(19 days)
VITROS Chemistry Products ALB Slides For in vitro diagnostic use only. VITROS ALB Slides quantitatively measure albumin (AL concentration in serum and plasma.
VITROS Calibrator Kit 4 For in vitro diagnostic use only. VITROS Calibrator Kit 4 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of ALB, BuBc, Fe, TBIL, TIBC, and TP.
The VITROS Chemistry System uses Vitros Slides to perform discrete chemistry tests on body fluid specimens. All reactions necessary for a single quantitative measurement take place within the multi-layered analytical element of a Vitros Slide.
The system is comprised of two main elements:
- The VITROS Chemistry Products range of chemistry products (in this case VITROS Chemistry Products ALB Slides, VITROS Chemistry Products Calibrator Kit 4, which are combined by the VITROS Chemistry System to perform the VITROS ALB test.
- The VITROS Chemistry System instrumentation, which provides automated use of the chemistry slides.
The provided document describes a 510(k) premarket notification for a modified in vitro diagnostic device, the VITROS Chemistry Products ALB Slides and VITROS Chemistry Products Calibrator Kit 4. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than outright performance acceptance criteria against a defined standard.
Therefore, the acceptance criteria and study details are primarily presented in terms of comparative equivalence to the predicate device, rather than explicit numerical thresholds.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state numerical acceptance criteria in the typical sense (e.g., sensitivity > X%, specificity > Y%). Instead, the "acceptance criteria" appear to be demonstration of substantial equivalence to the predicate device, particularly through performance with "patient and quality control samples with measured albumin values spanning the assay range."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (VITROS Chemistry Products ALB Slide (current) and VITROS Chemistry Products Calibrator Kit 4) | Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured albumin values spanning the assay range. |
| No significant change in clinical performance despite changes in sample volume (5.5 µL vs 10 µL) and quantity of reactive ingredients (bromcresol green dye: 125.4 µg vs 250 µg). | The information presented in the pre-market notification demonstrates that the performance of the VITROS ALB Slides (modified) for use with human serum and plasma is substantially equivalent to the cleared predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document only generically states "patient and quality control samples." No specific number is provided for the test set.
- Data Provenance: Not specified within the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For in vitro diagnostic devices like this, "ground truth" for albumin measurement is typically established by reference methods or highly accurate laboratory analyzers, not human expert consensus like in image analysis.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. As an in vitro diagnostic device measuring a quantitative biomarker, adjudication by human readers is not relevant. The "ground truth" would be established by laboratory methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers Improve with AI vs without AI Assistance
This information is not applicable and therefore not provided. This device is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging or decision support tool involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself is a standalone measurement system (an automated chemistry analyzer utilizing specific slides and calibrators). The "algorithm" here refers to the chemical reaction and reflectance spectrophotometry, not a machine learning algorithm. The study effectively assesses the standalone performance of this system against the predicate system. The performance is assessed without human interpretation of raw data, beyond operating the instrument and reviewing results.
7. The Type of Ground Truth Used
For this type of in vitro diagnostic device, the ground truth would be established by:
- Reference laboratory methods: Established, highly accurate methods for measuring albumin concentration.
- Predicate device results: As the goal is substantial equivalence, the results from the predicate device often serve as a comparative ground truth for the new device.
- Known concentrations in quality control samples: Quality control materials have certified albumin concentrations.
The document states "patient and quality control samples with measured albumin values." This implies that these samples had their albumin values determined by a reliable method (likely the predicate device or a reference method) to serve as the ground truth for comparison.
8. The Sample Size for the Training Set
This information is not provided and is largely not applicable in the context of this device. This is a chemical assay, not a machine learning model that requires a "training set" in the computational sense. The "training" of such a system involves the development and optimization of the chemical reagents and instrument parameters, which is a different process than data-driven machine learning training.
9. How the Ground Truth for the Training Set was Established
As explained above, the concept of a "training set" and associated "ground truth" in the machine learning sense does not directly apply to this in vitro diagnostic device. The development process would involve extensive experimentation and optimization against known chemical standards and clinical samples, but this is not typically referred to as establishing ground truth for a training set in regulatory submissions for chemical assays.
§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.