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It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

RS100 is a Mobility Scooter which provides mobility to a disabled or elderly person limited to a seated position. The Mobility Scooter is classified in the Class B and the maximum loading weight is 125kg. The scooter is a battery powered three-wheeled vehicle.

It consists Lithium-ion battery with an off-board battery charger, frame, controllers, motor, seat, back support, arm supports, control panel (including speed knob, battery gauge, power key switch, horn button, throttle control lever, charger port) two rear wheels, one front wheel, foot support.

For convenience of transportation and reduction of possible damage, the battery and arm supports can be dismantled and separately packaged. Users can also easily assemble these parts without use of the tools.

The provided document is an FDA 510(k) clearance letter for a "Magnesium alloy scooter (RS100)". This type of device, a motorized three-wheeled vehicle, is a physical mobility aid, not an AI/Software as a Medical Device (SaMD). Therefore, the concepts of acceptance criteria in the context of AI performance metrics (like sensitivity, specificity, AUC), ground truth establishment by experts, adjudication methods, MRMC studies, or training/test sets for AI algorithms simply do not apply to this device.

The "acceptance criteria" for this device are based on its compliance with international performance and safety standards, primarily the ISO 7176 series and ISO 10993-1 for biocompatibility, and IEC 60601 for electrical safety and electromagnetic compatibility. The "study that proves the device meets the acceptance criteria" refers to the non-clinical bench testing conducted to demonstrate compliance with these standards and substantial equivalence to a predicate device.

Given this, I cannot extract the information required by your prompt regarding AI/SaMD performance. I will explain why each point in your prompt is inapplicable to this document:

Inapplicability of Prompt Points:

1. A table of acceptance criteria and the reported device performance: While the document does compare the subject device's specifications to the predicate, and states that test results meet design specifications and ISO standards, it does not present these as a "table of acceptance criteria and reported device performance" in the way one would for AI metrics. The acceptance criteria are "compliance with ISO standards" and "meets design specifications," and the performance is implicitly satisfactory if it achieves this compliance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This would refer to a dataset used to evaluate an AI model. For a physical medical device like a scooter, the "test set" would be the physical prototypes tested. There's no "data provenance" in the sense of patient data. Testing is done on the device itself, likely within a lab setting.

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): Ground truth establishment by experts is relevant for diagnostic AI. For a scooter, the "ground truth" is whether it performs according to engineering specifications and safety standards, which is determined by objective physical measurements and adherence to specified test protocols (e.g., in the ISO standards), not expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Adjudication is for resolving disagreements among human experts labeling data for AI. Not applicable here.

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 studies evaluate the impact of AI on human reader performance, typically in imaging diagnostics. This is entirely irrelevant for a physical mobility scooter.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Standalone performance refers to an AI algorithm operating without human intervention. Not applicable to a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): As explained in point 3, the "ground truth" for a physical device's performance is adherence to defined engineering and safety standards, measured objectively.

8. The sample size for the training set: Training sets are for machine learning algorithms. This device is not an AI.

9. How the ground truth for the training set was established: As explained in point 8, not applicable.

In conclusion, this FDA 510(k) clearance document pertains to a physical mechanical device, a scooter, and not to an AI/SaMD. Therefore, addressing the specific points of your prompt as if it were an AI device is not possible with the provided information.

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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

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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.

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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.

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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.

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The Dimension Vista® Magnesium Flex® reagent cartridge (MG) method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista® 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 Dimension Vista® Chemistry 1 Calibrator (CHEM 1 CAL) is an in vitro diagnostic product for the calibration of Blood Urea Nitrogen (BUN),Calcium (CA), Cholesterol (CHOL), Creatinine (CRENCRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU) and Uric Acid (URCA) methods on the Dimension Vista® System.

CHEM 1 CAL is a liquid, frozen multi-analyte, bovine serum albumin based product used to calibrate blood urea nitrogen, calcium, cholesterol, creatinine, glucose, lactic acid, magnesium, thyroxine, thyronine uptake and uric acid. The kit consists of six vials, three vials of Calibrator A and three vials of Calibrator B.

The Dimension Vista® MG Flex® reagent cartridge uses a modified methylthymol blue (MTB) complexometric technique. MTB forms a blue complex with magnesium. Calcium interference is minimized by forming a complex between calcium and Ba-EGTA (chelating agent). The amount of MG-MTB complex formed is proportional to the magnesium concentration and is measured using a bichromatic (600 and 510 nm) endpoint technique.

