(25 days)
The Rex Medical Cleaner™ Rotational Thrombectomy System is designed for mechanical declotting of synthetic dialysis access grafts.
The Rex Medical Cleaner™ Rotational Thrombectomy System is percutaneous mechanical thrombectomy device which provides an effective means to restore patency to occluded synthetic dialysis access grafts. The device is used in exactly the same manner as the predicate devices.
Based on the provided text, the Cleaner™ Rotational Thrombectomy System is a medical device, and the submission is a Special 510(k) for device modification. This means the device is already cleared, and the submission addresses changes rather than proving initial effectiveness. Therefore, the information typically requested for AI/software-as-a-medical-device (SaMD) studies (like sample size, ground truth, expert adjudication, etc.) is largely "Not Applicable" or not explicitly detailed in this type of submission.
Here's the breakdown of the information as it relates to the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions that "Test methodology and acceptance criteria were derived from within Rex Medical and from related ISO standards for evaluation of this device" for the non-clinical tests. However, the specific acceptance criteria and the detailed results of these tests (e.g., in a table format) are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable/Not provided. The document states "Discussion of Clinical Tests Performed: Not Applicable." This indicates that no clinical studies were performed for this specific 510(k) submission, as it relates to a modification of an already cleared device. The non-clinical tests were likely bench or in-vitro tests, and the "sample size" in that context would refer to the number of devices or components tested, which is not specified.
- Data Provenance: Not applicable/Not provided, as no clinical data is presented for this modification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. Since no clinical studies were performed, there was no need for experts to establish ground truth in the context of clinical performance evaluation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As no clinical studies were performed, no adjudication method for a test set is 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
- MRMC Study: No. This device is a mechanical thrombectomy system, not an AI or imaging diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this product.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: No. This device is a mechanical thrombectomy system, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable for a clinical study. For the non-clinical tests, the "ground truth" would be engineering specifications, physical measurements, and performance benchmarks defined by Rex Medical and ISO standards. The specific details of these are not provided.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This document describes a physical medical device, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
Summary of Device Performance (from the document):
The document states: "The verification testing contained in our submission demonstrates that there are no differences in their technological characteristics due to the device modification, thereby not raising any new issues of safety or effectiveness." This implies that the device, with its modifications, performs identically to the predicate device in terms of safety and effectiveness. The specific details of how this was demonstrated (e.g., quantitative performance data) are not included in this 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).