Search Results

The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine on the ARCHITECT c8000 System.

Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

The Magnesium reagent kit contains Reagent 1 and Reagent 2. Magnesium present in the sample is a cofactor in an enzymatic reaction with isocitrate dehydrogenase. The rate of increase in absorbance at 340 nm, due to the formation of NADPH, is directly proportional to the magnesium concentration.

The provided document is a 510(k) summary for a medical device called "Magnesium" from Abbott Laboratories. It details the performance testing conducted to demonstrate its substantial equivalence to a predicate device. This document describes an in vitro diagnostic (IVD) device for measuring magnesium levels, not an AI/ML-based device. Therefore, many of the requested elements related to AI (e.g., ground truth establishment by experts, adjudication, MRMC studies, training set details) are not applicable to this submission.

However, I can extract information relevant to the acceptance criteria and performance of this IVD device.

Here's the breakdown of the acceptance criteria and study that proves the device meets them, based on the provided text:

Device: Abbott Laboratories Magnesium Assay (List No. 3P68)
Intended Use: Quantitation of magnesium in human serum, plasma, or urine on the ARCHITECT c8000 System for diagnosis and treatment of hypomagnesemia and hypermagnesemia.
Predicate Device: Roche Magnesium Gen.2 (K983416)

1. Acceptance Criteria and Reported Device Performance

The document describes various performance studies and their results. The implicit acceptance criteria are that the device's performance characteristics demonstrate substantial equivalence to the predicate device and are within acceptable ranges for clinical utility.

• Bio-Rad Level 1: 1.3 %CV
• Bio-Rad Level 2: 1.3 %CV
• LoQ Urine Pool -Low Mg: 2.4 %CV
• Human Urine Pool - Normal Mg: 1.8 %CV
• Human Urine Pool Abnormal Mg: 1.8 %CV |
  | Interference | Assay results should be impacted by no more than ±10% for specific interferent levels. | For magnesium samples targeted to 5 mg/dL: no more than ±10% interference for listed substances (Albumin ≤ 64.0 mg/dL, Ascorbic Acid ≤ 200 mg/dL, Bilirubin (Conjugated) ≤ 59.9 mg/dL, Calcium ≤ 26.0 mg/dL, Glucose ≤ 1220 mg/dL, Hemoglobin ≤ 1200 mg/dL, Phosphorous ≤ 307 mg/dL, Boric Acid ≤ 1000 mg/dL, 6N Hydrochloric Acid ≤ 3.0 mL/dL, Copper ≤ 21.6 µg/dL, Zinc ≤ 3504 µg/L, Iron ≤ 0.6 mg/dL).

For magnesium samples targeted to 14 or 15 mg/dL: similar results for the same interferents with slightly different calcium and bilirubin levels.

Acetic acid, nitric acid, and sodium fluoride did not meet the ±10% criterion and are noted as limitations. |
| Linearity | The assay should be linear across its analytical measuring interval. (No explicit R-squared or slope criterion, but stated that it was "demonstrated to be linear"). | Urine application demonstrated linearity across 1.04 to 36.24 mg/dL, spanning the analytical measuring interval of 1.81 to 26.35 mg/dL. |
| Measuring Interval (Analytical Measuring Range) | Defined by LoQ and highest linear point. | 1.81 to 26.35 mg/dL |
| Method Comparison (Correlation to Predicate) | Demonstrate acceptable correlation (slope and correlation coefficient) to the predicate device across the measuring interval. | Urine application showed acceptable correlation to predicate:

• pH

Ask a specific question about this device

The Magnesium assay is used for the quantitation of magnesium in human serum or plasma on the ARCHITECT e8000 System.

Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

The Magnesium reagent kit contains Reagent 1 and Reagent 2. Reagent 1 contains Isocitrate dehydrogenase and D-Isocitrate potassium salt. Reagent 2 contains NADP. Both reagents contain sodium azide (0.1%) as a preservative. The assay principle is enzymatic, where magnesium acts as a cofactor in a reaction with isocitrate dehydrogenase, and the rate of increase in absorbance at 340 nm due to NADPH formation is directly proportional to magnesium concentration.

The Abbott Laboratories Magnesium assay (LN 3P68) is intended for the quantitative determination of magnesium in human serum or plasma on the ARCHITECT c8000 System. This device is a Class I, reserved product, with product code JGJ.

