(75 days)
This kit is intended for the quantification of IgG subclasses in serum on the Hitachi 911 (7070). Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Human IgG Subclass Liguid Reagent Kit for use on the Hitachi 911/7070 Turbidimetric Analyzer
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Human IgG Subclass Liquid Reagent Kit":
Based on the provided document, which is an FDA 510(k) clearance letter, it's important to understand that this letter grants clearance based on a demonstration of substantial equivalence to a predicate device. It does not present the detailed study findings or acceptance criteria directly within the letter itself.
The letter refers to the "510(k) premarket notification" as the document that contains the actual study details and data. To answer your questions fully, one would typically need access to the full 510(k) submission, which is not provided here.
However, I can extract what is implied and what is explicitly not present in this particular document:
1. A table of acceptance criteria and the reported device performance
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Acceptance Criteria: Not explicitly stated in this document. For an in vitro diagnostic device like this, acceptance criteria would typically involve analytical performance characteristics such as:
- Accuracy/Correlation: Comparison with a reference method or predicate device, often assessed by linear regression (slope, intercept, r-value) and/or bias plots (e.g., Bland-Altman).
- Precision/Reproducibility: Within-run, between-run, and total precision studies (CV%).
- Analytical Measurement Range (AMR): The range over which the device can accurately quantify the analyte.
- Limit of Detection (LoD) / Limit of Quantitation (LoQ): The lowest concentration that can be reliably detected/quantified.
- Interference: Studies demonstrating lack of significant interference from common endogenous and exogenous substances.
- Specificity: Absence of cross-reactivity with related substances.
- Method Comparison: Direct comparison with the predicate device or a gold standard method using clinical samples.
- Clinical Performance: (Less common for new 510(k) analytes with well-established uses, but could involve comparing results with clinical diagnosis or outcomes).
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Reported Device Performance: Not explicitly stated in this document. The letter only confirms that the FDA reviewed the submission and found the device substantially equivalent. The actual performance data would be in the 510(k) submission itself.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in this document.
- Data Provenance: Not specified in this document.
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. For an in vitro diagnostic device that quantifies an analyte (IgG subclasses), the "ground truth" is typically established by:
- Quantitative results from a well-characterized reference method or a legally marketed predicate device.
- Certified reference materials or commutable reference materials.
- Pathology (e.g., for calibrator assignment if a new analyte).
- Expert consensus is not typically involved in establishing ground truth for quantitative laboratory tests in the same way it is for image interpretation or diagnosis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/not specified. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in scenarios involving human interpretation (e.g., image reading, clinical diagnosis), not for quantitative laboratory test results.
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
- No, an MRMC comparative effectiveness study was not done. This type of study applies to devices (often AI-based) that assist human readers (e.g., radiologists, pathologists) in interpreting complex data, especially images. This device is an in vitro diagnostic reagent kit for automated turbidimetric analysis, which does not involve human interpretation in the same way.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, in essence, this device represents a "standalone" performance. The "algorithm" here is the chemical reaction and optical measurement performed by the Hitachi 911/7070 Turbidimetric Analyzer using the provided reagents. The performance claimed for this device (quantification of IgG subclasses) is its direct analytical output, without requiring human interpretation or assistance for the measurement itself. The results are then used by clinicians for diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For an in vitro diagnostic device like this, the ground truth for performance studies (e.g., accuracy, method comparison) would typically be:
- Reference method results: Results obtained from a well-established, validated, and often more laborious or expensive laboratory method.
- Predicate device results: Comparison to the quantitative results generated by the legally marketed predicate device.
- Certified Reference Materials (CRMs) / Reference Materials (RMs): Samples with accurately assigned values.
8. The sample size for the training set
- Not applicable/not specified. This is a reagent kit for a turbidimetric analyzer. It is not an AI/machine learning device that requires a "training set" in the computational sense. The "training" of such a system involves calibrating the instrument with known standards and ensuring the reagents perform correctly; this is part of standard laboratory practice and manufacturing quality control, not a separate "training set" study for regulatory clearance in the AI context.
9. How the ground truth for the training set was established
- Not applicable/not specified. As explained above, the concept of a "training set" with established ground truth, as used in AI/ML, does not apply to this type of device.
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).