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