Search Results

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):

Correlation Study Results (Implicit Acceptance Criteria: Correlation Coefficient close to 1, Slope close to 1, Intercept close to 0):

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.

Ask a specific question about this device

The pHoenix ISE Reagents for Beckman CX Systems are intended for use as ISE Reagents for the determination of Na , K , C1 and C02 in human serum samples on the Beckman CX Systems.

The Electrolyte Buffer is diluted with the Wash Solution and introduced into the serum samples for the quantitative determination of Na+, K+, Cl- and C02.

The Electrolyte Reference Reagent is to provide reference points for Na+, K+, C1- and C02.

The C02 Acid Reagent is to release C02 from serum samples.

The C02 Alkaline Buffer is to provide a constant C02 concentration as reference for the C02 electrode. The Wash Concentrate is intended to be diluted with de-ionized water. The working Wash Solution is used to wash the systems sample probe and to dilute reagents on Beckman CX Systems.

The Calibrators are used for the calibration of the CX ISE Modules for the quantitative determination of Na+, K+ Cl+and C02 in serum samples.

pHoenix Diagnostics, Inc. is submitting a 510 (k) notification for the following: (1) Electrolyte Buffer, (2) Electrolyte Reference Reagent and (3) C02 Acid Reagent, (4) C02 Alkaline Buffer, (5) Wash Concentrate and (6) ISE Calibrator Level 1,2 and 3. These ISE Reagents are intended for use on the ISE Module of the Beckman CX Systems for the quantitative determination of Na+, K+, C1- and C02 in human serum.

The Electrolyte Buffer is intended to provide constant ionic strength for measuring electrolytes in human serum samples. The Electrolyte Buffer is combined with the Wash Solution and introduced into the serum samples for the quantitative determination of Na+, K+, C1- and C02. The Electrolyte Reference Reagent is to provide reference points for Na+, K+, C1- and C02. The C02 Acid Reagent is to release C02 from serum samples, The C02 Alkaline Reagent is to provide a constant C02 concentration as reference for the C02 electrode. The Wash Concentrate is intended to be diluted with de-ionized water. The working Wash Solution is used to wash the systems sample probe and to dilute reagents on Beckman CX Systems. The Calibrators are used for the calibration of the CX ISE Modules.

1. Table of Acceptance Criteria and Reported Device Performance

The device is a set of reagents for an In Vitro Diagnostic (IVD) system. Performance is primarily evaluated through precision and correlation studies against a predicate device.

Note: The document does not explicitly state acceptance criteria in numerical terms. The "acceptance criteria" presented above are inferred from the stated goal of demonstrating "performance equivalence" to the predicate devices and the robust correlation coefficients and low CV% values typically expected for IVD assays.

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

• Precision Study:
  • Sample Size: For each analyte (Na+, K+, Cl-, CO2), two levels of serum controls were measured. Each level had 80 total measurements (2 runs per day, 2 times per run for 20 days).
  • Data Provenance: The document states "Typical Results are as follows," suggesting the data was generated specifically for this submission. The origin of the serum controls (e.g., country) is not specified. It is a prospective study as the testing was conducted using the pHoenix reagents on Beckman CX Systems.
• Correlation Study:
  • Sample Size: 50 samples were used for each analyte (Na+, K+, Cl-, CO2).
  • Data Provenance: The samples included "patient serum samples, control samples and spiked samples." The country of origin is not specified. This is a prospective study as the measurements were taken using pHoenix reagents and compared to measurements with Beckman Coulter reagents on the same analyzer.

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

Not applicable. This device is an IVD reagent set, and the "ground truth" for performance studies (precision and correlation) is based on quantitative measurements generated by laboratory instruments, not expert interpretation. The comparison is made against a legally marketed predicate device (Beckman Coulter reagents).

4. Adjudication Method for the Test Set

Not applicable. As noted above, performance is based on quantitative laboratory measurements, not subjective interpretation requiring adjudication among experts.

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 device is an IVD reagent set, not an AI-powered diagnostic imaging or interpretation tool. The study focuses on the analytical performance of the reagents.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done

Not applicable. This device is an IVD chemical reagent set. Its performance inherently involves an instrument (Beckman CX Systems) and a human operator to perform the tests, although the performance data collected (precision and correlation) represents the analytical performance of the reagents themselves.

7. The Type of Ground Truth Used

For the precision study, the ground truth is the quantitative measurement obtained over multiple runs, and the benchmark is the expected variability for such assays (as indicated by NCCLS Guideline EP5-T). For the correlation study, the "ground truth" for comparison is the results obtained using the legally marketed predicate Beckman Coulter reagents. This is a comparative study against an established method.

