Search Results

For in vitro diagnostic use only. VITROS® Chemistry Products Calibrator Kit 3 is used to calibrate VITROS® 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ALT, ALKP, AMYL, AST, CK, GGT, LDH and LIPA.

VITROS® Calibrator Kit 3 contains three levels of calibrators: Calibrator 1, 2, and 3. The calibrators are lyophilized, multi-analyte products prepared from processed bovine serum to which enzymes, electrolytes, stabilizers, and preservatives have been added. VITROS Chemistry Products Calibrator Kit 3 contains four vials each of lyophilized calibrator 1, 2, and 3 and four vials each of calibrator diluent 1, 2, and 3.

This document describes the VITROS Chemistry Products Calibrator Kit 3, a multi-analyte calibrator. The submission focuses on modifications to the calibrator kit, specifically the addition of nominal values and traceability information for Lactate Dehydrogenase (LDH) to the IFCC/L->P method, and the removal of value-assignment information for Acid Phosphatase (ACP).

Here's the breakdown of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The core of this submission is demonstrating substantial equivalence to a predicate device (VITROS Chemistry Products Calibrator Kit 3, K001679). Unlike a diagnostic or screening algorithm with specific performance metrics like sensitivity and specificity, this device is a calibrator, meaning its performance is tied to its ability to accurately assign values and maintain stability for subsequent diagnostic tests.

The document does not present a single table of "acceptance criteria" and "reported device performance" in the typical sense of a diagnostic assay's accuracy metrics. Instead, the acceptance is based on establishing Substantial Equivalence to the predicate device and meeting stability and traceability requirements.

Implicit Acceptance Criteria and Reported Performance:

Summary of Differences from Predicate (and how they meet criteria):

• Target Concentrations (U/L) for LDH: New Device (LDH: 90, 320, 800) vs. Predicate Device (LDH: 225, 800, 2000). This change is justified by the updated traceability method.
• Traceability for LDH: New Device (Buhl method and IFCC method) vs. Predicate Device (Buhl method). The addition of IFCC method traceability is an improvement and aligns the calibrator with a recognized standard.

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

The document does not explicitly state a "test set" and its sample size in a manner typical for diagnostic device validation (e.g., a cohort of patient samples). The studies performed for this calibrator focus on stability testing and traceability/value assignment.

• Stability Studies: "Real-time stability studies for shelf-life and open-vial claims have been conducted..." No specific sample size (number of calibrator kits or vials) is given, nor is the data provenance by country. These are generally prospective studies done in-house by the manufacturer.
• Traceability and Value Assignment: "...using a panel of human samples as an intermediate Working Calibrator."
  • Sample Size for "panel of human samples": Not specified.
  • Data Provenance: The "panel of human samples" implies human-derived samples, but specific country of origin or whether they were retrospective/prospective is not mentioned. This is typically internal validation data.

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

N/A. This is a calibrator, not a diagnostic device that interprets clinical output requiring expert review for ground truth.

For the traceability and value assignment, the reference methods (e.g., IFCC recommended reference method) are the "ground truth" for the calibrator values themselves, rather than clinical experts establishing a ground truth for a test set. This process relies on scientific and metrological standards for enzyme activity measurement.

4. Adjudication Method for the Test Set

N/A. Not applicable for a calibrator device.

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

N/A. This is a calibrator, not a diagnostic device involving human readers or interpretation of cases.

6. Standalone Performance Study (Algorithm Only)

N/A. This is a physical calibrator product, not a software algorithm. Its "performance" is its ability to accurately transfer values and maintain stability. The "algorithm" for value assignment is described as analogous to the Broughton and Eldjarn method, which is a statistical and analytical process for value transfer.

7. Type of Ground Truth Used

• For Calibrator Values: The ground truth for the assigned values of the analytes, particularly LDH, is established by internationally recognized reference methods/procedures. For LDH, it is the "IFCC recommended reference method as described in IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 C. Part 3. Reference procedure for the measurement of catalytic concentration of lactate dehydrogenase." Other analytes also have their traceability linked to established reference methods (e.g., IFCC, PG5, NCCLS, pH Stat).
• For Stability: The ground truth is experimental measurement against predefined stability specifications/acceptance criteria.

8. Sample Size for the Training Set

N/A. This is a calibrator, not an AI/ML algorithm that is "trained" on data. The "training" for a calibrator (if an analogy must be made) is the process of its manufacturing and initial value assignment according to established scientific methods.

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

N/A, for the reasons mentioned above. However, the document does describe how the values are assigned:

"The process by which Supplementary Assigned Values (SAV) are assigned to VITROS Chemistry Products Calibrator Kit 3 is analogous to the value transfer process described by Broughton and Eldjarn... The major difference is that instead of transferring values from one serum pool to another, reference method values are transferred to product calibrator fluids, using a panel of human samples as an intermediate Working Calibrator."

This implies a multi-step process involving:

1. Reference method measurement (the ultimate ground truth).
2. Transferring these values to human samples (the "panel of human samples").
3. Using these human samples as an "intermediate Working Calibrator" to assign values to the final product calibrator fluids.

Ask a specific question about this device

ADVIA Chemistry Enzyme 1 Calibrator is intended for in vitro diagnostic use in the calibration of Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase P-L (LDPL), Lactate Dehvdrogenase L-P (LDLP), Cholinesterase (CHE), and Lipase (LIP) assays on the ADVIA Chemistry systems.

