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Dental Soft Tissue Indications: Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: Excisional and incisional biopsies, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivectomy, Gingivoplasty, Gingival incision and excision, Hemostasis and coagulation, Implant recovery, Incision and drainage of abscess, Leukoplakcia, Operculectomy, Oral papillectomies, Pulpotomy, Pulpotomy as an adjunct to root canal therapy, Reduction of gingival hypertrophy, Soft tissue crown lengthening, Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa, Vestibuloplasty, Tissue retraction for impression. Laser Periodontal Procedures, including: Laser soft tissue curettage, 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 mobility).

Principle: The semiconductor laser diode is excited by the generation power supply to generate the laser, which is effectively transmitted to the treatment site through the optical fiber tip. Intended operator: Dental surgeon. Component part: It is composed of laser host (including internal power system, laser drive system, optical path system, LCD screen, emergency stop button, laser) and optic fiber tip. Sterile: The Fiber optic tip and the handpiece cover require sterilization prior to use.

This document is a 510(k) premarket notification for a Class II medical device, the Dental Diode Laser, SOGA Laser, ILaser II. It focuses on demonstrating substantial equivalence to a predicate device (iLase™ by Biolase Technology, Inc., K093852) rather than proving meeting specific acceptance criteria through a performance study against a defined ground truth.

Therefore, the requested information regarding acceptance criteria, device performance, sample size, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment (which are typical for AI/ML-driven device performance studies) cannot be extracted from this document, as it describes a traditional medical device (a laser) and its regulatory submission based on substantial equivalence.

The document details the device's technical specifications and compares them to a predicate device to argue for substantial equivalence in safety and effectiveness, based primarily on non-clinical testing against recognized standards (e.g., IEC, ISO). Clinical testing was explicitly stated as not performed for this submission.

Here's what can be extracted based on the provided document, even though it doesn't align with the typical "acceptance criteria and study that proves the device meets the acceptance criteria" format for AI/ML devices:

1. A table of acceptance criteria and the reported device performance:

This document does not present quantitative performance metrics against specific acceptance criteria for a "study" in the way an AI/ML device would. Instead, it compares technical specifications to a predicate device to demonstrate substantial equivalence. The "acceptance criteria" here are effectively "being substantially equivalent to the predicate device in terms of safety and effectiveness."

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable. No clinical test set or data set for performance evaluation in the AI/ML sense was used. The submission relies on technical comparisons and non-clinical testing.
• Data Provenance: Not applicable for a "test set." The document refers to "literature referred [1]" for demonstrating efficiency equivalence but does not provide details of this literature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No ground truth establishment for a test set was performed, as it was a technical comparison for substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No adjudication was necessary as no test set requiring ground truth labeling was used.

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 study was done (or mentioned). This is a physical device (laser), not an AI-based diagnostic or assistive software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a physical laser device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable. The basis for safety and effectiveness is "substantial equivalence" to a legally marketed predicate device, supported by compliance with international electrical, laser, and biocompatibility standards.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established:

• Not applicable.

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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; frenotomy; biopsy; operculectomy; Implant recovery; gingivectomy; 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, 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:.

The semiconductor laser diode is excited by the generation power supply to generate the laser, which is effectively transmitted to the treatment site through the optical fiber tip. It is composed of laser host (including internal power system, laser drive system, optical path system, LCD screen, emergency stop button, laser) and optic fiber tip. The device mainframe not supplied sterile and do not require sterilization prior to use. The consumable component (Fiber optic tip) not supplied sterile but require sterilization prior to use.

This document describes the regulatory submission for the Shenzhen Soga Technology Co., Ltd. Dental Diode Laser (Model: ILaser I). It focuses on demonstrating substantial equivalence to a predicate device, SIROLaser Advance (Model: FonaLaser), rather than presenting a study to prove acceptance criteria with specific performance metrics.

Here's an analysis based on the provided text, addressing the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the device. Instead, it relies on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and adherence to recognized safety and performance standards. The "performance" reported is primarily that the device meets these safety and performance standards.

