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Randox Benzodiazepine Calibrator Set: The Randox Benzodiazepine Calibrator set consists of liquid calibrators containing Oxazepam. There are 5 levels of calibrator. They have been developed for use in the calibration of the RX series analysers in human urine, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only.

Randox Benzodiazepine Controls Level 1 & 2: The Randox Benzodiazepine Controls are liquid controls containing Oxazepam. There are 2 levels of controls. They have been developed for use in the quality control and validation of Benzodiazepine assay on the RX series analysers in human urine, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only.

The Benzodiazepine Calibrator Set contains 5 levels of calibrator containing the specific drug Oxazepam. The Calibrators are spiked at 4 different levels which assess below, at and above the cutoff of 200 ng/ml.

The Benzodiazepine Controls are manufactured at two levels, one below the cutoff and one above the cutoff of 200 ng/ml.

The base matrix used for the manufacture of Randox Benzodiazepine Calibrators and Controls is Drug Free Human Urine.

The Benzodiazepine Calibrators and Controls contain the specific drug Oxazepam. The Oxazepam is supplied by Cerilliant Corporation the accuracy of which is ensured by purity determinations (GC/FID, HPLC and NMR) and gravimetric preparation using balances calibrated with NIST traceable weights.

Randox Benzodiazepine Calibrators and Controls have been designed for in vitro diagnostic use only. They should not be pipetted by mouth and the normal precautions for handling laboratory reagents should be applied. Randox Benzodiazepine Calibrators and Controls contain sodium azide at 0.05%.

The provided document describes the Randox Benzodiazepine Calibrator Set and Randox Benzodiazepine Controls Level 1 and 2. This device is a set of calibrators and controls used for the calibration and quality control of Benzodiazepine assays on Randox RX series analyzers in human urine.

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

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

The document details two types of stability studies, each with specific acceptance criteria and reported performance:

• Day 7: Pass
• Day 21: Pass
• Day 28: Pass
  Controls (Batches 250-251DA, 51110, 61110):
• Day 7: Pass
• Day 21: Pass
• Day 28: Pass
  Conclusion: The Benzodiazepine Calibrators and Controls for three batches are stable for 28 days when opened, recapped and stored at +2°C to +8ºC. |
  | Real-Time Shelf Life (Unopened) | Calibrators: Calibration absorbance achieved at each time point should be 100% ±10% when compared to the fresh assessment.
  Controls: (1) For Control 1, the concentration should be less than the cutoff of 200 ng/ml. (2) For Control 2, the concentration should be greater than the cutoff of 200 ng/ml. | Calibrators (Batch 023-027DA):
• 1 Month: Pass
• 3 Months: Pass
• 6 Months: Pass
• 9 Months: Pass
• 12 Months: Pass
  Conclusion: The Benzodiazepine calibrators were stable for 12 months at +2℃ to +8℃ when stored unopened.
  Controls (Batches 482DA, 483DA):
• 3 Months: Pass
• 4 Months: Pass
• 6 Months: Pass
• 9 Months: Pass
• 12 Months: Pass
  Conclusion: The Benzodiazepine Controls are stable for at least 12 months at +2ºC to +8ºC when stored unopened. |
  | Accelerated Shelf Life (Unopened) | Storage at +37℃ for 5 days is equivalent to 12 months shelf life. (Implicit acceptance criteria: device remains stable at the specified time points under accelerated conditions, indicating stability for the claimed shelf life). | Calibrators (Batch 023-027DA):
• 1 Day: Pass
• 3 Days: Pass
• 5 Days: Pass
• 7 Days: Pass
• 10 Days: Pass
• 12 Days: Pass
  Conclusion: The Benzodiazepine calibrators are stable for at least 12 months at +2ºC to +8ºC when stored unopened. |
  | Value Assignment (Nest Testing) | Precision measured by the CV should be less than or equal to 15%.
  Recovery error of the master lot should be ± 10% for all calibrator and control levels. | The document states "Please see summary table below" and then lists the assigned concentrations for each calibrator and control level (e.g., Calibrator Level 1: 100 ng/ml). It implies that these values were successfully assigned according to the criteria but does not explicitly show the CVs or recovery errors for the tested batches. The passage states that the "concentration is calculated for each new batch... by nest testing," and the table presents the final calculated concentrations, suggesting the criteria were met. |

