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1. VITROS Chemistry Products CI- Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products Cl-Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

2. VITROS Chemistry Products ECO2 Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Bicarbonate/ carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

3. VITROS Chemistry Products GLU Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The VITROS Chemistry MicroSlide range of products (in this case VITROS Chemistry Products Cl- Slides, VITROS Chemistry Products ECO2 Slides, and VITROS Chemistry Products GLU Slides), are combined with the VITROS XT 7600 Integrated System to perform the VITROS CI-, ECO2, and GLU assays.

The provided text describes the performance evaluation of VITROS Chemistry Products Cl- Slides, ECO2 Slides, and GLU Slides on the VITROS XT 7600 Integrated System, demonstrating their substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the successful outcomes of the various performance studies (method comparison, precision, linearity, detection limits, specificity). Explicit numerical acceptance criteria are not always stated for each test result in the summary, but rather the conclusion that performance was "acceptable" or "supported the claimed measuring ranges."

Summary of VITROS XT 7600 Method Comparison Regression Analysis Data

Precision (Representative samples shown for Cl- Serum and ECO2)

The precision tables present the mean, N, SD, and %CV for Repeatability (Within Run), Within Day, Between Day, Between Calibration, and Within Lab (Total) for various fluids. The acceptance criteria are implicitly that the reported %CV and SD values are within acceptable clinical laboratory standards for these analytes, though specific numeric targets are not explicitly stated in this summary.

Detection Limits

The acceptance criterion for LoQ is explicitly mentioned: "Ortho defines LoQ as the lowest concentration with an imprecision of ≤20% and percent total allowable error

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The Alinity c ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine on the Alinity c analyzer.

Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The Alinity c ICT Sample Diluent is a reagent kit containing Reagent 1 (Buffer). It is used with the Alinity c ICT Serum Calibrator and Alinity c ICT Urine Calibrator on the Alinity c analyzer. The system utilizes ion-selective electrodes (ISE) for sodium, potassium, and chloride, which develop an electrical potential across membranes selective to each ion. This voltage is compared to calibrator voltages and converted into ion concentration. The methodology is Ion-selective electrode diluted (Indirect) and the detection is Potentiometric.

The provided document describes the Alinity c ICT Sample Diluent, a device used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine. The document mainly focuses on non-clinical performance studies to demonstrate substantial equivalence to a predicate device, rather than a clinical study with acceptance criteria in the traditional sense of diagnostic accuracy or reader performance.

Here's an analysis of the provided information based on your requested criteria:

The studies presented are primarily analytical performance studies (precision, linearity, interference, method comparison, and tube type equivalency) to demonstrate the device's accuracy and reliability compared to a predicate device. The acceptance criteria are internal, predefined thresholds for these analytical performance characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective, for patient samples. The studies are described as "Within-Laboratory Precision" and "Method Comparison," implying they were conducted in a controlled laboratory setting.

• Precision Studies (Test Set):
  • Serum Samples: For Sodium, Potassium, and Chloride assays, each control level (3 levels) typically had n=243 to n=252 measurements per control lot. For patient panels, n=485 to n=498 measurements were performed.
  • Urine Samples: For Sodium, Potassium, and Chloride assays, each control level (2 levels) typically had n=240 measurements per control lot. For patient panels, n=479 to n=480 measurements were performed.
• Method Comparison (Test Set):
  • Sodium (Serum): n=141
  • Sodium (Urine): n=101
  • Potassium (Serum): n=122
  • Potassium (Urine): n=107
  • Chloride (Serum): n=120
  • Chloride (Urine): n=112
  • Data Provenance: "Human serum and urine specimens that spanned the measuring interval of the assay were evaluated." The specific origin (e.g., country) is not mentioned. These are likely prospective samples collected for testing.
• Interference Studies (Test Set): Not explicitly stated, but typically these studies use spiked samples or samples with naturally elevated interferents.
• Tube Type Equivalency (Test Set): Samples were collected from a minimum of 40 donors.