• Wavelength: 980nm ±20nm (vs. 970nm ±15nm for predicate). The document states this difference was verified for safety (IEC 60825-1, IEC 60601-2-22) and that the subject device's efficiency is better based on literature.
• Frequency: 1Hz to 100Hz (same as predicate).
• Output Power: 4.0 W Max CW / 8.0 W Peak Power (Pulse Mode) (vs. 4.0 W Max CW / 7.0 W Peak Power for predicate).
• Aiming Beam: Laser diode, 5 mW, 680nm±20nm, Class 1 (vs. max 1 mW, 635-650nm, Class 1 for predicate).
• Laser Class: IV (4) (same as predicate).
• N.O.H.D.: 3.03 meters (vs. 1.5 meters for predicate). Other characteristics (Principle of Operation, Environment of Use, Software) are also compared and deemed substantially equivalent. |
  | Safety and Performance Standards | Compliance with recognized international standards for medical electrical equipment safety, electromagnetic compatibility, and laser product safety. Expected standards include:
• IEC 60601-1 (Electrical Safety)
• IEC 60601-1-2 (Electromagnetic Compatibility)
• IEC 60825-1 (Safety of laser products - Part 1)
• IEC 60601-2-22 (Particular requirements for basic safety and essential performance of surgical laser equipment) | The device has been Verified to comply with:
• IEC 60601-1 (Electrical Safety)
• IEC 60601-1-2 (Electromagnetic Compatibility)
• IEC 60825-1 (Performance Safety and Effectiveness)
• IEC 60601-2-22 (Performance Safety and Effectiveness) |
  | Sterilization Conditions | Specific conditions for sterilization of consumable components. | Consumable component (Fiber optic tip) requires sterilization at 121℃ (250°F) for 30 minutes. |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable. This submission is based on demonstrating substantial equivalence to a predicate device and adherence to recognized standards, not on a clinical trial with a "test set" of patients or data in the typical sense for performance evaluation (e.g., diagnostic accuracy).
• Data Provenance: The "data" provided relates to the technical specifications of the device and its predicate, and results from non-clinical testing performed in accordance with international standards. The country of origin for the subject device is China (Shenzhen, Guangdong).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable. There was no "test set" with ground truth established by experts in the context of this 510(k) submission for this type of device. The evaluation relies on engineering, safety, and performance testing against established standards.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as there was no test set requiring expert adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not performed. This device is a laser surgical instrument, not an AI-assisted diagnostic tool for "human readers."

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable. This device is a hardware surgical instrument, not an algorithm. Its performance is evaluated through physical and electrical safety, and functional testing, not standalone algorithmic performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: The "ground truth" in this context is the successful demonstration of compliance with established international safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22). This relies on objective measurement and testing against the requirements set by these standards, rather than expert consensus on diagnostic images or pathology.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This device is a physical instrument, not an AI model requiring a training set of data.

9. How the Ground Truth for the Training Set was Established

• Ground Truth Establishment: Not applicable, as there is no training set for this device.

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The indications for use of the subject device are given below.

1. Dental soft tissue indications

Incision, excision, vaporization, ablation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:

• fibroma removal

• frenectomy

• frenotomy

• gingival troughing for crown impressions

• gingivectomy

• gingivoplasty

• hemostasis and coagulation

• implant recovery

• incision and drainage of abscess

• operculectomy

• pulpotomy

• soft tissue crown lengthening

• treatment of herpetic and aphthous ulcers of the oral mucosa.

• 2. Laser periodontal procedures

• 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 mobility.)

• 3. Whitening

• light activation for bleaching materials for teeth whitening

• laser-assisted whitening/bleach of teeth

• 4. Pain Relief

• topical heating for the purpose of elevating tissue temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle

The SOLASE dental diode laser is a surgical and therapeutic device produced by Lazon Medical Laser Co., Ltd., designed for dental soft tissue indications, laser periodontal procedures, as well as teeth whitening and pain relief. It cannot be used for oral hard tissue.

The SOLASE laser uses a laser diode as the beam source to radiate invisible infrared light, which is delivered to the operating area by optical fiber. It can generate a short laser pulse up to 10us of interval. The SOLASE laser provides two different models with two different wavelengths - 808nm and 976mm, to meet customers' various requirements.

The SOLASE laser is a Class 4 laser product which may cause injuries in improper handling. Therefore, it MUST be operated only by trained and qualified personnel.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

The document (K180967) is a 510(k) Summary for a Dental Diode Laser System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials. As such, the information you've requested about specific acceptance criteria and detailed study designs in the context of AI/algorithm performance is largely not present in this document because it is not an AI-powered device, nor is it subject to specific performance criteria typical of diagnostic or AI-driven tools.

The "acceptance criteria" here primarily refer to meeting recognized safety and performance standards relevant to a medical laser system and demonstrating functional equivalence to a predicate device.

Here's a breakdown based on your questions, with explanations for what is and isn't available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The term "acceptance criteria" is used more broadly in this context to refer to compliance with recognized standards and demonstration of similar technical specifications to predicate devices. There isn't a table presenting specific numerical acceptance criteria for diagnostic performance (e.g., sensitivity, specificity) and reported performance against those. Instead, the document focuses on compliance with established international standards for medical electrical equipment and laser safety.

2. Sample Size Used for the Test Set and Data Provenance

• No specific "test set" in the context of an AI/algorithmic performance study is mentioned. The document is for a medical device (laser system), not an AI diagnostic tool.
• The tests conducted were non-clinical (e.g., electrical safety, EMC, laser safety, biocompatibility).
• For the biocompatibility tests (ISO 10993-5, -10), the sample size would refer to the number of biological samples or test articles used in the in vitro or in vivo (irritation/sensitization) studies, but this specific detail is not provided in the summary.
• Data provenance is not applicable in the sense of patient data in this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. This information pertains to studies establishing ground truth for diagnostic AI, which is not the focus of this 510(k) submission for a laser device.

