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PHS reagent, in conjunction with SYNCHRON® Systems and SYNCHRON PTIS reagent, in ochjanoued for use in the quantitative determination of inorganic phosphorus in human serum, plasma, or urine.

Measurements of phosphorus (inorganic) are used in the diagnosis and incasuromento of in disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

The SYNCHRON Systems PHS reagent is designed for optimal performance on the CX (CX4CE/4/4PRO, CX5CE/52/5PRO, CX7/7RTS/7A/7PRO, SYNCHRON CX9ALX/9PRO) and LX (LX20/PRO/LXi 725) Systems. The reagent kit contains two 300-test cartridges that are packaged separately from the associated calibrator.

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and the study that demonstrates the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the SYNCHRON® Systems Phosphorus (PHS) Reagent does not explicitly state pre-defined acceptance criteria with numerical targets (e.g., "Slope must be between 0.95 and 1.05"). Instead, it presents performance data (method comparison, linearity, and imprecision) and implies that these results demonstrate substantial equivalence to the predicate device.

However, based on the common practices for in vitro diagnostic (IVD) device submissions and the provided predicate comparison, we can infer the implied acceptance criteria:

• Slope: Close to 1.0
• Intercept: Close to 0.0
• R (Correlation Coefficient): Close to 1.0 (indicating a strong linear relationship) | Serum:
• Slope: 0.997 (Very close to 1.0)
• Intercept: -0.04 (Very close to 0.0)
• R: 0.998 (Excellent linear correlation)
  Urine:
• Slope: 0.976 (Close to 1.0)
• Intercept: 0.25 (Reasonably close to 0.0)
• R: 0.996 (Excellent linear correlation)
  Meets Criteria: The reported values for both serum and urine demonstrate excellent agreement and strong correlation with the predicate device, indicating substantial equivalence in measurement accuracy across relevant sample types. |
  | Imprecision | The device should demonstrate acceptable within-run and total imprecision (reproducibility) for various concentrations of inorganic phosphorus in serum and urine. This is usually assessed by a low %CV (Coefficient of Variation) at different concentration levels. The acceptable %CV values would be determined by clinical relevance and comparison to the predicate or similar devices. | Within-Run Imprecision:
• Serum 1 (2.0 mg/dL): 2.4 %C.V.
• Serum 2 (6.6 mg/dL): 1.4 %C.V.
• Urine 1 (41.1 mg/dL): 1.0 %C.V.
• Urine 2 (78.3 mg/dL): 1.2 %C.V.
  Total Imprecision:
• Serum 1 (2.0 mg/dL): 2.7 %C.V.
• Serum 2 (6.6 mg/dL): 1.5 %C.V.
• Urine 1 (41.1 mg/dL): 1.5 %C.V.
• Urine 2 (78.3 mg/dL): 1.6 %C.V.
  Meets Criteria: The %C.V. values for both within-run and total imprecision are consistently low (all below 3%), indicating excellent precision and reproducibility across the tested concentrations and sample types. This is generally considered acceptable for clinical chemistry assays. |
  | Linearity | The device should provide measurements that are linear across its claimed analytical measurement range. (While not explicitly detailed with data in the summary, linearity experiments are mentioned as being performed to demonstrate equivalence). | Reported: "Equivalence is demonstrated through method comparison, linearity, and imprecision experiments."
  Meets Criteria: The submission states that linearity experiments were performed and contributed to the finding of substantial equivalence. While specific data isn't provided, its inclusion in the summary implies acceptable results. |

2. Sample Sizes Used for the Test Set and Data Provenance

• Method Comparison Test Set:
  • Serum: 114 samples (n=114)
  • Urine: 81 samples (n=81)
• Imprecision Test Set:
  • For each of the 4 samples (Serum 1, Serum 2, Urine 1, Urine 2), the "N" value listed is 80. This typically refers to the number of replicates or data points used in the imprecision study.
• Data Provenance: Not explicitly stated. For 510(k) submissions, data is typically generated internally by the manufacturer or by a contracted lab. The document does not specify the country of origin or if the data was retrospective or prospective. Given the nature of a reagent performance study, it's most likely prospective data collected specifically for the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of device (in vitro diagnostic reagent). For a phosphorus reagent, the "ground truth" is established by a reference method or a highly accurate clinical analyzer (in this case, the predicate device, Beckman Coulter SYNCHRON PO4 Assay on CX Systems). Expert consensus or human interpretation (like in imaging studies) is not used to establish the "ground truth" for quantitative chemical measurements.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used when human interpretation or expert opinion is involved in establishing a ground truth for qualitative or semi-quantitative results, particularly in areas like medical imaging. For a quantitative chemical assay, the comparison is directly between the candidate device's numerical output and the predicate device's numerical output.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC study was not done. This type of study is relevant for devices where human readers interpret diagnostic information (e.g., radiologists reading images) and the AI aims to assist or replace that human interpretation. The SYNCHRON PHS Reagent is an automated in vitro diagnostic assay where the output is a numerical value, not an interpretation by a human reader.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The entire performance summary (method comparison, linearity, and imprecision) is a demonstration of the SYNCHRON PHS Reagent's in vitro performance, independent of human interpretation or intervention beyond operating the analyzer. The results presented directly reflect the algorithm's (reagent's) ability to measure phosphorus.

7. Type of Ground Truth Used

The ground truth for the method comparison study was established by the predicate device, the Beckman Coulter SYNCHRON PO4 Assay on CX Systems. For imprecision studies, the ground truth is the "true" concentration of the sample, which is often determined through meticulous preparation of control materials or by a highly accurate reference method.

8. Sample Size for the Training Set

This information is not provided and is not typically relevant for a traditional chemical reagent assay like the SYNCHRON PHS Reagent. Chemical reagents are designed based on established chemical reactions and principles. They do not typically involve "training sets" in the machine learning sense. The performance data presented (method comparison, imprecision) serves as the validation of the reagent's performance.

9. How the Ground Truth for the Training Set Was Established

As explained in point 8, a "training set" in the machine learning sense is not applicable here. The development of a chemical reagent involves chemical formulation, optimization of reaction conditions, and calibration using known reference materials. The "ground truth" for calibration and optimization would be highly characterized reference materials with known concentrations of inorganic phosphorus.

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