ADVIA® Chemistry Enzyme 2 Calibrator is intended for in vitro diagnostic use in the calibration of Alanine Aminotransferase (ALT); Alanine Aminotransferase, Concentrated Reagents (ALT c); Alanine Aminotransferase (P5P) (ALTP5P); Alanine Aminotransferase (P5P), Concentrated Reagents (ALTP c); Aspartate Aminotransferase (AST); Aspartate Aminotransferase, Concentrated Reagents (AST_c); Aspartate Aminotransferase (PSP)(ASTP5P); and Aspartate Aminotransferase (P5P), Concentrated Reagents (ASTP_c) assays on the ADVIA Chemistry systems.

The ADVIA® Chemistry Enzyme 1 Calibrator and Enzyme 2 Calibrator are liquid, multianalyte, bovine serum albumin based products. Enzyme 1 Calibrator kit consists of six vials of the same calibrator which is ready for use (no preparation is required). The volume per vial is 2.5 mL. Enzyme 2 Calibrator kit consists of six vials of calibrator of the same level which is ready for use (no preparation is required). The volume per vial is 1.5 mL.

The provided document describes the Siemens ADVIA® Chemistry Enzyme 1 and Enzyme 2 Calibrators, which are intended for in vitro diagnostic use in the calibration of various enzyme assays. The document is a 510(k) summary, which aims to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states: "Acceptance criteria is the mean concentration should be within ±15% of the target value." This acceptance criterion is applied during the verification of the commercial calibrator lot.

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

For the commercial calibrator lot value assignment:

• Sample Size: "Each instrument is calibrated using the Masterpool. The calibrators are run as unknowns with n=20 replicates." This indicates a sample size of 20 replicates for each analyte on each of the two instruments. The total number of calibrator vials used was three.
• Data Provenance: The data is prospective, generated during the manufacturing and verification process of the new calibrator lots. The country of origin is not explicitly stated but is implied to be where Siemens Healthcare Diagnostics Inc. (Tarrytown, NY) conducts its manufacturing and testing.

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

This information is not applicable in the context of calibrator performance. The "ground truth" for calibrators is their assigned target concentration based on reference materials and established methods, not clinical interpretation by experts.

4. Adjudication Method for the Test Set

This is not applicable as the "test set" involves quantitative measurements against target values, not subjective interpretations requiring adjudication.

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

No. This type of study is for comparing human reader performance, typically in diagnostic imaging or similar fields. This document is about calibrator performance in a laboratory setting.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, in a sense. The core "performance" described is the ability of the calibrator lots to meet their target concentration specifications when measured on the ADVIA Chemistry systems, without direct human cognitive input influencing the measurement results. The setup involves instruments measuring the calibrators as "unknowns," which is a form of standalone performance measurement for the calibrator's assigned values.

7. Type of Ground Truth Used

The ground truth for the calibrator's value assignment is based on:

• Reference Materials: For several analytes (LDLP, GGT, ALT, AST), the ground truth is traceable to IFCC Reference materials or IFCC Reference methods.
• Molar Extinction Coefficient: For CHE and LDPL, the ground truth relies on the molar extinction coefficient of the reaction product or NADH, respectively.
• Internal Standard: For LIP, an internal standard is used.
• Master Lot Assigned Bottle Values: Initially, the stock solution concentration is determined by comparison to Master Lot assigned bottle values, which themselves would be traceable to the aforementioned reference standards/methods.

8. Sample Size for the Training Set

This product is a calibrator, not an algorithm that requires a "training set" in the machine learning sense. The concept of a training set is not applicable here.

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

As explained above, there is no "training set" as this is not an AI/ML algorithm. The "ground truth" for the calibrators' assigned values is established through traceability to international reference materials, molar extinction coefficients, and internal standards, as detailed in point 7.

Ask a specific question about this device

ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.
ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.

ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDAapproved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. ELITROL I and ELITROL II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

The provided text describes information about the ELITech Clinical Systems ELICAL 2 (calibrator) and ELITROL I & II (control sera), specifically for the addition of new constituents (IRON FERENE and MAGNESIUM XYLIDYL). It focuses on demonstrating substantial equivalence to predicate devices rather than independent clinical performance studies for complex AI/ML devices. Therefore, much of the requested information (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable or not present in this document.

However, I can extract the acceptance criteria and performance related to the stability and value assignment for these in vitro diagnostic devices. The studies conducted are primarily focused on demonstrating the equivalency of the new lots/constituents to the existing product and predicate devices, and ensuring appropriate stability and accurate value assignment.

Here's an attempt to structure the available information according to your request, with explicit notes about what information is not present:

Acceptance Criteria and Reported Device Performance

The provided document describes the acceptance criteria and testing for ELITech Clinical Systems ELICAL 2 (calibrator) and ELITech Clinical Systems ELITROL I & II (control sera). The primary performance parameters evaluated are stability and value assignment. The study aims to demonstrate substantial equivalence to predicate devices by showing comparable performance characteristics.

