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510(k) Data Aggregation
(64 days)
PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM
The pHoenix Electrolyte Calibrator Set is intended for use as calibrators to calibrate Na ", K ", CI and TCO2 for the Dade/Behring Dimension® Chemistry System with MultiPLY™ Integrated Multisensor module installed.
The products encompassed by this 510 (k) submission are Class II (75 JIX) In Vitro Diagnostic Solutions manufactured by pHoenix Diagnostics, Inc., 8 Tech Circle, Natick, MA 01760. The Calibration Set consists of an A, B and Clevel and is intended for use in calibrating Nat, K., C." and TCO2 analytes on the Dade/Behring Dimension Chemistry Systems. Dade/Behring Chemistry Systems, Inc. is the original equipment manufacturer (OEM) of the system,
Here's an analysis of the provided 510(k) summary, extracting the requested information:
Acceptance Criteria and Device Performance Study (K012509)
The pHoenix Electrolyte Calibration Set is intended for use in calibrating Na+, K+, Cl-, and TCO2 analytes on the Dade/Behring Dimension® Chemistry Systems with the MultiPLY™ Integrated Multisensor module installed. The device seeks substantial equivalence to Alko Diagnostic Corporation products.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria (e.g., specific ranges of bias or correlation coefficients). Instead, it focuses on demonstrating "performance equivalence" to a predicate device. Therefore, the "reported device performance" is framed as achieving equivalence.
| Analyte | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Na+ | Demonstrated performance equivalence to Alko products | Achieved performance equivalence in method comparison and precision studies |
| K+ | Demonstrated performance equivalence to Alko products | Achieved performance equivalence in method comparison and precision studies |
| Cl- | Demonstrated performance equivalence to Alko products | Achieved performance equivalence in method comparison and precision studies |
| TCO2 | Demonstrated performance equivalence to Alko products | Achieved performance equivalence in method comparison and precision studies |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: Not explicitly defined with a distinct "test set" sample size. The studies described are performance equivalence studies rather than a validation against a labeled ground truth.
- Method Comparison:
- Sample Size: Not specified. The study involved comparing results from the Dade/Behring Dimension Chemistry System calibrated with pHoenix products versus the same analyzer calibrated with Alko products. The number of samples (patient samples or control samples) used for this comparison is not provided.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
- Precision Study:
- Sample Size: "samples were measured over 20 runs." The number of distinct samples used across these 20 runs is not specified, nor is the number of replicates per sample per run.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device is based on the performance of the predicate device (Alko Diagnostic Corporation products). This is a calibration set, and its performance is evaluated based on its ability to enable accurate measurement of analytes by the instrument. There is no mention of human experts establishing a ground truth in the traditional sense of diagnostic interpretation.
4. Adjudication Method for the Test Set
Not applicable. This is a calibration set for an in vitro diagnostic device, not a diagnostic imaging or interpretive aid that would typically involve human adjudication of results. The "adjudication" is implicitly the instrument's determination of analyte concentrations after calibration, which is then compared to a predicate's performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study is typically performed for diagnostic imaging devices or assistive technologies where human readers interpret results. This submission concerns a calibration set for an automated chemistry analyzer, where human interpretation is not the primary function being assessed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, effectively. The device being evaluated is a calibration set, which is an integral part of the automated chemistry system's measurement process. The studies described (method comparison, precision) assess the performance of the calibration set in the context of the automated system, without direct human intervention in the measurement of analyt the primary focus. The performance assessed is of the calibration set itself, enabling the instrument to produce accurate results.
7. The Type of Ground Truth Used
The "ground truth" for the equivalence demonstration is the performance of the predicate device, specifically the Alko Diagnostic Corporation calibration products when used with the Dade/Behring Dimension Chemistry Systems. The pHoenix calibration set aims to achieve similar performance. There is no mention of a primary, independent "gold standard" ground truth like pathology or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This device is a calibration set, not a machine learning algorithm that requires a training set. Its function is to provide known concentrations to the instrument for calibration.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set in the context of this device.
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