(185 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™ consists of three 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.
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 an analysis of the provided text regarding acceptance criteria and studies for the Penumbra Reperfusion Catheter 054 and Penumbra Separator 054:
The provided 510(k) summary (K090752) for the Penumbra Reperfusion Catheter 054 and Penumbra Separator 054 does not include detailed acceptance criteria or the specifics of a study proving device performance against such criteria in the way typically expected for an AI/ML device.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through various forms of testing, implying that if these tests are passed, the device is considered acceptable. The information provided is characteristic of a medical device submission that relies on engineering and material performance rather than diagnostic or prognostic accuracy as would be the case for AI.
Therefore, many of the requested fields regarding acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable or not detailed in this document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Materials are common, similar to predicate, and historically safe. | Materials are manufactured from medical grade materials commonly used, similar or identical to predicate devices, and have historically been demonstrated to be biocompatible and suitable for this use. |
| Functionality/Performance: Device materials, design, and final assemblies meet specifications. | Bench testing, in vitro testing, and in vivo testing have been performed on the device materials and final assemblies. The devices tested acceptably met the specifications. |
| Substantial Equivalence: Intended use, methods of operation, construction, and materials are identical or substantially equivalent to predicate devices. | The Penumbra Reperfusion Catheter 054 and Penumbra Separator 054 are substantially equivalent to the predicate devices. |
2. Sample sized used for the test set and the data provenance
- Not explicitly stated. The document mentions "bench testing, in vitro testing, and in vivo testing" but does not specify sample sizes or data provenance for these tests. Given the nature of a catheter, "in vivo" testing could refer to animal studies or potentially human clinical data from the predicate devices if used for equivalence, but this is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not stated. This device is a mechanical thrombectomy device, not a diagnostic AI/ML system that requires expert interpretation for a "gold standard" ground truth. The "ground truth" here would relate to engineering specifications and performance metrics rather than medical diagnosis.
4. Adjudication method for the test set
- Not applicable / Not stated. No mention of adjudication, as it's not a diagnostic system requiring expert consensus on findings.
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
- No. This is a medical device, not an AI assistance system, so MRMC studies for human reader improvement are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a standalone medical device (catheter system), but it's not an algorithm being tested for performance. Its performance is inherent to its design and mechanical function, used by a human clinician.
7. The type of ground truth used
- Implied Engineering/Performance Specifications: The "ground truth" for this device would be established engineering specifications, material properties, and mechanical performance targets. For example, catheter dimensions, tensile strength, flow rates, and thrombus removal efficacy in an in-vitro model. The clinical efficacy, while an outcome from use, is primarily demonstrated through substantial equivalence to existing devices that have established clinical utility.
8. The sample size for the training set
- Not applicable / Not stated. As this is not an AI/ML device, there is no "training set" in the computational sense. The design and manufacturing process would involve extensive iteration and testing, but these are not referred to as training sets.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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).