Search Results

The products encompassed by this request are intended for invitro diagnostic use and are intended for use in calibrating Nat, K+, Cli electrodes in Roche Cobas ISE module. Roche is the original equipment manufacturer for the analyzer and predicate reagents. phoenix electrolyte calibration set is intended for use in playe of like named products manufactured by Roche Diagnostics.

Device Description

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 2 levels and is intended for use in calibrating Na*, K* and CI on the Roche® Cobas™ ISE Module. Roche Diagnostics is the original equipment manufacturer (OEM) of the system. The pHoenix Calibrator Reagents are intended to serve as direct replacements to like named products manufactured by Roche Diagnostics. pHoenix Product 17-200 and 17-201 are equivalent to Roche Product 44224. pHoenix uses a similar composition, description and packaging design as that used by Roche Diagnostics in its products.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the pHoenix Electrolyte Calibration Set for the Roche® Cobas™ ISE Module, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to Roche products, which are the predicate. The performance of the pHoenix calibrators is demonstrated through precision and accuracy studies.

Category	Performance Metric	Acceptance Criteria (Implied)	Reported pHoenix Device Performance
Precision	Standard Deviation (STD) and Coefficient of Variation (CV%) for Na+, K+, Cl-	Acceptable analytical variation consistent with clinical requirements and predicate device performance. (Not explicitly stated in numerical terms, but "typical results" imply acceptable ranges.)	Level 1:
Na+: Total STD 1.50, CV% 1.20; Run to Run STD 0.80, CV% 0.60
K+: Total STD 0.110, CV% 5.0; Run to Run STD 0.040, CV% 1.5
Cl-: Total STD 0.60, CV% 0.60; Run to Run STD 0.25, CV% 0.30
Level 2:
Na+: Total STD 1.20, CV% 0.70; Run to Run STD 0.70, CV% 0.40
K+: Total STD 0.07, CV% 1.0; Run to Run STD 0.04, CV% 0.6
Cl-: Total STD 0.80, CV% 0.50; Run to Run STD 0.60, CV% 0.40
Accuracy	Correlation Coefficient (R)	"Performance equivalence" to Roche Diagnostic products, implying a high correlation (e.g., R ≥ 0.97 or 0.98 for clinical assays) to predicate device results.	Na+: 0.990
K+: 0.990
Cl-: 0.980
	Slope	Close to 1.0 (indicating proportional agreement)	Na+: 1.01
K+: 0.980
Cl-: 0.990
	Intercept	Close to 0.0 (indicating no significant constant bias)	Na+: 1.1
K+: 1.1
Cl-: 1.1

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

Precision Study Test Set:
- Sample Size: 2 levels of serum controls, measured 2 runs per day, 2 times per run for 20 days.
  - For "Total" precision, N = 80 (2 runs/day * 2 times/run * 20 days).
  - For "Run to Run" precision, N = 20 (20 days).
- Data Provenance: Not explicitly stated, but the study was conducted internally by pHoenix. It's prospective, as they "collected" the data following NCCLS Guideline EP5-T. No country of origin is mentioned beyond the company's location in Natick, MA, USA.
Accuracy (Correlation) Study Test Set:
- Sample Size: N = 50 for Na+, K+, and Cl- analysis. The samples included patient serum samples and control samples.
- Data Provenance: Not explicitly stated, but the study was conducted internally by pHoenix. It appears retrospective/concurrent, comparing results from two calibration methods on the same samples. No country of origin beyond the company's location in Natick, MA, USA.

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

This type of device (electrolyte calibrator) does not typically involve expert review for establishing ground truth in the way medical imaging or pathology devices do. The "ground truth" for the accuracy study is the measurement obtained when calibrating the Roche® Cobas™ ISE Module with Roche Diagnostics' own, predicate calibrator products. The performance of the predicate device is assumed to be the established "truth" or reference standard. No external human experts are mentioned for establishing this ground truth.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving subjective interpretation or expert consensus. The comparison is objective, based on instrument readings.

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 a device designed for human interpretation or an AI-assisted diagnostic tool. It's a calibrator for an automated laboratory instrument.

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

Yes, in a way. The performance studies for both precision and accuracy were conducted on the automated Roche® Cobas™ ISE Module, which is an "algorithm only" or automated system. The pHoenix calibrators are used by this automated system. The evaluation assesses the performance of the calibrators through the instrument's measurements, independent of human intervention in the result generation itself.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the accuracy study was the results obtained from the predicate device's calibrators (Roche Diagnostics products) when used with the same Roche® Cobas™ ISE Module. This is a form of reference standard comparison against an established, legally marketed product.

8. The Sample Size for the Training Set

Not applicable. This device is a calibrator, not a machine learning algorithm that requires a training set. The performance is evaluated based on its physical and chemical properties and how it interacts with the instrument.

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 Question

Ask a specific question about this device

Page 1 of 1