Search Results

The ATAC PAK Phosphorus Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of inorganic phosphorus in serum and plasma. Phosphorus results are used for the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

The ATAC PAK Phosphorus Reagent determines phosphorus through its reaction with molybdate to form a phosphomolybdate complex. The resulting increase in absorbance at 340 nm is proportional to the phosphorus concentration in the sample.

Here's a breakdown of the acceptance criteria and the study details for the ATAC PAK Phosphorus Reagent Kit, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Note on "Acceptance Criteria (Implied)": The document performs a substantial equivalence claim against an existing device (Beckman Synchron Phosphorus Reagent). Therefore, the "acceptance criteria" are not explicitly stated as hard numerical thresholds within this document, but rather are demonstrated by showing performance comparable to, or within acceptable limits for, clinical laboratory assays of this type, often implicitly benchmarked against the predicate device or established industry guidelines (like NCCLS EP3-T for precision). For regression analyses, slopes near 1, intercepts near 0, and high correlation coefficients (r-values) are generally considered good.

2. Sample sized used for the test set and the data provenance

• Linearity: 27 samples (implied from "n=27" associated with linearity regression, though the context indicates "% of the rod" which is a typo and likely meant "range" or "rod" as a unit for linearity standards). The samples used were "linearity standards that span the usable range."
• Precision:
  • Serum 1: n = 60 replicates
  • Serum 2: n = 60 replicates
  • Serum 3: n = 60 replicates
    The samples were "commercially available control serum."
• Method Comparison: n = 115 patient specimens. The specimens were "Mixed serum and plasma specimens, collected from adult patients." The data provenance is not explicitly stated as country of origin, but it is retrospective as the specimens were already collected.
• Detection Limit: 30 replicates of a diluted serum pool.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For an in vitro diagnostic (IVD) like a phosphorus reagent, "ground truth" is typically established by:

• Reference methods for linearity standards.
• Certified values for control sera used in precision studies.
• The results from a well-established, legally marketed comparative method (predicate device) in method comparison studies.
  No human experts are explicitly mentioned as establishing ground truth in this context; rather, the "truth" is derived from established analytical methods and reference materials.

4. Adjudication method for the test set

Not applicable. The "adjudication method" (e.g., 2+1, 3+1) typically refers to a process where multiple human readers independently interpret data, and discrepancies are resolved by a consensus or a senior expert. This concept is relevant for imaging or diagnostic algorithms where human interpretation is the primary ground truth. For an IVD reagent, the performance is assessed against quantitative analytical metrics, not human adjudication of results.

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. This document describes a new reagent for quantitative chemical analysis, not an AI or imaging diagnostic device that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The entire study described is a standalone performance study of the ATAC PAK Phosphorus Reagent Kit on the ATAC 8000 Random Access Chemistry System. It assesses the analytical performance of the reagent (linearity, precision, method comparison, detection limit, stability) without human intervention in the result generation itself, beyond standard laboratory practices for sample handling and system operation. There is no human-in-the-loop component described for the device's performance.

7. The type of ground truth used

• Linearity: Based on "standard values" from "linearity standards that span the usable range." These standards would have known, certified phosphorus concentrations.
• Precision: Based on "commercially available control serum" which have established target values and acceptable ranges.
• Method Comparison: The "competitive reagent" (predicate device) serves as the "ground truth" or reference for comparison. The assumption is that the predicate device is accurate and provides clinically acceptable results.
• Detection Limit: Derived from the statistical analysis of repetitive assays of a "diluted serum pool."
• Stability: Assessed against the initial, presumably accurate, values of "serum controls" over time.

In summary, the ground truth is primarily based on reference materials, certified controls, and comparison to an established predicate device.

8. The sample size for the training set

Not applicable. This device is an in vitro diagnostic reagent, not an AI or machine learning algorithm that requires a "training set." Its performance is based on chemical reactions and photometric measurements, validated through analytical studies.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device