(32 days)
The COVIDIEN Extended Tip Applicator is indicated for use in the simultaneous delivery of two non-homogenous solutions onto a surgical site.
The COVIDIEN Extended Tip Applicator is a single-use, disposable applicator intended for the simultaneous delivery of two non-homogenous solutions onto a surgical site. The COVIDIEN Extended Tip Applicator provides two (2) female luer fittings for connection to standard syringes containing two non-homogenous solutions. The shaft of the Extended Tip Applicator maintains two separate and independent lumens, which keep the two solutions separate and prevent premature mixing. The Extended Tip Applicator shaft is bendable up to 60 degrees to facilitate access to confined spaces at the surgical site.
The provided text describes a 510(k) premarket notification for the COVIDIEN Extended Tip Applicator. It does not contain information about acceptance criteria for a study, nor does it present "reported device performance' in the context of a comparative study with a human-in-the-loop or standalone AI. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Here's a breakdown of what can be extracted and what is missing based on your requested headings:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the given text. The document states:
"Safety and effectiveness of the Extended Tip Applicator have been demonstrated in this submission. Biocompatibility testing assures the device complies with applicable sections of industry and safety standards. Performance testing ensures that the Extended Tip Applicator meets all of its functional requirements and performs as intended."
However, it does not detail specific acceptance criteria or the numerical results of performance tests.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. The submission mentions "Performance testing" but does not specify sample sizes or data provenance.
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 provided in the given text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given text.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (applicator), not an AI/software device that would involve human readers or AI assistance. The document states that "Performance data, identical indications for use and identical operating principle demonstrate the Covidien Extended Tip Applicator to be substantially equivalent to a predicate device".
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the given text. For a physical device, "ground truth" would typically refer to direct measurements or functional assessment against specifications.
8. The sample size for the training set
This information is not provided in the given text. As this is a physical device, there would not be a "training set" in the context of AI/machine learning.
9. How the ground truth for the training set was established
This information is not provided in the given text and is not applicable as it's not an AI/machine learning device.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).