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RELiZORB is indicated for use in pediatric (ages 1 year and above) and adults patients to hydrolyze fats in enteral formula.

RELiZORB® is a point-of-care device designed to fit in-line with currently used enteral feeding circuits. RELiZORB functions 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 RELiZORB is intended to mimic the function of the enzyme 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 acrylic beads. The digestive enzyme, lipase, is covalently bound to the small white beads. 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 when it comes in contact with iLipase as the formula passes through the cartridge.

The provided text is a 510(k) summary for the RELiZORB device. It details various aspects of the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain a typical acceptance criteria table with reported device performance metrics in the format usually associated with diagnostic device evaluation (e.g., sensitivity, specificity, accuracy).

Instead, the submission focuses on extending the Indications for Use for the RELiZORB device to include pediatric patients aged 1 year and above, compared to the previous indication of 2 years and above. The "acceptance criteria" in this context are primarily related to demonstrating that this change in indication does not introduce new safety or effectiveness concerns, and that the device remains substantially equivalent to the predicate.

Here's an analysis of the "acceptance criteria" and the study that supports the change, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria with specific performance metrics (like sensitivity, specificity, or AUC) as one might expect for a diagnostic AI/ML device. Instead, the acceptance criteria for extending the age indication are implicitly:

• Safety: The device is safe for use in pediatric patients aged 1 to <2 years. This is "accepted" if post-market surveillance shows no new safety concerns in this age group.
• Effectiveness: The device is effective in hydrolyzing fats in enteral formula for pediatric patients aged 1 to <2 years. This is "accepted" if real-world data demonstrates effectiveness in this population.
• Substantial Equivalence: The device, with the updated indication, remains substantially equivalent to the predicate device (K232784) and raises no new questions of safety and effectiveness.

Reported Device Performance:

• Safety: The submission states "post-market surveillance of product complaints data supports the safety of RELiZORB in this age group." No specific numbers or detailed adverse event rates are provided in this summary.
• Effectiveness: The submission states, "These Real-World Data support the Real-World Evidence that device use in this population is effective." No specific quantitative effectiveness metrics (e.g., percentage of fat hydrolyzed, patient nutritional outcomes) are provided in this summary. The primary function of the device (hydrolyzing fats) is assumed to be consistent across the age range based on its mechanism of action and the lack of change in device design.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document mentions a "retrospective observational study" that "evaluated multiple data outputs in Medical Records for patients initiating RELiZORB use between ages 1 and <2 years." However, the specific sample size (i.e., number of patients) is not provided in the summary.
• Provenance: The study was "retrospective observational." The country of origin is not specified, though Alcresta Therapeutics is based in Waltham, Massachusetts, USA. The data is described as "Real-World Data" from "Medical Records."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the type of study conducted. The study is a retrospective observational study using real-world data from medical records and post-market surveillance. It does not involve expert readers establishing ground truth for diagnostic interpretations in the way an AI/ML diagnostic study would. The "ground truth" here would be clinical observations of safety and effectiveness from actual patient usage, rather than expert-labeled diagnostic findings.

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

This is not applicable. There was no expert "adjudication" in the traditional sense for a diagnostic test set. The study reviewed medical records and post-market surveillance data.

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 is not applicable. The RELiZORB device is an enzyme-packed cartridge, not an AI/ML diagnostic device that would assist human readers in interpretation. Therefore, no MRMC study or AI assistance effect size is discussed.

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

This is not applicable. The RELiZORB device is a medical device (an enzyme cartridge), not an algorithm. Its performance is inherent to its physical function.

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

The ground truth for demonstrating safety and effectiveness in the 1 to <2 year old age group was based on:

• Real-World Data/Evidence: Derived from "Medical Records" and "multiple data outputs" for patients using RELiZORB.
• Post-market Safety Surveillance: Product complaints data.

This broadly falls under outcomes data and safety monitoring data collected in a real-world setting.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML algorithm requiring a training set in the typical sense. The device's function is mechanistic (enzyme hydrolysis), and its initial design and validation would have involved laboratory and pre-clinical testing, not "training data" for a machine learning model.

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

This is not applicable for the same reason as point 8.

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