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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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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 - VIII is a human plasma immunodepleted of the indication 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 deficient plasma to be free of antigen of Factor VIII utilized in in vitro diagnostic use.

This document is a Summary of Safety and Effectiveness for a medical device (Factor deficient coagulation plasma - VIII) from 1997. The provided text does not describe a study involving an AI/Machine Learning device, but rather a conventional in-vitro diagnostic (IVD) product.

Therefore, most of the requested information (sample sizes, experts, adjudication, MRMC studies, standalone performance, training sets, etc.) is not applicable to this document as it pertains to AI/ML device studies.

However, I can extract the acceptance criteria and reported device performance from the document based on the comparison to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The "Acceptance Criteria" here are inferred from the attributes of the predicate device (OTC Factor VIII - K823453) which the new device aims to match or improve upon. The "Reported Device Performance" for the "Intended product" is indicated by "Yes" for meeting these attributes.

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

• Not Applicable. This document pre-dates widespread AI/ML product development. The performance testing described is for a chemical reagent (Factor deficient plasma). Specific sample sizes for "test sets" in the context of AI validation are not mentioned. Clinical studies for IVDs typically involve testing against known samples or patient samples, but the method and sample size are not detailed here beyond "Compare assay to known sample". Data provenance (country, retrospective/prospective) is also not specified.

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

• Not Applicable. This document refers to an In Vitro Diagnostic (IVD) product. "Ground truth" for such a product would typically be established by laboratory methods, reference standards, and established assays, not by expert consensus in a clinical image/data review setting as would be the case for AI/ML.

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

• Not Applicable. Adjudication methods are relevant for human interpretation tasks, especially in AI studies involving multiple readers. This document describes the performance of a lab reagent.

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 not an AI-assisted device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

• Not Applicable. This device is an in-vitro diagnostic reagent, not an algorithm. Its performance is inherent to its biochemical properties.

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

• For the performance testing, the ground truth is implicitly based on reference standards or known samples (e.g., "Compare assay to known sample," "Deficiency of relevant factor less than 1%"), as well as FDA-approved tests for viral markers (HIV, HBSAG, HCV).

8. The sample size for the training set:

• Not Applicable. There is no "training set" in the context of this traditional IVD product. This is not an AI/ML device.

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

• Not Applicable. As there is no training set for an AI/ML model, this question is not relevant to the provided document.

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Indicated use - Factor deficient plasma, Factor - VII 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 deficient coagulation plasma - VII is a human plasma immunodepleted of the specific factor and intended for use in in vitro diagnostic use.

This document does not contain information about acceptance criteria, device performance, or a study that evaluates a device against acceptance criteria in the way described in the prompt. The document is a "Non-Confidential Summary of Safety and Effectiveness" for "Factor deficient coagulation plasma - VII." It primarily serves to compare the intended product with predicate devices.

Here's a breakdown of why the requested information cannot be extracted:

• No defined acceptance criteria: The document lists "Performance Testing" attributes, but these are general characteristics (e.g., "Compare assay to known sample," "Deficiency of relevant factor less than 1%") rather than specific, quantitative acceptance criteria with thresholds.
• No reported device performance against criteria: While it states "Yes" for the intended product meeting certain characteristics, it doesn't provide numerical or qualitative results from a study demonstrating performance against specific, pre-defined acceptance criteria.
• No study details: The document mentions "Performance Testing" but does not describe a study. There is no information on sample size, data provenance, ground truth establishment, expert involvement, or adjudication methods. The "Performance Testing" section simply lists features the device will possess or is designed to meet, not the results of a test proving it.
• AI/Human-in-the-loop irrelevance: This document describes a diagnostic reagent, not an AI or imaging device, so questions related to MRMC studies, human reader improvement with AI, or standalone algorithm performance are not applicable.

Therefore, it is not possible to fill out the requested table and answer the study-related questions based on the provided text.

The document's purpose is to argue substantial equivalence to predicate devices, focusing on design features and intended use rather than presenting a performance study against acceptance criteria.

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Indicated use - Factor deficient plasma, Factor - V 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.

Environment of use: Clinical laboratories

Factor deficient plasma to be free of antigen of Factor V utilized in in vitro diagnostic use

The provided text describes a medical device, "Factor deficient coagulation plasma - V," and compares it to a predicate device, Helena - K792507 - Factor V. The document does not describe a study involving machine learning or AI. Therefore, I cannot extract information related to AI/ML acceptance criteria, study design (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance), or training set details.

