(116 days)
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.
| Acceptance Criteria Category | Reported Device Performance Summary (Qualitative) |
|---|---|
| Fluent Inflation Device Design Verification Tests | |
| Ease of Use | Met specified acceptance criteria |
| Pressure | Met specified acceptance criteria |
| Force | Met specified acceptance criteria |
| Plunger Torque | Met specified acceptance criteria |
| Tensile | Met specified acceptance criteria |
| Fluid Capacity | Met specified acceptance criteria |
| Luer Compatibility | Met specified acceptance criteria |
| Extension Tubing Design Verification Tests | |
| Luer Compatibility | Met specified acceptance criteria |
| Pressure | Met specified acceptance criteria |
| Biocompatibility Tests (for both Fluent inflation device and extension tubing) | |
| Cytotoxicity | Passed (required by ISO 10993-1) |
| Sensitization | Passed (required by ISO 10993-1) |
| Irritation/Intracutaneous Reactivity | Passed (required by ISO 10993-1) |
| Acute Systemic Toxicity | Passed (required by ISO 10993-1) |
| Material Mediated Pyrogenicity | Passed (required by ISO 10993-1) |
| ASTM Hemolysis | Passed (required by ISO 10993-1) |
| Complement Activation | Passed (required by ISO 10993-1) |
| Coagulation | Passed (required by ISO 10993-1) |
| In Vitro Hemocompatibility | Passed (required by ISO 10993-1) |
| Thrombogenicity (extension tubing only) | Passed (required by ISO 10993-1) |
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.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.