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

• Open Vial Stability:
  • Test set: Three batches of calibrators (242516, 51110, 61110) were tested, and three batches of controls (250-251DA, 51110, 61110) were tested. For each batch, a set of calibrators/controls was opened and assessed at Day 7, 21, and 28 against a freshly opened set.
  • Data Provenance: The studies were conducted by Randox Laboratories Limited, United Kingdom. The data is prospective, generated specifically for this submission.
• Real-Time Shelf Life:
  • Calibrators: One batch (023-027DA) was tested, with 5 calibrator sets set aside and assessed at 1, 3, 6, 9, and 12 months.
  • Controls: Two batches (482DA, 483DA) were tested, with 5 sets of controls set aside and assessed at 3, 4, 6, 9, and 12 months.
  • Data Provenance: The studies were conducted by Randox Laboratories Limited, United Kingdom. The data is prospective.
• Accelerated Shelf Life:
  • Calibrators: One batch (023-027DA) was tested, with six sets stored at +37°C and assessed at 1, 3, 5, 7, 10, and 12 days.
  • Data Provenance: The studies were conducted by Randox Laboratories Limited, United Kingdom. The data is prospective.
• Value Assignment (Nest Testing):
  • Test set: Ten replicates of the test calibrators/controls were assessed against a master lot. The specific number of batches tested for value assignment is not explicitly stated beyond "each new batch."
  • Data Provenance: The studies were conducted by Randox Laboratories Limited, United Kingdom. The data is prospective.

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

This information is Not Applicable to this device. This device is a calibrator and control set for an in vitro diagnostic assay. Its performance is measured by chemical and analytical stability and accuracy against a known standard, not by expert interpretation of clinical images or data. The "ground truth" for the test set (e.g., the concentration of Oxazepam) is established by the manufacturer (Randox) based on gravimetric preparation using NIST traceable weights and purity determinations.

4. Adjudication method for the test set

This information is Not Applicable. Clinical adjudication methods (like 2+1, 3+1) are used for evaluating diagnostic performance involving human interpretation, especially in imaging studies. For a chemical calibrator/control, performance is determined by meeting pre-defined analytical specifications.

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

This information is Not Applicable. This device is not an AI algorithm or a diagnostic tool that involves human readers interpreting cases. It is a calibrator/control for an automated assay.

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

This information is Not Applicable. This device is a calibrator/control, not a standalone algorithm. Its performance is evaluated through analytical stability and value assignment studies in conjunction with the RX series analyzers and Benzodiazepine Assay.

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

The ground truth for the Randox Benzodiazepine Calibrator Set and Controls is the known concentration of Oxazepam. This is established through:

• Gravimetric preparation: Oxazepam is spiked into the calibrators and controls at various concentrations.
• Traceability to NIST traceable weights: The accuracy of the Oxazepam is ensured by Cerilliant Corporation through purity determinations (GC/FID, HPLC, and NMR) and gravimetric preparation using balances calibrated with NIST traceable weights.
• Drug-free human urine: The base matrix for the calibrators and controls is drug-free human urine, ensuring a clear matrix for spiking.

8. The sample size for the training set

This information is Not Applicable. This device is not an AI/ML algorithm that requires a training set. The "samples" used in its development and validation are the manufactured batches of calibrators and controls themselves, which are then subjected to the stability and value assignment studies.

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

This information is Not Applicable, as there is no "training set" in the context of an AI/ML algorithm for this device. The equivalent of "ground truth" for its manufacturing and quality control, as described in point 7, is established through precise chemical formulation, gravimetric preparation, and analytical verification of the Oxazepam concentration and purity traceable to NIST standards.

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The QMS Lidocaine Calibrator set is intended for use in calibration of the QMS Lidocaine assay.

The QMS Lidocaine Calibrator set is a six-level set (0, 0.5, 1.0, 10 µg/mL) of single analyte (lidocaine) calibrators.

The provided text describes a 510(k) premarket notification for the QMS Lidocaine Calibrators. It aims to demonstrate substantial equivalence to a predicate device, the Roche Preciset TDM II Calibrators. However, the document primarily focuses on comparing the intended use, components, and matrix of the new device with the predicate device, rather than presenting a detailed study that proves the device meets specific performance acceptance criteria.

Therefore, many of the requested details about acceptance criteria, performance studies, sample sizes, expert qualifications, and ground truth establishment are not available in the provided text. The document concludes with a claim of substantial equivalence based on the technological characteristics without detailing a performance study with specific acceptance criteria.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated or defined in the provided text. The document aims to demonstrate "substantial equivalence" to a predicate device, implying that its performance attributes should be comparable, but specific numerical acceptance criteria are not provided.
• Reported Device Performance: Not explicitly detailed in the provided text. The "Comparison of Technological Characteristics" section compares the design and intended use of the device to the predicate, not a performance evaluation against specific metrics.

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

• Not available. The document does not describe a performance study with a test set.

