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The IMM™ Dental Irrigation Tubing Set is intended for providing passage of irrigating fluid from a solution reservoir to a dental handpiece.

The IMM™ Dental Irrigation Tubing Set is to be used for providing passage of irrigating fluid t from a solution reservoir to a dental hand piece. The device consists of one or more inlet spikes, drip chamber, PVC plastic tubes, clamps, silicone tube, consists of only caps.

The document provided is a 510(k) summary for the IMMTM Dental Irrigation Tubing Set. It describes a medical device, its intended use, and its equivalence to a predicate device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria in the way an AI/ML device would.

Therefore, the information requested in your prompt regarding acceptance criteria and performance studies, particularly those relevant to AI/ML devices (e.g., sample size for test set, experts for ground truth, MRMC studies, standalone performance, training set details), is not applicable to this traditional medical device submission.

However, I can extract the information that is present concerning performance and testing from the provided text.

Here's a summary based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable. The document does not describe a "test set" in the context of an AI/ML study. The testing performed was primarily functional, performance, and biocompatibility testing on the device itself, not on a dataset. Data provenance (country of origin, retrospective/prospective) is also not applicable for this type of device testing.

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

• Not Applicable. The concept of "ground truth" established by experts for a test set is specific to AI/ML performance evaluation, not to the functional and biocompatibility testing of a physical medical device like an irrigation tubing set.

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

• Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations within an AI/ML study's ground truth establishment. This is not pertinent to the present device.

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. An MRMC study is used to evaluate the impact of an AI system on human reader performance. This device is a passive tubing set and does not involve human "readers" or AI assistance.

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

• Not Applicable. Standalone performance refers to the performance of an AI algorithm independent of human interaction. This device is not an algorithm.

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

• Not Applicable. Ground truth, in the context of AI/ML, refers to the verified correct answers for a dataset. For this device, "ground truth" aligns with the objective measurements and adherence to the specified ISO standards for functional performance and biocompatibility.

8. The sample size for the training set:

• Not Applicable. A training set is used for machine learning models. This device does not involve machine learning.

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

• Not Applicable. Not an AI/ML device.

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