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The VALIDATE® Urine Chemistry Calibration Verification Test Sets are used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the analytes listed on the package insert.

VALIDATE Urine Chemistry Calibration Verification Test Sets are human urine or serum based calibration verification materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. There exists a linear relationship among each set of splutions.

The provided document is a 510(k) summary for the VALIDATE® Urine Chemistry Calibration Verification Test Sets. This type of device is a quality control material used in laboratories to verify the calibration and linearity of chemistry systems. As such, the concept of "device performance" in this context refers to the characteristics of the calibration verification material itself, rather than a diagnostic algorithm or decision-making aid. Therefore, many of the typical acceptance criteria and study aspects requested (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, effect size) are not applicable or described in the context of this 510(k) summary for a calibration verification material.

Based on the provided text, here's a breakdown of the available information:

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

The document does not explicitly state "acceptance criteria" in a quantitative manner for the performance of the device against a benchmark. Instead, the study's purpose is to demonstrate substantial equivalence to predicate devices. The "performance" being evaluated is the inherent characteristics of the new calibration verification material compared to existing, legally marketed controls.

The comparison table (TABLE 1 on page 1) highlights key characteristics of the new device and predicate devices. The implicit "acceptance criteria" for substantial equivalence would be that the new device shares similar intended use, analytes, matrix, number of levels, preparation, packaging, stability, and storage conditions as the predicates. The summary statement then declares that the new device meets this by claiming "substantial equivalence."

The document concludes that the VALIDATE® Urine Chemistry Calibration Test Sets are "substantially equivalent" to the predicate devices based on this comparison.

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 provided in the 510(k) summary. For a calibration verification material, the "test set" would typically refer to the various analytes and levels within the material itself, and the testing would involve evaluating these materials on different analytical systems. The specific details of how many different systems or how many runs were performed are not present. There is no information regarding data provenance (country, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is a calibration verification material, not a diagnostic algorithm requiring expert interpretation of images or clinical data for ground truth. The "ground truth" for each level of the calibration verification material would be its manufacturing-assigned target value, which is established under strict quality control processes.

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

Not applicable for a calibration verification material.

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 not an AI-powered diagnostic tool used by human readers.

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

Not applicable. This device is not a standalone diagnostic algorithm. It is a control material used in a laboratory setting. The "performance" of the device is its ability to provide stable and accurate reference values when tested on analytical systems, allowing those systems to be verified for calibration and linearity.

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

The "ground truth" for calibration verification materials typically refers to the assigned values for each analyte at each level. These assigned values are established through rigorous manufacturing processes, often including comparison to reference methods or master lots, and are part of the product specifications. The 510(k) summary does not specify the exact method used by Maine Standards Company to assign these values, but it would be based on internal quality control and analytical chemistry principles.

8. The sample size for the training set

Not applicable. This device is not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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The VALIDATE Lipoprotein Calibration Verification Test Set is intended for in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity on clinical chemistry for the following analytes: cholesterol, HDL-cholesterol, LDLcholesterol, Apolipoprotein A (Apo-A), and Apolipoprotein B (Apo-B).

The VALIDATE Lipoprotein Calibration Verification Test Set is used by trained laboratory professionals for the quantitative determination of linearity, calibration verification and verification of reportable range in manual, semi-automated and automated clinical chemistry systems for the following analytes: cholesterol, HDL cholesterol, LDL cholesterol, Apolipoprotein A, and Apolipoprotein B.

Quality control material (assayed and unassayed). VALIDATE Lipoprotein Calibration Test Set is a human protein serum based calibration verification test set containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. Each set contains one bottle each of six (6) levels, including zero. Each bottle contains 5 milliliters. There exists a linear relationship among each set of solutions.

This document is a 510(k) summary for the VALIDATE Lipoprotein Calibration Verification Test Set. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria for performance in a clinical setting.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (like sample size for test/training sets, expert involvement, MRMC studies, or standalone performance) are not directly applicable or available in this type of submission. The device is a quality control material, not a diagnostic algorithm.

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

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

This document does not present explicit "acceptance criteria" in terms of performance thresholds (e.g., sensitivity, specificity, accuracy) that a diagnostic device would typically have, nor does it present specific performance data beyond stating substantial equivalence. The "performance" described is the intended function of the calibration verification test set, which is to verify calibration, validate reportable ranges, and determine linearity.

The comparison table provided in the submission (Page 1) focuses on characteristics of the device and its predicate:

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

Not applicable. This submission describes a quality control material, not a diagnostic device that processes patient data. Therefore, there is no "test set" of patient data in the typical sense for evaluating diagnostic performance. The submission relies on a comparison of device characteristics to a legally marketed predicate device.

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. As this is not a diagnostic device involving interpretation of patient data, there were no experts establishing ground truth for a test set.

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

Not applicable.

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 not an AI diagnostic tool and does not involve human readers in this context.

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

Not applicable. This device is a physical calibration verification test set, not a software algorithm.

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

Not applicable. The "ground truth" for a calibration verification material would be its precisely manufactured and assigned values for the analytes. The submission implies these values are established through the manufacturing process, but details on how these specific values are determined are not part of this 510(k) summary.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable.

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