1. Table of Acceptance Criteria and Reported Device Performance:

• 15-25°C: 8 hours
• 2-8°C: 2 days
• (-25)-(-15)°C: 4 weeks (frozen once)
  Exceptions (when stored protected from light):
• Direct Bilirubin: 15-25°C: 3 hours, 2-8°C: 8 hours, (-25)-(-15)°C: 2 weeks (frozen once)
• Total Bilirubin: 15-25°C: 6 hours, 2-8°C: 1 day, (-25)-(-15)°C: 2 weeks (frozen once) | Lyophilized: Stable at 2-8°C until expiration date.
  After Reconstitution:
• 15-25°C: 12 hours
• 2-8°C: 5 days
• (-25)-(-15)°C: 4 weeks (frozen once)
  Exceptions (when stored protected from light):
• Direct Bilirubin: 15-25°C: 4 hours, 2-8°C: 8 hours, (-25)-(-15)°C: 2 weeks (frozen once)
• Total Bilirubin: 15-25°C: 8 hours, 2-8°C: 1 day, (-25)-(-15)°C: 2 weeks (frozen once) |
  | Reported Performance (Stability) | Confirmed to meet acceptance criteria (stated by "The following is claimed for stability:" and "The devices met all acceptance criteria"). The reported stability values match the acceptance criteria as they are directly stated. | Confirmed to meet acceptance criteria (stated by "The following is claimed for stability:" and "The devices met all acceptance criteria"). The reported stability values match the acceptance criteria as they are directly stated. |
  | Acceptance Criteria (Value Assignment) | For ELICAL 2: The mean analyte value is calculated based on measurements against appropriate standard reference material. Verification is performed by calibrating with new lot's assigned values and measuring quality control material at two levels, verifying that obtained values are within the labeled range of the quality control. | For ELITROL I & II: Target value for Level I and II is the median of the observed values range. A confidence range (high and low values) is calculated after validation of the target value. The expectation is that the controls perform as expected within these ranges. |
  | Reported Performance (Value Assignment) | Confirmed to meet acceptance criteria (stated by "The performance data...demonstrate...that they met all acceptance criteria"). The process of value assignment described implies that the assigned values and subsequent QC measurements were within acceptance. | Confirmed to meet acceptance criteria (stated by "The performance data...demonstrate...that they met all acceptance criteria"). The process of value assignment described implies that the assigned values and subsequent confidence ranges were within acceptance. |
  | Substantial Equivalence | Demonstrated by comparison to predicate device K033501 (Roche Diagnostics Calibrator for Diagnostics Systems (C f.a.s)) showing similarities in intended use, format, level, handling, traceability, and stability. | Demonstrated by comparison to predicate device K041127 (Roche Diagnostics Precinorm U & Precipath U) showing similarities in intended use, format, levels, handling, and stability. |

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

• ELICAL 2 (Calibrator):
  • For Value Assignment: "a target value is assigned on a minimum of 48 measurements taken." This is the number of measurements used to establish the value for each analyte.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The submitter, ELITech Clinical Systems SAS, is located in France. The predicate devices are Roche Diagnostics (a global company). The data is presented as prospective testing of new lots/constituents to establish their values and stability.
• ELITROL I & II (Control Sera):
  • For Value Assignment: "Each sample is tested in triplicate over several days using two separate ELITech Clinical Systems Selectra analyzers." A specific total number of measurements is not provided, but it implies multiple triplicate measurements.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The submitter, ELITech Clinical Systems SAS, is located in France. The predicate devices are Roche Diagnostics. The data is presented as prospective testing of new lots/constituents to establish their values and stability.

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

• Not Applicable. This is an in vitro diagnostic device for calibrators and control sera. The "ground truth" for these types of devices is established through analytical methods and reference materials, not expert consensus (e.g., radiologists interpreting images). The values are determined by analytical measurement against appropriate standards.

4. Adjudication method for the test set:

• Not Applicable. As the "ground truth" is established by analytical methods and reference materials, there is no expert adjudication process involved. The results are quantitative measurements compared against established standards or internal criteria.
  • For ELICAL 2, value assignment verification involved checking if measurements of quality control material fell within a labeled range.
  • For ELITROL I & II, the target value was the median of observed values, and a confidence range was calculated, indicating an analytical determination rather than 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 document describes in vitro diagnostic calibrators and control sera, not AI-powered image analysis or diagnostic systems that involve human readers.

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

• Not Applicable. This document describes in vitro diagnostic calibrators and control sera. These devices are reagents used in automated analytical instruments (Selectra Pro Series Analyzers), and their performance is inherent to the chemical properties and manufacturing process, not an algorithm. The "performance" is how accurately and reproducibly they can be used to calibrate and control other assays, which is assessed analytically.

7. The type of ground truth used:

• Analytical Standards/Reference Materials & Internal Consistency:
  • For ELICAL 2 (Calibrator): The ground truth for value assignment is established by testing against "appropriate standard reference material" on two separate analyzers. This means the values are traced to known, highly accurate reference standards.
  • For ELITROL I & II (Control Sera): The "target value" is determined as "the median of the observed values range" from multiple measurements on two analyzers. This indicates an internal analytical consensus approach based on repetitive testing and statistical methods to establish the expected control range.

8. The sample size for the training set:

• Not Applicable / Not provided. These are in vitro diagnostic reagents, not AI/ML algorithms that require training sets in the computational sense. The document describes processes for establishing performance characteristics of a manufactured product (calibrators and control sera).

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

• Not Applicable. (See point 8).

Ask a specific question about this device

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.

Ask a specific question about this device

The System Calibrator is a calibration serum intended to be used for the calibration of ALP, ALT, AST, Amylase, CK-NAC, GGT and LDH enzymes on Beckman Coulter AU480, AU680 and AU5800 analysers. For In Vitro Diagnostic use only.

