(18 days)
Dade TRU-Liquid Bilirubin Control is intended for use as an assayed quality control material in clinical laboratory quality assurance programs and in the monitoring of accuracy and precision.in the clinical laboratory assay of ... .. bilirubin.
Dade® TRU-Liquid™ Bilirubin Control Levels 1,2 and 3. Liquid Tri-Level Bilirubin Control. Quality Control Material (Assayed and Unassayed).
This is a 510(k) summary for a quality control material, not a medical device in the typical sense that would have performance criteria related to patient diagnosis or treatment. The acceptance criteria and "study" described are focused on demonstrating substantial equivalence to a predicate device, which is a different type of evaluation than assessing clinical performance.
Here's an analysis of the provided text in the context of your request:
1. A table of acceptance criteria and the reported device performance
The provided document does not contain a table of acceptance criteria or reported device performance in the way you might expect for a diagnostic or therapeutic device. Instead, the "acceptance criterion" for a 510(k) submission for a quality control material is substantial equivalence to an already legally marketed predicate device.
The document states:
"The proposed Dade® TRU-Liquid™ Bilirubin Control is substantially equivalent to the ChemTrak Liquid Bilirubin Control manufactured by Medical Analysis Systems, previously cleared under Document Control No., K833097, on 1/11/84."
Acceptance Criteria for Substantial Equivalence (Inferred):
The acceptance criteria for a quality control material like this would typically involve demonstrating that its characteristics (e.g., stability, commutability, assigned values, matrix effects) are comparable to the predicate device and that it performs its intended function (monitoring accuracy and precision of bilirubin assays) without raising new questions of safety or effectiveness. Specific numerical criteria are not provided in this summary.
Reported Device Performance:
The document does not provide numerical performance data for the Dade® TRU-Liquid™ Bilirubin Control itself. The "performance" assessment is implied through the claim of substantial equivalence.
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 explicitly stated in the provided 510(k) summary. For a quality control material demonstrating substantial equivalence, the "test set" would refer to the data collected to compare its characteristics with the predicate. This might involve running both controls on various bilirubin assay systems multiple times. However, the details of such a comparison study (sample size, data provenance) are not included in this high-level summary.
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 is not applicable to a quality control material in the same way it would be for an imaging or diagnostic device. "Ground truth" for a quality control material primarily relates to its assigned values, stability, and matrix characteristics, which are determined through laboratory testing and analytical methods, not typically by expert consensus of human readers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable, as there are no human readers or subjective interpretations involved in establishing the "ground truth" for a quality control material.
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 is not applicable. The device is a quality control material for laboratory tests, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a quality control material, the "ground truth" for its characteristics (e.g., assigned values for bilirubin, stability) would be established through analytical testing and reference methods in a laboratory setting. This involves precise measurements, calibration against primary standards (if available), and thorough characterization of the material itself. It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This is not applicable. Quality control materials do not typically have "training sets" in the context of machine learning or AI. Their characteristics are determined through analytical validation.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of device.
In summary:
The provided document is a 510(k) summary for a quality control material (Dade® TRU-Liquid™ Bilirubin Control). The primary "study" involved in its clearance is demonstrating substantial equivalence to a predicate device (ChemTrak Liquid Bilirubin Control). The information requested regarding AI performance, human reader studies, and training/test sets is not relevant to this type of device or its regulatory clearance process as described in this document.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.