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The Vectra Family of Laser Systems and Accessories are indicated for ablation, vaporization, coagulation, incision/excision of soft tissue in contact or non-contact mode including open surgery and via endoscopes, introducers, trocars, or catheters. The Vectra Family of Laser Systems and Accessories are indicated for use in surgical procedures on skin, subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph vessels and nodes, organs and glands in surgical specialties including but not limited to genitourinary surgery, urology (including BPH), gynecology (GYN), gastroenterology, general surgery (including specific treatment of varicose veins, varicosities associated with superficial reflux of the greater saphenous vein, removal of pigmented lesions, photothermolysis of hair follicles), neurosurgery, otolaryngology (ENT), orthopedics, ophthalmology, podiatry, pulmonary/ thoracic surgery, dentistry and oral surgery (intra/extra oral soft tissue, e.g., removal of diseased soft tissue in the periodontal pocket, and for light activation of bleaching materials for teeth whitening.)

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 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, general surgery, dermatology, plastic surgery, podiatry, urology, genecology, neurosurgery (peripheral nervous system), pulmonary and cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein.

The Vectra Family of Laser Systems emitting 980nm and 1470 nm wavelengths are substantially equivalent to the Xintec Corporation Vectra Laser Systems (Xintec Corporation, dba, Convergent Laser Technologies, Alameda, CA) and Ceralas D 980nm and 1470nm Diode Laser Systems (East Longmeadow, MA) which have been previously cleared for marketing under applicable 510(k) pre-market notification regulations.

This document is a 510(k) premarket notification for the Vectra™ Family of Laser Systems and Accessories. It describes the device's intended use and claims substantial equivalence to previously cleared predicate devices. Crucially, this document does not contain an acceptance criteria table, reported device performance metrics, or details of a study demonstrating the device meets performance criteria.

The 510(k) submission process for this type of device (surgical laser) typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical performance studies with specific acceptance criteria in the same way that novel diagnostic AI/ML devices might.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence to predicate devices, not on meeting new, specific algorithmic performance metrics.
2. Sample size used for the test set and the data provenance: Not applicable as a standalone performance study with a test set for acceptance criteria is not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 surgical laser, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide regarding "acceptance criteria" and "study":

• Acceptance Criteria (Implied by Substantial Equivalence): The implicit "acceptance criteria" for a 510(k) for a device like this is demonstrating substantial equivalence to existing predicate devices. This means showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate(s).
• "Study" (Demonstration of Substantial Equivalence): The document states:
  • "There should be no significant differences in laser delivery performance for each of 980nm and 1470nm wavelengths for the Vectra Family of Laser Systems compared to the cleared predicate devices."
  • This "performance data" statement, in the context of a 510(k), typically refers to non-clinical testing (e.g., bench testing, engineering comparisons) to confirm that the laser itself performs comparably to the predicate devices in terms of power output, wavelength stability, beam characteristics, safety features, etc. It does not refer to a clinical study with patients to evaluate diagnostic accuracy or a specific clinical outcome with acceptance criteria.

The 510(k) process for this device is centered on the comparison to predicate devices: Biolitec Ceralas 980nm and 1470nm Diode Laser, Convergent Laser Technologies 980nm Diode Laser and OptiLITE Accessories, and Cynosure Smart Lipo Multiwavelength Laser. The "study" here is the assessment that the new device's technological characteristics and intended uses are similar enough to these predicates that it doesn't require a new, full-scale clinical trial to prove safety and effectiveness.

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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 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.

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The Polaris Diode Laser System and accessories are indicated for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. Soft tissue which may be encountered in surgical procedures include skin, subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph vessels and nodes, organs and glands and specifically for the following indications. Specific surgical specialties include:

Dermatology and Plastic Surgery for

Photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, spider nevi, and other benign vascular lesions. Photothermolysis of blood vessels (treatment of facial and leg veins) Removal of pigmented lesions Photothermolysis

Dentistry (soft tissue only), including sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) and oral surgery; Ear Nose & Throat; Otorhinolaryngology; Neurosurgery (coagulation only);

Ophthalmology/Oculoplastic; Pulmonary/Thoracic Surgery; Gastroenterology; Urology; Gynecology; Orthopedics; Podiatry; and General Surgery.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. These details would typically be found in the 510(k) summary or the full submission, which are separate documents from the clearance letter itself.

Therefore, I cannot provide the requested information based solely on the provided text.

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The Protégé II Er:YAG Laser Systems and accessories are indicated for the surgical incision/excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, agans and glands.

Dentistry: Soft tissue (incision, excision, ablation and coagulation)

Dermatology Plastic Surgery: Indications include epidermal nevi, clangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors and cysts, skin resurfacial skin lesions, and performing: diagnostic biopsies.

General Surgery: Indications include surgical incision, vaporization, ablation and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated.