The document focuses on the intended use, design, materials, and performance testing for a diagnostic reagent. The performance testing section mentions:

Acceptance Criteria and Reported Device Performance (as described for this diagnostic reagent)

Study Details Related to AI/ML: Not applicable. The document describes a traditional in-vitro diagnostic device, not an AI/ML system. There is no information regarding:

1. Sample size for test set or data provenance.
2. Number or qualifications of experts.
3. Adjudication method.
4. MRMC comparative effectiveness study or effect size.
5. Standalone performance.
6. Type of ground truth (beyond "known sample" for assay comparison).
7. Sample size for training set.
8. How ground truth for training set was established.

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Indicated use - Factor deficient plasma, Factor - X 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 deficient plasma to be free of antigen of Factor X utilized in in vitro diagnostic use.

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

It is important to note that the provided documents (K964459) are from 1996, and the regulatory and scientific standards for device studies have significantly evolved since then. The information available in these summaries is quite limited compared to what would be required for a modern submission.

Based on the provided text, the device in question is a "Factor deficient coagulation plasma - X" intended for in vitro diagnostic use in quantitative determination of Factor X levels. The summary primarily focuses on comparing the new device to a predicate device (Sigma - K843310 - Factor X) to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria in the way modern device submissions do (e.g., a specific sensitivity or specificity threshold, or an agreement percentage). Instead, acceptance is implied by demonstrating substantial equivalence to a predicate device across various attributes.

Here's an interpretation of the performance-related comparisons, framed as implicit criteria and reported performance:

Key takeaway for Acceptance Criteria: The primary acceptance criterion appears to be "substantially equivalent to the predicate device, Sigma - K843310 - Factor X, for stated attributes, with additional safety features (HCV/HIV-1ag testing) as an improvement."

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

The document does not specify sample sizes for any test set. It mentions "Performance Testing: Compare assay to known sample" under the attributes, but no details on how many samples, what type of samples, or their origin are provided.

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified. It can be inferred that samples would be of human origin, related to coagulation testing, but no specific country or whether it was retrospective/prospective is mentioned.

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

The document does not provide any information about experts or their qualifications for establishing ground truth for any test set.

4. Adjudication Method (for the Test Set)

The document does not specify any adjudication method. Given the nature of a laboratory diagnostic reagent comparison, it's unlikely that a multi-reader adjudication process (like 2+1) would be directly applicable in the same way it is for image-based diagnostic AI. The "ground truth" for a Factor X level would typically be established by a reference method or known concentration.

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

No, an MRMC comparative effectiveness study was not done. This type of study (comparing human reader performance with and without AI assistance) is specific to AI/CAD devices, especially in imaging, where human interpretation is a key part of the diagnostic process. The "Factor deficient coagulation plasma - X" is a laboratory reagent, not an AI or CAD system, so such a study would not be relevant.

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

The concept of "standalone performance" for an algorithm is not directly applicable here because the device is a reagent, not an algorithm. The performance of the reagent would be assessed in a laboratory setting when used with instruments and other reagents to perform a coagulation assay. The performance data mentioned (e.g., negative for certain viruses, deficiency of relevant factor) relates to the quality and characteristics of the plasma itself, not an algorithm's output.

However, if we interpret "standalone" as the performance of the reagent itself (before human interpretation of the final assay results), then the performance attributes listed under "Performance Testing" and "Donor Criteria" could be considered an assessment of the reagent's inherent characteristics. The document implies that the device performs in a manner consistent with a factor-deficient plasma, but details on how that performance was measured (e.g., specific quantitative results, precision, accuracy) are absent.

7. The Type of Ground Truth Used

The document does not explicitly define the "ground truth" in detail. However, based on the context of the device:

• For "compare assay to known sample": The ground truth would likely be the known concentration/activity of Factor X in reference samples or spiked samples.
• For "Negative by FDA approved test for HIV 1/2 and HBsAG" etc.: The ground truth would be the results from the FDA-approved reference tests for these viral markers.
• For "Deficiency of relevant factor less than 1%": The ground truth would be established through a specific laboratory assay (presumably a reference method) that quantifies Factor X levels in donor plasma.

Essentially, it relies on established laboratory methodologies and reference materials as ground truth.

8. The Sample Size for the Training Set

The document does not mention a training set. This is because the device is a laboratory reagent and not an AI/machine learning algorithm that requires a training phase.

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

Since there is no training set mentioned (as it's not an AI device), this question is not applicable.

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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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