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

• Not applicable/Not available. No test set or expert read ground truth is described.

4. Adjudication method for the test set

• Not applicable/Not available. No test set or adjudication process is described.

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

• Not applicable. This device is a calibrator for an assay, not an AI-assisted diagnostic tool involving human readers.

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

• Not applicable/Not available. The document focuses on the substance and composition of the calibrator, not on an algorithm's performance.

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

• Not applicable/Not available. In the context of a calibrator, "ground truth" would typically refer to the known, accurate concentration of the analyte (lidocaine) in the calibrator solution. The document states the calibrators are "prepared by quantitative addition of lidocaine to human serum," implying that the concentration values are established by the manufacturing process.

8. The sample size for the training set

• Not applicable/Not available. This type of device (a calibrator) does not typically involve a "training set" in the context of machine learning or diagnostic algorithm development.

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

• Not applicable/Not available. As above, no training set is described. The "ground truth" for the calibrator concentrations is established by the precise manufacturing formulation ("quantitative addition of lidocaine to human serum").

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The CSAE CAL is an in vitro diagnostic product for the calibration of CSAE method on the Dimension Vista® system.

The Dimension Vista® Cyclosporine Extended Range Calibrator contains cyclosporine in a preserved whole blood hemolysate. The kit consists of three vials of Calibrator A (200 ng/mL) and three vials of Calibrator B (2000 ng/mL). The intermediate calibrator levels (400. 800 and 1400 ng/mL) are prepared on-board the Dimension® Vista analyzer.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dimension Vista® Cyclosporine Extended Range Calibrator:

Note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain a detailed formal study report with specific acceptance criteria beyond general statements about "pre-defined acceptance criteria" for stability. The primary "study" described here is a comparison of technological characteristics to a predicate device, rather than a clinical performance study with human subjects or a standalone analytical performance study with specific quantitative acceptance metrics.

Acceptance Criteria and Device Performance

Study Details

Given that this is a 510(k) summary for a calibrator, the "study" is primarily focused on demonstrating substantial equivalence through a comparison of technological characteristics and confirmation of performance aspects like stability and traceability. It is not a traditional clinical study or standalone performance validation with a large test set and ground truth established by experts in the same way a diagnostic algorithm would be evaluated.

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

   • Test Set: For stability, testing was conducted on "3 lots of product." The specific number of individual calibrator vials or measurements within each lot is not provided.
   • Data Provenance: Not explicitly stated, but assumed to be internal laboratory data generated by the manufacturer (Siemens Healthcare Diagnostics Inc. in Newark, DE, USA). The studies are retrospective from the perspective of this 510(k) submission, as they were conducted to support the submission.

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

   • Not applicable in the context of this device. The "ground truth" for a calibrator is established by its manufacturing process, purity of its components (USP cyclosporine A), and its assigned values confirmed by analytical techniques like LC/MS/MS, not by human expert interpretation of results. Therefore, no external experts were used for this purpose on the test set.

3. Adjudication method for the test set:

   • Not applicable. The "test set" here refers to the calibrator lots themselves and their analytical performance. Adjudication methods are typically relevant for human interpretation tasks or complex diagnostic outcomes.

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

   • No MRMC comparative effectiveness study was done. This device is a calibrator, an in vitro diagnostic product, not a diagnostic algorithm or AI intended for human interpretation or assistance.

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

   • This is not applicable in the sense of an "algorithm" as commonly understood in AI. However, the performance characteristics (stability, traceability) of the calibrator itself were evaluated in a standalone manner, independent of a specific human operator interpreting patient results. The calibrator's function is purely analytical within the Dimension Vista® system. The analytical performance of the calibrator itself forms the basis of its "standalone" evaluation.

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

   • The ground truth for the calibrator's values is established by analytical measurement and traceability to a primary standard. Specifically, the calibrator is traceable to an internal master pool containing USP (United States Pharmacopeia) cyclosporine A, with values confirmed by LC/MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry). This is a highly accurate and precise analytical method for determining concentration.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of a calibrator product. This is not a machine learning model.

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

   • Not applicable as there is no training set.

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The EXTC CAL is an in vitro diagnostic product for the calibration of the Ecstasy (EXTC) method on the Dimension Vista™ System.

EXTC CAL is a liquid, human urine-based product containing weighed-in quantities of methylenedioxymethamphetamine. The kit consists of six vials, three vials of Calibrator A and three vials of Calibrator B. EXTC CAL is ready for use (no preparation is required). The volume per vial is 2.3 mL. Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: The document does not explicitly state a specific "test set" sample size in terms of number of samples or analytes tested. For stability testing, samples (vials) were subjected to different storage conditions (4°C, -20°C, on-board, open/re-capped). The testing involved "multiple calibrations."
• Data Provenance: The data comes from prospective stability studies conducted by Dade Behring Inc. The text describes how "Calibrator shelf life is determined by comparing results of the product stored at 4℃ with control stored at -20℃" and that "Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc." The studies were conducted at Dade Behring, Inc., Newark, DE.