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

This type of device (in-vitro diagnostic for electrolyte measurement) does not typically involve human experts establishing ground truth in the way medical imaging or pathology devices do. The "ground truth" for these analytical studies is established by:

• Reference Methods: For calibrator concentrations, "flame photometry calibrated against NIST Standard Reference Material" and "titration with silver calibrated against NIST Standard Reference Material" were used.
• Predicate Device: For method comparison, the "ARCHITECT ICT Sample Diluent Sodium, Potassium, and Chloride" is used as the comparator method, implying its results are considered the established values for comparison.
• Known Concentrations: For precision, linearity, and interference studies, samples are often prepared with known concentrations or spiked with specific substances.

Therefore, the concept of "experts establishing ground truth" as in qualitative diagnostic interpretation is not applicable here.

4. Adjudication Method for the Test Set

Not applicable for this type of analytical performance study. Adjudication methods like 2+1 or 3+1 are used for qualitative assessments, typically when human interpretations are being compared, or when there's disagreement among experts on a ground truth.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. This is an analytical performance study for an in-vitro diagnostic instrument component, not a diagnostic imaging or AI-driven interpretive device. Therefore, a MRMC comparative effectiveness study involving human readers with and without AI assistance is not relevant.

6. Standalone (Algorithm Only) Performance Study

Yes, implicitly. The entirety of the reported Nonclinical Performance (precision, linearity, interference, method comparison, and tube type equivalency) represents the standalone performance of the Alinity c ICT Sample Diluent device on the Alinity c analyzer. There is no "human-in-the-loop" aspect to the measurement of electrolyte concentrations by this automated system.

7. Type of Ground Truth Used

• Reference Methods: NIST Standard Reference Materials, flame photometry, and titration with silver were used to establish the ground truth for calibrator concentrations.
• Comparator (Predicate) Device: The ARCHITECT ICT Sample Diluent was used as the comparator for method comparison studies.
• Known Concentrations/Spiked Samples: For precision, linearity, and interference studies, samples with known or precisely prepared concentrations were used.

8. Sample Size for the Training Set

This document does not describe the development of an algorithm that would require a separate "training set" in the context of machine learning. The device is an in-vitro diagnostic reagent and system based on established ion-selective electrode technology. Its performance is evaluated through analytical studies, not by training a model on a dataset.

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

Not applicable. As explained in point 8, there is no "training set" in the machine learning sense for this device.

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Rx. For in vitro diagnostic use only .VITROS® Chemistry Products Cl⁻ Slides quantitatively measure chloride (Cl⁻) concentration in serum, plasma, and urine using VITROS® Chemistry Systems. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The VITROS® Chemistry Products Cl⁺ Slide assay is performed using the VITROS® Chemistry Products Cl⁺ Slide and the VITROS® Chemistry Products Calibrator Kit 2 on the VITROS Chemistry Systems.
The VITROS® Cl- Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry for measurement of chloride ions. All reactions necessary for a single quantitative measurement of chloride take place within the multi-layered analytical element of a VITROS® Chemistry Products Cl⁺ slide. The slide consists of two ion- selective electrodes, each containing a protective layer, a silver layer and a silver chloride layer coated on a polyester support support. The protective layer inhibits interference from normal levels of bromide and uric acid.

The provided text describes the performance summary of the VITROS Chemistry Products Cl- Slides, a device for quantitatively measuring chloride (Cl-) concentration in serum, plasma, and urine. It does not contain information about an AI-powered device or an MRMC comparative effectiveness study. Therefore, sections related to AI, expert involvement, and MRMC studies cannot be filled from this document.

