Search Results

The Elevance is intended for use by professional dental practitioners in providing treatment to dental patients in a dental operatory. The system is designed to deliver air, water, vacuum and low-voltage electricity to hand-held dental instruments.

The Elevance Delivery Unit includes components to deliver air, water, electrical power, and vacuum to dental handpieces and accessories. The controls are contained in a Doctor's Unit, an Assistant's Unit, and a Cuspidor. Additional parts include mount arms, console mount housing, and a junction box that houses a power supply and air/water regulators. Handpiece accessories or instruments can be added to the Unit, Midmark does not manufacture these accessories but, do provide means to connect them into the Unit. These include high and low speed pneumatic handpiece tubing, electric handpiece motors, scalers, intraoral cameras, curing lights, air/water syringe, and SE and HVE vacuum instruments.

Here's an analysis of the provided 510(k) summary regarding the Midmark Elevance dental delivery unit, focusing on acceptance criteria and supporting studies:

This 510(k) document is for a dental delivery unit, not an AI or imaging device. Therefore, the typical "acceptance criteria" and "study" framework involving performance metrics like sensitivity, specificity, F1-score, and ground truth established by experts is not applicable in the same way it would be for an AI-powered diagnostic tool.

Instead, the acceptance criteria for this type of device revolve around demonstrating substantial equivalence to a predicate device, primarily through engineering and regulatory compliance testing.

1. Table of Acceptance Criteria and Reported Device Performance

For the remainder of the questions, the answers will reflect the nature of device clearance (510(k) for a medical device that is not an AI/imaging diagnostic tool) rather than an AI performance study.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable in the context of an AI/imaging diagnostic test set. The "testing" here refers to engineering and regulatory compliance tests on the physical device itself, not a dataset of patient images or conditions. The number of units tested for electrical safety or functional verification is not specified in the summary but would be determined by internal quality and regulatory standards for device manufacturing.
• Data Provenance: Not applicable in the context of clinical data provenance. The "data" comes from the physical testing of the Elevance device, likely performed in a lab setting by Midmark Corporation or a contracted testing facility.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable. "Ground truth" in the AI/imaging sense does not apply here. The "truth" for this device relies on its adherence to engineering specifications and international standards (like ISO and EN).
• Qualifications of Experts: Not applicable. The "experts" would be the engineers and technicians who designed, built, and tested the device, along with regulatory specialists who ensured compliance with standards. Their qualifications would be in engineering, quality assurance, and regulatory affairs, not clinical medical expertise for diagnostic ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no ambiguous result or expert discrepancy requiring adjudication for this type of device testing. Tests either pass or fail based on predetermined criteria outlined in the relevant standards (e.g., specific voltage limits, pressure ranges, insulation resistance).

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

• This is not applicable as the Elevance is a dental delivery unit, not an AI or imaging device that would involve human readers interpreting cases.

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

• This is not applicable as the Elevance is a dental delivery unit, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the AI/imaging diagnostic sense. The "ground truth" for this device is its adherence to established engineering specifications, safety standards (e.g., electrical, EMC), and functional performance criteria as defined by international standards (ISO, EN, IEC). It's about meeting an objective, defined physical state or performance level, rather than correlating with a clinical diagnosis or outcome.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. The Elevance is a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not applicable. As there is no AI model or training set, there is no "ground truth" to establish for a training set.

Ask a specific question about this device