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Multichem S Plus / S Plus (Assayed) control are intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

The use of quality control material is indicated as an objective assessment of the precision of methods and techniques and is an integral part of good laboratory practices. Three levels of control are available to allow performance monitoring within the analytical range. There is no difference in the formulation or manufacturing procedure between Multichem S Plus and Multichem S Plus (Assayed). Both are multi-analyte assayed QC materials with the same formula; however, there is a difference only in the product claims that are published to the users.

The provided 510(k) summary (K132751) describes the Multichem S Plus / S Plus (Assayed) control product, which is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures. As a quality control material, the "device" itself is designed to provide known values for various analytes, which are then used by laboratories to ensure the accuracy and precision of their analytical instruments and methods. The studies described are primarily focused on establishing the stability and value assignments of this control material, rather than on proving its diagnostic accuracy or comparative effectiveness in a clinical setting like an AI algorithm would.

Therefore, many of the typical acceptance criteria and study aspects you've asked for, such as "effect size of how much human readers improve with AI vs without AI assistance" or "adjudication method for the test set," are not applicable to this type of device. This submission focuses on the analytical performance (stability and value assignment) of a quality control product.

Here's an attempt to answer the questions based on the provided text, noting where specific questions are not applicable:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the format of pass/fail thresholds for specific performance metrics in a single table. Instead, it describes the methodology for establishing value assignment ranges and evaluating stability.

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

• Value Assignment Test Set: 32 data points per analyte (2 replicates from 16 runs).
• Open Vial Stability Test Set: Replicates of 3 for each analyte at each time point.
• Shelf-Life Stability Test Set: 3 lots for accelerated testing, 2 lots for real-time testing.
• Data Provenance: The studies were performed internally by Technopath, a company based in Ireland (Ballina, Co. Tipperary, Ireland). The data is generated from laboratory testing using specific instruments (Abbott ARCHITECT c8000, i2000, Beckman Coulter® AU480). This would be considered prospective data generation for the purpose of validating the control material.

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)

This question is not applicable. For this type of quality control material, the "ground truth" is typically established by precisely measuring the analyte concentrations using highly accurate and precise reference methods within a laboratory setting, rather than through expert consensus on qualitative observations. The document mentions "Value assignment testing was performed utilizing internal procedures and protocols to determine typical values," which implies a metrological approach, not expert adjudication.

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

This question is not applicable. Adjudication methods like '2+1' or '3+1' are used for interpreting subjective data (e.g., medical images) to establish a ground truth. For quantitative chemical measurements, the "ground truth" (assigned values) are determined through statistical analysis of multiple precise measurements, not by expert consensus or adjudication.

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

This question is not applicable. An MRMC study is relevant for evaluating the impact of AI on human diagnostic performance, typically with interpreting medical images or other complex diagnostic tasks. This device is a quality control material for laboratory instruments and does not involve AI or human readers in the diagnostic workflow.

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

This question is not applicable. This device is a quality control material, not an algorithm or an AI system. Its performance is evaluated by how accurately and stably it represents known analyte concentrations when measured by laboratory instruments.

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

The "ground truth" for the Multichem S Plus / S Plus (Assayed) control is the assigned value (concentration) for each analyte within the control material. This is established through meticulous laboratory measurement and statistical analysis across multiple runs, instruments, reagents, and calibrators, as described in section 8.1 "Value Assignment Summary." It is not based on expert consensus, pathology, or outcomes data, but on the accurate quantification of chemical substances.

8. The sample size for the training set

This question is not applicable in the context of an AI training set, as the device is not an AI algorithm. If "training set" refers to the data used to establish the assigned values for the control, then for "Value Assignment":

• For Multichem S Plus (Assayed) controls, 2 reagent lots and 2 calibrator lots were used where available.
• 2 replicates from 16 runs were performed to give a total of 32 data points per analyte.
• A minimum of 8 calibration events were performed.

