Search Results

The TROP method is used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to quantitatively measure cardiac troponin-1 in human serum and plasma. Measurements of TROP aid in the diagnosis of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

The TROP method is a one-step enzyme immunoassay. Sample is incubated with chromium dioxide particles (CrOz) coated with a monoclonal antibody specific for cardiac troponin-1 and conjugate reagent [alkaline phosphatase (ALP) labeled monoclonal antibody specific for cardiac troponin-I] to form a particle/cardiac troponin-I/conjugate sandwich. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ALP initiates an amplification cascade. ALP dephosphorylates synthetic flavin adenine dinucleotide phosphate (FADP) to give FAD. FAD binds to APO D-amino acid oxidase and converts it to active holo D-amino acid oxidase. Each molecule of holo D-amino acid oxidase then produces multiple molecules of hydrogen peroxide (H2O2), which in the presence of horseradish peroxidase (HRP), converts 3,5-dichloro-2-hydroxybenzenesulfonic acid (DCHBS) and 4-aminoantipvrine (4-AAP) to a colored product that absorbs at 510nm. The color measured is directly proportional to the concentration of cardiac troponin-I present in the patient sample.

Here's a breakdown of the acceptance criteria and the study proving 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

• Sample Size: 111 clinical patient samples.
• Data Provenance: The document does not explicitly state the country of origin. It refers to "clinical patient samples," implying they were obtained from a clinical setting, likely in the US given the FDA submission. The study is retrospective in the sense that these were pre-existing patient samples used for comparison.

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

The document does not describe the use of experts to establish a "ground truth" for the test set in the traditional sense of diagnostic imaging or clinical interpretation.

For this type of in vitro diagnostic (IVD) device, the "ground truth" for the comparison study is the measurement result from the predicate device (Stratus® Cardiac Troponin-I assay). The performance of the new device is being compared against the established performance of the predicate. Therefore, the "experts" in this context would be the developers and regulatory approvers of the predicate device, although their specific qualifications are not detailed in this document.

4. Adjudication Method for the Test Set

No adjudication method is described. As mentioned above, the comparison is against the predicate device's results, not an independent assessment by experts requiring 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

This is an in vitro diagnostic (IVD) device designed for quantitative measurement of a biomarker in serum/plasma. It is not an imaging or AI-assisted diagnostic device that involves human readers or interpretation of complex medical cases. Therefore, an MRMC study is not applicable and was not performed.

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

This refers to the performance of the device itself (the TROP method on the Dimension® RxL system) without human interpretation affecting the measurement of troponin-I. The comparison study is a standalone performance assessment of the new IVD device against an existing one. The results of the new device are directly compared to the results of the predicate device.

7. The Type of Ground Truth Used

For this comparison study, the ground truth is the quantitative measurement of cardiac troponin-I provided by the predicate device (Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay). The objective was to show that the new device produces results that are highly correlated and comparable to the predicate.

8. The Sample Size for the Training Set

The provided summary does not detail a "training set" in the context of machine learning or AI models. This is a traditional IVD device comparison. The method itself was likely developed and calibrated using internal data, but that is not referred to as a "training set" in this document.

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

Since there is no "training set" described in the context of the 510(k) submission for an AI/ML device, this question is not directly applicable. For the development of an IVD, the initial calibration and development of the assay would typically rely on:

• Reference standards: Materials with known concentrations of cardiac troponin-I.
• Spiked samples: Healthy samples to which known amounts of troponin-I are added.
• Clinical samples: Samples from patients with known clinical diagnoses (e.g., confirmed MI) to evaluate clinical performance and establish reference ranges.

However, the specific details of this initial development and calibration are not part of the 510(k) substantial equivalence comparison provided.

Ask a specific question about this device

The PSA Control is an in vitro diagnostic product intended to be used as a quality control product for the Prostate Specific Antigen (PSA) method on the aca® plus immunoassay system and Dimension® clinical chemistry system with the heterogeneous immunoassay module.

