(54 days)
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue; marginal and interdental gingival and epithelial lining of free gingiva; frenectomy; frenotomy; biopsy; operculectomy; Implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of deseased 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, infected, inflamed and necrosed soft tissue within the periodontal pocket; Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, 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.
The SIROLaser Advance is a Diode Laser System for dental soft tissue surgery. The system is comprised of the laser unit with handpiece, laser fibers of different diameters, bendable tips, and a wireless foot control. The SIROLaser Advance has the following basic functions: Ability to emit laser radiation either in continuous wave mode (cw) or in chopped mode; Setup and display of treatment parameters: power, treatment time, chop frequency, duty cycle; Selection of predetermined settings for different indications; Upgradeable firmware.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
Acceptance Criteria and Device Performance for SIROLaser Advance
Note: The provided document is a 510(k) summary, which generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data with detailed acceptance criteria and performance metrics typically found in a clinical trial report. Therefore, direct "reported device performance" against explicit, quantifiable acceptance criteria is not provided in the same way it would be for a novel device undergoing a full clinical efficacy trial. The acceptance is typically based on meeting safety and performance standards equivalent to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category/Type | Acceptance Criteria (Implicit from Predicate & Standards) | Reported Device Performance (as per 510(k) Summary) |
|---|---|---|
| Safety | Equivalent to predicate devices (Sirona SIROLaser Advance (K0092660) and Biolase iLase) and relevant safety standards. | "Performance testing to validate the safety... of the SIROLaser Advance includes electrical safety, electromagnetic compatibility..." |
| Effectiveness/Functionality | Equivalent to predicate devices for intended use (intra- and extra-oral soft tissue surgery including incision, excision, hemostasis, coagulation, and vaporization). | "Performance testing to validate the... effectiveness of the SIROLaser Advance includes... validation testing of both hardware and software functions." |
| The device possesses the reported basic functions: |
- Emit laser radiation in continuous wave or chopped mode
- Setup and display of treatment parameters (power, time, frequency, duty cycle)
- Selection of predetermined settings for different indications
- Upgradable firmware |
| Substantial Equivalence | Demonstrably similar in intended use, technology, design, and performance characteristics to legally marketed predicate devices, or differences do not raise new questions of safety or effectiveness. | The device is deemed "substantially equivalent" to Sirona SIROLaser Advance (K0092660) and Biolase iLase. |
2. Sample Size for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a clinical performance study with a defined sample size for patients or data collected for demonstrating direct clinical efficacy.
Instead, the submission relies on:
- Performance Testing: This likely refers to engineering, electrical safety, electromagnetic compatibility (EMC), and software validation testing performed on the device itself or in controlled environments. The sample size for these tests would typically be a limited number of devices or components, not a patient population.
- Comparison to Predicate Devices: The primary basis for clearance is demonstrating substantial equivalence to previously cleared devices. This implies that the clinical safety and effectiveness of the type of device (dental soft tissue laser) have already been established by the predicate devices.
Therefore:
- Sample size used for the test set: Not applicable in the context of a clinical test set from patient data. The relevant "sample" would be the device itself and its components for engineering and performance validation.
- Data provenance: Not applicable for a clinical test set. The validation data would originate from the manufacturer's internal testing facilities (e.g., for electrical safety, EMC, software).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. Since there is no clinical "test set" with patient data requiring expert adjudication, there were no experts used to establish ground truth in this context. The 510(k) process for this type of device typically relies on engineering data and comparison to predicate devices, not de novo clinical trials with independent expert assessment of patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. As no clinical test set requiring expert ground truth establishment is described, no adjudication method was employed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
- The document does not mention any studies involving human readers or comparing AI-assisted vs. non-AI-assisted performance.
- The SIROLaser Advance is a physical medical device (a laser system), not an AI/software as a medical device (SaMD) that typically relies on diagnostic imaging or data for interpretation where MRMC studies are relevant.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. The SIROLaser Advance is a hardware device for surgical procedures and does not rely on an "algorithm only" or AI component for standalone performance assessment in the way SaMDs do. The laser itself is the tool, operated by a human.
7. Type of Ground Truth Used
For the purpose of the 510(k) submission, the "ground truth" implicitly refers to:
- Engineering Standards and Specifications: For electrical safety, EMC, and hardware/software functionality, the ground truth is defined by adherence to recognized international and national standards (e.g., IEC standards for medical electrical equipment) and the device's own design specifications.
- Predicate Device Performance: The "ground truth" for clinical safety and effectiveness is largely established by the long-standing, safe, and effective use of the predicate devices (Sirona SIROLaser Advance (K0092660) and Biolase iLase) for the stated indications. The new device is deemed safe and effective because its performance is equivalent to these cleared devices.
8. Sample Size for the Training Set
Not applicable. This device is a laser system, not a machine learning or artificial intelligence model, therefore there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned or implied for an AI/ML algorithm, the concept of establishing ground truth for it 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.