(121 days)
The AMPLATZER TorqVue Low Profile Delivery System is indicated to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.
The AMPLATZER TorqVue Low Profile Delivery System is a sterile, single-use device designed to facilitate the introduction of devices to chambers and coronary vasculature of the heart and for introducing therapeutic devices to a location within the peripheral vasculature. The catheter has a single lumen for passage of devices with maximum outer diameters of 4 and 5 French. The catheters will be provided in 60 cm and 80 cm usable lengths. The system includes the following components: Delivery Catheter, Loader, Delivery Wire (optional), Plastic Vise (included with delivery wire), Hemostasis Valve.
The provided text describes the PMA for the AMPLATZER TorqVue Low Profile Delivery System. However, it does not include information about acceptance criteria, reported device performance in a table, or study details such as sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC). The submission is for a medical device (delivery system), not an AI/ML-based device, hence, many of the requested fields are not applicable.
Here's the information that can be extracted from the provided text, along with notes on what is not available due to the nature of the submission (a medical device 510(k) for a delivery system, not an AI/ML product):
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly state acceptance criteria in a table format with corresponding reported performance values. Instead, it states that "Verification and validation testing confirms that the functional characteristics of the AMPLATZER® TorqVue® Low Profile Delivery Systems are substantially equivalent to the predicate devices cited."
The testing included:
- Catheter integrity
- Catheter kink resistance
- Leak resistance
- Hub strength
- "The ability to deliver various implantable devices."
The implication is that the performance met the standards of the predicate devices for these functional characteristics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided in the document. The submission references "laboratory verification tests and in vitro performance information," but offers no details on sample sizes or data provenance for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable/not provided. For a medical device like a delivery system, "ground truth" as typically defined for AI/ML algorithms (e.g., expert consensus on image interpretation, pathology reports) is generally not relevant. The verification and validation testing would have involved engineering and functional tests to ensure the physical device met its design specifications and performance claims.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable/not provided. Adjudication methods are typically used in studies involving human interpretation or consensus for subjective assessments, which is not the primary focus of the engineering tests performed on a delivery system.
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:
This information is not applicable. This is a submission for a physical medical device (delivery system), not an AI software. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this medical device would be based on engineering specifications and established performance standards for medical catheters and delivery systems, demonstrating functional characteristics like integrity, kink resistance, leak resistance, hub strength, and delivery capability. It's not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic device would be.
8. The sample size for the training set:
This information is not applicable/not provided. This is not an AI/ML device that requires a training set. The device's performance is based on its physical design and manufacturing.
9. How the ground truth for the training set was established:
This information is not applicable/not provided. As above, no training set for an AI/ML algorithm is involved.
§ 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).