PSA Control is a frozen product containing human PSA-ACT in a bovine serum albumin base. The kit consists of twelve vials, six at each of two levels, containing 5 mL each.

This submission is for a quality control product, the Prostate Specific Antigen (PSA) Control, rather than a diagnostic or therapeutic medical device in the typical sense that would involve patient data, expert interpretations, or specific performance metrics like sensitivity and specificity. Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable.

The "study" in this context is a comparison of the new device to a predicate device to establish substantial equivalence.

Here's an adaptation of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Study Information (as applicable to this 510(k) submission):

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

  • This is a premarket notification (510(k)) that establishes substantial equivalence based on comparison to a predicate device, rather than a clinical trial with a "test set" of patient data for performance evaluation.
  • The "sample" here refers to the characteristics of the device itself and its predicate. The text states the new device consists of "twelve vials, six at each of two levels, containing 5 mL each." This describes the product's packaging.
  • The "study" is a comparison of product specifications and characteristics, not a clinical study involving patients or a test set in the traditional sense.
  • Data Provenance: The data comes from the specifications and characteristics of the new device (Dimension® RxL PSA Control) and its predicate (aca® plus PSA Control), provided by Dade International Inc. There is no mention of country of origin for validation data as it's a product comparison. It is considered a prospective submission of information about a new product for regulatory review.

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

  • Not applicable. Ground truth for a quality control product's substantial equivalence is established by comparing its physical, chemical, and intended use characteristics to a legally marketed predicate, rather than through expert interpretation of clinical results. The "experts" involved are the manufacturer's R&D/regulatory personnel who designed and characterized the device, and the FDA reviewers who assessed the submission.

• 4. Adjudication Method for the Test Set:

  • Not applicable. There is no "test set" requiring adjudication in this type of submission. The comparison is objective, based on product 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:

  • Not applicable. This is a quality control product, not an AI-powered diagnostic device, and it does not involve human readers interpreting results.

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

  • Not applicable. This is a physical quality control reagent, not an algorithm or AI system.

• 7. The Type of Ground Truth Used:

  • The "ground truth" for this substantial equivalence claim is the legally marketed predicate device (aca® plus PSA Control) and its established characteristics and performance. The new device's specifications (analyte, matrix, volume, levels, intended use) are compared directly to this predicate.

• 8. The Sample Size for the Training Set:

  • Not applicable. This is a quality control product comparison, not a machine learning model, 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 training set.

Ask a specific question about this device

The PSA Calibrator is an in vitro diagnostic product intended to be used to calibrate the Prostate Specific Antigen (PSA) method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassy module. This product was designed to meet the needs of users to assure accurate results over the assay range of this method.

Prostate Specific Antigen (PSA) Calibrator for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module is a frozen product. The Level 1 calibrator is horse serum based with no detectable PSA. Levels 2 through 5 contain human PSA-ACT in a bovine serum albumin base. The kit consists of ten vials; two at each of five levels, containing 1 mL each.

This document is a 510(k) premarket notification for a medical device called "Prostate Specific Antigen (PSA) Calibrator". It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way a clinical study for a diagnostic algorithm would.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than proving performance against acceptance criteria for a novel device.

Therefore, many of the requested items cannot be answered from the provided text as they pertain to a type of study that was not conducted or documented here.

Here's a breakdown based on the information provided:

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

This information is not present in the document. The document describes a comparison to a predicate device, not a performance study against predefined acceptance criteria for a novel device.

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

This information is not present. No test set or clinical study data is provided.

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 information is not present. No test set requiring ground truth establishment is described.

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

This information is not present. No test set requiring adjudication 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes a calibrator for a clinical chemistry system, not an AI-assisted diagnostic device.

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

A standalone performance study was not done in the context of an algorithm. This device is a calibrator, a reagent used to ensure the accuracy of an analytical instrument. Its performance is evaluated through its ability to calibrate the instrument, not as a standalone diagnostic algorithm.