For stability studies, multiple lots of control material were used with results generated over various time points.

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

Again, if "training set" refers to the data used for value assignment of the control material:

The "ground truth" (the assigned value for each analyte) was established through a rigorous value assignment process as described in section 8.1. This involved:

• Utilizing internal procedures and protocols.
• Running the controls on specific clinical chemistry and immunoassay systems (Abbott ARCHITECT c8000, ARCHITECT i2000).
• Incorporating reagent and calibrator variation by using 2 reagent lots and 2 calibrator lots.
• Performing 32 data points (2 replicates from 16 distinct runs).
• Ensuring minimum gaps of 2 hours between runs.
• Incorporating variation from calibration and environmental sources through a minimum of 8 calibration events.
• The "grand mean" of these comprehensive measurements was used to establish the assigned value, around which the value assignment ranges were then set.

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Multichem U is intended for use as an assayed urine quality control to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. Two levels of Controls (Level 1 and Level 2) are supplied in liquid form.

Technopath has developed two levels of a urine control prepared from human urine to which purified biochemical material (extracts of human and animal origin), chemicals, drugs/preservatives and stabilizers have been added. The control is used in liquid form for convenience. The two levels of control are available to allow performance monitoring within the analytical range.

The following kit configurations are available:

Model UC 201A.10 with Level 1 control; 15 vials with 10 mL contents
Model UC 202A.10 with Level 2 control; 15 vials with 10 mL contents
Model 05P80-10, with Bi-Level controls; 6 Level 1 vials and 6 Level 2 vials; vials have 5mL contents

The provided 510(k) summary for Multichem U describes a quality control material and focuses on its substantial equivalence to a predicate device rather than presenting formal acceptance criteria and a study proving the device meets those criteria in the typical sense of a diagnostic or therapeutic device. Quality control materials are evaluated differently.

However, I can extract the relevant performance characteristics and the "studies" (which are more accurately "testing protocols" for QC materials) that demonstrate the device performs as intended for its stated use.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For a quality control material, "acceptance criteria" revolve around its stability, value assignment, and consistent performance across different reagent lots and calibrator lots. The "reported device performance" demonstrates that these characteristics were met.

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

• Sample Size for Value Assignment: For each analyte, 2 replicates from 16 runs were performed, yielding a total of 32 data points.
• Sample Size for Stability Testing:
  • Open Vial: Replicates of 3 were tested at each time point.
  • Shelf-Life (Accelerated): Three lots of controls were used.
• Data Provenance: Not explicitly detailed regarding "country of origin for the data" for the internal studies. However, the manufacturer is Technopath from Ireland, and the contact is in the US (Global Compliance Plus). The serum used as a base material was tested using "United States Food and Drug Administration (FDA) approved methods." The studies were conducted internally by Technopath. All testing was performed on Abbott ARCHITECT c8000 clinical chemistry systems. The studies are prospective in the sense that they were designed and executed to determine the specific performance characteristics of the Multichem U product.

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

This section is not applicable in the traditional sense for a quality control material.

• Ground truth for QC materials is not established by human experts interpreting clinical cases. Instead, the "truth" (or target value) for an analyte in a QC material is determined through value assignment protocols using reference methods or well-calibrated laboratory instruments.
• The "experts" involved would be trained laboratory personnel and chemists following established protocols for analytical testing and possibly statisticians for data analysis, but not "radiologists with 10 years of experience" as one might see for an AI diagnostic device.

4. Adjudication Method for the Test Set

This section is not applicable.

• Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert interpretations of clinical data (e.g., medical images, pathology slides) to establish a gold standard.
• For quality control materials, the "truth" is determined by precise analytical measurement, not subjective interpretation requiring adjudication.

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 readers (e.g., radiologists) interpret cases (e.g., medical images) with and without the assistance of an AI algorithm.
• Multichem U is a quality control material used to assess the precision of laboratory instruments; it does not involve human interpretation of clinical "cases" in a way that would be assisted by an AI.

