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The 360° Gas Assisted Endoscopic Applicator is intended for the application of two non-homogenous fluids.

The 360° Gas Assisted Endoscopic Applicator is a sterile, single-use, disposable device intended for the application of two non-homogeneous liquids. The 360° Gas Assisted Endoscopic Applicator is designed with two luer connectors at the proximal end, which is used for connection to two syringes containing the non-homogeneous liquids. There is also a connector at the proximal end to be attached to a tubing set which is connected to a compressed air/inert gas power source. The 360° Gas Assisted Endoscopic Applicator is packaged with an air line with filter in a PETG tray/Tyvek lid configuration and sterilized using ethylene oxide. Five individually sterile packaged applicators are contained in a shelf carton along with the instructions for use.

The provided text describes a medical device, the "360° Gas Assisted Endoscopic Applicator," and its non-clinical performance data for 510(k) clearance. However, it does not contain details of a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-enabled device.

The document describes a traditional medical device submission (a special 510(k)) for a physical applicator, not a software or AI-driven diagnostic device. Therefore, many of the requested categories (like sample size for test set, data provenance, number of experts, MRMC studies, standalone performance, training set size, etc.) are not applicable to the information provided.

Despite this, I will extract the relevant information concerning acceptance criteria and the "study" (non-clinical testing) that demonstrates the device meets these criteria, as described in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document refers to "test articles" but does not quantify the number of devices or components tested for each non-clinical test.
• Data Provenance: Not applicable in the context of clinical data. This refers to design verification and biocompatibility testing performed by Micromedics, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This device is hardware for fluid application, not an interpretative AI or diagnostic tool requiring expert ground truth for a test set.

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

• Not applicable. This is not a study involving human interpretation or clinical adjudication.

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

• No. This is not an AI-enabled device; therefore, no MRMC study was conducted.

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

• Not applicable. This device does not involve an algorithm.

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

• Not applicable. The "ground truth" for this device's performance is based on engineering specifications, standardized test methods (like ISO 10993 for biocompatibility), and internal design verification criteria, not clinical outcomes or expert labels.

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it is not an AI/ML product.

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

• Not applicable. This device does not involve a training set.

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