Here's a summary of the acceptance criteria and study detailed in the document for the VITROS Chemistry Products Cl- Slides:

1. Table of Acceptance Criteria and Reported Device Performance

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For in vitro diagnostic use only. VITROS Cl- DT Slides quantitatively measure chloride (CI-) concentration in serum and plasma. Chloride measurements are used in the diagnosis and treatment of clectrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for the quantitative measurement of ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, CI-, Co2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

The VITROS Chemistry Products CI Slide assay is performed using the VITROS Chemistry Products Cl DT Slide and the VITROS Chemistry Products DT Calibrator Kit on the VITROS DT Chemistry Systems. The VITROS CI DT Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry for measurement of chloride ions. All reactions necessary for a single quantitative measurement of chloride take place within the multi-layered analytical element of a VITROS Chemistry Products CI DT Slide. The slide consists of two ionselective electrodes, each containing a protective laver, a silver laver and a silver chloride layer coated on a polyester support. The protective layer inhibits interference from normal levels of bromide and uric acid VITROS Chemistry Products CI DT Slides use ion-selective electrodes for potentiometric measurements of ionic chloride. Ionic chloride determinations are made by simultaneously depositing 10 uL each of a reference fluid and a sample fluid on separate halves of the VITROS Chemistry Products CT DT Slide. The electrode receiving the reference fluid is identified as the reference electrode. A paper bridge connects the reference electrode and the indicator electrode, which receives the sample fluid. A stable liquid junction between the two fluids is formed in the paper bridge. The chloride ions in the tested reference and sample fluids migrate to the silver/ silver chloride layers and establish equilibrium. Each electrode produces an electrical potential in response to the activity of chloride ions applied to it. The potential difference poised between the two electrodes is proportional to the chloride concentration in the sample. The test result is reported in millimoles per liter (mmol/ L). VITROS Chemistry Products DT Calibrator Kit contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from boyine serum albumin and processed bovine serum to which enzymes, electrolytes, stabilizers, preservatives, and other organic analytes have been added. The companion diluents are prepared from processed water to which inorganic salts have been added. The VITROS DT Systems and reagents are designed specifically for use with the VITROS Chemistry Products range of products.

Here's an analysis of the provided 510(k) summary, specifically focusing on acceptance criteria and the study conducted.

It's important to note that this document is a 510(k) summary for a modified device, demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" discussed here relate to showing that the modified device performs comparably to the previously cleared predicate, rather than establishing completely new performance benchmarks from scratch.

Acceptance Criteria and Device Performance

Summary of the Study Proving Acceptance Criteria:

The study was designed to demonstrate "substantial equivalence" of the modified VITROS Chemistry Products CI DT Slides to the previously cleared predicate device. This is a common approach for 510(k) submissions when minor modifications are made to an existing device.

1. Sample size used for the test set and the data provenance:

   • The document states: "Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured chloride values spanning the assay range."
   • Specific sample size is not provided in this 510(k) summary. This information would typically be in a more detailed technical report.
   • Data Provenance: Not explicitly stated, but clinical samples are implied ("patient samples"). It is common for such studies to use retrospective or prospective samples, often from diverse geographic regions for generalizability, but this summary doesn't specify.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable / Not specified. For in vitro diagnostic (IVD) devices like this, "ground truth" is typically established by reference methods or validated comparative methods, not by human experts interpreting results. The predicate device itself acts as the "gold standard" or reference in a substantial equivalence study. The "ground truth" here is the measured chloride values from patients and quality control samples.

3. Adjudication method for the test set:

   • Not applicable. As stated above, this is an IVD device measuring a chemical analyte. There is no human interpretation or adjudication in the sense of image review or clinical decision-making. The comparison is quantitative between the modified and predicate device results.

4. 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:

   • No. This is an in vitro diagnostic (IVD) assay for measuring chloride concentration, not an imaging or AI-assisted diagnostic device that involves human readers.

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

   • Yes, effectively. The "standalone" performance is the direct measurement by the modified chemical assay (VITROS Chemistry Products CI DT Slides) compared to the predicate device. There is no human intervention in the actual measurement process of chloride ions by the device itself.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" was established by the measured chloride values obtained from the predicate device (VITROS Chemistry Products CI DT Slide, K912844) and/or a comparable referance method using patient and quality control samples. The aim was to show the modified device produces results comparable to these established measurements.

