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RELiZORB™ is indicated for use with pediatric (ages 5 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 excr ete sufficient 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. The digestive enzyme, lipase, is covalently bound to the small white beads. The lipasebead 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.

Here's a breakdown of the acceptance criteria and study information for the RELiZORB device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical targets for each performance metric for the subject device (K191379), but rather implies equivalence to a predicate device. The performance data listed are the types of tests conducted to demonstrate this equivalence. The "Reported Device Performance" for the subject device is simply that it met the equivalence requirements for these tests. The predicate device's performance would have established the original acceptance criteria.

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

The document does not specify a distinct "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective) for a clinical study. The performance data focuses on non-clinical testing of the device itself (e.g., integrity, flow, hydrolysis), rather than clinical outcomes with human subjects.

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

Not applicable. This device is an enzyme-packed cartridge for hydrolyzing fats in enteral formula. The "ground truth" would be objective measurements of its physical and chemical properties and its ability to break down fats, not a diagnostic interpretation by human experts.

4. Adjudication Method for the Test Set

Not applicable, as no human expert adjudication is involved in the technical performance testing described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance testing for a device that acts on enteral formula. It focuses on the device's functional equivalence to a predicate, not on human reader performance with or without AI assistance.

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

Yes, in a way. The testing described is "standalone" in the sense that it evaluates the device's performance (hydrolysis, flow rate, integrity) directly, without human interaction during the measurement process. However, this is not an "algorithm-only" performance as the device is a physical product, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used is primarily based on objective physical and chemical measurements of the device's performance, such as:

• Measurement of seal strength, tensile strength, visual inspection results for pouch testing.
• Results from standardized shipping tests (ISTA 2A).
• Quantitative measurements of filter integrity.
• Biochemical assays to measure the extent of fat hydrolysis.
• Measurements of fluid flow rate through the cartridge.
• Leak detection methods.

These measurements are compared against established specifications for the predicate device to demonstrate equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI/ML algorithm that requires a "training set." The development would involve engineering and materials science, not machine learning training.

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

Not applicable, as there is no "training set" for this type of device.

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