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The Lp(a) Calibrators are for use in establishing the calibration curve for the Quantia Lp(a) reagents by turbidimetry on the ARCHITECT c Systems.

The Lp(a) Control I and Control II are intended for use as assayed quality control materials for the quantitative monitoring of Lipoprotein (a) with the Quantia Lp(a) reagents by turbidimetry on the ARCHITECT c Systems.

For in vitro diagnostic use.

The Lp (a) Calibrators are a set of 5 levels required to establish the calibration curve of the Quantia Lipoprotein (a) reagents (K050487) for the quantitative measurement of Lipoprotein (a) concentration in human serum or plasma using immunoturbidimetry technology on the ARCHITECT c Systems.

The Lp (a) Control are a set of 2 levels used to monitor the quantitative measurement of Lipoprotein (a) concentration in human serum or plasma with the Quantia Lipoprotein (a) reagents (K050487) using immunoturbidimetry technology on the ARCHITECT c Systems.

Quantia Lp(a) Reagent included two equivalent reagents presentation that only differ on the geographic distribution zone:

• Reference 7K00-40 Quantia Lp(a) Reagent (US) -
• Reference 7K00-01 Quantia Lp(a) Reagent (EX-US)

Both Quantia Lp(a) Reagents reference will use the Lp(a) Calibrators and Lp(a) Control products.

The human serum used in the Lp(a) Calibrators and Lp(a) Control is nonreactive for HBsAg, anti-HIV-1/HIV-2, and anti-HCV using FDA approved methods.

Here's a breakdown of the acceptance criteria and study information for the Lp(a) Calibrators and Lp(a) Control, based on the provided 510(k) summary:

Description of Device

The Lp(a) Calibrators and Lp(a) Control are for in vitro diagnostic use to assist in measuring Lipoprotein (a) concentration in human serum or plasma.

Device Components:

• Lp(a) Calibrators: A set of 5 levels used to establish the calibration curve for the Quantia Lipoprotein (a) reagents on the ARCHITECT c Systems.
• Lp(a) Control: A set of 2 levels (Control I and Control II) used to monitor the quantitative measurement of Lipoprotein (a) concentration with the Quantia Lipoprotein (a) reagents on the ARCHITECT c Systems.

Acceptance Criteria and Reported Device Performance

Study Information

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

   • Sample Size for Test Set:
     • Calibrator Value Assignment: 30 replicates for each level of the new manufactured calibrator lot, the Master lot, and the previously released calibrator lot.
     • Control Value Assignment: Data generated from multiple runs (specific number not provided) on the ARCHITECT c8000 System.
   • Data Provenance: Not explicitly stated, but the applicant's address is in Llica d'Amunt, Barcelona, Spain, suggesting the studies were conducted there. The studies appear to be prospective for product development and validation.

2. 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 is a clinical chemistry device, not an imaging device that relies on expert interpretation. The ground truth (assigned values for calibrators and controls) is established through analytical methods and comparisons to a Master lot, not by human experts in the traditional sense of image adjudication.

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

   • Not applicable. This is not an imaging or diagnostic device that requires human adjudication of results. The "adjudication" is based on statistical analysis of quantitative measurements against established criteria and comparison to a Master lot.

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 calibrator and control material for an automated clinical chemistry analyzer. It does not involve human readers or AI assistance in interpretation.

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

   • The device (calibrators and controls) operates in conjunction with the Quantia Lp(a) reagents on the ARCHITECT c Systems. The performance described is essentially the "standalone" analytical performance of the calibrators and controls to provide accurate values. There's no human-in-the-loop component for the calibrators/controls themselves; they are reagents used by the automated system.

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

   • The ground truth for the calibrators and controls is established via assigned values. These assigned values are determined:
     • For calibrators: By comparing to an "existing Master lot" of calibrators.
     • For controls: By repeated measurements on the ARCHITECT c8000 System using the Quantia Lp(a) Reagent, generating a mean value and acceptance ranges.
     • Traceability to a commercial EIA (Enzyme Immunoassay) method was used for in-house reference material establishment, as no international reference material exists for Lp(a) in mg/dL.

7. The sample size for the training set

   • Not explicitly defined as a "training set" in the context of an AI/ML device. For value assignment and stability studies:
     • Value Assignment Test: 30 replicates were used for each calibrator level.
     • Stability Studies: Involved comparing results over time to assigned values. The number of samples for the initial assignment and subsequent stability checks is not specified in detail beyond the 30 replicates for value assignment.

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

   • As noted above, this device doesn't have a "training set" in the AI/ML sense. The "ground truth" (assigned values for calibrators and controls) was established through:
     • Comparison to a Master lot for calibrators.
     • Multiple runs on the ARCHITECT c8000 System for controls to calculate their mean values and acceptance ranges.
     • In-house reference materials were value-assigned using a commercial EIA method due to the lack of an international reference standard for Lp(a) in mg/dL.

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