(341 days)
The Amplatz Thrombectomy Device is intended for mechanical dissolution of acute and subacute thrombus in dialysis fistulae. This device is not intended to be used for the removal of atheroma and is contraindicated in coronary, cerebral, and pulmonary vessels.
The Amplatz Thrombectomy Device is a polyurethane catheter that contains a distal rotor housing in which a small diameter, recessed impeller is attached to a drive shaft. The shaft is connected to a disposable, high-speed air-driven motor. An infusion line with luer connector, attached to the proximal casing, allows infusion of saline, contrast medium, or thrombolytic medications.
This document, K954205, is a 510(k) summary for the Amplatz Thrombectomy Device. It describes the device's intended use and provides a summary of its comparative analysis. However, it does not contain the detailed acceptance criteria or the specific study details needed to fully answer your request.
The 510(k) summary states: "It has been demonstrated (through clinical studies) that the ATD is as safe and effective as surgery for the removal of acute and subacute thrombus within dialysis fistulae." and "The Amplatz Thrombectomy Device has successfully undergone design validation, animal, and clinical testing."
To provide the information you requested, I would need access to the actual clinical study report that was submitted to the FDA, which is not available in this summary.
Based on the provided text, I can extract the following limited information, but please note that most of your requested details are not present in this 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| As safe as surgery for removing acute and subacute thrombus in dialysis fistulae. | Demonstrated to be as safe as surgery. |
| As effective as surgery for removing acute and subacute thrombus in dialysis fistulae. | Demonstrated to be as effective as surgery. |
Note: The actual quantitative acceptance criteria (e.g., specific success rates, complication rates, freedom from re-thrombosis rates) are not provided in this summary. The summary only broadly states "as safe and effective as surgery."
Regarding the rest of your questions, the information is not available in this 510(k) summary.
Here's why and what's missing:
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The summary mentions "clinical studies" but does not provide sample sizes, study design (retrospective/prospective), or data provenance.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- 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 device is a mechanical thrombectomy device, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers improving with AI assistance is not applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's a mechanical device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): While it mentions demonstrating safety and effectiveness compared to surgery, the exact "ground truth" used for effectiveness (e.g., angiographic clearance, patency rates, clinical success defined by specific metrics) is not detailed.
- 8. The sample size for the training set: Not applicable for a traditional medical device like this in the context of AI/algorithms. If "training set" refers to early development or pilot studies, that information is not provided.
- 9. How the ground truth for the training set was established: Not applicable.
To obtain the specific details of the clinical studies and their outcomes, you would need to refer to the full 510(k) submission or any published literature related to the Amplatz Thrombectomy Device from that period.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).