(139 days)
For breaking apart and removing thrombus from hemodialysis access grafts.
The XTD™ Thrombectomy System consists of the XTD™ Thrombectomy Catheter has a flexible, rotating spiral conveyor shaft contained within a plastic sheath, a Control Console, and a disposable Collection Bottle. As the agitator rotates it macerated thrombus within the graft and the rotating spiral conveyor shaft conveys the macerated thrombus through the sheath, assisted by negative pressure, to a disposable Collection Bottle. The Control Console provides power and control of the catheter operation.
The provided text describes the XTD™ Thrombectomy System and its 510(k) summary for FDA clearance. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, device performance metrics, study design specifics (sample sizes, data provenance, expert details, adjudication methods), or comparative effectiveness studies.
Based on the provided text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in the document. The document generally refers to "specifications" and "claims of substantial equivalence."
- Reported Device Performance:
- "Test results have demonstrated conformance of the XTD™ components to their specification."
- "Performance testing has demonstrated that the XTD™ Thrombectomy System is as safe and effective as the legally marketed predicated devices."
- These are qualitative statements, not quantitative performance metrics against specific acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not mentioned. The document states "Human Clinical Testing" was performed but gives no details about the number of subjects or cases.
- Data Provenance (country of origin, retrospective/prospective): Not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- 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, and Effect Size
- Not mentioned. The document only states the device is "as safe and effective as the legally marketed predicated devices," implying a comparison, but it doesn't describe an MRMC study or quantify any effect size.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This device is a physical medical device (thrombectomy system), not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" is not applicable here. Performance testing would refer to the device's mechanical, electrical, and biological safety and efficacy when used by an operator.
7. The Type of Ground Truth Used
- Not explicitly stated for clinical trials. For in-vitro and in-vivo (animal) testing, "specifications" are mentioned, which would serve as a form of ground truth for those tests (e.g., efficacy in removing thrombus in a controlled setting). For "Human Clinical Testing," the ground truth likely involved clinical outcomes (e.g., successful thrombus removal, complication rates) compared to the predicate device, but this is not detailed.
8. The Sample Size for the Training Set
- Not applicable as this is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable as this is a physical medical device.
Summary of Conducted Performance Testing (from the document):
- Mechanical Strength Testing
- Fatigue Strength Testing
- Electrical Safety Testing
- Biocompatibility Testing
- In-vitro Performance Testing
- In-vivo (animal) Testing
- Human Clinical Testing
Conclusion:
The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through various types of testing, but it lacks the detailed quantitative performance metrics, study design specifics, and expert-related information that your prompt requests. This level of detail is typically found in full study reports or more comprehensive regulatory submissions, not usually in a high-level 510(k) summary.
§ 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).