(203 days)
The HYDRAGEL 18 A1AT ISOFOCUSING kit is designed for the qualitative detection and identification of the different phenotypes of Alpha-1 antitrypsin (A1AT). Phenotyping results in conjunction with clinical findings and other laboratory assays aid in the diagnosis of Alpha-1 antitrypsin deficiency The analysis is performed on human sera separated into electrophoretic patterns ready for qualitative analysis. The procedure includes isoelectrofocusing on agarose gel, performed on the semi-automatic HYDRASYS system, followed by immunofixation with anti-Alpha-1 antitrypsin antiserum. The use of enzyme labeled anti-Alpha-1 antiserum enhanced the detection and identification of the different phenotypes.
The configurations of the HYDRAGEL 18 A1AT ISOFOCUSING kit consist of the components summarized in Tables I and II in main 510(k) submission. Each kit is supplied with Package Insert which contains instruction for use and all the necessary information on the reagents needed to run the tests that are sold separately. Each Package Insert also contains information on storage conditions, shelf-life and signs of deterioration of the kit components and the reagents sold separately, and on interpretation of the results.
The provided 510(k) summary for the SEBIA HYDRAGEL 18 A1AT ISOFOCUSING kit describes a traditional IVD device, not an AI/ML device. Therefore, the concepts of acceptance criteria for AI algorithms, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable in their usual sense.
The submission focuses on demonstrating substantial equivalence to a predicate device for the qualitative detection and identification of Alpha-1 antitrypsin (A1AT) phenotypes. The "acceptance criteria" here relate to the device showing comparable performance to the predicate method.
Here's an interpretation based on the given information, adapted for an IVD device submission:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria in the typical sense of sensitivity/specificity/accuracy thresholds that an AI/ML algorithm might have. Instead, the acceptance criterion implicitly is "substantial equivalence" to the predicate device. The performance is demonstrated through concordance and reproducibility studies.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Concordance with predicate device | Performance matches predicate: "Data are presented documenting substantial equivalency of the SEBIA and the polyacrylamide gel isoelectric focusing technique for Alpha-1 antitrypsin phenotype characterization." |
| Within-gel reproducibility | Satisfactory results reported |
| Gel-to-gel and lot-to-lot reproducibility | Satisfactory results reported |
| Sensitivity of detection of phenotypes | Satisfactory results reported |
| Validation | Satisfactory results reported |
| Stability | Satisfactory results reported |
2. Sample Size Used for the Test Set and Data Provenance
The exact sample size for the concordance study (which would act as the "test set" for equivalence) is not explicitly stated in the provided text. The document mentions "Performance study and comparisons of the HYDRAGEL 18 A1AT ISOFOCUSING KITS with polyacrylamide gels isoelectric focusing and comassie blue staining was done." and "Data are presented documenting substantial equivalency...".
- Sample Size for Test Set: Not explicitly provided.
- Data Provenance: Not explicitly stated, though the comparative predicate technique is described as "currently used in clinical diagnostic laboratories in the United States." This suggests the comparison data would likely derive from similar clinical settings. The nature of the study (comparison to an existing method) suggests it would be retrospective as it's comparing against previously characterized samples or existing results.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since this is a laboratory assay where the "ground truth" is established by a predicate analytical method (polyacrylamide gel isoelectric focusing with Coomassie Blue staining), the concept of "experts" establishing ground truth in the traditional sense of clinical opinion is not directly applicable. The "ground truth" here is the result obtained from the well-established predicate method. The reading and interpretation of the gels would likely be performed by trained laboratory personnel, but no specific number or qualification of "experts" is provided for this purpose.
4. Adjudication Method for the Test Set
As the "ground truth" is based on a laboratory analytical predicate method, an adjudication method (like 2+1, 3+1 typically used for discordant expert opinions) is not applicable. The comparison is between the new device's output and the predicate device's output. Any discrepancies would be investigated as part of the validation, not adjudicated through consensus of human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done, as this is an IVD device and not an AI/ML diagnostic system requiring human interpretation as the primary endpoint. The device performs a laboratory test resulting in an electrophoretic pattern. The evaluation is on the accuracy of this pattern generation and its agreement with a predicate method, not on how human readers' diagnostic accuracy improves with or without an AI assist.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, in a sense, a standalone performance was done. The device itself (HYDRAGEL 18 A1AT ISOFOCUSING kit on the HYDRASYS system) produces the electrophoretic patterns, which are then "evaluated visually." The core performance assessment is on the kit's ability to accurately produce these patterns, independent of human interpretation variability. The concordance study compares the patterns generated by the new device to those from the predicate device. While visual evaluation by a human is involved in reading the gels, the primary focus of the performance assessment is on the analytical capability of the device to produce patterns that are substantially equivalent to the predicate.
7. The Type of Ground Truth Used
The ground truth used is the results obtained from a legally marketed predicate device/method: polyacrylamide gel isoelectric focusing followed by Coomassie Blue staining, which is described as a "technique currently used in clinical diagnostic laboratories." This is essentially a "predicate analytical method" ground truth.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable for this type of conventional IVD submission. The device is a chemical reagent kit for a laboratory procedure, not an algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for this conventional IVD device, this question is not applicable.
§ 866.5130
Alpha -1-antitrypsin immunological test system.(a)
Identification. Analpha -1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition,alpha -1-antitrypsin deficiency has been associated with pulmonary emphysema.(b)
Classification. Class II (performance standards).