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Liquichek Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Liquichek Urine Chemistry Control is prepared from human urine with added constituents of human and animal origin, chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience.

The provided document describes a 510(k) premarket notification for the Bio-Rad Laboratories Liquichek Urine Chemistry Control. This document is for a quality control material, not a diagnostic device with complex performance criteria or AI components. Therefore, many of the requested elements for a diagnostic device performance study (e.g., sample size for test sets, data provenance, ground truth establishment, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of submission.

Here is an analysis based on the information provided, highlighting the applicable criteria and findings for this specific type of device (a quality control material):

1. Table of Acceptance Criteria and Reported Device Performance

For this quality control material, the "acceptance criteria" are related to its stability and its comparability to a predicate device for its intended use. The "reported device performance" demonstrates it meets these criteria.

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

• Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of a diagnostic device. For quality control materials, "testing" involves stability studies and value assignment. The "value assignment" states it used "replicate analyses" and a "representative sampling of this lot of product." The exact number of replicates or product units sampled is not specified.
• Data Provenance: The studies were performed by "the manufacturer and/or independent laboratories." No specific country of origin is mentioned for the data, and it is assumed to be retrospective to the manufacturing process for the specific lot.

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

• Not Applicable. For a quality control material, "ground truth" is established through analytical methods and value assignments, not expert consensus on interpretations like in diagnostic imaging. The values are assigned based on "replicate analyses" using "manufacturer supported reagents."

4. Adjudication method for the test set

• Not Applicable. As there are no expert interpretations or subjective assessments involved in the performance evaluation of a quality control material, no adjudication method would be used. Value assignment is typically based on rigorous statistical analysis of quantitative measurements.

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 material, not a diagnostic device that involves human readers or AI assistance.

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

• Not Applicable. This is a quality control material. There is no algorithm involved.

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

• For quality control materials, the "ground truth" (or accepted reference values) for the analytes within the control is established through analytical testing and quantitative measurement. The document states, "The mean values and the corresponding ±3SD ranges printed in the insert were derived from replicate analyses and are specific for this lot of product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents." This indicates a measurement-based analytical ground truth.

8. The sample size for the training set

• Not Applicable. This is a quality control product; there is no machine learning "training set."

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

• Not Applicable. As there is no training set.

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Liquichek™ Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory procedures listed in the package insert.

Liquichek™ Urine Chemistry Control is prepared from human urine with added constituents of human and animal origin, pure chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience.

The provided document is a 510(k) Premarket Notification for a Liquichek™ Urine Chemistry Control device, which is a quality control material. This type of device is used to monitor the precision of laboratory testing procedures for various analytes in urine.

The request asks for information typically associated with clinical studies of diagnostic or screening devices (e.g., sample size, expert ground truth, MRMC studies, standalone performance). However, since the Liquichek™ Urine Chemistry Control is a quality control material and not a diagnostic or screening device itself, the traditional metrics and study types for determining diagnostic performance (like sensitivity, specificity, or reader improvement with AI assistance) are not applicable.

Instead, the "acceptance criteria" for a quality control material typically relate to its stability, accuracy of assigned values, and its ability to consistently perform within expected ranges over its shelf life and open-vial period. The "study that proves the device meets the acceptance criteria" would therefore be stability studies and verification of manufacturing quality.

Based on the provided text, here's a breakdown of the requested information, adapted for a quality control device:

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

For a quality control material, acceptance criteria are generally related to its stability and the accurate assignment of analyte values. The document focuses on stability.

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

The document states: "Stability studies have been performed..." and "Real time studies will be ongoing to support the shelf life of this product."

• Sample Size (Test Set): The document does not specify the sample size (e.g., number of vials, batches) used for the stability studies.
• Data Provenance: The studies were conducted by Bio-Rad Laboratories, located in Irvine, California, USA. The studies supporting initial claims are likely prospective (real-time stability), with "ongoing" real-time studies for shelf life.

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)

For a quality control material, "ground truth" refers to the assigned values for each analyte. This is typically established through a rigorous process of testing using reference methods and/or multiple calibrated instruments in an accredited laboratory, often involving a consensus of results. The document does not specify the number or qualifications of experts involved in establishing these assigned values. This process is generally part of the manufacturer's quality system and product development, rather than a clinical expert panel.

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

Not applicable. Adjudication methods like 2+1 are used in clinical studies for interpretation of images or clinical events, often when ground truth is subjective or requires expert consensus. For a quality control material, the "ground truth" (assigned values) are determined analytically and through statistical analysis of multiple measurements, not through expert adjudication in this sense.

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. MRMC studies are designed for diagnostic or screening devices where human readers interpret patient data (e.g., medical images). This device is a quality control material, not a diagnostic tool for patient cases, and does not involve human "readers" in the context of diagnostic interpretation.

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

Not applicable. This is a physical reagent, not an algorithm.

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

For a quality control material, the "ground truth" is typically the assigned value for each analyte. These values are established by the manufacturer through a comprehensive assay process (using highly calibrated instruments and reference methods) and statistical determination, often referred to as "value assignment." It is not based on expert consensus for clinical diagnosis, pathology, or outcomes data, but rather on analytical accuracy and precision.

8. The sample size for the training set

Not applicable. This device does not use machine learning or algorithms that require a "training set." The performance is based on the inherent chemical and physical stability of the material, verified through laboratory studies.

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

Not applicable. As there is no training set for an algorithm, there is no "ground truth for the training set" to establish in this context.

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Liquichek Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Liquichek Urine Chemistry Control is prepared from human urine with added constituents of human and non-human origin and pure chemicals. The control is provided in liquid form for convenience. This product contains

This is a 510(k) premarket notification for a quality control material, not a medical device in the typical sense that would involve a study with human patients, performance metrics like sensitivity/specificity, or expert review. Therefore, many of the requested categories (like sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, and ground truth for training) are not applicable.

The submission focuses on establishing substantial equivalence to a legally marketed predicate device (Quantimetrix Corporation Human Urine Control) based on similar technological characteristics and intended use. The "acceptance criteria" here refer to meeting the requirements for substantial equivalence.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The "study" proving the device meets acceptance criteria is primarily a comparison of technological characteristics and intended use against a legally marketed predicate device, as presented in the table above and the overall 510(k) submission. The FDA reviewed this comparison and deemed the device "substantially equivalent."

Specific Responses to Your Questions:

2. Sample size used for the test set and the data provenance: Not applicable. This is a quality control material, not a diagnostic device tested on patient samples in the typical sense. The "test set" would implicitly refer to the characteristics of the control material itself, which were presumably validated internally by Bio-Rad to meet specifications, but these internal validation details are not provided in the 510(k) summary. The document does not describe patient data or clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for diagnostic device performance (e.g., presence/absence of disease) is not relevant for a quality control material.

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 a quality control material, not an AI-powered diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of clinical outcomes or disease. For quality control materials, "ground truth" would refer to the assigned values and stability of the analytes within the control, which are established through internal validation processes by the manufacturer. These specific data are not detailed in the 510(k) summary.

8. The sample size for the training set: Not applicable. No "training set" in the context of machine learning or algorithm development is mentioned or relevant for this type of product.

9. How the ground truth for the training set was established: Not applicable.

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