(94 days)
The Penumbra System™ is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.
The Penumbra System consists of four devices that work as a system to remove thrombus including the Penumbra Reperfusion Catheter, Penumbra Separator, and Aspiration Tubing. The Penumbra System is used with the Penumbra Aspiration Pump (K051758). Materials used in the Penumbra System devices are manufactured from medical grade materials that are commonly used in the industry, are similar or identical to the predicate devices, and have historically been demonstrated to be both biocompatible and suitable for this use.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific acceptance criteria or report a direct device performance metric in a quantifiable manner (e.g., a specific percentage of primary endpoint success that the device had to meet). Instead, it states that the device "met the specifications and the outcome measures of the clinical protocol."
The document focuses on demonstrating substantial equivalence to predicate devices. This means the acceptance criteria are implicitly linked to the performance and safety profile of the predicate devices. The "performance" reported is that the device was found to be substantially equivalent.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Bench testing, in vitro testing, in vivo testing, and a clinical study have been performed..." However, it does not specify the sample size used for the clinical study (test set).
Regarding data provenance, the document does not explicitly state the country of origin or whether the study was retrospective or prospective. Given it's a 510(k) submission to the FDA, it's highly likely to be a prospective clinical study, though this is not explicitly confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used to establish ground truth for the test set or their specific qualifications. It only refers to a "clinical study" without detailing its design or evaluation methodology.
4. Adjudication Method for the Test Set
The document does not provide information on any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Therefore, no effect size of human readers improving with or without AI assistance is reported. This is logical as the device is a medical device (catheter system) for mechanical thrombectomy, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
The document does not describe a standalone (algorithm-only) performance study. The Penumbra System is a physical medical device (catheter) used in a medical procedure, not an algorithm.
7. Type of Ground Truth Used
The document refers to a "clinical study" and "outcome measures of the clinical protocol." For a device like the Penumbra System, the ground truth for revascularization would typically be established by:
- Imaging results: Post-procedure angiographic assessments (e.g., TIMI score, mTICI score) to determine the degree of reperfusion.
- Clinical outcomes data: Such as modified Rankin Scale (mRS) scores at 90 days to assess functional independence, and potentially NIHSS scores to assess neurological deficit.
However, the document does not explicitly state the specific type of ground truth used, beyond implying it followed clinical protocol outcomes.
8. Sample Size for the Training Set
The document does not mention a "training set" as it is describing a physical medical device and its clinical evaluation, not an AI model.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (see point 8), this information is not applicable to the provided document.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).