(21 days)
For in vitro diagnostic use only. VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine. 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 Calibrator Kit 1 is used to calibrate the VITROS Chemistry Systems for the quantitative measurement of BUN/UREA, Ca, CREA, GLU, LAC, Li, Mg, PHOS, SALI, THEO, and URIC.
The VITROS Chemistry Products Ca Slide assay is performed using the VITROS Chemistry Products Ca Slide and the VITROS Chemistry Products Calibrator Kit 1 on the VITROS Chemistry Systems. The VITROS Ca 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 slide.
A drop of patient sample is deposited on the VITROS Ca Slide and is evenly distributed by the spreading layer to the underlying layers. 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 by a VITROS Chemistry System. 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 Calibrator Kit 1 contains three levels of lyophilized standards with corresponding diluents. The standards are prepared from processed bovine serum to which organic analytes, electrolytes, stabilizers, and preservatives have been added. The companion diluents are prepared from processed water to which inorganic salts have been added.
The VITROS Chemistry System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
The provided text describes a 510(k) premarket notification for a medical device, specifically the VITROS Chemistry Products Ca Slides (modified) and VITROS Chemistry Products Calibrator Kit 1. This submission aims to demonstrate substantial equivalence to a legally marketed predicate device.
However, the provided text does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. Instead, it makes a general statement about equivalence being demonstrated and the device being safe and effective.
Here's an analysis of what can be extracted and what information is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states:
"Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured calcium values spanning the assay range."
This is a very high-level statement and does not provide specific acceptance criteria (e.g., accuracy, precision targets) or detailed reported device performance values (e.g., bias, CV%). Therefore, a table cannot be constructed with this information.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "patient and quality control samples," but does not specify the sample size for the test set. It also does not provide data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not mention any experts being used to establish ground truth for a test set. This type of device (an in vitro diagnostic for calcium measurement) typically relies on reference methods or established assays for comparison, not necessarily expert consensus on image interpretation or diagnosis.
4. Adjudication Method for the Test Set:
Since there is no mention of experts or a ground truth established by them, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study information is provided. This type of study is more common for imaging or diagnostic interpretation devices where human readers are involved. This document describes an in vitro diagnostic chemistry assay.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The document describes the device as a standalone diagnostic assay ("VITROS Ca Slides quantitatively measure calcium (Ca) concentration"). The entire submission implicitly describes its standalone performance by comparing it to a predicate device. However, it doesn't present a formal "standalone study" with specific performance metrics and acceptance criteria in the way it might for an AI-powered diagnostic.
7. Type of Ground Truth Used:
The ground truth implicitly used for comparison is "measured calcium values spanning the assay range" from patient and quality control samples. This suggests comparison against a highly accurate reference method or the established predicate device's results. It's not explicitly stated as "pathology" or "outcomes data," but rather established quantitative measurements.
8. Sample Size for the Training Set:
The document does not mention a training set sample size. This device, a chemical assay, does not typically involve "training sets" in the same way machine learning algorithms do. Its performance is established through analytical validation studies (accuracy, precision, linearity, interference, etc.) rather than machine learning training.
9. How the Ground Truth for the Training Set Was Established:
Since there is no mention of a training set, this information is not applicable or provided.
In summary:
The provided 510(k) summary focuses on demonstrating "substantial equivalence" of a modified chemical assay (VITROS Chemistry Products Ca Slides) to a previously cleared predicate device. It highlights changes in manufacturing and composition of a spreading layer component. While it states that equivalence was "demonstrated using manufactured slides along with patient and quality control samples with measured calcium values spanning the assay range," it lacks the granular detail on acceptance criteria, specific performance metrics, sample sizes, expert involvement, and study designs that you requested for a comprehensive "acceptance criteria and study" description. This type of information is typically found in the detailed validation reports that support such a submission, but not necessarily in the summary itself.
§ 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.