Search Results

Medisystems Transducer Protectors are single use, disposable prescription devices intended for use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway.

Medisystems Transducer Protectors are designed to be used as protective devices for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.2 µm hydrophobic filter helps prevent cross-contamination by bacteria and particulate matter while preventing the flow of fluids to the machine pressure monitor at pressures less than 600 mmHg.

The provided 510(k) summary describes a medical device, the Medisystems Transducer Protectors, and its asserted equivalence to a predicate device. However, it does not include the kind of detailed study information (acceptance criteria, performance metrics, sample sizes, ground truth establishment, expert involvement, or comparative effectiveness studies) that would typically be found in a submission for a device involving AI or complex performance claims. This summary is for a relatively simple disposable component, and thus the "study" described is primarily quality control and manufacturing process validation rather than a clinical performance study.

Here's an analysis based only on the provided text, highlighting what's not present given the nature of the request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated. The submission refers to "all finished products" being tested as part of the release specifications. This implies a manufacturing quality control process rather than a discrete clinical/performance study with a defined sample size for a test set.
• Data Provenance: Not applicable in the context of clinical or AI-related data. The testing described is part of the manufacturing and quality assurance process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. The "ground truth" for this device's performance comes from its physical properties (0.2 µm filter, hydrophobic nature) and manufacturing quality control tests (sterility, pyrogenicity, physical testing, visual examination) against defined specifications, not from expert interpretation of complex data.

4. Adjudication method for the test set

• Not applicable. There is no expert adjudication process described. The acceptance criteria are objective tests against specifications.

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

• No. This device is a passive mechanical filter. It does not involve AI or human readers, so an MRMC study is not relevant or described.

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

• Not applicable. This device is a passive mechanical filter. There is no algorithm or AI component mentioned.

7. The type of ground truth used

• Objective physical and chemical properties, combined with manufacturing process control specifications. The device's function relies on its 0.2 µm pore size and hydrophobic material. "Ground truth" for its performance is established by demonstrating these properties and verifying manufacturing quality (sterility, pyrogenicity, physical integrity) according to internal procedures and specifications.

8. The sample size for the training set

• Not applicable. There is no training set mentioned, as this device does not involve machine learning or AI.

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

• Not applicable. There is no training set mentioned.

Ask a specific question about this device