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

• This device is a calibrator for a clinical toxicology assay, not an imaging or diagnostic device that typically involves expert interpretation for ground truth.
• For Value Assignment: The "ground truth" (or reference standard) is established by using Methylenedioxymethamphetamine (99% purity) from Cerilliant, Inc. as a primary reference material, and then verified through internal Master Pool lots and Gas Chromatography / Mass Spectrometry (GC/MS) testing. This suggests a rigorous chemical and analytical method for establishing the true concentration, rather than human expert consensus.
• Qualifications: The document does not specify qualifications of individuals performing the GC/MS or Master Pool verification, but it can be assumed that these would be trained analytical chemists or laboratory personnel.

4. Adjudication Method for the Test Set:

• No adjudication method is described, as the performance evaluation relies on objective analytical measurements (recovery percentages, GC/MS results) compared to predefined thresholds, rather than subjective interpretation by multiple human observers.

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:

• No, an MRMC comparative effectiveness study was not done. This device is a calibrator, which provides a known concentration standard for an assay, and does not involve human interpretation or AI assistance in the way a diagnostic imaging device would.

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

• This question is not applicable to a calibrator device. The "device" (calibrator) itself doesn't perform an algorithm or provide a diagnostic output independently. It's a reagent used by an instrument (Dimension Vista™ System) to perform an assay. Its performance is evaluated through its stability and accuracy in providing known concentrations.

7. The Type of Ground Truth Used:

• The ground truth for the calibrator's value assignment is based on gravimetric addition of highly pure reference material (Methylenedioxymethamphetamine, 99% purity from Cerilliant) and verified by Gas Chromatography / Mass Spectrometry (GC/MS) testing and comparison to previously approved Master Pool lots. This is a highly accurate chemical/analytical ground truth.

8. The Sample Size for the Training Set:

• The concept of a "training set" is not directly applicable to a chemical calibrator in the same way it would be for a machine learning algorithm.
• The document describes the preparation of "Master Pool" lots (five levels) which are then used to verify new commercial calibrator lots. While these Master Pools serve a foundational role in establishing acceptable concentration ranges, they are not a "training set" in the AI sense. The number of samples for forming these Master Pools or for verifying them is not specified beyond "Five levels of Master Pool are prepared."

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

• As noted above, a traditional "training set" for an algorithm is not present. However, the foundational "ground truth" for the calibrator's concentration, against which all subsequent production lots are validated, is established through:
  • Gravimetric addition of a precisely weighed, high-purity reference material (Methylenedioxymethamphetamine, 99% pure) to drug-free human urine to create the Master Pools. This is the primary method of establishing the "true" concentration.
  • Verification against previously approved Master Pool lots.
  • Verification using Gas Chromatography / Mass Spectrometry (GC/MS) testing. GC/MS is a highly accurate analytical technique for identifying and quantifying substances.

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The DRUG 3 CAL is an in vitro diagnostic product for the calibration of Cyclosporine (CSA) method on the Dimension Vista™ System.

DRUG 3 CAL is a frozen, liquid, human whole blood hemolysate containing cyclosporine. The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are frozen. The volume for Calibrator A is 2.0 mL per vial and for Calibrator B is 1.5 mL per vial. Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.

Here's an analysis of the provided information regarding the Dimension Vista™ System Drug 3 Calibrator (DRUG 3 CAL - KC430), broken down by your requested categories:

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

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 for Test Set: The document does not explicitly state the specific numerical sample size for the stability testing (e.g., number of vials, number of runs). It mentions "vials are opened/punctured on day zero" and testing on "days 8, 15, 22 and 32 versus freshly opened vials." This implies a prospective design for the open-vial stability studies. For the 12-month shelf life, it refers to "real-time data on file," suggesting a prospective study conducted over time.
• Data Provenance: The document does not specify the country of origin for the data. Given Dade Behring Inc.'s location in Newark, DE, USA, the testing was likely conducted in the United States. The studies are described as prospective, with real-time data for shelf life and specific timelines for open-vial stability.

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: This device is a calibrator material, not an AI/imaging diagnostic device that requires expert interpretation for ground truth. The "ground truth" here is the assigned value of Cyclosporine A, which is established gravimetrically against a reference material (USP Cyclosporine A Reference Material) and verified by LC/MS testing and instrument-based verification.

