(86 days)
The Monoject™ Enteral Feeding Syringe with ENFit Connector is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.
The Monoject™ Enteral Feeding Syringe with ENFit Connector is a disposable enteral feeding syringe provided in a variety of sizes from 6mL to 60mL. The device incorporates a female ENFit connector for connection to an enteral access device with male ENFit connector.
The provided document is a 510(k) premarket notification for a medical device, specifically an enteral feeding syringe. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe a study involving an AI algorithm or an acceptance criteria study related to an AI device's performance.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI device meets those criteria because the document is not about an AI device.
However, I can extract the acceptance criteria and test results for the physical characteristics of the Monoject™ Enteral Feeding Syringe with ENFit Connector, as detailed in the "Nonclinical testing" section.
Here's the information adapted to the prompt's structure for the physical device, recognizing this is not an AI study:
1. Table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Requirement Defined in AAMI /CN3 (PS):2014) | Reported Device Performance |
|---|---|---|
| Fluid Leakage | Clause 6.2 | Conforms to the requirements of AAMI /CN3 (PS):2014 |
| Stress Cracking | Clause 6.3 | Conforms to the requirements of AAMI /CN3 (PS):2014 |
| Resistance to separation from axial load | Clause 6.4 | Conforms to the requirements of AAMI /CN3 (PS):2014 |
| Resistance to separation from unscrewing | Clause 6.5 | Conforms to the requirements of AAMI /CN3 (PS):2014 |
| Resistance to overriding | Clause 6.6 | Conforms to the requirements of AAMI /CN3 (PS):2014 |
| Disconnection by unscrewing | Clause 6.7 | Conforms to the requirements of AAMI /CN3 (PS):2014 |
| Dimensional Analysis | Criteria in Table B.2 of AAMI /CN3 (PS):2014 | Conforms to the criteria in Table B.2 of AAMI /CN3 (PS):2014 |
| Biocompatibility | Not explicitly stated, implied by "demonstrated the biological safety" | Demonstrated the biological safety |
| Stability | Not explicitly stated, implied by "evaluated the properties... after accelerated aging" | Evaluated properties after accelerated aging in support of labeling |
2. Sample sized used for the test set and the data provenance
The document does not specify the exact sample sizes for each non-clinical test (e.g., number of syringes tested for fluid leakage). It mentions "accelerated aging" for stability testing, implying lab-based, prospective testing conducted by the manufacturer, Covidien, based in Mansfield, MA, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI device or a study requiring expert human interpretation for ground truth establishment. The ground truth for physical tests is based on objective measurements against international standards (ISO 80369 series and AAMI /CN3 (PS):2014).
4. Adjudication method for the test set
Not applicable. The tests are objective physical measurements against predefined criteria.
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 is not an AI device or a study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used
For the physical tests, the ground truth is based on objective measurements against established international and industry standards. For example, fluid leakage is "true" if the device meets Clause 6.2 of AAMI /CN3 (PS):2014.
8. The sample size for the training set
Not applicable. This is not an AI device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable.
Summary regarding the device:
The Monoject™ Enteral Feeding Syringe with ENFit Connector underwent non-clinical testing to demonstrate its substantial equivalence to predicate devices and conformity to relevant standards (ISO 80369-3, ISO 80369-20, and AAMI /CN3 (PS):2014). The testing covered aspects like fluid leakage, stress cracking, resistance to separation, resistance to overriding, disconnection by unscrewing, dimensional analysis, biocompatibility, and stability. All tested parameters met the specified criteria in the relevant standards. Clinical testing was not deemed necessary for the demonstration of safety and effectiveness.
§ 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.