(176 days)
Baxter Percutaneous Mechanical Thrombectomy (PMT) Device is indicated for removal of thrombus in synthetic dialysis access grafts.
The Baxter Percutaneous Mechanical Thrombectomy (PMT) Device consists of a 6-French catheter terminating at a stainless steel housing in which a small diameter helical screw is attached to a drive shaft. A battery-operated motor rotates a flexible drive shaft connected to the helical screw at approximately 3,100 rpm. A central lumen within the device is provided for guidewire placement or infusion of fluids.
The provided text is a 510(k) summary for the Baxter Percutaneous Mechanical Thrombectomy (PMT) Device and an FDA clearance letter. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, or the other specific information requested in your prompt (e.g., sample sizes, ground truth establishment methods, MRMC study details).
Here's an attempt to answer your questions based only on the provided text, highlighting what is missing or cannot be inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | As safe and effective as the predicate device (MICROVENA Amplatz Thrombectomy Device (ATD)) for the removal of thrombus within synthetic dialysis access grafts. |
Missing Information: The document states that clinical studies "demonstrated" the device is as safe and effective as the predicate, but it does not provide quantitative acceptance criteria (e.g., a specific percentage of thrombus removal, a certain patency rate, or a defined complication rate). It also does not present detailed performance metrics for the Baxter PMT Device.
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified.
- Data Provenance: The study is referred to as "clinical studies," implying human data, but no country of origin or whether it was retrospective or prospective is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
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
- MRMC Comparative Effectiveness Study: Not mentioned. This device is a mechanical thrombectomy device, not an AI or imaging interpretation device, so an MRMC study is not relevant in this context.
- Effect Size of AI: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a medical device for mechanical thrombus removal, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Implied to be clinical outcomes related to "safety and effectiveness" in thrombus removal, but the specific metrics or "ground truth" used (e.g., successful removal confirmed by subsequent imaging, patency rates, complication rates) are not detailed.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable. This document describes a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
Summary of what the document does state about the study:
- Study Type: "Clinical studies" were performed.
- Purpose: To demonstrate that the Baxter Percutaneous Mechanical Thrombectomy (PMT) Device is "as safe and effective as the predicate device for the removal of thrombus within synthetic dialysis access grafts."
- Predicate Device: MICROVENA Amplatz Thrombectomy Device (ATD).
- Additional Testing: The device also underwent "design validation, as well as functional, animal and clinical testing."
The provided text serves as a regulatory summary indicating substantial equivalence, rather than a detailed scientific publication of study results. Therefore, many of the specific details requested about acceptance criteria and study methodology are not present.
§ 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).