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The ACCU-CHEK Inform II Test strip is for use with the ACCU-CHEK Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heelstick, or fresh capillary whole blood samples drawn from the fingertip as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.

The ACCU-CHEK Inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices.

The ACCU-CHEK Inform II Controls are intended for quality control performance checks on the ACCU-CHEK Inform II system with ACCU-CHEK Inform II test strips.

The ACCU-CHEK Inform II Linearity Test Kit is intended for use for periodic verification of linearity of the ACCU-CHEK Inform II system using ACCU-CHEK Inform II test strips.

No technological, material, performance, or design changes to the ACCU-CHEK Inform II System have been implemented since its clearance on K121679.

Thus, the Device Description for the ACCU-CHEK Inform II System remains the same as that presented and cleared in K121679.

This submission deals only with the performance of Super Sani-Cloth wipes for the effective cleaning and disinfection of the ACCU-CHEK Inform II System housing and components.

Please note that we intend to modify the ACCU-CHEK Inform II System labeling by adding the Super Sani-Cloth for cleaning and disinfection of the system, in addition to the Clorox Germicidal Wipes, which were previously cleared for this purpose on K121679. The Super Sani-Cloth will not replace the current Clorox Germicidal Wipe. Both wipes will be included in the product labeling.

This 510(k) submission (K130138) is a "Special 510(k)" for a claim extension to the existing ACCU-CHEK® Inform II System. The purpose is to add another cleaning and disinfecting product, Super Sani-Cloth® wipes, for use with the device. Therefore, the acceptance criteria and study described focus on the effectiveness of the Super Sani-Cloth wipes for cleaning and disinfection, not on the glucose monitoring performance of the ACCU-CHEK Inform II System itself.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document states the test was performed on "the same six distinct components of the ACCU-CHEK Inform II System," but it does not specify the number of individual devices or components tested, nor the number of cleaning/disinfection cycles.
• Data Provenance: The document implies this was a prospective study conducted by Roche Diagnostics Corporation, as they are submitting the results. The country of origin is not explicitly stated, but the company is based in Indianapolis, IN, USA.

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

This information is not provided in the document. The "ground truth" here would relate to the assessment of cleanliness and disinfection efficacy, which would typically be determined by laboratory methods (e.g., microbial cultures, visual inspection for cleanliness) rather than expert human interpretation in the context of device performance.

4. Adjudication method for the test set

This information is not provided in the document, as the evaluation likely involved quantitative laboratory measurements rather than human reader 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

There was no MRMC comparative effectiveness study done. This submission is about the efficacy of a cleaning/disinfecting wipe, not an AI-assisted diagnostic tool.

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

A "standalone" study in the typical sense of algorithm performance was not done. The study evaluated the standalone performance of the Super Sani-Cloth wipes in cleaning and disinfecting the device components, according to a defined protocol. There is no algorithm involved.

7. The type of ground truth used

The ground truth used would be based on laboratory standards and measurements for cleaning efficacy (e.g., visual cleanliness, gravimetric analysis if applicable) and disinfection efficacy (e.g., reduction in microbial load according to established disinfectant testing standards). While the specific methods aren't detailed, "All components passed the cleaning and disinfection test protocol, based on the defined criteria" indicates adherence to such objective measures.

8. The sample size for the training set

There is no training set in the context of this submission. This is a validation study for a cleaning product, not a machine learning model.

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

As there is no training set, this question is not applicable.

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The Elecsys CA 19-9 CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys CA 19-9 reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use only.

The Elecsys CA 19-9 CalCheck 5 is a lyophilized product consisting of human CA 19-9 in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

This document describes the Elecsys CA 19-9 CalCheck 5, an assayed control for use in calibration verification and assay range verification for the Elecsys CA 19-9 reagent on Elecsys and cobas e immunoassay analyzers.

Here's an analysis based on the provided text, addressing your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative manner for the performance study. Instead, it states that the device "was evaluated for value assignment and stability." The reported performance is the established "Check Target Values" for each of the five levels of the CalCheck. These values essentially act as the performance targets that the control material is designed to demonstrate when used with the Elecsys CA 19-9 reagent.

Since specific performance metrics like accuracy, precision, or recovery rates against acceptance limits are not provided in the summary, the table below reflects what is available.

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

The document does not specify the sample size used for the performance evaluation of value assignment and stability. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the nature of a 510(k) summary for an in vitro diagnostic control, it's highly likely to be prospective testing performed by the manufacturer, but this is not explicitly stated.

