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510(k) Data Aggregation
(56 days)
This in vitro diagnostic method is intended to quantitatively measure thyroid stimulating hormone in human serum or plasma on the Bayer Immuno 1 System. Measurements of TSH, with a 3td Generation sensitivity of <20% total CV at 0.01 uIUmL to 0.02 µIU/mL (as defined by the American Thyroid Association), are used as an aid in the diagnosis of thyroid or pituitary disorders.
This diagnostic method is not intended for use on any other system.
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Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
Device: 3rd Generation TSH Method for the Bayer Immuno 1™ System
Intended Use: To quantitatively measure thyroid stimulating hormone (TSH) in human serum or plasma with 3rd generation sensitivity on the Bayer Immuno 1 System, for use in the diagnosis of thyroid or pituitary disorders.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the performance benchmarks set against legally marketed predicate devices (Bayer Immuno 1 TSH Assay, (Chiron) Ciba-Corning ACS™ TSH-3 Assay, and (Roche) Boehringer-Mannheim Elecsys® TSH Assay). The specific acceptance criterion for sensitivity is explicitly stated in the "Indications For Use" as <20% total CV at 0.01 uIU/mL to 0.02 µIU/mL (as defined by the American Thyroid Association).
| Acceptance Criteria Category | Specific Acceptance Criterion | Reported Device Performance (Bayer Immuno 1 3GEN TSH) | Comparison to Predicate Devices (Examples given in text) |
|---|---|---|---|
| Sensitivity | <20% total CV at 0.01-0.02 µIU/mL | At 0.019 µIU/mL: %CV (total) = 5.1% | Meets criteria, and is competitive with/better than some predicate lowest concentration total CVs (e.g., ACS:180 Total CV for 0.1 µIU/mL is 13.0%, Elecsys Total CV for 0.026 µIU/mL is 15.8%) |
| Expected Values (Normal Range) | Comparable to predicate devices. | 0.31 - 4.7 µIU/mL | Within range of common predicate devices (e.g., ACS:180 TSH: 0.47 - 6.9 µIU/mL; Elecsys TSH: 0.25 - 4.2 µIU/mL) |
| Precision (Within-Run) | Low %CV across different TSH concentrations, comparable to predicate devices. | See table in prompt. Example: 0.019 µIU/mL: 4.1% CV; 4.68 µIU/mL: 2.8% CV. | Appears competitive. For instance, at 4.68 µIU/mL, 2.8% CV is better than ACS:180 TSH-3 at 9.0 µIU/mL (1.7% CV) and ACS:180 (within-run) 4.81 µIU/mL (3.3% CV). |
| Precision (Total) | Low %CV across different TSH concentrations, comparable to predicate devices. | See table in prompt. Example: 0.019 µIU/mL: 5.1% CV; 4.68 µIU/mL: 3.1% CV. | Appears competitive and meets the specific sensitivity criterion. |
| Correlation/Regression | High correlation (r value close to 1) and small Sy.x with predicate devices. | Correlation with TSH (2nd Gen): r = 0.998, Sy.x = 1.655.Correlation with ACS:180: r = 0.996, Sy.x = 0.676.Correlation with Elecsys: r = 0.997, Sy.x = 1.049. | All correlations are very high (close to 1), indicating strong agreement with established methods. The Sy.x values are low, suggesting good quantitative agreement. |
| Specificity (Cross-reactivity) | Low or no significant cross-reactivity with structurally similar compounds. | hCG: < 0.001%LH: < 0.001%FSH: < 0.001% | Demonstrates excellent specificity, as these common interfering hormones show negligible cross-reactivity. |
Study Details:
The document describes a series of performance evaluations rather than a single, formal "study" in the clinical trial sense. The data presented covers analytical performance characteristics.
2. Sample Size Used for the Test Set and Data Provenance
- Precision Tests (within-run and total): n = 20 over 10 days for each concentration level tested. This refers to 20 replicates measured over 10 days. The provenance (country of origin, retrospective/prospective) is not specified in the provided text.
- Correlation/Regression Studies:
- Comparison with TSH (2nd Gen): n = 218 samples.
- Comparison with ACS:180: n = 203 samples.
- Comparison with Elecsys: n = 56 samples.
The provenance of these samples (country of origin, retrospective/prospective) is not specified.
- Specificity (Cross-reactivity) Test: Normal human serum pools were used, spiked with the compounds. The number of pools or specific sample size beyond "pools" is not specified. Provenance is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This device is an in vitro diagnostic (IVD) assay designed to provide quantitative measurements. For such devices, the "ground truth" for analytical performance (precision, accuracy, specificity) is typically established through reference methods, certified standards, or consensus values from established laboratory practices, rather than by human expert review of individual cases.
- The document does not mention the use of human experts to establish ground truth for the test set in the traditional sense of clinical adjudication. The ground truth for comparative studies is the result from the predicate devices or reference methods.
4. Adjudication Method for the Test Set
- Since the ground truth for this type of IVD performance study is based on analytical measurements (predicate device results, certified values, spiked samples), an "adjudication method" involving multiple human readers (e.g., 2+1, 3+1) is not applicable and not described in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- An MRMC study is not applicable to this type of IVD device. The device does not involve human readers interpreting images or data; it provides a quantitative measurement. Therefore, no information on the effect size of human readers improving with AI vs. without AI assistance is present or relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- This device is a standalone algorithm/assay (the "3rd Generation TSH Method"). The performance data presented (precision, correlation, specificity) is the standalone performance of the assay. There is no human-in-the-loop component for the measurement itself, though human interpretation of the results is part of the intended clinical use.
7. Type of Ground Truth Used
- For Precision: The ground truth is assumed to be the known concentration of commercially available controls or spiked samples used in the precision studies.
- For Correlation/Comparison: The ground truth is the measurement obtained from the predicate/established TSH assay methods (TSH (2nd Gen), Ciba-Corning ACS™ TSH-3, Boehringer-Mannheim Elecsys® TSH Assay).
- For Specificity: The ground truth is the known concentration of the spiked cross-reactant and the assumption that a highly specific assay should report negligible or no TSH value in the presence of these interfering substances.
8. Sample Size for the Training Set
- Details about a "training set" are not provided. Immunoassays typically do not involve machine learning models that require a separate, distinct "training set" in the same way AI algorithms do. The development process for an immunoassay involves extensive optimization and validation using various samples, but these are generally considered part of the assay development and analytical validation, not a distinct "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- As a traditional immunoassay, the concept of a "training set" with established ground truth as it applies to AI/ML is not relevant or described. The ground truth for assay development would typically involve reference materials, spiked samples, and comparison to established methods or clinical samples with known TSH levels (e.g., hypothyroid, euthyroid, hyperthyroid). The document doesn't detail this developmental phase specifically.
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