4. Adjudication Method for the Test Set

• Not applicable. This relates to human review of AI output or establishing ground truth, which is not part of this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. This is a type of clinical study often done for diagnostic devices, especially those with AI components. The document explicitly states: "No clinical study is included in this submission." (Page 7)

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. The device is a physical laser system, not an algorithm.

7. The Type of Ground Truth Used

• For the non-clinical tests, the "ground truth" is defined by the standards themselves (e.g., acceptable electromagnetic emissions per IEC 60601-1-2, non-cytotoxic result per ISO 10993-5). The device is tested against the requirements of these standards.
• For the substantial equivalence claim, the "ground truth" is the technical specifications and indications for use of the predicate devices (Biolase Epic 10 Diode Laser System and Denmat Sapphire ST Portable Laser). The proposed device's characteristics are compared directly to these.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. There is no "training set."

In summary, this 510(k) submission for the Dental Diode Laser System demonstrates substantial equivalence by:

• Compliance with recognized non-clinical performance and safety standards: AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 10993-5, and ISO 10993-10.
• Comparison of technical specifications and indications for use to two predicate devices (K121286 and K103667). The reported device performance aligns with or is comparable to the predicate devices and meets the requirements stipulated in the standards.

The document explicitly states that no clinical studies were included, which is typical for a 510(k) clearance where substantial equivalence can be demonstrated through non-clinical testing and comparison to legally marketed devices.

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The Dio-Dent 10 Dental Diode Laser System is intended for incision, excision, ablation, vaporization and/or coagulation (hemostasis) of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). In addition, the system is intended for teeth whitening. The Indications for Use of the Dio-Dent 10 Dental Diode Laser System include: Cosmetic Dentistry - Light activation for bleaching materials for teeth whitening, Laser-assisted bleaching/whitening of the teeth; Endodontology - Pulpotomy, Pulpotomy as an adjunct to root canal therapv; Periodontology - Sulcular debridement (removal of diseased or inflamed soft tissue in the periodental pocket); Oral Soft Tissue Surgery - Biopsy, Operculectomy, Gingivectomy, Gingivoplasty, Oral papillectomy, Leukoplakia, Treatment of aphthous ulcers, Fibroma removal, Frenectomy, Frenotomy, Tissue retraction for impressions. Incising and draining of abscesses, Draining fistulas, Exposure of unerupted partially erupted teeth, Lesion (tumor) removal, Implant recovery, Implant uncovering, Gingival troughing, Crown lengthening, Hemostasis of donor site, Coagulation and decontamination of extraction sites, Removal of granulation tissue, Degranulation of infrabony defects, Laser assisted flap surgery, Vestibuloplasty, Removal of hyperplastic tissues, Debridement of diseased epithelial lining

The Dio-Dent 10 Dental Diode Laser is designed to perform several medical procedures in the oral soft tissue and to perform laser assisted aesthetic tooth whitening procedures. A Gallium Aluminum Arsenide (GaAlAs) solid state laser diode provides optical energy to oral soft tissues. A fiber optic held by a handpiece delivers up to 10Watts laser energy. A visible light emitted from the handpiece's distal end targets the area of treatment. The optical power output and pulse may be adjusted to specific use requirements.

The provided text describes a 510(k) premarket notification for the Dio-Dent 10 Dental Diode Laser System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as typically found for novel devices or software.

Therefore, many of the requested categories for a rigorous study proving device performance against acceptance criteria cannot be answered directly from this type of regulatory submission. The information provided primarily pertains to compliance with safety standards and equivalence to existing devices.

Here's an analysis based on the provided text, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria with numerical targets for performance and corresponding results from a dedicated study. Instead, it asserts compliance with general safety and performance standards, and substantial equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not describe a clinical test set with a specific sample size. The "study" here is a demonstration of equivalence, relying on the established safety and effectiveness of predicate devices and compliance with recognized standards. There is no mention of a particular cohort of patients or data collected for this specific device's performance validation in a clinical setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The submission is not based on a study with a ground truth established by experts for performance evaluation. It relies on regulatory compliance and equivalence to predicate devices which have already undergone such assessments.

4. Adjudication Method for the Test Set:

Not applicable, as no specific test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study is mentioned. The device is a laser system, not an AI or imaging diagnostic tool that would typically undergo such a study.

6. Standalone (Algorithm Only) Performance:

Not applicable. The device is a physical laser system, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this submission is primarily:

• Compliance with international and national performance standards (e.g., 21 CFR 1040.10, 21 CFR 1040.11, IEC standards).
• Established safety and effectiveness of the predicate devices.
• Technical characteristics and output values that fall within the range of already cleared devices.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that involves a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this device.

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