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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.

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The Fluent inflation device is intended for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter. The sidearm extension tubing is intended to provide a sterile fluid pathway between two devices.

The Fluent inflation device consists of a barrel with a plunger, locking button, rotating handle, manometer, and high pressure tube with a rotating male luer lock. The manometer is graduated between vacuum and 30 atm. The extension tubing is a plastic tube with plastic luer lock connector hubs (one male and one female) at either end. It is available in 25 cm and 50 cm lengths.

This document describes the Fluent inflation device, intended for use during cardiovascular procedures, and its substantial equivalence to predicate devices. It does not contain information about an AI-powered device or a study involving human readers or AI assistance. Therefore, I cannot provide the requested information regarding acceptance criteria and study details related to AI performance.

However, based on the provided text, I can extract the acceptance criteria and the study that proves the Fluent inflation device meets these criteria. Please note that this is NOT an AI device, and therefore several requested sections of your prompt will be marked as "N/A" (Not Applicable).

Here is the information from the provided text about the Fluent inflation device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific quantitative acceptance criteria or detailed reported device performance values in a table format. Instead, it states that the design verification tests "met the specified acceptance criteria" and "passed" the biocompatibility tests.

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

The document does not specify the sample size used for each individual test or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "samples" of the device and extension tubing.

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

N/A. This is a medical device, not an AI model that requires expert annotation for ground truth. The 'ground truth' for device performance is established by meeting predefined engineering and biological specifications through testing.

4. Adjudication method for the test set

N/A. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human readers or AI systems to resolve discrepancies in diagnoses or interpretations. This is a physical medical device.

5. If a multi-reader multicase (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

N/A. This document describes a physical medical device, not an AI software.

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

N/A. This document describes a physical medical device, not an AI algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on predefined engineering specifications, international standards (like ISO 10993-1 for biocompatibility), and regulatory requirements for medical devices of its type. The device's functionality and safety are evaluated against these objective criteria rather than expert consensus on diagnostic images or pathology.

8. The sample size for the training set

N/A. This document describes a physical medical device, not an AI model that requires a training set.

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

N/A. This document describes a physical medical device, not an AI model.

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