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The SPIFE A1AT kit is designed for the qualitative detection of the different phenotypes of Alpha-1 Antitypsin (Al AT). 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 semiautomatic SPIFE Touch system followed by immunofixation with anti-Alpha-1 Antiserum. For in vitro diagnostic use only.

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I apologize, but the provided text from the FDA 510(k) clearance letter for the SPIFE A1AT kit does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets those criteria.

The document is a clearance letter stating that the device is substantially equivalent to a predicate device and outlines general regulatory requirements. It does not include the specifics of the performance study, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets, or data provenance.
• Details about expert involvement in ground truth establishment or adjudication methods.
• Information on MRMC studies or effect sizes.
• Whether standalone performance was evaluated.
• The type of ground truth used.
• How ground truth was established for the training set.

To obtain this information, you would typically need to refer to the 510(k) summary or the full 510(k) submission for the device, which are often available through the FDA's public databases or directly from the manufacturer. The clearance letter itself only confirms the regulatory approval.

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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.

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.

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