(62 days)
The pHoenix Electrolyte Calibrator Set for the Medica EasyLyte Calcium Analyzer is intended for use as The procedes to calibrate Nat, K+, Ca* and pH for the Medica EasyLyte Calcium Analyzer.
Phoenix Electrolyte Calibration Set for Medica Easylyte Analyzer consists of two standards A and B for use in calibrating Nat, Kt, Cat+ and pH electrodes. The Medica Easylyte Calcium Analyzer measures Na , K , Ca + , and pH using ion selective electrode technology. pHoenix calibration set is intended to serve as direct replacement to similar calibrator manufactured by Medica Corporation. pHoenix uses similar composition, description and packaging design as that used by Medica Corporation in its calibration set.
The provided text describes the pHoenix Electrolyte Calibration Set for Medica Easylyte Calcium Analyzer. This submission focuses on establishing substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance data in a typical study format for a diagnostic device. As such, some of the requested information cannot be fully extracted.
Here's the information that can be derived and a note on what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document describes "performance equivalence" through "method comparison" and "precision study" but does not provide specific numerical acceptance criteria (e.g., within X% of predicate) nor the detailed results of these studies. The table below represents the areas of comparison rather than quantitative performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent intended use as predicate device | Similar: Calibration of Na, K, Ca, and pH electrodes |
| Equivalent target population (Medica EasyLyte Calcium Analyzer) | Similar: Medica EasyLyte Calcium Analyzer |
| Equivalent design and material (composition) | Similar: Contains Sodium, Potassium, Calcium, and buffers in an aqueous base |
| Equivalent overall performance as predicate device (implicitly via method comparison and precision) | Similar: Demonstrated through method comparison and precision study (specific results not provided) |
| Equivalent sterility | Similar: No Growth |
| Equivalent biocompatibility | Similar: Not Applicable |
| Equivalent mechanical safety | Similar: Not Applicable |
| Equivalent chemical safety (no hazardous chemicals) | Similar: Both contain no hazardous chemicals |
| Equivalent human factors | Similar: Not Applicable |
| Equivalent energy used | Similar: Not Applicable |
| Equivalent compatibility with environment and other devices | Similar: Not Applicable |
| Equivalent where used (laboratories) | Similar: Laboratories |
| Equivalent standards (if any) | Similar: No known standards |
| Equivalent electrical, thermal, and radiation safety | Similar: Not Applicable |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions a "method comparison" and "precision study" but does not provide the number of samples or runs performed.
- Data Provenance: Not explicitly stated. It's safe to assume the data would have been generated in a controlled laboratory setting for the purpose of this submission, likely in the US, but the document does not specify "country of origin" or if it was retrospective/prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. This is a calibration set for an analyzer, not a diagnostic device requiring expert interpretation of results. The "ground truth" would be established by the reference methods/readings of the predicate device and internal quality control standards.
4. Adjudication Method for the Test Set
Not Applicable. This is not a study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a calibration set, not a device for interpretation by human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not Applicable / Partially applicable. The device itself is a calibrator, which performs its function standalone by interacting with the analyzer. Its "performance" is its ability to correctly calibrate the analyzer, which is then measured by its analytical accuracy and precision in comparison to a predicate, not in an interpretive sense.
7. The Type of Ground Truth Used
The "ground truth" for evaluating the pHoenix Electrolyte Calibration Set is based on its performance relative to the predicate Medica Electrolyte Calibration Set. This is established through:
* Method Comparison: Comparing the results obtained when using the pHoenix calibrator versus the Medica calibrator on the Medica EasyLyte Calcium Analyzer.
* Precision Study: Assessing the consistency and variability of results when using the pHoenix calibrator.
* Implicitly, the "ground truth" for the actual analyte values within the calibrator would be established by the manufacturer through traceable reference materials and methods.
8. The Sample Size for the Training Set
Not Applicable. This is a physical calibration solution, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. (As explained in point 8).
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special 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.