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510(k) Data Aggregation
(29 days)
The ST AIA-PACK hsE2 Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK hsE2 assay.
- 2 x 1 mL ST AIA-PACK hsE2 Calibrator (1) 0 pg/mL Human serum containing no detectable concentration of estradiol with sodium azide as a preservative.
- 2 x 1 mL ST AIA-PACK hsE2 Calibrator (2) 25 pg/mL (approx.)
- ST AIA-PACK hsE2 Calibrator (3) 50 pg/mL (approx.)
- ST AIA-PACK hsE2 Calibrator (4) 100 pg/mL (approx.)
- ST AIA-PACK hsE2 Calibrator (5) 500 pg/mL (approx.)
- ST AIA-PACK hsE2 Calibrator (6) 1,100 pg/mL (approx.)
Human serum containing the assigned concentration of estradiol (described on each vial) with sodium azide as a preservative.
ST AIA-PACK hsE2 Calibrator Set P/N # 025325
The ST AIA-PACK hsE2 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 hsE2 Calibrator Set is designed for use with ST AIA-PACK hsE2 and ST AIA-PACK hsE2 Sample Diluting Solution.
The provided document describes the ST AIA-PACK hsE2 Calibrator Set and its performance.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document details two types of stability studies, each with its own acceptance criteria and results for recovery and reproducibility (CV%).
| Test Type | Acceptance Criteria (Recovery) | Reported Device Performance (Recovery) | Acceptance Criteria (Reproducibility - CV%) | Reported Device Performance (Reproducibility - CV%) |
|---|---|---|---|---|
| Real Time Testing | 100% +/- 10% | Not explicitly stated; "Current Real Time Studies support a 12 month Shelf life at 2-8°C" implies criteria were met | <= 10% | Not explicitly stated; "Current Real Time Studies support a 12 month Shelf life at 2-8°C" implies criteria were met |
| Open Vial Stability | 100% +/- 10% | Not explicitly stated; "Current open vial studies support a reconstituted claim of 1 day when stored at 2-8°C" implies criteria were met | <= 10% | Not explicitly stated; "Current open vial studies support a reconstituted claim of 1 day when stored at 2-8°C" implies criteria were met |
Regarding Value Assignment, separate acceptance criteria are also provided:
| Test Type | Calibrator Levels | N | Acceptance Criteria (Grand Mean CV%) | Reported Device Performance (Grand Mean CV%) |
|---|---|---|---|---|
| Value Assignment (referencing 200 Standard) | Not applicable | Not applicable | < 10% | Not explicitly stated; "The grand mean value is the assigned value if this criteria is met" implies criteria were met |
| Value Assignment (ST-AIA PACK hsE2 Calibrator) | Cal (2) | 5 | < 10% | 6.3 % |
| Cal (3) | 5 | < 10% | 2.5 % | |
| Cal (4) | 5 | < 10% | 1.9 % | |
| Cal (5) | 5 | < 10% | 2.1 % | |
| Cal (6) | 5 | < 10% | 1.5 % |
2. Sample size used for the test set and the data provenance:
- Real Time Testing: The calibrator sets were tested at 6, 12, and 13 months. The exact number of calibrator sets (samples) used for each time point is not specified, but it refers to "ST AIA-PACK hsE2 Calibrator Set" in plural.
- Open Vial Stability: Samples were reconstituted and stored for 0, 7, and 8 days. The exact number of samples tested for each time point is not specified.
- Value Assignment (200 Standard): 5 replicates on each of 2 analyzers and 3 lots of reagent were used. This means 5 * 2 * 3 = 30 measurements for the 200 Standard assignment.
- Value Assignment (ST-AIA PACK hsE2 Calibrator): 5 replicates of each calibrator level on 2 analyzers and 3 lots of reagent were used. For each calibrator level shown in the table (Cal 2-6), this means 5 * 2 * 3 = 30 measurements.
- Data Provenance: The document does not specify the country of origin but implies data was generated internally by Tosoh Bioscience, Inc. The studies appear to be prospective as they involve specific testing protocols to assess stability and value assignment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is a calibrator set for an in vitro diagnostic assay. The "ground truth" here is the assigned concentration of estradiol, which is established through a metrological traceability chain rather than expert consensus on medical images or diagnoses.
- The calibrators are referenced to the IRMM (Institute for Reference Materials and Measurements) CRM577 (Traceability section).
- The 17β-estradiol chemical compound used is from SIGMA, derived from a plant source.
- The "experts" in this context are the analytical chemists and laboratory personnel conducting the value assignment studies, and ultimately, the established reference materials and their certification bodies (like IRMM). The document does not specify the number or qualifications of the personnel performing these lab tests.
4. Adjudication method for the test set:
Not applicable in the traditional sense of clinical interpretations. The "adjudication" for value assignment is based on meeting the predefined statistical acceptance criteria (<10% CV for grand mean).
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 is not applicable. The device is an in vitro diagnostic calibrator set, not an AI-assisted diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a calibrator set, not an algorithm. Its performance is evaluated through analytical stability and accuracy against reference materials.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth for the assigned values of estradiol in the calibrator set is established through:
- Reference Materials: Specifically, the IRMM CRM577.
- Chemical Purity and Dilution: 17β-estradiol purchased from SIGMA and diluted in a base matrix.
- Analytical Measurement: Rigorous analytical testing using multiple replicates, analyzers, and reagent lots, with statistical criteria to assign values.
8. The sample size for the training set:
This is not applicable. As a calibrator set, it does not involve machine learning or a "training set" in the conventional sense of AI development. Its purpose is to calibrate a measurement system.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set.
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