8. The Sample Size for the Training Set

Not applicable. This document describes the validation of an IVD reagent set, not a machine learning model. There is no concept of a "training set" in this context. The reagents themselves are "trained" through their manufacturing process to consistently produce accurate results.

9. How the Ground Truth for the Training Set Was Established

Not applicable. (See #8).

Ask a specific question about this device

The pHoenix ISE Reagents for Olympus® AU Chemistry Systems are intended for use as ISE Reagents for the determination of Nat, K+, and Cli for the Olympus® AU Clinical Chemistry Systems.

The ISE Buffer is intended for use as a diluent for patient samples for the quantitative determination of Nat, K+ and Cl in serum by ISE.

The ISE Internal Reference Solution is intended as a means of compensating for calibration drift in the quantitative determination of Na * and Cl in serum samples on the Olympus® AU Chemistry Systems.

The ISE High and Low Standards are intended to provide calibration points for the Na , K+ and Cli Electrodes on the Olympus® AU ISE systems.

The products encompassed by this 510 (k) submission are Class I (75JJG) and Class II (75 JIX) In Vitro Diagnostic Solutions manufactured by pHoenix Diagnostics, Inc., 8 Tech Circle, Natick, MA 01760. These pHoenix ISE Reagents are intended to serve as direct replacements to like named products manufactured by Olympus® Diagnostics. Listed below are pHoenix products and their Olympus® Diagnostics equivalents.

| pHoenix
Cat.# | Olympus
Cat. # | Description | Models | Class |
|------------------|-------------------|---------------------------------|--------|-------|
| TBD | AUH1011 | ISE Buffer | AU | 1 |
| TBD | AUH1017 | ISE Internal Reference Solution | AU | 1 |
| TBD | AUH1014 | ISE Low Standard | AU | 2 |
| TBD | AUH1015 | ISE High Standard | AU | 2 |

pHoenix uses a similar composition, description and packaging design as that used by Olympus® Diagnostics in its products.

Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets them:

Device: pHoenix ISE Reagents for Olympus® AU Chemistry Systems
Intended Use: For the determination of Na+, K+, and Cl- in serum by ISE. These reagents serve as direct replacements for Olympus® Diagnostics products.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance. Instead, it demonstrates performance by comparing the pHoenix reagents to the predicate Olympus® Diagnostics reagents through method comparison (correlation) and precision studies. The implicit acceptance criteria are that the pHoenix reagents should perform comparably to the predicate device.

Given the absence of explicit acceptance criteria, I will infer them based on what is typically expected for a method comparison and precision study in in-vitro diagnostics, and then present the reported performance.

• Na+: Slope = 1.06, Intercept = -4.9, Correlation Coefficient = 0.998
• K+: Slope = 1.03, Intercept = 0.11, Correlation Coefficient = 0.999
• Cl-: Slope = 0.98, Intercept = 4.8, Correlation Coefficient = 0.997 |

2. Sample Size 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.
    • This results in: 2 levels * 2 runs/day * 2 measurements/run * 20 days = 160 individual measurements in total for each analyte. (The table lists N=80 for "Total" for each level, implying 80 measurements per level).
  • Data Provenance: Not explicitly stated, but implies laboratory testing performance data rather than patient data from a specific country or retrospective/prospective collection of patient samples. The samples were "serum controls."

• Method Comparison Study Test Set:

  • Sample Size: 50 samples for each analyte (Na+, K+, Cl-).
  • Data Provenance: The samples consisted of "patient serum samples, control samples and spiked samples." The origin (e.g., country) is not specified, nor is whether the collection was retrospective or prospective.

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

• Not applicable in the conventional sense for this type of in-vitro diagnostic device (reagents for chemical analysis).
• The "ground truth" for the method comparison is the results obtained using the legally marketed predicate device (Olympus® Diagnostics standard reagents) on an Olympus AU Clinical Chemistry System. This is a comparative study against an established, accepted method, not a subjective interpretation by experts.
• For precision studies, the "ground truth" is the inherent variability of the analytical system, assessed statistically.

4. Adjudication Method for the Test Set

• Not applicable. This is an analytical performance study for IVD reagents, not a study involving expert interpretation or medical imaging with subjective decision-making that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices that involve human interpretation of results (e.g., medical imaging AI, pathology slides). The pHoenix ISE Reagents are for automated chemical analysis, where the result is a direct numerical output from the instrument.

