Search Results

Regulation Number

Type

Panel

Reference & Predicate Devices

K103501,K203441

Predicate For

N/A

Intended Use

The Alma Hybrid Laser System (Pixel and HyLight CO2 Applicators) is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee). The Alma Hybrid Laser System is cleared for use for the particular indications as follows:

Dermatology & Plastic Surgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:

Laser skin resurfacing
Laser dermabrasion
Laser burn debridement

Laser skin resurfacing (ablation and/or vaporization) for the treatment of:

Wrinkles, rhytids, and furrows (including fines lines and texture irregularities)

Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen.

Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:

Keratoses, including actinic and seborrheic keratosis, seborrheic vulgaris, seborrheic wart, and verruca seborrhoica
Vermilionectomy of the lip
Cutaneous horns
Solar/actinic elastosis
Cheilitis, including actinic cheilitis
Lentigines, including lentigo maligna or Hutchinson's malignant freckle
Uneven pigmentation/ dyschromia
Acne scars
Surgical scars
Keloids including acne keloidalis nuchae
Hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma pyogenicum/granuloma telagiectaticum)
Tattoos
Telangiectasia
Removal of small skin tumors, including periungual (Koenen) and subungual fibromas
Superficial pigmented lesions
Aden sebaceous hypertrophy or sebaceous hyperplasia
Rhinophyma reduction
Cutaneous papilloma (skin tags)
Milia
Debridement of eczematous or infected skin
Basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions
Nevi, including spider, epidermal and protruding
Neurofibromas
Laser de-epithelialization
Trichoepitheliomas
Xanthelasma Palpebrarum
Syringoma

Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy.

Vaporization/coagulation of:

Benign/malignant vascular/avascular skin lesions
Moh's Surgery
Lipectomy
Verrucae and seborrheic vulgaris, including paronychial, perifungal, and subungual warts

Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.

Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation.

Podiatry
Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of:

Verrucae vulgaris/plantar (warts), including paronychial, perifungal, and subungual warts
Fungal nail treatment
Porokeratoma ablation
Ingrown nail treatment
Neuromas/fibromas, including Morton's neuroma
Debridement of ulcers
Other soft tissue lesions

Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.

Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:

Choanal atresia
Leukoplakia, including oral, larynx, uvula, palatal, upper lateral pharyngeal tissue
Nasal obstruction
Adult and juvenile papillomatosis polyps
Polypectomy of nose and nasal passages
Lymphangioma removal
Removal of vocal cord/fold nodules, polyps and cysts
Removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords
Laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structure and tissue
Zenker's Diverticulum/pharyngoesophageal diverticulectomy [endoscopic laser-assisted esophageal diverticulectomy (ELAED)]
Stenosis, including subglottic stenosis; tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy
Pulmonary bronchial and tracheal lesion removal
Benign and malignant nodules, tumors and fibromas (larynx, pharynx, trachea, tracheobronchial/endobronchial)
Benign and malignant lesions and fibromas (nose and nasal passages)
Benign and malignant tumors and fibromas; (oral)
Stapedotomy/stapedectomy
Acoustic neuroma in the ear
Superficial lesions of the ear, including chondrodermatitis nondularis chronica helices/Winkler's disease
Telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue)
Cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea
Myringotomy/tympanostomy (tympanic membrane fenestration)
Uvulopalatoplasty (LAUP, laser UPPP)
Turbinectomy and turbinate reduction/ablation)
Septal spur ablation/reduction and septoplasty
Partial glossectomy
Tumor resection on oral, subfascial and neck tissues
Rhinophyma
Verrucae vulgaris (warts)
Gingivoplasty/gingivectomy

Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:

Conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN)
Condyloma acuminate, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosis (BP) lesions
Leukoplakia (vulvar dystrophies)
Incision and drainage (I&D) of Bartholin's and Nabothian cysts
Herpes vaporization
Urethral caruncle vaporization
Cervical dysplasia
Benign and malignant tumors
Hemangiomas

GYN Laparoscopy
Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of:

Endometrial lesions, including ablation of endometriosis
Excision/lysis of adhesions
Salpingostomy
Oophorectomy/ovariectomy
Fimbrioplasty
Metroplasty
Microsurgery (tubal)
Uterine myomas and fibroids
Ovarian fibromas and follicle cysts
Uterosacral ligament ablation
Hysterectomy

Neurosurgery
Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of:

Cranial

Posterior fossa tumors
Peripheral neurectomy
Benign and malignant tumors and cysts (e.g. gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas and large tumors)
Arteriovenous malformation
Pituitary gland tumors (transsphenoidal approach)

Spinal Cord

Incision/excision and vaporization of benign and malignant tumors and cysts
Intra- and extradural lesions
Laminectomy/ laminotomy/ microdiscectomy

Orthopedics
Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include:

Arthroscopy

Meniscectomy
Chondromalacia
Chondroplasty
Ligament release (lateral and other)
Excision of plica
Partial synovectomy

General

Debridement of traumatic wounds
Debridement of decubitus and diabetic ulcers
Microsurgery
Artificial joint revision
PMMA removal

General/Thoracic Surgery
Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include:

Debridement of decubitus ulcers, stasis, diabetic and other ulcers
Mastectomy
Debridement of burns
Rectal and anal hemorrhoidectomy
Breast biopsy
Reduction mammoplasty
Cytoreduction for metastatic disease
Laparotomy and laparoscopic applications
Mediastinal and thoracic lesions and abnormalities
Skin tag vaporization
Atheroma
Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips
Pilonidal cyst removal and repair
Abscesses
Other soft tissue applications

