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The ACCU-CHEK Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format.

The ACCU-CHEK Bolus Advisor, as a component of the ACCU-CHEK Connect Diabetes Management App, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data. Before its use, a physician or healthcare professional must activate the bolus calculator and provide the patient-specific target blood glucose. insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software.

The ACCU-CHEK Connect Diabetes Management App is designed to facilitate efficient collecting, transmitting, and analyzing of blood glucose results and other diabetes management data. The App helps:

• Wireless transfer of data from ACCU-CHEK Aviva Connect Blood Glucose Meter.
• Assist in general diabetes management through logging of contextual data.
• ACCU-CHEK Bolus Advisor support of mealtime insulin dosing calculations.
• Perform structured testing.
• Wireless transfer of data from mobile devices to ACCU-CHEK Connect Online Diabetes Management System and optionally share this data with healthcare provider (HCP) or caregiver.

The insulin bolus calculations provided by the app are meant for patients undergoing multiple daily injection therapy. Bolus calculators, such as the ACCU-CHEK Bolus Advisor, have been demonstrated to facilitate the optimization of glycemic control in patients who are trained in multiple daily insulin injection therapy and under the supervision of healthcare professional experienced in managing insulin-treated patients. Such calculators have also been shown to reduce patient fear of hypoglycemia and improve patient confidence in diabetes management.

The ACCU-CHEK Connect Diabetes Management App is not intended to serve as an accessory to an insulin pump.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ACCU-CHEK Connect Diabetes Management App, structured as requested:

Acceptance Criteria and Device Performance for ACCU-CHEK Connect Diabetes Management App

The provided FDA 510(k) summary (K141929) for the ACCU-CHEK Connect Diabetes Management App primarily focuses on demonstrating substantial equivalence to a predicate device (ACCU-CHEK Aviva Combo meter). While it mentions "performance requirements" and "algorithm validation," it does not explicitly state specific quantitative acceptance criteria (e.g., in terms of accuracy, sensitivity, specificity, or precision) with corresponding reported device performance values in a table. Instead, it refers to a qualitative assessment that the device "meets the performance requirements for its intended use" and "demonstrated that the device functions as intended."

The document emphasizes that the Bolus Advisor algorithm within the app is "unchanged as compared to the predicate device." Therefore, the performance of the algorithm is implicitly tied to the cleared performance of the predicate.

Here's an attempt to structure the available information, noting the absence of explicit quantitative criteria in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document mentions "software testing and performance testing of the device" and a "Human Factors clinical study."

• Software and Performance Testing: No specific sample size (e.g., number of test cases, specific data points) is provided for the device's main software and performance testing.
• Human Factors Clinical Study: No specific sample size (e.g., number of participants) is provided for the "Human Factors clinical study."
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. Given it's a 510(k) submission to the FDA, it's highly likely that the studies were conducted with data relevant to the US market or in a manner acceptable to the FDA.

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

This information is not provided in the given document. The submission focuses on demonstrating substantial equivalence to a predicate device whose bolus calculation algorithm is adopted directly. The Human Factors study involved "persons with diabetes mellitus or their caregivers," but these are considered users, not experts establishing ground truth for algorithmic performance.

4. Adjudication Method for the Test Set

This information is not provided in the given document. Given the nature of a software application for diabetes management and bolus calculation, adjudication might not be relevant in the same way it would be for diagnostic imaging where expert consensus is often used. For software functionality, ground truth often comes from predefined requirements and expected outputs based on established medical formulas.

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 as described in the provided text. The device is a "Drug Dosing Calculator" and a "diabetes management app," not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases. The document states that the Bolus Advisor algorithm is unchanged from the predicate device, implying that its effectiveness has already been established and accepted with that predicate. No effect size of human improvement with AI assistance is mentioned because this type of study was not conducted or reported.