The System calibrator kit is a lyophilized human serum based product intended to provide calibration for AU Enzyme reagents (ALP, ALT, AST, Amylase, CK-NAC, GGT and LDH) for the quantitative determination of the relevant analyte on Beckman Coulter AU analyzers. The following is the kit configuration for the system calibrator: 66300 kit has 20 vials with 5 ml contents for Level 1. The System calibrator is designed for optimal performance on Beckman Coulter AU analyzers. The System calibrator contains lyophilized human serum with chemical additives, preservatives, and enzymes of human, animal and plant origin.

This document describes the Beckman Coulter System Calibrator (66300), a lyophilized human serum-based product intended for the calibration of ALP, ALT, AST, Amylase, CK-NAC, GGT, and LDH enzymes on Beckman Coulter AU480, AU680, and AU5800 analyzers.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Open Vial Stability: 3 individual calibrator lots.
• Shelf Life Stability: 3 individual lots of calibrator.
• Value Assignment: Multiple reagent lots and calibrator vials were used. 10 replicates from 8 runs were performed, resulting in a total of 80 data points per individual enzyme. Distinct runs with minimum gaps of 2 hours were performed, and 8 calibration events were used.

The data provenance is not explicitly stated in terms of country of origin. The studies appear to be internal validation studies conducted by Beckman Coulter Ireland, Inc. and may be considered prospective as they were specifically designed for this submission.

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

Not applicable for this type of device. The ground truth for this calibrator is based on analytical performance specifications and traceability to theoretical extinction coefficients, not expert consensus interpretation.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. This device is a calibrator for in vitro diagnostic assays, and its performance is evaluated through quantitative analytical methods and stability testing, not through expert adjudication of qualitative outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is not relevant for this device. This product is a calibrator, not an imaging or diagnostic algorithm requiring human interpretation.

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

Yes, in the sense that the performance characteristics (stability, value assignment) are determined directly from the calibrator's analytical behavior on Beckman Coulter AU analyzers without human intervention in the result determination process. The "device" (calibrator) performs its function (calibrating assays) independently of human judgment on the results, although human operators perform the testing.

7. The Type of Ground Truth Used

The ground truth for the System Calibrator's values and performance is established through:

• Analytical Performance Specifications: The device's stability (open vial and shelf life) is evaluated against a maximum allowable drift of ±5%.
• Traceability to Theoretical Extinction Coefficients: The assigned values for each enzyme are traceable to specific theoretical extinction coefficients (e.g., Amylase OSR6x06: 11320, ALP OSR6x04: 17900), which are fundamental physicochemical properties.
• Internal Test Procedures and Protocols: Value assignment was determined utilizing internal procedures and protocols that involved multiple reagent lots and calibrator vials.

8. The Sample Size for the Training Set

Not applicable. This document describes a calibrator, not a machine learning or AI model that requires a training set. The "training" in this context refers to the calibration of an analyzer using the calibrator, not the development of 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 an AI/ML algorithm. For the calibrator's value assignment, the ground truth was established by calculating the overall mean from 80 data points (10 replicates from 8 runs) for each individual enzyme, ensuring incorporation of variation from calibration and environmental sources, and tracing these values to theoretical extinction coefficients.

Ask a specific question about this device

C.f.a.s. (Calibrator for automated systems) PAC (Prealbumin-ASLO-Ceruloplasmin) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
C.f.a.s. (Calibrator for automated systems) Proteins is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
PreciControl ClinChem Multi 1 is for the use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets. PreciControl ClinChem Multi 2 is for the use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
Precinorm Protein and Precipath Protein are for the use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.

C.f.a.s. Proteins is a liquid ready-to-use calibrator based on human serum. The concentrations of the components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers.
C.f.a.s. PAC is a lyophilized calibrator based on human serum. The concentrations of the components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers.
PreciControl ClinChem Multi 1 and 2 are lyophilized controls based on human serum. The adjusted concentrations and activities of the components of PCCC Multi 1 are usually in the normal range or at the normal/pathological threshold. The adjusted concentrations and activities of the components of PCCC Multi 2 are usually in the pathological range.
Precinorm Protein and Precipath Protein are liquid ready-for-use control sera based on human serum. The concentrations of the components of Precinorm Protein are usually in the normal range or at the normal/pathological threshold. The concentrations of the components of Precipath Protein are usually in the pathological range.

Below is a summary of the acceptance criteria and study information for the device based on the provided text.

1. Acceptance Criteria and Reported Device Performance

The study evaluates the impact of "device modifications" on the performance of four in-vitro diagnostic devices (calibrators and control sets). The modifications primarily involve changing the Antistreptolysin O (ASLO) analyte source material from human serum to sheep serum, and some biological additive changes for C.f.a.s. PAC and PCCC.

The performance characteristics assessed are:

• Stability: Shelf life and open vial stability.
• Method Comparison: Comparison of ASLO measurements between the candidate and predicate C.f.a.s. PAC calibrators.
• Lower Detection Limit (LDL): Verification of ASLO LDL.
• Control Recovery: Evaluation of ASLO control recovery using the modified control sets.
• Precision: Assessment of ASLO and Ferritin precision.