Dental/Oral Surgery
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:

Gingivectomy- removal of hyperplasia
Gingivoplasty
Incisional and excisional biopsy
Treatment of ulcerous lesions, including aphthous ulcers
Incision of infection when used with antibiotic therapy
Frenectomy (frenum release)
Excision and ablation of benign and malignant lesions
Homeostasis
Operculectomy
Crown lengthening
Removal of soft tissue, cysts and tumors
Oral cavity tumors and hemangiomas
Abscesses
Extraction site hemostasis
Salivary gland pathologies
Pre-prosthetic gum preparation
Leukoplakia
Partial glossectomy
Periodontal gum resection

Genitourinary
Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:

Benign and malignant lesions of external genitalia
Condyloma
Phimosis
Erythroplasia

ProScan
The Alma Hybrid ProScan CO2 fractional applicator, with wavelength of 10600 nm is indicated for:
Laser skin resurfacing (ablation and/or vaporization) of soft tissue.

The Alma Hybrid ProScan 1570nm fractional applicator, with wavelength of 1570 nm, is indicated for: Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue

The Alma Hybrid ProScan CO2 &1570nm fractional applicator, with wavelengths of 10600 nm & 1570nm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.

Device Description

The Alma Hybrid Laser System consists of:

Laser system console (containing the optical bench assembly and laser, the microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel)
LCD control panel with touch-screen technology: the LCD display provides information on the status and settings of The Alma Hybrid Laser System with touch-screen technology provided to input commands into the system.
Two wavelengths – CO2 and 1570 nm
Articulated arm
Footswitch
Delivery devices (Pixel applicators, Hylight applicators, Proscan applicator)

AI/ML Overview

This document is an FDA 510(k) clearance letter for the Alma Hybrid Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove device performance in the way requested.

Based on the provided text, there is no detailed information described related to acceptance criteria, specific performance metrics, or a study design to "prove the device meets the acceptance criteria" in terms of clinical efficacy. The document is a regulatory submission for substantial equivalence.

Here's an breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

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

Acceptance Criteria: Not explicitly stated for efficacy. The document focuses on showing the new device is "substantially equivalent" to predicate devices based on technical characteristics and intended use.
Reported Device Performance: No quantitative performance metrics are provided in the context of clinical efficacy (e.g., success rates for wrinkle reduction, scar removal, etc.). The tables provided (on pages 16-19) compare technical specifications (like wavelength, spot size, repetition rate, output energy, power) between the subject device and its predicates, and these are deemed "Same" across the devices. For "Indications for Use" (pages 20-43), the subject device's indications are primarily "Same as the Reference Predicate."

Table of Technical Specifications Comparison (Extracted from provided tables; acts as a proxy for 'performance' in this context of substantial equivalence, but not clinical outcomes):

Parameter	Subject Device (Alma Hybrid Laser System)	Primary Predicate (K203441 Alma Hybrid)	Reference Predicate (K103501 Alma Lasers Pixel CO2 Laser System)	Acceptance Criteria (Implied)	Reported Device Performance
Hybrid-Hylight Applicator
Wavelength	10600 nm	10600 nm	10600 nm	Same as Predicates	10600 nm
Pilot beam	650 nm, 3mW	650 nm, 3mW	650 nm, <5 mW	Same as Predicates	650 nm, 3mW
Operation Mode	Repeat pulse/CW	Repeat pulse/CW	Repeat/Super Pulse/CW	Same or equivalent to Predicates	Repeat pulse/CW
Spot size (mm)	0.15 – 3.1 mm	0.15- 3.1 mm	0.125 mm dia spot at tip of spatula at 50 mm / 0.2mm dia. Spot at tip of spatula at 100 mm	Same or equivalent to Predicates	0.15 – 3.1 mm
Repetition Rate	1-5 Hz	1-5 Hz	CW 1-5 Hz	Same as Predicates	1-5 Hz
Pulse Duration	10-1000 ms	10-1000 ms	10-1000 ms for CW	Same as Predicates	10-1000 ms
Min output energy	5 mJ	5 mJ	1 mJ	≥ 1 mJ	5 mJ
Fluence	Max 1746 J/mm2 (30W) / Max 3530 J/mm2 (70W)	Max 1746 J/mm2 (30W) / Max 3530 J/mm2 (70W)	Max 1746 J/mm2 (30W) / Max 3530 J/mm2 (70W)	Same as Predicates	Max 1746 J/mm2 (30W) / Max 3530 J/mm2 (70W)
Pixel Applicator
Spot size (mm)	0.125 to 0.20 mm dia. pixels	0.125 to 0.20 mm dia. pixels	0.125 to 0.20 mm dia. pixels	Same as Predicates	0.125 to 0.20 mm dia. pixels
Repetition Rate	0.5-2Hz	0.5-2Hz	1-5 Hz	Same or equivalent to Predicates	0.5-2Hz
Pulse Duration	1- 405 ms	1- 405 ms	100-300 ms for pulsed	Same or equivalent to Predicates	1- 405 ms
Min output energy	5 mJ/pixel	5 mJ/pixel	Up to 1000 mJ	≥ 5 mJ/pixel	5 mJ/pixel
Max output energy	SW limited to 150 mJ/pixel	SW limited to 150 mJ/pixel	Up to 1000 mJ SW limited to 150	SW limited to 150 mJ/pixel	SW limited to 150 mJ/pixel
Output Power	30 W, 70W	30 W, 70W	30 W, 70W	Same as Predicates	30 W, 70W
1570nm ProScan Applicator
Wavelength	1570nm	1570nm	N/A	Same as Primary Predicate	1570nm
Scan size (mm)	Up to 30mm diameter	Up to 30mm diameter	N/A	Same as Primary Predicate	Up to 30mm diameter
Output energy	24mJ-144mJ/pixel	24mJ-144mJ/pixel	N/A	Same as Primary Predicate	24mJ-144mJ/pixel

Regarding a "study that proves the device meets the acceptance criteria":

The document explicitly states:

VIII. Clinical Data [21 CFR 807.92(b) (2)]
Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no human clinical studies were deemed needed to support this submission.