Genitourinary: Indications include lesions of the external genitalia, urethra and anus, penis, scrown and uretira (includes condylomaacuminata, giant perineal condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon.

Gynecology: Indications include cervical intracoithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.

Oral Maxillofacial: Indications include benign oral tumor, oral and glossal lesions and gingivectorny.

Otorhinolaryigology/Head and Neck (ENT): Indications include ear, nose and throat lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue and oral leukoplakia.

Ophthe mology: Indications include soft tissue surrounding the eye and orbit and anteriorcapsulotomy.

Podiatry: Indications include warts, plantar verrucae, large mosaic verrucae andmatrixectorny.

Arthrescopy: Including open and laparoscopic procedures

Orthopedic Surgery

Thoracic Surgery

Protégé II (tm) Er: YAG Laser System and Accessories (Upgrade)

The provided document set is a 510(k) premarket notification letter for the Protégé II (tm) Er: YAG Laser System and Accessories, dated July 3, 1998. This document confirms that the FDA has reviewed the submission and found the device substantially equivalent to a legally marketed predicate device.

However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or multi-reader multi-case studies.

Therefore, I cannot provide the requested information from the given text. The letter primarily focuses on the regulatory approval of the device based on substantial equivalence, rather than detailing specific performance criteria or study results.

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The Alexis Alexandrite Laser System and accessories are indicated for: Cosmetic and Plastic Surgery Photocoagulation of dermatological vascular lesions Treatment of cutaneous vascular and pigmented lesions

Not Found

The provided document is a 510(k) clearance letter from the FDA for a medical device (Alexis™ Alexandrite Laser System and Accessories). It approves the device for market based on substantial equivalence to a predicate device, but it does not contain any information regarding acceptance criteria, study data, or performance metrics of the device.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval and indications for use, not on the technical performance specifications or the studies supporting those specifications.

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The Protégé and Protégé LP Er: YAG Laser Systems and accessories are indicated for incision/excision, ablation, and coagulation (hemostasis) of soft tissue which may be encountered in surgical procedure includes skin, subcutaneous tissue, striated and smooth muscle, mucous membrane, lymph vessels and nodes, organs and glands and specifically for the following indications. Specific surgical specialties include:

Dentistry
Soft tissue (incision, excision, ablation and coagulation)

Dermatology and Plastic Surgery
Epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers Oral/Maxillofacial (benign oral tumor, oral and glossal lesions and gingivectomy) Ear Nose & Throat (ENT), Head and Neck Surgery

GI, GU, GYN and Pulmonary Surgery
Orthopedic Surgery
Thoracic Surgery
Ophthalmology
Podiatry
General Surgery

Protégé and Protégé LP Er: YAG Laser Systems and Accessories

This document is a 510(k) clearance letter from the FDA for the Protégé and Protégé LP Er:YAG Laser Systems and Accessories, dated November 3, 1997. It explicitly states that the devices are substantially equivalent to pre-amendments devices.

Therefore, this document does not contain information related to specific acceptance criteria, device performance studies, or AI/software validation as presented in the request.

The concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as detailed in the prompt (e.g., sample size, expert ground truth, MRMC studies, standalone performance) typically applies to more modern submissions, especially for AI/ML-driven devices, or devices requiring more extensive clinical evidence beyond substantial equivalence to a predicate.

Thus, I cannot extract the requested information from the provided text.

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The Dentica Pulsed Nd: YAG Laser System and accessories is indicated for incision/excision, ablation, and coagulation (homeostasis) of soft tissue and cartilage. Soft tissue which may be encountered in surgical procedure includes skin, subcutaneous tissue, striated and smooth muscle, cartilage, mucous membrane. Ivmph vessels and nodes, organs and glands.

Specific surgical specialties include:

Dentistry Laser Curettage; Gingivectomy; Gingivoplasty; Incision and Excision

Oral Surgery

Frenectomy; Incisional and Excisional Biopsy; Incisional and Excisional aphous ulcers; Incision of infection when used with antibiotic therapy; Excision and ablation of benign and malignant lesions and conditions; Homeostasis; Operculectomy, and Crown lengthening.

Ear Nose & Throat (ENT)

Head and Neck Surgery

Thoracic Surgery

Neurology (homeostasis only)

Dermatology

Plastic Surgery

General Surgery

Not Found

I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) clearance letter from the FDA for a medical device (Dentica Pulsed Nd: YAG Laser System). It indicates that the device has been found substantially equivalent to a predicate device and lists its indications for use.

However, the document does not contain any information about the acceptance criteria, the study design, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies that prove the device meets specific performance criteria. This type of detailed performance data is typically found in the 510(k) submission itself, which is not provided here.

Therefore, I cannot populate the table or answer the specific questions regarding the device's performance study based on the given text.

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Ask a specific question about this device

Ask a specific question about this device