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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.

The Solea system is a dental laser device previously cleared by the FDA for soft tissue dental indications (K123494). The only changes from the previously cleared device are the addition of the hard tissue indications, which combines minor software and graphic changes that will be added to the Solea system. This software change does not change the operational software, but adds a material selection icon on the home screen to include enamel, dentin, and soft tissue. The enamel and dentin 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.

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 9.25pm to safely and effectively perform ablation, incision, excision, vaporization, coagulation and hemostasis procedures.

Here's an analysis of the acceptance criteria and study information for the Convergent Dental, Inc. Solea device, based on the provided text:

Important Note: The provided document is a 510(k) Premarket Submission for the Solea dental laser, specifically for the expansion of its indications to include hard tissue. The primary goal of a 510(k) is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove absolute effectiveness or ideal performance against predefined, standalone acceptance criteria in the same way a new drug might. The "acceptance criteria" here are therefore inferred from the documentation's focus on demonstrating equivalence in safety and performance to predicates through various tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Pulpal Safety Study (Clinical Testing):

  • Sample Size: Not explicitly stated as a number of teeth or patients. The text mentions "none of the test-subjects felt pain or discomfort," implying a human subject study, but the specific number is not disclosed.
  • Data Provenance: Prospective in-vivo study conducted at the UCSF School of Dentistry (United States).

• Usability Testing:

  • Sample Size: Not explicitly stated (e.g., number of dentists participating).
  • Data Provenance: Conducted using "dentists... on simulated tissues in a laboratory environment that replicates the intended deployment environment of the dental office." This suggests a prospective simulation-based study.

• Bench Testing (Hard Tissue Performance):

  • Sample Size: Not explicitly stated (e.g., number of samples or tests).
  • Data Provenance: Bench testing, which is generally laboratory-based (likely in the US, given the sponsor location).

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

• Pulpal Safety Study: The text mentions "Histological examination of pulp immediately after extraction." While this implies expert pathological assessment, the number and specific qualifications of the experts (e.g., pathologists, oral surgeons) are not explicitly stated.

• Usability Testing: "Participant feedback and ratings of usability" were used. The participants were "dentists," implying general practitioners or specialists. The number of dentists involved is not explicitly stated.

• Bench Testing: The ground truth for performance was established by direct measurement and comparison to predicate devices, not by expert consensus on a test set in the traditional sense of diagnostic accuracy.

4. Adjudication Method for the Test Set

• No information is provided about an explicit adjudication method (e.g., 2+1, 3+1 consensus) for any of the studies mentioned.

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

• No MRMC comparative effectiveness study was done. This device is a dental laser, not an AI diagnostic tool, so this type of study is 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 medical device (laser), not an algorithm or AI. The performance studies focus on the laser's physical effects and safety when operated by a human user.

7. The Type of Ground Truth Used

• Pulpal Safety Study: Histological examination of pulpal tissues (pathology-based ground truth) and absence of pain/discomfort (patient outcome/symptom-based ground truth). Studies used "in-vivo" methods, implying actual biological response.
• Usability Testing: Direct observation and subjective feedback/ratings from dentists.
• Hard Tissue Bench Testing: Direct physical measurements of thermal effects and comparison to established predicate device performance.

8. The Sample Size for the Training Set

• Not applicable. This device is a laser system, not an AI/machine learning algorithm that requires a training set in that context. The "training" for the device is its design and engineering based on known principles of laser physics and previous device clearances.

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

• Not applicable, as there is no training set in the context of AI/machine learning. The "ground truth" for the device's development and design would be established through scientific literature, engineering principles, and the performance characteristics of previously cleared predicate devices (K091746 and K101817 for hard tissue, K123494 for soft tissue). The submission explicitly states that the new hard tissue indications "combine minor software and graphic changes" and have "substantially equivalent fluence and irradiation as the hard tissue predicate devices." This indicates the design was guided by known safe and effective parameters from existing, cleared devices.

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