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

No, a standalone (algorithm only) performance study was not done.

• This concept is also relevant for AI/ML-driven diagnostic devices.
• Multichem U is a physical reagent used in conjunction with laboratory instrumentation; it is not an algorithm, and therefore, an "algorithm only" performance study is not applicable.

7. The Type of Ground Truth Used

For Multichem U, the "ground truth" for the analyte concentrations is established through value assignment testing protocols using calibrated laboratory instruments (Abbott ARCHITECT c8000 clinical chemistry systems) and associated reagent test systems.

• It is not expert consensus, pathology, or outcomes data. It's direct analytical measurement following validated procedures.
• The document states: "Value assignment testing was performed utilizing internal procedures and protocols to determine typical values that would be seen for the product..."

8. The Sample Size for the Training Set

This section is not applicable in the context of Multichem U.

• "Training set" refers to data used to train machine learning models.
• Multichem U is a physical quality control material, not a machine learning algorithm.

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

This section is not applicable for the reasons stated above. As there is no training set, there is no ground truth for a training set.

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Multichem P is intended for use as a single level assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

The Multichem P control is prepared from human serum to which purified biochemical material (extracts of human origin), chemicals, drugs/preservatives and stabilizers have been added. The control is used in liquid form for convenience. This control is provided in a single level control only with twelve vials, each vial containing 3 mL.

The provided document describes the Multichem P device, which is a quality control material intended to monitor the precision of laboratory testing procedures for specific analytes. This is a Class I reserved product, meaning it is considered low risk and subject to general controls. The acceptance criteria and supporting study are primarily focused on demonstrating its performance as a stable and reliable control material.

It's important to note that this is not an AI/ML powered device, nor is it a diagnostic device that requires human interpretation of outputs. Therefore, many of the typical criteria for AI/ML or diagnostic devices (like MRMC studies, expert adjudication for ground truth, standalone performance metrics like AUC, sensitivity, specificity, etc.) are not applicable here. The "device performance" in this context refers to the stability and reliability of the control material over time and across different testing systems.

Here's a breakdown based on the provided text, addressing the requested information where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a quantitative performance table like for a diagnostic device. Instead, the acceptance criteria are embedded within the stability testing summary and the comparison to the predicate device. The performance is reported in terms of stability claims and value assignment.

(Note: These criteria are inferred from the description of the performance studies rather than explicitly stated as pass/fail thresholds in a table.)

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

• Sample Size for Stability Testing (Test Set):
  • Accelerated Testing: Three lots of controls.
  • Real-time Testing: One lot of controls.
  • Initial Value Assignment: Not explicitly stated, but performed using "replicate analyses" for each specific lot. Given it's a quality control for monitoring precision, the "test set" would primarily refer to the samples used in stability studies.
• Data Provenance: Not explicitly stated regarding country of origin, but the submitter (Techno-path Manufacturing Ltd.) is based in Ireland. The testing was conducted "by the control manufacturer and/or by independent laboratories." The testing described is prospective in nature, as it involves initiating stability studies (accelerated and real-time) to generate data over time.

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

• Not applicable / Not explicitly mentioned. As this is a quality control material, the "ground truth" for its performance is objective chemical stability and the ability to produce consistent results on analytical instruments, rather than a subjective interpretation by experts. "Value assignment" is based on instrumental readings and statistical methods.

4. Adjudication Method for the Test Set

• Not applicable. There is no expert adjudication process described or needed for a quality control material. The assessment is based on objective analytical data.

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

• No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on human performance is being evaluated. Multichem P is a quality control material, not a diagnostic device with an interpretive output for human readers.