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

This information is not present. The concept of "ground truth" for a calibrator is related to the accuracy of the analyte concentration within the calibrator itself, typically established through reference methods or certified reference materials, but this specific detail is not provided.

8. The sample size for the training set

This information is not present. There is no mention of a training set as this is not an AI/algorithm-based device.

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

This information is not present. As there is no training set, this question is not applicable.

Summary of what the document does provide:

• Device Name: Prostate Specific Antigen (PSA) Calibrator
• Intended Use: To calibrate the PSA method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.
• Predicate Device: aca® plus Prostate Specific Antigen Calibrator
• Comparison to Predicate Device: The document highlights similarities in intended use, analyte (PSA-ACT), matrices (horse serum, BSA), and states that both are manufactured using the same matrices and contain PSA-ACT as the analyte source.
• Conclusion: The PSA Calibrator for the Dimension® RxL system is substantially equivalent to the aca® plus PSA Calibrator.

This document serves as a regulatory submission (510(k)) to demonstrate that the new device is as safe and effective as a legally marketed predicate device, rather than providing detailed performance studies against specific acceptance criteria for a novel technology.

Ask a specific question about this device

The PSA method for the Dimension® RxL with the heterogeneous immunoassay module is a device used to measure PSA in serum as an aid in the management of prostate cancer patients.

The PSA method is a one-step enzyme immunoassay. Sample is incubated with chromium dioxide particles (CrO2) coated with monoclonal antibodies specific for a binding site on the PSA molecule and conjugate reagent [β-galactosidase (β-gal) labeled monoclonal antibodies specific for a second binding site on the PSA molecule] to form a particle/PSA/conjugate sandwich. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ß-gal catalyzes the hydrolysis of chlorophenol red-β-d galactopyranoside (CPRG) to chlorophenol red (CPR). The color change measured at 577nm due to the formation of CPR is directly proportional to the concentration of PSA present in the patient sample.

Here's a breakdown of the acceptance criteria and study details for the Dade International Prostate Specific Antigen (PSA) Method, based on the provided document:

Acceptance Criteria and Reported Device Performance

The core of the acceptance criteria for this 510(k) submission is substantial equivalence to the predicate device, the aca® plus PSA Test Kit. This is primarily demonstrated by a strong correlation in performance.

Study Details

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

• Sample Size: 596 clinical patient samples.
• Data Provenance: The document does not explicitly state the country of origin. It refers to "clinical patient samples," implying real-world patient data. Given the submitter's location (Newark, DE, USA) and the FDA submission, it's highly probable the data is from the USA. The study design is retrospective as it involves "split sample comparison," meaning existing samples were tested on both devices.

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

• The document does not mention a number of experts or their qualifications for establishing ground truth. The "ground truth" in this context is implicitly the measurement from the predicate device (aca® plus PSA Test Kit). The comparative study focuses on the agreement between the new device and the predicate device.

4. Adjudication method for the test set:

• None explicitly stated in the context of expert adjudication. The study is a direct comparison of results between two devices on the same samples.

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 is an in vitro diagnostic (IVD) device for quantitative measurement, not an imaging device or one that involves human (reader) interpretation in the same way an AI-assisted diagnostic tool might. The "readers" here are laboratory instruments, and the comparison is between the instrument's output.

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

• Yes, the performance described is a standalone performance study. The device (Dimension® RxL PSA method) directly measures PSA levels. The comparison is between the output of this automated method and the output of the predicate automated method, without any human 'in-the-loop' interpretation influencing the quantitative result.

7. The type of ground truth used:

• The ground truth used for performance comparison is the results obtained from the legally marketed predicate device, the aca® plus PSA Test Kit. This is a common method for demonstrating substantial equivalence for IVDs. The "clinical status of the patient" is mentioned as being consistent with the data, but the primary ground truth for the statistical comparison is the predicate's measurement.

