(26 days)
The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of total cholesterol in serum and plasma.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in blood and lipoprotein metabolism disorders.
The COBAS Integra Cholesterol Gen.2 is an enzymatic colorimetric assay using cholesterol esterase, cholesterol oxidase, and peroxidase to form a red quinone-imine dye. The color intensity of the dye is directly proportional to the cholesterol concentration.
The provided text does not contain detailed acceptance criteria or a study proving the device meets acceptance criteria in the format requested. The document is a 510(k) summary for the COBAS Integra Cholesterol Gen.2 device, primarily focusing on its substantial equivalence to a predicate device.
However, based on the information provided, here's what can be inferred and what is explicitly stated:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state acceptance criteria in a structured table. Instead, it compares the proposed device's "Measuring range" to the predicate device. This "Measuring range" can be considered a performance characteristic.
| Performance Characteristic | Acceptance Criteria (from Predicate Device) | Reported Device Performance (COBAS Integra Cholesterol Gen.2) |
|---|---|---|
| Measuring range | 3 - 800 mg/dl | 0.1 - 800 mg/dl |
Note: The proposed device actually claims a wider lower detection limit (0.1 mg/dl) compared to the predicate (3 mg/dl), which is an improvement and would implicitly meet or exceed the predicate's lower limit as an "acceptance criterion."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the given text. The 510(k) summary is a high-level overview and does not delve into the specifics of study design or sample sizes for validation.
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):
This information is not provided in the given text. For an in vitro diagnostic device like a cholesterol assay, the "ground truth" is typically established by reference methods or laboratory standards, not by human expert interpretation in the same way it would be for imaging devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the given text. As mentioned above, for this type of device, adjudication by multiple human experts is typically not the method for establishing "ground truth."
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:
This information is not applicable and not provided in the given text. The COBAS Integra Cholesterol Gen.2 is an automated in vitro diagnostic assay, not an AI-assisted diagnostic tool that would involve human readers interpreting output. Therefore, an MRMC study related to human improvement with AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device itself is a standalone algorithm/system (an enzymatic colorimetric assay) for quantitative determination of cholesterol. Its performance is evaluated through analytical studies (e.g., accuracy, precision, linearity, interference) rather than "human-in-the-loop" studies. The document mentions "Enzymatic, colorimetric test" and "quantitative determination," implying a standalone analytical performance. However, specific details of these studies are not provided in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For a quantitative diagnostic assay like cholesterol, the "ground truth" would typically be established by:
- Reference materials/standards: Calibrated solutions with known cholesterol concentrations.
- Reference methods: Highly accurate and precise laboratory methods (e.g., isotope dilution mass spectrometry) against which the device's measurements are compared.
The document does not explicitly state the ground truth method but implies it would be based on established analytical standards for cholesterol measurement.
8. The sample size for the training set:
This information is not provided in the given text. As an enzymatic assay, it doesn't have a "training set" in the machine learning sense. Its development involves chemical optimization and analytical validation, not data training.
9. How the ground truth for the training set was established:
This information is not applicable as there is no "training set" for this type of device in the context of machine learning. The "ground truth" for its development would be based on fundamental chemical and biological principles, and then validated against established analytical standards and reference methods during its performance characterization.
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.