(28 days)
The ARCHITECT Free T3 Calibrators are for the ARCHITECT i System when used for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.
The calibrators are devices intended for medical purposes for use in the ARCHITECT Free T 3 assay test system to establish points of reference that are used in the quantitative determination of values in the measurement of substances in human specimens. Free T3 measurements are used as an aid in the assessment of thyroid status. The calibrators are designed to be used on the ARCHITECT i System (i 2000gg, i 2000, and i 1000sR) with the ARCHITECT Free T3 Reagents. The ARCHITECT Free T3 Calibrator kit contains: ARCHITECT Free T3 Calibrator A contains human serum. Preservative: Sodium Azide. ARCHITECT Free T3 Calibrators B through F contain different concentrations of L-Thyroxine and L-Triiodothyronine prepared in human serum. Preservative: Sodium Azide.
This document does not describe a study involving an AI/Machine Learning device or diagnostic imaging. Instead, it is a 510(k) summary for a medical device called "ARCHITECT Free T3 Calibrators," which are used in laboratory settings to calibrate instruments for measuring Free T3 in human serum and plasma.
Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria, study details, expert involvement, or ground truth for an AI/ML diagnostic imaging device, as this document pertains to a laboratory calibrator device.
The document focuses on demonstrating substantial equivalence to a predicate device, primarily by comparing:
- Intended Use: Remains the same.
- Instrumentation: Remains the same (ARCHITECT i System).
- Calibrator Levels: The candidate device uses 6 levels of calibrators (0.0, 1.4, 3.5, 7.0, 17.2, 30.0 pg/mL) compared to the predicate's 2 levels (1.4 and 30 pg/mL). This is a difference but is presented as an enhancement to provide broader calibration.
- Calibrator Composition: Similar, containing L-Thyroxine and L-Triiodothyronine in human serum with sodium azide as a preservative.
- Standardization Method: Remains the same (matched to an Abbott internal reference standard manufactured by gravimetric methods).
- Storage and Stability: Remains the same.
- Preparation for Use: Remains the same (ready to use).
The "study" described is a stability study for the calibrators, not a clinical trial evaluating diagnostic performance of an AI/ML algorithm.
Here's what the document mentions regarding acceptance criteria and the "study" for the calibrators:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a table of "acceptance criteria" in the sense of predefined performance metrics like sensitivity, specificity, or AUC for a diagnostic device. Instead, it discusses stability limits evaluation criteria for the calibrators themselves. The specific criteria are not detailed, but the results are reported:
| Acceptance Criteria (Implied: Meeting stability limits) | Reported Device Performance (Stability Results) |
|---|---|
| In-use stability limit evaluation criteria | The results "support a stability claim for the ARCHITECT Free T3 Calibrators of 11 months at 2 to 8°C." |
| Intended storage (closed vial) stability limit evaluation criteria | The results "support a stability claim of 12 months at 2 to 8°C." (However, the final claim is 11 months, aligning with in-use.) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Stability Test: For the in-use condition, "a minimum of 10 replicates each of the on-test calibrators, reference controls, and reference panel" were used. For the real-time (closed vial) stability study, "three lots of test material" were stored and tested.
- Data Provenance: Not explicitly stated, but it's an internal study conducted by Abbott Laboratories. It's a prospective stability study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a chemical/reagent calibrator, not a diagnostic device requiring expert interpretation of results for ground truth. The "ground truth" for the calibrators themselves is their assigned concentration values established by gravimetric methods and matching to internal reference standards.
4. Adjudication method for the test set:
Not applicable. This is not a clinical study involving human readers or interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
Not applicable. This is not an AI/ML diagnostic device study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is for an in-vitro diagnostic calibrator.
7. The type of ground truth used:
- For the calibrators' intrinsic values: Gravimetric methods and matching to Abbott internal reference standards whose concentrations are established using L-Triiodothyronine (Liothyronine USP) and L-Thyroxine (Levothyroxine USP) as primary standards. This is a form of analytical ground truth based on chemical purity and precise measurement.
- For the stability studies: The "ground truth" is the initial assigned concentration of the calibrators and the expectation that their performance (as measured by the ARCHITECT i System) remains within acceptable limits over time.
8. The sample size for the training set:
Not applicable. There is no concept of a "training set" for this calibrator device. Its "values" are assigned based on a defined manufacturing and standardization process, not learned from data.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.