Search Results

The 200 Micron Blood Component Filter and Syringe Adapter is designed to filter clots and other particles from blood and blood components for delivery.

Tubing assembly with a 200 micron filter connected by tubing with clamp and luer on one end and a purchased piston syringe on the other end.

The provided text describes a 510(k) summary for the "200 Micron Blood Component Filter and Syringe Adapter" and regulatory correspondence from the FDA. This device is a blood filter, not an AI/ML-driven diagnostic or image analysis tool, therefore many of the requested categories (e.g., efficacy studies, MRMC studies, ground truth establishment, sample sizes for training/test sets, expert qualifications, adjudication methods) are not applicable.

Here's an analysis based on the information provided, focusing on what is relevant to a non-AI medical device submission:

Acceptance Criteria and Device Performance

A direct table of acceptance criteria with reported device performance is not explicitly presented as a consolidated table in the document. However, the performance testing section states that the device is suitable for its intended use and performs equivalently to predicate devices. The acceptance criteria would be implicitly derived from the referenced standards and the comparison to the predicate devices.

Study Details (where applicable for a non-AI device):

1. Sample size used for the test set and the data provenance: Not applicable in the context of clinical data for an AI/ML system. Performance testing for this medical device would involve laboratory testing on a defined number of device units, potentially using simulated blood products or actual blood/blood components. The sample size for such engineering or biocompatibility tests is not specified in the summary but would be determined by the relevant ISO standards (e.g., for cytotoxicity, irritation, etc.) and good manufacturing practices. There is no "data provenance" in the sense of patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI systems (e.g., expert-labeled images) is not relevant here. The "ground truth" for this device would be its physical and chemical properties meeting the specified standards and performing its filtration function as intended.

3. Adjudication method for the test set: Not applicable. This is not an observational or diagnostic study requiring adjudication.

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: Not applicable. This is a physical blood filter, not an AI system that interacts with human readers or clinical cases in that manner.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.

6. The type of ground truth used: For this type of device, the "ground truth" is defined by adherence to recognized voluntary standards (e.g., ISO 10993 series for biocompatibility, ANSI/AAMI BF7 for filtration performance) and direct comparison of performance and characteristics to a legally marketed predicate device. This typically involves:

   • Laboratory Testing Results: Demonstrating the device's physical properties, filtration efficiency, flow rates, and material compatibility.
   • Predicate Device Comparison: Establishing substantial equivalence by showing that the new device has the same intended use, similar technological characteristics, and performs as safely and effectively as the predicate.

7. The sample size for the training set: Not applicable. No AI model is being trained.

8. How the ground truth for the training set was established: Not applicable. No AI model is being trained.

Ask a specific question about this device