(113 days)
The modified Amplatz Thrombectomy Device (ATD) is intended for use in the mechanical dissolution of acute and sub-acute thrombus within dialysis fistulae.
The Amplatz Thrombectomy Device (ATD) is a percutaneous, rotational thrombectomy device consisting of a polyurethane catheter. Inside the catheter, a distal rotor housing contains a small diameter, recessed impeller, attached to a drive shaft. The shaft is connected to a disposable, high speed, air driven motor. An infusion line with luer connector, attached to the proximal motor assembly, allows for infusion of saline through the catheter. A foot pedal/regulator assembly is required to operate the air motor.
The provided document is a 510(k) summary for the Amplatz Thrombectomy Device (ATD). It describes the device, its intended use, and states that it has undergone functional and safety testing to demonstrate substantial equivalence to a predicate device.
However, the document does not contain specific acceptance criteria for device performance or the details of a study proving those criteria were met in the way that would typically be described for clinical performance of a diagnostic device or a AI/ML-based system.
The document primarily focuses on functional and safety testing of modified design features, not clinical outcomes or performance against a specific metric. Therefore, I cannot extract the detailed information requested in your prompt regarding acceptance criteria and performance study specifics.
Here's a breakdown of what can be inferred or what is explicitly missing based on your requested points:
1. A table of acceptance criteria and the reported device performance
- Missing. The document states: "The modified Amplatz Thrombectomy Device (ATD) device has successfully undergone functional and safety testing of new design features, including joint strengths, flow rate tests, burst tests, flexibility tests, device life tests, maceration capability tests, and material biocompatibility tests." It does not provide specific acceptance criteria values (e.g., "joint strength must exceed X N") or the quantitative results achieved for these tests. It concludes that the device "successfully underwent" these tests, implying compliance without detailing the metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Missing. This refers to a clinical performance study, which is not detailed in this 510(k) summary. The testing mentioned (functional/safety) would involve engineering samples, not patient data.
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)
- Not applicable / Missing. This would be relevant for a clinical or diagnostic performance study, which is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Missing. Same as above.
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 / Missing. This is for AI/ML-based systems, and the ATD is a mechanical thrombectomy device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Missing. This is for AI/ML-based systems.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable / Missing. For the functional and safety testing, the "ground truth" would be engineering specifications and standards (e.g., material properties, physical dimensions, burst pressure ratings), not clinical outcomes or expert consensus on medical images.
8. The sample size for the training set
- Not applicable / Missing. This is for AI/ML-based systems, and the ATD is a mechanical thrombectomy device.
9. How the ground truth for the training set was established
- Not applicable / Missing. This is for AI/ML-based systems.
In summary: The provided 510(k) summary is for a mechanical thrombectomy device and focuses on establishing substantial equivalence through functional and safety testing of its design features. It does not include the type of clinical performance study details, expert ground truth establishment, or AI/ML-specific information requested in your prompt.
§ 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).