(66 days)
The Quantia A1-AT is intended for the in vitro quantitative determination of alpha-1-antitrypsin concentration in human serum or plasma (heparin with or without gel separator, EDTA) on the AEROSET® system as an aid in the diagnosis of juvenile and adult cirrhosis of the liver and pulmonary emphysema.
Quantia PROTEINS Control is intended for use in monitoring the quality control of results obtained with the Quantia A1-AT reagents by turbidimetry. (NOTE: This control has been also FDA 510(k) submitted for use with Quantia Beta-2 Microglobulin). For in vitro diagnostic use.
Quantia PROTEINS standard is intended for use in establishing the calibration curve for the Quantia A1-AT reagents by turbidimetry. For in vitro diagnostic use.
The Quantia A1-AT is intended for the in vitro quantitative determination of alpha-1-antityypsin concentration in human serum or plasma (heparin with or without gel separator, EDTA) on the AEROSET® system as an aid in the diagnosis of juvenile and adult cirrhosis of the liver and pulmonary emphysema.
Quantia PROTEINS Control is intended for use in monitoring the quality control of results obtained with the Quantia A1-AT reagents by turbidimetry. (NOTE: This control has been also FDA 510(k) submitted for use with Quantia Beta-2 Microglobulin). For in vitro diagnostic use.
Quantia PROTEINS standard is intended for use in establishing the calibration curve for the Quantia A1-AT reagents by turbidimetry. For in vitro diagnostic use.
Here's an analysis of the provided text regarding the Quantia A1-AT device, structured to answer your questions about acceptance criteria and the supporting study:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Quantia A1-AT) |
|---|---|---|
| Method Comparison | Substantially equivalent to predicate device (N Antisera to Human alpha-1-Antitrypsin). Implies acceptable correlation, slope, and intercept. | Slope: 1.002 (vs. predicate device) |
| Correlation Coefficient (r): 0.9890 (vs. predicate device) | ||
| Precision (CV%) - Low Control | Acceptable precision for clinical use (specific thresholds not stated, but implied by predicate equivalence). | Within Run: 1.2% |
| Between Run: 0.2% | ||
| Total: 1.4% | ||
| Precision (CV%) - Control (I + II) | Acceptable precision for clinical use. | Within Run: 0.7% |
| Between Run: 0.1% | ||
| Total: 0.8% | ||
| Precision (CV%) - High Control | Acceptable precision for clinical use. | Within Run: 1.3% |
| Between Run: 0.6% | ||
| Total: 1.8% |
Note on Acceptance Criteria: The document primarily focuses on demonstrating "substantial equivalence" to a predicate device. For in-vitro diagnostic devices like this, substantial equivalence means demonstrating that the new device is as safe and effective as a legally marketed predicate device. This typically involves showing comparable performance across key metrics. The specific numerical acceptance criteria (e.g., minimum 'r' value, maximum CV%) are not explicitly stated in the summary but are implied by the successful demonstration of substantial equivalence and the comparison to the predicate. The provided performance data (slope, correlation, precision) would have met the FDA's unstated, but understood, thresholds for equivalence.
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 (Test Set): 111 samples
- Data Provenance: Not explicitly stated. The submitting company (Biokit S.A.) is located in Barcelona, Spain. It's not clear from this summary if the samples themselves were from Spain, generated in specific clinical settings, or their origin. It is also not specified if the study was retrospective or prospective.
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)
- This device is an in-vitro diagnostic test for quantitative determination of alpha-1-antitrypsin concentration. The "ground truth" in this context is established by the predicate device's measurement and the assigned values of control materials, not by expert human interpretation of images or other subjective assessments.
- Therefore, the concept of "experts" to establish ground truth as described in the prompt (e.g., radiologists) is not applicable here. The comparison is made against the performance of an established, legally marketed device (N Antisera to Human alpha-1-Antitrypsin) and standardized control materials with known A1-AT levels.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study involving human interpretation or adjudication of cases. The comparison is between the quantitative results of two different assay methods (the new device vs. the predicate device).
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an automated in-vitro diagnostic test, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the performance study effectively represents a "standalone" assessment of the device's accuracy and precision. The "method comparison study" directly compares the results of the Quantia A1-AT system (algorithm/reagents only) to the predicate device's results. The precision studies also evaluate the device in isolation, without human-in-the-loop performance influencing the measurement itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the method comparison study was the results obtained from the predicate device (N Antisera to Human alpha-1-Antitrypsin). For the precision studies, the ground truth was the known, assigned values of the control materials (Low Control, Control (I + II), High Control).
8. The sample size for the training set
- The document does not mention a separate "training set." For an in-vitro diagnostic device like this, the development process (which would include internal validation and optimization) would involve various samples, but a distinct "training set" in the machine learning sense is not typically described in 510(k) summaries for such devices unless AI/ML is a core component, which is not the case here. The 111 samples described were for the performance evaluation (test set) to demonstrate equivalence.
9. How the ground truth for the training set was established
- Not applicable, as a distinct "training set" in the context of an AI/ML system with its associated ground truth establishment is not mentioned or relevant for this type of device. The device's calibration and performance would be based on established reference materials and comparison to a predicate, rather than a "training set" with expert-derived ground truth.
§ 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).