(35 days)
The intended use to HemosIL Special Test Controls Level 1 & 2 is being expanded with the addition of value assignments for chromogenic Factor VIII tests (Levels 1 and 2) and clotting factor assays (Level 2 only). There are no changes in product formulation or alterations in the fundamental scientific technology introduced with the new value assignments.
HemosIL Special Test Controls Level 1 & 2 is labeled:
- For the quality control in the abnormal range of the chromogenic tests (Antithrombin, Plasminogen, Plasmin Inhibitor, Protein C and Factor VIII) and Free Protein S assay performed on the IL Coagulation Systems.
- For the Quality Control of von Willebrand Factor assay in the normal (Level 1) and abnormal range (Level 2) on the IL Coagulation Systems.
- For the Quality Control of factor assays (clotting) in the abnormal range (Level 2) on the IL Coagulation Systems.
The intended use to HemosIL Special Test Controls Level 1 & 2 is being expanded with the addition of value assignments for chromogenic Factor VIII tests (Levels 1 and 2) and clotting factor assays (Level 2 only). There are no changes in product formulation or alterations in the fundamental scientific technology introduced with the new value assignments.
The provided text describes the 510(k) summary for the HemosIL Special Test Controls Level 1 & 2, focusing on the expanded indications for use for chromogenic Factor VIII tests and clotting factor assays. It details the performance data that supports the substantial equivalence of the device.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" as a separate, defined threshold. Instead, it presents the "reported device performance" in terms of "Mean (%)" and "Within-Run %CV" for various assays. The implication is that these reported values are deemed acceptable for the expanded indications, as the device received 510(k) clearance, signifying substantial equivalence to a legally marketed predicate device.
| Reagent (Expanded Indication) | Instrument | Level | Reported Mean (%) (n=32) | Reported Within-Run %CV | Acceptance Criteria (Implied) |
|---|---|---|---|---|---|
| ELECTRACHROME Factor VIII | ACL 9000 | Level 1 | 67.5 | 3.30 | Not explicitly stated |
| ELECTRACHROME Factor VIII | ACL 9000 | Level 2 | 37.9 | 3.53 | Not explicitly stated |
| HemosIL Factor II | ACL Classic | 33.0 | 4.31 | Not explicitly stated | |
| HemosIL Factor II | ACL Futura/ACL Advance | 30.8 | 8.77 | Not explicitly stated | |
| Deficient Plasma (Factor II) | ACL 9000 | 34.1 | 3.16 | Not explicitly stated | |
| HemosIL Factor V | ACL Classic | 33.6 | 2.50 | Not explicitly stated | |
| HemosIL Factor V | ACL Futura/ACL Advance | 37.1 | 3.15 | Not explicitly stated | |
| Deficient Plasma (Factor V) | ACL 9000 | 36.5 | 2.27 | Not explicitly stated | |
| HemosIL Factor VII | ACL Classic | 30.5 | 3.09 | Not explicitly stated | |
| HemosIL Factor VII | ACL Futura/ACL Advance | 34.8 | 6.76 | Not explicitly stated | |
| Deficient Plasma (Factor VII) | ACL 9000 | 33.1 | 3.53 | Not explicitly stated | |
| HemosIL Factor VIII | ACL Classic | 33.7 | 5.54 | Not explicitly stated | |
| HemosIL Factor VIII | ACL Futura/ACL Advance | 36.1 | 5.52 | Not explicitly stated | |
| Deficient Plasma (Factor VIII) | ACL 9000 | 32.4 | 6.93 | Not explicitly stated | |
| HemosIL Factor IX | ACL Classic | 34.8 | 3.23 | Not explicitly stated | |
| HemosIL Factor IX | ACL Futura/ACL Advance | 34.1 | 10.07 | Not explicitly stated | |
| Deficient Plasma (Factor IX) | ACL 9000 | 34.2 | 7.45 | Not explicitly stated | |
| HemosIL Factor X | ACL Classic | 31.6 | 1.65 | Not explicitly stated | |
| HemosIL Factor X | ACL Futura/ACL Advance | 32.8 | 2.12 | Not explicitly stated | |
| Deficient Plasma (Factor X) | ACL 9000 | 34.3 | 2.13 | Not explicitly stated | |
| HemosIL Factor XI | ACL Classic | 28.5 | 2.99 | Not explicitly stated | |
| HemosIL Factor XI | ACL Futura/ACL Advance | 30.0 | 13.24 | Not explicitly stated | |
| Deficient Plasma (Factor XI) | ACL 9000 | 30.2 | 4.34 | Not explicitly stated | |
| HemosIL Factor XII | ACL Classic | 34.1 | 7.22 | Not explicitly stated | |
| HemosIL Factor XII | ACL Futura/ACL Advance | 29.7 | 7.40 | Not explicitly stated | |
| Deficient Plasma (Factor XII) | ACL 9000 | 34.3 | 2.61 | Not explicitly stated |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: The "n=32" is explicitly stated for the "Mean (%)" in the performance tables, indicating 32 measurements were taken for each reported value.
- Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The study involves quality control materials for in vitro coagulation studies, where "ground truth" would typically refer to the target or reference values established for the control material itself, rather than expert interpretation of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. The study focuses on the analytical performance (mean and precision) of the control material on specific instruments, not on the interpretation of results by multiple human readers.
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
An MRMC comparative effectiveness study was not performed, nor is it relevant to this type of device (in vitro diagnostic quality control material). This device is a control material for laboratory tests, not an AI-powered diagnostic tool requiring human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the device. The "device" itself is a control material, not an algorithm. The performance data presented is the "standalone" performance of the control material when assayed on various laboratory instruments.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for quality control materials refers to the assigned or target values for the analytes within the control. This is typically established through rigorous analytical methods, often characterized through inter-laboratory studies or traceability to reference materials. The document states that the intended use is being expanded with the addition of "value assignments," implying such a characterization was performed, but the specific type of "ground truth" establishment (e.g., a specific reference method or consensus process) is not detailed here.
8. The sample size for the training set
This is not applicable as the device is a quality control material and not an algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as the device does not involve a training set.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.