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

• Sample Size:
  • Method Comparison (ASLO): "a data set of human serum samples." The specific number of samples is not provided, but it states "human serum samples."
  • Lower Detection Limit (ASLO): n = 21 replicates for the calculation.
  • Precision (ASLO and Ferritin): 21 replicates were measured in a single run in a single day for each test system (total 2 test systems for ASLO, 1 for Ferritin).
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of submitting to the FDA, it is likely that the data was generated in a controlled, prospective manner following industry standards for manufacturing and testing of in-vitro diagnostics. The materials (calibrators and controls) are for use with Roche clinical chemistry analyzers (Roche/Hitachi and COBAS INTEGRA families), which are widely available globally. The source of some materials changed FROM "human" TO "sheep," but the "human serum samples" used for method comparison are not detailed as to their origin.

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

Not applicable. This is a study for in-vitro diagnostic calibrators and controls, not an imaging device or a diagnostic algorithm requiring expert interpretation of results to establish ground truth. The "ground truth" here refers to reference values established through traceable methods and master lots, and the comparison is based on quantitative analytical performance against these established reference values.

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

Not applicable. As this is not a study involving human readers or subjective interpretations, no adjudication method was used. Performance is assessed against quantitative analytical criteria.

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. No MRMC study was conducted as this device is an in-vitro diagnostic calibrator/control, not an AI-assisted diagnostic tool.

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

Yes, a standalone performance evaluation was done in the sense that the analytical performance of the modified calibrators and controls was tested directly on analyzers (cobas c 501 and INTEGRA 800) against predefined quantitative criteria. There is no "human-in-the-loop" component in the direct measurement and assessment of these IVD devices for their intended use (calibration and quality control).

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

The ground truth used for performance evaluation is based on reference values established through traceable master lots and reference methods. For calibrators, value assignment is "traceable through master lot to reference methods or materials." For controls, "target values" are used, and analytical results are compared to these target values to determine recovery. In the context of lab diagnostics, this is the accepted standard for defining "ground truth" or reference for quantitative measurements.

8. The sample size for the training set

Not applicable for this type of IVD device modification submission. This is not an AI/machine learning device that requires a training set. The "training" in this context would refer to the historical data and method development that led to the predicate devices and the current testing methodologies, rather than a distinct "training set" for 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 AI/ML. The reference values for calibrators and control materials are established through rigorous analytical measurement processes, often involving comparison to international reference materials or highly accurate reference methods, and internal master lot value assignment protocols.

Ask a specific question about this device

ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

The provided text describes the regulatory submission for calibration and control devices (ELITech Clinical Systems ELICAL 2, ELITROL I, and ELITROL II) for use with Lipase testing on ELITech Clinical Systems Selectra Analyzers. The focus of the submission is to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating the device's performance in diagnosing patients.

Therefore, many of the requested points, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types related to diagnostic performance of an AI model, are not applicable to this type of device submission.

The "study" referenced in this document is a value assignment and verification process for the calibrator and control materials, not a clinical trial of a diagnostic device.

Here's the information that can be extracted from the provided text, adapted to the context of a calibrator and control material:

1. Table of Acceptance Criteria and Reported Device Performance (for Lipase value assignment):

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

• Test Set (for ELICAL 2 Lipase Value Assignment): "The test system" was calibrated using "a previously qualified lot of ELICAL 2 and two different approved lot of lipase reagents." The amount of lipase in the "new lot of ELICAL 2" was then measured. The exact number of measurements or samples within this process is not specified, but it involves a comparison against two different approved lots of lipase reagents.
• Test Set (for ELITROL I and ELITROL II Lipase Value Assignment): "The test system" was calibrated using "a previously qualified lot of ELICAL 2 with two different approved lots of lipase test reagents" and then measuring the amount of lipase in the "new lots of ELITROL I and ELITROL II." The exact number of measurements or samples within this process is not specified but involves a comparison against two different approved lots of lipase test reagents.
• Data Provenance: The data is generated internally by ELITech Clinical Systems as part of their manufacturing and quality control process for calibrators and control materials. No country of origin for the "data" as clinical patient data is provided, as it's a lab-based calibration process. This is a prospective process for each new manufacturing lot.

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

• Not Applicable. The "ground truth" here is the established value of lipase in the calibrator/control material, which is determined through internal procedures and traceability to a titrimetric manual method, not through consensus of human experts interpreting diagnostic results.

4. Adjudication method for the test set:

• Not Applicable. As the "ground truth" is a measured value against a target, there is no expert adjudication involved in the typical sense of interpreting clinical data. The process involves meeting predefined numerical acceptance criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is not a diagnostic AI device; it's a calibrator/control material. MRMC studies are not relevant here.

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

• Not Applicable. This is not an algorithm or AI device. Its purpose is to ensure the accuracy of laboratory measurements by providing known reference points (calibrators) and quality control materials.

7. The type of ground truth used:

• For ELICAL 2 and ELITROL I/II: The "ground truth" for the lipase values is established through a process traceable to a titrimetric manual method. This serves as the reference standard against which the device's assigned values are verified. The ultimate "ground truth" is therefore a chemical/analytical reference standard.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning or AI device that requires a training set. The "training" of the device is its manufacturing and formulation.

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

• Not Applicable. No training set is used. The inherent "ground truth" for the calibrator and control materials is their chemical composition and the established lipase activity, which is then verified against a titrimetric manual method.

Ask a specific question about this device

The CHEM III CAL is an in vitro diagnostic product for the calibration of Ammonia (AMM), Carbon Dioxide (EC02) and Ethyl Alcohol (ETOH) assays on the Dimension® clinical chemistry system.