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 typically used for establishing ground truth in medical imaging or clinical assessment where subjective interpretation is involved. For a calibrator, the "truth" is based on the traceable reference material and quantitative analytical methods, not human consensus.

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

• Not Applicable: This device is a calibrator for an in vitro diagnostic test, not an AI-powered diagnostic tool requiring human readability or interpretation. Therefore, MRMC studies and "human readers improve with AI" metrics are irrelevant.

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

• Yes (inherently): The performance of the calibrator itself is standalone. It's a physical material with defined properties. Its "performance" refers to its stability and its ability to properly calibrate the associated Cyclosporine (CSA) method on the Dimension Vista™ System. The characteristics reported (stability, traceability, bottle value assignment) are intrinsic to the calibrator material and not dependent on human intervention during its use in calibrating the instrument.

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

• Traceable Reference Material and Analytical Methods: The ground truth for the calibrator's values is established through traceability to United States Pharmacopeia (USP) Cyclosporine A Reference Material. This involves:
  • Gravimetric weighing of Cyclosporine Reference Material into drug-free whole blood hemolysate.
  • Verification against weighed-in Master Pool values.
  • Verification by LC/MS testing (Liquid Chromatography-Mass Spectrometry).
  • Verification using an instrument calibrated with Master Pools.

8. The sample size for the training set

• Not Applicable: As a calibrator material, there is no "training set" in the context of machine learning or AI. The product manufacturing involves creating stock solutions and commercial lots using established gravimetric and analytical methods. The stability studies and value assignments are performance validations, not training.

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

• Not Applicable: See point 8. There is no training set for this type of device. The "ground truth" for the calibrator's assigned values is established through the robust analytical methods and traceability described in point 7.

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The Dimension® CSAE Cyclosporine Extended Range Calibrator is an in vitro diagnostic product intended to be used to calibrate the CSAE Cyclosporine Extended range method for the Dimension® clinical chemistry system and the Syva® Emit® 2000 Cyclosporine assay.

The Dimension® CSAE Cyclosporine Extended Range Calibrator contains cyclosporine in a preserved whole blood hemolysate. The kit consists of 2 sets of the following: one vial of sample diluent (0.0 ng/ml of cyclosporine ) and one vial of levels 1 through 5. Target concentrations for the five calibrator levels are approximately 200, 400, 800, 1400 and 2000 ng/ml of cyclosporine.

Level 0 is included for dilution of over-range samples (>2000 ng/mL) in order to obtain results within the assay range; it is not used in calibration. Levels 1 thru 5 are used for calibration of the CSAE method.

The provided text describes the Dimension® CSAE Cyclosporine Extended Range Calibrator (DC108A), a calibrator material used for the Syva® Emit® 2000 Cyclosporine assay and the Dimension® clinical chemistry system. The submission (K061503) concludes that the new device is substantially equivalent to a predicate device based on performance testing.

Here's an analysis of the acceptance criteria and study information provided, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for performance metrics like accuracy, precision, or detection limits typically associated with diagnostic devices. Instead, the performance characteristic described is stability, which is crucial for a calibrator material. The acceptance hinges on demonstrating that the new calibrator is "substantially equivalent" to its predicate device. This implies that the stability of the new device must be comparable to or meet the requirements that the predicate device satisfied for its clearance.

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

• Sample Size for Test Set: For stability studies, three (3) lots of product were used. Each lot was tested at 14 different time points over 13 months. This is a prospective study design for real-time stability.
• Data Provenance: Not explicitly stated, but given that Dade Behring Inc. is located in Newark, DE (USA), and the calibrator is manufactured in Glasgow, Delaware, it is highly likely that the data was generated in the USA and retrospectively analyzed for the submission, though the studies themselves were prospectively conducted over time (real-time stability).

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

This information is not applicable and not provided for this device submission. This device is a calibrator material, which means its "ground truth" (i.e., the true concentration of cyclosporine) is established through analytical chemistry methods, not expert human interpretation of medical images or clinical outcomes. The ground truth for calibrators is typically formed by:

• Primary Reference Materials: Using highly pure, certified reference materials (e.g., Novartis Pharmaceutical USP Grade CSA powder).
• Reference Methods: Using highly accurate and precise analytical methods (e.g., LC/MS/MS).

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where subjective human interpretation needs to be reconciled (e.g., radiologists interpreting images). For a chemical calibrator, the "ground truth" (target concentration) is determined analytically, not through human consensus.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided. This is a submission for a chemical calibrator, not a diagnostic imaging or AI-enabled device that would involve human readers or AI assistance.

