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Dimension Vista™ IGM Flex® reagent cartridge: The IgM method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin M in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of IgM aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) methods on the Dimension Vista™ System.

Dimension Vista™ Protein 1 Control L, M and H: Protein 1 Control L, M and H are assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) on the Dimension Vista™ System.

Dimension Vista™ IGM Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing Immunoglobulin A, Immunoglobulin G, and Immunoglobulin M.

Dimension Vista™ Protein 1 Control L, M and H: Protein 1 Control L, M and H are multi-analyte, liquid human serum based products containing Immunoglobulin A, Immunoglobulin G, and Immunoglobulin M.

The provided text describes a 510(k) summary for an in vitro diagnostic device, specifically the Dimension Vista™ IGM Flex® reagent cartridge, Dimension Vista™ Protein 1 Calibrator, and Dimension Vista™ Protein 1 Control L, M and H. This submission is for substantial equivalence to a predicate device for the quantitative measurement of Immunoglobulin M (IgM).

However, the document does not provide specific acceptance criteria or details of a study structured to prove the device meets those criteria in the format requested. The text focuses on the device description, intended use, and comparison to a legally marketed predicate device to establish substantial equivalence for regulatory purposes. It lacks the detailed performance study information typically found when proving a device meets specific acceptance criteria, especially for algorithm performance.

Therefore, many of the requested sections below cannot be fully populated from the provided text.

Here's what can be inferred or stated based on the given information:

Acceptance Criteria and Reported Device Performance

Explanation: The document establishes "substantial equivalence" as the primary criterion for regulatory clearance. It does not provide specific numerical or statistical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds with confidence intervals) that a performance study would typically demonstrate. Instead, it claims equivalence to a predicate device which implies that its performance is comparable and acceptable for the intended use.

Study Details

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). Studies for in-vitro diagnostics often involve clinical samples, but details are not given here.

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

• Number of Experts: Not applicable/Not specified. For in-vitro diagnostic assays measuring an analyte like IgM, the "ground truth" is typically established by reference methods or laboratory techniques, not by expert interpretation in the same way it would be for imaging diagnostics.
• Qualifications of Experts: Not applicable/Not specified.

4. Adjudication method for the test set:

• Not applicable/Not specified. As noted above, the "ground truth" for this type of device is typically established through analytical methods rather than expert 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:

• MRMC Study: Not applicable. This device is an in-vitro diagnostic assay for quantitative measurement of Immunoglobulin M, not an AI-assisted diagnostic tool that human readers would interact with to improve interpretation of medical cases.
• Effect Size: Not applicable.

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

• The device itself (Dimension Vista™ IGM Flex® reagent cartridge) is a standalone diagnostic assay for quantitative measurement. Its performance is measured directly, without a human-in-the-loop component in the context of interpreting its primary output (a numerical concentration). The "algorithm" here refers to the chemical reaction and spectrophotometric measurement process, which operates independently to produce a result. The document does not detail specific "standalone performance" metrics (like accuracy, precision, linearity) typically reported for such devices, beyond the claim of substantial equivalence.

7. The type of ground truth used:

• The "ground truth" for this type of in-vitro diagnostic device would typically be established by:
  • Reference methods: Comparing the device's measurements to established, highly accurate laboratory methods for IgM quantification.
  • Known concentration standards: Using samples with precisely known concentrations of IgM to assess accuracy and linearity.
  • Clinical correlation: Demonstrating that the measured IgM levels correlate with clinical status or diagnosis as expected.
• The provided text does not explicitly state which specific ground truth method was used in detail for their studies.

8. The sample size for the training set:

• Not applicable/Not specified. This is a traditional in-vitro diagnostic device, not a machine learning model that requires a distinct "training set." The development of the assay involves optimization and validation, but not in the sense of training a neural network.

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

• Not applicable. As this is not an AI/ML device requiring a training set, this question is not relevant in the context of the provided document.

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The IGM Flex™ reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic test intended to quantitatively measure immunoglobulin M (IgM) in serum and plasma.

The IGM Flex™ reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay based on the precipitation of IgM by its polyclonal antibodies. IgM from serum or plasma reacts with its polyclonal antibodies to form an immunoprecipitate. Addition of polyethylene glycol accelerates the formation of the precipitate. Turbidity created by immunoprecipitation is measured as bichromatic endpoint measurements at 340 and 700 nm. The increase in turbidity is proportional to the concentration of IgM and it is calculated from a five point calibration curve.

Here's an analysis of the provided text, focusing on acceptance criteria and the study conducted for the IGM Flex™ Reagent Cartridge:

This submission is a 510(k) premarket notification for a medical device, which typically involves demonstrating substantial equivalence to a legally marketed predicate device rather than setting and proving specific acceptance criteria in the same way a novel device might establish clinical utility. For 510(k)s, the "acceptance criteria" are often implicitly tied to demonstrating comparable performance to the predicate.

Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to the predicate device, the Beckman Array® Immunoglobulin M Method. This is primarily assessed through correlation between the new device and the predicate device.

Interpretation: The reported performance metrics (correlation coefficient, slope, and intercept) are presented as evidence that the IGM Flex™ Reagent Cartridge is "substantially equivalent in principle and performance" to the predicate, thus meeting the implicit acceptance criteria for a 510(k) clearance.

Study Details

The study described is a split sample comparison between the IGM Flex™ Reagent Cartridge and the predicate Beckman Immunoglobulin M Assay.

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

   • Sample Size: 94 clinical patient samples.
   • Data Provenance: Not explicitly stated, but it refers to "clinical patient samples," suggesting human samples. The country of origin for the data is not specified, and neither is whether it was retrospective or prospective.

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

   • Not applicable / Not explicitly stated. For this type of in vitro diagnostic device (IVD) comparison, the "ground truth" for the test set is established by the predicate device's measurement. The study aims to correlate the new device's readings with the predicate's readings, rather than establishing a gold standard through expert consensus.

3. Adjudication method for the test set:

   • Not applicable. There was no human adjudication process involved in this direct comparison of quantitative measurements from two IVDs. The measurements from each device were compared statistically.

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. This was a comparison of two in vitro diagnostic assays, not an AI-assisted human reader study.

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

   • Yes, in essence. Both devices (the IGM Flex™ cartridge on the Dimension® system and the Beckman Array® IgM method) operate as standalone automated analytical systems. The study compared the direct output of these two systems. There is no "human-in-the-loop" component for interpretation described.

6. The type of ground truth used:

   • The "ground truth" in this comparative performance study is the measurements obtained from the legally marketed predicate device (Beckman Array® Immunoglobulin M Method). The new device's performance is gauged against this established method.

7. The sample size for the training set:

   • Not applicable / Not explicitly stated. This device is an IVD reagent cartridge, not a machine learning algorithm that requires a "training set" in the computational sense. The data presented is for performance validation, not for algorithm training.

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

   • Not applicable. As explained above, there isn't a "training set" for this type of device in the context of the provided information.

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