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

This information is not provided in the document. For a control material like this, the "ground truth" (i.e., the target values) would typically be established through highly precise and accurate measurement methods by the manufacturer during the production and analytical characterization of the control lots, rather than by external experts in the same way, for instance, a diagnostic imaging AI might use clinical experts.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The development of target values for a quality control material involves robust analytical methods and statistical analysis by the manufacturer, not a consensus or adjudication process involving multiple external experts.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human interpretation is involved (e.g., radiology AI). The Elecsys CA 19-9 CalCheck 5 is an in vitro diagnostic control material, and its performance is assessed analytically, not through human reader interpretation.

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

This question is not directly applicable in the terms usually associated with AI or imaging devices. The Elecsys CA 19-9 CalCheck 5 itself is a physical control material, not an algorithm. Its performance is assessed as a standalone product (i.e., its ability to yield expected results when measured by the Elecsys CA 19-9 assay) in laboratory settings. The document states it was "evaluated for value assignment and stability," which implies such standalone analytical performance testing was conducted.

7. The Type of Ground Truth Used

The "ground truth" for the Elecsys CA 19-9 CalCheck 5 is the assigned target values for each of its five levels, along with its established stability characteristics. These values are determined by the manufacturer (Roche Diagnostics) through their internal analytical methods and quality control processes during the development and manufacturing of the control material. It is a form of analytical reference standard determination.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical control material, not an AI algorithm that requires a training set.

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

This information is not applicable for the reasons stated in point 8.

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The cobas 8000 Modular Analyzer Series is a fully automated system for clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit. It is intended for use in conjunction with certain materials to measure a variety of analytes that may bbe adaptable to the below analyzers depending on the reagents used.

The cobas c701 analyzer is a fully automated, discrete clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.

The cobas c502 analyzer is a fully automated discrete clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.

The cobas 8000 ISE module is a fully automated ion- specific analyzer intended for the in vitro potentiometric determination of chloride, potassium and sodium in serum and plasma using ion-selective electrodes. Measurements obtained by this device are used in the diagnosis and treatment of diseases or conditions involving electrolyte imbalance.

IGA-2 is an in vitro test for the quantitative determination of IgA in human serum and plasma on Roche/Hitachi cobas c systems. IgA measurements aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

The cobas 8000 Modular Analyzer Series is a fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (cobas 8000 ISE module) and photometric analysis modules (cobas c 701 and c 502 modules). The cobas c 701 and c 502 analyzer modules are new members of the Roche / Hitachi family of clinical chemistry analyzers.

The cobas 8000 ISE module is an Ion-selective electrode system for the determination of sodium, potassium and chloride in serum and plasma.

The cobas c 701 module is a fully automated, discreet, computerized instrument for in vitro tests on a wide range of analytes. It is designed to use serum/plasma, urine, CSF supernatant and whole blood sample types. The related sample buffer module offers a random access buffer function for samples.

The cobas c 502 module is analytically identical to the cobas c 501 module (cobas 6000 analyzer series. K060373), but without an integrated ISE module. The related sample buffer module offers a random access buffer function for samples.

The cobas 8000 Data Manager acts as a command/control center between the cobas 8000 instrument and the LIS. The data manager software is installed on a PC. It also provides enhanced sample tracking, test management, result traceability, storage and reporting, quality control and calibration management, has LIS backup functionality and serves as a robust storage location for the instrument.

The control unit uses a graphical user interface to control all instrument functions, and is comprised of a touch screen monitor, keyboard and mouse and a personal computer.

The core unit is comprised of several components that manage conveyance of samples to each assigned analytical module. The actual composition of the core unit depends on the configuration of the analytical modules. Features of the Core Unit include a barcode reader (for racks and samples), automatic tube position if barcode position is misaligned, system power switch and circuit breaker, the sample rack loader/unloader, a STAT port, a water supply and a system interface port.

The Roche cobas 8000 Modular Analyzer Series is a fully automated system for clinical chemistry analysis. The submission focuses on modifications to the predicate device (cobas 6000 Analyzer Series).

1. Acceptance Criteria and Reported Device Performance

The device's performance was evaluated through application testing based on a risk analysis. While specific quantitative acceptance criteria are not explicitly detailed for each test, the general statement is that "All testing met specifications." This implies that the observed performance was acceptable for each parameter.

Here’s a table summarizing the tests and the reported performance (where available):

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

The document does not explicitly state the numerical sample sizes used for the test set. However, it mentions that "application testing done on the cobas c701 and c502, using IgA as a representative assay," and that Sodium, Potassium, and Chloride were also tested.

