(32 days)
The AMPLATZER™ TorqVue™ LP Catheter is intended 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 Catheter (TVLPC) is an extension of the AMPLATZER TorqVue Low Profile Delivery System (TVLP) product line. The TVLPC is identical to the TVLP with the exception of a delivery wire, which is omitted on the TVLPC catheter only product. The TorqVue LP Catheter includes a catheter, loader, Tuohy-Borst hemostasis valve, and a self-sealing hemostasis valve. The TorqVue LP Catheter is intended for use with AMPLATZER devices packaged with a delivery wire. Figure 1 illustrates the delivery system and identifies the following essential components: Catheter – Single-lumen catheter that is used to deliver the device after it has . been positioned by the physician. The body of the catheter is radiopaque to increase visibility when using fluoroscopy. The distal end of the catheter is curved approximately 90°. Tuohy-Borst hemostasis valve – An adapter designed to control back-bleeding ● from the Delivery Catheter. . Loader - catheter short tube with luer fittings that aids in placing the desired devices into the Delivery Catheter. ● Self-sealing hemostasis valve - An adapter designed to control back-bleeding from the Delivery Catheter. The self-sealing valve provides additional sealing capabilities for use with delivery wires of smaller diameters.
The provided text is a 510(k) Summary for a medical device (AMPLATZER TorqVue Low Profile Delivery Catheter). It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, it does not include information about acceptance criteria for a study, nor does it detail a study that proves the device meets specific performance criteria in the way an AI/ML device would be evaluated.
The document is a submission to the FDA for market clearance, not a study report. It focuses on demonstrating equivalence to existing devices rather than proving novel performance.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as the document does not contain this type of data.
To directly answer your numbered points based only on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present in the document. The document describes functional and safety testing as being performed and provided in cleared applications for predicate devices, implying that the current device leverages those existing approvals for its components.
- Sample sized used for the test set and the data provenance: Not applicable. The document refers to "Design Verification and Design Validation testing" performed on predicate devices, but doesn't specify test set sizes or data provenance for the current device's performance claims.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This type of information is not relevant for the kind of device and submission described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a clinical study involving human assessment of outcomes for a test set.
- 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: Not applicable. This is not an AI/ML device, and no MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical catheter, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of device performance in a clinical setting for this type of device. The "ground truth" would be engineering specifications and safety standards for the functional components.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
§ 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).