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The SmartCheck INRTM System is intended for quantitative testing of Prothrombin Time in capillary blood. Results are given in International Normalized Ratio (INR) units.

The SmartCheck INR System is indicated for use by trained medical professionals in a point of care setting for monitoring the INR of patients on oral anticoagulant therapy.

The SmartCheck INRTM system consists of a hand held battery- powered meter with ROM calibration chip, disposable, dual- chambered, test strips and high and low level external liquid controls. When blood is applied to the strip it migrates by capillary action to the reaction chambers of the strip. The reaction chamber contains a metallic disc and rabbit brain thromboplastin reagent. When blood enters the reaction chamber a magnetic field is applied to the strip to activate disc movement. Upon clot formation, the disc becomes immobilized and clotting is optically detected. Clotting time is calculated and displayed as an INR value.

The provided text describes the SmartCheck INR™ System, a device for quantitative testing of Prothrombin Time in capillary blood. The submission focuses on demonstrating its substantial equivalence to a predicate device through non-clinical and clinical performance evaluations.

Here's an analysis of the acceptance criteria and the study used to prove the device meets them:

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

The submission does not explicitly state pre-defined acceptance criteria in terms of specific numeric thresholds for accuracy and precision. Instead, it presents regression analysis results and aims to show "correlated favourably" and "substantially equivalent" to a venous plasma based PT test and the predicate device.

However, we can infer performance metrics that are implicitly considered for acceptance based on the reported data:

Study Proving Acceptance Criteria:

The study involved two main components:

• Accuracy Study: Comparing SmartCheck INR capillary blood results against venous plasma INR measured by an ACL 10000 laboratory analyzer using three different thromboplastin reagents (recTP, PTHS+, and PT/Fib).
• Precision Study: Measuring SmartCheck INR capillary blood from duplicate finger-sticks to assess within-device variability.

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

• Accuracy Test Set Sample Size:
  • 315 for recTP reagent
  • 310 for PTHS+ reagent
  • 314 for PT/Fib reagent
• Precision Test Set Sample Size: 280
• Data Provenance: The document does not explicitly state the country of origin. It indicates the submitter, Unipath Ltd, is based in the UK. The studies are referred to as "non-clinical and clinical performance," implying prospective data collection for the clinical part.

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

This section is not applicable to this type of device. The ground truth for INR measurements in this context is established by a reference laboratory method (venous plasma INR on an ACL 10000 analyzer) rather than expert consensus/adjudication of images or clinical assessments.

4. Adjudication method for the test set

This is not applicable (see point 3). The comparison is between the device's measurement and a laboratory reference measurement, not a subjective interpretation requiring 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

This is not applicable. The SmartCheck INR System is a diagnostic device that measures a biomarker (INR); it is not an AI-assisted diagnostic tool for human readers/interpreters, nor does it involve "readers" in the traditional sense of interpreting images or other complex data.

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

Yes, the accuracy and precision studies described represent the standalone performance of the SmartCheck INR system. The device itself provides the INR value, and its performance is evaluated directly against a reference method (accuracy) and internally (precision). There is no "human-in-the-loop" interpretation of the device's primary output. The human interaction is limited to operating the device and applying the blood sample.

7. The type of ground truth used

The ground truth used for the accuracy study was the venous plasma INR results obtained from an ACL 10000 laboratory analyzer using recombinant thromboplastin (recTP), PTHS+ reagent, and PT/Fibrinogen reagent (PT/Fib). This is a well-established, objective laboratory reference method for INR measurement.

8. The sample size for the training set

The document does not report a separate training set sample size. This is typical for a device like the SmartCheck INR, which uses a pre-defined chemical and mechanical detection method rather than a machine learning or AI algorithm that requires a distinct training phase on clinical data. The calibration of the device would likely be done internally and validated through the clinical studies presented here.

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

As there's no explicitly mentioned training set in the context of machine learning, this question is not directly applicable. For devices that are calibrated, the "ground truth" for calibration would be established by standardized reference materials and methods during manufacturing and internal testing, ensuring accuracy across the device's operating range before clinical evaluation.