The provided text describes the performance characteristics of the Dimension Vista® Magnesium Flex® reagent cartridge (MG) and the Dimension Vista® Chemistry 1 Calibrator (CHEM 1 CAL). The focus is on demonstrating substantial equivalence to predicate devices and meeting established clinical laboratory guidelines. However, the information is primarily focused on analytical performance rather than clinical effectiveness or diagnostic accuracy in specific patient populations.

Here's an attempt to extract the requested information, acknowledging that some categories may not be directly applicable or fully detailed given the nature of an in vitro diagnostic device's analytical validation.

1. Table of Acceptance Criteria and Reported Device Performance

Device: Dimension Vista® Magnesium Flex® reagent cartridge (MG) for quantitative measurement of magnesium.

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The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitative determination of carbon dioxide concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry 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. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Direct Bilirubin Reagent is intended for the quantitative determination of direct bilirubin concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Total Bilirubin Reagent is intended for the quantitative determination of total bilirubin concentration in serum and lithium heparin plasma using the ACE, ACE Alera and ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Magnesium Reagent is intended for the quantitative determination of magnesium in serum and lithium heparin plasma using the ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems. 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). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

In the ACE Carbon Dioxide (CO2-LC) Reagent assay, serum carbon dioxide (in the form of bicarbonate) reacts with phosphoenolpyruvate in the presence of phosphoenolpyruvate carboxylase and magnesium to yield oxaloacetic acid and phosphate. In the presence of malate dehydrogenase, the reduced cofactor is oxidized by oxaloacetic acid. The reduced cofactor absorbs strongly at 408 nm whereas its oxidized form does not. The rate of decrease in absorbance, monitored bichromatically at 408 nm/692 nm, is proportional to the carbon dioxide content of the sample.

In the ACE Direct Bilirubin Reagent assay, sodium nitrite added to sulfanilic acid forms diazotized sulfanilic acid. Bilirubin glucuronide in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The increase in absorbance, measured bichromatically at 554 nm/692 nm, one minute after sample addition, is directly proportional to the direct bilirubin concentration.

In the ACE Total Bilirubin Reagent assay, sodium nitrite, when added to sulfanilic acid, forms diazotized sulfanilic acid. Bilirubin in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The inclusion of dimethyl sulfoxide (DMSO) in the reagent as an accelerator causes both direct and indirect bilirubin to react rapidly. The increase in absorbance, measured bichromatically at 554 nm/692 nm, is directly proportional to the total bilirubin concentration in the sample.

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 provided text describes several in vitro diagnostic reagents (ACE Carbon Dioxide (CO2-LC) Reagent, ACE Direct Bilirubin Reagent, ACE Total Bilirubin Reagent, and ACE Magnesium Reagent) and their associated performance data. There isn't information about an AI-powered device or software. Therefore, questions related to AI aspects like multi-reader multi-case studies, effect size of AI assistance, or standalone algorithm performance are not applicable.

The acceptance criteria are not explicitly stated as clear thresholds in the provided document; rather, the document presents detailed performance data (precision, linearity, interference, and method comparison) that demonstrates the device's capability to perform as intended and to be substantially equivalent to its predicate devices. The "reported device performance" is presented directly through tables and statistical analyses for each reagent.

Here's an attempt to structure the available information based on the request, interpreting "acceptance criteria" as the performance demonstrated to support substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit "acceptance criteria" (i.e., predefined thresholds for performance metrics) are not provided in the document, the "Reported Device Performance" below represents the data presented that presumably met the internal criteria for demonstrating substantial equivalence. The document primarily focuses on precision, linearity, interference, and method comparison with predicate devices and between different systems (ACE, ACE Alera, ACE Axcel).

ACE Carbon Dioxide (CO2-LC) Reagent

ACE Direct Bilirubin Reagent

ACE Total Bilirubin Reagent

ACE Magnesium Reagent

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

The document describes several types of studies:

• In-House Precision:

  • CO2-LC: Low, Mid, High serum and plasma samples were tested (number of replicates per sample and runs is implicitly part of SD/CV calculation, but not explicitly stated).
  • Direct Bilirubin: Low, Mid, High serum and plasma samples.
  • Total Bilirubin: Low, Mid, High serum and plasma samples.
  • Magnesium: Low, Mid, High serum and plasma samples.
  • Data Provenance: In-house (Alfa Wassermann Diagnostic Technologies, LLC, West Caldwell, NJ), prospective testing.

