(131 days)
The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.
The Penumbra System ACE 64 and ACE 68 Reperfusion Catheters are components to the currently available Penumbra System. The Penumbra System ACE AC 64 and ACE 68 Reperfusion Catheters are used with the Aspiration Pump to aspirate thrombus from an occluded vessel in the neurovasculature. The devices are provided sterile, non-pyrogenic, and intended for single use only.
The provided text describes the Penumbra System ACE 64 and ACE 68 Reperfusion Catheters, which are medical devices intended for revascularization in patients with acute ischemic stroke. The submission is a 510(k) premarket notification, indicating a claim of substantial equivalence to a predicate device.
The document does not contain details about acceptance criteria, reported device performance in terms of clinical outcomes, sample sizes for test or training sets in the context of device performance metrics (like sensitivity/specificity), or the involvement of experts for ground truth establishment for such metrics.
Instead, the "study" described is primarily focused on safety verification through animal testing and a reliance on leveraging non-clinical data from the predicate device due to identical designs.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance:
The document describes acceptability in terms of meeting "established requirements" for the device, primarily related to safety in a vascular model. It does not provide quantitative performance metrics typical for diagnostic or AI-driven devices (e.g., sensitivity, specificity, accuracy).
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| No significant vessel response on contrast angiograms | No significant vessel response was noted. |
| No significant pathological findings during gross/histological evaluation | No significant pathological findings were identified. |
| Meeting all established requirements (Design Validation) | The subject Penumbra System ACE 64 and ACE 68 Reperfusion Catheters met all established requirements. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample size: Not explicitly stated for any "test set" in terms of patient numbers or specific metrics. The study refers to an "accepted porcine vascular model," implying animal subjects. The number of animals used is not specified.
- Data provenance: Porcine vascular model (animal study).
- Retrospective/Prospective: The animal study described is prospective, as it involved evaluating the device in a controlled setting.
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):
- Number of experts: One expert is explicitly mentioned: "Sponsor Pathologist."
- Qualifications: "Sponsor Pathologist." Further specific qualifications (e.g., years of experience, board certification) are not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. The evaluation was performed by a single "Sponsor Pathologist." There is no mention of a multi-reader adjudication process.
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 device (catheter) for mechanical thrombectomy, not an AI or diagnostic software. There is no mention of human readers, AI assistance, or MRMC studies.
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.):
The ground truth for the animal study (safety and vascular response) was established by:
- Contrast angiography findings.
- Gross necropsy and histopathology performed by the Sponsor Pathologist.
8. The sample size for the training set:
Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set."
Summary of what the document does provide:
The document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K142458). The key elements for this claim are:
- Identical design, materials, manufacturing, packaging, and sterilization methods to the predicate.
- Design validation through GLP Animal Testing to assess safety and performance in a "wedged" position using maximum aspiration. The animal study concluded no significant vessel response on angiography and no significant pathological findings.
- Leveraging non-clinical data (biocompatibility, bench-top, sterilization, stability) from the predicate device because the new devices are identical.
The FDA 510(k) clearance process often relies heavily on demonstrating substantial equivalence to a predicate device, which can involve a combination of non-clinical testing and leveraging existing data, rather than requiring extensive new clinical trials or complex performance metrics for novel AI/diagnostic devices.
§ 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).