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For removal of caries and for cavity preparation in primary and secondary teeth.

DeL2940 Dental Erbium Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench. Delivery is via fiber optic with a quartz contact tip. At 10 pulses per second an a pulse energy of 1 Joules, the average power from the laser is 10 watts.

The provided text describes a 510(k) Premarket Notification for the DeL2940 Dental Erbium Laser. It outlines the device's intended use and presents summaries of nonclinical and clinical performance data to demonstrate substantial equivalence to a predicate device. However, it does not explicitly define specific numerical acceptance criteria for performance metrics. Instead, it states that the studies "supported the safety and effectiveness" of the Er:YAG laser.

Therefore, I cannot fill out Table 1 with specific acceptance criteria and reported device performance values. The document focuses on demonstrating substantial equivalence rather than meeting pre-defined quantitative performance targets.

Here's a breakdown of the other requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit numerical acceptance criteria are provided in the document. The studies aimed to demonstrate "safety and effectiveness" and "substantial equivalence" rather than meeting pre-defined quantitative performance thresholds for the device itself.

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

• Nonclinical Studies:
  • Bovine Studies: 22 teeth.
  • Canine Studies: 174 teeth. One study compared laser treatment to a drill.
  • Data Provenance: Not explicitly stated, but implies laboratory studies.
• Clinical Studies (Test Set):
  • Foreign Data: 245 human teeth (18 extracted, 23 scheduled for extraction, 204 in vivo).
  • Domestic Data (IDE Study): 94 pediatric subjects and 121 adult subjects.
  • Data Provenance: Foreign data from four clinical studies. Domestic data from an IDE study. Both are prospective clinical studies.

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

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set in either the nonclinical or clinical studies.

4. Adjudication Method for the Test Set

The document does not provide information on any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

A Multi Reader Multi Case (MRMC) comparative effectiveness study was not explicitly mentioned. One canine study compared the laser treatment to a drill, which suggests a comparative study, but it's not described as an MRMC study involving human readers and AI. The document is about a laser device, not an AI diagnostic tool.

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

This question is not applicable as the device is a medical laser system, not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" implicitly used for the studies would be:

• For caries removal: Successful removal of carious tissue, likely confirmed visually and perhaps tactilely by dental professionals or researchers.
• For cavity preparation: Successful preparation of a cavity meeting clinical standards for restorative dentistry.
• For safety: Absence of adverse events, excessive thermal damage, or other complications.

The document does not detail how "ground truth" was formally established beyond supporting "safety and effectiveness."

8. The Sample Size for the Training Set

This question is not applicable as the device is a medical laser system, not an AI model that requires a training set.

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

This question is not applicable as the device is a medical laser system, not an AI model that requires a training set.

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