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2 x 1 mL ST AIA-PACK PROG III Calibrator (1) 0 nq/mL Bovine protein matrix containing no detectable concentration of progesterone with sodium azide as a preservative (Liquid).
2 x 1 mL ST AIA-PACK PROG III Calibrator (2) 0.5 ng/mL (approx.)
ST AIA-PACK PROG III Calibrator (3) 1.5 ng/mL (approx.)
ST AIA-PACK PROG III Calibrator (4) 5.0 ng/mL (approx.)
ST AIA-PACK PROG III Calibrator (5) 15 ng/mL (approx.)
ST AIA-PACK PROG III Calibrator (6) 45 ng/mL (approx.)
Bovine protein matrix containing the assigned concentration of progesterone (described on each vial) with sodium azide as a preservative.
The ST AIA-PACK PROG III Calibrator Set is designed specifically for use on the Tosoh AIA System Analyzers which have been previously cleared as a family of instruments under K971103. Only materials obtained from Tosoh should be used. Materials obtained elsewhere should not be substituted since assay performance is characterized based strictly on Tosoh materials.
The ST AIA-PACK PROG III Calibrator Set is designed for use with ST AIA-PACK PROG III and ST AIA-PACK PROG III Sample Diluting Solution.

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Acceptance Criteria and Device Performance Study for ST AIA-PACK PROG III Calibrator Set

This document describes the ST AIA-PACK PROG III Calibrator Set, a device intended for in vitro diagnostic use for the calibration of the ST AIA-PACK PROG III assay. The information provided heavily focuses on stability and value assignment studies to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Study Type	Acceptance Criteria	Reported Device Performance
Real Time Stability (Shelf Life)	Recovery: 100 +/- 10%	Supports an 8-month shelf life at 2-8°C.
	Reproducibility (CV%): ≤ 10%	(Specific CV% values not provided for shelf life, but implied to meet criteria)
Open Vial Stability	Recovery: 100 +/- 10%	Supports a 1-day reconstituted claim when stored at 2-8°C.
	Reproducibility (CV%): ≤ 10%	(Specific CV% values not provided for open vial, but implied to meet criteria)
Value Assignment Precision	Precision (CV%): Within 10% (for each calibrator level)	Cal (2): 4.8% CV
Cal (3): 2.2% CV
Cal (4): 2.2% CV
Cal (5): 2.0% CV
Cal (6): 2.9% CV
Value Assignment Recovery	(Not explicitly stated as an acceptance criterion for individual calibrator levels but implied by "assigned value" and "Reference Value")	Cal (2) Mean: 0.504 ng/mL (Reference: 0.5 ng/mL)
Cal (3) Mean: 1.53 ng/mL (Reference: 1.5 ng/mL)
Cal (4) Mean: 5.08 ng/mL (Reference: 5.0 ng/mL)
Cal (5) Mean: 15.0 ng/mL (Reference: 15 ng/mL)
Cal (6) Mean: 45.5 ng/mL (Reference: 45 ng/mL)

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

Test Set Sample Size:
- Real Time Stability: Not explicitly stated, but calibrator sets were assayed at 3, 6, and 9 months (implied multiple samples/replicates at each time point).
- Open Vial Stability: Not explicitly stated, but samples were "reconstituted and stored... for 2 days and tested."
- Value Assignment: 5 replicates of the test calibrator were analyzed for each calibrator level (Cal 2-6).
Data Provenance: Not specified, but generally, such studies for regulatory submission are prospective and conducted in-house or by contract research organizations under the manufacturer's control. No country of origin is explicitly mentioned for the data itself, beyond the US location of the submitter.

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

This device is a calibrator set for an in vitro diagnostic assay, not an AI or imaging device requiring human expert ground truth. The "ground truth" for calibrators is related to the reference materials and their assigned concentrations.
For Value Assignment: The primary reference material was USP (United States Pharmacopeia) Standard (Lot #I1J239). The progesterone value of this reference material was assigned gravimetrically, which is a chemical/analytical method, not typically involving human expert consensus in the diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable. This is a calibrator set for an in vitro diagnostic device, and adjudication methods (like 2+1, 3+1 for medical image interpretation) are not relevant here. The evaluation relies on analytical performance criteria (recovery, CV%) against established reference values.

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

No. This is not an AI or imaging device; therefore, an MRMC study is not relevant.

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

The device itself is a calibrator, which is a reagent used by an instrument. Its performance is evaluated analytically, which is inherently "standalone" in the sense that its function (calibration) is determined by its chemical and physical properties and how it interacts with the instrument. There isn't an "algorithm only" performance metric in the typical sense of AI. The "algorithm" here is the assay procedure itself on the Tosoh AIA System Analyzers, and the calibrator's performance helps ensure the accuracy of that system.

7. The Type of Ground Truth Used

Analytical/Reference Standard: The ground truth for the calibrator concentrations is established by referring to the USP (United States Pharmacopeia) Standard (Lot #I1J239). The values were assigned gravimetrically (for the primary reference material). This is a highly controlled chemical/analytical method, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is an in vitro diagnostic calibrator, not an AI model that requires a training set of data. The "training" in this context refers to the development and manufacturing of the calibrator itself, where the concentrations are established and verified against reference standards.

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

Not applicable, as there is no "training set" in the AI sense for this type of device. The "ground truth" for the calibrator's assigned values is based on traceability to the USP (United States Pharmacopeia) Standard (Lot #I1J239), with primary reference material values assigned gravimetrically. These are highly standardized analytical procedures to ensure accuracy and consistency. The product calibrator values were then assigned using AIA-2000 instruments with the secondary reference material as calibrator.

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