7. The sample size for the training set:

   • For an IVD device substantial equivalence study, particularly for a modification where the fundamental technology is similar, there isn't typically a "training set" in the machine learning sense. The device is calibrated, and its performance is verified and validated. The calibrators themselves (VITROS Chemistry Products DT Calibrator Kit) are used to establish the measurement curve, but this isn't a "training set" for an algorithm. The summary does not specify details about calibrator lots or usage.

8. How the ground truth for the training set was established:

   • As there isn't a "training set" in the typical ML/AI sense, this question is not directly applicable. The calibrator kit (composed of lyophilized standards with known concentrations) is used to establish the instrument's calibration curve. The values assigned to these calibrators would have been established through a primary reference measurement system or by careful gravimetric/volumetric preparation and verification, ensuring accuracy and traceability.

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The AutoDELFIA® Neonatal IRT L kit is intended for the quantitative determination of human immunoreactive trypsin (ogen) (IRT) in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the 1235 AutoDELFIA® automatic immunoassay system.

The AutoDELFIA Neonatal IRT assay is a solid phase, two-site fluoroimmunometric assay based on the direct sandwich technique in which two monoclonal antibodies (derived from mice) are directed against two separate antigenic determinants on the IRT molecule. Standards, controls and test specimens containing IRT are reacted simultaneously with immobilized monoclonal antibodies directed against a specific antigenic site on the IRT molecule and europium -labeled monoclonal antibodies (directed against a different antigenic site) in assay buffer. The assay buffer elutes IRT from the dried blood spots on the filter paper discs. The complete assay requires only one incubation step. Enhancement Solution dissociates europium ions from the labelled antibody into solution where they form highly fluorescent chelates with components of the Enhancement Solution. The fluorescence in each well is the measured. The fluorescence of each sample is proportional to the concentration of IRT in the sample.

This document describes the AutoDELFIA Neonatal IRT L kit, an in vitro diagnostic device used for screening newborns for cystic fibrosis by quantitatively determining immunoreactive trypsin(ogen) (IRT) in dried blood specimens. The submission seeks to demonstrate substantial equivalence to a previously cleared device, the AutoDELFIA Neonatal IRT kit (K003668).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the comparison of the new device (AutoDELFIA Neonatal IRT L kit, B022-112) with the predicate device (AutoDELFIA Neonatal IRT kit, B005-112). The goal is to show equivalent analytical performance characteristics.

Note: The text explicitly states "The analytical performance characteristics of the two kits are equivalent" implying that the performance of the new device matching or being comparably close to the predicate device serves as the acceptance criteria. For the IRT distribution, the differences are noted, suggesting that while not identical, they are considered within acceptable equivalence for substantial equivalence.

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

The document does not explicitly state the sample size used for the test set for the studies on precision, limit of blank, linearity, hook effect, or IRT distribution.

• Data Provenance: The document does not specify the country of origin for the data or whether the studies were 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. The studies described are analytical performance studies of an IVD kit, not studies requiring expert interpretation of results for ground truth. The "ground truth" for these tests would typically be defined by reference methods or established statistical analysis of the assay's performance characteristics.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple readers or experts assess cases. This document describes analytical performance studies of a diagnostic assay kit. Therefore, an adjudication method is not applicable and not mentioned.

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 document describes the analytical validation of an in vitro diagnostic kit, not a study involving human readers interpreting results with and without AI assistance.

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

The device is an automated immunoassay system (AutoDELFIA® automatic immunoassay system) that performs quantitative measurements. The performance data presented (precision, limit of blank, linearity, hook effect, IRT distribution) are standalone performance metrics of the assay kit itself, without human interpretation as part of the primary measurement. Human intervention would be for laboratory procedures and interpretation of the quantitative result against clinical cut-offs, but the device performance itself is standalone in terms of generating the IRT concentration.

7. The Type of Ground Truth Used

For the analytical performance characteristics:

• Precision: Established by repeated measurements.
• Limit of blank: Determined statistically from blank sample readings.
• Linearity: Assessed by analyzing samples of known, serially diluted concentrations.
• Hook effect: Investigated using samples with very high IRT concentrations.
• IRT distribution in newborns: This likely represents observed data from a population of newborns, which serves as the "ground truth" for reflecting the typical range of IRT in the target population. However, the exact method for establishing this, beyond sample analysis, is not detailed.