The data provenance (country of origin, retrospective or prospective) is not specified. However, given that it's a submission to the FDA, the testing would likely have been conducted in a controlled, prospective manner to evaluate the new device's performance, potentially at Roche Diagnostics development sites or clinical study sites.

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

This information is not provided in the document. The type of ground truth used is clinical measurements from established methods (predicate device, flame photometry for Sodium/Potassium, coulometry for Chloride). The interpretation of "ground truth" in this context refers to the values obtained from these established reference methods, rather than expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the study involves analytical performance comparison rather than subjective assessment needing adjudication (like image interpretation). The "ground truth" is based on instrument readings from established methods.

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

An MRMC comparative effectiveness study was not performed as this device is a chemistry analyzer and its performance is assessed by analytical accuracy and precision, not by human reader interpretation of results.

6. Standalone (Algorithm Only) Performance

This entire submission describes the standalone performance of the instrument. The cobas 8000 Modular Analyzer Series is an automated system designed to run without human intervention during the analytical process, once samples and reagents are loaded. The results are generated by the algorithm/instrument directly.

7. Type of Ground Truth Used

The ground truth for the test set was established using recognized reference methods and performance of the predicate device:

• For IgA: Method comparison was performed against the cobas c501 (predicate device).
• For Sodium, Potassium: Method comparison was performed against the cobas c501 (predicate device) and flame photometry. Flame photometry is a well-established analytical technique for determining the concentration of certain metal ions.
• For Chloride: Method comparison was performed against the cobas c501 (predicate device) and coulometry. Coulometry is a precise electroanalytical technique used for quantitative determination of substances.

These are considered objective, analytical measurements from established laboratory techniques.

8. Sample Size for the Training Set

The document does not provide information regarding a specific "training set" or its sample size. This type of device (clinical chemistry analyzer) is typically developed and validated against established analytical principles and reference methods, rather than being "trained" on a dataset in the way a machine learning algorithm would be. The "training" in this context would implicitly refer to the development and optimization process based on chemical and physical principles, rather than an explicit dataset.

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

As no explicit training set is mentioned in the context of machine learning, the concept of "ground truth for the training set" as it would apply to AI is not applicable. The development and "training" of this device would involve engineering, chemical, and physical principles, with performance validated against known standards, calibrators, and reference methods as described in point 7.

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ACCU-CHEK® Ultraflex is an infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps.

The ACCU-CHEK® Ultraflex is a disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The unit is designed to interface with commercially available insulin infusion pumps with suitable connections. The insulin infusion pump systems are designed to control the delivery of insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus.

This 510(k) summary describes a re-submission for an existing device, the ACCU-CHEK® Ultraflex infusion set. The submission is for minor design modifications due to a transfer of manufacturing to a new manufacturer, Unomedical A/S. As such, the study conducted is primarily for functional equivalence rather than a full de novo clearance.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "in vitro functional testing" and "Biocompatibility testing" but does not specify the sample sizes used for these tests. The data provenance is implied to be from the manufacturer (Roche Diabetes Care AG and Unomedical A/S) but no country of origin for the test data is explicitly stated. The studies are essentially retrospective in the sense that they are to re-validate an existing product with minor modifications.

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

Not applicable. This device is an infusion set, and the "ground truth" for its performance is based on engineering specifications and laboratory testing, not expert interpretation of medical images or clinical outcomes that would require expert consensus.

4. Adjudication Method for the Test Set

Not applicable. As described above, the evaluation is based on functional and biocompatibility testing against predefined specifications, not on expert adjudication of clinical data.

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

No. This type of study is not relevant for an infusion set as it's not a diagnostic imaging or interpretive aid where human readers' performance is being evaluated. The document explicitly states: "Human clinical studies were not deemed necessary to evaluate the safety or effectiveness of the ACCU-CHEK® Ultraflex infusion set."

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

Yes, in a sense. The functional and biocompatibility testing represents a standalone evaluation of the device's physical and material properties against specifications, without human intervention in the device's functional assessment. It's not a software algorithm, but the principle of standalone evaluation applies to the hardware.

7. The Type of Ground Truth Used

The ground truth used is based on predefined engineering specifications and biocompatibility standards. The device is tested to ensure it meets these established technical and safety requirements.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device, so there is no training set in the conventional sense. The "training" for such a device would be its initial design and manufacturing process validation.

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

Not applicable, as there is no training set for an AI/ML algorithm. The "ground truth" for the device's design and manufacturing is established through engineering design principles, material science, and regulatory standards for medical devices of this type.

