(84 days)
The SIROLaser Advance+ is intended for intra- and extra-oral surgery including incision, hemostasis, coagulation and vaporization of soft tissue including marginal and epithelial lining of free gingiva and is indicated for: frenectomy; frenotomy; implant recovery; gingivectomy; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty ; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket, sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.
Whitening: The SIROLaser Advance+ is indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.
Low Level Laser Therapy: The SIROLaser Advance+ is intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and or temporary relaxation of muscles.
The SIROLaser Advance+ is a solid state laser in which laser energy is generated by internal diodes. The laser output energy of the device is in the infrared and red spectra at wavelengths of 970 nm and 660nm, respectively. The output settings of the SIROLaser Advance+ can be adjusted by the user and also features preset operating modes which are designed to correspond with its proposed surgical, periodontic, and endodontic applications.
SIROLaser Advance+ primarily consists of a laser control unit with graphical touch screen user interface, a laser handpiece, and single-use, disposable, "EasyTip" laser fiber guides (for surgical applications), as well as, reusable "MultiTip" light guides (for non-contact, low-power, "soft laser" applications). The laser control unit contains the 970 nm and 660 nm laser diodes, electronic hardware, touchscreen graphical user interface, and software to control the laser functionality.
The SIROLaser Advance+ handpiece assembly consists of an internal handpiece body with laser activation finger switch. The handpiece includes a removable stainless steel outer sleeve which can be cleaned and sterilized between patient procedures. The SIROLaser Advance+ is also offered with an optional wireless footswitch.
The provided text describes a 510(k) premarket notification for the SIROLaser Advance+ device, which is an laser surgical instrument. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than establishing new safety and efficacy through extensive clinical trials with specific acceptance criteria related to disease detection or treatment outcomes.
Therefore, the information you're looking for, such as a table of acceptance criteria with reported device performance related to a clinical outcome, sample sizes for test sets, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, and detailed training set information, is not typically included or required in this type of regulatory submission because the device itself does not make a diagnostic or prognostic claim that would necessitate such studies.
Instead, the "acceptance criteria" for a 510(k) submission generally revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved through non-clinical performance data, primarily focusing on engineering, safety, and operational specifications.
Here's a breakdown based on the provided text, explaining why certain requested information is absent:
Acceptance Criteria and Study Supporting Device Equivalence (Not Clinical Performance)
The "acceptance criteria" in this context refer to the successful demonstration of equivalence to predicate devices and adherence to relevant safety and performance standards. The "study" refers to the non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for substantial equivalence based on safety and operational performance, there isn't a direct equivalent to a clinical "acceptance criteria" table and reported "device performance" in terms of clinical accuracy (e.g., sensitivity, specificity for a diagnostic device).
Instead, the performance verification is against engineering standards and specific operational specifications, which are compared to predicate devices for substantial equivalence.
| Acceptance Criteria (General for 510(k)) | Reported Device Performance (from Non-Clinical Data) |
|---|---|
| Safety and Electrical Standards | - Conformity to IEC 60601-1 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance). |
- Conformity to IEC 60601-1-2 (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic compatibility). |
| Laser Safety Standards | - Conformity to IEC 60825-1 (Safety of laser products – Part 1: Equipment classification and requirements). - Conformity to IEC 60601-2-22 (Medical electrical equipment Part 2: Particular Requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment). |
| Usability | - Usability study conducted in conformity with IEC 62366 (Medical devices – Application of usability engineering to medical devices). |
| Biocompatibility | - Biocompatibility assessment of patient contacting components according to ISO 10993-5 (Biological evaluation of medical devices Part 5: Tests for cytotoxicity). |
| Software Validation | - Validation of the device's software in conformity with IEC 62304 (Medical device software – Software lifecycle processes). |
| Functional Equivalence | - Wavelengths: 970 nm (-10 nm/+15 nm) & 660 nm (+/- 5 nm), comparable to predicates (Epic 10: 940 nm; SIROLaser Advance: 970 nm; THOR VR: 660 nm). - Optical Power: 970 nm: 0.2W-7.0W (CW), 14W (peak); 660 nm: 25mW, 50mW, 100mW. Comparable to predicates (Epic 10: 10W; SIROLaser Advance: 7.0W, 14W peak; THOR VR: 30mW, 75mW, 200mW).
- Emission Modalities & Pulse Duration: Continuous Wave, Chopped (1Hz-10kHz), Peak Pulse (1.5kHz-20kHz), comparable to predicates.
- Aiming Beam: 660 nm (+/- 5 nm), 1mW (max), comparable to predicates (625-670 nm, 1mW max).
- Fiber Diameter: 200 µm, 320 µm, comparable to predicates (200 µm, 300 µm, 400 µm).
- User Interface: Color touch screen graphical user interface, same as primary predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "No human clinical data was included to support substantial equivalence." Therefore, there is no "test set" in the sense of patient data for clinical performance evaluation. The "test set" here refers to the actual device units tested under various engineering standards and for biocompatibility. The provenance would be the Dentsply Sirona testing labs or certified third-party testing facilities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not Applicable. Since no human clinical data was included, there was no need for experts to establish ground truth on patient cases. The qualification for the engineers and technicians performing the non-clinical tests would be their certifications in electrical, laser, mechanical, and software engineering, as well as biocompatibility.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not Applicable. Adjudication methods are used in clinical studies to resolve discrepancies in expert opinions on patient data. This was not a clinical study.
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 surgical instrument, not an AI-assisted diagnostic or therapeutic tool that would involve human "readers" interpreting output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This is a hardware device (laser) with accompanying software for control. "Standalone performance" in this context refers to the device's adherence to its specified performance parameters (e.g., power output, wavelength stability, safety features) without human intervention in operating the device itself during these tests, which were performed per the listed IEC standards.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For this 510(k) submission, the "ground truth" for the non-clinical tests is:
- Engineering Specifications and International Standards: The device's performance (e.g., laser power, wavelength, electrical safety, EMC, software functionality) is compared against pre-defined, industry-accepted standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, IEC 62366, IEC 62304) and the manufacturer's own design specifications.
- Biocompatibility Standards: The patient-contacting components are tested against ISO 10993-5 (cytotoxicity) for biological safety.
8. The Sample Size for the Training Set
Not Applicable. There is no "training set" in the context of machine learning or AI models, as this device does not incorporate such algorithms for diagnostic or prognostic purposes.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set as defined for AI or machine learning, this question does not apply.
§ 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.