Search Results

RELiZORB® is indicated for use with pediatric (ages 2 years and above) and adult patients to hydrolyze fats in enteral formula.

RELiZORB® is a single-use, point-of-care digestive enzyme cartridge that connects in-line with existing enteral feeding circuits. RELiZORB is designed to hydrolyze (digest) fats contained in enteral formulas from triglycerides into fatty acids and monoglycerides to allow for their absorption and utilization by the body. This hydrolysis of fats by RELiZORB is intended to mimic the function of the digestive enzyme lipase in patients. RELiZORB is comprised of a clear cylindrical, plastic cartridge with a single inlet connection port and a single outlet connection port. Inside the cartridge, there are small white beads covalently bonded to the digestive enzyme, lipase. This lipase-bead complex, iLipase™ (immobilized lipase) is retained within the cartridge during use by filters on both ends of the cartridge. The fat in enteral formulas is hydrolyzed upon contact with iLipase as the formula passes through the cartridge.

This document is a 510(k) summary for the RELiZORB® device, which is an enzyme-packed cartridge used to hydrolyze fats in enteral formula. It is a submission to the FDA seeking clearance for a modified version of an already cleared device.

The provided text focuses on demonstrating the substantial equivalence of the subject device (RELiZORB® K232784) to its predicate device (RELiZORB® K231156). It does not contain information about the acceptance criteria and study proving performance for an AI/Software as a Medical Device (SaMD).

Specifically, the document does not contain the following information typically found in acceptance criteria and study designs for AI/SaMD devices:

• A table of acceptance criteria and reported device performance (for an AI/SaMD)
• Sample sizes used for a test set (as would be used for an AI/SaMD model's performance evaluation)
• Data provenance for a test set
• Number of experts and qualifications for ground truth establishment
• Adjudication method for a test set
• MRMC comparative effectiveness study details
• Standalone (algorithm-only) performance results
• Type of ground truth used (e.g., pathology, outcomes data)
• Sample size for the training set (for an AI/ML model)
• How ground truth for the training set was established

Instead, the document details performance testing related to the physical and chemical characteristics of the RELiZORB® cartridge, which is a hardware medical device with an enzymatic function.

Here's a breakdown of the performance testing cited for this hardware device, which is different from "acceptance criteria" for an AI/SaMD:

Overview of Performance Testing for RELiZORB® (Hardware Device):

The performance testing listed is geared towards a physical device with a biological function (enzyme action). The "acceptance criteria" for this device would therefore relate to its physical integrity, chemical activity, and biocompatibility, rather than diagnostic accuracy or algorithmic performance.

1. Table of "Acceptance Criteria" (Inferred from Performance Testing) and Reported Device Performance:

The document lists categories of testing rather than specific numerical acceptance criteria or detailed results. However, we can infer some "acceptance criteria" that would be met by these tests:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not applicable in the context of an AI/ML test set. For physical and chemical tests, typically specific numbers of units are tested according to standard protocols (e.g., n=3, n=5, n=10 per batch), but these specific numbers are not provided in the summary.
• Data Provenance: The preclinical studies were conducted in a porcine model. The document does not specify the country of origin for the studies, nor whether they were retrospective or prospective, though preclinical animal studies are typically prospective.

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

• Not applicable as this is not an AI/ML diagnostic device requiring human expert ground truth for interpretation of imaging or other complex data. The "ground truth" for this device's performance would be the scientific measurement of its physical properties and chemical activity (e.g., fat hydrolysis percentage).

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

• Not applicable. Adjudication methods are relevant for human interpretation or consensus in diagnostic studies, not for the performance testing of a physical medical device.

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. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant or performed.

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

• No. This is a physical device, not an algorithm.

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

• For this device, the "ground truth" for its performance is established through standard laboratory testing for:
  • Chemical Analysis: Measuring the hydrolysis of fats (e.g., quantifying fatty acids and monoglycerides produced).
  • Physical Measurements: Tensile strength, flow rates, bead retention, appearance.
  • Biological Testing: Biocompatibility tests (e.g., cytotoxicity, sensitization), and in vivo animal studies (porcine model) to assess safety and efficacy (fat absorption, impact on parenteral nutrition weaning).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a "training set."

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

• Not applicable.

In summary: The provided text details the regulatory clearance process for a physical medical device (enzyme-packed cartridge), not an AI/Software as a Medical Device (SaMD). Therefore, the criteria and study types described in the prompt (which are typical for AI/SaMD) are not present in this document. The "performance data" here refers to standard engineering, chemical, and biological testing of a hardware product.

Ask a specific question about this device