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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 who do not excretesufficient levels of the lipase enzyme. 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 that the digestive enzyme, lipase, is covalently bound to. The 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 as it comes in contact with iLipase as the formula passes through the cartridge.

The provided text describes a 510(k) premarket notification for the RELiZORB® enzyme packed cartridge. This submission is primarily focused on updating the indications for use to include pediatric patients aged 2 years and above, extending from the previous clearance for 5 years and above. The core device (RELiZORB®) itself has not changed technologically since its previous clearance (K191379).

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for device performance. Instead, it states that the technological characteristics, design, materials composition, principal of operation, and all other features of RELiZORB® have not changed since the clearance of K191379. Therefore, the device performance is assumed to be consistent with the performance demonstrated for the predicate device.

The primary "acceptance criterion" addressed in this specific submission is the safety and effectiveness of the device for a younger pediatric population (2-5 years old). The device's performance in terms of fat hydrolysis would be the same as previously established.

Regarding the expanded indication for use:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document states that the retrospective registry study "evaluated multiple data outputs in Electronic Medical Records (EMRs) for patients between ages 2 year and 5 years to whom RELiZORB® had been prescribed to them." However, the exact sample size (number of patients) used in this retrospective study is not specified.
• Data Provenance: The data is described as "Real World Data" from "Electronic Medical Records (EMRs)". The specific country of origin is not mentioned, but given the FDA submission, it's highly likely to be U.S. data. The study is explicitly described as retrospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not describe the use of experts to establish ground truth for this particular retrospective registry study. The study appears to rely on clinical outcomes and data from Electronic Medical Records, implying that the "ground truth" concerning safety and effectiveness in the 2-5 year old population was derived from the real-world clinical experience and documentation within those EMRs.

4. Adjudication Method for the Test Set

No adjudication method is described. The retrospective EMR data analysis would likely involve data extraction and analysis by the submitting company, Alcresta Therapeutics, Inc.

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

This section is not applicable as the device is an enzyme packed cartridge, not an AI or imaging diagnostic device that involves human readers or an AI assistance component.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. The RELiZORB® is a physical device that performs a chemical function (fat hydrolysis), not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the expanded indication of use (safety and effectiveness in 2-5 year olds) was established through Real World Evidence (RWE) derived from Real World Data (RWD), specifically "multiple data outputs in Electronic Medical Records (EMRs)" reflecting actual clinical outcomes and experiences of patients who had already used the device.

8. The Sample Size for the Training Set

There is no mention of a "training set" in the context of this submission. The device itself (enzyme cartridge) is not a machine learning model that requires a training set. The retrospective registry study is analyzing existing real-world data to support an expanded indication for use, not to train a device or algorithm.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable as there is no training set for the device itself or a machine learning component.

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