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510(k) Data Aggregation
(24 days)
This in vitro method is intended to quantitatively measure Free T3 in human serum on a Technicon Immuno-1 system. Measurements of Free T3 are used in the diagnosis and treatment of thyroid diseases.
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The request asks to describe the acceptance criteria and the study proving the device meets these criteria, based on the provided text.
Based on the provided text, the "Free T3 Method for Bayer Technicon Immuno 1® System" is being compared to a "Clinical Assays 'GammaCoat' Free T3 RIA kit" (predicate device) to demonstrate substantial equivalence. The acceptance criteria are implicitly derived from the performance characteristics of the predicate device, with the Immuno 1 Free T3 method demonstrating comparable or superior performance.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as target values but are inferred from the performance of the predicate device (Clinical Assays Free T3 method). The new device (Immuno 1 Free T3) is shown to have comparable performance.
| Performance Metric | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Immuno 1 Free T3) |
|---|---|---|
| Minimum Detectable Conc. | 0.02 pg/mL | 0.2 pg/mL |
| Precision (Between-Run) | ||
| - at 2.2 pg/mL | 6.9% | 8.2% (at 1.7 pg/mL) |
| - at 8.3 pg/mL | 7.1% | 4.1% (at 5.4 pg/mL) |
| - at 15.8 pg/mL | 8.4% | 2.7% (at 12.8 pg/mL) |
| Correlation | (Reference: Clinical Assays Free T3 method) | y = 0.95x - 0.08 r = 0.94 Svx = 0.71 pg/mL (where y = Immuno 1, x = Clinical Assays, n = 103) |
| Specificity (% Crossreactivity) | (Immuton 1 performance generally comparable to or better than Clinical Assays for reported substances) | |
| Diiodo-L-tyrosine | <0.02 | <0.1 |
| 3-Iodo-L-tyrosine | <0.02 | <0.1 |
| Methimazole | N/R | 0.0 |
| Phenylbutazone | <0.02 | <0.1 |
| 6-n-Propyl-2-thyouracil | N/R | <0.1 |
| Tetraiodothyro-acetic acid | N/R | <0.1 |
| L-Thyroxine (T4) | <0.02 | <0.1 |
| D-Thyroxine | <0.02 | <0.1 |
| Ibuprofen | N/R | 0 |
| Phenobarbital | N/R | 0 |
| Phenytoin | N/R | 0 |
| Acetaminophen | N/R | 0 |
| 3,5 Diiodo-L-Thyronine | <0.02 | <0.1 |
| Acetyl Salicylic Acid | N/R | <0.1 |
| Heparinic Acid | N/R | <0.1 |
| L-3,3'5'Triiodo-Thyronine | N/R | 0.34 |
| Triiodothyroacetic acid | N/R | 0.37 |
| Fenoprofen | N/R | <0.1 |
Note on "Minimum Detectable Conc.": The Immuno 1 method has a higher minimum detectable concentration (0.2 pg/mL) compared to the predicate (0.02 pg/mL). This might be a point of difference rather than direct equivalence. However, the overall context implies that the performance is considered acceptable for the intended use despite this difference, possibly due to other strong performance indicators.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: 103 (for the correlation study, indicated by 'n=103').
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The document is a summary for regulatory affairs in Tarrytown, New York, US, but doesn't specify the source of the samples themselves. It's likely from clinical samples used in a laboratory setting for method comparison. It is presumed to be retrospective data from internal studies for method validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This study involves the comparison of one quantitative assay (Immuno 1 Free T3) against a cleared predicate device (Clinical Assays Free T3 RIA kit). The "ground truth" for the test set is established by the measurements from the predicate device, which itself is a laboratory assay. No human expert interpretation of images or clinical cases is involved in establishing ground truth for this type of in vitro diagnostic device performance study.
4. Adjudication method for the test set
Not applicable. This is a quantitative assay comparison study, not a study involving human interpretation or adjudication for diagnostic outcomes. The comparison is based on numerical results from two different measurement methods.
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
Not applicable. This is an in vitro diagnostic (IVD) device comparison study, not a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in essence, the study presents the standalone performance of the Immuno 1 Free T3 method (the 'algorithm' in this context) and compares its numerical output directly against the standalone numerical output of the predicate device. There is no human-in-the-loop component in the measurement process for either device.
7. The type of ground truth used
The "ground truth" (or reference standard) for evaluating the Immuno 1 Free T3 method's performance is the measurements obtained from the Clinical Assays 'GammaCoat' Free T3 RIA kit. This is a quantitative measurement from an already cleared diagnostic device, serving as the benchmark for comparison.
8. The sample size for the training set
Not applicable. This document describes a method comparison study for an IVD device, not a machine learning or AI algorithm where a separate "training set" would typically be defined. The device itself (Immuno 1 Free T3 method) is a biochemical assay, not a learning algorithm that requires a training set in the computational sense.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an IVD assay method comparison.
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