Search Results

Type

Special

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, 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

GEX

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

The Alma Soprano Titanium

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

K230371

Device Name

Manufacturer

Alma Lasers Inc.

Date Cleared

2023-02-22

(9 days)

Product Code

GEX,ILY,OUG

Regulation Number

Type

Special

Panel

The Alma Soprano Titanium

Reference & Predicate Devices

K222064

Predicate For

K231896,K241951

Intended Use

The Soprano Titanium diode laser module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser module include:

The Super Hair Removal (SHR) Mode is intended for temporary hair reduction.

The Soprano Trio diode laser module HR mode is intended for use in dermatology procedures requiring coagulation. The indications for the Soprano Trio diode laser HR module include: Benign vascular and vascular dependent lesions.

810nm Applicator

Soprano Titanium 810 nm applicator intended use and indications for use:

The indications for use for the 810nm Modified Diode Laser Module 2 cm2 include:

• The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6.9 and 12 months after the completion of a treatment regimen.

Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)

755nm applicator

Soprano Titanium 755 nm applicator intended use and indications for use:

The indications for use for the 755nm Diode Laser Module include:

• The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.

· Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR Modes)

NIR Applicator

NIR Applicator intended use and indications for use

The Alma Lasers NIR Modules intended use is to emit energy in the near infrared (NIR) spectrum to provide topical heating.

The indications for use for NIR Modules are:

· 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.

Device Description

The Alma Lasers Soprano Titanium Laser System consists of:

System console (contains the laser diodes, the system software, power supply and various other electronic and mechanical parts)
Operator control panel with touch screen technology (GUI)
810 nm applicator ●
755 nm applicator
Small NIR applicator
Trio 4 cm2 applicator ●
Trio 2 cm2applicator .

AI/ML Overview

This document is a 510(k) premarket notification from the FDA, asserting the Alma Soprano Titanium device's substantial equivalence to a predicate device (K222064). This means that the device is deemed to be as safe and effective as a previously cleared device. Therefore, a separate study to prove the device meets acceptance criteria is not explicitly provided in this document, as the substantial equivalence framework relies on comparison to an already approved device.

However, based on the provided text, we can infer some information about performance testing and clinical data:

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

The document does not explicitly state "acceptance criteria" and "reported device performance" in a table format for the newly submitted device. Instead, it refers to performance testing against established safety and essential performance standards for medical electrical equipment and laser products. The implicit "performance" is that the device conforms to these standards.

Acceptance Criteria (Inferred from regulatory standards)	Reported Device Performance (Inferred from submission)
Compliance with general requirements for safety and essential performance (e.g., ANSI/AAMA ES 60601-1)	Tested and found compliant.
Compliance with particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment (e.g., IEC 60601-2-22)	Tested and found compliant.
Compliance with safety of laser products - equipment classification and requirements (e.g., IEC 60825-1)	Tested and found compliant.
Compliance with particular requirements for basic safety and essential performance of non-laser light source equipment (e.g., IEC 60601-2-57)	Tested and found compliant.
Software verification and validation (e.g., IEC 62304)	Performed and found compliant.
Biocompatibility conformance to FDA standards	Established and found compliant.
Fluence remains the same for the new Trio 2 cm2 handpiece as the cleared Trio 4 cm2 handpiece.	Confirmed.
New Smart Clinic software functions as a Medical Device Data System (MDDS) within FDA guidance.	Confirmed.

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

The document 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 indicates that there was no new clinical test set for this specific 510(k) submission. The device's safety and effectiveness are established through its substantial equivalence to the predicate device K222064.

Therefore, questions regarding sample size, data provenance (country of origin, retrospective/prospective), number of experts, and adjudication methods for a test set are not applicable to this submission, as no new clinical test data was generated.

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, as no new clinical studies were conducted for this submission.

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

Not applicable, as no new clinical studies were conducted for this submission.

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 Smart Clinic software is classified as an MDDS (Medical Device Data System), which is focused on data management and display, not AI-assisted diagnosis or interpretation requiring MRMC studies.

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

Not applicable. The document focuses on hardware (laser modules, applicators) and an MDDS software component. There is no mention of a standalone algorithm for diagnostic or interpretative purposes.

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

Not applicable to this 510(k) submission directly, as it relies on substantial equivalence. The "ground truth" for the predicate device (K222064) would have been established through its own clearances and supporting data, which is not detailed here. For the current submission, the "ground truth" is that the device conforms to the relevant performance standards mentioned in Section VII and maintains similar technical characteristics to the predicate.

8. The sample size for the training set:

Not applicable, as no new clinical studies involving training sets for algorithms are mentioned or deemed necessary for this submission. The Smart Clinic software is an MDDS and does not appear to involve a learning algorithm requiring a training set in the context of this document.

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

Not applicable, as no new clinical studies involving training sets for algorithms are mentioned or deemed necessary for this submission.

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K Number

K222064

Device Name

Manufacturer

Alma Lasers Inc.

