(263 days)
The Nutricair enteral ENFit adapter: ENFit male - stepped/Christmas tree connector is a disposable, sterile medical device intended to be used as an adapter between ENFit connections and funnel connections, used in enteral nutrition. A doctor, a nurse or the adult laypersons can do enteral feeding. The target population is adults.
The Nutricair™ enteral ENFit adapter: ENFit male – stepped/Christmas tree connector is sterile single use device. The adapter presents a ENFit connection in ABS at one extremity and a notched connection (in ABS) at the other extremity. The device has also a female ENFit cap in PEHD attached to the adapter with a link. This device incorporates a male ENFit connection to enteral access device with a female ENFit connector that is compliant to ISO 80369-3. It is provided with a sterility protector.
The provided text describes a medical device, the "Nutricair enteral ENFit adapter: ENFit male - stepped/Christmas tree connector," and its substantial equivalence to a predicate device. However, it does not include information about AI/ML device performance or a comparative effectiveness study with human readers. Therefore, I cannot provide details regarding:
- Sample size used for the test set and data provenance specific to an AI/ML study.
- Number of experts used to establish ground truth for an AI/ML test set.
- Adjudication method for an AI/ML test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
- Standalone AI algorithm performance.
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on non-clinical performance criteria and demonstrates compliance with established international standards for medical device connectors and biocompatibility.
Here's the information about the device's acceptance criteria and how it was shown to meet them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria (Standard Reference) | Reported Device Performance (Met/Not Met) |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | ISO 10993-5:2009 | Met |
| Guinea Pig Maximization Sens. | ISO 10993-10:2010 | Met |
| Irritation | ISO 10993-10:2010 | Met |
| Acute Systemic Toxicity | ISO 10993-11:2017 | Met |
| Material-Mediated Pyrogenicity | ISO 10993-11:2017 | Met |
| Visual Inspections | Visual inspection for the aspect | Met |
| Enteral Device Performance | ||
| Leakage (air and liquids) | ISO 20695:2020 | Met |
| Enteral Connector Performance | ||
| Fluid leakage | ISO 80369-20:2019 (met 80369-3 standards) | Met |
| Stress cracking | ISO 80369-20:2019 (met 80369-3 standards) | Met |
| Resistance to separation (axial) | ISO 80369-20:2019 (met 80369-3 standards) | Met |
| Resistance to separation (unscrew) | ISO 80369-20:2019 (met 80369-3 standards) | Met |
| Resistance to overriding | ISO 80369-20:2019 (met 80369-3 standards) | Met |
| Disconnection by unscrewing | ISO 80369-20:2019 (met 80369-3 standards) | Met |
| ENFit dimensional verification | ISO 80369-3:2016 | Met |
| Risk Analysis | ISO 14971:2019 | Met |
| Usability Analysis | ISO 62366-1:2015 | Met |
2. Sample size used for the test set and the data provenance
The document does not specify general "test set" sample sizes or data provenance in terms of country of origin or retrospective/prospective for the non-clinical tests conducted. The tests refer to compliance with ISO standards, which typically specify the number of samples required for each test. The tests are non-clinical, involving physical and chemical properties of the device, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for the non-clinical performance tests is defined by the objective pass/fail criteria specified within the referenced ISO standards. Human expert interpretation of results is not described as part of establishing the 'truth' for these mechanical, chemical, and biological performance tests, though qualified personnel would be required to execute and analyze the tests according to the standards.
4. Adjudication method for the test set
Not applicable. The tests are objective and based on compliance with specific ISO standard criteria. No human adjudication process, such as 2+1 or 3+1, is mentioned or implied for determining the outcome of these physical and chemical 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 a physical medical adapter, not an AI/ML software device for diagnostic imaging or similar applications requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
For the non-clinical performance tests, the "ground truth" is established by the specified pass/fail criteria and methodologies outlined in the referenced international standards (e.g., ISO 10993, ISO 20695, ISO 80369). These standards define acceptable limits for various physical, chemical, and biological properties.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML software device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI/ML software device.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.