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This product is intended for use in the quantitative determination of factor levels in patients suspected of congenital or acquired deficiency of this coagulation protein or factor, XII. Factor immunodeficient plasma XII is made from human plasma that has been artificially depleted. This plasma has normal levels of all other factors.

Factor deficient plasma to be free of antigen of Factor XII utilized in in vitro diagnostic use. Factor immunodeficient plasma XII is made from human plasma that has been artificially depleted. This plasma has normal levels of all other factors.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Factor deficient coagulation plasma - XII" device.

Unfortunately, the provided document is a 510(k) summary for a medical device (Factor deficient coagulation plasma - XII) and does not contain information about acceptance criteria or a detailed study proving the device meets specific performance criteria.

The document focuses on demonstrating substantial equivalence to a predicate device (Pacific Hemostasis Factor XII). Substantial equivalence means the new device is as safe and effective as a legally marketed device that does not require premarket approval. It's a regulatory pathway, not a detailed performance study with explicit acceptance criteria and statistical analysis as one might find for a novel device or a clinical trial.

However, I can extract what is implied to be performance aspects they are comparing and some "claims" that function like implicit criteria.

Therefore, for your request, I will explain why much of the requested information is not available and then approximate answers based on the provided text's context of substantial equivalence.

Explanation of Missing Information

The document is a "Non-Confidential Summary of Safety and Effectiveness" for a 510(k) submission. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a predicate device already on the market. It does not typically include:

• Explicit Acceptance Criteria: While performance characteristics are compared, specific numerical thresholds for acceptance (e.g., "sensitivity must be >90%") are usually not stated for substantial equivalence. The goal is to show the device performs similarly to the predicate.
• Detailed Study Design/Results: It summarizes comparison points rather than presenting a full study protocol, data analysis, or statistical results.
• Sample Sizes, Data Provenance, Ground Truth Establishment: These are details of a formal study that are generally not part of a 510(k) summary, unless it's a novel device or there's a specific performance experiment conducted to bridge a difference.
• Expert Consensus/Adjudication, MRMC studies, Standalone Performance: These are methodologies typically associated with clinical performance evaluations for diagnostic accuracy, especially for image-based or more complex diagnostic devices. This device is a reagent for a laboratory clotting assay.

Attempted Answers Based on Available Information

Since the document focuses on substantial equivalence, the "acceptance criteria" are implicitly met if the device is comparable to the predicate device in the listed attributes.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not explicitly stated. The document refers to "Performance Testing: Compare assay to known sample" which implies some form of testing, but the sample size (number of "known samples," or patient samples if used) is not provided.
• Data Provenance: Not stated. It would likely be internal testing data from Universal Reagents, Inc., potentially using commercially available materials or characterized in-house samples. Retrospective or prospective is not specified.

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

• Not applicable/Not stated. For a coagulation reagent, the "ground truth" would typically come from reference methods, certified reference materials, or well-characterized patient samples with established diagnoses, not expert consensus in the same way an imaging study would use radiologists. The document uses phrases like "known sample" and "Deficiency of relevant factor less than 1%," implying laboratory characterization.

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

• Not applicable/Not stated. This refers to methods for resolving discrepancies among expert readers, which isn't relevant for a reagent's performance testing where objective measurements against standards are expected.

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

• No. This type of study is for diagnostic devices that assist human interpretation, often in imaging or pathology. This device is a laboratory reagent; there are no "human readers" in this context that would be "assisted by AI."

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

• Not applicable. This device is a reagent for an in vitro diagnostic test. It's not an AI algorithm. Its "standalone performance" is its ability to correctly aid in the quantitative determination of Factor XII deficiency when used in a lab assay. The document implies this is assessed by comparing its assay results to "known samples."

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

• Based on "Compare assay to known sample" and "Deficiency of relevant factor less than 1%", the ground truth would be laboratory characterization against established reference standards (e.g., certified Factor XII deficient plasma, or well-characterized patient samples), and likely comparison to the predicate device's performance using these same known samples.

8. The sample size for the training set

• Not applicable/Not stated. This device is a reagent, not a machine learning model. There is no "training set."

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

• Not applicable. See point 8.

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