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Amphetamines II (AMPII) is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamines and methamphetamines in human urine on COBAS INTEGRA systems at cutoff concentrations of 300 ng/mL, 500 ng/mL and 1000 ng/mL when calibrated with a-methamphetamine. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Semiquantitative assays are intended to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC/MS).

Amphetamines II provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.1 Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The Amphetamines II test is an immunoassay for use on automated clinical chemistry analyzers. The device consists of two wet reagents; a soluble drug-conjugate, and an antibody-bound microparticle solution. During the assay, in the absence of sample drug in urine, soluble drug-conjugates bind to antibody-bound microparticles, causing the formation of particle aggregates. When a urine sample contains the drug in question, this drug competes with the drug derivative conjugate for microparticle-bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. The rate of absorbance change is proportional to the concentration of drug in the sample. Calibrators, ranging in concentration from 0-5000 ng/mL depending on cutoff and test mode, are run with the assay. Concentrations of controls and unknowns are calculated from the standard curve in semi-quantitative mode. Results for controls or calibrators are determined as preliminary positive or negative relative to the cutoff in qualitative mode.

C.f.a.s. DAT Qualitative Clinical, C.f.a.s. DAT Qualitative Plus, C.f.a.s. DAT Qualitative Plus Clinical, Preciset DAT Plus I Calibrators, and Preciset DAT Plus II Calibrators are ready to use, multianalyte calibrators prepared by the quantitative addition of drug or drug metabolite to drug-free human urine.

Control Set DAT I, II, and III, and Control Set DAT Clinical are ready to use multianalyte controls prepared by the quantitative addition of drug or drug metabolite to drug-free urine.

Here's an analysis of the provided text regarding the Amphetamines II Assay, structured to address your specific points:

The provided document describes the Amphetamines II Assay for Integra Family of Analyzers, an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamines and methamphetamines in human urine. The device's performance is primarily evaluated through precision and accuracy studies against Gas Chromatography/Mass Spectrometry (GC/MS).

1. Table of Acceptance Criteria and Reported Device Performance

The general acceptance criteria for this type of immunoassay are implicit in the performance studies: accurate detection of amphetamines/methamphetamines in urine relative to established cutoffs, with good precision and minimal interference from other substances. The detailed criteria would typically be established internally by the manufacturer and submitted to regulatory bodies.

Here's a summary of the stated performance, interpreted against general expectations for such assays:

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

• Precision Test Set Sample Size:
  • For each cutoff (300, 500, 1000 ng/mL) and each drug (d-methamphetamine, d-amphetamine): 9 concentrations were tested.
  • Each concentration was tested in 2 replicates per run, 2 runs per day for 21 days.
  • Total N = 84 determinations per concentration level. (e.g., 9 concentrations * 84 determinations = 756 total determinations per drug per cutoff for precision).
  • Data Provenance: "9 samples obtained from a human urine sample pool" for initial spiking. The source of this urine pool is not specified (e.g., country of origin). This was a retrospective study measuring inherent characteristics of the assay.
• Accuracy Test Set Sample Size:
  • Negative Samples: 36 urine samples confirmed negative by GC/MS.
  • Positive Samples: 36 samples confirmed positive by GC/MS (containing d-methamphetamine or d-amphetamine).
  • Near Cutoff Samples: For each cutoff, 4 negative near cutoff samples and 4 positive near cutoff samples were assayed.
  • 4 additional unaltered samples (d-methamphetamine, 85-204 ng/mL) evaluated with 500 ng/mL cutoff.
  • Data Provenance: "samples obtained from a clinical laboratory" and "unaltered near cutoff samples." Geographic origin is not specified. This was a retrospective study comparing the device to a gold standard.
• Analytical Specificity Test Set Sample Size: Not explicitly stated as a count of individual samples, but inhibition curves were generated for each of the many tested compounds.
• Interference Test Set Sample Size: Not explicitly stated as a count of individual samples, but various compounds were added to urine pools at specified concentrations. This appears to be a laboratory retrospective study.

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

• The ground truth for the test set (accuracy study) was established by Gas Chromatography/Mass Spectrometry (GC/MS).
• This method is explicitly stated as "the preferred confirmatory method" and the device's traceability is stated as "Traceability: This method has been standardized against GC/MS."
• There is no mention of human expert involvement in establishing the ground truth; it relies on the analytical capabilities of GC/MS. Therefore, qualifications of human experts for ground truth are not applicable in this context.

