(30 days)
The ST AIA-PACK PROG II Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK PROG II assay.
2 x 1 mL ST AIA-PACK PROG II Calibrator (1) 0 ng/mL Protein matrix containing no detectable concentration of PROG with sodium azide as a preservative (Liquid).
2 x 1 mL ST AIA-PACK PROG II Calibrator (2) 0.5 ng/mL (approx.)
ST AIA-PACK PROG II Calibrator (3) 1.5 ng/mL (approx.)
ST AIA-PACK PROG II Calibrator (4) 5.0 ng/mL (approx.)
ST AIA-PACK PROG II Calibrator (5) 15 ng/mL (approx.)
ST AIA-PACK PROG II Calibrator (6) 45 ng/mL (approx.)
Human serum containing the assigned concentration of progesterone (described on each vial) with sodium azide as a preservative.
The ST AIA-PACK PROG II 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 II Calibrator Set is designed for use with ST AIA-PACK PROG II and ST AIA-PACK PROG II Sample Diluting Solution.
Here's a breakdown of the acceptance criteria and study information for the ST AIA-PACK PROG II Calibrator Set, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Stability) | Requirement | Reported Performance (ST AIA-PACK PROG II Calibrator Set) |
|---|---|---|
| Real-Time Stability | Recovery within 100 ± 10% | Met (supports 6-month shelf life) |
| Real-Time Stability | Reproducibility (CV%) ≤ 10% | Met (supports 6-month shelf life) |
| Open Vial Stability | Recovery within 100 ± 10% | Met (supports 1-day reconstituted claim) |
| Open Vial Stability | Reproducibility (CV%) ≤ 10% | Met (supports 1-day reconstituted claim) |
| Value Assignment Precision | Precision (CV%) ≤ 10% | Met (all calibrator levels were ≤ 5.8%) |
| Acceptance Criterion (Value Assignment - Precision) | Test for Calibrator levels (Mean CV%) |
|---|---|
| CV% ≤ 10% (for 5 replicates) | Cal (2): 5.8% |
| Cal (3): 3.5% | |
| Cal (4): 1.9% | |
| Cal (5): 2.2% | |
| Cal (6): 1.8% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- For stability studies (Real-Time and Open Vial): The exact number of individual samples tested isn't explicitly stated, but it mentions "AIA-PACK Progesterone Calibrator Set were stored..." and "Samples were reconstituted..." implying multiple sets or vials.
- For value assignment: 5 replicates for each of the 5 calibrator levels (Cal 2-6) were analyzed.
- Data Provenance: The document does not specify the country of origin for the data. The data appears to be prospective as it involves the testing of the newly formulated ST AIA-PACK PROG II Calibrator Set under defined conditions (stability studies, value assignment protocol).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not mention the use of experts to establish the ground truth for the test set.
- The ground truth for the calibrators is established through a chain of traceability:
- Primary reference material uses USP (United States Pharmacopeia) Standard as calibrator.
- Secondary reference material is assigned against the primary reference material.
- Product calibrators are assigned against the secondary reference material.
- The "experts" are the "Tosoh AIA-2000" instruments and the established calibration process rooted in the USP Standard.
4. Adjudication Method for the Test Set
- No human adjudication method (e.g., 2+1, 3+1) is mentioned or implied for the test set.
- The determination of acceptance is based on quantitative measurements against predefined criteria (recovery % and CV%).
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
- No, an MRMC comparative effectiveness study was not done.
- This device is a calibrator set for an in vitro diagnostic assay, not an AI-powered diagnostic tool that assists human readers. Therefore, this type of study is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This device is a calibrator set, not an algorithm. Therefore, "standalone algorithm performance" is not applicable in the context of AI.
- However, the performance of the calibrator itself is tested in a "standalone" fashion in that its stability and assigned values are determined within the analytical system (Tosoh AIA-2000 with the specified assay) without human interpretation being part of the performance measurement itself. The results are quantitative and objective based on instrument readings.
7. The Type of Ground Truth Used
- The ground truth for the calibrator values is established based on a reference standard and hierarchical assignment process:
- The highest level of truth is the USP (United States Pharmacopeia) Standard for progesterone.
- Subsequent calibrator lots and levels are then assigned values through a traceable process against this primary reference and internal secondary standards.
8. The Sample Size for the Training Set
- This document describes a calibrator set and its performance validation, not a machine learning or AI model. Therefore, there is no training set in the context of AI. The "training" for this device would be analogous to the manufacturing and value assignment process itself, ensuring each lot meets specifications.
9. How the Ground Truth for the Training Set Was Established
- N/A, as there is no training set in the AI context. The ground truth for the calibrator's assigned values is established through traceability to the USP Standard as described in point 7.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.