This indicates that no new clinical study was conducted specifically for this 510(k) submission to assess the device's performance against defined clinical acceptance criteria. The clearance is based on substantial equivalence to existing predicate devices, implying that their known safety and effectiveness profiles are sufficient.

Given the above, the remaining points cannot be answered from the provided text, as they pertain to clinical study details that were not part of this clearance process.

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

Not applicable. No clinical test set or data provenance is mentioned as no human clinical studies were deemed necessary for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set required ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set required 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 system, not an AI-powered diagnostic tool involving human readers.

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

Not applicable. This device is a laser system, not an algorithm.

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

Not applicable. As no new clinical studies were performed, no ground truth was established for "new" clinical data. The substantial equivalence relies on the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. No clinical training set is mentioned.

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

Not applicable. No clinical training set is mentioned.

In summary, the provided FDA 510(k) clearance letter demonstrates substantial equivalence of the Alma Hybrid Laser System to previously cleared predicate devices based on technical specifications and intended uses. It explicitly states that no new human clinical studies were required, meaning no specific acceptance criteria for clinical performance were established or tested in the context of this submission. The "acceptance criteria" in this document implicitly refers to meeting regulatory standards and demonstrating equivalent technical and safety profiles to predicate devices.

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K Number

K243044

Device Name

Alma Harmony

Manufacturer

Alma Lasers, Inc.

Date Cleared

2025-04-11

(196 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K041743,K073618,K040212,K003504,K971933,K990799,K993414,K954848

Predicate For

N/A

Intended Use

1064nm mode is indicated for the removal or lightening of unwanted facial or body hair, for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery, benign pigmented lesions (dermal melanocytosis) and tattoo removal for dark and blue inks.

The 1064nm fractional mode is indicated for the treatment of wrinkles in Fitzpatrick Skin Types I-IV.

532 nm mode is indicated for tattoo removal including red, blue and light blue and green inks, for the treatment of benign vascular lesions including telangiectasias, spider angiomas, cherry angiomas, spider nevi and the treatment of benign pigmented lesions including Cafe-au-lait birthmarks, solar lentigines, Becker's nevi, freckles nevus spilus and nevus of ota. 532nm mode is also indicated for incision, excision, ablation and vaporization of soft tissue in general dermatology.

The Iris Diode is intended for use for vascular lesions, spider veins, spider naevi, teleangiectasis, red superficial veins of the legs and face, pigmented lesions (e.g. cafe-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided FDA 510(k) clearance letter for the Alma Harmony Laser Device (K243044) does not contain the detailed information required to answer your request regarding acceptance criteria and the study that proves the device meets those criteria.

The letter primarily focuses on:

Confirming the substantial equivalence determination for the device based on its indications for use.
Listing relevant regulations and requirements for medical device manufacturers.
Providing contact information for regulatory inquiries.
Stating that the submitter will make information on safety and effectiveness available upon request.

Here's what is missing from the provided text that would be necessary to answer your specific questions:

Acceptance Criteria: The document does not define any specific performance metrics (e.g., sensitivity, specificity, accuracy, precision, power output tolerances, treatment efficacy rates) that the device must meet, nor does it list numerical targets for these metrics. Laser devices typically have performance specifications related to wavelength, energy, pulse duration, spot size, etc., but these are not present as acceptance criteria in this document.
Study Design and Results: There is no mention of a clinical or technical study conducted to prove the device meets performance criteria. The letter doesn't include:
- Performance data: No tables of reported device performance.
- Sample size and data provenance: No details on test sets, training sets, or where data came from.
- Ground truth establishment: No information on how ground truth was determined (e.g., expert consensus, pathology, outcomes).
- Expert qualifications or adjudication: No details on experts, their number, or adjudication methods.
- MRMC or standalone studies: No mention of these types of studies or their outcomes.
- Effect size of AI assistance: Not applicable as this is a laser device, not an AI diagnostic tool.

In summary, to answer your questions, I would need a different type of document, such as:

The 510(k) summary document itself: Submissions typically include a summary of the data and methods used to demonstrate substantial equivalence, which might contain some of this information.
Clinical study reports: Detailed reports of any studies conducted.
Performance testing protocols and results.

Without this information, I cannot fulfill your request.

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K Number

K233024

Device Name

Alma Harmony

Manufacturer

Alma Lasers, Inc.

Date Cleared

2024-02-08

(139 days)

Product Code

GEX,ILY,ONF

Regulation Number

Type

Panel

Reference & Predicate Devices

K231054,K230371,K230308,K203441,K072564,K170850

Predicate For

N/A

Intended Use

The Alma Harmony is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery).

Clear Skin Pro 1540nm Applicator:
The ClearSkin Pro 1540nm is indicated for : Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.

