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755 nm Indications for Use:
The 755 nm Profile Multi-Platform System with its accessories is indicated for stable long-term, or permanent hair reduction for all skin types (Fitzpatrick I - VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions and wrinkles.
1320 nm Indications for Use:
The 1320nm Profile Multi-Platform System with its accessories is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Profile 1320nm laser is further indicated for laser assisted lipolysis.
2940 nm Indications for Use:
The 2940 nm Profile Multi-Platform System with Profractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.

The Profile Multi-Platform System is a modular, multi-wavelength laser/light system. The system uses scanning and focusing optics to deliver a pattern of thermal energy to the treatment site. The system consists of control console which houses the power supply, cooling system, fiber optic delivery system and/or articulated arm delivery system with handpiece and/or scanner.

The provided text is a 510(k) Summary for the Sciton, Inc. Profile Multi-Platform System (K081352). This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, many of the requested fields cannot be directly extracted from the provided text.

Here is an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or report specific performance metrics from a study to demonstrate device performance against such criteria. The submission relies on demonstrating substantial equivalence to predicate devices.

2. Sample size used for the test set and the data provenance

Not applicable. The document does not describe a clinical performance study with a test set. It is a 510(k) submission based on substantial equivalence.

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

Not applicable. The document does not describe a clinical performance study involving experts to establish ground truth.

4. Adjudication method for the test set

Not applicable. The document does not describe a clinical performance study with a test set requiring adjudication.

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 laser/light system, not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

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

Not applicable. This device is a laser/light system, not an algorithm or AI product.

7. The type of ground truth used

Not applicable. The document does not describe a study involving ground truth. The submission's argument for safety and effectiveness is based on the technological characteristics and indications for use being substantially equivalent to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. The document does not describe a training set for an algorithm or AI model.

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

Not applicable. The document does not describe a training set for an algorithm or AI model.

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1064 nm Indications for Use: Coagulation and hemostasis of benign vascular lesions such as, but not limited to-telangiectasia and rosacea. Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles. Incision/excision and cutting, vaporization, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. It is further indicated for laser assisted lipolysis.

1320 nm Indications for Use: It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne, atrophic acne scars and mild to moderate inflammatory acne vulgaris. Profile Multi-Platform System with fiber delivery is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities, and for treatment of incompetence and reflux of superficial veins in the lower extremity.

2940 nm Indications for Use; Skin resurfacing and treatment of wrinkles.

Pulsed Light (300-1400 nm) Indications for Use: The Profile Multi-Platform Systems and Accessories are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology. It is intended for use for: The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); (515nm LP filter, 560nm LP filter) The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; (560nm LP filter, 590nm LP filter) The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction: (590nm LP filter, 640nm LP filter, 695nm LP filter) Treatment of facial wrinkles, treatment of fine lines and wrinkles; and (590nm LP filter, 640nm LP filter, 695nm LP filter, 800nm LP filter) Topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain. (800nm LP filter)

The Profile Multi-Platform System is a modular, multi-wavelength laser/light system. The system uses scanning and focusing optics to deliver a pattern of thermal energy to the treatment site. The system consists of control console which houses the power supply, cooling system, fiber optic delivery system and/or articulated arm delivery system with handpiece and/or scanner.

This submission (K070388) is for the Sciton Profile Multi-Platform System, a modular, multi-wavelength laser/light system. It is a 510(k) submission, meaning the device is seeking clearance based on substantial equivalence to existing legally marketed predicate devices, rather than requiring new clinical studies to prove safety and effectiveness from scratch.

Therefore, the document does not contain explicit acceptance criteria and a study demonstrating the device meets those criteria in the way one might expect for a novel device or a device claiming superior performance. Instead, the "acceptance criteria" are implied by the substantial equivalence determination process, where the device must demonstrate comparable performance and safety characteristics to established predicates.

Here's an analysis of the provided information in the context of a substantial equivalence submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a substantial equivalence submission, there are no explicit "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy that a diagnostic AI device would typically have. The "performance" is demonstrated by asserting that the device shares the same intended use, similar design features, and functional features as the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

This is a physical medical device submission (laser/light system), not an AI/software device that requires a test set of data for performance evaluation. Therefore, there is no "test set" in the context of an algorithm's performance on a dataset. The device's performance is established through equivalence to predicate devices, which implies that the predicate devices have already demonstrated safety and effectiveness through their own clinical use and/or studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As described in point 2, there is no "test set" or ground truth establishment in the context of evaluating an algorithm's performance.

4. Adjudication Method for the Test Set

Not applicable. There is no test set in the context of evaluating an algorithm's performance.

