(90 days)
The Solea system is indicated for the following:
- Incision .
- . Excision
- . Vaporization
- . Coagulation
- Hemostasis .
of soft tissue in the oral cavity.
The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy 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 incision, excision, vaporization, coagulation, and hemostasis.
The provided text describes a 510(k) submission for the Solea system, a CO2 laser for dental treatment. The submission aims to establish substantial equivalence to a predicate device, the Lutronic Corporation Spectra DENTA II Laser System (K091320), rather than demonstrating a new level of performance or effectiveness through a clinical trial. Therefore, the information typically associated with acceptance criteria for device performance and a study proving those criteria (as specified in your request) is not explicitly detailed in the context of this 510(k) summary.
However, based on the provided text, we can infer some "acceptance criteria" through the non-clinical testing performed to establish substantial equivalence in safety and performance. The study described is a bench testing comparison against the predicate device.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly that the Solea system's performance should be substantially equivalent to the predicate device in terms of safety and performance characteristics for soft tissue cutting. The reported device performance is that these criteria were met.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Solea System Performance |
|---|---|
| Electrical Safety (compliance with medical electrical equipment requirements) | Passed electrical safety testing |
| Electromagnetic Compatibility (EMC) (compliance with medical electrical equipment requirements) | Passed EMC testing |
| Laser Safety (compliance with particular requirements for diagnostic and therapeutic laser equipment) | Passed laser safety requirements |
| Cleaning and Sterilization (validations for reusable medical devices) | Handpieces passed cleaning and sterilization validations |
| Software Functionality (meet stated pass/fail criteria for intended use) | All tests completed successfully, deemed appropriate for intended use |
| Usability (meet acceptance criteria for user design validation) | All acceptance criteria for user design validation met based on participant feedback and ratings |
| Soft Tissue Performance (depth, width, length of cuts, histological assessment, effect on surrounding tissue) should be substantially equivalent to predicate device | Showed substantially equivalent results to the predicate device in terms of depth, width, and length of cuts, histological changes, and effects on surrounding tissue. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Bench Testing (Soft Tissue): Not explicitly stated. The text only mentions "Performance data was collected using the Solea system and the predicate device" and "a quantitative analysis was conducted." It does not provide the number of samples, tissue types, or experimental repetitions.
- Data Provenance: The bench testing was conducted by Convergent Dental, Inc. (the submitter) as non-clinical testing to support the 510(k) submission. The exact location or origin of the tissue samples is not specified. It is an internal, retrospective study for regulatory purposes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This type of information is generally not applicable for a bench test comparing physical characteristics of a laser.
- For the histological assessment, implied in "histological assessment of changes in sample tissue," it would typically involve a pathologist. However, the number of pathologists or their qualifications are not specified in the document.
4. Adjudication Method for the Test Set
- Not applicable as this was a bench test with objective measurements and comparative histological assessment, not a diagnostic imaging study requiring expert adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the Solea system is a physical laser device, not an AI algorithm. Its "standalone performance" refers to its physical output and effect on tissue, which was assessed in the bench testing. No human-in-the-loop element beyond operating the device is relevant here in the context of device performance.
7. The Type of Ground Truth Used
- For the bench testing, the "ground truth" was established through direct physical measurement (depth, width, length of cuts) and histological assessment (microscopic analysis of tissue changes). These are objective measurements and expert pathological interpretation, respectively.
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."
9. How the Ground Truth for the Training Set was Established
- Not applicable for the same reason as above.
§ 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.