(27 days)
HemosIL Factor XII Deficient Plasma immunodepleted of factor XII and intended for the in vitro diagnostic quantitative determination of factor XII activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation Systems.
Factor XII activity in a patient's plasma is determined by performing a modified activated partial thromboplastin time test (APTT). Patient plasma is diluted and added to plasma deficient in factor XII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of that factor in the patient plasma, interpolated from a calibration curve.
The provided text describes a 510(k) submission for a medical device called "HemosIL Factor XII Deficient Plasma." This submission is a "Special 510(k)" because the changes are limited to an updated on-board instrument stability claim, which means only specific performance characteristics related to this change were tested.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Key Takeaway from the Document: This is not a study proving the overall efficacy or safety of a new diagnostic algorithm or AI system. Instead, it's a regulatory submission for a minor modification to an existing reagent used in a diagnostic test. The study described focuses solely on validating a change in the reagent's "on-board instrument stability" claim, meaning how long the reagent is stable once placed on the testing instrument. Therefore, many of the typical acceptance criteria and study aspects found in AI/algorithm submissions (like MRMC studies, expert consensus on images, etc.) are not applicable here.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by standard laboratory validation practices for a changed stability claim, specifically referencing CLSI EP25-A. The performance is the outcome of this validation.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Validation of "on-board instrument stability" claim | New claim of 6 Hours for on-board stability on ACL TOP Family and ACL TOP Family 50 Series coagulation systems. (Previously 24 Hours) |
| Compliance with CLSI EP25-A requirements for validation of stability | Testing was conducted "under design control and in accordance with CLSI EP25-A." |
| Continued equivalence to predicate device in other performance characteristics | Stated: "HemosIL Factor XII Deficient Plasma ... share the same Intended Use/ Indications for Use, same test principle, same formulation and the same performance characteristics, except for the updated on-board instrument claim." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size (number of patient samples, runs, or measurements) used for the stability testing. It only mentions "additional testing done to current CLSI EP25-A requirements" and that "verification testing to establish the modified on-board instrument stability claim... was conducted under design control."
- Data Provenance: The document does not specify the country of origin of the data or whether the testing was retrospective or prospective. It implies the testing was conducted by Instrumentation Laboratory Co. as part of their design control process. Given it's a stability study for a reagent, it would inherently be a prospective study conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This is not a study involving expert readers interpreting medical images or data where "ground truth" is established by human consensus. The "ground truth" for a reagent's stability is determined by laboratory measurements and adherence to pre-defined acceptance limits for analytical performance (e.g., maintaining accuracy, precision within a certain range over time).
4. Adjudication Method for the Test Set
- Not Applicable. As this is a laboratory stability study for a reagent, there is no "adjudication" of human interpretations involved. The "adjudication" would be based on objective analytical measurements compared against pre-defined statistical criteria (e.g., drift, bias within acceptable limits according to CLSI EP25-A).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is relevant for evaluating human performance (e.g., diagnostic accuracy of radiologists) with and without AI assistance. This submission is for a reagent, not an AI system or diagnostic algorithm that interacts with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm or AI system. It's a laboratory reagent. The "performance" being evaluated is the chemical stability of the reagent on an automated instrument.
7. The Type of Ground Truth Used
- Analytical Performance Data / Reference Method. The "ground truth" for reagent stability in this context would be defined by the reagent's ability to produce accurate and precise results when tested immediately after reconstitution (time zero) and then over the claimed stability period (e.g., 6 hours). This would be compared against a reliable reference method or pre-established acceptable analytical performance ranges. The CLSI EP25-A guideline would specify how this analytical "ground truth" is established and evaluated.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not a machine learning model or AI algorithm. This is a chemical reagent.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set, this question is not relevant.
§ 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).