4. Adjudication Method for the Test Set

• Adjudication methods like 2+1 or 3+1 typically apply to studies where human readers interpret data, and discrepancies need to be resolved.
• In this context, the device's results are compared directly to the quantitative results from GC/MS. There is no human interpretation of the device's output or a need for expert adjudication of "truth" beyond the GC/MS result itself. Therefore, no adjudication method as described (e.g., 2+1) was used or is applicable.

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

• No, an MRMC comparative effectiveness study was not done.
• This device is an automated immunoassay for analytical detection, not a system designed to assist human readers in a diagnostic task (e.g., interpreting medical images). Therefore, a study comparing human readers with and without AI assistance is not relevant to this device.

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

• Yes, this entire submission details standalone (algorithm only) performance.
• The Amphetamines II Assay is an automated in vitro diagnostic test run on COBAS INTEGRA systems. Its performance data (precision, accuracy, specificity, interference) are all based on the analytical capabilities of the instrument and reagents without human intervention in the result determination process. Human involvement would be limited to operating the analyzer, reviewing quality control, and interpreting the final preliminary positive/negative result in a clinical context (which the device explicitly states should be followed by GC/MS confirmation and professional judgment).

7. The Type of Ground Truth Used

• The primary ground truth used for the accuracy study was Gas Chromatography/Mass Spectrometry (GC/MS) results. This is a highly accurate and specific analytical method, often considered the "gold standard" for drug confirmation in toxicology.
• For precision and some interference studies, spiked urine samples with known concentrations of d-methamphetamine or d-amphetamine were used, where the known concentration is the ground truth.

8. The Sample Size for the Training Set

• The document does not mention a training set sample size.
• This is an immunoassay, not a machine learning or AI-based diagnostic tool that typically requires a large training set. The "training" of such a system involves the development and optimization of the reagents and assay parameters by the manufacturer, rather than a data-driven training process in the sense of machine learning.

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

• As a traditional immunoassay, there is no explicit "training set" in the machine learning sense.
• The development of the assay's reagents, antibody specificity, and reaction conditions would have been guided by extensive biochemical research and experimentation to ensure specific binding and accurate signal generation across the desired concentration range. The "ground truth" during this development (or "training") phase would be the known concentrations of target analytes and interfering substances used to optimize the assay's performance characteristics. This is an iterative process of development and validation, rather than a single training set with established ground truth.

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The Elecsys Insulin CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Insulin reagent on the indicated Elecsys and cobas e immunoassay analyzers.

The Elecsys Insulin CalCheck 5 is a lyophilized product consisting of recombinant human insulin in bovine serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

The provided text is a 510(k) summary for the Elecsys® Insulin CalCheck 5. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval for a quality control material, not a diagnostic device with performance metrics like sensitivity, specificity, or accuracy for diagnosing a condition.

Therefore, the information typically requested in your prompt (e.g., acceptance criteria for diagnostic performance, sample size for test sets with ground truth, MRMC studies, standalone algorithm performance) is not applicable to this type of device and submission.

Here's a breakdown of why and what information is provided:

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

• Acceptance Criteria: Not explicitly stated in terms of diagnostic performance. For a quality control material, acceptance criteria would typically relate to its manufacturing consistency, stability, and its ability to challenge the assay within expected ranges.
• Reported Device Performance: The primary "performance" studied and reported here is related to value assignment and stability. The document states: "The Elecsys Insulin CalCheck 5 was evaluated for value assignment and Performance Characteristics stability." However, specific numerical results or acceptance ranges for these evaluations are not detailed in the provided 510(k) summary. The conclusion simply states that the data demonstrates "substantially equivalent" performance to the predicate.

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

• Not Applicable. As a quality control material, there isn't a "test set" of patient data for diagnostic evaluation. The evaluations would involve laboratory experiments to assess the material itself. The document does not specify the number of lots or experimental runs used for value assignment or stability studies.
• Data Provenance: Not specified, but the manufacturer is Roche Diagnostics (Indianapolis, IN, USA).

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. Ground truth, in the context of diagnostic performance, is not relevant for a quality control material.

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

• Not Applicable. No test set for diagnostic performance is involved.

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 a quality control material, not an AI-assisted diagnostic device.

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

• Not Applicable. This is not an algorithm or AI device.

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

• Not Applicable.

8. The sample size for the training set:

• Not Applicable. This is not an algorithm or AI device that requires "training data."

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

• Not Applicable.

In summary, for K101075 (Elecsys® Insulin CalCheck 5):

The submission is for a quality control material used for calibration verification and assay range verification. The study focused on demonstrating "substantial equivalence" of its "value assignment and Performance Characteristics stability" to a previously cleared predicate device (Elecsys HCG+β CalCheck 5). The detailed technical data from these evaluations (e.g., specific stability curves, results of value assignment studies) is not included in the provided 510(k) summary, only the general conclusion of equivalence.