The Chemistry III Calibrator (CHEM III CAL) is a three level, liquid calibrator. It is packaged as a kit of six vials, two vials each of Levels 1, 2 and 3 with 2.5 mL per vial. CHEM III CAL is a multianalyte, aqueous product containing ammonium bicarbonate, sodium carbonate and ethyl alcohol.

The provided text describes a 510(k) premarket notification for a medical device, the Dimension® Chemistry III Calibrator (CHEM III CAL). It details the device's intended use and compares it to a predicate device for substantial equivalence. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the way typically expected for an AI/CADe device.

This document is for a calibrator, which is a reference material used to ensure the accuracy of assays on a clinical chemistry system. The performance characteristics discussed here relate to the stability of the calibrator itself, not to the diagnostic performance of an AI algorithm based on patient data.

Therefore, many of the requested fields (like sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth, training set size, and how training ground truth was established) are not applicable to this type of device and FDA submission.

Here's a breakdown of the available information:

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

The document describes performance characteristics related to the stability of the calibrator, which can be interpreted as demonstrating its functional acceptance.

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

• Not Applicable. This device is a calibrator, and its performance is evaluated in terms of its stability and ability to maintain assigned values over time and under specific storage conditions. It does not analyze patient data.

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):

• Not Applicable. Ground truth for this device relates to the accurately assigned values of the analytes within the calibrator (Ammonia, Carbon Dioxide, Ethyl Alcohol), which are established through certified reference materials and analytical chemistry methods, not expert consensus on patient data. The traceability to ASC Grade Ammonium Sulfate, NIST SRM 351, and USP Grade Ethyl Alcohol for the analytes (AMM, ECO2, ETOH) is mentioned, indicating the origin of the referent values.

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

• Not Applicable. Adjudication methods are relevant for subjective interpretations of data, typically in AI/CADe diagnostic device studies. This is a chemical calibrator.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is not an AI/CADe device.

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

• Not Applicable. This is not an AI/CADe device or an algorithm.

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

• The closest equivalent to "ground truth" for this device is the traceability of the analyte values to recognized standards:
  • AMM - ASC Grade Ammonium Sulfate
  • EC02 - NIST SRM 351
  • ETOH - USP Grade Ethyl Alcohol
    These standards ensure the accuracy of the assigned values in the calibrator.

8. The sample size for the training set:

• Not Applicable. This device does not use a training set in the context of machine learning.

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

• Not Applicable. This device does not use a training set.

Study/Evidence that Proves the Device Meets Acceptance Criteria:

The document states: "The shelf life of the Dimension® CHEM III CAL is 12 months." and "For opened products, once the cap is removed, assigned values are stable for 7 days . stored on the Dimension® clinical chemistry system." and "Once cap is removed, assigned values are stable for 30 days when recapped immediately after use and stored at 2-8°C."

The "study" or evidence for these claims would typically involve a stability study, designed according to recognized guidelines such as CLSI EP25-A, "Evaluation of Stability of In Vitro Diagnostic Reagents." This guideline, which is referenced in the document, outlines protocols for determining the shelf life and in-use stability of diagnostic reagents and calibrators by measuring the analyte concentrations at various time points under different storage conditions and comparing them to initial values or reference standards. The acceptance criteria would be that the measured values remain within a pre-defined acceptable range (e.g., ±X% of the assigned value) throughout the claimed stability period.

While the document references the CLSI guideline, it does not provide the specific raw data, methodology details of the stability study (e.g., number of lots tested, analytical methods used for measurements), or the exact acceptance limits used to determine the stated stability claims (7 days, 30 days, 12 months). It only reports the results of such studies.

Ask a specific question about this device

Abbott Lipid Multiconstituent Calibrator is an in vitro diagnostic product intended for the calibration of Abbott Apolipoprotein A1, Apolipoprotein B, HDL-Cholesterol and LDL-Cholesterol assays on the ARCHITECT c8000 clinical chemistry analyzer.

This is an in vitro diagnostic product intended for use as a calibrator in clinical chemistry assays. Lipid Multiconstituent Calibrator (LipidMCC) contains Apolipoprotein A1, Apolipoprotein B. HDL-Cholesterol and LDL-Cholesterol in a lyophilized human serum-based matrix. The concentrations and activities are suitable for calibration of the Abbott ARCHITECT c8000. LipidMCC contains one level of the four analytes in a lyophilized human serum-based matrix.

Here's a breakdown of the acceptance criteria and the study that proves the Lipid Multiconstituent Calibrator (LipidMCC) meets those criteria, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally focused on accuracy and stability, ensuring the calibrator provides reliable measurements for the target analytes over time.

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

The document describes several distinct "test sets" for different aspects of performance:

• Standardization (HDL & LDL): Human serum samples were analyzed. The exact number of samples is not specified, but it's referred to as a "method comparison study" using an unspecified quantity of "human serum samples."
• Standardization (Apolipoprotein A1 & B): 40 serum samples with assigned reference values were used in a method comparison study to verify the values after calibration with reference materials.
• Value Assignment: For each analyte, 10 replicates of the test calibrator and 10 replicates of the master calibrator lot were tested (5 replicates from each of two vials). "Quality control samples" and "control samples" (typically a previously assigned calibrator lot) were also used, but their exact number isn't specified beyond being "samples."
• Shelf-life Stability: Three lots of calibrator were tested. For each lot, pairs of vials (one from 2-8°C, one from -80°C) were tested at eight designated time points up to 190 weeks.
• Open Vial Stability: Three lots of lyophilized calibrator were tested. For each lot, sets of three vials were used for different storage conditions (7 days at 2-8°C, 10 days at 2-8°C, and opened daily for 10 days).