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The Albumin Cobalt Binding Test (ACB®) Assay Verification Set (AVS) is intended for use in verifying the accuracy of the ACB Test on the Roche INTEGRA 700/800, the Roche/Hitachi 917 and the Roche MODULAR P. It is recommended as part of assay installation. For In Vitro Diagnostic Use

The Assay Verification Set consists of twenty (20) single vial 0.5 mL aliquots of frozen serum based samples with assigned IMA values over the physiological range.

The Inverness Medical Innovations, Inc. Albumin Cobalt Binding Test (ACB®) Assay Verification Set (AVS) is a quality control material intended for verifying the accuracy of the ACB Test on specific Roche clinical analyzers (INTEGRA 700/800, Roche/Hitachi 917, and Roche MODULAR P). The provided documentation describes its intended use and a general statement about its performance, but lacks specific details on the acceptance criteria and the comprehensive study design, results, and ground truth establishment typically associated with a detailed device validation study.

Here's an attempt to extract and infer information based on the provided text, while also highlighting what is not explicitly stated in the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The specific numerical acceptance criteria (e.g., target ranges, allowable percentage deviation from assigned values, precision requirements) are not detailed in the provided text. The statement "using revised acceptance criteria" further implies that such criteria exist but are not disclosed.

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

• Sample Size: The Assay Verification Set consists of "twenty (20) single vial 0.5 mL aliquots of frozen serum based samples." This represents the test set (the verification set itself).
• Data Provenance: The testing was conducted "internally and at multiple clinical sites." The country of origin for the data is not specified. The study appears to be prospective in nature, as it's described as an evaluation for range setting values and performance verification.

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

• Not explicitly stated. The document mentions the samples have "assigned IMA values over the physiological range." The method and number of experts/assigners for these values are not detailed.
• Qualifications of Experts: Not explicitly stated.

4. Adjudication Method for the Test Set

• Not explicitly stated. The document refers to "assigned IMA values," implying that a definitive value exists for each sample. How these values were agreed upon if multiple assessments were involved (e.g., 2+1, 3+1 consensus) is not described.

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

• No, an MRMC study was NOT done. This device is a quality control material, not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation. The study focuses on the device's ability to verify the accuracy of an assay on an analyzer.

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

• Yes, effectively a "standalone" evaluation of the AVS was done. The study evaluated how the AVS performed on various clinical analyzers to verify the accuracy of the ACB Test. This is an assessment of the AVS's performance as a material without direct human interaction interpreted for diagnostic purposes. It's about the material's consistency and its ability to challenge the analytical system.

7. The Type of Ground Truth Used

• The ground truth for the AVS samples is the "assigned IMA values." These are likely reference values established through a highly accurate and precise analytical method, often using calibrated reference materials or methods with known traceability. This would be a form of expert consensus/reference method data for the chemical properties of the control material.

8. The Sample Size for the Training Set

• Not applicable. This device is a quality control material, not a machine learning model or algorithm that requires a "training set" in the conventional sense. The "test set" described (the 20 vials) serves as the entirety of the AVS product itself that is being validated.

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

• Not applicable, as there is no training set for this type of device. The "assigned IMA values" for the AVS samples (which serve as the ground truth for performance verification) would have been established through a rigorous process of analytical measurement, often involving multiple runs on a reference instrument and statistical analysis, possibly with certified reference materials. The exact method is not detailed.

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The Ischemia ACB® Assay Verification Set is intended for use in verifying accuracy of the ACB Test on the Roche Integra 700/800. It is recommended as a part of assay installation. For In Vitro Diagnostic Use.

The Assay Verification Set consists of twenty (20) single vial 0.5 mL aliquots of frozen serum based samples with assigned IMA values over the physiological range.

This looks like a submission for a "Quality Control Material" device, not an AI or imaging device. The provided text describes a verification set for an assay, which is a laboratory test. Therefore, many of the requested fields are not applicable to this type of device.

