(46 days)
The pHoenix ISE Standard for Roche AVL Instruments are intended for use as ISE Reagents for the determination of Na', K', Cli, Ca and Li* in human serum samples on the Roche AVL Systems.
The standards are used for the calibration of the Roche AVL Instruments for the quantitative determination of Nat, K* Cl*, Ca* and Li+ in serum samples.
pHoenix Diagnostics, Inc. is submitting a 510 (k) notification for Standard A. B. and C for the Roche AVL Systems for the quantitative determination of Na+, K+, Cl-, Ca+ and Li+ in human serum. These Standards are used for the calibration of the Roche AVL Systems.
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. These pHoenix ISE Standards are intended to serve as direct replacements to like named products manufactured by Roche Diagnostics.
pHoenix Diagnostics uses a similar composition and design as that used by Roche Diagnostics in its products.
The provided text describes the performance of "pHoenix ISE Standards for Roche AVL Systems," which are intended for the quantitative determination of Na+, K+, Cl-, Ca+, and Li+ in human serum. These standards are used for the calibration of Roche AVL Systems.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria (e.g., "CV% must be less than X%"). Instead, it presents precision data and correlation data to demonstrate performance equivalence to the predicate device. The implicit acceptance criterion is that the performance of the pHoenix standards should be comparable to or within acceptable limits for a clinical assay, as demonstrated by the precision and correlation studies.
Precision Study Results (Typical - Specific acceptance criteria are not explicitly stated within each table):
| Analyte | Level | N | Mean | STD | CV% | Min | Max |
|---|---|---|---|---|---|---|---|
| AVL 983 | |||||||
| Na | 1 | 80 | 124 | 1.52 | 1.2 | 121 | 127 |
| Na | 3 | 80 | 164 | 2.6 | 1.6 | 162 | 166 |
| K | 1 | 80 | 1.93 | 0.11 | 5.5 | 1.7 | 2.2 |
| K | 3 | 80 | 6.5 | 0.06 | 0.96 | 6.4 | 6.6 |
| Cl | 1 | 80 | 85.6 | 1.4 | 1.7 | 82 | 89 |
| Cl | 3 | 80 | 148 | 0.82 | 0.56 | 146 | 149 |
| AVL 984 | |||||||
| Na | 1 | 80 | 124 | 1.48 | 1.2 | 121 | 127 |
| Na | 3 | 80 | 165 | 1.75 | 1.06 | 162 | 170 |
| K | 1 | 80 | 1.91 | 0.105 | 5.5 | 1.7 | 2.2 |
| K | 3 | 80 | 6.7 | 0.101 | 1.52 | 6.4 | 6.8 |
| Ca | 1 | 80 | 2.36 | 0.112 | 4.76 | 2.2 | 2.6 |
| Ca | 3 | 80 | 0.84 | 0.014 | 1.69 | 0.81 | 0.87 |
| AVL 985 | |||||||
| Na | 1 | 80 | 123 | 1.33 | 1.1 | 121 | 126 |
| Na | 3 | 80 | 165 | 1.73 | 1.05 | 162 | 170 |
| K | 1 | 80 | 1.84 | 0.08 | 4.43 | 1.7 | 2 |
| K | 3 | 80 | 6.6 | 0.12 | 1.85 | 6.4 | 6.8 |
| Li | 1 | 80 | 1.75 | 0.087 | 5 | 1.6 | 1.9 |
| Li | 3 | 80 | 2.56 | 0.1 | 3.71 | 2.4 | 2.8 |
Correlation Study Results (Implicit Acceptance Criteria: Correlation Coefficient close to 1, Slope close to 1, Intercept close to 0):
| Analyte | AVL Model | N | Slope | Intercept | Correlation Coefficient | Range |
|---|---|---|---|---|---|---|
| Na+ | 983 | 50 | 1.03 | -1.36 | 0.992 | 75 - 178 |
| Na+ | 984 | 50 | 1.03 | -0.71 | 0.996 | 74 - 177 |
| Na+ | 985 | 50 | 1.03 | 0.98 | 0.994 | 75 - 177 |
| K+ | 983 | 50 | 1.005 | 0.32 | 0.996 | 2.9 - 6.7 |
| K+ | 984 | 50 | 1.001 | 0.29 | 0.998 | 2.8 - 6.7 |
| K+ | 985 | 50 | 0.98 | 0.402 | 0.997 | 3.1 - 6.8 |
| Cl- | 983 | 50 | 0.98 | 6.18 | 0.997 | 52 - 151 |
| Ca+ | 984 | 50 | 1.02 | 0.02 | 0.997 | 0.7 - 2.2 |
| Li+ | 985 | 50 | 0.989 | 0.03 | 0.998 | 0.3 - 2.4 |
2. Sample sizes used for the test set and the data provenance
- Precision Study: For each analyte and level, N=80 measurements were performed across 20 days (2 runs per day, 2 times per run). These were conducted on Roche AVL Systems using "2 levels of serum controls." The provenance is not explicitly stated as country of origin, but the study was performed in the context of demonstrating equivalence for US market clearance, implying compliance with US regulatory expectations. The samples used were "serum controls." The study design (20 days, 2 runs/day, 2 measurements/run) is typical for prospective precision studies in clinical laboratories.
- Correlation Study: N=50 samples were used for each analyte/AVL model combination. These samples included "patient serum samples, control samples and spiked samples." The provenance is not explicitly stated. This appears to be a prospective comparison, where samples were measured with both the predicate and test devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. For this type of in vitro diagnostic device (calibrators), ground truth is typically established by reference methods or gravimetric/volumetric preparation for control materials, rather than expert interpretation of patient data. The "ground truth" in the correlation study would be the results obtained from the predicate Roche Diagnostics reagents.
4. Adjudication method for the test set
This is not applicable as this is a quantitative analytical device, not an interpretative device where adjudication of human readers is performed. The "adjudication" is essentially the comparison of numerical results between the predicate and test device using statistical methods (linear regression).
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
This is not applicable. The device is an in vitro diagnostic calibrator, not an AI-assisted diagnostic tool that involves human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is applicable in the sense that the device's performance (precision and correlation) was evaluated independently of human interpretation of results, as it is a calibrator. The "algorithm" here refers to the Roche AVL System's measurement process, which the calibrators enable. The performance presented is the standalone performance of the calibrators enabling the instrument.
7. The type of ground truth used
- Precision study: The "ground truth" for evaluating precision is the measured mean and variation around that mean for the control materials. The known target values of the control materials serve as a reference.
- Correlation study: The "ground truth" for the purpose of demonstrating substantial equivalence is the measurements obtained using the Roche Diagnostics reagents (the predicate device). The pHoenix Diagnostics reagents are compared against these predicate results.
8. The sample size for the training set
This device is not an AI/machine learning algorithm, so there is no "training set" in the conventional sense. The development of the pHoenix ISE Standards would involve formulation and testing to ensure they meet concentration specifications, but this is a manufacturing/chemistry process, not an AI training process.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for an AI algorithm. The performance of the calibrators themselves is established through rigorous chemical and analytical validation processes to ensure their stated concentrations are accurate and stable.
§ 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.