(79 days)
The Penumbra Embolectomy Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial system. Not for use in the coronaries, the venous system or the neurovasculature.
The Penumbra Embolectomy Aspiration System's fundamental mechanism of action is aspiration. Aspiration draws the embolus or thrombus into the Aspiration Catheter to remove the embolus or thrombus from the body. All Separators function to break up the clot inside of the catheter to make it more amenable to removal from the body via aspiration. The Aspiration Catheter, Separator and Aspiration Tubing are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only.
The provided document describes the Penumbra Embolectomy Aspiration System and its premarket notification for FDA clearance. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing, including biocompatibility, bench-top testing, and animal studies. However, it does not include information about AI/algorithm performance, human reader studies, or explicit acceptance criteria for a device with AI components. The information requested in the prompt, such as acceptance criteria for an AI device, sample sizes for test sets (in the context of AI), ground truth establishment for AI models, and MRMC studies, are not present in this document because the device described is a physical medical device (embolectomy system), not an AI/software as a medical device (SaMD).
Therefore, I will provide the information based on the content available, noting where the requested details are not applicable or not provided.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several non-clinical tests with acceptance criteria being "All established requirements and acceptance criteria were met." and "All established acceptance criteria were met." or specific pass/fail results for biocompatibility.
| Test Category | Specific Test / Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Non-Toxic | Non-Toxic |
| Sensitization | Non-Sensitizing | Non-Sensitizing | |
| Intracutaneous Reactivity (Irritation) | Non-Irritant | Non-Irritant | |
| Systemic Toxicity (Acute) | Non-Toxic | Non-Toxic | |
| Haemocompatibility (Complement Act.) | No greater biological response than corresponding control | No greater biological response than corresponding control | |
| Haemocompatibility (Hemolysis) | Non-Hemolytic | Non-Hemolytic | |
| Haemocompatibility (Coagulation - PT) | No Statistical Difference from control | No Statistical Difference from control | |
| Haemocompatibility (Coagulation - PTT) | No Statistical Difference from control | No Statistical Difference from control | |
| Haemocompatibility (In vivo thrombog.) | Non-Thrombogenic | Non-Thrombogenic | |
| Pyrogenicity | Non-Pyrogenic | Non-Pyrogenic | |
| Bench-top Testing | Visual & Dimensional | All established acceptance criteria were met (based on design specifications, risk analysis, and guidance docs). | All established acceptance criteria were met. |
| Pouch Seal Strength | All established acceptance criteria were met | All established acceptance criteria were met. | |
| Tensile Strength | All established acceptance criteria were met | All established acceptance criteria were met. | |
| Bond Strength | All established acceptance criteria were met | All established acceptance criteria were met. | |
| Hub Air Aspiration | All established acceptance criteria were met | All established acceptance criteria were met. | |
| Burst Test | All established acceptance criteria were met | All established acceptance criteria were met. | |
| Friction Test | All established acceptance criteria were met | All established acceptance criteria were met. | |
| Flow Rate Test | All established acceptance criteria were met | All established acceptance criteria were met. | |
| Elongation Test | All established acceptance criteria were met | All established acceptance criteria were met. | |
| Corrosion Test | All established acceptance criteria were met | All established acceptance criteria were met. | |
| Torsion Test | All established acceptance criteria were met | All established acceptance criteria were met. | |
| Simulated Use | All established acceptance criteria were met | All established acceptance criteria were met. | |
| Particulate Test | All established acceptance criteria were met | All established acceptance criteria were met. | |
| Flexibility | All established acceptance criteria were met | All established acceptance criteria were met. | |
| Animal Study | Vessel Injury (final angiograms) | No vessel injury | No vessel injury was noted. |
| Gross/Histology Findings (test vessels) | No abnormal findings | No abnormal gross or histology findings were noted. | |
| Vascular Response | No significant vascular response | The use of the devices resulted in no significant vascular response. |
2. Sample size used for the test set and the data provenance
This document describes physical device testing, not an AI/algorithm-based device with a "test set" in the computational sense.
- Biocompatibility: Tests were conducted on device materials. The specific number of samples for each test (e.g., number of animals for in vivo tests, number of cell cultures) is not provided.
- Bench-top Testing: Devices were assembled, packaged, and sterilized for mechanical testing. The specific number of devices tested for each parameter is not provided.
- Animal Study: Animal studies were conducted. The specific number of animals used is not provided.
- Data Provenance: The studies were conducted by Penumbra, Inc. (USA) and were part of their 510(k) submission to the FDA. They are considered prospective in the sense that they were designed and executed to fulfill regulatory requirements for the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the studies do not involve expert interpretation of data for AI ground truth. The "ground truth" for the device's performance is established by objective laboratory measurements and observations in animal models. For example:
- Biocompatibility: Standardized laboratory tests (e.g., L929 MEM Elution Test, Kligman Maximization) with clear pass/fail criteria.
- Animal Study: Observations by veterinary professionals and pathologists (e.g., "No abnormal gross or histology findings were noted") whose qualifications are implicit in their role in GLP-compliant studies but not explicitly detailed beyond their observational findings.
4. Adjudication method for the test set
Not applicable. There's no interpretive test set requiring adjudication in the context of an AI algorithm. The tests conducted are objective physical and biological assessments.
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 device is a physical medical instrument, not an AI system or an AI-assisted diagnostic tool that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical embolectomy system, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is based on:
- Regulatory Standards: Compliance with EN ISO 10993 -1 guidelines for biocompatibility and EN ISO 10555-1 for intravascular catheters, as well as FDA guidance documents.
- Objective Measurements: Results from standardized laboratory tests for physical properties (e.g., tensile strength, flow rate) and biological responses (e.g., cytotoxicity, hemolysis).
- In Vivo Observations: Direct observations and histological analysis in animal models (e.g., absence of vessel injury, absence of abnormal gross or histology findings).
8. The sample size for the training set
Not applicable. This device is a physical medical instrument, not an AI system. There is no concept of a "training set" in the context of this device's evaluation.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI algorithm, there is no corresponding ground truth establishment process in this context.
§ 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).