Study Type: Analytical Performance Study

Acceptance Criteria and Reported Device Performance:

Details of the Studies:

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

   • Limit of Blank, Limit of Detection, and Limit of Quantitation:
     • Test Set: LoB: 4 saline samples (zero-analyte), each tested in 10 replicates. LoD and LoQ: Minimum of 2 low-analyte level samples at each of 4 target concentrations (0.05, 0.15, 0.30, and 0.60 mg/dL), each tested in 10 replicates.
     • Data Provenance: Not explicitly stated, but likely laboratory-prepared samples. Retrospective/Prospective not specified.
   • Within-Laboratory Precision (20-Day):
     • Test Set: 6 control materials (Bio-Rad Level 1, Bio-Rad Level 2, LoQ Serum Pool, Human Serum Pool – Normal Mg, Human Serum Pool – Elevated Mg, Human Serum Pool – Abnormal Mg). Each tested in 2 replicates, 2 times per day for 20 days.
     • Data Provenance: Laboratory-prepared and commercially available controls. Human serum pools and diluted normal human serum used. Retrospective/Prospective not specified.
   • Specimen Tube Type (Matrix Comparison):
     • Test Set: Minimum of 40 sample sets for each evaluated tube type. 36 unaltered, 3 spiked, 1 diluted. These samples spanned the measuring interval (0.60 to 9.50 mg/dL).
     • Data Provenance: Fresh or frozen patient samples. Country of origin not specified. Retrospective/Prospective not specified.
   • Interference:
     • Test Set: Control and test level samples for each potential interferent. Tested in a minimum of 6 valid replicates for general interferents, 3 replicates for sulfasalazine and sulfapyridine, and a minimum of 7 replicates for copper, iron, zinc, ibuprofen, acetaminophen, salicylic acid, and triglycerides.
     • Data Provenance: Likely laboratory-prepared samples (spiked serum) and control samples. Retrospective/Prospective not specified.
   • Linearity:
     • Test Set: 3 sets of linearity standards, each with 12 levels of magnesium target concentrations (0.30 to 12.50 mg/dL). Each level tested in a minimum of 4 replicates.
     • Data Provenance: Laboratory-prepared standards using magnesium standard and 4% HSA. Retrospective/Prospective not specified.
   • Method Comparison:
     • Test Set: 122 patient serum specimens. 11 of these were normal serum samples spiked with magnesium hexachloride.
     • Data Provenance: Patient serum specimens, some spiked. One replicate of the predicate device was run at UT Southwestern Medical Center (UTSW, Dallas). Country of origin not specified, but UTSW suggests USA. Retrospective/Prospective not specified.
   • Manual Dilution:
     • Test Set: Three serum pools (human serum and magnesium chloride) at magnesium concentrations of 8, 15, and 25 mg/dL (±10%). Each pool evaluated neat, 1:2 diluted, and 1:5 diluted. Samples tested in a minimum of 7 replicates.
     • Data Provenance: Laboratory-prepared human serum pools. Retrospective/Prospective not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are analytical performance studies for an in-vitro diagnostic device measuring a chemical analyte (Magnesium), not studies requiring expert interpretation of images or clinical outcomes. The "ground truth" for these tests refers to the known concentrations or characteristics of the prepared samples or reference methods.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used in studies involving subjective expert review (e.g., image interpretation). These are objective analytical measurements.

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: Not applicable. This is an analytical performance study for an in-vitro diagnostic device, not an AI-assisted diagnostic imaging study involving human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Yes, all studies described are standalone analytical performance evaluations of the device (Magnesium assay on the ARCHITECT c8000 System). There is no "human-in-the-loop" component in the measured performance of this chemical assay.

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

   • Limit of Blank, Limit of Detection, and Limit of Quantitation: Gravimetrically prepared low-analyte samples and saline.
   • Within-Laboratory Precision: Commercially available control materials and laboratory-prepared human serum pools with known target concentrations.
   • Specimen Tube Type (Matrix Comparison): Comparison against results from the control tube type (serum glass tube).
   • Interference: Comparison against control samples without the interferent, with target magnesium levels.
   • Linearity: Laboratory-prepared linearity standards with known magnesium target concentrations.
   • Method Comparison: Comparison against a legally marketed predicate device (Roche Magnesium Gen.2).
   • Manual Dilution: Laboratory-prepared serum pools with known magnesium concentrations and expected dilution values.