SupErb 2940nm Applicator:
The 2940 nm Er.Y AG Laser Module handard and scanner accessory tips (with and without contactcooling) is indicated for use in soft tissue (skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.
Dermatology and Plastic Surgery: Skin resurfacing, Treatment of wrinkles, Epidermal nevi, Telangiectasia, Spider veins, Actinic chelitis, Keloids, Verrucae, Skin tags, keratoses, Scar revision (including acne scars), Debulking benign tumors, Debulking cysts, Superficial skin lesions, Diagnostic biopsies, Decubitus ulcers.
General Surgery: 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: Treatment of: Lesions of the external genitalia, urethra and anus, penis, scrotum, and urethra (includes condyloma acuminate, giant perineal condyloma, and verrucous carcinoma), vulvar, lesions, polyps, and familiar polyps of the colon.
Gynecology: Treatment of: Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts, and condyloma.
Oral/Maxiofacial: Treatment of: Benign oral tumors, oral and glossal lesions, and gingivectomy.
Otothrynolaringology / Head and Neck (ENT): Treatment of: Ear, nose and throat lesions, polyns, cysts, hyperkeratosis, Excision of carcinogenic tissue and oral leukoplakia.
Ophthalmology : Treatment of: Soft tissue surrounding the eye and orbit.
Podiatry: Treatment of: Warts, plantar verrucae, large mosaic verrucae, Matrixectomy.

Clear Lift Pro Q-Switched Cr: Nd: YAG 1064 / 532 nm Applicator
1064mm mode is indicated for the removal or lightening of unwanted facial or body hair, for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery, benign pigmented lesions (dermal melanocytosis) and tattoo removal for dark and blue inks.
532 nm mode is indicated for tattoo removal including red, blue and green inks, for the treatment of benign vascular lesions including telangiectasias, spider angiomas, spider nevi and the treatment of benign pigmented lesions including Café-au-lait birthmarks, solar lentigines, Becker's nevi, freckles nevus spilus and nevus of ota. 532mm mode is also indicated for incision, ablation and vaporization of soft tissue in general dermatology.

ClearVas Nd:YAG 1064nm
For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stams, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins.
Treatment of wrinkles.
Removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB).
The ClearVas Nd: YAG 1064nm is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

Iris VL / PL Applicator:
Intended for use in 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.
The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait macules.
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations. Use on all skin types (Fitzpatrick I- VI).

Iris Dye VL / Dye SVL Applicator:
The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus of Ota, and Becker's Nevi. • The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques. • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. • Use on skin types (Fitzpatrick I-V).

Iris SHR Applicator:
The Advanced Fluorescence Technology (AFT) 650-950 nm handpiece (with and without contact-cooling) is indicated for: The treatment of tattoos, the treatment of moderate inflammatory acne vulgaris, the treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait, the treatment of cutaneous lesions including warts, scars and striae, 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. The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Use on all skin types (Fitzpatrick I-VI), including tanned skin

Iris Acne Applicator:
Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical special and plastic surgery and dermatology.
The Advanced Fluorescence Technology (AFT) 420-950 nm Acne Module Applicator (with and without contact-cooling) is indicated for:
The treatment of moderate inflammatory acne vulgaris.
The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles).
The treatment of cutaneous lesions including warts, scars and striae.
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civate, leg veins and venous malformations.
Use on all skin types (Fitzpatrick I-VI).

Iris NIR Applicator: Intended to emit energy in the infra-red spectrum to provide topical heating for the purpose of elevating the tissue temperature.
For the temporary relief of minor muscle 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; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Iris Diode Applicator
The Iris diode is intended for use for vascular lesions, spider naevi, teleangiectass, red superficial veins of the legs and face, pigmented lesions (e.g. cafe-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.

Device Description

The Alma Harmony is a Class II Medical Device that combines multiple technologies into one platform for use in dermatologic, aesthetic procedures and pain management procedures. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics, and the user interface. It has 10 applicators that are attached to the console, which can be selected for use in treatment through the user interface.
In addition, this submission will add the Smart Clinic Software that was previously cleared in the Soprano Titanium (K210371).

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA, evaluating the substantial equivalence of the Alma Harmony device to previously cleared predicate devices. It describes the device, its intended use, and a comparison of its technological characteristics with the predicate devices. The document references performance testing and animal studies. However, it does not describe acceptance criteria for an AI/ML powered medical device, nor does it detail a study proving such a device meets those criteria.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on demonstrating the substantial equivalence of the Alma Harmony, which is a laser and light-based medical device, to existing laser and light-based devices. There is no mention of AI or machine learning components with specific performance criteria or studies in the context of diagnostic accuracy, human-in-the-loop performance, or standalone algorithm performance.

The section titled "Software verification and validation testing was conducted, and documentation provided as recommended by the FDA's 'Guidance for the Content of Premarket Submissions Contained in Medical Devices." is the only mention of software, and it's a general statement about V&V testing, not specific to AI/ML or its performance metrics. The statement "this submission will add the Smart Clinic Software. This software was previously cleared in the Alma Titanium K230371" confirms that any software component is previously cleared, implying it's not a novel AI/ML component being tested for new performance criteria.

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K Number

K230308

Device Name

Alma Harmony

Manufacturer

Alma Lasers, Inc.

