(209 days)
The AKónya Eliminator™ Mechanical Thrombectomy Device is indicated for use in the mechanical declotting of synthetic dialysis grafts.
The AKónya Eliminator™ Mechanical Thrombectomy Device is comprised of three discrete elements:
- An outer member, connected distally to the proximal end of the thrombasket. The proximal end is connected to a hemostasis Y-connector, having a side port for flushing, and a Tuohy-Borst connector on the central port for securing to hypotube, as an aid for handling during the surgical procedure.
- An inner member, connected distally to the distal end of the thrombasket. Proximally, the inner member is connected to a handle.
- A thrombasket, composed of woven or braided stainless steel wire.
The provided text describes the AKónya Eliminator™ Mechanical Thrombectomy Device and its 510(k) summary for substantial equivalence to a predicate device. However, the document does not contain explicit acceptance criteria or a study designed to directly prove the device meets specific performance criteria in a quantitative manner that would be typically presented in a table.
Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Arrow-Trerotola™ PTD) through comparisons of technological characteristics and successful completion of various non-clinical performance tests.
Here's a breakdown of the information that can be extracted, and where the requested details are missing:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned above, the submission does not present a table of quantitative acceptance criteria with corresponding performance metrics for the AKónya Eliminator™ in the context of clinical efficacy or specific functional thresholds beyond basic engineering tests.
The document discusses "functional and safety testing requirements to ensure substantial equivalence," and lists several non-clinical tests:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accelerated Aging / Packaging: | Device and packaging materials sustained 1-year shelf life. Tests |
| - Effects on device & packaging | included Seal Peel, Burst, Dye Penetration, and device functionality post-aging. |
| - 1-year shelf life substantiated | |
| - Package Seal Peel, Burst, Dye Penetration, device functionality | |
| Packaging / Shipping Integrity: | Successfully withstood shipping & transportation environments. |
| - Survivability of device packaging & construction materials | |
| Dimensional / Flexibility / Pushability: | Met dimensional requirements as defined in product specification. |
| - Pushability and trackability comparable to predicate | |
| - Dimensional requirements from product specification met | |
| Tensile: | Met minimum tensile strength requirements at all joints as defined in product specification. |
| - Minimum tensile strength at all joints met | |
| Fatigue: | Fatigue life determined (no specific value given, but implied met requirements). |
| - Fatigue life determined | |
| Biocompatibility: | Potential toxicity from component materials evaluated (implied acceptable). |
| - Potential toxicity evaluated | |
| Animal Study: | Evaluated safety and efficacy, and operational characteristics with respect to predicate device. |
| - Safety and efficacy | |
| - Operational characteristics vs. predicate |
Note: The "acceptance criteria" here are implied by the successful completion of the tests and the statement of substantial equivalence. No specific numerical thresholds or target values are provided in this document.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for any clinical or direct performance test. The submission mentions an "Animal Study" which would involve a sample size of animals, but this size is not provided.
- Data Provenance: The tests listed are explicitly non-clinical performance testing and an Animal Study. This indicates the data is from laboratory and animal model environments, not human data. The geographical origin of these studies is not specified, but given the submitter's location (Houston, Texas) and the FDA filing, it's likely U.S.-based. The studies appear to be prospective in nature, as they involve testing the new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This section is relevant for studies involving human interpretation (e.g., radiologist reads) where a "ground truth" needs to be established, typically through expert consensus or biopsy. Since the primary evidence presented is non-clinical (engineering tests, animal study), there is no mention of experts establishing ground truth for a test set in this context. The "ground truth" for these tests would be the physical properties and performance measured by the testing equipment.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this concept typically applies to human-read studies where discrepancies between readers might occur and need resolution. For non-clinical and animal studies, adjudication methods in the sense of expert consensus on interpretations are not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention any clinical study, let alone an MRMC study, comparing human readers with and without AI assistance for this mechanical thrombectomy device. This type of study is not relevant for this device submission which focuses on substantial equivalence through non-clinical and animal testing.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Not applicable. This device is a mechanical thrombectomy device, meaning it is a physical instrument for medical intervention, not an AI algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this product.
7. Type of Ground Truth Used
For the non-clinical tests (Accelerated Aging, Packaging, Dimensional, Tensile, Fatigue, Biocompatibility), the "ground truth" is established by physical measurements, material analysis, and adherence to predefined product specifications and industry standards.
For the Animal Study, the "ground truth" would be established by direct observation of safety and efficacy within the animal model, possibly through histological analysis or outcome measures specific to the animal study design (which are not detailed here).
8. Sample Size for the Training Set
Not applicable. This question pertains to machine learning models. The AKónya Eliminator™ is a physical medical device, not an AI algorithm, and therefore does not have a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).