7. The sample size for the training set: Not applicable. This device is an in-vitro diagnostic assay for measuring magnesium, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The development of such assays involves reagent formulation and optimization, calibration, and validation, but not a distinct "training set" like in AI.

8. 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 Randox RX daytona plus magnesium (Mg) test system is intended for the quantitative in vitro determination of magnesium concentration in serum, urine and lithium heparinized plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).

The Magnesium kit assay consists of a ready to use reagent solution.

The document describes the analytical performance characteristics of the Randox RX daytona plus magnesium (Mg) test system, which is a quantitative in vitro diagnostic device for measuring magnesium levels in serum, urine, and lithium heparinized plasma. The study aims to demonstrate substantial equivalence to a predicate device, the Siemens Magnesium (MG) test system (K991576).

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

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

Please note that the document does not explicitly state predetermined acceptance criteria for all performance characteristics. Instead, it often describes the methodology and then presents the results. For some sections, like Analytical Specificity, an acceptance criterion is mentioned. I will infer or state the presented performance for others.

The studies described in the document, demonstrating good precision (low CVs), linearity over the stated ranges, low detection limits, minimal interference from common analytes, and strong correlation with the predicate device, collectively prove that the device meets the implicit acceptance criteria for analytical performance of a magnesium test system.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Precision Test Set: Not explicitly stated as "test set" in the context of ground truth, but for the precision study:

  • Serum: 5 different levels of unaltered human serum samples, spiked or diluted. Each level run in 80 replicates (2 replicates per run for 20 non-consecutive days, across 2 systems). So, a total of 5 levels * 80 replicates = 400 measurements for serum samples, plus control samples.
  • Urine: 3 levels of human urine supplemented with magnesium chloride, plus one "LIN" sample (normal urine pool spiked). Each level run in 80 replicates. So, a total of 4 levels * 80 replicates = 320 measurements for urine samples, plus control samples.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The use of "unaltered human serum samples" and "human urine supplemented with magnesium chloride" suggests real human samples, and the study design implies a prospective collection for the purpose of the study.

• Linearity Test Set:

  • Serum & Urine: 11 levels of samples, created by mixing low and high serum/urine pools. Each level run in 5 replicates. This means 11 levels * 5 replicates = 55 measurements per matrix (serum/urine).
  • Data Provenance: Not explicitly stated. The samples were prepared from "low and high serum pools," indicating human samples were used as a base.

• Detection Limit Test Set:

  • Serum & Urine: 4 low-level samples for LoD/LoB/LoQ. Based on 240 determinations.
  • Data Provenance: Not explicitly stated.

• Analytical Specificity / Interference Test Set:

  • Serum & Urine: Not specific sample sizes per interferent listed, but analytes tested at specific magnesium concentrations (e.g., 3.89 mg/dl and 6.32 mg/dl for serum; 4.87mg/dl and 24.33mg/dl for urine). Interferent levels tested are specified.
  • Data Provenance: Not explicitly stated. The samples were likely prepared in-house by spiking interferents into human control matrices.

• Method Comparison Test Set:

  • Serum: 108 serum patient samples.
  • Urine: 108 urine patient samples.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). These are "patient samples," which typically implies retrospective or prospectively collected clinical samples.

• Matrix Comparison Test Set:

  • Serum vs. Lithium Heparin Plasma: A minimum of 42 matched patient sample pairs (serum and lithium heparin plasma).
  • Data Provenance: Not explicitly stated. These are "patient samples," implying clinical samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This device is an in vitro diagnostic (IVD) for quantitative measurement of magnesium, not an imaging device or a device requiring human interpretation for "ground truth" in the typical sense of expert consensus. The ground truth for such devices is established through reference methods, traceability to certified reference materials, and the inherent analytical measurement of the analyte.