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

Yes, implicitly, a standalone assessment of the algorithm was done. The document states: "The insulin bolus calculator algorithm is unchanged as compared to the predicate device." This means the algorithm's performance was previously validated in its standalone form within the predicate device (ACCU-CHEK Aviva Combo meter). The current submission leverages that prior validation. There's no new, separate standalone study explicitly described for the ACCU-CHEK Connect Diabetes Management App, beyond the confirmation that it uses the same algorithm.

7. The Type of Ground Truth Used

For the bolus calculation algorithm, the ground truth would be based on established medical formulas and diabetes management guidelines for insulin dosing and carbohydrate intake calculations. The accuracy of these calculations against the established formulas would have been the ground truth for the predicate device. For the ACCU-CHEK Connect App, the ground truth for its software functionality relies on validated software requirements and the expected output of its operations.

8. The Sample Size for the Training Set

This information is not applicable/not provided in the context of this device. The ACCU-CHEK Connect Diabetes Management App, particularly its Bolus Advisor, is a rule-based system employing an "unchanged" algorithm from a predicate device. It is not an AI/Machine Learning model that would typically have a "training set" in the conventional sense. The algorithm is based on well-defined clinical parameters (target blood glucose, insulin-to-carbohydrate ratio, insulin sensitivity, etc.) provided by a healthcare professional.

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

As noted above, this device does not appear to involve machine learning or AI that would require a "training set" with ground truth established through typical methods like expert annotation or pathology. The "ground truth" for the bolus calculation algorithm stems from established medical science and clinical practice guidelines for insulin dosing, which determine the correct output for given input parameters. The validation of such an algorithm would involve testing it against a wide range of clinically relevant scenarios, where the "correct" insulin dose is derived from these established medical principles.

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The ACCU-CHEK Aviva Expert System is indicated as an aid in the treatment of insulin-requiring diabetes. The ACCU-CHEK Aviva Expert System consists of the ACCU-CHEK Aviva Expert Meter, ACCU-CHEK Aviva Plus test strips, ACCU-CHEK Aviva control solutions, and ACCU-CHEK Bolus Advisor. The ACCU-CHEK Aviva Expert System is intended to facilitate the optimization of glycemic control in multiple daily insulin injection therapy and are under the supervision of healthcare professionals experienced in managing insulin treated patients. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used by a single person and should not be shared. The ACCU-CHEK Aviva Expert blood glucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should NOT be used with the ACCU-CHEK Aviva Expert blood glucose monitoring system. The ACCU-CHEK Aviva Expert System is intended for prescription home use only.

The ACCU-CHEK Aviva Expert meter is also indicated for the calculation of an insulin dose or carbohydrate intake based on user-entered data. The ACCU-CHEK Bolus Advisor, as a component of the Accu-Chek Aviva Expert meter, is intended for use in providing insulin dose recommendations in response to blood glucose, health events, and carbohydrate input. The ACCU-CHEK Bolus Advisor is intended to provide direction for insulin adjustment within the scope of a preplanned treatment program from a healthcare professional. Before its use, a physician or healthcare professional must prescribe the ACCU-CHEK Aviva Expert System and provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the ACCU-CHEK Bolus Advisor. Once programmed, a patient must consult with his/her physician or healthcare professional before making any changes to these ACCU-CHEK Bolus Advisor settings.

The ACCU-CHEK Aviva Expert System consists of the following which was originally cleared under K131366:

• ACCU-CHEK Aviva Expert meter
• ACCU-CHEK Bolus Advisor (a component of the Aviva Expert meter)
• ACCU-CHEK Aviva Plus test strips
• ACCU-CHEK Aviva control solutions

The ACCU-CHEK Aviva Expert system is a blood glucose monitoring system that makes use of the ACCU-CHEK Aviva Plus test strips and the ACCU-CHEK Aviva control solutions.

