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The Quantimetrix Cardiasure Assayed Controls are intended for use as quality control materials to assess the accuracy and precision of assay procedures for the analytes included in the control.

The Quantimetrix Cardiasure Control is to be used as a quality control material to assess the accuracy and precision of laboratory test methods used to measure the specific serum analytes contained in the control material in order to validate the measurement of these analytes in patient samples.

Cardiasure Assayed Controls are supplied in three levels, 3 x 3 mL each level per box and as a Tri-Level pack: 3 vials at 3 mL of each level; the controls are supplied as a ready-to-use frozen liquid, requiring no reconstitution or dilution. They are prepared in a human serum matrix fortified to target levels with human source material and reagent grade chemicals added at different concentrations to achieve the three levels. Sodium Azide has been added as preservative to inhibit microbial growth.

The provided K993723 510(k) Summary describes a quality control material, not a diagnostic device that directly "measures" or "detects" a condition in a patient. Therefore, many of the typical acceptance criteria and study parameters for AI/ML-based diagnostic devices (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable in this context.

This submission focuses on proving the stability and reliable performance of the control material itself, which then allows laboratories to assess the accuracy and precision of their own assay procedures.

Here's an analysis based on the information provided, highlighting the differences:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Cardiasure Assayed Cardiac Markers Control primarily revolve around its stability and the consistency of analyte recovery over time and under different storage conditions.

• Performance Metric: Increase or decrease of >10% of analyte recovery compared to the initial test value ± the highest allowable instrument/reagent imprecision was used as the analyte failure criterion. | - Based on accelerated stability studies.
• Control stored at 2 to 8°C for over 60 days to simulate 3 years storage at -10 to -20°C.
• Specific passing/failing results not explicitly stated but implied the claim was met. Real-time stability testing is ongoing. |
  | Closed & Opened Vial Stability (Refrigerated Storage) | - Claim: 30 days at 2 - 8°C (for most analytes).
• Performance Metric: Analyte recovery (vs. day 0) measured at regular intervals.
• Failure Criterion: Same as above (>10% change compared to initial test value ± highest allowable instrument/reagent imprecision). | - Control stored at 2 - 8°C.
• Recovery measured up to 35 days for open vial and up to 64 days for closed vial.
• Result: "All lots passed the 30 day refrigerated stability for opened/closed vials (with the exception of Tn-I which has a 14 day stability claim)." |
  | Inter-lot Consistency | - Performance Metric: No significant difference in performance or stability across multiple manufacturing lots. | - "Multiple lots of product were tested with no significant difference in performance or stability." |
  | Analyte Value Establishment | - Performance Metric: Assayed values for specific analytes established from interlaboratory data using instrument manufacturers' reagents. Mean values and expected ranges were calculated from multiple instruments and reagent lots. | - This process was performed, indicating the product can provide consistent reference values for laboratory quality control. |
  | Substantial Equivalence to Predicate Device | - Predicate Stability: Liquichek™ Cardiac Markers Control claims 2-year shelf life at -10 to -20°C and 20-day opened/closed vial stability at 2-8°C (with exceptions for Tn-I and T at 10 days). | - The Cardiasure control demonstrated comparable or superior stability claims (3 years frozen, 30 days refrigerated for most analytes). |

Study Details for Device Performance

Given that this is a quality control material and not a diagnostic device, the study design will not align with typical diagnostic device studies.

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

• Test Set: Not applicable in the traditional sense of patient data. The "test set" consisted of multiple lots of the Cardiasure control material itself and specific analytes within those control materials.
• Sample Size: Multiple lots of the product were manufactured and tested.
• Data Provenance: The studies were conducted internally by Quantimetrix Corporation. This would be considered prospective data for device testing (i.e., new lots were produced and subjected to stability testing). The source matrix (human serum) contains human source antigens and enzymes.

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

• Not applicable. The "ground truth" for this device is its inherent chemical stability and the established concentrations of its analytes. This is determined through analytical chemistry techniques and interlaboratory studies, not expert consensus on medical images or patient diagnoses. The stability criteria are based on analytical recovery within defined limits.

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

• None applicable. Adjudication is typically for resolving discrepancies in expert interpretations of clinical data. Here, the "truth" is objective chemical measurement against predefined stability thresholds.

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

• Not applicable. This device is a quality control material, not an AI/ML diagnostic system intended for human reader assistance.

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

• Not applicable. This is a physical reagent, not an algorithm. Its "performance" is its ability to maintain stable analyte concentrations and to be accurately assayed by laboratory instruments.

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

• The "ground truth" for stability was based on analytical recovery of target analytes compared to initial measurements, verified against scientifically established stability models (like the L. Kennon model referenced). The criteria were defined as a percentage change (>10%) relative to the initial value and instrument/reagent imprecision.
• The "ground truth" for the assayed values (concentrations) was established through interlaboratory data, meaning multiple laboratories using various instruments and reagent lots performed assays on the control material to determine mean values and expected ranges. This is a form of empirical measurement consensus within the analytical testing community.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

• Not applicable. As above, no training set for an AI/ML algorithm is involved.

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