(111 days)
The Amplatz Thrombectomy Device (ATD) is intended for use in the mechanical dissolution of acute and subacute thrombus within dialysis fistulae.
The Amplatz Thrombectomy Device (ATD) is a percutaneous, thrombectomy device consisting of a catheter, a small diameter impeller encased in a distal housing, and a driveshaft. The driveshaft is the connection between the impeller and a disposable, high speed, air driven motor. An infusion line with luer connector, attached to the proximal motor housing, allows infusion of saline. A foot pedal/regulator assembly is required to operate the air motor.
Here's an analysis of the provided text regarding the Amplatz Thrombectomy Device's acceptance criteria and study information, specifically noting the absence of certain data as this is a 510(k) summary and approval letter, not a detailed clinical study report:
This 510(k) submission for the Amplatz Thrombectomy Device focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with acceptance criteria for device performance as one might see for a diagnostic AI device. Therefore, much of the requested information (like specific performance metrics, sample sizes for test/training sets, expert qualifications, etc., which are typical for AI/diagnostic device evaluations) is not present in this type of regulatory document.
However, based on the provided text, here's what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | "Substantially equivalent to the Predicate ATD." |
| Functional and Safety Testing of New Design Features (Joint strengths, flow rate, flexibility, material biocompatibility) | "successfully undergone functional and safety testing of new design features, including joint strengths, flow rate tests, flexibility tests, and material biocompatibility tests." |
| Intended Use: Mechanical dissolution of acute and subacute thrombus within dialysis fistulae | Device is intended for this use. (Performance to achieve this is implied by substantial equivalence) |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document refers to "functional and safety testing" rather than a clinical human-subject test set as understood for AI performance.
- Data Provenance: Not specified. The testing likely occurred in a laboratory setting or on simulated models for functional and safety aspects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable to this type of submission. This document describes the acceptance of a medical device based on engineering and safety tests, and equivalence to a predicate, not performance against an established ground truth in a diagnostic context.
4. Adjudication method for the test set
- Not applicable. (See answer to point 3).
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 device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a thrombectomy device, not an algorithm or AI. The device operates mechanically.
7. The type of ground truth used
- For the functional and safety testing: Engineering specifications, material standards, and possibly performance benchmarks against the predicate device.
- For the overall regulatory decision: Substantial equivalence to a legally marketed predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. (See answer to point 8).
Summary of what the document IS:
This is a 510(k) premarket notification for the Amplatz Thrombectomy Device. The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed "predicate device." This usually involves comparing the new device's technological characteristics, indications for use, safety, and effectiveness to the predicate. Clinical studies with detailed performance metrics and ground truth establishment (as described in your questions) are more common for novel devices or those seeking PMA approval, or for AI/diagnostic devices where performance metrics are critical for regulatory acceptance.
In this case, the "study" is the submission demonstrating substantial equivalence, supported by functional and safety testing, rather than a clinical trial directly measuring treatment efficacy against an outcome "ground truth" or diagnostic accuracy.
§ 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).