(29 days)
The ACUITY™ Pro Lead Delivery System is intended to access the coronary venous system, and may be used alone (9F) or in a dual catheter delivery (9F with 7F). The catheter 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™ Pro Lead Delivery System is 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 a PTFE inner liner, a reinforcing layer of stainless steel braid, and an outer polymer jacket. The distal end has a radiopaque polymer tip, while the proximal end has a hub with flush luer fitting to allow flush, contrast injection and aspiration polymer.
The approximate working lengths of the catheters are 45-54cm for the 9F design and 60-69 cm for the 7F design.
The ACUITY Pro 9F is provided with the following accessories: 0.014 inch guidewire torquer, 0.014 inch guidewire introducer, ACUITY™ Universal Cutter, two transvalve introducer tools, and a venous access dilator
The provided document is a 510(k) summary for a medical device called the ACUITY™ Pro Lead Delivery System. This type of document is for a medical device, not an AI model or software. Therefore, the questions related to AI/algorithm performance (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance) are not applicable.
The document discusses the substantial equivalence of the ACUITY™ Pro Lead Delivery System to a previously cleared predicate device (K132914). The key change in the new device is a modified hub seal design and material. The "acceptance criteria" here refers to demonstrating that this modified device performs as safely and effectively as the predicate device for its intended use.
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a direct "table of acceptance criteria" with specific numerical thresholds, but rather lists the types of performance tests conducted and concludes that the device continues to meet specifications and user requirements. The reported performance is that the device "continues to meet the specification requirements impacted by the design change as well as meet the new product specification requirement for air aspiration" and that "no new safety or performance issues were raised."
| Acceptance Criteria Category | Tests Performed | Reported Device Performance |
|---|---|---|
| Functional/Performance | - Ancillary Device Passage through Valve |
- 7F Catheter Passage through 9F Valve
- Hub Valve Hemostasis/Static Leak
- Air Aspiration | Met specification requirements for design changes and new air aspiration requirement. No new safety/performance issues raised. |
| Usability | - Catheter provides a conduit/back-up support for other devices to pass - Catheter is able to be removed by cutting | Continues to meet all user requirements. |
| Biocompatibility/Chemical Safety | - Volatile/Semi-volatile organic compounds observed by GC-MS - Non-volatile organic compounds observed by LC-MS | Extractable species in modified hub seal material and process do not pose an increased chemical safety risk when compared to predicate seal material. |
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 summary. The testing described is bench testing, which typically involves a certain number of devices or components. The document doesn't specify the sample sizes for these tests, nor the "provenance" in the sense of patient data, as this is a physical device evaluation.
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)
This is not applicable as the document describes bench testing of a physical medical device, not a diagnostic AI or algorithm requiring expert-established ground truth on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the document describes bench testing of a physical medical device, not a diagnostic AI or algorithm requiring adjudication of clinical interpretations.
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 is not applicable. This document describes the regulatory clearance of a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document describes a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on engineering specifications and established performance requirements for similar percutaneous catheters, as demonstrated through various bench tests (e.g., measuring leak, force, materials properties). The comparison is largely against the performance of the predicate device (K132914).
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of this physical medical device. The device's design and manufacturing processes are validated through engineering and design controls, not machine learning training.
9. How the ground truth for the training set was established
This is not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it is irrelevant in this context.
§ 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).