8. The sample size for the training set:

• The document does not mention a separate training set. As this is an immunoassay (chemical detection) method, rather than a machine learning/AI algorithm, the concept of a "training set" for the device itself is not directly applicable in the same way it would be for an AI-based diagnostic. The device's operational parameters and calibration would be established through internal development and validation, but this document focuses on its performance using a clinical test set against a predicate.

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

• Not applicable in the context of a "training set" for an AI algorithm. For the development and internal validation of the immunoassay method, the ground truth would typically be established through highly characterized reference materials, spiked samples, and potentially clinical samples with established PSA levels using recognized reference methods or established assays. However, this level of detail is not provided in a 510(k) summary for an immunoassay.

Ask a specific question about this device

The FT4 Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module is used to quantitatively measure free thyroxine (FT4) in human serum and heparinized plasma.

The FT4 assay is a two-step competitive enzyme immunoassay. Sample is incubated with chromium dioxide particles, coated with monoclonal antibodies specific for FT4 to form a particle/T4 complex. Particles are separated magnetically and the supernatant removed. The particle/T4 complex is incubated with conjugate reagent to react with unoccupied binding sites on the particles. Unbound conjugate is removed by washing. The bound alkaline phosphatase triggers an amplification cascade, resulting in the formation of a colored product. The color change measured at 510nm is inversely proportional to the concentration of free thyroxine present in the patient sample.

Here's a breakdown of the acceptance criteria and study information for the Dade International Inc. FT4 Method for the Dimension® RxL Clinical Chemistry System, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: 156 clinical patient samples.
   • Data Provenance: The document does not specify the country of origin, but refers to "clinical patient samples," implying human samples. It's a retrospective comparison, as it involved existing samples.

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

   • This information is not provided in the given text. For an immunoassay, the "ground truth" would typically refer to the reference method result against which the new device is compared.

3. Adjudication Method for the Test Set:

   • This information is not applicable to this type of study which is comparing a new device to a predicate device. Adjudication methods like 2+1 or 3+1 are common in studies involving human interpretation of images or symptoms, where discrepancies need to be resolved. This study focuses on quantitative measurement agreement.

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

   • No, an MRMC study was not done. This study is a "split sample comparison" between the new FT4 method and a predicate device (Abbott Imx® Free T4 assay). MRMC studies are typically used for diagnostic imaging or interpretation tasks where multiple human readers assess cases.

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

   • Yes, this is effectively a standalone performance study. The device itself is an automated clinical chemistry system. The comparison is between the quantitative output of the new device and the quantitative output of the predicate device, both operating as automated systems. There is no human "loop" being evaluated in this context.

6. The Type of Ground Truth Used:

   • The "ground truth" in this context is the results obtained from the predicate device (Abbott Imx® Free T4 assay). The study establishes equivalence to an already approved and accepted method, using its results as the comparative standard.

7. Sample Size for the Training Set:

   • This information is not explicitly provided. Immunoassays are typically developed and validated using a range of samples during their design phase, but the document focuses on the validation against the predicate, not the training of the assay itself.

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

   • As the training set size and details are not provided, how its ground truth was established is also not detailed. For an immunoassay, the "ground truth" for training would involve characterizing the assay's response to known concentrations of the analyte (FT4) and optimizing its components and procedures.

Ask a specific question about this device

The HCG method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module is used to quantitatively measure intact hCG in serum and plasma, for the early detection of pregnancy.

The HCG method for the Dimension® RxL system with the heterogeneous immunoassay module is a two-step enzyme immunoassay based on the "sandwich" principle. Sample is incubated with chromium dioxide particles coated with monoclonal antibodies specific for the hCG alpha subunit to form a particle/hCG complex. Particles are separated magnetically and the supernatant removed. The particle/hCG complex is incubated with conjugate reagent (β-galactosidase labeled monoclonal antibodies specific for the hCG beta subunit) to form a particle/hCG/conjugate sandwich. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ß-galactosidase is combined with the chromogenic substrate chlorophenol red-ß-d-galactopyranoside (CPRG) and catalyzes the hydrolysis of CPRG to the chromophore chlorophenol red (CPR). The concentration of hCG in the patient sample is directly proportional to the rate of color change measured at 577nm due to formation of CPR.

