(25 days)
For in vitro diagnostic use only. VITROS Ca DT Slides quantitatively measure calcium (Ca) concentration in serum and plasma. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disorders, chronic renal disease and tetany (intermittent muscular contractions or spasms).
For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMY, AST, TBIL, NBIL, BUN/CREA, Ca, CHOL, CK, CI, CO2 CREA, CRSC, Fe, GGT, GLU, HDLC, K*, LAC, LDH, LIPA, Mg, Na*, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.
The VITROS Chemistry Products Ca DT Slide assay is performed using the VITROS Chemistry Products Ca DT Slide and the VITROS Chemistry Products DT Calibrator Kit on the VITROS DT60/ DT60 II Chemistry Systems. The VITROS Ca DT Slide is a multilayered, analytical element coated on a polyester support. All reactions necessary for a single quantitative measurement of calcium take place within the multi-layered analytical element of a VITROS Chemistry Products Ca DT slide. A drop of patient sample is deposited on the VITROS Ca DT Slide and is evenly distributed by the spreading layer to the underlying lavers. The bound calcium is dissociated from binding proteins, allowing the calcium to penetrate through the spreading layer into the underlying reagent layer. In the reagent layer, the calcium forms a complex with Arsenazo III dye, causing a shift in the absorption maximum. After incubation, the reflection density of the colored complex is measured spectrophotometrically. The amount of colored complex formed is proportional to the calcium concentration in the sample fluid. The test result is reported in milligrams per deciliter (mg/dL) or millimoles per liter (mmol/ L). VITROS Chemistry Products DT Calibrator Kit contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from bovine serum albumin and processed bovine serum to which enzymes, electrolytes, stabilizers, preservatives and other organic analytes have been added. The companion diluents are prepared from processed water to which inorganic salts have been added. The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the VITROS Chemistry Products Ca DT Slides.
Disclaimer: The provided document is a 510(k) summary for a diagnostic test system, not a typical document detailing AI/ML model performance. Therefore, many standard AI/ML study components (like expert ground truth, MRMC studies, training set details) are not applicable or explicitly mentioned in this type of submission. The analysis below extracts what is available and notes what is not.
Acceptance Criteria and Reported Device Performance
The document describes a modification to an existing device, the VITROS Chemistry Products Ca DT Slides, and asserts its substantial equivalence to the predicate device. The primary characteristics compared are:
| Device Characteristic | New Device VITROS Chemistry Products Ca DT Slide (Modified) | Predicate Device VITROS Chemistry Products Ca DT Slide (Current) | Reported Performance (Implied Acceptance) |
|---|---|---|---|
| Intended Use | No Change | For in vitro diagnostic use only. VITROS Ca DT Slides quantitatively measure calcium (Ca) concentration in serum and plasma. | The modified device maintains the same intended use. This implies performance must meet the requirements for this intended use. |
| Fundamental scientific technology | No Change | Dry, multilayered slide utilizing spectrophotometrics | The core technology and methodology remain unchanged, implying similar performance characteristics. |
| Test Type | No Change | Colorimetric | The colorimetric detection method is unchanged. |
| Reactive Ingredients per cm² | No Change | Arsenazo III dye 60 µg | The key reactive ingredient and its concentration are unchanged. |
| Sample type | No Change | Serum and plasma | The device continues to be validated for serum and plasma samples. |
| Instrumentation | No Change | VITROS DT60/DT60 II Chemistry Systems | The device is compatible with the same instrumentation, indicating no change in operational performance. |
| Composition of the Spreading Layer* | TiO2: New Supplier | ||
| Cellulose Acetate: New lot | |||
| Estane: Increased to 1.7 times the current level (70% increase). | TiO2, Cellulose Acetate, Estane, Surfactants. | The document implies that despite changes in the spreading layer composition, the overall performance remains substantially equivalent. This is the primary area of modification and thus the focus for proving equivalence. | |
| Manufacturing Process Changes* | Increased concentration of Estane raised viscosity, requiring modifications to solution delivery system and non-solvent flow rate. | Current Manufacturing Process. | Modifications were made to the manufacturing process to accommodate the higher Estane concentration, with the implication that these changes did not negatively impact performance. |
Acceptance Criteria (Implicit from Substantial Equivalence): The fundamental acceptance criterion for this 510(k) submission is substantial equivalence to the predicate device. This means the modified device must perform comparably to the previously cleared device, not introducing new questions of safety oreffectiveness. The "reported device performance" is essentially the claim of substantial equivalence, backed by data showing comparable analytical performance to the predicate.
Study Details (Based on an IVD 510(k) Submission)
2. Sample size used for the test set and the data provenance:
- Sample Size: "patient and quality control samples with measured calcium values spanning the assay range." (Page 3) No specific number of samples is given.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in the sense that it evaluates the modified device's performance against historical or concurrent data from the predicate device. It is a performance verification rather than a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable for this type of in vitro diagnostic device submission concerning analytical performance. The "ground truth" for a calcium assay is typically established through reference methods or the predicate device's measured values, not by human expert interpretation.
4. Adjudication method for the test set:
- Not applicable. This pertains to expert consensus on interpretation, which is not relevant for a quantitative chemical assay.
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:
- No. This is an in vitro diagnostic device for quantitative measurement, not an AI/ML-based diagnostic imaging or assessment tool. Therefore, MRMC studies and human reader improvement with AI are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. The device is an automated, quantitative chemical assay. Its performance is measured independently of human interpretation of the result (though humans operate the instrument and interpret the final numerical value relative to clinical ranges). The "algorithm" here is the chemical reaction and spectrophotometric measurement, which operates in a standalone fashion.
7. The type of ground truth used:
- The ground truth for this type of IVD device is the actual calcium concentration in the samples. This would be established by:
- Reference methods or highly characterized control materials.
- Agreement with the predicate device's measurements for comparison/equivalence.
- The "measured calcium values spanning the assay range" implies these are known or established concentrations against which the device's accuracy and precision are evaluated.
8. The sample size for the training set:
- Not applicable in the context of AI/ML training sets. This device system, while involving some manufacturing process adjustments, is based on established chemical principles, not a machine learning model that undergoes a "training" phase with a dataset. The "training" in this context refers to the calibration of the instrument, for which the VITROS Chemistry Products DT Calibrator Kit is used. The calibrator kit contains "four levels of lyophilized standards." (Page 2)
9. How the ground truth for the training set was established:
- For the calibrator kit (which serves a similar function to a training set in establishing the measurement curve), the ground truth (assigned values for each of the four levels) would be established by certified reference materials and/or traceability to international standards for calcium measurement. The document states they are "lyophilized standards" prepared from "bovine serum albumin and processed bovine serum," with "enzymes, electrolytes, stabilizers, preservatives and other organic analytes" added (Page 2).
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.