Search Results

The Fluent inflation device is intended for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.

The Fluent inflation device consists of a barrel with a plunger, locking button, rotating handle, manometer, and high pressure tube with a rotating luer lock. The manometer is graduated between vacuum and 30 atm.

The provided text is a 510(k) premarket notification for a medical device called the "Fluent Inflation Device." It describes the device, its intended use, and claims substantial equivalence to a predicate device based on bench testing. However, it does not contain the detailed information requested regarding acceptance criteria and a study proving those criteria are met in the format of a clinical or AI-based diagnostic study.

Here's an analysis of what can be extracted and what information is missing based on your request:

1. A table of acceptance criteria and the reported device performance

Missing Specifics: The document states that "results of the verification tests met the specified acceptance criteria," but it does not provide the specific quantitative acceptance criteria (e.g., "pressure retention for X minutes with < Y% drop") nor the specific quantitative performance results (e.g., "achieved X PSI and maintained for Y minutes with Z% drop").

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: Not specified for any of the tests.
• Data Provenance: Not specified. This typically refers to a clinical study, but the document only mentions "bench tests."

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)

• Not Applicable: This device is a mechanical inflation device, not a diagnostic imaging or AI device that relies on expert interpretation for ground truth. The "ground truth" for this device would be based on engineering specifications and physical measurements.

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

• Not Applicable: Adjudication methods are typically used in clinical trials or AI studies where human interpretation or consensus is required. For bench testing of a mechanical device, performance is typically measured against pre-defined engineering 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, not done: This is a mechanical device, not an AI or diagnostic imaging device. An MRMC study is irrelevant to this submission.

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

• Not Applicable: This is a mechanical device, not an algorithm.

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

• Engineering Specifications/Physical Measurements: The "ground truth" for a device like this would be its ability to physically perform to its engineering specifications (e.g., maintaining pressure, ease of use measurements, torque values).

8. The sample size for the training set

• Not Applicable: This is a mechanical device, not an AI device that requires a training set.

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

• Not Applicable: No training set or associated ground truth for this type of device.

Summary of what the document does provide regarding the "study":

The study referenced is a series of "bench tests" to evaluate the modified Fluent inflation device's functionality and technological characteristics. The tests performed include:

• Pressure (hand pressurization, repeat hand pressurization, static pressure)
• Force (button lock and unlock)
• Plunger Torque
• Ease of Use

Conclusion:

The provided document is a 510(k) submission for a mechanical inflation device. It describes "bench tests" to demonstrate substantial equivalence to a predicate device. However, it does not contain the detailed clinical or AI-related study information, acceptance criteria specifics, or sample sizes as requested in your prompt. The questions you've posed are largely applicable to AI/diagnostic imaging devices, whereas this submission pertains to a physical, mechanical medical device.

Ask a specific question about this device