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Plenity® is indicated to aid in weight management in adults with excess weight or obesity, with a Body Mass Index (BMI) of 25 to 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 OTC is non-systemic and works directly in the gastrointestinal (GI) tract. Plenity OTC hydrogel is made from two naturally derived 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 OTC is provided non-sterile. The capsules disintegrate in the stomach and release the Plenity OTC particles, which can hydrate up to 100 times their original weight. When fully hydrated, the individual non-clustering Plenity OTC 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 OTC 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 OTC is supplied in peelable pods that provide the two doses patients take daily. Each individual pod holds a single dose of three (3) capsules. Plenity OTC pods are supplied in a monthly kit.

The provided text describes the 510(k) premarket notification for Plenity®, an ingested device for weight management. However, it does not contain information about a study proving the device meets acceptance criteria for an AI/algorithm-based medical device, as implied by the detailed questions about acceptance criteria for AI, training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance.

The document is a clearance letter for a physical medical device (hydrogel capsules), not an AI/Software as a Medical Device (SaMD). The "acceptance criteria" discussed in the document are related to the physical and chemical properties of the capsules (e.g., capsule disintegration time, media uptake, elasticity, loss on drying) and the results of non-clinical bench studies, biocompatibility, stability, shipping, and usability studies for an over-the-counter switch.

The "study that proves the device meets the acceptance criteria" refers to the pre-existing GLOW and GLOW-EX clinical studies that demonstrated the efficacy and safety of the Plenity device (which is the predicate for the OTC version presented here). These studies assess the device's effect on weight loss in human subjects, not the performance of an AI algorithm.

Therefore, I cannot directly answer the questions regarding AI/algorithm acceptance criteria, training sets, expert adjudication, MRMC, or standalone performance based on the provided text, as this information is irrelevant to the type of device described.

However, I can extract the information relevant to the physical device's acceptance criteria and the studies mentioned:

Here's a breakdown of the information present in the document related to "acceptance criteria" for the physical device and the studies mentioned:

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

The document provides "Technological Characteristics" for Plenity/Plenity OTC which function as specifications/acceptance criteria for the physical properties of the hydrogel capsules. It states that "Plenity OTC was tested and shown to perform according to its specifications that are the same as those of the Plenity (DEN180060)." However, it does not provide a direct table linking each criterion to specific reported performance data from a compliance study in the format requested. It only lists the criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Clinical Efficacy (GLOW study): The document mentions "58.6% of patients losing ≥5% total body weight in 6 months." While a sample size isn't explicitly stated here, this is typically associated with a large prospective clinical trial. The specific sample sizes for GLOW and GLOW-EX studies are not provided in this summary.
• Usability Studies:
  • First summative usability study: 27 subjects.
  • Second summative comprehension study: 28 subjects.
• Data Provenance: Not specified in terms of country of origin. The sponsor is Gelesis Srl, Italy, but this doesn't confirm where the clinical trials took place. The clinical studies (GLOW and GLOW-EX) were prior to this OTC submission, so they were prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This is not an AI/algorithm device. The "ground truth" for the device's effectiveness is established through clinical outcomes (weight loss) in human subjects, not expert medical image annotation.
• For the usability studies, the "ground truth" for effective communication was derived from subject performance on tasks related to self-selection and safe use, not expert medical opinion.

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

• Not applicable as this is not an AI/algorithm study involving image annotation or similar expert-based ground truth establishment.

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:

• Not applicable as this is not an AI/algorithm device.

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

• Not applicable as this is not an AI/algorithm device. The device itself (the hydrogel) is the "standalone" product.

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

• For the efficacy of the device (Plenity), the ground truth was outcomes data (total body weight loss, incidence of adverse events) from clinical trials (GLOW and GLOW-EX).
• For the usability studies, the "ground truth" for successful design validation was the subjects' comprehension and ability to safely self-select and use the device.

8. The sample size for the training set:

• Not applicable as this is not an AI/algorithm device. There is no "training set" in the context of machine learning. The clinical trials (GLOW and GLOW-EX) functioned as the primary evidence.

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

• Not applicable as this is not an AI/algorithm device.

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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."
}

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