Date Cleared

2023-03-01

(26 days)

Product Code

GEX,ILY,ONF

Regulation Number

Type

Panel

ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION

Reference & Predicate Devices

K033946,K222064,K141237,K181298,K072564,K053604

Predicate For

K233024

Intended Use

Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical special and plastic surgery, and dermatology.
The treatment of benign pigmented epidermal lesions including dyschromia. hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait macules.
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations. Use on all skin types (Fitzpatrick I- VI).
The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus of Ota, and Becker's Nevi. • The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques. • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. • Use on skin types (Fitzpatrick I-V).
The Advanced Fluorescence Technology (AFT) 650-950 nm handpiece (with and without contact-cooling) is indicated for: The treatment of tattoos, the treatment of moderate inflammatory acne vulgaris, the treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait, the treatment of cutaneous lesions including warts, scars and striae, the treatments 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. The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Use on all skin types (Fitzpatrick I-VI), including tanned skin
Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical special and plastic surgery and dermatology The Advanced Fluorescence Technology (AFT) 420-950 nm Acne Module Applicator (with and without contact-cooling) is indicated for:
The treatment of moderate inflammatory acne vulgaris.
The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles).
The treatment of cutaneous lesions including warts, scars and striae.
The treatment of benign cutaneous vascular lesions including port wine stains hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
Use on all skin types (Fitzpatrick I-VI).
Intended to emit energy in the infra-red spectrum to provide topical heating for the purpose of elevating the tissue temperature.
For the temporary relief of minor muscle 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; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The Iris diode is intended for use for vascular lessons, spider naevi, teleangiectasis, red superficial veins o fthe legs and face, pigmented lesions (e.g. cafe-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.

Device Description

The Alma Harmony is a Class II Medical Device that combines multiple technologies into one platform for use in dermatologic, aesthetic procedures and pain management procedures. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics and the user interface. It has 6 applicators that are attached to the console, which can be selected for use in treatment through the user interface.
There are 6 separate applicators. Each handpiece has its own indication for use.

Iris VL / PL is an IPL handpiece operating in the wavelength range of 540nm-950nm ●
Iris Dye VL and Dye SVL is an IPL handpiece operating in the wavelength range of ● 500nm-600nm
Iris SHR is an IPL handpiece that operates in the wavelength range of 650nm-950nm
Iris Acne is an IPL handpiece operating in the wavelength range of 420nm 950nm ●
Iris NIR is near infrared with a wavelength of 1300nm ●
Iris Diode is a 520nm diode laser.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA regarding Alma Lasers, Inc.'s Alma Harmony device. This document focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than proving that the device meets specific performance-based acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving the device meets them, particularly regarding AI-assisted performance, reader studies, or detailed performance metrics. The crucial sentence in Section VIII states: "Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no clinical studies were deemed needed to support this submission."

This means the submission relies on bench testing, software verification/validation, and comparison to predicate devices to demonstrate safety and effectiveness, rather than a clinical trial with acceptance criteria for performance.

Therefore, I cannot populate the requested information regarding acceptance criteria, study data, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/performance study, as this information is not present in the provided document.

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K Number

K112031

Device Name

Manufacturer

Date Cleared

2011-09-13

(60 days)

Product Code

Regulation Number

Type

Panel

MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM

Reference & Predicate Devices

K102716,K083848

Predicate For

K122567,K123483,K131838,K140009,K153718,K181019

Intended Use

The Alma Lasers Family of Soprano XL Multi-Application Platforms is intended for use in dermatologic and general surgical procedures.

The Alma Lasers Modified Diode Laser Module (used with the Alma Lasers Family of Soprano XL Multi-Application Platforms):

The HR Mode is intended for hair removal, permanent hair reduction. .
. The SHR Mode is intended for hair removal, permanent hair reduction.
The LaserBlanche Mode is intended for the treatment of benign vascular and pigmented . lesions.

The Alma Lasers Family of Soprano XL Multi-Application Platforms is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

Device Description

The Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platforms, and the delivery accessories that are used with it, is comprised of the following main components:

A module housing with: .
- Module trigger switch (must be pressed at the same time the Soprano system A footswitch is depressed to deliver laser energy to the treatment site);
- A Light guide
  - TEC-cooled to provide contact skin cooling 9
- A Light guide retainer
Umbilical cable and connector that attaches the Diode Laser Module to the Soprano . system console and includes the electrical and cooling connections to the Soprano system.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for K112031:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K112031 510(k) Summary) does not explicitly list "acceptance criteria" in a quantitative, measurable format for this device submission. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly defined by the safety and effectiveness demonstrated in peer-reviewed literature for similar technology.

Acceptance Criteria (Inferred from Substantial Equivalence Basis)	Reported Device Performance (from literature)
Safe for dermatologic and general surgical procedures	Demonstrated safety and effectiveness in 2,879 patients.
Effective for hair removal	Demonstrated safety and effectiveness for hair removal.
Effective for permanent hair reduction	Demonstrated safety and effectiveness for permanent hair reduction.
Effective for treatment of benign vascular lesions	Demonstrated safety and effectiveness for treatment of benign vascular lesions (implied by predicate, not explicitly re-stated with data for this device).
Effective for treatment of pigmented lesions	Demonstrated safety and effectiveness for treatment of pigmented lesions (implied by predicate, not explicitly re-stated with data for this device).
Usable on all skin types (Fitzpatrick I-VI), including tanned skin	Demonstrated safety and effectiveness on Fitzpatrick skin types I-VI, including tanned skin.
Performance immediately following treatment	Studies reported safety and effectiveness immediately following treatment.
Long-term performance (1, 6, and 18 months post-treatment)	Studies reported safety and effectiveness at 1, 6, and 18 months following treatment.
Low fluence, high repetition rate, multiple-pass treatment regimen	Demonstrated safety and effectiveness using these parameters.

Note: The FDA's substantial equivalence determination for this 510(k) means they found the device as safe and effective as legally marketed predicate devices. The acceptance criteria are therefore aligned with the demonstrated performance of those predicate devices and the clinical literature supporting the technology.

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

Sample Size for the Test Set: 2,879 patients
Data Provenance: The document states "published peer-reviewed medical literature provided device validation information." This indicates the data is retrospective, drawn from previously conducted clinical studies. The country of origin is not specified.

