(59 days)
The SIROLaser Blue is intended for:
(970 nm and 445 nm): 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; biopsy; operculectomy; imglant recovery; 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 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 index, gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.
Whitening (970 nm and 445 nm): The SIROLaser Blue is indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.
Low Level Laser Therapy (660 nm and 970 nm): The SIROLaser Blue is intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the for minor muscle and joint pain and stiffness, minor arthritis pain, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.
The SIROLaser Blue is a solid state laser device in which laser energy is generated by internal diodes. The laser output energy of the device is in the infrared, red, and blue spectra at wavelengths of 970 nm, 660nm, and 445 nm respectively. The output settings of the SIROLaser Blue can be adjusted by the user.
SIROLaser Blue primarily consists of a laser control unit with graphical touch screen user interface, a laser handpiece, single-use, disposable, "EasyTip" laser fiber guides (for surgical applications), and reusable "MultiTip" light guides (for non-contact, low-power, "soft laser" applications). The laser control unit contains the 970 nm, 660 mm, and 445 nm laser diodes, electronic hardware, touchscreen graphical user interface, and software to control the laser functionality.
The SIROLaser Blue 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 Blue is also offered with an optional wireless footswitch.
This document describes the non-clinical performance data for the SIROLaser Blue device (K180044). The information provided is primarily focused on engineering and safety compliance testing rather than diagnostic performance or comparative effectiveness with human readers.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a table of acceptance criteria with specific numerical performance metrics for the device's functional use (e.g., cutting speed, tissue vaporisation rate). Instead, it lists the standards the device was tested against and claims conformity. The only performance data mentioned directly relates to "cutting efficiency."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformity with IEC 60601-1 (Basic safety and essential performance) | Testing conducted and verified conformity. |
| Conformity with IEC 60601-1-2 (Electromagnetic compatibility) | Testing conducted and verified conformity. |
| Conformity with IEC 60825-1 (Laser product safety) | Testing conducted and verified conformity. |
| Conformity with IEC 60601-2-22 (Surgical laser equipment) | Testing conducted and verified conformity. |
| Conformity with IEC 62366 (Usability engineering) | Usability study conducted in conformity. |
| Conformity with IEC 62304 (Medical device software lifecycle) | Validation of the device's software in conformity. |
| Equivalent cutting efficiency of 445 nm laser wavelength with 970 nm laser wavelength | Published bench test data summarized to show comparable cutting efficiency (histological examination of cutting depth and tissue denaturation). |
| Biocompatibility of patient-contacting accessories | Patient-contacting accessories are identical to predicate device; no new testing performed for substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size:
- For the cutting efficiency study: The document mentions "summarize studies conducted utilizing the SIROLaser Blue device comparing the cutting efficiency of the 445 nm laser wavelength... with the 970 nm laser wavelength." It doesn't specify the sample size of tissue specimens or tests performed.
- For other conformity tests (IEC standards, usability, software validation): The sample sizes are not explicitly stated. These typically involve testing of device units and system components rather than patient data.
- Data Provenance: The document does not specify the country of origin. The bench tests described are non-clinical and would have been conducted in a laboratory setting. All data is retrospective to the submission date.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- For the cutting efficiency study: The ground truth was established through "histological examination of cutting depth and tissue denaturation." This implies the involvement of experts in histology or pathology for evaluating the tissue samples. However, the specific number of experts and their qualifications (e.g., "pathologist with X years of experience") are not mentioned.
- For other conformity tests: These are engineering and safety tests, and while experts would be involved in conducting and interpreting them, the nature of "ground truth" and "experts" as understood in clinical diagnostic studies is not directly applicable here.
4. Adjudication Method for the Test Set:
- The document does not mention any adjudication method like 2+1 or 3+1. For the cutting efficiency study, the histological examination would likely be a direct measurement or a consensus among histologists if multiple were involved, but this is not detailed.
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 laser surgical instrument, not an AI-assisted diagnostic or decision-support system. The study described is a non-clinical bench test comparing the physical cutting performance of different laser wavelengths.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This question is not applicable as the SIROLaser Blue is a physical medical device (a laser surgical instrument), not a software algorithm or AI. The "standalone" performance described refers to the device's intrinsic physical characteristics and safety compliance, as opposed to its performance in conjunction with human interpretation of data.
7. The Type of Ground Truth Used:
- For the cutting efficiency study: The ground truth was established through histological examination of tissue samples to assess cutting depth and tissue denaturation. This is a direct, objective measurement from pathological assessment of the treated tissue.
- For other non-clinical tests (IEC standards, usability, software validation): The "ground truth" refers to compliance with the requirements of the respective standards and specifications, confirmed through various engineering tests and validations.
8. The Sample Size for the Training Set:
- Not applicable. This device is a physical laser instrument. There is no "training set" in the context of machine learning or AI algorithms to improve its performance. Its functionality is based on its physical design and laser parameters, validated through engineering tests.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for an algorithm, there is no ground truth established for a training set.
In summary: The provided document is a 510(k) summary for a physical medical device. The "study" mentioned is a non-clinical bench test designed to demonstrate the equivalence of a new laser wavelength's cutting efficiency to an existing one, alongside various engineering and safety compliance tests. The concepts of AI performance metrics, human reader studies, and training/test sets for algorithms are not relevant to this type of device submission.
§ 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.