In essence, the "ground truth" for these studies is derived from analytical measurements and statistical analysis against reference materials or established methods, rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

The document describes the validation of an IVD kit, not an AI/ML algorithm that typically has a "training set." Therefore, the concept of a "training set sample size" as commonly understood in AI/ML is not applicable to this submission. The kit is based on established fluoroimmunometric assay principles and monoclonal antibodies.

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

As noted in point 8, the concept of a "training set" in the AI/ML context is not applicable. The assay's performance is established through calibration and validation studies using known standards and samples, similar to how analytical methods are developed and validated in general.

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The ISE module of the DataPro™ Plus Clinical Chemistry Analyzer is intended for the quantitative determination of sodium, potassium and chloride in serum, using ion-selective (ISE) electrodes.

Sodium: Disorders of the sodium ion (Na ) can be caused by excessive loss, gain or retention of Na or excessive retention of water. Low Na * can be associated with renal failure, congestive heart failure and cirrhosis. An increase in Na+ is seen in neurological disorders such as tremors, ataxia, confusion and coma.

Potassium: Disturbances of potassium (K*) homeostasis has serious consequences and can lead to tachycardia when low. When high, respiratory weakness peripheral vascular collapse and cardiac arrest is evident. It is also seen in conditions associated with Addison's disease. Levels higher than 10mmol/L are fatal in most cases.

Chloride: When the chloride ion (CI) is unbalanced in the serum, it is usually a sign of an underlying disturbance in fluid and acid-base homeostasis. A low Cl" concentration is observed in individuals with salt-losing nephritis whereas an increase in Cl can indicate acute renal failure and metabolic acidosis.

The ISE module, and all of the reagents included in this test system are for in vitro diagnostic use only.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a device called "ISE Module for the DataPro™ Plus". This document primarily communicates the FDA's decision regarding the substantial equivalence of the device to a predicate device and states that it can be marketed.

It briefly mentions the indications for use, but it does not contain information about acceptance criteria, detailed study design, device performance, sample sizes, ground truth establishment, or expert qualifications. The document is a regulatory approval letter, not a pivotal study report.

Therefore, I cannot provide the requested information based on the input text.

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The ISE module of the COBAS INTEGRA systems is intended for use for the quantitative determination of sodium, potassium, chloride in serum, plasma and urine, and lithium in serum and plasma, using ion-selective electrodes. This Chloride electrode is recommended to be used if a significant amount of the samples are plasma samples. Serum and urine samples may also be analyzed with this electrode. Chloride measurements are used in diagnosis and treatment of electrolyte and metabolic disorders.

The ISE module of the COBAS INTEGRA systems is intended for use for the quantitative determination of sodium, potassium, chloride in serum, plasma and urine, and lithium in serum and plasma, using ion-selective electrodes. The ion-selective electrode is using undiluted (ISE Direct) or automatically diluted (ISE Indirect, ISE Urine) specimens. This Chloride electrode is recommended to be used if a significant amount of the samples are plasma samples. Serum and urine samples may also be analyzed with this electrode.

Here's a breakdown of the acceptance criteria and study information for the Chloride Electrode Gen. 2, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document compares the "Modified Chloride Electrode Gen. 2" to a "Predicate Device – Chloride Electrode (approved via K963627)". While explicit "acceptance criteria" for the modified device are not stated as separate numerical targets, the study's goal is to demonstrate "substantial equivalence" to the predicate. Therefore, the "acceptance criteria" implicitly are that the modified device's performance should be comparable to or better than the predicate device for all relevant characteristics, and within acceptable clinical ranges.

