(77 days)
AIA-PACK IGE II is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of immunoglobulin E (IgE) in human serum on TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of atopic disorders, allergic conditions and the body's inability to resist infectious agents.
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Here's a breakdown of the acceptance criteria and study information based on the provided text for the AIA-PACK IqE II Assay:
Device Name: AIA-PACK IqE II Assay
Indications For Use: The AIA-PACK IGE II is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of immunoglobulin E (IgE) in human serum on TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of atopic disorders, allergic conditions and the body's inability to resist infectious agents.
1. Acceptance Criteria and Reported Device Performance
The provided 510(k) submission summary (K972697) does not explicitly list a table of acceptance criteria or detailed reported device performance metrics in the format normally associated with clinical studies for AI/ML devices (e.g., sensitivity, specificity, AUC). This document is primarily an FDA clearance letter and an "Indications For Use" statement.
For in-vitro diagnostic (IVD) assays like the AIA-PACK IqE II, typical acceptance criteria often relate to:
- Precision/Reproducibility: Within-run, between-run, and total precision (e.g., %CV x, bias within y%).
- Analytical Sensitivity: Limit of Detection (LoD), Limit of Quantitation (LoQ).
- Analytical Specificity: Interference studies (e.g., no significant interference from common substances).
- Linearity/Measuring Range: Demonstrate accurate results across the reportable range.
- Reference Range: Establishment of normal values.
Since these specific details are not present in the provided text, a table cannot be generated. The document only confirms the device's substantial equivalence to a predicate device, implying that the performance was deemed acceptable for its intended use by the FDA.
2. Sample Size Used for the Test Set and Data Provenance
The provided document (an FDA 510(k) clearance letter and Indications for Use) does not contain any information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature) of any studies. This type of detail would typically be found in the full 510(k) submission's performance data section, which is not included here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide any information regarding the number of experts used, their qualifications, or how ground truth was established for a test set. Given this is an in-vitro diagnostic assay for quantitative measurement, the "ground truth" would likely be established through a primary reference method or a highly accurate predicate device, rather than expert consensus on images.
4. Adjudication Method for the Test Set
The document does not provide any information regarding an adjudication method for a test set. For quantitative IVD assays, adjudication methods like 2+1 or 3+1 (common for image-based diagnostics) are generally not applicable. Instead, discrepancy analysis between the investigational device and a reference method would be performed if there were significant differences.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, nor would it be applicable for this type of in-vitro diagnostic device. MRMC studies are typically performed for imaging diagnostics where human readers interpret medical images, often with and without AI assistance, to measure the impact of AI on reader performance. The AIA-PACK IqE II Assay is an automated quantitative measurement system that doesn't involve human interpretation of complex visual data in the same way.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device, being an "AIA-PACK IGE II Assay" on "TOSOH AIA System analyzers," inherently operates as a standalone algorithm/system (without human-in-the-loop for result generation). The system performs the quantitative measurement of IgE in serum. Human involvement would be in sample preparation, loading, and interpretation of the numerical output, but not in the analytical measurement itself, thus it is a standalone performance by nature. The provided text doesn't explicitly state "standalone study" but the nature of the device implies its core function is standalone.
7. The Type of Ground Truth Used
For an in-vitro diagnostic quantitative assay, the ground truth is typically established by:
- A "gold standard" reference method: A highly accurate and well-established method for measuring IgE.
- A legally marketed predicate device: The performance of the new device is compared to a previously cleared device that measures the same analyte.
The provided document does not explicitly state which type of ground truth was used, but given the substantial equivalence determination, it strongly implies comparison to one or more predicate devices. Pathology or outcomes data are generally not used as direct ground truth for analytical performance of such a quantitative assay (though outcomes data might be used in broader clinical utility studies).
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size for a training set. For in-vitro diagnostic assays, the concept of a "training set" (as understood in AI/ML model development) may not be directly applicable in the same way. Instead, developmental studies involve analytical validation (precision, accuracy, linearity, etc.) and potentially small clinical studies for method comparison and reference range establishment.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information regarding how ground truth was established for a training set, nor does it mention a training set in the context of AI/ML. For IVD development, "ground truth" during development (if applicable) would be established by the reference method or predicate device against which the assay's performance is optimized and validated.
§ 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).