The provided text is a 510(k) summary for a medical device (Human Chorionic Gonadotropin Method for the Dimension RxL system) and does not describe acceptance criteria for performance, nor does it detail a study proving the device meets specific acceptance criteria in the way a clinical trial or a more extensive validation report would.

The document focuses on demonstrating substantial equivalence to a predicate device, the Abbott IMx® hCG. This is a common regulatory pathway for medical devices seeking FDA clearance.

Here's an analysis based on the information provided, framed to address your questions where possible, and noting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state pre-defined acceptance criteria in terms of sensitivity, specificity, accuracy, or other performance metrics. Instead, it presents a comparison to a predicate device as the primary measure of performance and equivalence.

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

• Sample Size for Test Set: 134 clinical patient samples.
• Data Provenance: The text states "clinical patient samples." It does not specify the country of origin. It is a retrospective comparison, as samples were collected and then split for testing on both devices.

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

• This information is not provided. The "ground truth" in this context is implicitly the measurement from the predicate device (Abbott IMx® hCG), as the study aims to show equivalence to it, not an absolute truth established by external experts or pathology.

4. Adjudication Method for the Test Set:

• This information is not applicable/provided in the context of this type of comparison study. There was no adjudication process described for establishing ground truth; the predicate device's result was the comparison standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No, an MRMC comparative effectiveness study was not done. This study is an analytical performance comparison between two diagnostic assays, not an assessment of human reader performance with or without AI assistance. The device is an automated chemistry system, not an AI-assisted diagnostic tool for human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Yes, effectively. The study described is a comparison of the automated performance of the "HCG method for the Dimension® RxL system" in a standalone capacity (algorithm only, as it's an automated immunoassay) against another automated system (Abbott IMx® hCG). There is no "human-in-the-loop" component in the direct operation or result generation of these chemistry systems.

7. The Type of Ground Truth Used:

• The "ground truth" for the comparison in this study was the measurement obtained from the predicate device (Abbott IMx® hCG) for the same split patient samples. The study's goal was to demonstrate that the new device's measurements correlated strongly with those of the established predicate device.

8. The Sample Size for the Training Set:

• Not provided. This document describes a validation study (comparison to predicate), not the development of a machine learning model, which would typically involve a training set. The HCG method for the Dimension® RxL system is an immunoassay, not an AI/ML algorithm that requires a "training set" in the computational sense.

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

• Not applicable. As stated above, this is not an AI/ML device, so there is no "training set" in that context.

Ask a specific question about this device

The MMB Calibrator is intended to be used to calibrate the MMB method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.

The MMB Calibrator is a lyophilized horse serum-based product. The Level 1 calibrator contains no detectable CKMB. Levels 2 through 5 contain human CKMB. The kit consists of ten vials; two at each of five levels.

The provided text is a summary of safety and effectiveness information for the MMB Calibrator, a medical device used to calibrate a clinical chemistry system for CKMB (Creatine Kinase-MB) testing. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for a diagnostic performance. Therefore, I cannot provide the requested information.

The document does not contain:

• A table of acceptance criteria and reported device performance.
• Details about sample size, data provenance, number of experts, or adjudication methods for a test set.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• The type of ground truth used.
• Sample size for a training set or how its ground truth was established.

The document primarily describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence based on similar characteristics like intended use, analytes, and general nature as a calibrator.

Ask a specific question about this device

The TSH method is used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to quantitatively measure TSH in human serum and plasma. Measurements of TSH aid in the diagnosis of thyroid or pituitary disorders.

