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EURO/DPC's TMC is an assayed, human serum-based, tri-level control containing several human source-derived analytes associated with malignancy which are commonly measured by immunoassay. It is intended strictly for in vitro diagnostic use as an aid in monitoring the day-to-day performance of assays for these constituents.

Quality Control Material

I am sorry, but the provided text does not contain information on acceptance criteria, device performance, clinical study details, or ground truth establishment. The document is a 510(k) summary for a "Tumor Marker Control Device," which is a quality control material, not a diagnostic device with performance metrics related to patient outcomes.

Therefore, I cannot populate the table or answer the questions related to clinical studies, human readers, or ground truth.

Here's what I can tell you based on the provided text:

• Device Name: Tumor Marker Control Device (Trade: TMC, Catalog Number: TMCO)
• Intended Use: "an aid in monitoring the day-to-day performance of assays for these constituents." (referring to analytes associated with malignancy)
• Clinical Studies: The document explicitly states "Not applicable" for clinical studies. This is expected for a quality control material, as its performance is evaluated against established assay values, not clinical outcomes.

Since there are no clinical studies or performance data against specific acceptance criteria for a diagnostic device, the requested information cannot be extracted from this document.

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DPC's Tumor Marker Control Module is an assayed, tri-level control intended for use with DPC's tumor marker assays. It is intended strictly for in vitro diagnostic use.

Quality Control Material

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Diagnostic Products Corporation Tumor Marker Control Module:

Based on the provided K965114 510(k) Summary, the "Diagnostic Products Corporation Tumor Marker Control Module" is a Quality Control Material. Its intended use is as an assayed, tri-level control for DPC's tumor marker assays, strictly for in vitro diagnostic use.

The document explicitly states: "Clinical Studies: Not applicable." This is a key piece of information, as it indicates that the device's performance is not evaluated through traditional clinical trials or studies designed to assess diagnostic accuracy in human patients. Instead, as a quality control material, its "performance" is evaluated based on its stability, precision, and ability to provide expected values when tested with the corresponding assays.

Since it's a quality control material and clinical studies are not applicable, many of the typical questions relating to diagnostic device performance (like sensitivity, specificity, accuracy, and reader studies) are not relevant in the context of this specific filing.

Here's a breakdown of the requested information based only on the provided text, acknowledging limitations due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a quality control material and clinical studies are "not applicable," the acceptance criteria and performance would be related to its manufacturing consistency, stability, and its ability to act as a reliable control for the target assays. The provided summary does not contain any specific performance metrics or acceptance criteria for the Tumor Marker Control Module itself.

For a quality control material, "performance" would typically involve:

• Assigned Values and Ranges: The expected values (and acceptable ranges) for the control module when run on specific tumor marker assays.
• Stability: Verification that the control material remains stable over its shelf-life under specified storage conditions.
• Homogeneity: Ensuring consistency across vials within a lot.
• Lot-to-Lot Consistency: Demonstrating that different manufacturing lots perform comparably.

Since these details are not in the 510(k) summary, typical "acceptance criteria" and "reported device performance" as applicable to a diagnostic test for disease are not available here.

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

• Sample Size for Test Set: Not applicable/Not provided. The document states "Clinical Studies: Not applicable." For a QC material, a "test set" in the diagnostic sense (e.g., patient samples) is not used.
• Data Provenance: Not applicable.

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

Not applicable. As a quality control material, there is no "ground truth" related to a disease state or diagnosis that needs to be established by experts. Its "truth" lies in its analytically assigned values.

4. Adjudication Method for the Test Set

Not applicable.

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

• Was it done?: No. The document explicitly states "Clinical Studies: Not applicable."
• Effect size: Not applicable.

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

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

7. The Type of Ground Truth Used

For a quality control material, the "ground truth" would be the analytically assigned target values and their acceptable ranges, established through rigorous testing by the manufacturer using reference methods and statistical analysis. This is not "expert consensus," "pathology," or "outcomes data" in the traditional clinical sense. The document does not detail how these assigned values were derived.

8. The Sample Size for the Training Set

Not applicable/Not provided. For a quality control material, there isn't a "training set" in the context of machine learning or diagnostic algorithm development. The development process would involve formulation, stability studies, and value assignment, but not "training data."

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

Not applicable. (See #8).

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