(416 days)
This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.
The Neonatal Total Galactose kit makes use of a fluorescent galactose oxidase method. The assay measures total galactose, i.e. both galactose and galactose-1-phosphate.
The provided information describes a medical device called the "Neonatal Total Galactose Kit" and its performance in a substantial equivalence study as submitted for 510(k) clearance (K071649).
Here's an analysis of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on demonstrating substantial equivalence to a predicate device (BioRad QuantaseTM Neonatal Total Galactose Screening Assay, K990654) rather than explicit acceptance criteria for a novel performance claim alone. However, performance characteristics are compared, which implicitly serve as acceptance benchmarks against the predicate.
For the purpose of this analysis, "acceptance criteria" are interpreted as the comparable performance metrics of the predicate device that the new device aims to match or demonstrate equivalency to. "Reported device performance" refers to the results obtained for the Neonatal Total Galactose Kit.
| Performance Metric | Predicate Device Performance | Neonatal Total Galactose Kit Performance | Acceptance Criteria (implied, based on predicate) |
|---|---|---|---|
| Analytical Sensitivity | 0.60 mg/dL | 1.3 mg/dL | Performance comparable to 0.60 mg/dL |
| Linearity | 0.6 to 55 mg/dL | 1.3 to 56 mg/dL | Performance comparable to 0.6 to 55 mg/dL |
| Measuring Range | 0.6 to 50 mg/mL | 1.3 to 40 mg/mL | Performance comparable to 0.6 to 50 mg/mL |
| Specificity/Recovery (D(+) galactose) | Mean recovery: 95.07% (S.D: 7.49%) in presence of various sugars/metabolites | Mean recovery: 79-81% in presence of galactose, galactose-1-phosphate or both | High recovery and low interference. Results within a clinically acceptable range compared to predicate. |
| Interference | No interference with known antibiotics, non-antibiotics, and metabolites | No interference with glucose, mannose, fructose, ascorbate, bilirubin, hemoglobin, protein BSA, and acetaminophen. Interference with Glutathione (60 mg/dL) and lipemic samples (0.25 - 1 g/dL). | Comparable lack of significant interference with common substances. Specific identified interferences for the new device must be manageable. |
| Intra-assay Precision (%CV) | Low: 3.94% (at 33.96 mg/dL) | Low: 5.3% (at 20.2 mg/dL) | Comparable or improved precision. |
| Total Assay Precision (%CV) | Low: 6.27% (at 6.97 mg/dL) | Low: 8.4% (at 23 mg/dL) | Comparable or improved precision. |
| Method Comparison (Correlation) | N/A (this is the predicate) | y = 0.6Sx + 1.73, r = 0.87 (n = 842) | Sufficient correlation with the predicate device (r > 0.85 is often considered acceptable). |
| Screening Summary (95th percentile) | Overall Percent Agreement: N/A | Positive agreement: 64% (73/114). Overall percent agreement: 95.9% ((73+1956)/2116). | High agreement with predicate for screening purposes. |
| Screening Summary (99th percentile) | Overall Percent Agreement: N/A | Positive agreement: 72.4% (21/29). Overall percent agreement: 99.2% ((21+2078)/2116). | High agreement with predicate for screening purposes, particularly at higher cut-offs. |
| True Positive Detection | Detected 3/3 true positives | Detected 3/3 true positives (at varying concentrations) | Detection of all known true positive cases. |
Note: The analytical sensitivity, linearity, and measuring range are numerically different between the predicate and the new device. The acceptance is implicitly based on these ranges being clinically acceptable for newborn screening and demonstrating equivalence in the overall clinical screening performance.
2. Sample Size Used for the Test Set and Data Provenance
Sample Size:
- Method Comparison: 842 samples for correlation analysis.
- Cut-off Value Determination & Screening Summary: 2109 routine newborn screening dried blood specimens + 7 retrospective specimens (3 diagnosed true positives for galactosemia), totaling 2116 samples.
Data Provenance:
- Country of Origin: The samples represented an "US population."
- Retrospective/Prospective: Primarily retrospective, using "routine newborn screening dried blood spot specimens" and "retrospective specimens."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The documentation does not specify the number or qualifications of experts used to establish the ground truth for the test set.
4. Adjudication Method for the Test Set
The documentation does not describe an adjudication method for the test set. The "ground truth" for the test set appears to be based on "diagnosed galactosemia" and routine screening results (implied by the comparison against a predicate device's findings).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study concerns an in-vitro diagnostic kit for measuring an analyte, not typically a visual interpretation task where human readers are involved. Therefore, there's no "human readers improve with AI vs. without AI assistance" effect size to report.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the study describes a standalone device performance. The Neonatal Total Galactose Kit is an in-vitro diagnostic assay. Its performance (analytical sensitivity, linearity, precision, method comparison, and screening summaries) is evaluated as the device itself, separate from human interpretation, although the results would be used by clinicians for decision-making.
7. The Type of Ground Truth Used
The ground truth implicitly used for the screening summary tables (which included "Diagnosed galactosemia") seems to be clinical diagnosis or outcomes data for the "true positives." For the majority of routine samples, the ground truth for comparison is the result obtained from the predicate device.
8. The Sample Size for the Training Set
The documentation does not explicitly mention a separate "training set" or its sample size. The studies described are performance evaluation studies for regulatory submission, typically focusing on validation rather than algorithm training for AI/ML devices. For IVD kits, the "development" or "optimization" phase might use internal samples, but these are not usually referred to as a "training set" in the context of the 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned, the method for establishing its ground truth is also not described. For a traditional IVD kit, the "ground truth" for calibrators and controls (which might be seen as analogous to training data in a broader sense) would be established through a traceable reference method or gravimetric preparation with certified materials.
§ 862.1310 Galactose test system.
(a)
Identification. A galactose test system is a device intended to measure galactose in blood and urine. Galactose measurements are used in the diagnosis and treatment of the hereditary disease galactosemia (a disorder of galactose metabolism) in infants.(b)
Classification. Class I.