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510(k) Data Aggregation
(80 days)
For in vitro diagnostic use only. VITROS Chemistry Products AAT Reagent is used to quantitatively measure α₁-antitrypsin concentration in human serum. The measurement of α₁-antitrypsin in serum aids in the diagnosis of cirrhosis of the liver and pulmonary emphysema.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of α₁-antitrypsin (AAT).
For in vitro diagnostic use only. VITROS Chemistry Products AAT Performance Verifiers are assayed controls used to monitor performance of VITROS AAT Reagents on VITROS 5,1 FS Chemistry Systems.
The VITROS Chemistry Products AAT Reagent is used in conjunction with the VITROS Chemistry Products Calibrator Kit 99 and VITROS Chemistry Products FS Diluent Pack 2 (BSA/Saline) on VITROS 5,1 FS Chemistry Systems for the quantitative measurement of α₁-antitrypsin (AAT) in human serum.
The VITROS AAT Reagent is a dual chambered package containing ready-to-use liquid reagents. Samples, calibrators and controls are automatically diluted in saline from VITROS FS Diluent Pack 2 and mixed with Reagent 1 containing a polymer. Addition of antisera specific for human α₁-antitrypsin (Reagent 2) produces an immunochemical reaction yielding antigen/antibody complexes. The light scattering properties of the antigen/antibody complexes increase solution turbidity proportional to α₁-antitrypsin concentration in the sample. The turbidity is measured spectrophotometrically at 340 nm. Once a calibration has been performed for each reagent lot, the a1-antitrypsin concentration in each unknown sample can be determined using the stored calibration curve and the measured absorbance obtained in the assay of the sample.
The VITROS Chemistry Products Calibrator Kit 99 are prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added. These standards are used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of α₁-antitrypsin (AAT).
The VITROS Chemistry Products FS Diluent Pack 2 (BSA/Saline) is a common reagent that is used by multiple assays on the VITROS 5,1 FS System. This is a dual chambered package containing two ready-to-use liquid diluents. Diluent 1 is prepared from processed water to which inorganic salt has been added. Diluent 2 is prepared from processed water to which bovine serum albumin, inorganic salts and preservatives have been added.
The VITROS 5,1 FS Chemistry System is a clinical chemistry instrument that provides automated use of the VITROS Chemistry Products MicroTip® and MicroSlides® range of products. The VITROS 5,1 FS System was cleared for market by 510(k) premarket notification (K031924).
The VITROS Chemistry Products AAT Performance Verifiers I, II and III are prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added. These are assayed controls used to monitor performance of VITROS AAT Reagent on VITROS 5,1 FS Chemistry Systems.
Here's an analysis of the acceptance criteria and supporting studies for the VITROS Chemistry Products AAT Reagent, Calibrator Kit 99, and Performance Verifiers, based on the provided text.
Note: This document describes an in vitro diagnostic device, not an AI/ML-driven medical device for image analysis as might be typical for some of these questions. Therefore, some of the requested categories (e.g., number of experts for ground truth, adjudication method, MRMC study, sample size for training set) are not directly applicable or are not explicitly detailed in the provided text for this type of device. I will address the relevant sections and note when information is not present or applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit, quantifiable acceptance criteria with specific performance targets (like sensitivity/specificity for clinical decisions). Instead, performance is shown through correlation and comparison to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Correlation with Predicate Device (AAT Reagent) | Passing & Bablock linear regression: y = 0.93x + 2.06 mg/dL (where y = VITROS AAT assay, x = IMMAGE AAT assay) |
| Specificity Validation | Bench testing performed (details not quantified) |
| Expected Values Validation | Bench testing performed (details not quantified) |
| Limit of Detection Validation | Bench testing performed (details not quantified) |
| Dilution Validation | Bench testing performed (details not quantified) |
| Specimen Matrix Validation | Bench testing performed (details not quantified) |
| Reportable Range (AAT Reagent) | 30.00 - 450.00 mg/dL (VITROS AAT assay) vs. 10 - 3,600 mg/dL (IMMAGE AAT assay). Note: This is a difference, not necessarily an "acceptance criterion" per se, but a characteristic acknowledged. |
| Intended Use Equivalence (AAT Reagent) | Quantitative measurement of α₁-antitrypsin in human samples to aid in diagnosis of α₁-antitrypsin deficiency. |
| Intended Use Equivalence (Performance Verifiers) | Assayed controls used to monitor performance on VITROS Chemistry Systems. |
| Assay Method Equivalence (AAT Reagent) | Immunoturbidimetric (New) vs. Nephelometric (Predicate). Note: This is a difference, but overall equivalence was demonstrated. |
| Calibrator Levels & Format Equivalence (AAT Reagent) | Five levels, Liquid (New) vs. Single level, Lyophilized (Predicate). Note: Differences acknowledged, but overall equivalence demonstrated. |
| Analyte Equivalence (Performance Verifiers) | α₁-Antitrypsin (AAT) (New) vs. Several including C3, C4, IgA, IgG, IgM, transferrin (Predicate). Note: Difference acknowledged, but specific for AAT. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions that equivalence was demonstrated "using a commercially available assay along with patient samples." However, the exact number of patient samples used in the correlation studies (test set) is not specified in the provided text.
- Data Provenance: The data provenance is stated as "patient samples," but the country of origin or whether it was retrospective or prospective data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable in the context of this in vitro diagnostic device. The "ground truth" for an AAT assay would typically be established by comparing its results to a well-established reference method or a predicate device on patient samples, based on quantitative measurements rather than expert interpretation of images or clinical cases.
4. Adjudication Method for the Test Set
This question is not applicable for this in vitro diagnostic device. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation where experts disagree), not for quantitative chemical measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used for diagnostic imaging devices where human readers interpret cases, and performance with/without AI assistance is evaluated. This document describes a chemical assay, not an imaging device with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes, a standalone performance study was done. The entire submission describes the performance of the VITROS AAT assay system (reagent, calibrator, verifiers, and instrument) as a standalone device to measure α₁-antitrypsin concentration in human serum. Its performance is compared to a predicate device and validated through various bench tests (specificity, expected values, limit of detection, dilution, specimen matrix). The "algorithm" in this context is the immunoturbidimetric chemical reaction and the spectrophotometric measurement by the VITROS 5,1 FS Chemistry System.
7. The Type of Ground Truth Used
The ground truth for validating the VITROS Chemistry Products AAT assay was established through comparison to a predicate device (IMMAGE® Immunochemistry Systems AAT assay) using patient samples, and through bench testing for various analytical performance characteristics (specificity, limit of detection, etc.). For a quantitative chemical assay, the "ground truth" is typically a known, well-characterized value or the result obtained from a recognized reference method.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of an AI/ML algorithm. For an IVD assay like this, product development involves a series of experiments and optimizations to establish reagent formulations, calibration curves, and analytical procedures. The phrase "training set" doesn't directly apply in the same way it would for AI model development. The development data used to optimize the assay would implicitly serve this purpose, but its sample size is not specified.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" ground truth as applied to AI/ML isn't directly applicable here. The development of the assay would involve establishing the expected concentrations of AAT in various samples, using reference methods or characterized materials, to ensure the assay accurately measures the analyte. The specific methodology or exact sample sizes for this developmental phase are not provided in the summary.
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