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

This information is not applicable and not provided. This device is a chemical calibrator, and there is no algorithm or AI component involved. Its performance is evaluated through analytical testing.

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

The ground truth for the cyclosporine concentrations within the calibrator is established by:

• Primary Reference Material: Novartis Pharmaceutical USP Grade CSA powder.
• Definitive Analytical Method: LC/MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry). This is considered a highly accurate and precise method for quantifying drug concentrations, serving as the "gold standard" or definitive truth for chemical assays.
• Gravimetric Procedures: For preparing stock solutions.

8. The Sample Size for the Training Set

This information is not applicable and not provided. Calibrators are not "trained" in the way an algorithm or AI model would be. Their formulation and value assignment are based on established chemical and analytical principles.

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

This information is not applicable and not provided for the reasons stated in point 8.

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The Dimension® TACR Calibrator is an in vitro diagnostic product intended to be used to calibrate the Tacrolimus (TACR) method for the Dimension® clinical chemistry system.

The Dimension® TACR Calibrator is a stabilized human whole blood hemolysate product containing tacrolimus. The kit consists of two vials of each calibrator level 1-5. The target concentrations are approximately 0, 3, 6, 12, 32.5 ng/mL tacrolimus.

The provided text describes the 510(k) summary for the Dimension® TACR Calibrator. However, it does not contain the specific details required to fully address your request regarding acceptance criteria, study results, sample sizes, expert qualifications, or ground truth establishment.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not contain any explicit acceptance criteria or reported device performance data. It focuses on the device description, intended use, and substantial equivalence to a predicate device. For diagnostic/calibrator devices, acceptance criteria would typically involve metrics like accuracy, precision, linearity, stability, and possibly bias relative to a reference method, but these are not present in this summary.

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

The document does not mention any specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective study) from primary performance studies.

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

The document does not describe the establishment of ground truth by experts for a test set. As a calibrator, its "ground truth" would likely be the reference concentration of tacrolimus used in its manufacturing, not expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set:

Since no test set or expert evaluation is described, there is no mention of an adjudication method.

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

A MRMC study involves human readers interpreting cases, often with and without AI assistance, to assess the AI's impact on human performance. This type of study is not applicable to a device like the Dimension® TACR Calibrator, which is an in vitro diagnostic calibrator and not an AI-powered diagnostic imaging tool. Therefore, no such study was performed or is relevant here, and no effect size for human improvement with AI is mentioned.

6. Standalone (Algorithm Only) Performance:

The Dimension® TACR Calibrator is a physical product (stabilized human whole blood hemolysate containing tacrolimus) used to calibrate an instrument. It is not an algorithm or software that would have "standalone performance" in the way an AI diagnostic tool would. Its performance is related to its ability to accurately provide known concentrations for calibration. The document does not present any standalone performance data in terms of accuracy, precision, etc., but rather focuses on its composition and intended use.

7. Type of Ground Truth Used:

The "ground truth" for a calibrator like this would be the known, manufactured concentrations of tacrolimus in each calibrator level. The document states: "The target concentrations are approximately 0, 3, 6, 12, 32.5 ng/mL tacrolimus." This indicates the intended values used for calibration. It's not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set:

This device is a calibrator, not a machine learning model that requires a "training set" of data in the conventional sense. The concept of a training set does not apply here.

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

As there is no training set, this question is not applicable. The "ground truth" (target concentrations) for the calibrator itself would be established through a carefully controlled manufacturing process using highly accurate reference materials and methods.

Summary of Missing Information in the Provided Text:

The provided 510(k) summary is a high-level regulatory document intended to demonstrate substantial equivalence, not a detailed scientific study report. It specifically lacks:

• Quantitative acceptance criteria for the calibrator's performance.
• Results from any performance studies (e.g., accuracy, precision, stability).
• Details on test sets, sample sizes, or data provenance for performance evaluation.
• Information on expert involvement or ground truth establishment related to diagnostic accuracy, as it's a calibrator.

To get the detailed information you are seeking regarding performance metrics and study specifics for the Dimension® TACR Calibrator, you would typically need to consult the full submission to the FDA, product manuals, or other technical documentation that would be more extensive than this 510(k) summary.

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The CSAE Calibrator is an in vitro diagnostic product intended to be used to calibrate the Dimension® clinical chemistry system Cyclosporine Fr, it® 2000 Cyclosporine Specific Assay.