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

This type of information is generally not provided or required for 510(k) submissions, especially when relying on published literature for substantial equivalence for a physical device like a laser. The evaluation of "ground truth" (e.g., successful hair removal, lesion treatment) would have been performed by the clinicians conducting the studies, but their specific number or qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Not applicable/Not specified. Given that the submission relies on existing published literature for device validation (rather than new clinical trials), there's no mention of a specific adjudication method for the "test set" in this context. The peer-review process of the scientific literature would have served as the form of validation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Information

MRMC Study Done? No. This type of study (comparing human readers with and without AI assistance on multiple cases) is typically associated with AI/CAD image analysis devices. This submission is for a physical laser device, not an AI diagnostic tool.
Effect Size of Human Readers with vs. Without AI Assistance: Not applicable.

6. Standalone Performance (Algorithm Only) Study Information

Standalone Performance Study Done? No. This concept is relevant for AI algorithms. This submission is for a physical laser device.

7. Type of Ground Truth Used

The ground truth was established by clinical outcomes observed and reported in the published peer-reviewed medical literature. This would include direct clinical assessment of:

Hair removal status
Degree of permanent hair reduction
Effectiveness of treatment for benign vascular lesions (implied by predicate and technology type)
Effectiveness of treatment for pigmented lesions (implied by predicate and technology type)
Safety outcomes (adverse events, skin reactions, etc.)

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The "training" for the device's development would be through engineering and testing, not data-driven machine learning.

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

Not applicable, as there is no training set in the context of machine learning for this physical device.

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K Number

K101147

Device Name

Manufacturer

Date Cleared

2011-01-21

(273 days)

Product Code

NUV,GEI,ISA

Regulation Number

Type

Panel

ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES

Reference & Predicate Devices

K070004,K072699,K082622

Predicate For

K121150,K132431

Intended Use

The Modified Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL, Accent Elite] is intended for use in dermatologic and general surgical procedures.

The Alma Lasers Family of Accent™ RF Systems [Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with unipolar and bipolar handpieces.

The massager component of the Alma Lasers Accent UniForm Handpiece is intended for use with the Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] to provide:
Temporary reduction in the appearance of cellulite. .
Simultaneous application of the RF energy and mechanical manipulation of the skin is intended for use with the Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] to provide:
Temporary reduction in the appearance of cellulite. .

Device Description

The Alma Lasers Accent Elite system similar to Accent™ RF Systems [Accent, Accent XL } is comprised of the following main components:
. Console
a Bipolar RF module
A Unipolar RF module (UniLarge)
A UniForm (RF and Massage) module
. Control panel
Footswitch. .
Modules are used to deliver radiofrequency energy to the treatment site. Each RF module consists of the following components:
. Handle - used for holding the module
. Trigger - activates the radiofrequency energy emission when pressed in Ready mode
Applicator tip establishes contact with the patient's skin .
. Thermoelectric cooler - integrated within the module, provides internal module cooling
. RF emission indicator - blue LED illuminates prior to- and during RF emission
Umbilical cable contains coolant tubes. RF-power cable and the communication . cable that controls the operation of the module
. Module connector - connects the module to its port. It incorporates an integrated impedance matching network (IMN) and a memory chip which stores information about the module and the parameter settings.
The UniForm module additionally employs a massaging mechanism that works in conjunction with the RF energy application.
The Accent Elite is a computerized system with embedded software that controls its operation. The software also runs the graphical user interface, which enables user-friendly control of the system operation.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Modified Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL, Accent Elite]), seeking substantial equivalence to predicate devices. It does not describe or conduct a study involving acceptance criteria and reported device performance in the way typically associated with clinical trials or AI/algorithm evaluation.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared devices based on technical characteristics and safety performance testing rather than clinical efficacy studies with specific performance metrics against a defined ground truth.

Therefore, many of the requested elements for describing an acceptance criteria study and the methodology behind it (like sample size, data provenance, expert ground-truthing, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission.

However, I can extract the information that is present concerning the rationale for substantial equivalence and the listed safety performance testing.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance Study Information

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

The document does not explicitly state "acceptance criteria" in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical outcome. Instead, the "acceptance criteria" for this submission are compliance with recognized safety standards and demonstration of substantial equivalence in technical characteristics.

Acceptance Criteria Type (Implicit)	Reported Device Performance (Compliance/Equivalence)
Technical & Functional Equivalence	The Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] shares: • The same indications for use. • The same operation principle. • Similar technical and functional capabilities as the predicate Accent™ Family of RF Systems (K072699 and K070004). (See detailed comparison table in Section VI for specific RF frequency, treatment energy, operational modes, etc., all matching predicate devices).
Safety and Essential Performance	Compliance with applicable FDA Recognized Consensus Standards: • IEC 60601-1-2: 2004: Medical electrical equipment Part 1: General requirements for safety: Electromagnetic compatibility • IEC 60601-1:1988, Amendment 1:1991, Amendment 2:1995: Medical electrical equipment Part 1: General requirements for safety • IEC 60601-2-2:2006: Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories The results of the performance testing showed compliance with these standards.
Clinical Equivalence (Implicit)	Based on the above, the device is considered "safe and effective, and performs at least as safely and effectively as the predicate Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL] for the intended use and indications." (This is a conclusion drawn from the technical and safety equivalence, not from a comparative clinical efficacy study provided in this summary).

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

Not Applicable / Not Provided. This document does not describe a clinical performance study with a test set of patient data. The "performance testing" refers to engineering and electrical safety standards compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable / Not Provided. No clinical ground truth was established for a test set in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Provided. No clinical test set or adjudication method is described.