• POL (Physician Office Laboratory) Precision: Studies conducted at 3 POL sites.

  • CO2-LC: 3 samples at each of 3 POL sites and in-house.
  • Direct Bilirubin: 3 samples at each of 3 POL sites and in-house.
  • Total Bilirubin: 3 samples at each of 3 POL sites and in-house.
  • Magnesium: 3 samples at each of 3 POL sites and in-house.
  • Data Provenance: Not explicitly stated but inferred to be from POLs in the USA (prospective testing under typical POL conditions).

• In-House Matrix Comparison (Serum vs. Plasma):

  • CO2-LC: 53-54 pairs (serum/plasma) on ACE and ACE Alera; 51 pairs on ACE Axcel.
  • Direct Bilirubin: 102 pairs on ACE; 101 pairs on ACE Alera; 56 pairs on ACE Axcel.
  • Total Bilirubin: 102 pairs on ACE and ACE Alera; 56 pairs on ACE Axcel.
  • Magnesium: 101 pairs on ACE and ACE Alera; 55 pairs on ACE Axcel.
  • Data Provenance: In-house, retrospective (presumably collected for a range of values).

• POL Method Comparison (In-House ACE vs. POL ACE/Alera):

  • CO2-LC: 45-46 samples per POL site comparison.
  • Direct Bilirubin: 49-51 samples per POL site comparison.
  • Total Bilirubin: 48-50 samples per POL site comparison.
  • Magnesium: 50-52 samples per POL site comparison.
  • Data Provenance: Not explicitly stated but inferred to be from POLs in the USA (prospective testing under typical POL conditions) compared against in-house data.

• Detection Limits (LoB, LoD, LoQ), Linearity, Interferences (ACE Alera):

  • Sample sizes for detection limits and linearity: Not explicitly stated, typically involves multiple replicates at various concentrations.
  • Sample sizes for interferences: Not explicitly stated, typically involves samples spiked with various concentrations of interferents.
  • Data Provenance: In-house.

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. For in vitro diagnostic assays, the "ground truth" is typically the reference method or established clinical laboratory results obtained from a highly accurate and calibrated instrument or laboratory using validated methods, rather than human expert consensus for image or clinical interpretation. The document compares performance against other (presumably established) methods and predicate devices.

4. Adjudication Method for the Test Set

This concept (e.g., 2+1, 3+1 for resolving discrepancies) is not applicable to these types of in vitro diagnostic device studies. Performance is measured numerically and objectively.

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

No. This is an in vitro diagnostic assay, not an AI-powered diagnostic imaging device.

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

Not applicable. This is not an AI algorithm. The performance data presented are for the reagent and instrument system.

7. The Type of Ground Truth Used

For precision studies, the "ground truth" is the true concentration of the analyte in the control material or patient sample, which is established by reference methods or manufacturing specifications of the control materials. For method comparison studies, the predicate device's results or an established in-house method are used as the comparative reference. The document states the intended use is for "quantitative determination" of analytes, implying comparison to a quantitative gold standard.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning device and therefore does not have a "training set" in that context. The development of reagents and the establishment of their performance characteristics do not involve machine learning training sets.

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

Not applicable, as there is no "training set" for these reagents in the context of AI/ML.

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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).

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The ACE Axcel Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative determination of constituents in blood and other fluids.

The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitative determination of carbon dioxide concentration in serum using the ACE Axcel Clinical Chemistry System. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Direct Bilirubin Reagent is intended for the quantitative determination of direct bilirubin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Total Bilirubin Reagent is intended for the quantitative determination of total bilirubin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

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.

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.

In the ACE Carbon Dioxide (CO2-LC) Reagent assay, serum carbon dioxide (in the form of bicarbonate) reacts with phosphoenolpyruvate in the presence of phosphoenolpyruvate carboxylase and magnesium to yield oxaloacetic acid and phosphate. In the presence of malate dehydrogenase, the reduced cofactor is oxidized by oxaloacetic acid. The reduced cofactor absorbs strongly at 408 nm whereas its oxidized form does not. The rate of decrease in absorbance, monitored bichromatically at 408 nm/692 nm, is proportional to the carbon dioxide content of the sample.

In the ACE Direct Bilirubin Reagent assay, sodium nitrite added to sulfanilic acid forms diazotized sulfanilic acid. Bilirubin glucuronide in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The increase in absorbance, measured bichromatically at 554 nm/692 nm, one minute after sample addition, is directly proportional to the direct bilirubin concentration.

