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For breaking apart and removing thrombus from hemodialysis access grafts.

The XTD™ Thrombectomy Catheter is a sterile, single-use, disposable catheter designed to simultaneously fragment and remove thrombus from clotted hemodialysis access grafts. The catheter consists of a flexible, spiral-conveyor shaft rotating within a plastic sheath. The shaft has a small, flexible, curved agitator which extends out of the sheath. As the agitator rotates it breaks the thrombus to particles are aspirated into the sheath and are conveyed by the rotating spiral shaft through the sheath to a collection line connected to a disposable vacuum syringe. A pinch clamp on the collection line isolates the svringe and allows the operator to manually control the delivery of suction to the catheter tip. The battery supply and a luer connection for the syringe are incorporated directly onto the catheter.

This document is a 510(k) premarket notification for the XTD™ Thrombectomy Catheter, issued by the FDA. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting formal acceptance criteria and a detailed study proving the device meets them in the way clinical studies for AI/software devices typically do.

Therefore, much of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication, MRMC studies, standalone performance, and ground truth establishment for this specific device (a physical medical device, not an AI/software product) is not directly present in the provided text.

However, I can extract the relevant information from the document as it pertains to the safety and effectiveness testing conducted for this device.

Here's a breakdown based on the provided text, addressing what can be inferred and what is not applicable:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with specific numerical thresholds for performance. Instead, it states that "Test results have demonstrated conformance of the XTD™ Thrombectomy Catheter to its specification requirements." The general acceptance criterion is demonstrating substantial equivalence to the predicate device and meeting its own specifications.

2. Sample sizes 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 document. The testing described (mechanical bench, battery life, electrical safety, electrical emissions, ship testing) refers to physical device characteristic testing, not clinical data or a "test set" in the context of an AI/software 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 device is a physical thrombectomy catheter, not an AI/software product requiring expert-established ground truth on clinical images or data. The "ground truth" here would be the physical specifications and performance under various engineering tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the type of device and testing described.

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. An MRMC study is relevant for AI-assisted diagnostic or interpretative devices. The XTD™ Thrombectomy Catheter is a therapeutic surgical tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical catheter used by a human operator, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this physical device, the "ground truth" or reference standards for the performance testing would be:

• Engineering specifications and validated test methods for mechanical, electrical, and battery performance.
• Established regulatory standards for electrical safety and emissions.
• Industry standards for ship testing (packaging integrity).
• The performance characteristics of the legally marketed predicate device against which substantial equivalence is claimed.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI/software product that requires a training set.

9. How the ground truth for the training set was established

This is not applicable.

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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.

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