(23 days)
Sigma Diagnostics ACCUCLOT™ CONTROL II is a human plasma control that is suitable for use as an abnormal control with patient citrated plasma in the one-stage prothrombin time (PT), in the activated partial thromboplastin time (APTT), the chromogenic Antithrombin III (AT-III) assay and in fibrinogen determinations using a clotting method. Plasma controls are routinely used in the coagulation laboratory as a means of quality control for coagulation testing.
Sigma Diagnostics ACCUCLOT™ Control II is a lyophilized human plasma based product. After reconstitution with water, ACCUCLOT™ Control II is stable for 48 hours when stored at 2-8°C.
The provided text describes a 510(k) submission for a medical device (ACCUCLOT™ Control II) that is seeking substantial equivalence to a predicate device (Sigma Diagnostics Coagulation Control, Level II). The document focuses on regulatory approval rather than a detailed device performance study against specific, quantified acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory submission. The primary "study" proving its meeting of criteria is the demonstration of substantial equivalence to a previously approved device.
Here's an attempt to answer based on the provided text, with many fields indicating "Not specified" or "Not applicable" due to the nature of the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Criterion: Substantial Equivalence to Predicate Device | Device is substantially equivalent to Sigma Diagnostics Coagulation Control, Level II (Cat. No. 8916). |
| Functionality as an abnormal control in: | Demonstrated through substantial equivalence. Specific performance metrics (e.g., specific PT, APTT, AT-III, or fibrinogen values/ranges) are not provided in this summary but would have been part of the underlying data submitted for equivalence. |
| - One-stage prothrombin time (PT) | |
| - Activated partial thromboplastin time (APTT) | |
| - Chromogenic Antithrombin III (AT-III) assay | |
| - Fibrinogen determinations (clotting method) | |
| Stability after reconstitution (48 hours at 2-8°C) | Stated as a characteristic of the device. Direct performance data demonstrating this stability within performance specifications are not provided in this summary but would have been part of the submission. |
2. Sample sized used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The submission relies on demonstrating equivalence, which likely involved comparative testing, but the number of samples used for this comparison is not detailed here.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/Not specified. For substantial equivalence of a control material, ground truth isn't typically established by expert consensus on individual cases in the same way it would be for a diagnostic algorithm. Performance is assessed against a predicate device.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/Not specified.
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
- MRMC Study: No, this is not applicable. This device is a plasma control material, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a diagnostic reagent/control, not an algorithm. Its performance is intrinsic to the material itself when used in laboratory assays.
7. The type of ground truth used
- Type of Ground Truth: For a control material, "ground truth" would implicitly refer to its established and expected performance characteristics (e.g., target ranges for clotting times or AT-III activity) when run on validated diagnostic systems. The study likely involved demonstrating that the ACCUCLOT™ Control II performed within acceptable ranges relative to the Sigma Diagnostics Coagulation Control, Level II. The specific values or ranges are not provided here.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable. This is a manufactured control product, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not applicable.
§ 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.