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The Orthopedic iPlus Soft Tissue Loser is intended for use as a laser surgical instrument in orthopedic and podiatric surgery. It is indicated for the following Indications for Use, including the previously cleared dental indications, for completeness:

DENTAL INDICATIONS FOR USE

General Indications*

• Class I, II, III, IV and V cavity preparation
• Caries removal
• Hard tissue surface roughening or etching
• Enameloplasty, excavation of pits and fissures for placement of sealants
  *For use on adult and pediatric patients

Root Canal Hard Tissue Indications

• Tooth preparation to obtain access to root canal
• Root canal preparation including enlargement
• Root canal debridement and cleaning

Root Canal Disinfection

• Laser root canal disinfection after endodontic treatment

Endodontic Surgery (Root Amputation) Indications

• Flap preparation incision of soft tissue to prepare a flap and expose the bone
• Cutting bone to prepare a window access to the apex (apices) of the root(s)
• Apicoectomy amputation of the root end
• Root end preparation for retrofill amalgam or composite
• Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex
  NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.

Bone Surgical Indications

• Cutting, shaving, contouring and resection of oral osseous tissues (bone)
• Osteotomy

Soft Tissue Indications including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:

• Excisional and incisional biopsies
• Exposure of unerupted teeth
• Fibroma removal
• Flap preparation - incision of soft tissue to prepare a flap and expose the bone
• Flap preparation - incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions)
• Frenectomy and frenotomy
• Gingival troughing for crown impressions
• Gingivectomy
• Gingivoplasty
• Gingival incision and excision
• Hemostasis
• Implant recovery
• Incision and drainage of abscesses
• Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery
• Leukoplakia
• Operculectomy
• Oral papillectomies
• Pulpotomy
• Pulp extirpation
• Pulpotomy as an adjunct to root canal therapy
• Root canal debridement and cleaning
• Reduction of gingival hypertrophy
• Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex
  NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
• Soft tissue crown lengthening
• Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
• Vestibuloplasty
  *For use on adult and pediatric patient

Laser Periodontal Procedures

• Full thickness flap
• Partial thickness flap
• Split thickness flap
• Laser soft tissue curettage
• Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
• Removal of highly inflamed edematous tissue affected by bacterial perpetration of the pocket lining junctional epithelium
• Removal of granulation tissue from bony defects
• Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility)
• Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours)
• Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
• Osseous crown lengthening
• Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage
• Waterlase MD Er,Cr:YSSG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)

ORTHOPEDIC INDICATIONS FOR USE
Incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an arthroscope, in contact and non-contact with tissue, in orthopedic and podiatric surgery, including:

• Soft and cartilaginous tissue in small and large joints (e.g., knee meniscectomy, debridement of inflamed synovial tissue)

The Orthopedic iPlus Soft Tissue Laser is an erbium, yttrium, scandium, gallium garnet (Er, Cr:YSGG) solid state laser that provides optical energy to the user controlled distribution of atomized water droplets at 2.78 μm (2780 nm). The laser consists of a cabinet which houses the power supply, the cooling system, microcontroller, laser, foot switch, and fiber optic for delivery of laser energy with fiber optic handpiece setup. The Orthopedic iPlus Soft Tissue Loser utilizes direct laser energy either with or without water for cooling and hydration to perform soft tissue incision, resection, ablation, vaporization, coagulation and hemostasis.

The provided text is a 510(k) summary for the Orthopedic iPlus Soft Tissue Laser. It details the device's description, indications for use, and a claim of substantial equivalence to predicate devices, but it does not include acceptance criteria or the results of a study designed to prove the device meets specific performance criteria.

510(k) submissions typically demonstrate substantial equivalence to legally marketed predicate devices, rather than conducting new performance studies with specific acceptance criteria as might be seen with a PMA or a more rigorous de novo submission. The document explicitly states:

"Comparison of this device with the previously cleared devices provided in this 510(k) submission demonstrates the safety and effectiveness of this device for the above indications, and supports substantial equivalence to the legally-marketed predicate devices."

Therefore, based on the provided text, I cannot complete the requested tables and information. The document focuses on demonstrating similarity to existing devices and expanding indications, not on presenting novel performance data against defined acceptance criteria.

To answer your request, here's what the document does provide in relation to what you asked for, and what it does not provide:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot be provided. The document does not define specific acceptance criteria (e.g., accuracy, sensitivity, specificity, or surgical outcome metrics) for the Orthopedic iPlus Soft Tissue Laser. Instead, it relies on substantial equivalence to predicate devices. There are no reported performance metrics for the device against such criteria.

All other points (2-9) are not applicable or cannot be answered based on the provided 510(k) summary. This type of submission relies on the established safety and effectiveness of predicate devices. It typically does not involve new clinical studies for performance metrics or ground truth establishment in the way a de novo or PMA submission might.

Summary of missing information and reasons:

• Sample size and data provenance (test set): Not applicable, as no new performance study with a test set is described.
• Number of experts and qualifications (ground truth): Not applicable, as no new ground truth establishment process for a performance study is described.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not conducted or reported in this document. The focus is on substantial equivalence.
• Standalone performance study: Not conducted or reported. Substantial equivalence relies on the predicate devices' established performance.
• Type of ground truth: Not applicable, as no new ground truth was established for a performance study.
• Sample size for training set: Not applicable, as this is not an AI/ML device and no training set is mentioned.
• How ground truth for training set was established: Not applicable.

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