The ACCU-CHEK Aviva Expert system provides the user with the ability to measure capillary blood glucose levels when a sample of capillary blood is applied to the test strip. The meter also provides an optional insulin bolus calculator (the ACCU-CHEK Bolus Advisor) designed for use by individuals with diabetes who require insulin. This feature is optional in that a user can simply obtain a blood glucose value through capillary blood testing and does not need to use the insulin bolus calculator portion of the system if it is not desired. For the ACCU-CHEK Aviva Expert system, this bolus calculator is meant to be used by patients with diabetes on multiple daily insulin injection (MDI) therapy. In order to calculate the appropriate bolus of insulin, the ACCU-CHEK Bolus Advisor takes the measured bG, the target bG, the carbohydrate intake, the insulin-to-carbohydrate ratio, the insulin sensitivity, health events (such as exercise), the time of day, and the active insulin into account. Before using the ACCU-CHEK Aviva Expert system, a physician or healthcare professional must provide the patient-specific target blood glucose, insulin-to-carbohydrate ration, and insulin sensitivity parameters.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the performance of the ACCU-CHEK Aviva Expert Blood Glucose Monitoring system:

The document describes the ACCU-CHEK Aviva Expert Blood Glucose Monitoring system and refers to performance testing that was submitted and cleared under a previous 510(k) (K131366). The current submission (K142089) states that "The ACCU-CHEK® Aviva Expert System has not changed since this prior submission and the information submitted here is provided to support the clarification in the intended use statement." Therefore, the performance data presented is for the identical device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document presents performance data as evidence of the device meeting requirements for its intended use, but does not explicitly state predetermined "acceptance criteria" as separate rows. However, to construct a table, we can infer the acceptance criteria from the reported results, assuming the reported values met the relevant regulatory standards for blood glucose monitoring systems at the time of clearance.

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The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The ACCU-CHEK Aviva Plus Test Strips are for use with the ACCU-CHEK Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

The modified ACCU-CHEK Aviva meter used in conjunction with the ACCU-CHEK® Aviva Plus test strips. The new ACCU-CHEK Aviva meter no longer uses a code key.

The single-patient use ACCU-CHEK Aviva Blood Glucose Monitoring System will consist of:
Meter: ACCU-CHEK Aviva Meter
Test Strip: ACCU-CHEK Aviva Plus Test Strip
Controls: ACCU-CHEK Aviva Control Solutions

Here's an analysis of the provided text regarding the ACCU-CHEK Aviva Plus Blood Glucose Monitoring System, focusing on acceptance criteria and study details.

Based only on the provided text, the specific details regarding the acceptance criteria and a detailed study proving the device meets them are very limited. The document is primarily a 510(k) summary for a modified device, emphasizing its substantial equivalence to a predicate device.

Here's what can be extracted and what is explicitly not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for performance metrics. Instead, it makes a general statement about meeting performance requirements and being substantially equivalent to the predicate device.

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

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). The document only states "Performance testing on the ACCU-CHEK Aviva System demonstrated..."

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 given text. For blood glucose monitoring systems, ground truth is typically established using a high-precision laboratory reference method, not necessarily by human experts in the same way it would be for imaging diagnostics. The text does not elaborate on the method used to establish reference glucose values.

4. Adjudication method

This information is not provided in the given text.

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

• MRMC Study: Not applicable/not mentioned. This device is a blood glucose monitoring system, which typically does not involve human "readers" interpreting results in the same way an imaging AI system would. Its primary function is to provide a quantitative measurement.
• AI Improvement Effect Size: Not applicable. There is no mention of AI integration in this blood glucose monitoring system.

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

The device itself is a standalone system in the sense that the meter provides the glucose reading without requiring human interpretation or intervention beyond performing the test procedure. However, the document does not distinguish between "standalone algorithm performance" and "system performance" as it might for an AI-driven diagnostic. The "performance testing" referred to would inherently be of the "algorithm only" (i.e., the device's measurement capability) without a human interpreting the result to determine the glucose level.