• Reference Methods: The predicate device itself (Siemens Magnesium (MG)) serves as the "reference" for method comparison.
• Traceability: The Randox Calibration Serum Level 3 is stated to be traceable to Magnesium reference material NIST 909b. This NIST standard is the ultimate "ground truth" for magnesium concentration.
• No human experts are mentioned or typically involved in establishing the "ground truth" for the concentration values in these types of analytical studies. The "ground truth" is analytical, not interpretive.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like "2+1" or "3+1" are used in studies where human readers provide interpretations and discrepancies need to be resolved. This document describes analytical performance studies of a laboratory diagnostic assay, where quantitative results are compared to known concentrations or a predicate device. There is no human interpretation involved in generating the "ground truth" for the concentrations themselves, nor in interpreting the results of the device in a way that would require adjudication.

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 an in vitro diagnostic (IVD) device for quantitative measurement of magnesium, not an AI-powered imaging device or a device requiring human readers/interpreters. Therefore, no MRMC study was conducted, and there's no concept of human readers improving with or without AI assistance for this type of device.

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

This is an analytical instrument and reagent system. By its nature, its performance is "standalone" in generating a quantitative result. The device (Randox RX daytona plus system with Randox Magnesium reagents) processes samples and provides a numerical magnesium concentration. There is no "human-in-the-loop" in the sense of modifying or assisting the algorithmic output of the concentration measurement. The operator's role is to load samples and reagents and initiate the automated analysis, and then review the instrument's quantitative output.

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

The ground truth for the analytical performance studies is established by:

• Reference materials/standards: Traceability to NIST 909b for calibrators, and the use of control materials with known concentrations.
• Known sample preparations: For linearity and detection limit studies, samples are often prepared by spiking or diluting to known target concentrations.
• Predicate device: For method comparison, the results obtained from the new device are compared to results obtained from a legally marketed predicate device (Siemens Magnesium (MG) on Advia 1800), which itself is established as accurate.

There is no expert consensus, pathology, or outcomes data used to establish the "ground truth" for magnesium concentration values in these studies.

8. The sample size for the training set

The provided document describes studies for demonstrating analytical performance and substantial equivalence to a predicate device. These are validation studies, not machine learning or AI development studies that typically involve "training sets." Therefore, the concept of a training set as understood in AI/ML is not applicable here, and no training set sample size is mentioned.

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

As there is no "training set" in the context of AI/ML, this question is not applicable. The ground truth for the validation of the device (as discussed in point 7) is established through analytical traceability, known preparations, and comparison to an established predicate device.

Ask a specific question about this device

The Atellica™ CH Magnesium (Mg) assay is for in vitro diagnostic use in the quantitative determination of magnesium in human serum, plasma (lithium heparin), and urine using the Atellica™ CH Analyzer. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).

The Atellica CH Mg assay is based on the modified xylidyl blue reaction, which was first described by C.K. Mann and J.H. Yoe. 1-2 The reagent was modified to eliminate the use of organic solvents. Magnesium ions react with xylidyl blue in an alkaline medium to form a water-soluble purple-red complex. The increase in absorbance of xylidyl blue at 505/694 nm is proportional to the concentration of magnesium in the sample. Calcium is excluded from the reaction by complexing with EGTA.

This document describes the performance assessment of the Siemens Atellica CH Magnesium (Mg) assay, an in vitro diagnostic device used for the quantitative determination of magnesium in human serum, plasma, and urine.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the performance characteristics demonstrated in the study and compared to the predicate device. The document does not explicitly list "acceptance criteria" as a separate column with pass/fail remarks, but rather presents the study results, implying that these results met the internal validation requirements for substantial equivalence.

Ask a specific question about this device

The ACE Magnesium Reagent is intended for the quantitative determination of magnesium concentration in serum using the ACE Axcel Clinical Chemistry System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low serum levels of magnesium) and hypermagnesemia (abnormally high serum levels of magnesium). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Magnesium ions in serum react with Xylidyl blue-1 in an alkaline medium to produce a red complex which is measured bichromatically at 525 nm/692 nm. The intensity of color produced is directly proportional to the magnesium concentration in the sample. EGTA prevents calcium interference by preferential chelation of calcium present in the sample. A surfactant system is included to remove protein interference.

The ACE Axcel Clinical Chemistry System consists of two major components, the chemistry instrument and an integrated Panel PC. The instrument accepts the physical patient samples, performs the appropriate optical or potentiometric measurements on those samples and communicates that data to an integral Panel PC. The Panel PC uses keyboard or touch screen input to manually enter a variety of data, control and accept data from the instrument, manage and maintain system information and generate reports relative to patient status and instrument performance. The Panel PC also allows remote download of patient requisitions and upload of patient results via a standard interface.