The TSH method is a one-step enzyme immunoassay. Sample is incubated with chromium dioxide particles (CrO2) coated with monoclonal antibodies specific for the intact TSH molecule and conjugate reagent [alkaline phosphatase (ALP) labeled monoclonal antibodies specific for the TSH beta subunit] to form a particle/TSH/conjugate sandwich. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ALP initiates an amplification cascade. ALP dephosphorylates synthetic flavin adenine dinucleotide phosphate (FADP) to give FAD. FAD binds to APO d-amino acid oxidase and converts it to active holo d-amino acid oxidase. Each molecule of holo d-amino acid oxidase then produces multiple molecules of hydrogen peroxide (H2O2), which in the presence of horseradish peroxidase (HRP), converts 3,5-dichloro-2-hydroxybenzenesulfonic acid (DCHBS) and 4-aminoantipyrine (4-AAP) to a colored product that absorbs at 510nm. The color measured is directly proportional to the concentration of TSH present in the patient sample.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study, formatted as requested:

Acceptance Criteria and Device Performance

This document describes a diagnostic device, the Dade International TSH Method, and its comparison to a predicate device, the Abbott AxSYM® Ultrasensitive hTSH. The primary way the device demonstrates equivalence and thus performance is through a direct comparison study against this predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

The study described is a split sample comparison between the Dade International TSH method on the Dimension® RxL clinical chemistry system and the Abbott AxSYM® Ultrasensitive hTSH assay.

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

• Sample Size for Test Set: 86 clinical patient samples.
• Data Provenance: The document refers to "clinical patient samples." It does not specify the country of origin. The study appears to be retrospective in nature, as it uses existing patient samples for comparison.

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

• Not Applicable. This type of diagnostic device (immunoassay) is not typically evaluated by human experts establishing "ground truth" in the same way an image analysis AI might be. Instead, the "ground truth" for comparison is established by the performance of the predicate device, which is an already FDA-cleared and accepted diagnostic tool. The performance of the predicate device is considered the reference standard in this context.

4. Adjudication Method for the Test Set

• Not Applicable. As the comparison is between two automated diagnostic assays, there is no human adjudication process involved in resolving discrepancies between results. The raw measurements from both devices are compared statistically.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This is not an MRMC study. MRMC studies are typically used for evaluating the effectiveness of AI in assisting human readers in interpreting medical images. This study evaluates an automated diagnostic assay's performance against a predicate device.

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

• Yes. This study evaluates the standalone performance of the Dade International TSH Method (the "algorithm only") by comparing its output directly to the output of the predicate device. There is no human intervention in the result generation or interpretation for either device within this comparison.

7. The Type of Ground Truth Used

• Predicate Device Performance: The "ground truth" in this context is established by the results obtained from the Abbott AxSYM® Ultrasensitive hTSH assay, which serves as the reference standard. This is a common approach for demonstrating substantial equivalence for new diagnostic devices.

8. The Sample Size for the Training Set

• Not specified/Not applicable for this type of submission. This document describes a traditional immunoassay, not a machine learning or AI algorithm that would typically involve a "training set" for model development. The development process for an immunoassay involves reagent optimization, calibration, and validation, rather than machine learning training.

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

• Not applicable. As stated above, there is no "training set" in the context of an AI/ML algorithm for this specific device and submission type. The "ground truth" for the predicate comparison is the predicate device's output.

Ask a specific question about this device

The HCG Calibrator is intended to be used to calibrate the HCG method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.

The Human Chorionic Gonadotropin (HCG) Calibrator for the Dimension® RxL system is a lyophilized horse serum-based product. The Level 1 calibrator contains no detectable hCG. Levels 2 through 5 contain human unne chorionic gonadotropin. The kit consists of ten vials; two at each of five levels.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Human Chorionic Gonadotropin Calibrator:

The provided document is a 510(k) summary for a medical device called "Human Chorionic Gonadotropin Calibrator." It is not a study that proves a device meets acceptance criteria in the sense of a diagnostic algorithm or AI system. Instead, it's a submission for regulatory clearance based on substantial equivalence to a predicate device.

