Search Results

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.

Ask a specific question about this device