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

• Yes, in a sense. The performance presented (precision and method comparison) is that of the reagents and the analytical system (Olympus AU Chemistry Systems) calibrated with pHoenix reagents. There is no human interpretation component in the direct measurement process that these reagents support. The entire process is automated once the sample is loaded and the instrument is calibrated.

7. The Type of Ground Truth Used

• Precision Study: Statistical measures of repeatability and reproducibility (Mean, STD, CV%). No external "ground truth" in the clinical sense, but rather a characterization of the system's inherent variation using control materials.
• Method Comparison Study: The results generated by the predicate device (Olympus® Diagnostics standard reagents) on the Olympus AU Clinical Chemistry Systems. This is considered the "reference method" for comparison.

8. The Sample Size for the Training Set

• Not applicable. This document describes performance verification studies for a chemical reagent, not a machine learning model that requires a "training set." The studies are designed to demonstrate the analytical performance of the product.

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 specific question about this device

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.

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.

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.

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 specific question about this device

The pHoenix ISE Reagents for Roche Hitachi 700/900 series are intended for use as ISE Reagents for the determination of Nat, K*, and Cli for the Roche Hitachi 700/900 Series Clinical Chemistry Systems.

The ISE Diluent are intended for use as a diluent for patient samples for the quantitative determination of Nat, K+ and CI in serum by ISE.

The ISE Internal Reference Solutions are intended as a means of compensating for calibration drift in the quantitative determination of Na*, K* and CI in a serum sample on the Roche Hitachi Clinical Chemistry Systems.

The ISE High and Low Standards are intended to provide callbration points for the Na , K and Cl Electrodes on the Roche Hitachi ISE system.

pHoenix ISE reagent for Roche Hitachi Clinical Chemistry 700 and 900 Series Systems: pHoenix Diagnostics, Inc. is submitting a 510 (K) notification for the following: (1) pHoenix ISE Diluent, (2) ISE Internal Reference Solution and (3) ISB Low and High Standards. These ISE Reagents are intended for use on the ISE Module of the Roche Hitachi Clinical Chemistry Systems. The ISE Diluent dilutes all measured patient samples for the quantitative determination of Nat, K* and CI in serum by ISE. The ISE Internal Reference Solutions are intended as a means of compensating for calibration drift in the quantitative determination of Na", K+ and CI' in serum samples on the Roche Hitachi Clinical Chemistry Systems. The ISE High and Low Standards are intended to provide calibration points for the Nat, K+ and Cl Electrodes on the ISE system.

The pHoenix ISE Reagents for Roche/Hitachi Models 700/900 Series were determined to be substantially equivalent to predicate devices manufactured by Roche Diagnostics Corporation based on method comparison and precision studies.

1. A table of acceptance criteria and the reported device performance

The provided text describes performance equivalence in general terms (method comparison and precision study) but does not contain a detailed table of specific acceptance criteria (e.g., specific ranges for bias or precision) or the reported device performance values. It states these reagents are "similar in composition and performance" to Roche Diagnostics equivalents and "have shown performance equivalence."

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).

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 in the document.

4. Adjudication method for the test set

This information is not provided in the document.

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

A multi-reader multi-case comparative effectiveness study is not applicable as this device is a reagent for in vitro diagnostic testing, not an AI-assisted diagnostic tool for human readers.

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

This is not applicable as the device is a reagent, not an algorithm. The performance evaluation would be for the reagent's analytical accuracy and precision when used with the specified instruments.

7. The type of ground truth used

The ground truth for evaluating the pHoenix ISE Reagents would likely be established through:

• Reference Method Comparison: Comparing the results obtained using the pHoenix ISE Reagents with those obtained from the predicate device (Roche Diagnostics equivalents) or an established reference method.
• Known Concentration Standards: Using samples with accurately known concentrations of Na+, K+, and Cl- to assess the accuracy of the measurements.

8. The sample size for the training set

This information is not provided, and the concept of a "training set" in the context of analytical reagent performance testing (as opposed to machine learning) is generally not applicable in the same way. Performance studies for reagents typically involve testing across a range of concentrations and conditions to characterize their analytical performance.

9. How the ground truth for the training set was established

As noted above, a "training set" as understood in machine learning is not directly applicable here. For the performance studies, the ground truth would be established by comparing against the predicate device's performance characteristics or recognized analytical standards.

Ask a specific question about this device

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.

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).

Ask a specific question about this device

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.

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.

Ask a specific question about this device

Ask a specific question about this device