(148 days)
Plenity 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.
Plenity is a porcine gelatin capsule that contains thousands of absorbent hydrogel particles (0.75 grams [g] per capsule); each particle is approximately the size of a grain of salt. Plenity is non-systemic and works directly in the gastrointestinal (GI) tract. Plenity hydrogel is made from two natural ingredients, cellulose and citric acid, that form a three-dimensional matrix designed to occupy volume in the stomach and small intestine, to create a sensation of fullness. Plenity is provided non-sterile. The capsules disintegrate in the stomach and release the Plenity particles, which can hydrate up to 100 times their original weight. When fully hydrated, the individual non-clustering Plenity particles from the 2.25 g/dose occupy about a quarter of the average stomach volume. The gel particles mix with ingested foods, creating a larger volume with higher elasticity and viscosity in the stomach and small intestine. Plenity passes through the digestive system, maintaining its three-dimensional structure in the stomach and small intestine before breaking down in the colon. The water is then released and reabsorbed by the body. Plenity particles are eliminated through normal bowel movements; they are not absorbed by the body. Patients consume three (3) capsules (2.25 g/dose) with water before both lunch and dinner. Plenity is supplied in double blister packs that, together, provide the two doses patients take daily. Each individual blister pack holds a single dose of three (3) capsules. Seven (7) double blister packs are supplied in a weekly package.
{
"acceptance_criteria_table": [
{
"Test": "Media Uptake Ratio (MUR)",
"Purpose": "Determine the hydration capacity of the hydrogel particles",
"Method": "Weight of the hydrated hydrogel particles in simulated gastric fluid, minus the weight of the dry hydrogel particles, divided by the weight of the dry hydrogel particles",
"Acceptance Criteria": "(b) (4)",
"Results": "(b) (4)"
},
{
"Test": "MUR after disintegration",
"Purpose": "Determine the hydration capacity of the hydrogel particles after gelatin capsule disintegrates",
"Method": "Weight of the hydrated hydrogel particles in simulated gastric fluid, minus the weight of the dry hydrogel particles, divided by the weight of the dry hydrogel particles",
"Acceptance Criteria": "(b) (4)",
"Results": "(b) (4)"
},
{
"Test": "In vitro simulation of device transit through the GI tract",
"Purpose": "Ensure that hydrogel particles uptake and release fluid at the correct times during the digestion process",
"Method": "Measure MUR and elastic modulus across time in simulated gastric, intestinal, and colonic fluid",
"Acceptance Criteria": "Hydration kinetics and capacity must adequately correlate with GI environment",
"Results": "Results are acceptable"
},
{
"Test": "Moisture content determination",
"Purpose": "Ensure that moisture content does not unnecessarily promote microbial growth",
"Method": "Samples are analytically weighed and then dried at (b) (4) for minutes and then weighed again",
"Acceptance Criteria": "(b) (4)",
"Results": "(b) (4)"
},
{
"Test": "Elastic modulus",
"Purpose": "Demonstrate that hydrated hydrogel has comparable mechanical properties to food in the stomach",
"Method": "Swollen particles are put on rheometer plates and tested for rheological properties",
"Acceptance Criteria": "(b) (4)",
"Results": "(b) (4)"
},
{
"Test": "Disintegration time",
"Purpose": "Verify time that it takes for the capsule to disintegrate in the stomach",
"Method": "Capsules are immersed and visually checked at pre-defined time points",
"Acceptance Criteria": "Dissolution time ≤ minutes at (b) (4)",
"Results": "Pass"
},
{
"Test": "Particle size distribution",
"Purpose": "Confirm particle dimensions",
"Method": "Testing is conducted by means of analytical sieving",
"Acceptance Criteria": "(b) (4) % of particles are between (b) (4) µm (un-hydrated particles)",
"Results": "(b) (4)"
},
{
"Test": "Bulk (tapped) density",
"Purpose": "Support that the correct amount of hydrogel can be encapsulated",
"Method": "Volume of known weight of powder is measured (b) (4)",
"Acceptance Criteria": "Hydrogel tapped density (b) (4) mg/ml",
"Results": "(b) (4)"
},
{
"Test": "Uniform hydration and disintegration test",
"Purpose": "Confirm absence of clumps in hydrated material",
"Method": "Hydrate material",
"Acceptance Criteria": "Uniform hydration without clumps",
"Results": "Pass"
},
{
"Test": "Package integrity (simulated distribution and shipping followed by associated package integrity testing)",
"Purpose": "Validate packaging in environmental conditions",
"Method": "Environmental conditioning done in accordance with ASTM F2825:2010 (2015); simulated distribution in accordance with ASTM D4169-16, followed by inspection and bubble emission testing (ASTM D3078-02)",
"Acceptance Criteria": "Intact boxes and non-leaking blister packs",
"Results": "Pass"
},
{
"Test": "Performance tests on packaged capsules",
"Purpose": "Ensure that capsules can remain intact and do not prematurely hydrate while in packaging",
"Method": "Pre-determined test methods",
"Acceptance Criteria": "Gelatin capsules will visually look unchanged, capsules will disintegrate in no more than (NMT) (b) (4) min, the make ratio of the powder in the capsules will be no less than (NLT) (b) (4) the elastic modulus of the powder in the capsules will be NLT (b) (4) the loss of drying of the power in the capsules will be NMT (b) (4)",
"Results": "Pass"
}
],
"study_type": "clinical trial",
"acceptance_criteria_description": "The acceptance criteria for the Plenity device were evaluated through non-clinical/bench studies and a pivotal clinical study (GLOW), with an extension study (GLOW-EX). The non-clinical studies focused on biocompatibility, integrity, and performance (e.g., hydration capacity, disintegration time, particle size, moisture content, elastic modulus, and packaging integrity). The clinical study established effectiveness and safety, with co-primary endpoints focusing on percent total body weight loss (%TBWL) and the proportion of subjects achieving at least 5% TBWL.",
"sample_size_test_set": "For the pivotal clinical study (GLOW): 436 subjects (223 in Plenity group, 213 in Sham group) were randomized. The ITT-MI population included all randomized subjects with multiple imputation for missing data. The ITT-Obs population was used for tertiary endpoints and included subjects who completed the study. The PP population was 154 for Plenity and 141 for Sham.",
"data_provenance": "The data for the GLOW study was collected from 33 study sites across the US and Europe. It was a prospective, multicenter, randomized, double-blind, sham-controlled, parallel-group study.",
"number_of_experts_ground_truth": "Not applicable for this type of device and study. The ground truth for effectiveness was direct measurement of physiological parameters (body weight, BMI, etc.).",
"qualifications_of_experts": "Not applicable.",
"adjudication_method": "Not applicable.",
"multi_reader_multi_case_study": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is a weight management device, not an image-based diagnostic or screening tool with human readers.",
"standalone_performance": "Yes, a standalone performance of the algorithm (device) was assessed in the clinical trials by comparing the Plenity group to a sham (placebo) group. The 'algorithm' in this case refers to the device itself and its mechanism of action, as there's no AI algorithm involved in the traditional sense.",
"type_of_ground_truth_test_set": "The ground truth for the clinical study was based on direct physiological measurements and clinical outcomes, including body weight, BMI, waist circumference, and the occurrence and severity of adverse events, as recorded by clinical staff and reported by subjects.",
"sample_size_training_set": "Not applicable. This is a medical device and not an AI/ML algorithm that requires a training set in that context. The 'training' for the device's efficacy is the clinical trial data used for evaluation, not an independent training set.",
"how_ground_truth_for_training_set_was_established": "Not applicable."
}
§ 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.