(151 days)
The Wallaby Avenir Coil System is intended for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Wallaby Avenir Coil System is also intended for arterial and venous embolization in the peripheral vasculature.
The Wallaby Avenir Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are mechanically detached from the delivery pusher in serial manner until the aneurysm is occluded.
The provided text describes a medical device, the Wallaby Avenir Coil System, and its substantial equivalence to a predicate device. It includes a table of technical characteristics and a summary of performance data from various tests. However, it does not include the specific information requested about acceptance criteria for device performance, particularly related to AI/algorithm performance. It is a submission for a neurovascular embolization device, which is a physical medical device, not an AI/algorithm-driven one.
Therefore, most of the requested information regarding AI/algorithm performance, such as:
- Acceptance criteria related to AI/algorithm performance.
- Study proving device meets acceptance criteria specifically for AI/algorithm performance.
- Sample size and data provenance for AI test set.
- Number of experts and qualifications for AI ground truth.
- Adjudication method for AI test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm-only) performance.
- Type of ground truth for AI.
- Sample size for AI training set.
- How AI training set ground truth was established.
...is not available in the provided document, as it pertains to a physical medical device.
The document states that "All necessary testing has been performed for the Wallaby Avenir Coil System to assure substantial equivalence to the predicate device and demonstrate the device performs as intended." The "Performance Data" table lists various tests conducted, and for each, it states "All devices performed as intended" or similar positive outcomes. These are the "reported device performance" and the "study that proves the device meets the acceptance criteria" in a general sense for a physical device.
Here's the relevant information that can be extracted, largely focusing on the physical device performance rather than AI:
1. Table of acceptance criteria and the reported device performance:
The document doesn't explicitly state quantitative acceptance criteria for each test in a clear table format, except by implying that the device successfully met the "established criteria" or "performed as intended." The "acceptance criteria" are generally derived from relevant standards (e.g., ASTM, ISO, USP) and the intended function of the device to be substantially equivalent to the predicate. The reported performance is consistently positive.
| Test | Implicit Acceptance Criteria (based on "as intended" or "established criteria") | Reported Device Performance |
|---|---|---|
| Dimensional Analysis | Device dimensions meet established specifications. | All devices met the established criteria. |
| Delivery and retrieval Forces | Forces for delivery and retrieval remain within acceptable, characterized limits for safe operation through microcatheter. | All devices performed as intended. |
| Resheathability | Device can be resheathed multiple times under worst-case tortuosity vessel conditions. | All devices performed as intended. |
| Detachment Characterization | Detachment force and reliability are within specified limits; detachment system activates reliably. | All devices performed as intended. |
| Tensile Testing | Stretch resistant member, full system, and detachment wire joint tensile strengths meet specifications. | All devices performed as intended. |
| Coil Stiffness | Coil stiffness characteristics are equivalent to the predicate device. | All devices performed as intended. |
| Physician Simulated Use Validation | Physician users evaluate the device as clinically equivalent to the predicate device in simulated use. | All devices performed as intended. |
| GLP Survival Animal Study | In vivo performance and histopathology metrics are comparable to the predicate device in a chronic canine model. | All devices performed as intended. |
| Pitting Corrosion Resistance (implant) | Meets ASTM F2129 corrosion resistance standards. | All devices performed as intended. |
| Galvanic Corrosion Resistance (implant) | Meets ASTM F3044 galvanic corrosion resistance standards. | All devices performed as intended. |
| Corrosion Resistance (pusher) | Meets ISO 10555-1 and ISO 11070 corrosion resistance standards. | All devices performed as intended. |
| Particulate Testing | Particulate levels (≥10µm and ≥25µm) meet USP 788 criteria. | All devices performed as intended. |
| MR Compatibility | Meets ASTM F2119, ASTM F2213, ASTM F2052, ASTM F2128, and MRA characterization testing requirements for MR conditional status. | Testing demonstrated the device is MR conditional. |
| Packaging and Shelf Life Validation | Sterile barrier integrity and seal strength maintained through labeled shelf life according to ISO 11607-1/-2, ASTM F88, ASTM F1980, ASTM D4169, ISTA 2A, including post-accelerated aging. | Packaging and device demonstrates the ability to perform as intended through the labeled shelf life of the device. |
| Sterilization Validation | Achieves a Sterility Assurance Level (SAL) of 10^-6 per ISO 11135, Annex B Overkill Method. | Sterilization process achieves sterility assurance level of 10^-6. |
| Endotoxin Testing | No interfering factors; endotoxin levels are below 2.15 EU/device per USP 85 and USP 161. | There are no interfering factors associated with the device. The endotoxin levels for the device are below 2.15 EU/device. |
| Biocompatibility Testing (Cytotoxicity, Sensitization, Irritation, etc.) | Various ISO 10993 standards (e.g., ISO 10993-5, -10, -11, -4, -3, -6, -17/-18) met for non-cytotoxicity, non-sensitization, non-irritation, no acute systemic toxicity, non-pyrogenicity, non-hemolysis, satisfactory complement activation, etc. | Non-cytotoxic, Did not elicit sensitization response, Non-irritant, No signs of toxicity, Non-pyrogenic, Non-hemolytic, Satisfactory results, Not greater biocompatibility risk, Non-thrombolytic, Non-mutagenic, Non-clastogenic, Biologically safe. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for most tests (e.g., "All devices performed as intended"). For the GLP Survival Animal Study, it refers to a "chronic canine model" but doesn't specify the number of animals. For particulate testing, it's implied that a statistically relevant sample was tested per USP 788.
- Data Provenance: The animal study was a "GLP Survival Animal Study," implying a controlled laboratory setting. Other tests were "performed on test units representative of finished devices" in a laboratory environment, likely at the manufacturer's facility or a certified contract lab. Country of origin not specified, but the applicant is Wallaby Medical, Inc. in California, USA. The studies are prospective in the sense that they are specifically designed to test the device before market submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical medical device, not an AI/algorithm.
- For the "Physician Simulated Use Validation," it mentions "physician users" but does not specify the number or their qualifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for a physical medical device. The tests are typically objective measurements or observations against established standards.
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 not an AI-assisted device. Therefore, no MRMC study as described was performed. The "Physician Simulated Use Validation" might be seen as a form of human interaction but not in the context of improving human reading with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For physical performance characteristics, the "ground truth" is defined by engineering specifications, material science standards (ASTM, ISO), biological safety standards (ISO 10993), and regulatory requirements for medical devices. For the animal study, histopathology results likely served as a form of ground truth regarding biological response.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).