7. The type of ground truth used

The type of ground truth is not explicitly stated beyond the implication that it's a quantitative measurement of glucose. For blood glucose meters, the ground truth is typically established by comparative measurements against a laboratory reference method (e.g., YSI analyzer) known for its high accuracy. The text only mentions "quantitative measurement of glucose (sugar)."

8. The sample size for the training set

This information is not provided in the given text. Blood glucose meters are not typically "trained" in the same way a machine learning algorithm would be. Their performance is based on the chemical and electrical design of the test strip and meter. If any statistical models or calibrations were involved, the training set details are omitted.

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

This information is not provided in the given text. (See point 8 regarding "training set.")

Summary of Limitations due to Document Scope:

The provided document, a 510(k) Summary, primarily focuses on demonstrating substantial equivalence to a predicate device for a modified blood glucose monitoring system (specifically, a meter that no longer uses a code key). It states that performance testing was done and that the device "meets the performance requirements for its intended use" and is "substantially equivalent to the predicate device." However, it does not provide detailed technical specifications, exact acceptance criteria, or granular study results (like sample sizes for performance studies, specific ground truth methods, or any statistical analysis) that would be found in a full submission or a detailed study report. These details are often proprietary or contained in other sections of a 510(k) submission not included here.

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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

• Meet performance requirements for intended use. | "All components passed the cleaning and disinfection test protocol, based on the defined criteria."
  "The corresponding test results demonstrate that the Super Sani-Cloth wipes are effective for the cleaning and disinfection of the device..." |
  | Substantial equivalence to the predicate device (ACCU-CHEK Inform II System with Clorox® Germicidal Wipes for cleaning and disinfection). | "The Super Sani-Cloth is substantially equivalent to the Clorox Germicidal Wipe when used on the ACCU-CHEK Inform II System."
  "Overall, the data demonstrate that the ACCU-CHEK Inform II System operates in the same manner when cleaning and disinfecting occurs with the Super Sani-Cloth wipes." |

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 T4 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 T4 reagent on the indicated Elecsys and cobas e immunoassay analyzers.

The Elecsys T4 CalCheck 5 is a lyophilized product consisting of T4 in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

Here's a breakdown of the acceptance criteria and study information for the Elecsys T4 CalCheck 5, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to a predicate device (Elecsys T3 CalCheck 5) rather than explicitly stating specific numerical acceptance criteria for the Elecsys T4 CalCheck 5. However, the performance characteristics section mentions "value assignment and stability" as evaluation points. From the comparison table with the predicate, we can infer some targets or expected ranges for "Check Target Values" and "Assay Measuring Range".

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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:

• 300 ng/mL Cutoff (MAMP): 84/84 Negative at zero, -75%, -50% of cutoff. 83/84 Negative at -25% of cutoff. 27/84 Negative, 57/84 Positive at cutoff. 84/84 Positive at +25%, +50%, +75%, +100% of cutoff.
• 500 ng/mL Cutoff (MAMP): 84/84 Negative at zero, -75%, -50% of cutoff. 84/84 Negative at -25% of cutoff. 28/84 Negative, 56/84 Positive at cutoff. 84/84 Positive at +25%, +50%, +75%, +100% of cutoff.
• 1000 ng/mL Cutoff (MAMP): 84/84 Negative at zero, -75%, -50%, -25% of cutoff. 13/84 Negative, 71/84 Positive at cutoff. 84/84 Positive at +25%, +50%, +75%, +100% of cutoff.
• 300 ng/mL Cutoff (AMP): 84/84 Negative at zero, -75%, -50% of cutoff. 83/84 Negative at -25% of cutoff. 2/84 Negative, 82/84 Positive at cutoff. 84/84 Positive at +25%, +50%, +75%, +100% of cutoff.
• 500 ng/mL Cutoff (AMP): 84/84 Negative at zero, -75%, -50% of cutoff. 82/84 Negative, 2/84 Positive at -25% of cutoff. 6/84 Negative, 78/84 Positive at cutoff. 84/84 Positive at +25%, +50%, +75%, +100% of cutoff.
• 1000 ng/mL Cutoff (AMP): 84/84 Negative at zero, -75%, -50% of cutoff. 82/84 Negative, 2/84 Positive at -25% of cutoff. 7/84 Negative, 77/84 Positive at cutoff. 1/84 Negative, 83/84 Positive at +25% of cutoff. 84/84 Positive at +50%, +75%, +100% of cutoff.

