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510(k) Data Aggregation
(56 days)
Sigma Diagnostics CX 3 Calibration Standard Level 2 is used to calibrate the Beckman SYNCHRON CX®3 System. This reagent is used for the quantitative determination of BUN/urea, calcium, and total carbon dioxide in serum or plasma; of creatinine, potassium, and sodium in serum, plasma, or urine; and of chloride and glucose in serum, plasm, urine, or cerebrospinal fluid. Calibration Standard Level 2 should be used with CX 3 Calibration Standard Level 1.
CX 3 Calibration Standard Level 2 contains the following analytes and other non-reactive components: Chloride 65 mmol/L, Potassium 10.0 mmol/L, Sodium 100 mmol/L, Total CO2 30 mmol/L.
This document is a 510(k) notification for a calibration standard, not a device that would typically involve a "study that proves the device meets the acceptance criteria" in the way an AI/ML medical device would. The provided text describes a calibration standard, which is a laboratory reagent used to calibrate instruments for quantitative measurements. The "acceptance criteria" here refer to the performance of the calibration standard itself, specifically its ability to accurately calibrate an instrument, and that it is substantially equivalent to a predicate device.
Therefore, many of the requested fields (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size) are not applicable to this type of submission.
Here's an attempt to answer the questions based on the provided text, while also noting the inapplicability of certain questions:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (Implied by Substantial Equivalence):
The CX®3 Calibration Standard, Level 2, should perform equivalently to the predicate device (Beckman Calibration Standard 2, Part No. 443365) in calibrating the Beckman SYNCHRON CX®3 System. This implies that:
- It accurately calibrates for the specified analytes (BUN/urea, calcium, total carbon dioxide, creatinine, potassium, sodium, chloride, glucose).
- It provides the stated analyte concentrations.
- It is safe and effective for its intended use.
Reported Device Performance:
The document states "The safety and effectiveness of Sigma Diagnostics CX®3 Calibration Standard, Level 2, Procedure Number C7433, are demonstrated by its substantial equivalency to Beckman Calibration Standard 2, Part No. 443365."
| Analyte | Stated Concentration (Performance) | Acceptance Criteria (Implied by Predicate) |
|---|---|---|
| Chloride | 65 mmol/L | Equivalent to predicate's chloride value |
| Potassium | 10.0 mmol/L | Equivalent to predicate's potassium value |
| Sodium | 100 mmol/L | Equivalent to predicate's sodium value |
| Total CO2 | 30 mmol/L | Equivalent to predicate's Total CO2 value |
| BUN/urea | Not specified in table | Equivalent to predicate's BUN/urea value |
| Calcium | Not specified in table | Equivalent to predicate's calcium value |
| Creatinine | Not specified in table | Equivalent to predicate's creatinine value |
| Glucose | Not specified in table | Equivalent to predicate's glucose value |
Note: The document only explicitly lists the concentrations for Chloride, Potassium, Sodium, and Total CO2 as components of "Calibration Standard Level 2." It also mentions other analytes for which this reagent is used to calibrate the system, implying the standard would have relevant concentrations for those as well, even if not explicitly listed in the table.
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This is a calibration standard, not a diagnostic device tested on patient samples in the typical sense. The "test" would involve comparing its calibration performance to a predicate device, likely using internal validation data rather than patient data. The document does not specify any sample size for testing.
- Data Provenance: Not applicable. The document does not mention testing with patient-derived data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a chemical calibration standard's concentration would be established through analytical chemistry methods and quality control, not expert consensus interpretation.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on image or clinical data, which is not relevant here.
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
Not applicable. This is not an AI/ML device, nor does it involve human readers interpreting data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI.
7. The type of ground truth used
The ground truth for a calibration standard's specified analyte concentrations would be established through analytical chemistry methods and metrology, traceable to recognized reference standards. The document does not explicitly state how the concentrations within the standard were verified, but this would be standard practice for such a product.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
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