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The Fidmi Low Profile Enteral Feeding Device is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means.

Fidmi Low Profile Enteral Feeding Device Measuring kit is indicated for measuring the length of the stoma prior to placement of a low-profile feeding tube.

The Fidmi Low Profile Enteral Feeding Device Replaceable Tube is intended for use only with the Fidmi Low Profile Enteral Feeding Device, for the replacement of an existing tube. It is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means.

The Fidmi Low Profile Enteral Feeding Device and its components kits allow for enteral nutrition and / or medication delivery directly into the stomach. The device and components are supplied sterile.

Fidmi Medical's Low-Profile Enteral Feeding Device includes kits for initial placement of the tube, and complete removal of the gastrostomy tubes.

Fidmi Low-Profile Enteral Feeding Device incorporates three major components:

The Stoma Measuring Device – The Fidmi Medical Stoma Measuring Device is a single use, sterile, disposable device designed for use in the selection of an appropriate length of the Feeding Device to be used exclusively with the Fidmi Low-Profile Enteral Feeding Device.

Low Profile Enteral Feeding Device - The Low Profile Enteral Feeding Device consists of a gastric port that on one side (on the skin surface) includes the flexible external bumper that stabilizes the stoma and keeps the site dry and allows ventilation. On the other side (the stomach side), it includes the bumper that is designed to stay in place and to be dismantled apart for removal when enteral feeding is no longer required.

The Replacement Feeding Tube – The replaceable tubing is designed to be easily replaced when needed. The replacement tube is designed as an internal component that may be retracted, disposed and replaced without any manipulation to the device itself, i.e., the gastrostomy tube implant. It is designed to be replaced by personnel at a medical facility or at a home setting. As depicted in the instructions for use document supplied with the device, it is recommended to replace the tube either upon accidental dislodgement, clogging or once a week.

This document is a 510(k) premarket notification for the Fidmi Low Profile Enteral Feeding Device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the way typically found for AI/ML-driven devices. Instead, it demonstrates substantial equivalence to existing predicate devices based on a comprehensive set of bench tests and animal testing.

Here's an analysis based on the provided text, focusing on what's available and what's missing in relation to your specific request:

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

The document does not explicitly present a table of "acceptance criteria" with corresponding "reported device performance" values in a quantitative manner for a comparative study against a benchmark or ground truth.

Instead, it lists the types of performance data (bench tests and animal testing) conducted to demonstrate that the device performs as intended and is substantially equivalent to predicate devices. The implication is that meeting the standards referenced (e.g., BS EN 1618:1997, ASTM F2528-06(2014)) constitutes "acceptance."

The general studies performed are:

• Back Flow and Liquid Leakage
• Dimensional Attributes
• Functional Evaluation
• Replaceable Tube & Extension Tube Detachment Force
• Flow Rate
• Bond Strength
• Feeding Device Pullout Force
• Packaging Integrity and Shelf life Testing
• Animal testing

For biological evaluation, the following ISO standards were cited, implying compliance with their requirements:

• EN ISO 10993-1:2018 (Biological Evaluation)
• EN ISO 10993-3:2014 (Genotoxicity, carcinogenicity, reproductive toxicity)
• EN ISO 10993-5:2009 (in vitro Cytotoxicity)
• EN ISO 10993-6:2016 (Local effects after implantation)
• EN ISO 10993-10: 2010 (Irritation and Skin Sensitization)
• EN ISO 10993-11:2017 (Systemic toxicity)
• EN ISO 10993-12:2012 (Sample preparation and reference materials)
• EN ISO 10993-7:2008:AC 2009 (Ethylene Oxide Sterilization Residuals)

The document concludes that "Bench testing of the Fidmi Low-Profile Enteral Feeding Device and components demonstrates that the device performs as intended and is substantially equivalent." This is the reported device performance in the context of a 510(k).

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

The document mentions "bench testing" and "animal testing." It does not specify the sample sizes for these tests, nor does it provide details on the data provenance (e.g., country of origin, retrospective/prospective nature) as it would for a clinical study involving human subjects and diagnostic outputs. The testing appears to be primarily laboratory-based and pre-market validation.

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 information is not applicable and hence not provided in the document. The device is a physical medical device (enteral feeding device), not an AI/ML diagnostic tool requiring expert consensus for ground truth establishment. The "ground truth" for this device would be established by measuring physical properties, mechanical performance, and biological compatibility against established scientific and engineering standards.

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

Not applicable. Adjudication methods like '2+1' or '3+1' are typically used in clinical studies where disagreement among human readers or interpreters needs to be resolved, often for diagnostic image interpretation or similar qualitative assessments. The tests described are primarily quantitative engineering and biological tests.

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 device is not an AI/ML diagnostic or assistive device that would involve human readers or image interpretation. Therefore, an MRMC study is not relevant to its regulatory submission.

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

Not applicable. This device is a physical medical device, not an algorithm.

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

For the bench tests and animal testing, the "ground truth" would be established by:

• Engineering specifications and standards: For physical and mechanical properties (e.g., dimensional attributes, flow rate, bond strength, pullout force, back flow, leakage).
• Biological evaluation standards: For biocompatibility (e.g., cytotoxicity, irritation, systemic toxicity, genotoxicity, local effects after implantation), as defined by the EN ISO 10993 series.
• Animal physiology/pathology: For animal testing, assessing the device's performance and safety in a living system.

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. As noted above, this is not an AI/ML device.

Summary in relation to your request:

The provided document describes a traditional 510(k) submission for a physical medical device. It focuses on demonstrating substantial equivalence to predicate devices through bench testing and animal testing, complying with various engineering and biological standards. It does not involve AI/ML technology, and therefore, many of the requested elements pertaining to acceptance criteria, ground truth, expert involvement, and study types (like MRMC or standalone algorithm performance) are not applicable to this type of device and submission. The "acceptance criteria" are intrinsically tied to meeting the requirements of the referenced standards and demonstrating performance comparable to the predicate device.

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