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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, IX.

Factor Deficient Coagulation Plasma Factor - IX (nine) is made from human plasma that has been artificially depleted. This plasma has normal levels of all other factors.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.

The document is a 510(k) clearance letter from the FDA for a device called "URI Factor IX Regulatory Class: II Product Code: GJT, GGP". It states that the device is "substantially equivalent" to previously marketed devices.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study that proves the device meets specific acceptance criteria.
• Information on sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, types of ground truth, or training set details.

The document mainly focuses on the regulatory clearance of the device based on substantial equivalence, rather than providing a detailed performance study report.

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This product is intended for use in the quantitative determination of Indicated use factor levels in patients suspected of congenital or acquired deficiency of this coagulation protein or factor, XI.

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

This document describes the safety and effectiveness of the Factor Deficient Coagulation Plasma - XI, a device used for quantitative determination of Factor XI levels. The submission is a 510(k) premarket notification, which means it aims to demonstrate substantial equivalence to a legally marketed predicate device.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, statistically defined manner typically found in modern device submissions. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Pacific Hemostasis Factor XI) by comparing attributes and performance. The "performance testing" section outlines specific checks rather than performance targets.

Note on "Acceptance Criteria": For a 510(k) in 1997, the primary "acceptance criterion" was substantial equivalence to a predicate device. The performance characteristics listed above are the evidence presented to demonstrate that equivalence. There are no specific quantitative thresholds like "sensitivity > X%" or "specificity > Y%" mentioned, which are more common in contemporary submissions for higher-risk devices or those without clear predicates.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: Not explicitly stated. The document refers to "Performance Testing" which includes comparing the assay to a "known sample," but the number of such samples or tests performed is not quantified.
• Data Provenance: Not explicitly stated. Given the context of a diagnostic product submission, the testing would likely have been conducted in a laboratory setting. There's no information regarding the country of origin of the data, nor whether it was retrospective or prospective. It is implied to be laboratory-based testing conducted to validate the product's characteristics.

3. Number of Experts and Qualifications

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method

• No adjudication method is described. This type of submission (for a laboratory reagent) typically relies on direct laboratory measurement outcomes rather than human expert interpretation needing adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic systems where human interpretation is a key component and AI provides assistance. The device in question is a laboratory reagent; its performance is measured biochemically.

6. Standalone Performance Study

• Yes, a form of standalone performance was implicitly done. The "Performance Testing" section describes characteristics of the intended product itself (e.g., deficiency of relevant factor less than 1%, negative for various viruses, no inhibitor present). The comparison with the predicate device also assesses the standalone performance of the new device against an established one. The results listed in the table are the device's standalone characteristics.

7. Type of Ground Truth Used

• The ground truth used for specific performance claims appears to be:
  • "Known sample": For comparing assay performance, implying a reference standard or samples with known characteristics.
  • "FDA approved test": For viral negativity claims (HIV 1/2, HBsAG, HCV, HIV-1ag), implying established and validated diagnostic tests as the ground truth.
  • Analytical measurement: For "deficiency of relevant factor less than 1%" and "no inhibitor present," implying direct biochemical measurements against established analytical methods.

8. Sample Size for the Training Set

• Not applicable/Not mentioned. The device is a laboratory reagent (Factor XI deficient plasma) and not an AI/ML algorithm that requires a "training set" in the computational sense. The manufacturing process of immunodepleting plasma is a biochemical one, not an iterative learning process with data.

9. How Ground Truth for the Training Set Was Established

• Not applicable/Not mentioned for the same reasons as in point 8.

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Indicated use - Factor deficient plasma, Factor - II, V, VII, VIII, IX, XI, XII, XII, is a human plasma immunodepleted of the specific factor and intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay. Factor VIII is human plasma and bovine material.

Factor deficient plasma to be free of antigen of Factor II, V, VII, VIII, IX, X, XI, XII, respectively, utilized in in vitro diagnostic use.

The provided document is a summary of safety and effectiveness for Factor Deficient Coagulation Plasma, intended for use in determining specific factor levels in patients.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria with corresponding performance data in the typical sense of accuracy, sensitivity, or specificity. Instead, it focuses on attributes and features that are compared to predicate devices, inferring that meeting these attributes constitutes acceptable performance. The "Performance Testing" section outlines criteria related to safety and functionality.

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

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective). It mentions "known samples" for assay comparison but provides no details on their number or characteristics.

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

The document does not provide any information regarding the number or qualifications of experts used to establish ground truth.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss the effect size of human reader improvement with or without AI assistance. This is expected as the device is a reagent, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

The document does not describe a standalone performance study in the context of an algorithm. This is not applicable as the device is a reagent for in-vitro diagnostic use, not an algorithm. Performance is assessed through its functional characteristics in laboratory tests.

7. Type of Ground Truth Used

The type of ground truth can be inferred from the "Performance Testing" section:

• Comparison to known samples: This suggests that the ground truth for some performance aspects (e.g., accuracy of coagulation determination) was based on pre-established values or characteristics of control samples.
• Negative by FDA approved tests for specific viruses and contaminants: The ground truth for safety aspects (e.g., HIV, HBsAg, HCV) was based on results from validated FDA-approved diagnostic tests.
• Deficiency of relevant factor less than 1% and no inhibitor present: The ground truth for the purity and specificity of the deficient plasma was likely established through quantitative laboratory assays designed to measure factor levels and detect inhibitors.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This concept is typically relevant for machine learning algorithms, which is not what this device is.

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

Since there is no mention of a training set, the document does not describe how ground truth for a training set was established.

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