The Dimension® CSAE Cyclosporine Extended Range Calibrator contains cyclosporine in a preserved whole blood hemolysate. The kit consists of one vial of each calibrator level 0-5. The target concentrations of the calibrator levels are approximately 0, 200, 400, 800, 1400 and 2000 ng/mL of cyclosporine. Level 0 is used for dilution of over-range samples (>2000 ng/mL) in order to obtain Lover o lood for analyange; it is not used in calibration. Levels 1 through 5 are used for calibration of the CSAE Cyclosporine Extended range method for the Dimension® clinical chemistry system or the Syva® Emit® 2000 Cyclosporine Specific Assay.

The provided text is a 510(k) Premarket Notification for a medical device (Dimension® CSAE Cyclosporine Extended Range Calibrator). This type of document is administrative and regulatory, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the way a clinical trial report would.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication methods, and MRMC studies is not contained within the provided document. The document describes the device, its intended use, and claims equivalence to a previously cleared calibrator, but it does not detail a study proving specific performance metrics against pre-defined acceptance criteria.

To directly address your request given the provided text:

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

• Information not provided in the document. The document does not define specific performance acceptance criteria (e.g., accuracy, precision targets) for the calibrator, nor does it report performance metrics against such criteria. It states that the device is "substantially equivalent" to a predicate device.

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

• Information not provided in the document. There is no mention of a test set, sample size, or data provenance.

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)

• Information not provided in the document. The concept of "ground truth" as it applies to an image analysis or diagnostic AI device (along with experts to establish it) is not relevant to a calibrator for a clinical chemistry assay, and therefore, this information is not present.

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

• Information not provided in the document. Adjudication methods are not applicable to the assessment of a calibrator's performance described in this type of regulatory submission.

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

• Information not provided in the document. MRMC studies are not applicable to a calibrator. This type of study is relevant for diagnostic imaging AI tools that assist human readers.

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

• Information not provided in the document. This question is not applicable to a calibrator. The calibrator itself is a reagent used in an automated clinical chemistry system.

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

• Information not provided in the document. "Ground truth" in the context of calibrators typically refers to the accurately assigned values of the analytes (cyclosporine in this case) within the calibrator vials. The document states the "target concentrations" are approximately 0, 200, 400, 800, 1400, and 2000 ng/mL, but it does not describe how these precise ground truth values were established methodologically for validation purposes.

8. The sample size for the training set

• Information not provided in the document. The concept of a "training set" is not applicable to a chemical calibrator.

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

• Information not provided in the document. Not applicable.

In summary, this 510(k) submission focuses on regulatory equivalence for a chemical calibrator and does not contain the detailed clinical study performance data or methodology typically found for diagnostic AI devices, which your questions are geared towards.

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The Dimension® CSAE Cyclosporine Extended Range Calibrator is an in vitro diagnostic product intended to be used to calibrate the CSAE Cyclosporine Extended range method for the Dimension® clinical chemistry system.

The Dimension® CSAE Cyclosporine Extended Range Calibrator contains cyclosporine in a preserved whole blood hemolysate. The kit consists of 2 sets of the following: one vial of sample diluent (0.0 ng/ml of cyclosporine) and one vial of levels 1 through 5. The target concentrations for the five calibrator levels are approximately 200, 400, 800, 1400 and 2000 ng/ml of cyclosporine. Level 0 is included for dilution of over-range samples (>2000 ng/mL) in order to obtain a result; it is not used in calibration. Levels 1 thru 5 are used for calibration of the CSAE method. Refer to the method insert sheet for instructions on calibration and making appropriate manual dilutions.

The provided document describes the acceptance criteria and a study to prove the Dimension® Extended Range Cyclosporine Calibrator meets these criteria.

Acceptance Criteria and Reported Device Performance

Study Details

Due to the nature of the device (a calibrator material) and the provided 510(k) summary, the study described is not a typical clinical performance study involving human readers or patient outcomes, but rather a stability and value assignment study to ensure the calibrator's accuracy and reliability.

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

   • Sample Size: The document mentions that the product (calibrator) was tested at various time points (0, 7, 14, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 390 days) during its testing cycle. The control material was tested at the same frequency. These time points represent the "samples" for the stability study. The calibrator itself consists of 5 levels (plus a diluent level 0), meaning each "sample" involves testing these 5 levels at each time point.
   • Data Provenance: Not explicitly stated but implied to be generated in-house through laboratory testing by Dade Behring Inc. The study is prospective in nature, as it involves real-time monitoring of the product's stability over an extended period.

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

   • This question is less applicable to a calibrator device. The "ground truth" for calibrators is primarily established through analytical and metrological traceability, not expert consensus on diagnostic interpretation.
   • Traceability: The document states that Novartis Pharmaceutical Grade CSA powder was used to formulate a reference stock solution, and its concentration was assigned by HPLC. A reference lot was then formulated and assigned by LC/MS/MS. This establishes the highly accurate "ground truth" values for the cyclosporine concentrations.
   • Qualifications: While not explicitly mentioned for the individual performing the HPLC or LC/MS/MS, these are standard analytical chemistry techniques that would be performed by qualified laboratory scientists with expertise in these methods.