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 / Not Provided. This device is an RF system for dermatologic/surgical procedures, not an AI or imaging diagnostic tool. Therefore, an MRMC study is irrelevant to this submission.

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

Not Applicable / Not Provided. This device does not feature an algorithm for standalone performance evaluation in the context of AI or diagnostic systems.

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

Not Applicable / Not Provided. The "ground truth" for this submission relates to compliance with engineering safety standards and established technical specifications, not clinical outcomes or expert consensus on a diagnostic task.

8. The sample size for the training set

Not Applicable / Not Provided. This device is not an AI/machine learning system, so there is no concept of a "training set" in this context.

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

Not Applicable / Not Provided. No training set exists.

Summary of the Study (as described in the 510(k) Summary):

The "study" described in this document is a regulatory submission demonstrating substantial equivalence rather than a clinical performance study measuring specific outcomes. The primary "studies" conducted were non-clinical performance testing to ensure safety and compliance:

Type of Study: Non-clinical performance testing for electrical safety and electromagnetic compatibility.
Purpose: To demonstrate that the Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] is as safe and effective as its predicate devices, primarily through compliance with international standards (IEC 60601 series).
Methodology: The system was tested against the requirements of IEC 60601-1-2: 2004 (electromagnetic compatibility), IEC 60601-1:1988 with amendments (general safety), and IEC 60601-2-2:2006 (particular requirements for high-frequency surgical equipment).
Conclusion: The tests demonstrated compliance with these standards, supporting the conclusion of substantial equivalence to the predicate devices. This equivalence is based on the device sharing the same intended use, indications for use, operation principle, and similar technical and functional capabilities, alongside meeting safety criteria.

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K Number

K103501

Device Name

Manufacturer

Date Cleared

2011-01-14

(46 days)

Product Code

GEX,HQF

Regulation Number

Type

Panel

MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS

Reference & Predicate Devices

K080463

Predicate For

K141658,K151655,K182270,K203441,K250071

Intended Use

The Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee).

The Alma Lasers Pixel CO2™ Laser System is cleared for the particular indications as follows:

Dermatology & Plastic Surgery: The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: laser skin resurfacing, laser derm-abrasion, laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) for the treatment of: wrinkles, rhytids, and furrows (including fines lines and texture irregularities). Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen. Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: keratoses, including actinic and seborrheic keratosis, seborrhoecae vulgares, seborrheic wart, and verruca seborrheica; vermillionectomy of the lip; cutaneous horns; solar/actinic elastosis; chelitis, including actinic chelitis; lentigines, including lentigo maligna or Hutchinson's malignant freckle; uneven pigmentation/ dyschromia; acne scars; surgical scars; keloids including acne keloidalis nuchae; hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma pyogenicum/granuloma telagiectaticum); tattoos; telangiectasia; removal of small skin tumors, including periungual (Koenen) and subungual fibromas; superficial pigmented lesions; adenosebaceous hypertrophy or sebaceous hyperplasia; rhinophyma reduction; cutaneous papilloma (skin tags); milia; debridement of eczematous or infected skin; basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions; nevi, including spider, epidermal and protruding; neurofibromas; laser de-epithelialization; tricoepitheliomas; xanthelasma palpebrarum; syringoma. Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy. Vaporization/coagulation of: benign/malignant vascular/avascular skin lesions; Moh's Surgery; Lipectomy; Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungaual warts. Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty. Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation.

Podiatry: Laser ablation, vaporization and for excision of soft tissue for the reduction, removal, and/or treatment of: verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts; fungal nail treatment; porokeratoma ablation; ingrown nail treatment; neuromas/fibromas, including Morton's neuroma; debridement of ulcers; other soft tissue lesions. Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.

Otolaryngology (ENT): Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of: choanal atresia, leukoplakia, including oral, larynx, uvula, palatal, upper lateral pharyngeal tissue; nasal obstruction; adult and juvenile papillomatosis polyps; polypectomy of nose and nasal passages; lymphangioma removal; removal of vocal cord/fold nodules, polyps and cysts; removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords; laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue; Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser-assisted esophagodivertuculostomy (ELAED)]; stenosis, including subglottic stenosis; tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy; pulmonary bronchial and tracheal lesion removal; benign and malignant nodules, tumors and fibromas (larynx, pharynx, trachea, tracheobronchial/endobronchial); benign and malignant lesions and fibromas (nose and nasal passages); benign and malignant tumors and fibromas; (oral); stapedotomy/stapedectomy; acoustic neuroma in the ear; superficial lesions of the ear, including chondrodermatitis nondularis chronica helices/Winkler's disease; telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue); cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea; myringotomy/tympanostomy (tympanic membrane fenestration); uvulopalatoplasty (LAUP, laser UPPP); turbinectomy and turbinate reduction/ablation); septal spur ablation/reduction and septoplasty; partial glossectomy; tumor resection on oral, subfacial and neck tissues; rhinophyma; verrucae vulgares (warts); gingivoplasty/gingivoctomy.

Gynecology (GYN): Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of: conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN); condyloma acuminate, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions; leukoplakia (vulvar dystrophies); incision and drainage (I&D) of Bartholin's and nubuthian cysts; herpes vaporization; urethral caruncle vaporization; cervical dysplasia; benign and malignant tumors; hemangiomas.

GYN Laparoscopy: Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of: endometrial lesions, including ablation of endometriosis; excision/lysis of adhesions; salpingostomy; oophorectomy/ovariectomy; fimbroplasty; metroplasty; microsurgery (tubal); uterine myomas and fibroids; ovarian fibromas and follicle cysts; uterosacral ligament ablation; hysterectomy.

