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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 150W Ceralas D980 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
• Synovectomy
• 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 acuminata
• 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 Surgery
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 150W Ceralas D980 has the same technological characteristics as the cleared 100W Ceralas D980 and substantially similar technological characteristics as compared to the INTERmedic Diode Laser and the Xintec Vectra Diode Laser.

The provided text is a 510(k) summary for a medical device (Biolitec Inc.'s 150W Ceralas Diode 980nm Laser System). It discusses the device's intended use, indications for use, technological characteristics, and substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or specific studies proving the device meets acceptance criteria.

The document focuses on demonstrating substantial equivalence to already cleared devices, which is the regulatory pathway used for this laser system. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new safety or effectiveness concerns compared to predicate devices. It does not typically involve reporting on a study with specific acceptance criteria in the way you've outlined for performance analysis.

Therefore, I cannot populate the requested table or answer most of your questions as the information is not present in the provided text.

Here's what I can extract based on your questions, acknowledging the significant gaps due to the nature of the provided document:

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

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

Not specified in the document. The document states "Performance data demonstrate that the Ceralas D150 is as safe and effective as the predicate devices," but no details on specific studies, sample sizes, or data provenance are provided.

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

Not applicable/specified. This type of information is typically found in studies evaluating diagnostic or AI-driven devices, which is not the case here. This document pertains to a surgical laser system.

4. Adjudication method for the test set

Not applicable/specified.

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 document describes a surgical laser system, not an AI-driven or diagnostic imaging device that would typically involve a multi-reader multi-case study.

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

Not applicable. This is a surgical laser system, so the concept of an "algorithm only" performance study is not relevant.

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

Not applicable/specified. The document does not describe studies that would rely on "ground truth" as typically defined for diagnostic or AI algorithm evaluation. The "performance data" mentioned generally refers to demonstrating the device's physical operational parameters and
(presumably) safety profile in comparison to existing devices.

8. The sample size for the training set

Not applicable/specified. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable/specified. There is no mention of a "training set" or "ground truth" in this context.

Ask a specific question about this device

The device is intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscope. The device 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, neurosurgery (peripheral nervous system), pulmonary and 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
Synovectomy
Chondromalacia

Gastroenterology
Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts an 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 homeostasis of urological, including BPH/prostatic, tissues. Examples include:
Vaporization of uretheral tumors
Release of urethral stricture
Removal of bladder neck obstruction
Excision and vaporization of condyloma
Lesions of external genitalia

Gynecology
Ablation, excision, incision, coagulation, hemostasis and vaporization of gynechological 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:
Hemeostasis in conjunction with menigiomas

Cardiac Surgery
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, operculectorny, implant recovery, gingivoplasty, 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, papillectorny, vestibulopasty, 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 in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

The Vectra™ Laser System and Accessories is substantially equivalent to the Optica and Odyssey Laser Systems (Xintec Corporation, dba, Convergent Laser Technologies, Alameda, CA) and Ceralas D 980 Diode Laser Systems (East Longmeadow, MA)) previously cleared for marketing under applicable 510(k) pre-market notification regulations.

Table I summarizes device specifications of the Vectra Laser Systems compared to the Xintec Corporation Optica and Odyssey Laser Systems (Xintec Corporation, dba, Convergent Laser Technologies, Alameda, CA) and Ceralas D 980 Diode Laser System (East Longmeadow, MA)) which have been previously cleared for marketing under applicable 510(k) pre-market notification regulations.

The provided text describes a 510(k) summary for the Vectra™ Laser System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Substantial equivalence is established by showing that the new device has the same intended use and similar technological characteristics as a legally marketed predicate device, or that any differences do not raise new questions of safety and effectiveness.

Therefore, the input document does not contain the information requested regarding acceptance criteria and the study that proves the device meets them in the context of clinical performance metrics like sensitivity, specificity, accuracy, etc. The document primarily compares the technical specifications and intended uses of the Vectra™ Laser System to existing predicate devices.

Specifically, the following points cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: No such clinical performance criteria or results are reported. The provided table (Table I) compares technical specifications (wavelength, maximum output power, operating modes, etc.) to predicate devices, not clinical performance acceptance criteria.
• Sample size used for the test set and the data provenance: No test set (clinical or otherwise for performance evaluation) is mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical performance study is described.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 is a laser system, not an AI-assisted diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device