In the ACE Total Bilirubin Reagent assay, sodium nitrite, when added to sulfanilic acid. forms diazotized sulfanilic acid. Bilirubin in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The inclusion of dimethyl sulfoxide (DMSO) in the reagent as an accelerator causes both direct and indirect bilirubin to react rapidly. The increase in absorbance, measured bichromatically at 554 nm/692 nm, is directly proportional to the total bilirubin concentration in the sample.

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.

This document describes the performance of the ACE Carbon Dioxide (CO2-LC) Reagent, ACE Direct Bilirubin Reagent, ACE Total Bilirubin Reagent, and ACE Magnesium Reagent when used with the ACE Axcel Clinical Chemistry System. The study aims to demonstrate substantial equivalence to the predicate device, the Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K931786).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided in the document are implicitly established by demonstrating comparability to the predicate device. The performance data presented are the results obtained for the current device and reagents.

The study demonstrates that the ACE Axcel Clinical Chemistry System with the listed reagents achieves precision and accuracy comparable to the predicate device, supporting substantial equivalence.

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

The studies conducted are primarily accuracy (correlation) and precision studies.

• ACE Carbon Dioxide (CO2-LC) Reagent:
  • Accuracy (correlation study): 120 samples.
  • Accuracy (patient correlation studies): Conducted at three separate Physician Office Laboratory (POL) sites; the number of samples per POL site is not specified, but the total across all sites for CO2 values ranged from 3.2 to 47.6 mEq/L.
  • Precision: Four CO2 levels tested for 22 days; three separate POL sites tested for 5 days.
• ACE Direct Bilirubin Reagent:
  • Accuracy (correlation study): 116 samples.
  • Accuracy (patient correlation studies): Conducted at three separate POL sites; the number of samples per POL site is not specified, but the total across all sites for Direct Bilirubin values ranged from 0.2 to 12.5 mg/dL.
  • Precision: Four direct bilirubin levels tested for 22 days; three separate POL sites tested for 5 days.
• ACE Total Bilirubin Reagent:
  • Accuracy (correlation study): 117 samples.
  • Accuracy (patient correlation studies): Conducted at three separate POL sites; the number of samples per POL site is not specified, but the total across all sites for Total Bilirubin values ranged from 0.2 to 34.8 mg/dL.
  • Precision: Four total bilirubin levels tested for 22 days; three separate POL sites tested for 5 days.
• ACE Magnesium Reagent:
  • Accuracy (correlation study): 108 samples.
  • Accuracy (patient correlation studies): Conducted at three separate POL sites; the number of samples per POL site is not specified, but the total across all sites for Magnesium values ranged from 0.6 to 5.5 mg/dL.
  • Precision: Four magnesium levels tested for 22 days; three separate POL sites tested for 5 days.

Data Provenance: The document does not explicitly state the country of origin for the data. The "POL sites" (Physician Office Laboratory sites) suggest these are real-world clinical samples, likely from within the United States given the 510(k) submission. The data appears to be prospective in nature, as indicated by the description of testing conducted over 22 days and 5 days at different sites for precision and the collection of samples for correlation studies.

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

This is a clinical chemistry device for quantitative determination. The ground truth is established by comparing the device's measurements against a predicate device (Alfa Wassermann ACE Clinical Chemistry System). Therefore, no human experts are explicitly mentioned as establishing a "ground truth" in the diagnostic interpretation sense. The predicate device itself serves as the reference standard.

4. Adjudication method for the test set

Not applicable. This study involves quantitative measurements by a device and comparison to a predicate device, not qualitative interpretations requiring human 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 a clinical chemistry analyzer and reagent system, not an AI-assisted diagnostic imaging or interpretation system involving human readers.

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

Yes, the performance data presented are for the standalone algorithm/device (ACE Axcel Clinical Chemistry System with the specified reagents) measuring analytes in samples, compared directly against a predicate device. There is no human-in-the-loop component mentioned in the context of the reported performance data.

7. The type of ground truth used

The type of ground truth used is comparison to a legally marketed predicate device. The ACE Axcel Clinical Chemistry System and its reagents were compared to the Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K931786). The predicate device's measurements serve as the reference for established accuracy.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that typically involves a distinct "training set." The device's performance is based on established chemical reactions and detection methods. The studies described are for validation/testing of the device's performance against a predicate, not for training an algorithm.

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.

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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

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