Semiquantitative Mode (SD, CV% ranges reported):

• For MAMP at 300, 500, 1000 ng/mL cutoffs:
  • Repeatability (within-run) CV% for zero to +100% of cutoff generally good (e.g., 5.7%-95.4% for 300 ng/mL, with highest CVs at very low concentrations).
  • Intermediate Precision (total) CV% for zero to +100% of cutoff also generally good (e.g., 6.5%-123.8% for 300 ng/mL, with highest CVs at very low concentrations).
• For AMP at 300, 500, 1000 ng/mL cutoffs:
  • Repeatability (within-run) CV% generally good (e.g., 5.3%-110.0% for 300 ng/mL).
  • Intermediate Precision (total) CV% also generally good (e.g., 6.5%-135.7% for 300 ng/mL). |
    | Accuracy (Agreement with GC/MS) | MAMP (d-methamphetamine):
• Qualitative & Semiquantitative Assays:
  • 100% agreement for High Positive by GC/MS (greater than +50% of cutoff) across all cutoffs (300, 500, 1000 ng/mL).
  • 100% agreement for Near Cutoff Positive by GC/MS (between cutoff and +50%) across all cutoffs.
  • For Low Negatives (below cutoff) / Near Cutoff Negative (between -50% and cutoff):
    • 300 ng/mL Cutoff: 90% (Qualitative & Semiquantitative).
    • 500 ng/mL Cutoff: 91% (Qualitative & Semiquantitative).
    • 1000 ng/mL Cutoff: 90% (Qualitative & Semiquantitative).

AMP (d-amphetamine):

• Qualitative & Semiquantitative Assays:
  • 100% agreement for High Positive by GC/MS (greater than +50% of cutoff) across all cutoffs.
  • 100% agreement for Near Cutoff Positive by GC/MS (between cutoff and +50%) across all cutoffs.
  • For Low Negatives (below cutoff) / Near Cutoff Negative (between -50% and cutoff):
    • 300 ng/mL Cutoff: 92.5% (Qualitative & Semiquantitative).
    • 500 ng/mL Cutoff: 92.5% (Qualitative & Semiquantitative).
    • 1000 ng/mL Cutoff: 97.5% (Qualitative), 95% (Semiquantitative). |
      | Analytical Specificity / Cross-reactivity | A wide range of structurally similar compounds (e.g., MDMA, MDA, MDEA, BDB, l-Methamphetamine, l-Amphetamine) show varying degrees of cross-reactivity, with some "designer drugs" showing higher cross-reactivity than others (e.g., MDMA at 264% at 300 ng/mL MAMP equivalent). Most other common drugs/substances (e.g., acetaminophen, ibuprofen, caffeine, opiates, benzodiazepines) show either no significant interference or proper recovery of spiked samples at specified high concentrations (100,000 ng/mL). |
      | Interference from Common Substances | No interference observed from high concentrations of common urine components (e.g., Acetone, Ascorbic Acid, Bilirubin, Creatinine, Ethanol, Glucose, Hemoglobin, Human serum albumin, Oxalic Acid, Sodium Chloride, Urea) for both qualitative and semiquantitative modes across all cutoffs when spiked with d-methamphetamine or d-amphetamine at -25% and +25% of cutoff. |
      | pH and Specific Gravity Interference | No control cross-overs for specific gravities from 1.001 to 1.034. ≤ 5% cross-overs for pH ranging from 4.5 to 8.0. |

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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