The table below summarizes the key performance characteristics that were compared:

2. Sample Sizes and Data Provenance for the Test Set

• Sample Size for Precision Studies:
  • ISE Direct mode (Modified Device):
    • Within run CV%: n=21 for serum (86 mmol/L and 99 mmol/L), n=20 (low) and n=21 (high) for plasma (89.2 mmol/L and 125 mmol/L).
    • Between day CV%: n=21 for serum (86 mmol/L and 99 mmol/L), n=21 for plasma (91.6 mmol/L and 126.0 mmol/L).
  • ISE Indirect mode (Modified Device):
    • Within run CV%: n=21 for serum (90.3 mmol/L and 124.1 mmol/L), n=21 for plasma (86.4 mmol/L and 121.9 mmol/L).
    • Between day CV%: n=21 for serum (92.0 mmol/L and 122.8 mmol/L), n=21 for plasma (88.7 mmol/L and 121.6 mmol/L).
  • ISE Urine mode (Modified Device):
    • Within run CV%: n=21 (low) and n=20 (high) for urine (61.4 mmol/L and 194.4 mmol/L).
    • Between day CV%: n=21 for urine (64.9 mmol/L and 186.4 mmol/L).
  • (Predicate Device Precision): Sample sizes for the predicate device's precision studies (n=20 for within-run and between-run CV%) are also mentioned for comparison.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is a laboratory performance study rather than a clinical study with patient samples for diagnosis. The samples would typically be control materials or spiked samples.

3. Number of Experts and Qualifications for Ground Truth

• N/A. This device is an in vitro diagnostic (IVD) for quantitative determination of analytes using an ion-selective electrode. The "ground truth" for performance studies like precision and linearity is established through reference methods, certified reference materials, or gravimetric preparations, not expert clinical consensus.

4. Adjudication Method

• N/A. As this is an IVD device performance study, there is no expert adjudication of results. The performance is assessed against established analytical standards and the predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is not a diagnostic imaging device or an AI-assisted diagnostic tool that involves human readers. It's an automated laboratory assay.

6. Standalone Performance (Algorithm Only)

• Yes, effectively. The performance data presented (precision, linearity, sensitivity, interference) are all measures of the device's inherent analytical performance without human intervention in the measurement process (beyond operating the instrument). This is a standalone performance study of the device itself.

7. Type of Ground Truth Used

• The ground truth for these types of studies is based on:
  • Reference materials/known concentrations: For precision, linearity, and sensitivity, samples with known or target concentrations of chloride are used.
  • Comparative methods: The performance is also implicitly compared to the predicate device, which itself would have been validated against established reference methods.
  • Clinical ranges: Expected values for adults are given, implying the device measures within clinically relevant ranges.

8. Sample Size for the Training Set

• N/A. This is not a machine learning or AI device that requires a "training set." It's an ion-selective electrode system.

9. How Ground Truth for the Training Set Was Established

• N/A. See point 8.

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The Osmetech OPTI LION Electrolyte Analyzer is intended to be used for the measurement of pH, sodium, potassium, ionized calcium, and chloride in samples of whole blood, serum, plasma and aqueous controls in either a traditional clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.

The OPTI LION Electrolyte Analyzer is a small [4.7 x 14.2 x 9.1 inches, 10 pounds}, microprocessor-based instrument using optical fluorescence for the measurement of pH, sodium, potassium, ionized calcium, and chloride and utilizes a graphical touch screen user interface.

The disposable, single use cassette contains five optical fluorescent sensors placed in a polycarbonate substrate, which is packaged with an insert-able sample probe into a sealed foil pouch which bears a bar-code label with calibration, lot identification, and expiration dating information.

The Osmetech OPTI LION Electrolyte Analyzer is a medical device intended for the measurement of pH, sodium, potassium, ionized calcium, and chloride in whole blood, serum, plasma, and aqueous controls. The following information details the acceptance criteria and the study that proves the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria values for each analyte. Instead, it refers to the "medically allowable errors as defined in CLIA'88 performance standards" as the benchmark for comparison. The study's conclusion is that the device's performance is acceptable against these standards.

Without specific numerical acceptance criteria from the document, we can infer the performance metrics reported as evidence of meeting an unspecified acceptable level based on CLIA'88 standards.

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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.

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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.

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