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

• Yes, in essence, the "performance characteristics" section describes standalone performance. The device (Multichem P control) is itself the "algorithm" or material being tested. Its stability and performance are evaluated objectively on analytical systems (Abbott ARCHITECT c8000 Chemistry system) without human interpretive intervention beyond running the tests and analyzing the quantitative results. The data presented for stability is purely the performance of the control material.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for this quality control material is its inherent chemical stability and the expected analyte concentration values as determined through analytical methods on specified laboratory instruments.
  • For Value Assignment, the "ground truth" is the statistically determined typical value and range for each analyte on the specified instrument, established by "replicate analyses."
  • For Stability Testing, the "ground truth" is the maintenance of these assigned values within predefined limits (e.g., 10% drift limit) over time and temperature conditions. This relies on objective quantitative measurements.

8. The Sample Size for the Training Set

• Not applicable in the conventional sense for an AI/ML device. This is a physical quality control material, not a software algorithm that undergoes machine learning. The term "training set" doesn't apply.
  • If interpreted as "data used to initially develop and optimize the control formulation," the text doesn't provide this detail. The document describes studies to validate the manufactured product's performance.

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

• Not applicable (as per point 8). There is no "training set" ground truth in the context of an AI/ML algorithm. The underlying principles for formulating such a control product would rely on established biochemical and analytical chemistry principles to ensure stability and appropriate analyte concentrations.

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The Multichem WBT control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. The Multichem WBT control consists of 3 different levels of control solutions prepared from human whole blood.

Technopath has developed whole blood control materials prepared from human whole blood, to which whole blood purified biochemical material (extracts of human origin), chemicals, drugs, preservatives and stabilizers have been added. Three levels of control are available to allow performance monitoring within the analytical range.

The provided document is a 510(k) summary for the Multichem WBT control, a quality control material used to monitor the precision of laboratory testing procedures for specific analytes (Cyclosporine, Sirolimus, Tacrolimus).

It describes the device, its intended use, comparison to a predicate device, and performance characteristics focused on traceability, value assignment, and stability. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC) against a ground truth through a clinical study involving human readers or standalone algorithm performance.

The "performance characteristics" detailed in the document refer to:

• Traceability Summary: States the analytes are from commercial sources or endogenous to the base matrix, and no claim of traceability to higher order reference materials is made. This is not a measure of accuracy against a clinical ground truth.
• Value Assignment Summary: Describes how typical values for the control material were determined using an Abbott ARCHITECT i2000 chemistry system. It involved 2 reagent lots, 2 calibrator lots, 16 runs (32 data points), and 8 calibration events. The "predetermined criteria of 30% around the grand mean" was used to establish value assignment ranges, and all values fell within these ranges. This is about establishing the expected range for the control itself, not about its diagnostic accuracy or impact on human performance.
• Stability Testing Summary: Details open-vial and shelf-life stability studies. Open-vial stability was assessed using CLSI EP25A, with a maximum allowable drift (degradation) of 10% to determine the point of failure. Shelf-life was supported by accelerated and preliminary real-time testing using CLSI EP25A, also with a 10% drift limit, predicting stability for 30 months. This relates to the product's physical and chemical integrity over time, not its performance in a diagnostic context.

Since the device is a quality control material, the typical metrics for a diagnostic device (like sensitivity, specificity, reader performance) are not applicable in this context. The "performance" here refers to the consistency and stability of the control material itself.

Therefore, the requested information elements cannot be fully addressed in the format of a typical diagnostic device study due to the nature of the device (a quality control material).

However, I can extract the relevant information where it exists:

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

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

• Value Assignment:
  • Test Set Sample Size: 32 data points (replicates from 16 runs)
  • Data Provenance: Not explicitly stated, but performed internally by Technopath. Implied prospective as it was done to determine typical values for the product.
• Stability Testing:
  • Test Set Sample Size: "Multiple time points" tested for open-vial stability; three lots of controls for accelerated testing; three lots of controls for preliminary real-time testing.
  • Data Provenance: Not explicitly stated, but performed internally by Technopath. Prospective studies.

