(77 days)
The Phosphorus assay is used for the quantitation of inorganic phosphorus in human serum, plasma, or urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
Phosphorus is an in vitro diagnostic assay for the quantitative determination of inorganic phosphorus in human serum, plasma, or urine. The Phosphorus assay is a clinical chemistry assay in which the inorganic phosphorus reacts with ammonium molybdate in dilute sulfuric acid to form the unreduced phosphomolybdate complex. The formation of the unreduced phosphomolybdate is measured at 340 nm and is directly proportional to the amount of inorganic phosphorus present.
The provided text describes a 510(k) summary for the Abbott Laboratories Phosphorus assay, which is an in vitro diagnostic device. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria or conducting studies to meet such criteria for a new type of device. The information requested aligns more with the evaluation of AI/ML-driven medical devices or other devices where performance metrics like sensitivity, specificity, accuracy, and expert consensus are central to the acceptance criteria.
However, I can extract the information provided in the context of demonstrating substantial equivalence for this IVD, mapping it as closely as possible to your requested structure.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of IVD, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices, meaning the new device should have "similar performance characteristics." The reported performance metrics are comparative.
| Performance Metric | Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (Phosphorus Assay) |
|---|---|---|
| Serum Application: | ||
| Correlation Coefficient | Acceptable correlation with predicate device | 0.9885 (vs. Roche Cobas Mira Plus Phosphorus assay) |
| Slope | Acceptable correlation with predicate device | 1.049 (vs. Roche Cobas Mira Plus Phosphorus assay) |
| Y-intercept | Acceptable correlation with predicate device | 0.264 mg/dL (vs. Roche Cobas Mira Plus Phosphorus assay) |
| Total %CV (Level 1) | Acceptable precision | 2.8% (Level 1/Panel 111 control) |
| Total %CV (Level 2) | Acceptable precision | 2.7% (Level 2/Panel 112 control) |
| Urine Application: | ||
| Correlation Coefficient | Acceptable correlation with predicate device | 0.9947 (vs. Boehringer Mannheim Phosphorus assay on Hitatchi 717 Analyzer) |
| Slope | Acceptable correlation with predicate device | 0.973 (vs. Boehringer Mannheim Phosphorus assay on Hitatchi 717 Analyzer) |
| Y-intercept | Acceptable correlation with predicate device | -1.582 mg/dL (vs. Boehringer Mannheim Phosphorus assay on Hitatchi 717 Analyzer) |
| Total %CV (Level 1) | Acceptable precision | 3.2% (Level 1/Panel 111 control) |
| Total %CV (Level 2) | Acceptable precision | 2.4% (Level 2/Panel 112 control) |
| General Performance: | ||
| Linearity | Acceptable range | Up to 16 mg/dL |
| Limit of Quantitation | Acceptable sensitivity | 0.3 mg/dL |
2. Sample size used for the test set and the data provenance
The document mentions "Comparative performance studies were conducted" and "Precision studies were conducted using the Phosphorus assay. Within-run, between-run, and between-day studies were performed using two levels of control material." However, it does not specify the sample size used for these studies (e.g., number of serum/urine samples, number of replicates).
The data provenance is not explicitly stated in terms of country of origin but is from "human serum, plasma, or urine." The studies appear to be prospective as they were conducted to demonstrate equivalence for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of IVD study. The "ground truth" (or reference method) is established by the predicate devices themselves (Roche Cobas Mira Plus Phosphorus assay and Boehringer Mannheim Phosphorus assay on the Hitatchi 717 Analyzer), which are established clinical chemistry assays. There is no mention of experts establishing ground truth for individual samples.
4. Adjudication method for the test set
This information is not applicable. As it's a quantitative chemical assay, expert adjudication for results is not typically performed in the way it would be for image interpretation or diagnosis. The "reference" or "ground truth" values for comparison come from the predicate devices.
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
This is not applicable. MRMC studies are relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) often with AI assistance. This device is an in vitro diagnostic chemical assay, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable in the context of an "algorithm only" device as described for AI/ML. The Phosphorus assay itself is a standalone chemical assay without human interpretation in the workflow of its quantitative result. Its performance is measured directly as an analytical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance comparison is the results obtained from legally marketed predicate devices:
- Roche Cobas Mira Plus Automated Chemistry System Phosphorus assay (for serum)
- Boehringer Mannheim Phosphorus assay on the Hitatchi 717 Analyzer (for urine)
These predicate devices serve as the reference methods to which the new Phosphorus assay is compared.
8. The sample size for the training set
This information is not applicable to this type of IVD, as there is no "training set" in the context of machine learning or AI models. The assay is a chemical reaction-based method.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set.
§ 862.1580 Phosphorus (inorganic) test system.
(a)
Identification. A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.