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510(k) Data Aggregation
(395 days)
D-Laser Blue and D-Laser 16 are intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and epithelial lining of free gingiva and are 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: papillectory; 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: D-Laser Blue and D-Laser 16 are indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.
Low Level Laser Therapy: D-Laser Blue and D-Laser 16 are 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 dental diode laser systems, D-Laser Blue and D-Laser 16, realize oral soft tissue surgery, periodontal disease, endodontic disease, pain treatment, soft laser therapy and other oral diseases by vaporizing, carbonizing and solidifying the tissue by laser. The device features include: Using a capacitive touch screen which has the clear display and is easy to operate; Builtin large-capacity rechargeable lithium battery with longer time of endurance; The handpiece sleeve and the fiber tip can be autoclaved to prevent from cross infection; Preset more than 20 treatment procedures to reduce the difficulty of use; A secure protection mechanism that automatically shuts down the device after 5 minutes of inactivity.
The D-Laser Blue and the D-Laser 16 respectively consist of a main unit, a laser transmission system and a power adapter. The main unit includes a semiconductor laser, a power supply system and a control device, a safety protection device and a display device.
The D-Laser Blue employs the diodes with wavelengths of 976nm, 650nm and 450nm, and the device emits laser output energy in the infrared, red and blue spectra respectively. The D-Laser 16 employs the diodes with wavelengths of 976nm and 650nm, and the device emits laser output energy in the infrared, red spectra respectively.
The provided text does not contain typical acceptance criteria and a study design for evaluating a medical device's performance in terms of diagnostic accuracy (e.g., sensitivity, specificity). Instead, this document is a 510(k) summary for laser surgical instruments (D-Laser Blue and D-Laser 16), primarily focusing on demonstrating substantial equivalence to legally marketed predicate devices.
The "acceptance criteria" presented are primarily comparisons of technological characteristics, indications for use, and a list of non-clinical tests confirming compliance with various electrical, safety, and biocompatibility standards. The study mentioned is a non-clinical comparison of cutting efficiency.
Therefore, many of the requested fields (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, and training set ground truth establishment) are not applicable to the type of information presented in this 510(k) summary.
Here's an attempt to extract and format the available information according to your request, with "N/A" for criteria not present in the document.
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like the D-Laser Blue and D-Laser 16, substantial equivalence is often demonstrated by showing that the proposed device has the same intended use and similar technological characteristics to a predicate device, or that any differences do not raise new questions of safety or effectiveness. The "acceptance criteria" here are largely met by demonstrating these similarities and confirming compliance with relevant standards and functional tests.
| Acceptance Criterion (Implicit/Explicit) | Reported Device Performance/Comparison (D-Laser Blue and D-Laser 16) |
|---|---|
| Indications for Use (IFU) | The indications for use of D-Laser Blue and D-Laser 16 are totally same as those of their respective predicate devices (SIROLaser Blue and SIROLaser Advance+). |
| Technological Characteristics | The document presents detailed comparisons of various technological characteristics, highlighting similarities and discussing how differences do not affect substantial equivalence or raise new risks. Examples of comparisons and reported findings: - Product Code: Matches GEX, ILY. - Regulation Number & Classification: Matches 21 CFR 878.4810, Class II. - Surgical IFU: Matches predicate devices. - Laser Periodontic IFU: Matches predicate devices. - Tooth Whitening IFU: Matches predicate devices. - Low Level Laser Therapy IFU: Matches predicate devices. - Application: Dental Laser (Matches). - Laser Classification: - D-Laser Blue: 976 nm (Class IV), 650 nm (Class II), 450 nm (Class IV). Predicate: 970 nm (Class IV), 660 nm (Class II), 445 nm (Class IV). Accepted based on reference devices. - D-Laser 16: 976 nm (Class IV), 650 nm (Class II). Predicate: 970 nm (Class IV), 660 nm (Class II). Accepted based on reference devices. - Laser Type: Solid state diode (Matches). - Laser Wavelength: - D-Laser Blue: 976 nm (+/-20 nm), 650 nm (+/-20 nm), 450 nm (+/-20 nm). Accepted based on range compatibility with predicate/reference devices (e.g., K103753, K163128, K071687, K930210). - D-Laser 16: 976 nm (+/-20 nm), 650 nm (+/-20 nm). Accepted based on range compatibility with predicate/reference devices (e.g., K103753, K163128, K071687). - Optical Power: - D-Laser Blue: 976 nm (0.2-4W CW, 7W peak), 650 nm (25-200 mW CW), 450 nm (0.2-3W CW, 4W peak). Accepted based on predicate/reference devices (e.g., K163128, K071687, K180044). - D-Laser 16: 976 nm (0.3-7W CW, 16W peak), 650 nm (25-200 mW CW). Accepted based on predicate/reference devices (e.g., K163128, K071687, K170500). - Emission Modalities: Continuous Wave, Chopped (1 Hz - 20 kHz). Accepted based on reference device K163128. - Pulse Duration: Chopped Mode (5 µsec - 0.9 sec). Accepted based on reference device K163128. - Aiming Beam: 650±20 nm, Pmax < 5 mW. Accepted based on reference device K071687 and performance test report. - Optical Fiber Surgical Tips (Fiber Diameter): 200 µm, 300 µm, 400 µm. Accepted based on K180044 and K163128. - Optical Fiber Surgical Tips (Material/Sterility): Single-use, integral fiber, plastic proximal connection, bendable stainless steel cannula, non-sterile. (Compared to sterile predicate in some aspects, but considered acceptable). - Laser Handpiece: Connected by flexible optical fiber, finger switch activation, removable/sterilizable outer sleeve. (Matches predicate). - Laser Therapy Light Guides: N/A (Predicate had curved light guides). - Activation Method: Handpiece finger switch, Wireless foot switch. (Matches predicate). - Laser Control Unit Dimensions: Different sizes, but stated "doesn't affect the substantial equivalence". - Laser Control Unit User Interface: Color touch screen graphical user interface. (Matches predicate). |
| Compliance with Standards | Demonstrated conformity with: - IEC 60601-1 (Basic safety and essential performance) - IEC 60601-1-2 (EMC) - IEC 60825-1 (Laser product safety) - IEC 60601-2-22 (Surgical laser equipment specific requirements) - IEC 62366 (Usability) - IEC 62304 (Software lifecycle processes) - ISO 10993-5 (Biocompatibility - cytotoxicity) |
| Clinical Performance (if applicable) | The document mentions summarizing studies comparing cutting efficiency of the proposed devices to the predicate devices. This indicates that functional performance testing was done. (Details on exact metrics and results are not tabulated in this summary beyond "testing results do support substantial equivalence"). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for the "cutting efficiency" comparison. This type of test typically involves laboratory measurements on tissue simulants or ex vivo tissue, not human patient data.
- Data Provenance: The document explicitly states "No human clinical data is needed for D-Laser Blue and D-Laser 16." The non-clinical tests (e.g., cutting efficiency, safety standards) would be laboratory-based, likely conducted by the manufacturer in China or by a certified testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This document describes non-clinical testing and substantial equivalence, not a diagnostic accuracy study requiring expert adjudication for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No ground truth establishment or adjudication process is described as it's not a diagnostic 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 tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a laser surgical instrument, not an algorithm. Performance evaluation is for the physical device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For the non-clinical tests (like cutting efficiency), the "ground truth" would be established by objective physical measurements and engineering specifications, often against a benchmark from the predicate device.
8. The sample size for the training set
- Not Applicable. This is a hardware device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable. No training set for machine learning is involved.
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