(30 days)
The ACUITY™ Cut-Away™ Lead Delivery System is intended to access the coronary venous system and may be used alone (8F or 6F) or in a dual catheter delivery (8F and 6F). The system serves as a conduit for the delivery of contrast medium and devices, including implantable coronary venous leads, introduced into the coronary venous system.
The ACUITY™ Cut-Away™ Guide Catheters are designed for venous use to aid in the selective placement of cardiac resynchronization therapy (CRT) implantable venous leads in the cardiac vasculature.. The catheter shafts are comprised of an inner liner of polytetrafluoroethylene (PTFE), a reinforcing layer of 304V stainless steel braid, and an outer jacket of radiopaque bismuth subcarbonate-loaded polvether block amide (PEBAX). This construction creates a thin catheter wall that is pushable, steerable, and kink-resistant. The stiffness of the PEBAX jacket changes along the catheter from more stiffness proximally to less distally.
A radiopaque PEBAX tip is thermally attached to the distal end of the quide catheter shaft. This tip consists of a layer of tungsten loaded PEBAX co-extruded with an outer layer of bismuth subcarbonate-loaded PEBAX.
A PEBAX hub is attached to the proximal end of the shaft. One wing of the hub is used for the orientation of the curve shape relative to the hub.
The approximate working length of the catheter is 69-74 cm.
The provided text describes a 510(k) premarket notification for the ACUITY™ Cut-Away™ Guide Catheter. It details the device, its intended use, and substantial equivalence to predicate devices, but it does not contain information related to an AI/ML device or its performance.
Therefore, I cannot provide details on the acceptance criteria and study that proves an AI/ML device meets them, as the input document is for a medical device that is not an AI/ML device. The document primarily describes non-clinical testing for a physical medical catheter.
Based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various non-clinical tests performed, but it does not provide specific acceptance criteria values or detailed quantitative results for each test. It only states that testing was performed to "verify the performance and usability" and that the device "remains substantially equivalent" to predicate devices.
| Acceptance Criteria (Implied by testing categories) | Reported Device Performance (Summary) |
|---|---|
| Hub Separation Performance | Verified (implicitly met performance/usability) |
| Hub Cutting Performance | Verified (implicitly met performance/usability) |
| Hub Internal Diameter Conformity | Verified (implicitly met performance/usability) |
| Particulates Presence | Verified (implicitly met performance/usability) |
| Biocompatibility | Verified (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity (Acute), Hemocompatibility, Latex, USP Physicochemical testing) |
| Usability of Multiple Catheter Shapes & Lengths | Verified (implicitly met performance/usability) |
| Compatibility with Accessories & Adjunctive Devices | Verified (implicitly met performance/usability) |
| Torquability | Verified (implicitly met performance/usability) |
| Pushability & Shaft Stiffness | Verified (implicitly met performance/usability) |
| Product Marking & Identification | Verified (implicitly met performance/usability) |
| Catheter Removal | Verified (implicitly met performance/usability) |
| Product Integrity | Verified (implicitly met performance/usability) |
| Radiopacity | Verified (implicitly met performance/usability) |
| Ease of Removal of Device & Accessories from Packaging | Verified (implicitly met performance/usability) |
| Animal Testing Performance | Performed to verify performance and usability |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified. The document only mentions "mechanical bench testing, and animal testing" but does not give the number of units or animals tested.
- Data Provenance: Not applicable in the context of AI/ML data. The data provenance would be from laboratory bench tests and animal studies. No country of origin for such data is specified. The studies were likely prospective in nature (i.e., designed and executed to test the device).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This device is not an AI/ML device, so there is no notion of "ground truth" established by experts in the context of image interpretation or diagnostic accuracy. Performance was assessed through engineering and biological testing.
4. Adjudication Method for the Test Set:
- Not applicable. No adjudication method is mentioned as it's not relevant for this type of device and testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is not an AI/ML device, and no MRMC study was performed. The document explicitly states: "Clinical Evaluation was not required for these devices."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used:
- Not applicable in the AI/ML sense. For this physical catheter, the "ground truth" for performance would be objective measurements against design specifications and established safety/performance standards (e.g., strength, durability, biocompatibility test results).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).