Neurosurgery: Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of: Cranial: posterior fossa tumors; peripheral neurectomy; benign and malignant tumors and cysts (e.g. gliomas, menigiomas (including basal tumors), acoustic neuromas, lipomas and large tumors); arteriovenous malformation; pituitary gland tumors (transphenoidal approach). Spinal Cord: incision/excision and vaporization of benign and malignant tumors and cysts; intra- and extradural lesions; laminectomy/ laminotomy/ microdiscectomy.

Orthopedics: Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include: Arthroscopy: menisectomy; chodromalacia; chondroplasty; ligament release (lateral and other); excision of plica; partial synovectomy. General: deridement of traumatic wounds; debridement of decubitus and diabetic ulcers; microsurgery; artificial joint revision; PMMA removal.

General/Thoracic Surgery: Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include: debridement of decubitus ulcers, stasis, diabetic and other ulcers; mastectomy; debridement of burns; rectal and anal hemorrhoidectomy; breast biopsy; reduction mammoplasty; cytoreduction for metastatic disease; laparotomy and laparoscopic applications; mediastinal and thoracic lesions and abnormalities; skin tag vaporization; atheroma; cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips; pilonidal cyst removal and repair; abscesses; other soft tissue applications.

Dental/Oral Surgery: Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include: gingivectomy- removal of hyperplasias; gingivoplasty; incisional and excisional biopsy; treatment of ulcerous lesions, including aphthous ulcers; incision of infection when used with antibiotic therapy; frenectomy (frenum release); excision and ablation of benign and malignant lesions; homeostasis; operculectomy; crown lengthening; removal of soft tissue, cysts and tumors; oral cavity tumors and hemangiomas; abscesses; extraction site hemostasis; salivary gland pathologies; preprosthetic gum preparation; leukoplakia; partial glossectomy; periodontal gum resection.

Genitourinary: Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include: benign and malignant lesions of external genitalia; condyloma; phimosis; erythroplasia.

Device Description

The Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories are used to deliver light energy and are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties, including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), oral surgery and genitourinary surgery.

The Alma Lasers Pixel CO2™ CO2 Laser System consists of the following major components: Laser system console (containing the optical bench assembly and laser, the microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel), LCD control panel with touch-screen technology, 7-joint articulated arm, Footswitch, Delivery Device Handpieces: Focusing handpieces, Pixel handpieces.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories:

Observation: The provided documentation is a 510(k) Premarket Notification from the FDA. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific performance metrics and acceptance criteria. Therefore, the document does not contain details about acceptance criteria, efficacy studies with sample sizes, expert ground truth establishment, or MRMC comparative effectiveness studies in the way one might expect for a de novo submission or a device claiming a novel mechanism of action.

The key to this submission is the claim of "substantial equivalence" to a predicate device, which implies that the new device is as safe and effective as the predicate without requiring new clinical performance data to establish specific metrics.

Acceptance Criteria and Device Performance:

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics for the Alma Lasers Pixel CO2™ Laser System. Instead, it relies on demonstrating substantial equivalence to a predicate device, the Alma Lasers ThermoXEL™ CO2 Laser System and Delivery Device Accessories (K080463).

The "performance" of the device is implicitly accepted if it performs similarly to the predicate device for the stated indications. The rationale for substantial equivalence is based on the following similarities:

Acceptance Criterion (Implied by Substantial Equivalence)	Reported Device Performance
Same intended use and indications for use	Met (Identical)
Same operating principle (technology)	Met
Same basic design	Met
Same materials	Met
Packaged using the same materials and processes	Met

Explanation: In a 510(k) pathway, the "acceptance criteria" are effectively met if the new device can demonstrate that it shares fundamental characteristics and functions in a sufficiently similar manner to a previously cleared predicate device, and thus does not raise new questions of safety or effectiveness. The reported performance is that it is substantially equivalent based on these shared attributes.

Study Information (Based on 510(k) Content):

Sample size used for the test set and the data provenance:
- Test Set: No specific test set of patient data, images, or clinical outcomes is mentioned or used to evaluate the device's performance against specific acceptance criteria. The comparison is primarily technical and functional against the predicate device.
- Data Provenance: Not applicable, as no such test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no test set requiring ground truth established by experts.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set was used requiring adjudication.
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:
- No. This is a laser system, not an AI-assisted diagnostic device, and no MRMC study or AI component is mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical laser system, not an algorithm, and no standalone performance testing in this context is discussed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No ground truth was established as there was no test set of patient data.
The sample size for the training set:
- Not applicable. This is a physical medical device. The "training" for such a device would relate to engineering design, testing, and manufacturing quality, not a machine learning training set.
How the ground truth for the training set was established:
- Not applicable, as no training set (in the machine learning sense) is relevant for this type of device submission.

Conclusion on the provided text:

The document is a regulatory approval letter for a 510(k) premarket notification. Its purpose is to demonstrate "substantial equivalence" of the new device to a predicate device, not to present a comprehensive study with quantitative acceptance criteria and detailed performance data against specific clinical outcomes in the manner that might be expected for a novel efficacy claim, especially for AI/ML devices. Therefore, most of the requested information about acceptance criteria, study design, and ground truth is not present in this type of regulatory submission. The "study" for this submission is essentially the demonstration of technical and functional equivalence to the predicate device.

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K Number

K102716

Device Name

Manufacturer

Date Cleared

2010-09-28

(7 days)

Product Code

Regulation Number

Type

Panel