(493 days)
The IT / IF Control is designed for the qualitative quality control of the detection and characterization of human monoclonal immunoglobulins (IgG, IgA, IgM, Kaopa and Lambda) with the electrophoresis methods:
- Immunotyping performed using capillary electrophoresis on SEBIA MINICAP instrument.
- Immunofixation methods: SEBIA HYDRAGEL IF, HYDRAGEL IF Penta, -HYDRAGEL BENCE JONES (Standard mask and Dynamic mask) performed using the HYDRASYS and HYDRASYS 2 instruments and the K20 electrophoresis chamber.
The IT / IF Control is designed for laboratory use. It should be used (with its barcode label for MINICAP procedure) like a human serum sample.
The electrophoretic pattern obtained is specific for each batch of IT/IF control.
For In Vitro Diagnostic Use.
Not Found
The provided text is a 510(k) premarket notification letter for an in vitro diagnostic quality control material called "IT/IF Control." It is not a medical device that performs a diagnosis or uses AI. Therefore, most of the requested information (acceptance criteria for device performance, sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this type of device or this document.
The document indicates that the IT/IF Control is a quality control material used for the qualitative quality control of immunoelectrophoresis methods. Its purpose is to ensure the proper functioning of other diagnostic devices (e.g., SEBIA MINICAP, HYDRASYS instruments) when detecting and characterizing human monoclonal immunoglobulins.
Here's a breakdown of what can be extracted from the provided text, and where your questions are not applicable:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for the IT/IF Control itself. For quality control materials, acceptance criteria would typically involve demonstrating that the material consistently produces expected results (e.g., specific electrophoretic patterns) when tested with the designated diagnostic instruments.
- Reported Device Performance: The document doesn't provide performance data in terms of sensitivity, specificity, accuracy, or similar metrics because it is a control material, not a diagnostic device. Its performance is implicitly linked to its ability to serve as a reliable control for the larger diagnostic systems.
- What is mentioned: "The electrophoretic pattern obtained is specific for each batch of IT/IF control." This implies that consistency and specificity of the pattern are key performance characteristics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: This device is a quality control material. Studies involving "test sets" for diagnostic performance (like AI or imaging devices) are not typically conducted for control materials in the same way. The 510(k) application would have included validation data demonstrating the control's stability and consistency, but not a "test set" in the context of diagnostic accuracy.
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: "Ground truth" in the sense of expert consensus for diagnostic interpretation is not relevant for a quality control material. The "ground truth" for a control material is its known composition and expected behavior, which is established by the manufacturer through analytical testing and characterization.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods are used in diagnostic studies to resolve discrepancies in expert interpretations. This is not pertinent to 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
- Not Applicable: MRMC studies are for evaluating diagnostic systems (often imaging or AI-assisted systems) where human interpretation is involved. This device is a quality control material for laboratory instruments.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This device has no "algorithm" in the sense of an AI or diagnostic algorithm. It is a physical control material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of "Ground Truth": For a quality control material, the "ground truth" is its known, characterized chemical composition and established electrophoretic pattern. This is determined through rigorous analytical testing during manufacturing. The manufacturer would have established that the material contains specific IgG, IgA, IgM, Kappa, and Lambda components, and that these components consistently produce a predictable pattern when run on the specified instruments.
8. The sample size for the training set
- Not Applicable: "Training sets" are associated with machine learning and AI development. This product is a chemical control material.
9. How the ground truth for the training set was established
- Not Applicable: See point 8.
Summary regarding the IT/IF Control:
The IT/IF Control is a qualitative quality control material used in clinical laboratories. Its "performance" is about consistently providing a known and specific electrophoretic pattern when used with immunoelectrophoresis instruments. The 510(k) clearance indicates that the FDA deemed it substantially equivalent to existing control materials, meaning it is considered safe and effective for its intended purpose of ensuring the reliability of other diagnostic tests.
The information you are requesting is typically found in submissions for diagnostic medical devices, especially those involving imaging, AI, or direct diagnostic claims, rather than for ancillary quality control materials.
§ 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.