3. 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 involving human interpretation (e.g., radiology reads) where there might be disagreement among experts. For an analytical calibrator, the ground truth is established chemically and instrumentally, not through subjective human interpretation requiring adjudication.

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 device is a calibrator for a clinical chemistry system, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.

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

   • Yes, in a sense. The "standalone performance" of the calibrator is its ability to maintain its assigned values over time (stability) and for its assigned values to be accurate (traceability and value assignment). The performance characteristics section (L) directly addresses this for the calibrator itself, independent of operator interaction after its initial formulation and validation.

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

   • The ground truth for the calibrator's concentrations is established through analytical and metrological techniques, specifically:
     • HPLC (High Performance Liquid Chromatography) for the initial stock solution concentration.
     • LC/MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) for assigning the reference lot values.
     • Gravimetric procedures for preparing the cyclosporine stock solution.

7. The sample size for the training set:

   • Not applicable in the conventional sense of an AI/machine learning model's training set. For a calibrator, the "training" analogous process is its initial development, formulation, and rigorous characterization to ensure its stability and accurate value assignment. The document describes the process of preparing stock solutions and calibrator levels using controlled methods, which is a form of "training" or establishment of the product.

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

   • As mentioned above, the "ground truth" (i.e., the target concentrations of cyclosporine for each calibrator level) was established through:
     • Preparation of a cyclosporine stock solution using standard gravimetric procedures.
     • Confirmation of the stock solution concentration using HPLC.
     • Aliquots of this stock solution were then added to measured amounts of calibrator matrix (preserved whole blood hemolysate) to achieve the desired concentrations for each calibrator level.
     • The recovery of these levels was verified against a control calibrator lot and a frozen reference lot, with the reference lot assigned by LC/MS/MS.

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LabOne Micro-Plate Cotinine EIA is a competitive micro-plate immunoassay for the qualitative and semi-quantitative determination of cotinine in oral fluid collected with the OraSure® Oral Fluid Specimen Collection Device. LabOne Micro-Plate Cotinine EIA is used as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine. The test is for in Vitro use only.

The LabOne Microplate Cotinine Calibrators are a device intended for medical purposes for use with the LabOne Microplate Cotinine assay to establish points of reference that are used in determination of values in the measurement of cotinine in saliva.

The LabOne Microplate Cotinine Controls are intended for use as an assayed quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for cotinine.

LabOne Micro-Plate Cotinine EIA is a solid phase competitive enzyme immunoassay for the qualitative and semi-quantitative analysis of cotinine in oral fluid specimens collected with the OraSure® Oral Specimen Collection Device.

The provided text describes a 510(k) summary for the LabOne Micro-Plate Cotinine EIA, which is a device for detecting cotinine in oral fluid. However, the document does NOT contain detailed information about specific acceptance criteria and the comprehensive study results to "prove" the device meets them in the way described by the requested table and points.

Specifically, the document states:
"Performance characteristic studies on precision, analytical sensitivity, interference and antibody cross-reactivity showed that the LabOne Micro-Plate Cotinine EIA is substantially equivalent to the OraSure Micro-Plate Cotinine EIA."
And:
"Results tested from self-claimed patient specimens and diluted samples with both the LabOne Micro-Plate Cotinine EIA and the OraSure Micro-Plate Cotinine EIA also showed that the sample results from this two test systems are substantially equivalent when using self-claimed specimen results and urine results as references."

This indicates that studies were performed, but the actual acceptance criteria (e.g., minimum sensitivity, specificity, or precision values) and the specific reported device performance values for these criteria are not provided in the summary. The core of the submission is to demonstrate "substantial equivalence" to a predicate device (OraSure Micro-Plate Cotinine EIA, K974234), rather than proving it meets standalone, predefined performance metrics with detailed study data.

Therefore, many of your requested points cannot be directly extracted from the provided text.

Here's an attempt to answer what can be inferred from the document, along with explanations for what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document focuses on declaring substantial equivalence to the predicate device, K974234. It states that "performance characteristic studies on precision, analytical sensitivity, interference and antibody cross-reactivity showed that the LabOne Micro-Plate Cotinine EIA is substantially equivalent" and that "sample results from this two test systems are substantially equivalent when using self-claimed specimen results and urine results as references." However, the specific quantitative acceptance criteria (e.g., "precision CV

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