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.

Device Description

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

AI/ML Overview

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.

Attribute (Acceptance Criteria - Compared to Predicate)	Reported Device Performance (Intended Product)
Use:
Indicated for use in determination of coagulation of plasma	Yes
In vitro diagnostic use	Yes
Used as a quantitative assay	Yes
Design:
Factor VIII deficient plasma offered	Yes
Packaging either - Frozen or Dry / lyophilized	Yes
Can be used with different instruments and reagents per manufacturer instructions	Yes
Materials:
Donor human plasma	Yes
Enhanced bovine factor V	Yes
Various buffers	Yes
Performance Testing:
Compare assay to known sample	Yes
Negative by FDA approved test for HIV 1/2 and HBSAG	Yes
Negative by FDA approved test for HCV and HIV-1ag	Yes
Deficiency of relevant factor less than 1%	Yes
Negative for HIV and HBSAG	Yes
Negative for HCV, HIV-1ag	Yes
No inhibitor present	Yes

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.

Summary

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Universal Reagents, Inc.

2858 N. Pennsylvania St. Indianapolis, IN 46205

UNIVERSAL REAGENTS, INC. 2858 North Pennsylvania Street Indianapolis, Indiana 46205 PHONE: (317) 926-0015 FAX: (317) 926-0014

K970593

PR 25 1997

Non-Confidential Summary of Safety and Effectiveness February 17, 1997 page 1 of 2

Tel - (317) 926-0006 Fax - (317) 926-0014

Official contact:	Jorge Miller, Director, Coagulation Products
Proprietary or Trade Name:	Factor deficient coagulation plasma - VIII
Common/Usual Name:	Qualitative and Quantitative Factor Deficiency Test - VIII
Classification Name:	Qualitative and Quantitative Factor Deficiency Test
Intended device:	Factor deficient coagulation plasma - VIII
Predicate devices:	OTC Factor VIII - K823453
Device description:	Factor deficient plasma to be free of antigen of Factor VIIIutilized in in vitro diagnostic use.

Intended use:

Environment of use: Clinical laboratories

Comparison to predicate devices:

Attribute	Intended product	OTC
Use
Indicated for use in determinationof coagulation of plasma	Yes	Yes
In vitro diagnostic use	Yes	Yes
Used as a quantitative assay	Yes	Yes
Design
Factor VIII deficient plasma offered	Yes	Yes

{1}------------------------------------------------

Non-Confidential Summary of Safety and Effectiveness (continued)

February 17, 1997

page 2 of 2

Comparison to predicate devices: (continued)

Attribute	Intended products	OTC
Packaging either -Frozen or Dry / lyophilized	Yes	Yes
Can be used with differentinstruments and reagents permanufacturer instructions	Yes	Yes
Materials
Donor human plasma	Yes	Yes
Enhanced bovine factor V	Yes	Yes
Various buffers	Yes	Yes
Performance Testing
Compare assay to known sample	Yes	Yes
Negative by FDA approved test forHIV 1/2 and HBSAG	Yes	Yes
Negative by FDA approved test forHCV and HIV-1ag	Yes	not known
Deficiency of relevant factorless than 1%	Yes	not known
Negative for HIV and HBSAG	Yes	Yes
Negative for HCV, HIV-1ag	Yes	not known
No inhibitor present	Yes	not known

Differences

The only difference is that the intended product is claimed to be negative for HCV and HIV-1ag by an FDA approved test.

Any other differences that do exist would not have a significant effect on the safety or effectiveness of the device.

Regulation Number and Section

§ 864.7290 Factor deficiency test.

(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).