However, I can extract the relevant information where possible:

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

The document does not explicitly state formal "acceptance criteria" with numerical targets for the Assay Verification Set itself. Instead, it describes its intended use for verifying the accuracy of another device (the ACB Test) and its characteristics.

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

• Sample size: The device itself is the "test set" and consists of "twenty (20) single vial 0.5 mL aliquots of frozen serum based samples."
• Data provenance: Not specified, but the evaluation was done "internally and at multiple clinical sites."

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 quality control material with "assigned IMA values." These values are likely laboratory-derived and not based on expert consensus in the way a diagnostic imaging device would be.

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

Not applicable. "Adjudication" typically refers to the process of resolving disagreements among experts when establishing ground truth, which is not relevant for a quality control material with assigned values.

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 quality control material, not an AI or imaging device that would involve human readers or AI assistance.

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

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

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

The ground truth for this device is described as "assigned IMA values over the physiological range." This implies laboratory-determined values for the components of the serum samples.

8. The sample size for the training set

Not applicable. This device is a quality control material, not a machine learning model that requires a training set.

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

Not applicable. As above, this device does not have a training set in the context of machine learning.

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The Ischemia Albumin Cobalt Binding Test (ACB®) is a quantitative in vitro diagnostic test used on human serum that detects Ischemia Modified Albumin (IMA™) by measuring the cobalt binding capacity of albumin in human serum. IMA is intended for use in conjunction with ECG and cardiac troponin as an aid to the short term risk stratification of patients presenting with chest pain suggestive of cardiac origin.

Thus, in patients with chest pain or equivalent symptoms suggestive of cardiac origin, with non-diagnostic ECG and normal troponin, a negative IMA can be used as an aid to rule out Acute Coronary Syndrome (ACS) in low risk patients.

The safety and effectiveness of this device for use in patients with potential Acute Coronary Syndrome (ACS) with negative ECG; or positive ECG; or positive ECG combined with negative, low, or normal troponin levels; or positive troponin levels also has not been established. IMA results do not correlate with blood flow and in the event of a positive IMA, ECG, or troponin test result, could be misleading as either ruling in or ruling out ACS.

The Ischemia ACB® Test measures the cobalt binding capacity of albumin in a serum specimen. Cobalt is added to serum and allowed to react. Dithiothreitol (DTT), a colorimetric indicator, is added to the reacted specimen and the degree of color formation is detected spectrophotometrically on clinical chemistry analyzers.

In normal patients, cobalt binds at the N-terminus of albumin leaving little cobalt to react with DTT and form a colored product. In serum of patients with ischemia, cobalt does not bind to the metal binding sites leaving more free cobalt to react with DTT and form a darker color.

Here's a breakdown of the acceptance criteria and study information for the Ischemia Albumin Cobalt Binding Test (ACB® Test), based on the provided documents:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds). Instead, it lists the types of verification/validation testing performed. The "reported device performance" would be the results obtained from these tests, which are not detailed in this submission.

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

The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "patients presenting with chest pain suggestive of cardiac origin" for the intended use.

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

This information is not available in the provided document.

4. Adjudication Method for the Test Set

This information is not available in the provided document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an in-vitro diagnostic test for a biomarker, not an imaging or diagnostic device requiring human reader interpretation in the same way. The intended use is "in conjunction with ECG and cardiac troponin as an aid to the short-term risk stratification of patients."

6. Standalone (Algorithm Only) Performance Study

The Ischemia Albumin Cobalt Binding Test (ACB® Test) is an in-vitro diagnostic test that measures the cobalt binding capacity of albumin. While it's a quantitative test and can be run on clinical chemistry analyzers, it's not an "algorithm only" device in the sense of AI-driven image analysis or decision support. Its performance is inherent to the chemical reaction and measurement, not a separate algorithm. The "standalone performance" is implicitly covered by the "Typical Calibration Curve, Linearity, Sensitivity, Precision, Test Method Comparison, On Board Component Stability, Specificity, and Interfering Substances" testing.