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Immunoassay for the in vitro quantitative determination of testosterone in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.

Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and androgenital syndromes.

The Elecsys Testosterone II immunoassay is based on a competitive test principle with streptavidin-coated microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve provided with the reagent bar code. The Elecsys Testosterone II reagent kit consists of a Reagent Pack (R1, R2, and M[Streptavidin-coated microparticles]).

The Elecsys® Testosterone II Immunoassay is a device for the in vitro quantitative determination of testosterone in human serum and plasma using electrochemiluminescence immunoassay (ECLIA). The study provided focuses on establishing substantial equivalence to a predicate device (Elecsys® Testosterone Assay, K964889) through method comparison tests and performance characteristic comparisons.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical format that must be met (e.g., "slope must be between 0.9 and 1.1"). Instead, it demonstrates performance through regression analysis and comparisons to the predicate device and reference methods. The implicit acceptance is that the Elecsys® Testosterone II Assay performs comparably to the predicate device and accurately against reference standards.

The table below summarizes the key performance characteristics and method comparison results for the Elecsys® Testosterone II Assay as described:

Acceptance Criteria (Implied):
While not explicitly stated as numerical acceptance criteria, the strong correlation coefficients (close to 1.0) and slopes (close to 1.0) and small y-intercepts in the regression analyses, coupled with low CVs for precision, indicate the device is performing comparably to both reference methods and the predicate device across its measuring range. This demonstrates that the new device is substantially equivalent to the legally marketed predicate.

2. Sample Sizes and Data Provenance

The studies are quantitative performance analyses of an in vitro diagnostic device, not human reader studies for image-based AI. Therefore, the "test set" concept here refers to the clinical samples used for method comparison.

• Test Set (Method Comparison):
  • Study 1: 52 serum samples
  • Study 2: 55 serum samples
  • Study 3: 142 female serum samples
  • Study 4: 239 male and 148 female serum samples (total 387)
• Data Provenance: Not explicitly stated, but the submission is from Roche Diagnostics, based in Indianapolis, IN, indicating a US-based submission. The nature of in vitro diagnostic device studies typically involves clinical samples, likely collected from various clinical sites. The document does not specify if the data is retrospective or prospective, but based on the type of study (method comparison), it would involve testing collected samples.

3. Number of Experts and Qualifications for Ground Truth

This is not applicable as the device is an immunoassay for quantitative determination of testosterone. The "ground truth" is established by highly accurate reference methods (ID-GC/MS and validated ID/LC-MS/MS), not by human experts interpreting data or images.

4. Adjudication Method

Not applicable. Adjudication methods (e.g., 2+1) are typically used for establishing ground truth in clinical evaluations involving subjective expert interpretation (like radiology reads). For quantitative assays, ground truth is based on objective measurements from reference methods.

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

Not applicable. This is an immunoassay device, not an AI or imaging device that would involve human readers.

6. Standalone (Algorithm Only) Performance

Yes, the studies evaluate the standalone performance of the Elecsys® Testosterone II Immunoassay. The assay directly measures testosterone levels, and its performance is assessed by comparing its results against established reference methods and the predicate device. There is no "human-in-the-loop" once a sample is loaded into the analyzer for the measurement itself.

7. Type of Ground Truth Used

The ground truth for the test set (method comparison studies) was established using:

• ID-GC/MS (Isotope Dilution Gas-Chromatography/Mass Spectrometry): This is considered a gold standard reference method for testosterone measurement, providing highly accurate and precise quantitative values.
• Validated ID/LC-MS/MS (Isotope dilution/liquid chromatographic-tandem mass spectrometry): This method was validated against the ID-GC/MS reference method and used as a highly accurate comparison method.

8. Sample Size for the Training Set

The document does not specify a "training set" in the context of machine learning. For an immunoassay, the concept of a training set typically refers to samples used during the development and optimization of the assay's reagents and calibration parameters. This information is usually proprietary to the manufacturer and not detailed in a 510(k) summary, which focuses on validation studies proving performance for regulatory submission.

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

As there's no explicitly defined "training set" in the provided document, the method for establishing its ground truth is not detailed. However, for an immunoassay, the development process would involve extensive use of characterized calibrators and controls, often traceable to international reference standards, to establish the assay's curve and ensure accurate measurement across its range. These calibrators would be assigned values using highly accurate reference methods (like ID-GC/MS) similar to those used for the test set ground truth.