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. The Sciton Profile Multi-Platform System is a laser/light system, not an AI software intended to assist human readers (e.g., radiologists interpreting images). Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.

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

Not applicable. This is a physical laser/light system, not an AI algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable. There is no "ground truth" in the context of evaluating an AI algorithm's performance. The basis for safety and effectiveness is substantial equivalence to legally marketed predicate devices, which would have had their own evidence for safety and effectiveness, potentially including clinical outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is a physical medical device.

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1064 nm Indications for Use:
The Profile Multi-Platform Systems and Accessories are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.
Dermatology:
Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser/light treatments.
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles.
The intended use of the contact cooling system in the Profile handpiece is to provide cooling of the skin prior to, during and after laser treatment, for the epidermal protection and reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
Surgical Applications:
Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.
1320 nm Indications for Use;
The Profile Multi-Platform Systems and Accessories are intended for use in general surgery and dematology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne, atrophic acne scars and mild to moderate inflammatory acne vulgaris.
Profile Multi-Platform System with fiber delivery is indicated for the treatment of reflux of saphenous veins associated with varicose veins and varicosities.
Profile 2000 nm Indications for Use:
The Profile Multi-Platform Systems and Accessories are indicated for incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an endoscope, in contact and non-contact with tissue, with or without a hand piece, in the following indications:
Dermatology and Plastic Surgery
Dermatologic and Plastic Surgery of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars, tattoo removal, vascular lesions (including port wine stains, hemangioma, telangiectasias [facial, leg] and rosacea), corns, papillomas, basal cell carcinomas, lesions of skin and subcutaneous tissue, plantar warts, periungual and subungual warts, debridement of decubitus ulcer, skin tag vaporization,
Gastroenterological/Gastrointestinal Surgery
Open and endoscopic gastroenterologic surgery of soft tissue(for incision, excision, resection, ablation, vaporization, coagulation and hernostasis) including; cholecystectorny, lysis of adhesions, appendectorny, biopsy, pylorostenotorny, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, uicers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding furnors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Oster-Weber-Rendu disease.
General Surgery
General surgery of soft tissues, including; skin incision, tissue dissection, excision of external turnors and lesions, complete or partial resection of internal organs, turnors and lesions, and tissue ablations; removal of benign and malignant lesions; mastectorny, hepatectorny, pancreatectorny, splenectorny, thyroidectorny, parathyroidectorny, herniorthaphy, tonsillectorny, lymphadenectorny, partial nephrectomy, pilonidal cystectomy, resection of lipoma, pelvic adhesiolysis, debridement of decubitus ulcer, hemorrhoids, pilonidal cyst removal and repair, debridement of statis ulcer, biopsy, appendectorny, pylorostenotomy, removal of polyps of the sigmoid colon, lysis of adhesions, cholecystectomy.
Genitourinary Surgery/Urology
Genitourinary surgery of soft tissue, including: treatment of bladder, urethral and ureteral tumors, superficial urinary bladder tumors, invasive bladder carcinomas; urethral and penile hemangioma; urethral strictures; lesions of the external genitalia; condylomas; bladder neck obstructions.
Endoscopic transurethral incision of prostate, ablation of benign prostatic hypertrophy, transurethral incision of prostate, laser resection of the prostate, laser enuculeation of the prostate, laser ablation of the prostate, bladder neck incision of the prostate, laser ablation, enucleation and resection of prostate, hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy.
Gynecological Surgery
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue, including condyloma acuminate, intra-uterine treatment of submucous fibroids, benign endometrial polyps and uterine septurn by incision, excision, ablation and or vessel coagulation, soft tissue excision procedures such as excisional conization of the cervix.
Lithotripsy and Percutaneous Urinary Lithotripsy
Lithotripsy and percutaneous urinary lithotripsy, including: fragmentation of urinary calculi, fragmentation of calculi in the ureter and ureteropelvic junction, fragmentation of kidney calculi, fragmentation of urethral calculi and treatment of distal impacted fragments of steinstrasse when guide wires cannot be passed.
Lumbar Discectorny
Lumbar discectorny in soft, cartilaginous and bony tissue, including: vaporization of the L.4-5 and L.5-S1 lumbar discs of the vertebral spine; open, percutaneous and endoscopic spine procedures; foraminotomy.
Orthopedic Surgery and Arthroscopy
Orthopedic surgery in soft and catiliaginous tissue in small and large joints, including. knee meniscectorny, knee synovectorny, chondrornalacia and tears, loose body debridement, lateral retinacular release, plica removal, ligament and tendon release, contouring and sculpting of articular surfaces, debridement of inflamed synovial tissue, loose body debridement, capsulectorny in the knee, chondroplasty in the knee, chondromalacia ablation, ablation of soft and cartilaginous tissue in minimal invasive spinal surgery including percutaneous laser disc decompression/ discectorny, foraminoplasty, ablation and coaqulation of soft vascular and non-vascular tissue in minimally invasive spinal surgery.
