(89 days)
The Solea system is indicated for the following:
- Ablation of hard tissue for caries removal and cavity prevention
- Incision, excision, vaporization, coagulation and hemostasis of soft tissue in the oral cavity
- Cutting, shaving, contouring and resection of oral osseous tissue (both)
- Aiding in the reduction of mineral loss in dental enamel
The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy for 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 utilizes CO2 laser technology with a wavelength of 9.3 um.
The modification to the cleared Solea system is the introduction of the DR Handpiece which allows the system to deliver controlled sub-ablative energy necessary to heat the tooth surface mineral without ablation for the new treatment of aiding in the reduction of mineral loss in the tooth enamel.
The information provided describes the Solea laser system, which is intended for dental procedures, including a new indication for "aiding in the reduction of mineral loss in dental enamel."
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria for the new indication ("aiding in the reduction of mineral loss in dental enamel") with corresponding reported performance values. Instead, it describes generic safety and performance testing for various aspects of the device and a specific finding from "bench testing" relating to the new indication.
Implicit Acceptance Criteria (for the new indication related to mineral loss in dental enamel):
| Acceptance Criteria | Reported Device Performance (for the new indication) |
|---|---|
| Pulpal temperature increase below 5.5º C | Increase in pulpal temperature following the procedure was less than the maximum threshold of 5.5º C |
| No visually observed structural changes (melting, charring, carbonization) in the tooth | No visually observed structural changes such as melting, charring or carbonization |
| Significant benefit in aiding in the reduction of mineral loss in dental enamel (measured by relative mineral loss in depth and surface mineral loss) | In vitro testing demonstrated a significant benefit of the Solea system in aiding in the reduction of mineral loss in dental enamel as measured by the relative mineral loss in depth and surface mineral loss |
| No significant damage to the enamel | No significant damage to the enamel |
| Inhibition of surface softening and surface loss during pH cycling | Inhibition of surface softening and surface loss during pH cycling was observed |
General Safety and Performance Criteria (for the device as a whole):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety (IEC 60601-1) | Passed electrical safety testing |
| Electromagnetic Compatibility (IEC 60601-1-2) | Passed electromagnetic compatibility (EMC) testing |
| Laser Safety (IEC 60601-2-22 and IEC 60825-1) | Passed laser safety particular requirements |
| Cleaning and Sterilization (AAMI TIR12, ANSI/AAMI ST79) | Passed cleaning and sterilizations for reusable medical devices; achieved SAL of at least 10^-6 |
| Software Verification and Validation | Verification and validation testing completed successfully with respect to stated pass/fail criteria |
2. Sample size used for the test set and the data provenance
The document states, "The in vitro studies found that the increase in pulpal temperature following the procedure was less than the maximum threshold of 5.5º C and there were no visually observed structural changes such as melting, charring or carbonization." It also mentions, "In vitro testing demonstrated a significant benefit of the Solea system in aiding in the reduction of mineral loss in dental enamel as measured by the relative mineral loss in depth and surface mineral loss, without significant damage to the enamel. Additionally, inhibition of surface softening and surface loss during pH cycling was observed."
- Sample Size for test set: Not specified.
- Data Provenance: The studies are described as "in vitro studies" and "bench testing," indicating laboratory-based studies. The country of origin of the data is not specified. The studies appear to be prospective to evaluate the device's performance under specific conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The studies mentioned are in vitro/bench testing, which often relies on objective measurements rather than expert consensus on subjective interpretations (like image-based diagnoses). Thus, the concept of "ground truth established by experts" as typically seen in diagnostic AI is not directly applicable or reported here.
4. Adjudication method for the test set
This information is not provided in the document. Since the testing involves in vitro objective measurements and assessments of physical changes (pulpal temperature, structural changes, mineral loss), an adjudication method as typically used for subjective expert evaluations is unlikely to have been relevant or performed.
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, a multi-reader, multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or implied. This device is a laser system for treatment, not a diagnostic AI tool, so an MRMC study comparing human reader performance with and without AI assistance is not applicable to its stated purpose.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a laser system operated by a healthcare professional. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in the typical sense of a diagnostic AI algorithm. The performance mentioned ("significant benefit in aiding in the reduction of mineral loss," etc.) refers to the device's direct physical effect on dental enamel as tested in vitro, not an algorithmic output.
7. The type of ground truth used
For the specific new indication:
- The "ground truth" implicitly used for the effectiveness testing (reduction of mineral loss, inhibition of softening/loss) would be quantitative measurements of mineral content, depth, and surface characteristics of dental enamel, along with objective measurement of pulpal temperature and visual observation for structural damage. This falls under scientific measurement/bench testing data.
For other safety aspects (electrical, EMC, laser, sterilization):
- Compliance with established industry standards and regulatory requirements (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, AAMI TIR12, ANSI/AAMI ST79) serves as the "ground truth" for these safety parameters.
8. The sample size for the training set
The document describes this as a medical device (laser system), not an AI/machine learning algorithm that typically requires a training set. Therefore, information about a "training set sample size" is not applicable and not provided.
9. How the ground truth for the training set was established
As described above, the device is a laser system, not an AI/machine learning algorithm requiring a training set, so this information is not applicable and not provided.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.