Search Results

The Smart 2940D Er:YAG Laser system is indicated to be used for ablation, incision, excision, vaporization and coagulation of hard and soft intraoral tissue. The procedures include caries removal, cavity preparation and enamal etching.

Smart 2940D is a Er:YAG laser, having a Er:YAG crystal rod as the lasing medium. It is a laser with a wavelength of 2,940 nm. Laser activation is by footswitch. Overall weight of the laser is 47 Kg, and the size is 145x23x65 cm (HxWxD). Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase.

This device, the Smart 2940D Laser, did not undergo a study to prove its performance against specific acceptance criteria in the sense of a typical diagnostic algorithm. The provided information is a 510(k) summary for a medical laser system seeking substantial equivalence to existing devices, not a study evaluating an AI device's performance.

Here's an analysis of the provided information in the context of your questions, explaining why many of those questions are not applicable to this submission:

1. A table of acceptance criteria and the reported device performance

• Not applicable. This submission is for a medical device (a laser) and not a diagnostic algorithm. Therefore, there are no "acceptance criteria" related to diagnostic performance metrics (like sensitivity, specificity, or AUC) that would be reported for an AI/algorithm-based device. The "performance" for such a device is typically assessed through safety and efficacy, often by comparing it to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. No clinical test set data is presented or required for this type of 510(k) submission. The "Nonclinical Performance Data" and "Clinical Performance Data" sections explicitly state "none." Substantial equivalence in this case is primarily based on comparison of the device's characteristics and intended use to legally marketed predicate devices.

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)

• Not applicable. As there is no test set or diagnostic performance evaluation, there is no ground truth to be established by experts.

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

• Not applicable. No test set or diagnostic performance evaluation was conducted.

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. This device is a laser for surgical applications, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reading improvement with AI is not relevant.

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

• Not applicable. This is a hardware medical device (a laser), not a standalone algorithm.

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

• Not applicable. As there is no diagnostic algorithm being evaluated, there is no ground truth of this nature required.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.

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

• Not applicable. No training set was used for this device.

Summary of the K031389 510(k) Submission:

The K031389 submission for the Cynosure Smart 2940D Laser is a 510(k) Premarket Notification seeking to demonstrate substantial equivalence to predicate devices already on the market (Fotona Fidelis & American Dental Technologies Pulsemaster Er:Y:YAG).

The basis for substantial equivalence is documented as follows:

• Intended Use: The Smart 2940D is indicated for ablation, incision, excision, coagulation, and vaporization of intraoral hard and soft tissue, with specific procedures including caries removal, cavity preparation, and enamel etching. This is equivalent to the intended uses of the predicate devices.
• Principle of Operation: The device is an Er:YAG laser with a wavelength of 2,940 nm, operating on the same principle as the predicate devices.
• Wavelength: 2,940 nm, which is the same as the predicate devices.
• Pulse Energy Range: Essentially the same as the predicate devices.
• Performance Data: The submission explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none." This indicates that the FDA did not require new performance studies for this particular 510(k) submission, likely because the device's characteristics and intended use were sufficiently similar to the legally marketed predicate devices to warrant a determination of substantial equivalence based on technical specifications and comparison.

In conclusion, the questions posed are designed for the evaluation of AI/algorithm-driven diagnostic devices. The Smart 2940D Laser is a conventional medical laser system, and its approval through the 510(k) process relied on demonstrating substantial equivalence to pre-existing, legally marketed devices rather than undergoing de novo clinical performance studies or AI-specific validation.

Ask a specific question about this device