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Ear, Nose and Throat and Oral Surgery: Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity. Arthroscopy: Hemostasis, incision, excision, coagulation, vaporization, and ablation of joint tissues during arthroscopic surgery. Gastroenterology: Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy. Orthopedics: Dissect and coagulate. General Surgery, Dematology & Plastic Surgery, and Podiatry: Excision, ablation, vaporization, and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation, and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue, and dermabrasion. GI/GU: Excision, vaporization, and hemostasis of abdominal and rectal tissues. Gynecology: Ablation, excision, incision, coagulation, hemostasis, and vaporization of tissue. Neurosurgery: Vaporization, coagulation, excision, incision, ablation and hemostasis of tissue. Ophthalmology: Dacryocystorhinostomy transcanalicular, Open DCR, Tumor Excision, Blepharoplasty. Pulmonary Surgery: Hemostasis, vaporization, coagulation, incision, ablation, and excision of tissue. Cardiac Surgery: Coagulation and hemostasis of cardiac tissue. Thoracic Surgery: Thoracotomy, Pulmonary resection, Hemostasis, Pericardiectomy, Adhesiolysis, Coagulation of blebs and bullae. Urology: Hemostasis, vaporization, incision, coagulation, ablation, and excision of tissues. Dermatology/Aesthetics: Photocoagulation of vascular & dermatological lesions of the face and extremities, Photocoagulation of telangiectasia, venulectasia of the legs and face, Treatment of reticular veins and branch varicosities, Pyrogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas, Superficial benign vascular lesions including Telangiectasias, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi, Dermatological surgery: Condyloma acuminate, warts, small non-malignant skin tumors, small semi-malignant tumors as basaliomas, Bowe, Kaposi sarcoma. Warty leucoplasty and ulcers debridement, Seborrheic keratosis, Mixoid cyst, Papillary varix, Acne treatment. Vascular Surgery: Photocoagulation of vascular & dermatological lesions of the face and extremities, Photocoagulation of telangiectasia, venulectasia of the legs and face, Treatment of reticular veins and branch varicosities.

The Diolase™ 10S system uses an Indium Gallium Arsenide Phosphorous (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a hand piece that emits the energy to the target site. A visible light is emitted at the same time to visually identify the treatment location. The Diolase™ 10S laser consists of two permanently connected components: Console, and Delivery System. The Console has a Control Panel (Touch Screen and Keypad) in front and a detachable base attached at the bottom rear of the Console. The Diolase™10S Laser Delivery System consists of the following: Fiber Optic Assembly and Surgical Handpiece.

The provided document is a 510(k) summary for the Diolase™ 10S laser system, seeking expanded indications for use. This document asserts substantial equivalence to previously cleared devices rather than providing a performance study with acceptance criteria and results for the device itself.

Therefore, most of the requested information cannot be extracted from this document as it does not contain a study evaluating the device against specific acceptance criteria. Specifically, the document states: "Non-clinical performance data is not presented. Comparison with previously cleared devices is included in the body of the 510(k) submission for the demonstration of safety and effectiveness of the new indication of this device and to support substantial equivalence to legally marketed devices."

However, I can provide what can be inferred or directly stated from the document regarding the basis of its clearance for expanded indications.

Acceptance Criteria and Device Performance (Inferred/Stated Basis for Substantial Equivalence)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. No specific performance study with a test set was conducted for this 510(k) submission. The submission relies on substantial equivalence to predicate devices that already have these indications, implying that any required testing was done on the predicate devices.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No specific performance study with a test set was conducted.

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

• Not applicable. No specific performance study with a test set was conducted.

4. 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/imaging device requiring MRMC studies.

5. 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. The 510(k) is for the physical device itself and its expanded indications for use.

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

• Not applicable. No specific performance study with a ground truth was conducted for this submission. The "ground truth" for the expanded indications effectively comes from the regulatory clearance of the predicate devices based on their established safety and effectiveness.

7. The sample size for the training set

• Not applicable. No new training set or performance study was involved in this 510(k) submission.

8. How the ground truth for the training set was established

• Not applicable. No new training set or performance study was involved in this 510(k) submission.

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The ezlase™ diode system emits energy in the near- infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

The ezlase™ diode laser system, was cleared for dental soft tissue indications under KQ61898 and K083069. The system uses a Gallium Aluminum Arsenide (GaAlA) and/or an Indium Gallium Arsenide Phosphorus (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiberoptic cable to a handpiece that emits the energy to the targeted site. A visible light is emitted at the same time to visually identify the treatment location.

This document, K083595, describes a Special 510(k) Summary Statement for the Biolase Technology, Inc. ezlase™ diode laser system. The purpose of this 510(k) is to expand the current indications for use to include therapeutic indications.

Acceptance Criteria and Device Performance:

The document does not explicitly state "acceptance criteria" in a quantitative performance metric table as might be found for a diagnostic device. Instead, the justification for the expanded indications relies on substantial equivalence to already cleared predicate devices. The "performance" being demonstrated is that the ezlase™ meets the same therapeutic claims as these predicates.

Study Details:

This submission is a Special 510(k) for expanding indications based on substantial equivalence to existing cleared devices, not a clinical trial demonstrating novel performance against new, specific acceptance criteria through a newly conducted study. Therefore, many of the typical elements of a standalone clinical study are not applicable or explicitly provided in this document.

1. Sample size used for the test set and the data provenance: Not applicable. This submission doesn't describe a new clinical test set. The basis for approval is substantial equivalence to previously cleared devices.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no new clinical test set described in this document. The "ground truth" for the predicate devices would have been established during their respective clearances, but details are not provided here.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

4. 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 system for therapeutic use, not an AI-assisted diagnostic tool involving human readers.

5. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. The "performance" assessment is based on the functional and claims equivalence to predicate devices, not a standalone algorithm's performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the purpose of this 510(k) submission, the "ground truth" or evidence of effectiveness for the therapeutic indications is derived from the prior FDA clearance of the predicate devices with identical (or very similar) Indications for Use. This implicitly relies on the data and "ground truth" (likely clinical study outcomes or established physiological effects) that supported the original clearances of those predicate devices.

7. The sample size for the training set: Not applicable. This document does not describe a machine learning algorithm requiring a training set.

8. How the ground truth for the training set was established: Not applicable.

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