(71 days)
For in vitro diagnostic use only. VITROS Chemistry Products %A1c Reagent Kit is used to calculate percent glycated hemoglobin (%A1c) in pretreated human whole blood by quantitative measurement of hemoglobin (Hb) and hemoglobin A1c (HbA1c). Measurements of percentage Alc are effective in monitoring long-term glucose control in individuals with diabetes mellitus.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 18 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the calculation of percent glycated hemoglobin (%A1c).
For in vitro diagnostic use only. VITROS Chemistry Products %A1c Performance Verifiers are assayed controls used to monitor performance of %A1c Reagent Kit on VITROS 5,1 FS Chemistry Systems.
The VITROS 5,1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS Chemistry System is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.
The system is comprised of four main elements:
- The VITROS 5,1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents.
- The VITROS Chemistry Products range of MicroTip assays, in this case the VITROS Chemistry Products %A1c Reagent Kit, VITROS Chemistry Products Hemolyzing Reagent, VITROS Chemistry Products Calibrator Kit 18, VITROS Chemistry Products FS Calibrator 1, and the VITROS Chemistry Products %A1c Performance Verifiers, which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS %A1c assay.
- The VITROS Chemistry Products Thin Film range of products, which are dry, multilayered, analytical elements, coated on polyester supports.
- Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 2 and VITROS Chemistry Products FS Reconstitution Diluent).
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
The provided text describes the submission for 510(k) clearance of the VITROS Chemistry Products %A1c Assay and related components. It details the device, its intended use, and its comparison to predicate devices, but it does not contain a detailed study proving the device meets specific acceptance criteria in the format requested.
The document states that "studies were performed to determine the precision, expected values, linearity, and specificity of the VITROS %A1c assay," and these results are summarized in the "VITROS Chemistry Products %A1c Reagent Kit Instructions for Use." However, these specific study details, acceptance criteria, and reported performance are not included in the provided text.
Therefore, I cannot provide a complete answer to your request in the specified format from the given text. I can only infer what the general acceptance criteria might be based on the type of study mentioned (correlation, precision, linearity, specificity) for a device like this, but I cannot give the actual criteria and reported performance values.
Here's what I can extract and what is missing, based on your request:
1. A table of acceptance criteria and the reported device performance
Missing. The document states that studies were performed (precision, expected values, linearity, specificity) but does not provide the acceptance criteria for these studies or the reported performance values.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions a "correlation study" that used "patient samples."
- Sample Size for Test Set: Not specified.
- Data Provenance: "patient samples." No country of origin is mentioned. It is implied to be retrospective as existing patient samples would be used for correlation, but not explicitly stated as prospective or retrospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable/Not specified. This is an in-vitro diagnostic (IVD) chemistry assay, not an imaging device requiring expert interpretation for ground truth. The ground truth for such devices is typically established through direct comparison to a reference method or predicate device performance using quantitative measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/None. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiology reads) where discrepancies between readers need resolution. For a quantitative IVD assay, ground truth is typically established by laboratory measurements against a reference method or by comparing to a cleared predicate device, rather than human adjudication.
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
Not applicable. This device is an in-vitro diagnostic chemistry assay, not an AI-powered imaging or diagnostic tool designed to assist human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant or performed for this type of product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, implicitly. This is a standalone diagnostic assay running on an automated chemistry system. The performance characteristics (precision, linearity, specificity, correlation with predicate) would be evaluated for the assay and instrument system without human-in-the-loop performance influencing the assay's direct analytical output. The "algorithm" here is the chemical reaction and measurement process within the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth or reference for comparison appears to be the predicate device's performance (A1c 2.2 Plus Glycohemoglobin Assay, Tosoh Medics, Inc.) as stated in the correlation study:
"The relationship between the VITROS %A1c assay and the predicate device in NGSP units, determined by least squares linear regression, is: VITROS %A1c assay = 1.0374 X = 0.3426 %A1c with a correlation coefficient of 0.9872, where X is the Tosoh A1c 2.2 Plus Glycohemoglobin Assay on the TOSOH Automated Glycohemoglobin Analyzer."
Additionally, the device's standardization is "Traceable to both the Diabetes Control and Complications Trial (DCCT) and IFCC reference methods and Certified by the National Glycohemoglobin Standardization Program (NGSP)," which implies these reference methods also form the basis of the "ground truth" for accurate HbA1c measurement.
8. The sample size for the training set
Not applicable/Not specified. This is a chemical assay, not a machine learning or AI model that requires a "training set" in the conventional sense. The "training" of the device involves calibration using calibrator kits. The document refers to "Calibrator Kit 18" and "FS Calibrator 1" for calibration but does not specify a sample size for this training/calibration process in terms of patient samples.
9. How the ground truth for the training set was established
Not applicable (for a training set in the AI sense). For the calibration process (analogous to "training" for IVDs), the ground truth is established by using calibrator kits (VITROS Chemistry Products Calibrator Kit 18 and VITROS Chemistry Products FS Calibrator 1). These calibrators have known, assigned values traceable to reference methods (DCCT and IFCC, and NGSP certified). The instrument uses these known values to establish its measurement curve.
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).