and verified against established chemical standards to ensure the stated concentration levels are correct.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation or clinical decision-making) where human performance is compared to human performance with AI assistance. The RNA Medical Glucose and ß-Ketone Calibration Verification Controls are calibration and linearity controls, not a diagnostic device.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study: No, a standalone performance study was not done. This type of study is relevant for AI algorithms to assess their performance without human intervention. The device in question is a chemical control solution, not an algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the control solution's values (glucose and ß-ketone concentrations) is established through analytical chemistry and metrology. This involves precise formulation and quantitative measurement using highly accurate reference methods and traceable standards to determine the exact concentration of glucose and ß-hydroxybutyrate in each level of the control. The manufacturer refers to an internal document "EDMS014536 Rev. 001, Summary of Expected G3CH And Ketones II Values for Bionostics Calibration Verification Control Solutions," which would contain these detailed analytical ground truth values.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a chemical control solution, not an AI/ML algorithm that requires a "training set" of data.

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

• How Ground Truth for Training Set Was Established: Not applicable. As there is no training set for an AI algorithm, there is no ground truth to be established for it. The ground truth for the control product itself is established through precise chemical formulation and analytical validation during manufacturing.

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