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The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The 180W Ceralas D 980 is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein.

The device is specifically indicated for use as follows:

Ear, Nose and Throat and Oral Surgery (Otolaryngology)
Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include:

• Removal of benign lesions from the ear, nose and throat
• Excision and vaporization of vocal cord nodules and polyps
• Incision and excision of carcinoma in situ
• Ablation and vaporization of hyperkeratosis
• Excision of carcinoma of the larynx
• Laryngeal papillomectomy
• Excision and vaporization of herpes simplex I and II
• Neck dissection

Arthroscopy
Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include:

• Menisectomy .
• Synovectorny .
• Chondromalacia .

Gastroenterology
Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include:

• Hemostasis of upper and lower GI bleeding
• Excision and vaporization of colorectal carcinoma
• Excision of polyps

General Surgery, Dermatology, 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. Examples include:

• . Matrixectomy
• Excision of neuromas .
• Excision of periungual and subungual warts
• Excision of plantar warts .
• Excision of keloids ●
• Liver resection .
• Excision of cutaneous lesions ●
• Hemorrhoidectomy .
• Appendectomy
• Debridement of decubitus ulcers
• Hepatobiliary tumors
  Mastectomy
  Dermabrasion
• Vaporization and hemostasis of capillary hemangioma
• Excision, vaporization and hemostasis of abdominal tumors
• Excision, vaporization and hemostasis of rectal pathology
• Pilonidal cystectomy
• Herniorapphy
• Adhesiolysis
• Parathyroidectomy
• Laparoscopic cholecystectomy
• Thyroidectomy
• Resection of organs
• Debridement of wounds
• Photocoagulation of teleangectasia of the legs and face
• Photocoagulation of vascular lesions of the face and extremities
• Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
• Treatment of reticular veins and branch varicosities

Urology
Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include:

• Vaporization of urethral tumors .
• Release of urethral stricture
• Removal of bladder neck obstruction
• Excision and vaporization of condyloma
• Lesions of external genitalia
• Vaporization of the prostate to treat benign prostatic hyperplasia (BPH)

Gynecology
Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:

• Endometrial ablation .
• Excision or vaporization of condylomata acuminate
• Vaporization of cervical intraepithelial neoplasia
• Cervical conization
• Menorrhagia

Neurosurgery
Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas

Cardiac Surgerv
Hemostasis and coagulation of soft tissue, including cardiac tissue.

Pulmonary Surgery
Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:

• . Tracheobronchial malignancy or stricture
• Benign and malignant pulmonary obstruction .
• Endoscopic pulmonary applications

Dental Applications
Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): 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 diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux
Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

The 180W Ceralas D 980 has the same technological characteristics as the cleared 150W Ceralas D 980.

The provided text is a 510(k) summary for the Biolitec Inc.'s 180W Ceralas Diode 980nm Laser System (Model D180). This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study proving the device meets specific acceptance criteria in the way one would for novel AI or diagnostic devices.

The laser device described is a surgical tool, and its "acceptance criteria" are related to its safety and effectiveness in achieving its intended surgical functions, which are demonstrated through its technological characteristics and intended uses being substantially equivalent to a predicate device that has already been cleared by the FDA.

Therefore, the requested information about acceptance criteria and a study proving the device meets them, particularly regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, does not apply to this 510(k) summary for a surgical laser.

Instead, the "study" demonstrating its acceptance is the comparison to the predicate device as outlined in the "Substantial Equivalence" section.

Here's how to interpret the provided information in the context of a medical device submission demonstrating substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:
This concept is not applicable here. There is no "test set" in the sense of a dataset for an AI or diagnostic algorithm. The "test" is the comparison against the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This concept is not applicable. "Ground truth" for this type of device is established by the existing regulatory clearance and long-term clinical use of the predicate device, and the general understanding of laser physics and surgical applications. There isn't a specific set of experts adjudicating performance for this submission in the way one would for a diagnostic study.

4. Adjudication Method:
Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This type of study is for evaluating human performance, often with and without AI assistance for interpretation tasks. This is a surgical laser, not an interpretive device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a surgical device requiring human operation, not a standalone algorithm.

7. The Type of Ground Truth Used:
For this submission, the "ground truth" for demonstrating substantial equivalence is established based on the prior FDA clearance of the predicate device (Biolitec's 150W Ceralas D 980nm Diode Laser, K072106). The assumption is that the predicate device is already deemed safe and effective for its indicated uses.

8. The Sample Size for the Training Set:
Not applicable. This is not a machine learning device.

9. How the Ground Truth for the Training Set Was Established:
Not applicable.

In summary: The provided 510(k) summary is for a surgical laser system seeking clearance based on substantial equivalence to an already approved predicate device. The "study" demonstrating its acceptability is not a clinical trial in the traditional sense, but rather a comparative analysis of its technical specifications and intended uses against those of the predicate device. The evidence presented focuses on showing that the new device does not raise new issues of safety or effectiveness compared to the predicate, due to their similar characteristics and principles of operation.

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