Data Provenance:

• Human Serum Samples (Standardization): The source of these samples (e.g., country of origin) is not specified. They appear to be retrospective samples used in method comparison studies.
• Calibrator Lots (Value Assignment, Shelf-life, Open Vial Stability): These are internal lots manufactured by Abbott Laboratories.

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

The concept of "experts" and "ground truth" in this context refers to established reference methods and materials, rather than individual human experts interpreting data like in imaging studies.

• HDL-Cholesterol & LDL-Cholesterol: The "ground truth" was established by the CDC described reference method for determination of HDL/LDL-cholesterol, performed by a CDC-certified CRMLN (Cholesterol Reference Method Laboratory Network) laboratory. This implies adherence to highly standardized and validated laboratory procedures, effectively serving as the gold standard.
• Apolipoprotein A1 & Apolipoprotein B: The "ground truth" was established using WHO/IFCC/CDC reference materials (SP1-01 and SP3-08). The standardization process was conducted by the Northwest Lipid Metabolism and Diabetes Research Laboratories (University of Washington), which is the designated apolipoprotein standardization facility for the CDC Lipid Standardization Program (LSP). This indicates the use of internationally recognized reference materials and highly specialized, accredited laboratories.

The qualifications of the individuals within these certified laboratories are inherent in the certification and recognition of the institutions they belong to. They are implicitly experts in their field.

4. Adjudication Method for the Test Set

The concept of "adjudication" (e.g., 2+1, 3+1) is typically associated with studies where human readers interpret data, and discrepancies need to be resolved. This is not applicable to the analytical performance studies described for this calibrator.

Instead, the "adjudication" or decision-making process here relies on:

• Comparison to Reference Methods/Materials: Direct comparison of results from the device to established, gold-standard reference methods or materials (e.g., CDC reference methods, WHO/IFCC/CDC reference materials).
• Statistical Analysis: Calculation of bias and percentage deviation, and verification that these fall within predefined acceptance criteria.
• Internal Protocols: The standardization, value assignment, and stability studies followed "procedures approved by Abbott Laboratories, Inc."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for medical devices that involve human interpretation of diagnostic results (e.g., AI-assisted radiology tools) and aims to quantify the improvement in human reader performance with the aid of the device. The LipidMCC is a calibrator, an in-vitro diagnostic product that directly influences the accuracy of an automated analyzer, not a device that assists human readers in interpreting clinical cases.

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

This question is not directly applicable in the conventional sense of an "algorithm" performing a diagnostic task without human involvement. LipidMCC is the "standalone" product in question here; it's a calibrator. Its "performance" is its ability to accurately set the measurement scale for an analyzer. The studies conducted (standardization, value assignment, stability) are essentially standalone performance evaluations of the calibrator itself, demonstrating its fitness for purpose without human intervention in the calibration process once the calibrator is used.

7. The Type of Ground Truth Used

The ground truth used is a combination of:

• Reference Methods: Specifically, CDC-described reference methods for HDL- and LDL-cholesterol.
• Reference Materials: WHO/IFCC/CDC reference materials for Apolipoprotein A1 and Apolipoprotein B.
• Assigned Reference Values: For the 40 serum samples used to verify Apolipoprotein A1 and B standardization.

This represents the highest possible standard of analytical truth for these analytes.

8. The Sample Size for the Training Set

The document does not explicitly describe a "training set" in the context of machine learning. The calibrator itself is not an algorithm that is "trained." Instead, the "training" equivalent here refers to:

• Master Calibrator Lot Standardization: This is where the primary values for the master calibrator lot are meticulously established against the foundational reference methods and materials. This process involves multiple measurements and comparisons to ensure accuracy.
• Individual Calibrator Lot Value Assignment: Subsequent production lots of the calibrator are then assigned values based on comparison to the standardized master calibrator lot.

The sample sizes for these processes are described as:

• Standardization (HDL & LDL): "human serum samples" (number not specified).
• Standardization (Apolipoprotein A1 & B): Analysis of the master calibrator lot using WHO/IFCC/CDC reference materials for calibration.
• Value Assignment (Per Lot): 10 replicates of the master calibrator lot, along with 10 replicates of the new test calibrator lot.

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

As noted above, there isn't a "training set" in the machine learning sense. The "ground truth" for establishing the values of the calibrator itself (especially the master calibrator lot, which serves as the reference for subsequent lots) was established through:

• Direct Analytical Comparison to Gold Standard Reference Methods: For HDL and LDL, this involved method comparison studies against CDC described reference methods performed by a CDC-certified CRMLN laboratory. Bias estimation was used to adjust values to minimize bias to these reference methods.
• Direct Analytical Comparison to Certified Reference Materials: For Apolipoprotein A1 and Apolipoprotein B, this involved calibrating an ARCHITECT c8000 instrument using WHO/IFCC/CDC reference materials and then analyzing the master calibrator lot. The successful completion was documented by certificates from the Northwest Lipid Metabolism and Diabetes Research Laboratories, confirming the traceability to these reference materials.

Essentially, the "ground truth" for the calibrator's values is derived from internationally recognized and highly validated analytical reference standards.

