Search Results

The Solea system is indicated for the following:

• Ablation of hard tissue for caries removal and cavity preparation
• Incision, Excision, Vaporization, Coagulation and Hemostasis of soft tissue in the oral cavity
• Cutting, shaving, contouring and resection of oral osseous tissue (bone)

The Solea system is a dental laser device previously cleared by the FDA for soft tissue dental indications (K123494) and hard tissue indications (K130420). The only changes from the previously cleared device are the addition of the osseous tissue indications. There have been no software changes or graphic changes to the Solea system. The osseous tissue settings are the same as the previously cleared device (K130420). The osseous settings have substantially equivalent fluence and irradiation as the hard tissue predicate devices. There are no other hardware or software changes to the Solea system device pending herein when compared to the device cleared under K123494 and K130420.

The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy to cut and ablate hard tissue and to cut soft tissue in the oral cavity. The Solea system utilizes advanced CO2 laser technology with a wavelength of 9.25μm to safely and effectively perform ablation, incision, excision, vaporization, coagulation and hemostasis procedures.

The provided text does not contain detailed acceptance criteria or a study that directly proves the device meets specific acceptance criteria in a quantitative manner as typically expected for assessing diagnostic accuracy (e.g., sensitivity, specificity).

However, it outlines a series of non-clinical tests that demonstrate the device's substantial equivalence to predicate devices in terms of safety and performance, indirectly serving as "acceptance criteria" for regulatory clearance. Since no clinical testing was performed or required due to substantial equivalence, metrics like sensitivity, specificity, or reader improvement with AI assistance are not applicable in this context.

Here's an interpretation of the non-clinical testing and how it relates to acceptance criteria fulfillment:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not provide specific sample sizes (e.g., number of handpieces for sterilization, number of samples for hard tissue testing, number of participants for usability). It generally describes "testing."
• Data Provenance: The testing was "non-clinical testing" and "bench testing." This implies laboratory or simulated environments, rather than human clinical data. The country of origin for the data is not specified, but the submission is to the U.S. FDA, suggesting the testing was conducted under standards acceptable for U.S. regulatory review. The data is retrospective in the sense that it's reported after the tests were performed to support the 510(k) submission.

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

This is not applicable to the non-clinical testing described. The "ground truth" for these tests are objective measurements against established engineering, safety, and performance standards (e.g., IEC standards for electrical safety, AAMI standards for sterilization validation). Expert consensus or qualifications for ground truth establishment are not relevant for these types of tests.

4. Adjudication method for the test set

Not applicable. Testing against objective engineering and safety standards typically involves direct measurement and comparison to pass/fail criteria, not consensus-based adjudication as would be used for image interpretation.

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. The Solea system is a dental laser device for ablation, incision, excision, etc., not an AI-assisted diagnostic imaging device. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are not relevant to this submission.

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

Not applicable. The Solea system is a physical device used by a human operator, not a standalone algorithm.

7. The type of ground truth used

The "ground truth" for the non-clinical tests were:

• Established engineering standards and regulatory requirements: For electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and laser safety (IEC 60601-2-22, IEC 60825-1).
• Established sterilization validation protocols: For cleaning and sterilization (AAMI TIR12, ANSI/AAMI ST79).
• Software verification and validation criteria: For software performance.
• Usability evaluation criteria: For usability (IEC 62366), presumably objective metrics and participant feedback aligned with the standard.
• Comparative performance data against predicate devices: For hard tissue performance (thermal effects were shown to be "substantially equivalent" to predicate systems).

8. The sample size for the training set

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

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

Not applicable, as there is no training set mentioned or implied for this device.

Ask a specific question about this device