(43 days)
The AMS soft tissue approximation system ("ASTA") is intended for use as a general use suture retention device. The ASTA system provides a method to deploy and anchor suture internally from a single access point, which may be used to grasp, manipulate, or affix the attached tissue.
The AMS soft tissue approximation system has two components: a clip and an applicator. The clip is shaped as a rod and is available in two different sizes. Each clip has a central hole through which non-absorbable suture up to and including size No. I may be threaded. The applicator is composed of a straight or curved stainless steel tube in which the tip of the clip is positioned and has a handle with a release button for clip deployment. The choice of shaft configuration and clip size depends upon the desired application.
The provided text focuses on regulatory approval (510(k) submission) for the "AMS Soft Tissue Approximation System" and does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against those criteria. The submission is primarily concerned with establishing substantial equivalence to predicate devices rather than presenting a performance study with detailed metrics against defined acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, and expert involvement are not available in the provided document.
Here's a summary of what can be extracted and what is not available from the text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The submission states: "Bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to a 510(k)-cleared device." However, it does not specify what acceptance criteria were used for "safe and effective," nor does it present quantitative performance data against such criteria.
2. Sample size used for the test set and the data provenance
This information is not provided. The text mentions "bench testing," which implies that a test set was used, but details on its size, composition, and provenance are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. As no specific performance study with a test set is detailed, there's no mention of experts or their qualifications for establishing ground truth.
4. Adjudication method for the test set
This information is not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
This information is not provided. The focus is on demonstrating substantial equivalence through bench testing, not a comparative effectiveness study with human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. The device described is a physical medical device (implantable clip and applicator), not an algorithm or AI system.
7. The type of ground truth used
This information is not provided. Given the nature of the device (implantable clip), "ground truth" would likely relate to material properties, mechanical performance (e.g., tensile strength, deployment success), and biocompatibility, but the specific methods for establishing ground truth for any bench testing are not detailed.
8. The sample size for the training set
This information is not applicable/not provided. The device is a physical product, not a machine learning algorithm.
9. How the ground truth for the training set was established
This information is not applicable/not provided.
In summary: The provided document is a 510(k) summary focused on regulatory clearance by demonstrating substantial equivalence to predicate devices. It references "bench testing" that showed the device is "safe and effective," but it does not provide the detailed study design, specific acceptance criteria, quantitative performance metrics, or information regarding sample sizes, ground truth establishment, or expert involvement that would be present in a comprehensive performance study.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.