Ask a specific question about this device

The RAPIDPoint® 500 System measurement cartridge with calibrators is an in vitro diagnostic product for the calibration of the analytes on the RAPIDPoint® 500 System. The analytes measured are partial pressure of carbon dioxide (pCO2), partial pressure of oxygen (pO2), pH, Sodium (Na*), Potassium (K*), ionized Calcium (Ca**), Chloride (Cl7), Glucose (Glu), total hemoglobin (tHb), Neonatal Bilirubin and Lactate (Lac).

The RAPIDPoint® 500 System consists of four (4) calibrators contained in the measurement cartridge and wash/waste cartridge that are used to calibrate the following analytes: pH, partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), Sodium (Na ), Potassium (K ), ionized Calcium (Ca *), Chloride (Cl), Glucose (Glu), total hemoglobin (tHb) and Lactate (Lac). There is no unique calibration measurement for Neonatal Bilirubin (nBili) as the tHb calibration is used.

The measurement cartridge contains the following calibrators: 200 Cal, Reagent C and Low Sulfite Zero Cal. The wash/waste cartridge contains the wash reagent.

The provided text describes the RAPIDPoint® 500 System Measurement Cartridge with Calibrators, an in vitro diagnostic product intended for the calibration of analytes on the RAPIDPoint® 500 System. The document is a 510(k) summary submitted to the FDA for market clearance.

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

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

The document does not explicitly present a table of acceptance criteria and reported device performance in the same manner one might expect for a clinical study comparing an AI device to ground truth. Instead, the "acceptance criteria" are implied by the process of establishing traceability and stability for the calibrators, and the "reported device performance" is the successful demonstration that these criteria were met.

The key acceptance criteria for this type of device (calibrator) relate to stability and traceability of the assigned values.

Traceability Methods (which inherently function as acceptance criteria for the accuracy of calibrator values):

• pH: Traceable to NIST SRM186 reference materials via the IFCC blood reference method.
• pCO2: Traceable to tonometered aqueous standards prepared using NIST traceable temperature and pressure standards and gravimetrically prepared precision gas standards.
• pO2: Traceable to tonometered aqueous standards prepared using NIST traceable temperature and pressure standards and gravimetrically prepared precision gas standards.
• K+: Traceable to NIST SRM 918 reference materials using flame photometry.
• Na+: Traceable to NIST SRM 919 reference material using flame photometry.
• Ca++: Traceable to gravimetrically prepared internal standards using NIST SRM 915 and ISE methods embodied in Siemens blood gas analyzers.
• Cl-: Traceable to NIST SRM 919 or 918 reference materials using a Coulometric reference method.
• Glucose: Traceable to NIST SRM 917 reference materials using the Hexokinase method.
• tHb: Traceable to internal standards calibrated against the CLSI Cyanmethemoglobin method.
• Lactate: Traceable to high purity lactate using the Lactate dehydrogenase spectrophotometric method.
• Neonatal Bilirubin (nBili): No unique calibrator; associated with tHb, which is traceable as noted above.

Study Type:

The "study" described is primarily a validation process to ensure the calibrators meet predefined performance specifications related to stability, traceability, and value assignment. This is not a typical clinical trial with patient cohorts, but rather a quality control and analytical performance validation for an in vitro diagnostic calibrator.

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

This document does not refer to a "test set" or "training set" in the context of an AI/algorithm. Instead, it discusses the testing of calibrator lots to confirm their stability and the methods used to establish their traceability and assigned values.

• Sample size: The document mentions "multiple measurements" and "multiple test systems" for value assignment, and "testing data" for stability. It does not provide specific numerical sample sizes for these tests (e.g., number of calibrator vials tested, number of measurements per vial, number of lots).
• Data provenance: Not specified. Given it's a product from Siemens Healthcare Diagnostics Inc., based in Norwood, MA, USA, the testing would likely have been conducted in their labs or by accredited partners. The "retrospective or prospective" nature usually applies to patient data collections; here, it would be a prospective manufacturing and quality control process for each lot of calibrator.

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 is not applicable to this type of device. The "ground truth" for the calibrators is established through traceability to internationally recognized reference materials (e.g., NIST SRMs) and validated reference methods (e.g., IFCC, CLSI). It does not involve human expert interpretation of images or clinical cases. The "experts" involved would be analytical chemists, metrologists, and quality control professionals with expertise in these highly standardized laboratory techniques.

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

Not applicable. This concept pertains to resolving discrepancies among human readers or between human readers and an AI algorithm in diagnostic accuracy studies. For calibrator validation, the "adjudication" is inherent in the rigorous, multi-measurement, and traceable methods used to assign values and confirm stability, following established quality management systems.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-powered diagnostic device, but a calibrator for a blood gas analysis system. Therefore, MRMC studies and "human reader improvement with AI assistance" are irrelevant.

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

Not applicable. This device is not an algorithm. It is a physical calibrator used within an analytical instrument (RAPIDPoint 500 System).

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

The "ground truth" for the calibrator values is based on traceability to primary and secondary reference materials and reference methods, rather than expert consensus, pathology, or outcomes data.

• For instance, pH is traceable to NIST SRM186.
• Sodium (Na+) is traceable to NIST SRM 919.
• Hemoglobin (tHb) is traceable to internal standards calibrated against the CLSI Cyanmethemoglobin method.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, so there is no training set in that context.

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

Not applicable. As there is no AI training set, this question is not relevant. The "ground truth" for the performance characteristics of the calibrator itself is established through the rigorous metrological traceability and analytical validation processes outlined above.

Ask a specific question about this device