Otorhinolaryrigological (ENT) Surgery
Otorhinolaryrigological (ENT) surgery in soft, mucosal, cartilaginous and bony tissue. including: endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinoplasty, turbinectorny), dacı yocystorhinostomy (DCR), ethmoidectorny, polypectorny, maxillary antrotomy, frontal sinusotomy, sphenoidotomy, hereditary hemorrhagic telangectasia, septoplasty, lesions or turnors of the oral, nasal, glossal, pharyngeal, tonsillectomy, adenoidectorny, adenoidectorny.
Thoracic and Pulmonary Surgery
Open and endoscopic thoracic and pulmonary surgery (incision, resection, ablation. vaporization, coagulation and hernostasis) of soft tissue, including laryngeal lesions, airway obstructions including carcinoma, polyps and granulomas, palliation of obstructing carcinomas of the tracheobroncial tree.
2940 nm Indications for Use:
The Profile Multi-Platform Systems and Accessories are designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Surgical specialties and applications include general surgery, plastic surgery, aesthetic surgery, dermatology, urology, gynecology, genitourinary, ENT, pulmonary surgery, thoracic surgery, podiatry, oral & maxillofacial surgery, opthamology (including oculoplasty), small and large joint arthroscopy, microdiscectomies, and endoscopic procedures.
Aesthetic Surgery
Skin resurfacing and treatment of wrinkles.
Dental Application of Er: YAG
It is indicated for a variety of hard tissue (tooth and bone) applications, and for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry.
Hard Tissue Indications of Er. YAG Laser Energy: Caries removal, cavity preparation, enamel etching, enameloplasty, excavation of pits and fissures for placement of sealant.
Bone Indications of ETYAG Laser Energy. Contact and non-contact cutting, shaving, contouring, and resection of oral osseous tissue, apicoectorny, osseous crown lengthening, culting bone to prepare a window access to the apex of the root, osseoplasty, osteotomy.
Soft Tissue and Periodontal Indications of Er.YAG Laser Energy. Excisional and incisional biopsies, exposure of unerrupted teeth, incision and drainage of abscesses, gingival incision and excision, gingivoplasties, gingivectomies, gingivectorny in case gingwal mondow of the gingival or excision of hyperplasias, gingival troughing for or nyperplasias of the girls of the start recovery, frenectomies and frenotomies, fibromatosis, benign and malignant lesion removal, operculectorny, oral papillectornies, reduction of gingival hypertrophy, soft tissue crown lengthening, papilletin surgery (flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasia, epulides, papilomas, fibrormatoses, benign growths), vestibuloplasty, sucular debridement
Endodontal Applications of Er.YAG Laser Energy: Tooth preparation to obtain access to root canal, pulpotomy, pulpotomy as an adjunct to root canal therapy, pulp extirpation, root canal debridement and cleaning, root canal preparation including enlargement.
Dermatology & Plastic Surgery
Indications include, epidermal nevi, telangietasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers. It is also used for laser assisted site preparation for hair transplantation.
Gastroenterology
Gastroenterologic surgery of soft tissue, including: cholecystectorny, lysis of adhesions, appendectorny, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, nonbleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding turnors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Osler-Weber-Rendu disease.
General Surgery
The Er: YAG is intended for the surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of external turnors and lesions, complete or partial resection of internal organs, tumors, tissue ablation and/or vessel coagulation.
Genitounnary/Urology
Genitounnary surgery of soft tissue, including: treatment of bladder, urethral and ureteral tumors; superficial urinary bladder turnors; invasive bladder carcinomas; urethral and penile hemangioma; urethral strictures; lesions of the external genitalia; condylomas; bladder neck obstructions.
Endoscopic transurethral incision of prostate, bladder neck incision of the prostate, laser ablation, enucleation and resection of prostate, hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy.
Gynocology
Indications include cervical intracpithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.
Ophthalmology
Optimalitions include soft tissue surrounding the eye and orbit and anterior capsulotomy.
Oral/Maxillofacial
Indications include oral/dental procedures for incision, excision, ablation, vaporization mulations more of soft tissue during gingivoplasties, gingivectornies, frenectomies, benign and malignant lesion removal, biopsies, leukoplakia and fibrotorny,
Otorhinolaryrigological (ENT) Surgery
Otominolaryngological (ENT) surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate including. Chaosinus ourgery, turbinectomy), dacryocystorhinostomy (DCR), ethmoidectorny, polypectorny, maxillary antrotomy, frontal sinusotomy, sphenoidotomy, hereditary hemorrhagic telangectasia, septoplasty.
Podiatry
Indications include warts, plantar verruae, large mosaic verrucae and matrixectorny.
Pulmonary Surgery
Open and endoscopic pulmonary surgery.
Thoracic Surgery
Intended for the surgical incision/excision, vaporization and coagulation of soft tissue during any thoracic surgery.
Pulsed Light (300-1400 nm) Indications for Use:
The Profile Multi-Platform Systems and Accessories are indicated for use in surgical. aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.
It is intended for use for.

