(199 days)
Epitomee is indicated to aid in weight management in overweight and obese adults with a Body Mass Index (BMI) of 25 - 40 kg/m², when used in conjunction with diet and exercise.
The subject device of this 510(k) notification, Epitomee, is comprised of two components: The outer component is a capsule and the inner component contains superabsorbent hydrogel particles. Each particle is approximately 250 microns in size. The particles are enclosed in pH sensitive compartments. Once Epitomee is swallowed, the capsule disintegrates in the stomach and releases the pH sensitive compartments. By absorption of water in the stomach fluid, the superabsorbent particles within the compartments swell to form a three-dimensional matrix designed to occupy volume in the stomach that creates a sensation of fullness, enabling weight loss. Epitomee mechanism of action is purely mechanical and does not involve any chemical activity. Epitomee works directly in the gastrointestinal (GI) tract. Epitomee is provided non-sterile.
The provided document is a 510(k) summary for the device "Epitomee," which is an ingested, transient, space-occupying device for weight management. The document describes the device, its intended use, and the performance data that supports its substantial equivalence to a predicate device.
However, the document does not contain specific acceptance criteria or an explicit study proving that the device meets those acceptance criteria in the format requested by the prompt. Instead, it discusses the outcomes of clinical studies (RESET and ELECT) in comparison to a placebo or to demonstrate continued safety and efficacy. It focuses on demonstrating substantial equivalence to a predicate device (Gelesis Inc.'s Plenity) rather than meeting predefined, quantitative acceptance criteria for a new, novel device.
The prompt specifically asks for a table of acceptance criteria and reported device performance, sample sizes, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training and test sets. This information is typically found in detailed study reports or regulatory submissions for devices that require proof of meeting specific performance endpoints, especially for software or AI/ML-based devices. Epitomee is a physical medical device, not a software or AI/ML device in the conventional sense that would require the rigorous performance evaluation methods listed in the prompt (e.g., ground truth established by experts, MRMC studies, standalone algorithm performance).
Therefore, based on the provided text, I cannot extract the specific information requested in your prompt regarding acceptance criteria and the study proving the device meets them, because such a section or study design (as understood in the context of AI/ML or software device evaluation) is not present. The document describes a clinical trial (RESET study) demonstrating efficacy and safety compared to a placebo, and an extended study (ELECT) for long-term safety, to support "substantial equivalence" to a predicate device.
To answer your prompt, I must state that the detailed information about "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the format requested (especially points 1, 3, 4, 5, 6, 7, 8, 9) is NOT available in the provided 510(k) summary. The document's purpose is to demonstrate substantial equivalence, which relies on showing similar intended use, technological characteristics, and comparable safety and effectiveness, often through non-inferiority or superiority trials against a placebo/standard of care, rather than meeting pre-specified quantitative performance metrics for a diagnostic or AI system.
I can, however, provide the closest relevant information from the document that might relate to "performance" and "study outcomes" as a proxy, but it will not directly answer your prompt's specific requirements.
Closest Related Information from the Provided Document:
The document describes the Pivotal Clinical Study (RESET Study) as the primary evidence for the device's performance.
1. A table of acceptance criteria and the reported device performance:
The document does not provide a formal table of "acceptance criteria" for its performance as would be expected for a diagnostic or AI device. Instead, it states that "both co-primary endpoints were successfully met." These endpoints function as the 'criteria' for success.
| Metric / Endpoint | Acceptance Criteria (Met/Achieved) | Reported Device Performance (Epitomee Group) | Control Group (Placebo) Performance | Statistical Significance |
|---|---|---|---|---|
| Co-primary Endpoint 1: | Significant reduction in total body weight (TBW) compared to placebo at 24 weeks. | Mean TBW reduction: 6.6% (SD 6.5) | Mean TBW reduction: 4.6% (SD 4.7) | P35% threshold met) |
| Secondary Endpoint: | Higher percentage of responders losing between 7.5-12.5% of TBW compared to placebo. | ≥ 7.5% TBW loss: 38.7% | ||
| ≥ 10% TBW loss: 26.9% | ||||
| ≥ 12.5% TBW loss: 16.8% | ≥ 7.5% TBW loss: 21.5% | |||
| ≥ 10% TBW loss: 10.7% | ||||
| ≥ 12.5% TBW loss: 6.6% | Implied significance (stated "significantly higher percentage") | |||
| Safety: | Favorable safety profile, low incidence of adverse events, no serious adverse device effects (SADEs). | Fewer patient dropouts (13.8%) | ||
| No SADEs | ||||
| Overall incidence of treatment-emergent AEs similar to placebo (mild/moderate for >95%) | ||||
| No difference in gastrointestinal AEs. | Patient dropouts (14.2%) | Met |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The "test set" in this context refers to the subjects enrolled in the clinical trial.
- Total Enrolled: 279 men and non-pregnant, non-lactating women.
- Epitomee Group: 138 subjects (13.8% dropouts, so ~119 completed)
- Placebo Group: 141 subjects (14.2% dropouts, so ~121 completed)
- Data Provenance:
- Country of Origin: All 9 study sites were in the US, located across 9 different states.
- Retrospective or Prospective: Prospective, randomized, double-blind, placebo-controlled, multicenter trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided. "Ground truth" established by experts is typically for diagnostic interpretation (e.g., radiologist reads). For a weight management device, the "ground truth" for efficacy is objective clinical measurements (body weight, BMI) and for safety, it's reported adverse events and monitoring by investigators.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable and not provided. Adjudication methods are typically used for interpreting diagnostic images or clinical events by multiple readers/experts. For a device like Epitomee, efficacy is measured directly (weight change), and safety is based on adverse event reporting by subjects and assessment by clinical investigators, not adjudicated panel reviews for "ground truth".
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:
- This is not applicable. MRMC studies are specific to evaluating AI/software performance in diagnostic tasks by comparing human reader performance with and without AI assistance. Epitomee is a physical device, not an AI or diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. Standalone performance refers to the performance of an algorithm or software system without human interaction. Epitomee is a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for efficacy was objective outcomes data (measured Total Body Weight reduction, percentage of subjects achieving specific weight loss thresholds, BMI reduction, improvements in quality of life scores).
- The "ground truth" for safety was adverse event reporting by subjects and assessment by the investigational site staff (physicians, nurses).
8. The sample size for the training set:
- This information is not provided because Epitomee is a physical device, not an AI/ML model that requires a "training set." Device development typically involves bench testing, non-clinical studies (e.g., animal studies), and clinical trials, not "training" in the AI sense.
9. How the ground truth for the training set was established:
- This is not applicable as there is no "training set" in the context of an AI/ML model for this physical device.
§ 876.5982 Ingested, transient, space occupying device for weight management and/or weight loss.
(a)
Identification. This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible for its intended use.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, as follows:
(i) Performance bench testing in a simulated use model must evaluate device disintegration and device hydration state throughout the gastrointestinal tract;
(ii) Bioburden and moisture content assessments must evaluate device infection risk throughout the labeled shelf life; and
(iii) Performance data must support the shelf life of the device by demonstrating continued package integrity and device functionality over the labeled shelf life.
(3) Clinical performance testing must demonstrate the device performs as intended and evaluate the following:
(i) Weight change;
(ii) All adverse events, including obstruction, dilation, diarrhea, constipation, and dehydration; and
(iii) Interaction with representative medications.
(4) Physician and patient device labeling must state:
(i) The clinical benefit of the device as assessed by using percent total body weight loss;
(ii) Treatment must be offered in combination with diet and exercise;
(iii) Instructions on how to use the device as intended including how to avoid interaction with medication; and
(iv) The shelf life of the device.