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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 (<60 minutes) and are not intended to be taken home.
• -Trial Insert (Insert): Single-patient-use vaginal insert intended for short term use (approximately 1 week, but no more than 2 weeks) during the fitting and evaluation process. Multiple Trial Inserts may be attempted to achieve a correct fit. The Trial Inserts are identifiable by their white color.
• Eclipse Insert (Insert): Single-patient-use vaginal insert intended for longer-term use (up to 1 year). The Eclipse Inserts are identifiable by their indigo color.
• -Pump, including Regulator: The pump is used by the patient for inflating and deflating the balloon with a goal of improving control over bowel movements. The Pump includes a replaceable Regulator which regulates the maximum pressure of the Insert's Balloon. Regulators are available for different pressure levels, and can be replaced to adjust the maximum pressure of the Insert's Balloon.

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.

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

The Eclipse System is a device intended to treat women with fecal incontinence (FI), also referred to as "accidental bowel leakage", or "bowel control disorder". The Eclipse System contains the Eclipse Insert and the Pump, including Regulator. The Eclipse 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 (Figure 1). The compression of the rectal space results in decreased frequency of fecal incontinence events. The Eclipse Insert consists primarily of a silicone and stainless steel base with an inflatable silicone balloon. The pump is used by the patient for inflating and deflating the balloon with a goal of improving control over bowel movements.

"The Eclipse System is designed to treat fecal incontinence in adult women. The acceptance criteria and the study proving the device meets these criteria are detailed below:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Eclipse System were primarily focused on its effectiveness in reducing fecal incontinence (FI) episodes, safety, and specific bench testing parameters.

2. Sample Size Used for the Test Set and Data Provenance

• Pivotal Study Sample Size (Test Set):
  • Consented: 200 subjects.
  • Entered Treatment Period (Intent-to-Treat - ITT Cohort): 61 subjects.
  • Per Protocol (PP) Cohort: 56 patients (those with fully analyzable diary data).
• Data Provenance: The study was a multi-center, prospective, open-label study. While specific country of origin is not stated, "multi-center" implies data collection from several clinical sites. The "prospective" nature means data was collected specifically for the study as events occurred.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The ground truth for the effectiveness of the Eclipse System was established based on patient-reported outcomes, primarily through patient diaries tracking fecal incontinence episodes. There is no mention of external experts (e.g., clinicians, radiologists) establishing a separate "ground truth" for each patient's FI status or reduction. The primary endpoint definition relies on self-reported data from the subjects themselves.

4. Adjudication Method for the Test Set

Since the ground truth for effectiveness was based on patient-reported diaries, there was no explicit adjudication method by independent experts mentioned for the clinical endpoints. The study design likely included mechanisms for data integrity and completeness for the diaries, but not an external adjudication of the FI episodes themselves.
For safety events, adverse events were reported by investigators and classified as "device-related/possibly device-related," likely by the study investigators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, there is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study is typically performed for diagnostic imaging devices where different readers interpret the same cases. The Eclipse System is a therapeutic device for fecal incontinence, and its effectiveness was measured by changes in patient symptoms and quality of life, not by interpretive accuracy. Therefore, an MRMC study is not applicable here.

6. If a Standalone Study (Algorithm only without human-in-the-loop performance) was done

Yes, "standalone" performance in this context would refer to the device's efficacy when used as intended by the patient, without continuous human (clinician) intervention beyond fitting and instruction. The pivotal study assesses the "algorithm only" in the sense that it evaluates the device's performance as a therapeutic tool used by patients at home. The study directly measures how well the device, when used by the patient, reduces FI episodes and improves quality of life.

7. The Type of Ground Truth Used for the Test Set

The primary ground truth used for effectiveness was patient-reported outcomes via subject diaries.

• FI Episodes: Patients recorded the number of major or minor soiling episodes during baseline and treatment periods.
• Safety: Adverse events were reported by subjects and/or investigators.
• Quality of Life: Measured using validated questionnaires (FIQOL, MMHQ, PGI-I) and patient self-assessment of lifestyle restrictions.

8. The Sample Size for the Training Set

The document does not explicitly describe a separate "training set" in the context of an AI/algorithm where ground truth is independently established to train a model. This device is a physical medical device, not an AI or diagnostic algorithm that learns from data in that manner. The "training" for this device would refer to its development and iterative testing.
However, if "training set" is considered in the broader sense of initial clinical data used to refine the device or inform the pivotal study, then the two feasibility studies involved 102 subjects. This early data informed the pivotal study design and understanding of device performance and safety.

9. How the Ground Truth for the Training Set was Established

Given that this is a physical medical device and not an AI/ML algorithm requiring a distinct "training set" with established ground truth in the AI sense:

• For the feasibility studies (analogous to early development/training data), the goal was to "evaluate the proof of the Eclipse System by evaluating the device's stability and positioning, rectal occlusion, and patient comfort. The fitting process, comfort, and safety were evaluated, as well as usability feedback from those subjects suffering from FI."
• The ground truth in these feasibility studies would have been established through direct observation, patient feedback, and reporting of adverse events during device use, similar to the pivotal study but on a smaller scale and likely with broader objectives for product refinement rather than formal hypothesis testing."

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