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The Elecsys Troponin T CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Troponin T reagent on the indicated Elecsys and cobas e immunoassay analyzers.

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The provided document is a 510(k) clearance letter from the FDA for a quality control material, the Elecsys Troponin T CalCheck 5. This type of device does not involve studies with "device performance," "sample sizes for test sets," "experts for ground truth," "adjudication methods," or "MRMC comparative effectiveness studies" in the way these terms are typically used for diagnostic or AI-driven medical devices.

Instead, the "performance" of a quality control material refers to its ability to accurately verify the calibration and assay range of an in vitro diagnostic (IVD) test (in this case, the Elecsys Troponin T reagent on specific immunoassay analyzers).

Therefore, a direct answer to your request in the context of a diagnostic or AI device is not applicable for this document.

However, I can extract the relevant information about the acceptance criteria and how a device like this would meet them, based on the principles of regulatory clearance for IVD quality control products.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the Study for Acceptance Criteria:

The "study" for a quality control material like Elecsys Troponin T CalCheck 5 is typically a verification and validation (V&V) program conducted by the manufacturer. This program encompasses various tests and analyses rather than a single clinical trial with patient data or expert reads.

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

• Test Set Sample Size: Not applicable in the sense of patient samples. For a QC material, the "test set" would be the number of vials/lots of the QC material tested and the number of measurements taken to establish its characteristics (e.g., homogeneity, stability, value assignment). This is typically determined by statistical sampling plans to ensure representativeness and sufficient power for the specific tests. The provenance would be the manufacturer's internal laboratories.
• Data Provenance: The data would originate from prospective internal laboratory studies conducted by Roche Diagnostics during the product development and manufacturing process. This would typically be conducted at their facilities in a controlled environment.

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

• Not applicable. For a quality control material, "ground truth" for its characteristics (assigned values, stability) is established through rigorous analytical testing and metrological traceability using established reference methods and calibrated instruments, not by expert interpretation of clinical data. The experts involved would be analytical chemists, biochemists, and statisticians with expertise in IVD manufacturing and assay development, rather than clinical experts like radiologists.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication (e.g., 2+1, 3+1 for clinical consensus) is used to resolve discrepancies in expert interpretation of clinical data. For a QC material, objective analytical measurements are the primary data source. Statistical methods are used to analyze the results and determine if they meet pre-defined specifications.

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

• No. An MRMC study is relevant for evaluating the impact of a diagnostic device (especially imaging or AI-driven) on human reader performance. Elecsys Troponin T CalCheck 5 is a quality control material, not a diagnostic device that humans interpret.

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

• No. This concept is specific to AI or algorithmic diagnostic devices. A quality control material like CalCheck 5 does not involve an algorithm with "standalone performance" in this context. Its function is to verify the performance of an analyzer/reagent system.

7. Type of Ground Truth Used:

• The "ground truth" for a quality control material is its analytically determined and metrologically traceable assigned value for each analyte (Troponin T in this case) at each control level. This value is established through a comprehensive process involving:
  • Reference Methods: Often comparing results to a higher-order reference measurement procedure (e.g., isotope dilution mass spectrometry, if available and appropriate).
  • Consensus Studies: Using multiple instruments and laboratories to generate a robust mean value.
  • Certified Reference Materials (CRMs): Ensuring traceability to international or national standards.

8. Sample Size for the Training Set:

• Not applicable. This device does not use machine learning or AI, 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 for an AI/ML model.

In summary, the provided document pertains to regulatory clearance for a quality control material. The acceptance criteria and "studies" for such a device are fundamentally different from those for diagnostic or AI-powered medical devices. The focus is on analytical performance, stability, homogeneity, and traceability of the control material itself, rather than clinical performance based on patient data or expert interpretation.

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The CoaguChek XS Plus System measures blood-clotting time for people who are taking warfarin anticoagulation medications. The CoaguChek XS Plus System uses blood from a fingerstick. The system is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.

The CoaguChek XS Plus System was previously cleared for professional use under premarket notification K071041. This premarket notification is being submitted to obtain clearance for patient self-testing.

Here's a breakdown of the acceptance criteria and the study details for the CoaguChek® XS Plus System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states "Acceptance Criteria" under each performance characteristic evaluated in the study.