Therefore, many of the requested categories related to algorithm performance, sample sizes for training/test sets, expert ground truth, MRMC studies, and standalone performance are not applicable to this type of regulatory submission. The "acceptance criteria" here refer to demonstrating that the new calibrator is equivalent to an existing, legally marketed calibrator.

Here's the breakdown based on the provided information, noting where sections are not applicable:

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

For a calibrator, "acceptance criteria" revolve around its intended use and composition being comparable to a predicate device. The "performance" is implicitly its suitability for calibrating an assay, which is established by its equivalence.

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: Not applicable. This is not a study evaluating diagnostic performance on patient data. It's a comparison of a new calibrator to an existing one.
• Data Provenance: Not applicable.

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. There is no "ground truth" established by experts in the context of an algorithm's diagnostic performance for this type of device. The ground truth, in a general sense, is the established performance and suitability of the predicate calibrator.

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

• Not applicable. No adjudication process for a test set is described or implied.

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-assisted diagnostic device, nor is it a study involving human readers or comparative effectiveness in that context.

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

• Not applicable. This is not an algorithm-based device.

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

• Not applicable in the context of an algorithm's diagnostic performance. The "ground truth" for this submission is the accepted performance and characteristics of the existing predicate device (aca® plus HCG Calibrator), to which the new device is being compared for substantial equivalence.

8. The sample size for the training set

• Not applicable. There is no algorithm training involved.

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

• Not applicable. There is no algorithm training involved.

Summary of the "Study" (Rationale for Equivalence):

The "study" presented here is based on a comparison to a predicate device rather than a traditional performance study.

• Rationale for Equivalence: The document states that the HCG Calibrator for the Dimension® RxL system is "substantially equivalent to the aca® plus HCG Calibrator based on the comparison summarized above."
• Key points for equivalence:
  • Both are horse serum based products.
  • Both contain human urine chorionic gonadotropin as the analyte source.
  • Both are intended to be used as calibrators for human chorionic gonadotropin assays.
• Differences noted but implicitly deemed non-critical for equivalence:
  • The new device has 5 levels compared to the predicate's 3 levels.
  • The new device has 2.0 mL per vial (reconstituted) compared to the predicate's 3.0 mL.

In conclusion, this document demonstrates regulatory compliance through a comparison of characteristics to a predicate device to establish substantial equivalence for a calibrator, not through a performance study of a diagnostic or AI-driven system.

Ask a specific question about this device

The Thyroid Calibrator is intended to be used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to calibrate the FT4 and TSH methods.

The Thyroid Calibrator is a liquid bovine albumin based product. The Level 1 calibrator contains no detectable thyroxine or TSH. Levels 2 through 5 contain thyroxine and human TSH. The kit consists of ten vials; two at each of five levels.

The provided text describes a Thyroid Calibrator, a liquid bovine albumin-based product designed for calibrating FT4 and TSH methods on the Dimension® RxL clinical chemistry system. The document is a "Summary of Safety and Effectiveness Information" for a 510(k) submission, indicating a comparison to a predicate device for substantial equivalence.

However, the document does not contain information related to acceptance criteria or a study proving device performance in the way requested by the prompt. This document is a summary of safety and effectiveness information and focuses on comparing the new device to a predicate device to establish substantial equivalence, not on detailed performance validation studies with acceptance criteria, sample sizes for test sets, ground truth establishment, or clinical effectiveness studies.

Specifically, the requested information elements are not available in the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document compares features of the new calibrator to predicate calibrators but does not define or report performance against specific acceptance criteria for accuracy, precision, or other analytical characteristics.
2. Sample sized used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method: Not mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable, as this is a calibrator, not a diagnostic imaging or interpretive device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable for a calibrator.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

The document's purpose is to argue for substantial equivalence based on intended use, analytes, matrix, form, volume, and levels, not to report on detailed performance studies against pre-defined acceptance criteria.

Ask a specific question about this device