Here's a breakdown of the acceptance criteria and study information for the ACE Magnesium Reagent based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values (e.g., "The CV must be less than X%"). Instead, it reports the performance values achieved by the device. The "acceptance criteria" are implied by the reported performance being deemed sufficient for substantial equivalence.

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

• Sample Size for Accuracy Test Set: 110 samples for the primary correlation study.
• Sample Size for Precision Test Set: Not explicitly stated as a count of individual samples, but "four magnesium levels for ≥21 days" and "three separate Physician Office Laboratory (POL) sites over 5 days" implies multiple measurements across different samples or levels.
• Data Provenance: The document does not specify the country of origin. It conducted studies "at four magnesium levels" and "at three separate Physician Office Laboratory (POL) sites," suggesting internal testing and potentially external POL sites. The studies are retrospective as they involve analyzing samples for performance.

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

The document describes an in vitro diagnostic reagent for quantitative determination of magnesium. The ground truth for such devices is established by comparison to a reference method or predicate device, not by expert interpretation of images or clinical assessments.

• Number of Experts: Not applicable in the context of this type of diagnostic device.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Not applicable for this type of quantitative diagnostic device. Ground truth is established by comparing the device's output to a known reference method or another validated device (the predicate).

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

• MRMC Comparative Effectiveness Study: No, this is not an AI/human reader study. This document describes a chemical reagent for an automated clinical chemistry system.

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

Yes, the performance data presented (precision, accuracy, detection limit) are for the ACE Magnesium Reagent operating on the ACE Axcel Clinical Chemistry System in a standalone manner. The measurements are automated, and the results are quantitative values obtained directly from the system.

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

The ground truth for the accuracy study was established by comparing the results from the ACE Magnesium Reagent on the ACE Axcel Clinical Chemistry System against the results from the predicate device, the "Alfa Wassermann ACE Clinical Chemistry System."

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. For an in vitro diagnostic reagent, the development process involves formulating the reagent and optimizing its performance characteristics. The validation studies (precision, accuracy, detection limit) on the ACE Axcel Clinical Chemistry System served as the testing of the final product, not a training set for an algorithm.

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

Not applicable, as this is not an AI/machine learning device with a distinct training set in that sense. The "ground truth" during the development and validation phase would be derived from known-concentration controls, reference materials, and comparative analysis against established methods (like the predicate device).

Ask a specific question about this device

The Sekisui Magnesium Assay is for the quantitative determination of magnesium in human serum and plasma (Lithium Heparin) on automated chemistry analyzers. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium). This device is intended for professional use and IN VITRO diagnostic use only.

The Sekisui Magnesium assay kit consists of the following: Magnesium Reagent: A solution containing buffer (pH 11.2 at 25°C), 0.14 mmol/L xylidy/ blue-1, 0.1 mmol/L EGTÅ, and a surfactant.

Here's a breakdown of the acceptance criteria and the study information for the Sekisui Magnesium Assay, based on the provided text:

Acceptance Criteria and Device Performance

Ask a specific question about this device

The EasyRA Magnesium Reagent is for the in-vitro quantitative measurement of magnesium in serum on the Medica EasyRA analyzer. Magnesium measurements are used in the diagnosis and treatment of: Hypermagnesemia occuring during renal failure, acute diabetic acidosis, dehydration or in Addison's disease. Hypomagnesemia observed in cases of chronic alcoholism, malabsorption, acute pancreatitis and kidney disorders. For in vitro diagnostic use only.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "Magnesium EasyRA Reagent." It indicates that the device has been found substantially equivalent to a legally marketed predicate device. The information provided is primarily regulatory in nature and does not contain details about specific acceptance criteria or a study proving the device meets them.

Therefore, I cannot provide the requested information based on the provided text. The document states the device name, intended use, and regulatory classification but lacks specific performance metrics, study designs, sample sizes, or ground truth establishment relevant to the questions asked.

