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An assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

The Lyphochek® Whole Blood Metals Control is a lyophilized control prepared from human whole blood with pure chemicals and stabilizers added. The control is provided in lyophilized form for increased stability.

Here's an analysis of the provided text regarding the Lyphochek® Whole Blood Metals Control, structured according to your request.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA submission for the Lyphochek® Whole Blood Metals Control focuses on demonstrating substantial equivalence to a predicate device and establishing stability claims, rather than defining and directly reporting against specific numerical "acceptance criteria" in the way one might see for diagnostic accuracy. The key performance indicators are related to the stability of the control material.

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

• Sample Size: The document does not specify a distinct "test set" sample size in terms of number of patient samples or production lots. The stability studies likely involved multiple vials/lots of the control material. For the substantial equivalence argument, the comparison is qualitative between the new and predicate device specifications rather than a quantitative test of a specific dataset.
• Data Provenance: The data comes from internal "stability studies" performed by Bio-Rad Laboratories. The information provided does not specify the country of origin for the data or whether it was retrospective or prospective. Given that it's a stability study for a new product, it would inherently be prospective in nature, testing the product over time.

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

This type of information is not applicable to this device. The Lyphochek® Whole Blood Metals Control is a quality control material, not a diagnostic device that requires expert interpretation of results to establish ground truth. Its performance is assessed through analytical stability testing using established laboratory methods for measuring the target analytes.

4. Adjudication Method for the Test Set

This is not applicable. There is no "adjudication method" in the context of stability testing for a quality control material. The performance is determined by instrument measurements against specified analytical criteria over time.

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 not applicable. This device is a quality control material, not an AI-powered diagnostic tool. Therefore, MRMC studies or AI assistance are not relevant to its evaluation.

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

This is not applicable. This device is a physical control material, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the stability studies would be the expected analytical values for each analyte within the control material, determined by reference methods or manufacturing specifications. The stability is then assessed by measuring the analytes over time and comparing the results to these established reference values, ensuring they remain within acceptable limits. This is an analytical ground truth, not a clinical ground truth derived from pathology or patient outcomes.

8. The Sample Size for the Training Set

This is not applicable. This device is a quality control material and does not involve machine learning or a "training set" in the conventional sense.

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

This is not applicable for the same reasons as point 8.

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Lyphochek Urine Metals 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.

Lyphochek Urine Metals Control is prepared from human urine with added trace elements, heavy metals and other chemical compounds. The control is provided in lyophilized form for increased stability.

This document describes the Lyphochek Urine Metals Control, a quality control urine product. It is intended to monitor the precision of laboratory testing procedures for certain analytes. The provided text is a 510(k) summary for a medical device and does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found for a diagnostic or therapeutic medical device.

The document essentially establishes "substantial equivalence" of the new Lyphochek Urine Metals Control to a previously marketed version (K891691/A). This type of submission generally doesn't require performance studies against specific acceptance criteria for safety and effectiveness in the same way a novel device would. Instead, it relies on demonstrating that the new device is as safe and effective as the predicate device.

However, I can extract the relevant information based on the typical requirements implied by your request, even if the specific details are not fully present for each point.

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

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for a quality control product like this primarily revolves around demonstrating that it performs its intended function (monitoring precision) comparably to an existing, cleared product. Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are implied to be at least as good as the predicate device, particularly for stability and intended use.

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

The document does not detail specific "test set" sample sizes or data provenance in the way a clinical trial for a diagnostic device would. For substantial equivalence of a quality control product, the "test set" would primarily involve demonstrating that the new product, including its new analytes, is stable and performs as expected with laboratory instruments. This information is typically proprietary to the manufacturer and not detailed in the public 510(k) summary.

The comparison table indicates the device claims are based on combining "Domestic and International products" and adding new analytes. This suggests internal data collection for these modifications.

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

This type of information is generally not applicable to the 510(k) submission of a quality control product. Ground truth, in the context of a quality control, refers to the accurately known concentrations of the analytes within the control material. This is established by the manufacturer through rigorous analytical methods and reference standards, not typically by "experts" in the sense of clinical decision-makers.

4. Adjudication Method for the Test Set

Not applicable for a quality control product.

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

Not applicable. MRMC studies are typically for imaging or diagnostic devices where human interpretation plays a role. This is a quality control material.

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

Not applicable. This is a physical quality control material, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for a quality control product is the assigned value (concentration) of each analyte in the control material, established through certified reference materials or highly accurate analytical methods during manufacturing. The document doesn't explicitly state "certified reference materials" but that is the standard practice for assigning values to quality controls.

8. The Sample Size for the Training Set

Not applicable. This is a manufactured quality control product, not an AI/ML algorithm that requires a "training set" of data.

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

Not applicable.

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