(367 days)
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.
| Acceptance Criteria (Technological Characteristics) | Reported Device Performance (Implicitly Met) |
|---|---|
| Capsule disintegration time: NMT 15 minutes | Stated as "tested and shown to perform according to its specifications" |
| Media uptake after disintegration: NLT 70 g/g | Stated as "tested and shown to perform according to its specifications" |
| Capsule content uniformity: 760 mg ± 10% | Stated as "tested and shown to perform according to its specifications" |
| Media uptake: NLT 70 g/g | Stated as "tested and shown to perform according to its specifications" |
| Elastic modulus: NLT 500 Pa | Stated as "tested and shown to perform according to its specifications" |
| Loss on drying: NMT 10% | Stated as "tested and shown to perform according to its specifications" |
| Dosing: Twice a day, 20-30 minutes before lunch and dinner, 3 capsules/dose | Follows established protocol for use |
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.
§ 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.