Ask a specific question about this device

The Piccolo Magnesium Test System used with the Piccolo Chemistry Analyzer is intended to be used for the in vitro quantitative determination of magnesium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia and hypermagnesemia.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the Piccolo Magnesium Test System, which is an in vitro diagnostic device. This type of document typically does not contain detailed information about acceptance criteria, study designs, sample sizes, or ground truth establishment in the way that would apply to AI/ML or imaging devices.

The FDA 510(k) clearance process for in vitro diagnostics usually relies on demonstrating substantial equivalence to a predicate device, which involves analytical performance studies (e.g., accuracy, precision, linearity, interference) rather than clinical outcome studies or expert-based ground truth for image interpretation.

Therefore, many of the specific details requested in your prompt (e.g., test set sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or not present in this type of regulatory document for an in vitro diagnostic test system.

However, I can extract what is explicitly stated or can be inferred:

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

This information is typically found in the summary of safety and effectiveness, which is not fully included in this clearance letter. The letter confirms substantial equivalence without detailing the specific performance metrics used to establish that.

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

• Sample Size: Not specified in the provided document.
• Data Provenance: Not specified in the provided document. Studies for IVDs are typically performed by the manufacturer, but country of origin isn't stated here.
• Retrospective/Prospective: Not specified.

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

This is not applicable for an in vitro diagnostic magnesium test. Ground truth for an IVD refers to the correct concentration of the analyte, often determined by a reference method, not by human expert interpretation.

4. Adjudication method for the test set:

This is not applicable for an in vitro diagnostic magnesium test. Adjudication is relevant for subjective assessments, typically in imaging or clinical endpoints.

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 as the Piccolo Magnesium Test System is an automated in vitro diagnostic device, not an AI-assisted imaging or interpretation tool for human readers.

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

The device is inherently a "standalone" system in the sense that it performs the
quantitative determination of magnesium without human-in-the-loop interpretation of the result once the sample is loaded. However, this question's phrasing is more suited to AI/ML software. The device itself is the "algorithm," and its performance is determined directly.

7. The type of ground truth used:

For a quantitative diagnostic test like magnesium, the ground truth would typically be established by a reference method or a thoroughly validated, higher-accuracy method of measuring magnesium concentration (e.g., atomic absorption spectroscopy or another established/calibrated clinical chemistry analyzer). The document does not explicitly state the reference method used.

8. The sample size for the training set:

This is not applicable in the context of this device as it's an analytical instrument, not an AI/ML model that learns from a training set in the conventional sense. The "training" for such a device would be its calibration and validation based on chemical and electrical engineering principles, not a data-driven learning process.

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

This is not applicable as explained in point 8. The "ground truth" for calibration would be based on certified reference materials or highly accurate standards.

Ask a specific question about this device

The Diagnostic Chemicals Limited Magnesium Assay (XB) is for the quantitative determination of magnesium in human serum. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium). This device is intended for professional use and IN VITRO diagnostic use only.

The Diagnostic Chemicals Limited Magnesium Assay (XB) Standard is used for the callbration of the Diagnostic Chemicals Limited Magnesium Assay (XB) when used for the quantitative determination of magnesium in human serum.

Not Found

The provided text is a 510(k) premarket notification acceptance letter from the FDA for a Magnesium Assay (XB) device. It confirms the device's substantial equivalence to legally marketed predicate devices. However, this document does not contain the detailed acceptance criteria or the study data that proves the device meets those criteria.

The information requested in your prompt (e.g., acceptance criteria table, sample sizes, ground truth establishment, MRMC studies) is typically found in the technical documentation submitted by the manufacturer as part of the 510(k) application, not in the FDA's acceptance letter itself.

Therefore, I cannot fulfill your request with the provided input. The document mainly states that the device was reviewed and found substantially equivalent, but it doesn't elaborate on how that determination was made in terms of specific performance data and criteria.

Ask a specific question about this device

The Vitalab Magnesium Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of magnesium in serum and plasma. Magnesium results may be used for the diagnosis and treatment of hypomagnesemia (abnomally low plasma levels of magnesium) and hypermagnesemia (abnomally high plasma levels of magnesium).

The Vitalab Magnesium Reagent is a single-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines magnesium through chelation by xylidyl blue producing a colored complex.

Here's a breakdown of the acceptance criteria and study information for the Vitalab Magnesium Reagent, based on the provided text:

Acceptance Criteria and Device Performance

Ask a specific question about this device