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 (N/A): This device is a quality control material, not a diagnostic device that requires expert-established ground truth for diagnostic accuracy. The "ground truth" for this device relates to its chemical properties and performance on a specific analytical instrument.

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

• N/A: As above, this is not a diagnostic device requiring adjudication of expert interpretations.

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

• N/A: This is not a diagnostic device, and thus no MRMC study, human reader improvement, or AI assistance is relevant.

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

• N/A: This is a physical quality control material, not an algorithm. Its performance is measured through its interaction with an analytical instrument (Abbott ARCHITECT i2000).

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

• Value Assignment: The "truth" is an internally determined grand mean, against which individual measurements were compared to establish ranges. This is a form of internal reference standard based on instrument performance.
• Stability Testing: The "truth" is the initial established value of the control material, and subsequent measurements over time are compared against this initial value to determine drift/degradation.

8. The sample size for the training set

• N/A: This device is a quality control material and does not involve AI model training. The performance studies described are for quality control and stability, not for training a predictive model.

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

• N/A: As there is no training set for an AI model, this is not applicable.

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Multichem IA Plus is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

The Multichem IA Plus control is prepared from human serum to which purified biochemical material (extracts of human and animal origin), chemicals, drugs, preservatives and stabilizers have been added. The control is used in liquid form for convenience. Three levels of control are available to allow performance monitoring within the analytical range. Multichem IA Plus Level 1. Level 3 controls are available in tri-level and single level kit configurations. Individual analyte values listed in the package insert are specific for the instrument system utilized.

Here's a summary of the acceptance criteria and study information for the Multichem IA Plus device, based on the provided text:

Acceptance Criteria and Device Performance

The core of the performance evaluation for this device, a quality control (QC) material, revolves around its stability and value assignment accuracy. The established acceptance criteria are related to the stability claims (open vial and shelf-life) and the accuracy of the assigned analyte values.

Study Details

This document describes the regulatory submission for a quality control material and primarily focuses on demonstrating substantial equivalence to a predicate device. The performance characteristics described are related to the analytical performance of the control material itself, rather than a clinical study involving patients or diagnostic accuracy.

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

   • Value Assignment: The document mentions "replicate analyses" but does not specify the exact number of replicates or the total sample size of control material used for value assignment. It involved testing across "Abbott ARCHITECT i2000 and c8000 Chemistry systems" and by "the control manufacturer and/or by independent laboratories." No specific country of origin is mentioned for this testing, but the manufacturer is based in Ireland. The data is prospective, generated specifically for this submission.
   • Stability Testing: No specific sample size (number of control vials or batches) is provided for either open-vial or shelf-life stability studies, only that "internal procedures and two protocols methods" were utilized for open-vial stability and "accelerated and real-time testing" for shelf-life, following CLSI EP25A.

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

   • Not applicable in the traditional sense of a diagnostic device. The "ground truth" for a quality control material refers to its assigned analyte values, established through a rigorous process of testing on calibrated laboratory instruments and methods. No human experts are described as establishing a "ground truth" for the test set in the way radiologists or pathologists would for an imaging or pathology study.

3. Adjudication method for the test set:

   • Not applicable. This is not a study requiring adjudication of findings to determine a ground truth.

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

   • Not applicable. This is a quality control material, not an AI-assisted diagnostic device.

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

   • This is a laboratory control material, not an algorithm. The performance evaluation is inherently "standalone" in that it assesses the chemical and physical stability and assigned values of the control material itself, independent of real patient samples or diagnostic algorithms.

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

   • For value assignment: The "ground truth" is established by running the control material on various validated analytical instruments and methods, establishing a "grand mean" for each analyte. This is an analytical 'truth' derived from laboratory measurements, not a clinical ground truth like pathology or expert consensus.
   • For stability: The "ground truth" is measured analytical values over time, compared against initial values and established precision requirements.

7. The sample size for the training set:

   • Not applicable. This is a quality control material and does not involve machine learning algorithms requiring a training set.

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

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

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