Search Results

Biophen Plasma Calibrator is normal citrated human plasma used as the calibrator in the assay for the coagulation factors Antithrombin III and Protein C. The Biophen Plasma Calibrator is tested for the absence of Lupus Anticoagulant and can be used for this investigation.

Biophen Normal and Abnormal Control Plasma is a set of 12 vials each of normal citrated human plasma used as quality control of some coagulation factors. The Biophen Normal and Abnormal Control Plasma are tested for the absence of Lupus Anticoagulant and can be used as a negative control for this investigation. This control plasma is also tested for the absence of Activated Protein C resistance (APCR): when tested with or without Activated Protein C (APC), the ratio obtained (APTT + APC/APTT) is ≥ 2.00 for the Normal Control Plasma.

BIOPHEN Plasma Calibrator reagent is composed of citrated normal human plasma, lyophilised in the presence of additives and preservatives. It contains 12 vials of lyophilised reagent to be reconstituted with 1 ml distilled water.

Biophen Normal and Abnormal Control Plasma is a set of 12 vials each of normal citrated human plasma used as quality control of some coagulation factors.

The provided text describes three medical devices: the Biophen Plasma Calibrator, Biophen Normal Control Plasma, and Biophen Abnormal Control Plasma. The information provided is primarily focused on their intended use, composition, and comparison to predicate devices, rather than a detailed study evaluating their performance against specific acceptance criteria.

Therefore, I cannot fully complete all sections of your request as the document does not contain the specific details of a performance study with acceptance criteria, sample sizes, ground truth establishment, or expert involvement as you've outlined.

However, I can extract information related to the device's characteristics and its intended use, which indirectly serve as a form of "acceptance criteria" in the context of substantial equivalence to predicate devices.

Here's a breakdown based on the available information:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)

The "acceptance criteria" for these devices appear to be their ability to perform equivalently to their predicate devices for their intended uses. The document states that the devices use the same principles as the predicate devices and are "substantially equivalent in performance, intended use and safety and effectiveness."

Study Details Based on the Provided Information:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • The document does not specify a numerical sample size for any test set.
   • The data provenance is not explicitly stated as a formal "study" with a test set in the traditional sense. The submission is a 510(k) for substantial equivalence, which relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often involves comparative testing, but the details of such testing (e.g., number of samples, origin) are not provided here. The manufacturer is Hyphen Biomed, based in France.

2. 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)

   • The document does not provide information about experts establishing ground truth for a test set. This type of information is typically part of a detailed clinical or performance study report, which is not present here.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • The document does not provide information about an adjudication method.

4. 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

   • No MRMC study was mentioned or implied. These devices are calibrators and controls for in-vitro diagnostic assays, not AI-assisted reading tools.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • These are reagents (plasma calibrators and controls), not algorithms. Therefore, a standalone algorithm performance study is not applicable.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • For "Biophen Plasma Calibrator": The "ground truth" implicitly refers to the established values of coagulation factors (ATIII, Protein C) in normal human plasma as determined by validated laboratory methods, against which the calibrator would be standardized. For Lupus Anticoagulant, the ground truth is the absence of Lupus Anticoagulant as determined by specific testing.
   • For "Biophen Normal and Abnormal Control Plasma": The "ground truth" for these controls would be their expected diagnostic values for ATIII, Protein C, and the presence/absence of Lupus Anticoagulant, and APC resistance status, established through validated assays and comparison to predicate devices and potentially reference materials. The Normal Control Plasma explicitly has a ground truth for APC resistance (ratio ≥ 2.00).

7. The sample size for the training set

   • The document does not mention a "training set" as this is not an AI/machine learning device. The closest concept would be the pooled normal human plasma used in the manufacturing process (e.g., "Normal human citrated pooled plasma" for the calibrator, which contains >75% human plasma). The size of this pool is not specified.

8. How the ground truth for the training set was established

   • Not applicable as there is no "training set" in the context of an AI device. The controls and calibrators are derived from pooled human plasma, and their characteristics are established through analytical testing against known standards and predicate devices.

Ask a specific question about this device