Search Results

The Eclipse System is indicated for treatment of fecal incontinence in adult women. It is intended for prescription use.

The Eclipse System includes two main components, an Insert and a Pump. The Insert is used intra-vaginally, is insertable/removable by the patient, and includes a balloon that when inflated, exerts a force posteriorly (trans-vaginally) against the wall in the rectum resulting in a decrease in the lumen of the rectum. The compression of the rectal space results in decreased frequency of fecal incontinence events. The Eclipse System also contains two tools for the fitting process: a Sizing Kit, consisting of Sizers in each available Insert Base size, and a Trial Insert. Each component is described below.

• -Sizing Kit / Sizers: Reusable (multi-patient) Insert Bases (Sizers), intended to aid in selecting appropriate Trial Insert Sizes. Sizers are only used in a clinical setting (

This document is a 510(k) premarket notification decision letter for the Eclipse System, indicating that the device has been found substantially equivalent to a predicate device. This type of regulatory document is typically focused on demonstrating equivalence rather than presenting an exhaustive clinical study report with detailed acceptance criteria and performance metrics for a novel device.

Therefore, the requested information regarding detailed acceptance criteria, specific study designs (like MRMC studies), ground truth establishment for test and training sets, and expert details are not explicitly contained within this regulatory decision letter. The letter primarily refers to bench testing and the clinical performance data from the predicate device's de novo application.

However, I can extract and infer some information based on the typical requirements for 510(k) submissions, particularly what is mentioned about performance data.

Here's an attempt to answer your questions based only on the provided text, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

The document lists types of bench testing performed, but does not provide specific acceptance criteria values or quantitative performance results for these tests. It only states, "The Eclipse System met all specified design, safety, and performance requirements."

2. Sample sizes used for the test set and the data provenance

• Test Set Sample Size:
  • For the bench testing, the sample sizes are not specified in this document.
  • For clinical performance, the document states: "The clinical performance data submitted in support of the de novo application for the predicate device are sufficient to address safety and effectiveness of the subject device." The sample size for the predicate device's clinical study is not provided in this document.
• Data Provenance: The document does not specify the country of origin of the data. The studies mentioned (bench testing and predicate device clinical data) would likely be considered prospective studies at the time they were conducted, but the current 510(k) leverages existing data.

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 in the document. The document primarily focuses on bench testing and referencing the predicate device's clinical data, not the establishment of a ground truth for a test set of an AI or diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as the document does not describe a clinical study for this specific 510(k) submission that would require such adjudication.

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 MRMC comparative effectiveness study was performed or is mentioned in this document. This device (Eclipse System) is a physical medical device (vaginal insert and pump), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the Eclipse System is a physical medical device, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the bench testing, the "ground truth" would be established by engineering specifications and standards for device performance, not expert consensus or pathology in a clinical sense.

For the predicate device's clinical data, which demonstrated the device's effectiveness in treating fecal incontinence, the "ground truth" would presumably be patient-reported outcomes and objective measures of fecal incontinence events (which are categorized as outcomes data). Details are not provided.

8. The sample size for the training set

This question is not applicable as this document describes a physical medical device and its bench testing and leverage of predicate clinical data, not the development or validation of an AI algorithm using a training set.

9. How the ground truth for the training set was established

This question is not applicable as there is no mention of a training set or AI algorithm in this document concerning the Eclipse System.

Ask a specific question about this device