• · The treatment of tattoos;
• (560nm LP filter, 590nm LP filter)
• · The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); (515nm LP fifter, 560nm LP fifter)
• · The treatment of cutaneous lesions including warts, scars and striae; (515nm LP filter, 560nm LP filter)
• · The treatment of benign cutaneous vascular lesions, including port wine stains, The treathern of beliginical and leg telangiectasias, rosacea, erytherna of rosacea, angiomas and spider angiomas, poikilodema of Civatte, leg veins and venous malformations; (580nm LP filter, 590nm LP filter)
• · Treatment of psociasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, (350nm BP filter)
• · The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction; and
• (590nm LP filter, 640nm LP filter, 695 LP filter)
• · Mild to moderate inflammatory and pustular inflammatory acne vulgaris, (420nm BP filter, 515nm LP filter, 560 LP filter)
  The integral thermo-electric cooler is indicated for use in cooling the epidemis at the r the integral them of during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
• · Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
• · Reduce discomfort during and/or associated with light or laser treatment:
• · Ninimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation;
• · Allow the use of higher light or laser fluences for light or laser treatments (such Allow the use of mgner light of the treatment of vascular or pigmented lesions); and
• as for hair removal and the a suarront of laser treatments (such as for hair removals and the treatment of vascular or pigmented lesions).

The Profile Multi-Platform System is a modular, multi-wavelength laser/light system. The system uses scanning and focusing optics to deliver a pattern of thermal energy to the treatment site. The system consists of control console which houses the power supply, cooling system, fiber optic delivery system and/or articulated arm delivery system with handpiece and/or scanner.

This is not a medical device that uses AI/ML. The device appears to be a laser/light system intended for various surgical and aesthetic applications. The provided text primarily focuses on establishing substantial equivalence to predicate devices and detailing the wide range of indications for use across different wavelengths and surgical specialties.

Here's an analysis of the provided text based on your request, highlighting why many points cannot be addressed due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission is for a multi-platform laser/light system, not an AI/ML diagnostic or predictive device with performance metrics like sensitivity, specificity, etc., that would typically have acceptance criteria. The document establishes substantial equivalence based on indications for use, design features, and functional features being comparable to predicate devices.

2. Sample Size for the Test Set and Data Provenance

Not applicable. This is not an AI/ML device that underwent a performance study with a test set. Substantial equivalence is claimed based on device characteristics comparable to existing predicate devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. There's no AI/ML model being evaluated against a ground truth.

4. Adjudication Method for the Test Set

Not applicable. There's no AI/ML model being evaluated against a ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This is a laser/light device, not an AI/ML system where human reader improvement with AI assistance would be relevant.

6. If a Standalone (Algorithm Only) Performance Study Was Done

Not applicable. This is a hardware device, not a standalone algorithm.

7. The Type of Ground Truth Used

Not applicable. There is no AI/ML algorithm being evaluated against ground truth.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device, not an AI/ML system requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is a hardware device, not an AI/ML system.

Summary of Device and Regulatory Basis:

The "Profile Multi-Platform System" is a modular, multi-wavelength laser/light system. It is intended for a broad range of surgical and aesthetic applications across various medical specialties (dermatology, plastic surgery, general surgery, gastroenterology, gynecology, ENT, neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery, urology).

The submission, K060033, establishes substantial equivalence to existing legally marketed predicate devices (K023881, K041879, K032459, etc.). The basis for this claim is that the Profile Multi-Platform System shares:

• The same indications for use.
• Similar design features (wavelength, laser/light medium, delivery systems, power supply, cooling and control system).
• Similar functional features (power output, repetition rate, energy, spot size, fluence).

The FDA's letter explicitly states that they have reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This approval means the device can be marketed subject to general controls and, if applicable, special controls.

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