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The RELiZORB device is a point-of-care accessory designed to fit in line with currently used enteral feeding circuits. RELiZORB is designed to hydrolyze (break down) fats present in enteral formulas from triglycerides into fatty acids and monoglycerides to allow for their absorption and utilization by the body. This breakdown of fats by the RELiZORB is intended to mimic the function of the enzyme lipase in patients who do not excr ete sufficient levels of pancreatic lipase. RELiZORB is comprised of a cylindrical, hollow cartridge with a single inlet port and a single outlet port connection. Inside the cartridge, there are small white beads. The digestive enzyme, lipase, is covalently bound to the small white beads. The lipase-bead complex, iLipaseTM (immobilized lipase), is retained within the cartridge during use by filters on both ends of the cartridge. The fat in enteral formulas is hydrolyzed as it comes in contact with iLipase as the formula passes through the cartridge.

AI/ML Overview

This document describes a 510(k) premarket notification for the RELiZORB™ device, an enzyme-packed cartridge designed to hydrolyze fats in enteral formula. The submission aims to demonstrate substantial equivalence to a previously cleared RELiZORB™ device (DEN150001).

Since this is a submission for an enzyme-packed cartridge and not a diagnostic AI/ML device, the detailed questions about acceptance criteria, test sets, ground truth establishment, expert adjudication, and comparative effectiveness studies as typically applied to AI/ML software are not directly applicable in the same manner. This submission focuses on the chemical and mechanical performance of the device rather than the diagnostic accuracy of an algorithm.

However, I can extract the relevant performance data and criteria mentioned in the document in the spirit of your request:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Specific Criteria (Implicitly Met)	Reported Device Performance
Shelf Life	Product stability over time, retaining intended function.	"Shelf life testing of RELIZORB was completed and met the acceptance criteria in the protocol. The shelf life test results support the proposed edit to the labeling with respect to product stability."
Device Performance	Device performs as intended under anticipated conditions of use.	"The RELIZORB device was previously tested to demonstrate that the device performs as intended under anticipated conditions of use, and safety, including: Tensile and mechanical strength, Flow rate, Demonstration of enzymatic effect on macronutrients, Impurities/degradants characterization, Animal testing to demonstrate hydrolysis effect, Human factors testing." (These tests were deemed sufficient for the predicate device and are implicitly accepted for the current device due to no changes in design, technology, or functionality).
Safety	No significant changes to risk assessment due to proposed minor labeling change.	"The Risk management file was reviewed and there was no significant change to the risk assessment as a result of the proposed minor change to the labeling."
Quality System Compliance	Compliance with medical device quality system regulations.	"Alcresta develops and manufactures RELIZORB in compliance with the Quality System regulations (21 CFR 820)."
Biocompatibility	Biological safety of materials in contact with the body/formula.	Referenced standard: ISO 10993-1:2009/Cor 1:2010 Biological evaluation of medical devices. (Implicitly met through prior testing of predicate).
Usability/Human Factors	Device is safe and effective for users.	Referenced standard: EN 62366:2008 Medical devices - Application of usability engineering. (Implicitly met through prior testing of predicate).
Risk Management	Application of risk management processes.	Referenced standard: EN ISO 14971:2012 Medical devices. Application of risk management. (Implicitly met through prior testing of predicate and current review).
Packaging/Shipping	Device integrity maintained during transport.	Referenced standard: ISTA 2A: Packaged-Products weighing 150 lb (68 kg) or Less. Basic Requirements: atmospheric conditioning, compression, fixed displacement or random vibration and shock testing. (Implicitly met through prior testing of predicate).
Connectors/Adapters	Compatibility and safety of enteral feeding set adapters and connectors.	Referenced standard: AAMI/ANSI ID54: 1996/(R)2012: Enteral feeding set adapters and connectors. (Implicitly met through prior testing of predicate).
Controlled Environments	Manufacturing in appropriate environments.	Referenced standard: ISO-14644: Cleanrooms and associated controlled environments. (Implicitly met through prior manufacturing of predicate).

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

Test set sample size: Not explicitly stated for each specific performance test (tensile, flow rate, enzymatic effect, etc.). The document mentions "shelf life testing" was completed, but not the number of units or replicates. For prior testing of the predicate device, it indicates a range of tests were performed, but no numbers of devices tested are provided.
Data provenance: Not explicitly stated (e.g., country of origin). The testing seems to have been conducted by or for Alcresta Therapeutics, Inc. (Newton, MA, USA). The studies appear to be prospective as they involve testing the device under various conditions.

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

Not applicable in the typical sense for this device. This device is not a diagnostic tool requiring expert interpretation of results for ground truth. The "ground truth" for this device would be established by objective measurements of its physical properties (tensile strength, flow rate) and chemical activity (enzymatic effect on macronutrients), likely performed by laboratory technicians or engineers following validated protocols, rather than expert interpretation of a diagnostic outcome.

4. Adjudication method for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used to reconcile disagreements among human readers in diagnostic studies. For this device, performance is evaluated against objective, measurable criteria and laboratory standards.

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. This is not an AI/ML diagnostic device and does not involve human readers interpreting cases with or without AI assistance.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

For the enzymatic effect: Objective chemical measurements (e.g., measuring the breakdown of triglycerides into fatty acids and monoglycerides).
For mechanical/physical properties: Engineering measurements against established standards (e.g., tensile strength, flow rate).
For biocompatibility: Laboratory testing results compared to biological safety standards.

8. The sample size for the training set:

Not applicable. This device does not use an algorithm that requires a training set.

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

Not applicable. As there is no training set for an algorithm, there is no ground truth to be established for it.

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