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

• Sample Size for Accuracy Test Set: 307 patients (for the comparison between self-tester and healthcare professional results).
• Sample Size for Precision Test Set: 296 for self-testers, 308 for professionals.
• Data Provenance: The study was conducted by Roche Diagnostics. It was a prospective clinical study involving four visits to a clinical site, with subjects self-testing in a home setting for up to 8 weeks, and also having 3 scheduled visits to their study site to collect user vs. technician data. The demographic information for the trained users who completed all visits (103 patients) lists "Age range (years) 34-86", with educational levels ranging from "Some high school through advanced college degree." The specific country of origin is not explicitly stated, but Roche Diagnostics is based in Indianapolis, IN, USA, and the 510(k) submission is to the FDA, suggesting a US-based study.

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

The ground truth for comparison was established by "healthcare professionals trained in the use of the CoaguChek XS Plus System" (referred to as "technician" in the regression analysis). The exact number of individual healthcare professionals is not specified, nor are their specific qualifications (e.g., number of years of experience, specific medical degrees). However, the study involved a comparison against "healthcare professionals," implying a standard of reference for accurate PT/INR measurement.

4. Adjudication Method

The document does not explicitly describe an adjudication method for conflicting results. The study compares results from "trained users" (self-testers) against "healthcare professionals." It's implied that the healthcare professional's measurement serves as the reference or "ground truth" against which the self-tester's performance is compared, rather than a conciliation process between discrepant readings.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is focused on the performance of a device used by patients (self-testers) compared to its use by healthcare professionals, not on how an AI system changes human reader performance.

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

Yes, this study is inherently a standalone performance evaluation of the device. The "algorithm" here is the entire CoaguChek XS Plus System. The study evaluated its performance when used by two distinct "classes" of users: self-testers and healthcare professionals. The objective was to demonstrate the device's accuracy and precision in the hands of self-testers, without a human-in-the-loop AI component being assessed. It compares the device's performance under different user conditions.

7. The Type of Ground Truth Used

The ground truth for the test set was established by measurements obtained by trained healthcare professionals using the same CoaguChek XS Plus System. This serves as the reference standard for evaluating the accuracy of results obtained by self-testers.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" in the context of machine learning. The study describes training for the users of the device (self-testers) rather than training for an algorithm. The patient demographics section describes the characteristics of the study subjects who were trained and whose data was collected.

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

As there is no "training set" for an algorithm in the machine learning sense, this question is not applicable. The "training" described in the document refers to the face-to-face training provided to the study subjects (self-testers) on how to use the CoaguChek XS Plus System, not the training of an AI model with ground truth data.

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The Elecsys HCG STAT CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys HCG STAT reagent on the indicated Elecsys and cobas e immunoassay analyzers.

The Elecsys HCG STAT CalCheck 5 is a lyophilized product consisting of HCG in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

The provided text describes the Elecsys HCG STAT CalCheck 5, a control solution used for calibration verification and assay range verification of the Elecsys HCG STAT reagent on specific immunoassay analyzers.

Here's an analysis of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states, "The Elecsys HCG STAT CalCheck 5 was evaluated for value assignment." However, it does not explicitly define specific numerical acceptance criteria (e.g., target ranges, precision limits, deviation thresholds) for this "value assignment." Instead, it relies on the similarity of its formulation to a previously cleared device.

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

• Sample Size: Not explicitly stated for the "value assignment" evaluation.
• Data Provenance: Not explicitly stated. Given that it's a control solution for in-vitro diagnostics, the "test set" would refer to the characteristics of the control material itself rather than patient samples. The information indicates the device was internally evaluated by Roche Diagnostics.

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

This type of information is generally not applicable to a control solution which is itself used to establish the "truth" of an assay's performance against known values. The "ground truth" for the control solution's own value assignment would be based on highly precise and accurate analytical methods, typically performed by expert analytical chemists or qualified laboratory personnel. The document does not specify the number or qualifications of individuals involved in the value assignment process.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically employed in studies involving human interpretation or subjective assessments, which is not the case for the value assignment of an assayed control.

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

Not applicable. MRMC studies compare the performance of human readers, sometimes with and without AI assistance, on diagnostic tasks. This device is an assayed control for an immunoassay, not a diagnostic imaging or interpretive AI device.

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

Not applicable. This device is a biochemical control solution, not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for the Elecsys HCG STAT CalCheck 5 is its assigned HCG concentration values. These are established through:

• Analytical Methods: Precise and accurate laboratory measurements using reference methods or highly calibrated instruments.
• Manufacturing Specifications: The analyte is "spiked into the matrix at the desired concentration levels" during manufacture, indicating a known, engineered ground truth.

8. Sample Size for the Training Set

Not applicable. This device is a control solution, not an AI/ML algorithm that requires a training set.

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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