(25 days)
The Applied Medical Dual-Lumen Embolectorny Catheter is a sterile disposable balloon It is indicated for the removal of arterial thromboemboli, for temporary catheter. occlusion, and for infusion of fluids. It may be used with or without a guidewire.
The Applied Medical Dual-Lumen Embolectorny Catheter is a sterile disposable balloon It is indicated for the removal of arterial thromboemboli, for temporary catheter. occlusion, and for infusion of fluids. It may be used with or without a guidewire. The catheter body features two channels through the length of its main body and includes access ports on the inflation and fluid infusion lumens, a Y connector, and a latex balloon on the distal end. Radiopaque marker bands are proximal and distal to the balloon. A 1cc syringe is supplied with the 3F, 4F and 5F models while a 3cc syringe is supplied with the 6F and 7F models.
The provided text describes a medical device, the Applied Medical Dual-Lumen Embolectomy Catheter, and its claimed substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics, or a study designed to evaluate and report on such criteria. The document is a 510(k) summary, which focuses on establishing substantial equivalence based on design, materials, and intended use.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided input. The input simply states that:
- "Mechanical and biocompatibility tests were performed to verify functional and structural integrity as well as material safety."
- "All testing demonstrates the Applied Medical Dual-Lumen Embolectomy Catheter to be equivalent to the predicate devices and introduces no new safety and effectiveness issues when used as indicated."
Without specific performance metrics (e.g., balloon inflation pressure limits, tensile strength, flow rates, etc.) and their corresponding acceptance limits, a detailed table and study description cannot be generated.
Here's how I would answer your request given the information (or lack thereof):
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document. The document states "Mechanical and biocompatibility tests were performed to verify functional and structural integrity as well as material safety" and that the device is "equivalent to the predicate devices." Specific quantifiable acceptance criteria (e.g., burst pressure, tensile strength, material biocompatibility standards) and the results demonstrating compliance are not provided. | Not specified in the provided document. While tests were performed, the actual performance values against any established criteria are not detailed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in the document.
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)
Not applicable. This device is an embolectomy catheter, not an AI/diagnostic device that requires expert-established ground truth for image interpretation or diagnosis. The "testing" referred to is against mechanical and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically relevant for studies involving subjective clinician assessments or diagnostic interpretations, which is not the case for the testing described here (mechanical and biocompatibility).
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
Not applicable. This is a physical medical device (catheter), not an AI diagnostic tool or system that would be evaluated in an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical tests, the "ground truth" would be the established engineering specifications and material standards for the device and its components (e.g., strength requirements, leakage rates, material composition). For biocompatibility tests, the "ground truth" refers to recognized ISO standards for biological evaluation of medical devices.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML model.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).