7. Type of Ground Truth Used

For diagnostic tests like this, the "ground truth" would typically refer to the clinical diagnosis of Acute Coronary Syndrome (ACS) established by a combination of clinical assessment, ECG, cardiac troponin levels, and potentially other diagnostic procedures (e.g., angiography, outcomes data). The document itself does not specify how the ground truth was established for the study cohort, but mentions its use "in conjunction with ECG and cardiac troponin as an aid to the short-term risk stratification of patients presenting with chest pain suggestive of cardiac origin." The negative IMA result is used to "rule out Acute Coronary Syndrome (ACS) in low risk patients" with non-diagnostic ECG and normal troponin.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. For an in-vitro diagnostic device, this would typically refer to the samples used during development and optimization of the assay. This information is not provided.

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

As there is no explicit mention of a "training set" in the AI/ML context, this information is not applicable and not provided in the document. The development processes for chemical assays involve different methodologies for optimizing performance and establishing reference ranges.

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The InDuo™ Blood Glucose Meter is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The InDuo™ meter is intended for use outside the body ( in vitro diagnostic use) by healthcare professionals and by diabetics at home as an aid to monitor the effectiveness of diabetes control.

The InDuo™ Blood Glucose Meter also functions as the cap for the InDuo™ Insulin Doser. The two devices fit together to form a single unit for user convenience.

The InDuo™ Blood Glucose Meter is a Class II Device for home use, as per 21 CFR § 862.1345. The changes made to the meter were done under design controls, and include ergonomic changes to allow for inclusion of the InDuo™ Insulin Doser to form a single unit for user convenience. The modified device has the same technological characteristics as the legally marketed predicate. The InDuo™ Blood Glucose Meter also functions as the cap for the InDuo™ Insulin Doser. The two devices fit together to form a single unit for user convenience.

The provided 510(k) summary for the InDuo™ Blood Glucose Meter states that "Laboratory and clinical studies demonstrate that the InDuo™ Blood Glucose Meter provides equivalent performance to the ONE TOUCH® Ultra™ Blood Glucose Meter." However, it does not explicitly detail the acceptance criteria or the specific results from these studies. It only makes a general claim of equivalence to a predicate device (K002134).

Therefore, based solely on the provided text, many of the requested details cannot be extracted as they are not present.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated in the provided text. The submission claims "equivalent performance" to the predicate device, but the specific metrics for this equivalence (e.g., accuracy percentages, standard deviations) are not provided.

Reported Device Performance: Not explicitly stated in the provided text. The submission claims "equivalent performance" to the ONE TOUCH® Ultra™ Blood Glucose Meter, but no specific performance statistics (e.g., accuracy, precision, bias) are given for the InDuo™ meter.

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

Sample Size: Not specified in the provided text.
Data Provenance: Not specified in the provided text. It mentions "Laboratory and clinical studies," which implies prospective data collection, but no details on country of origin are given.

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

Not specified in the provided text. For a blood glucose meter, the "ground truth" would likely come from a reference laboratory method (e.g., YSI analyzer), not expert consensus.

4. Adjudication Method for the Test Set

Not applicable/specified in the provided text. Adjudication methods are typically used in studies where human interpretation of medical images or other subjective data is involved. For a blood glucose meter, the "ground truth" is typically an objective lab measurement.

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

Not applicable. MRMC studies are relevant for medical imaging devices where multiple readers interpret cases. This is a blood glucose meter.

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

This is a standalone device (blood glucose meter). Its performance would inherently be "standalone" in how it measures glucose from a blood sample. The "human-in-the-loop" aspect would be the user performing the test, but the device's measurement function is automated. The document implies a standalone performance comparison to a predicate device.

7. The Type of Ground Truth Used

Not explicitly stated in the provided text. For blood glucose meters, the ground truth is typically established by reference laboratory methods (e.g., YSI glucose analyzer) that are considered the gold standard for glucose measurement.

8. The Sample Size for the Training Set

Not applicable/specified. This type of device (blood glucose meter) does not typically have a "training set" in the context of machine learning algorithms. Its design and calibration are based on established chemical and electrical engineering principles, not adaptive learning from data.

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

Not applicable. See point 8.

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