Date Cleared

2022-10-12

(91 days)

Product Code

GEX,ILY

Regulation Number

Type

Panel

Alma Diode Tabletop Laser

Reference & Predicate Devices

K172193

Predicate For

K222862,K230308,K230371,K230580,K240611,K250206,K251329,K242859

Intended Use

The Soprano Titanium diode laser module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser module include: The Super Hair Removal (SHR) Mode is intended for temporary hair reduction. The Soprano Trio diode laser module HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode include: Benign vascular and vascular dependent lesions.

810nm Applicator: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)

755nm applicator: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR Modes)

NIR Applicator: The Alma Lasers NIR Modules intended use is to emit energy in the near infrared (NIR) spectrum to provide topical heating. The indications for use for NIR Modules are: 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.

Device Description

The Alma Lasers Soprano Titanium Laser System consists of: System console (contains the laser diodes, the system software, power supply, and various other electronic and mechanical parts), Operator control panel with touch-screen technology (GUI), Trio applicator with 1064 nm, 810 nm and 755 nm wavelengths applied simultaneously, 810 nm applicator, 755 nm applicator, Small NIR applicator, Footswitch and other laser safety accessories.

AI/ML Overview

The provided text describes the acceptance criteria and a human clinical study performed for the Soprano Titanium device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Primary Endpoint)	Reported Device Performance
At least thirty percent (30%) reduction in hair count from baseline to 3 months, as assessed by 3 blinded evaluators.	An average reduction of -42.7% ± 17.1 (range -77.9% to 36.5%) was observed in hair count from baseline to 3 months. This met the primary endpoint with statistical significance (p

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K Number

K212073

Device Name

Manufacturer

Alma Lasers, Ltd.

Date Cleared

2022-07-14

(377 days)

Product Code

GEX

Regulation Number

Type

Panel

The Alma Opus System, Colibri Applicator and Tips

Reference & Predicate Devices

K160952

Predicate For

N/A

Intended Use

The Alma Diode Tabletop Laser is intended for use in dermatologic and general surgical procedures.
Indications for Use
The Alma Diode Tabletop Laser includes three possible diode laser modules depending on the customer order.
Diode Laser Modules:
The indications for use for the 810 nm Alma Diode Tabletop Laser include:
-The Alma 810 rm diode tabletop laser is indicated for endoluminal or endovenous laser surgery for saphenous incompetent veins.
The indications for use for the 980 nm Alma Diode Tabletop Laser include:
-The Alma 980 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980 mm diode tabletop laser assisted lipolysis.
The indications for use for the 1470 nm Alma Diode Tabletop Laser include:
-The Alma 1470 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470 nm diode tabletop laser is further indicated for laser assisted lipolysis.

Device Description

The Diode Tabletop System is a small, tabletop laser console that can be sold with one of three wavelengths - 1470nm, 980mm or 810mm. It is comprised of 4 major components. The main console unit contains the laser moduler, cooling and user interface. The Footswitch is used to activate the laser. The diode laser modules are contained in the main console and emit laser energy in the required wavelength. All of the accessories connect via a fiber to the SMA connection port on the laser console. A single use, radial emitting fiber will be provided sterile by an OEM manufacturer. The fiber is sterilized using ETO. It is for prescription use only.

AI/ML Overview

The provided text pertains to a 510(k) premarket notification for a medical device called the "Alma Diode Tabletop Laser." It describes the device, its intended use, comparison to a predicate device, and the non-clinical testing performed.

However, the document does not contain information related to acceptance criteria, device performance against those criteria, sample sizes for test or training sets, data provenance, expert involvement for ground truth, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance, as would be expected for a product relying on AI/ML or complex diagnostic capabilities.

The core of this 510(k) submission is for a laser surgical instrument, and the significant change described is the addition of a temperature sensing thermistor to a cannula used during laser lipolysis. The testing for this modification focused on bench testing to verify the performance of the temperature sensor and its accuracy in an ex vivo porcine model, rather than complex AI/ML performance metrics.

Therefore, many of the requested elements of your prompt are not applicable or cannot be extracted from this specific document.

Here's what can be extracted based on the provided text, and where gaps exist:

Acceptance Criteria and Study Details for the Alma Diode Tabletop Laser (K212073)

Summary of Device and Key Change:
The Alma Diode Tabletop Laser is a laser surgical instrument used in dermatologic and general surgical procedures, specifically for saphenous incompetent veins and laser-assisted lipolysis. The K212073 submission describes a modification to a previously cleared device (K160952), primarily the addition of a temperature-sensing thermistor to a cannula used during laser lipolysis procedures. This thermistor is designed to detect tissue temperature in near real-time and alert the user if a preset temperature is exceeded.

Study Type:
The study described is non-clinical bench testing to verify the performance of the modified device, particularly the added temperature sensing functionality.

Missing Information:

This document does not describe the testing of an AI/ML component. Therefore, acceptance criteria regarding AI diagnostic performance (e.g., sensitivity, specificity, AUC) are not present.
No human reader studies (MRMC) were conducted as the device's function does not involve diagnostic interpretation by human readers.
No standalone algorithm performance metrics are provided as it's not an AI-driven diagnostic algorithm.
Ground truth establishment methods (expert consensus, pathology, outcome data) are not relevant in the context of this device's functional testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria and corresponding reported performance values for properties like sensitivity, specificity, or similar metrics typically associated with AI/ML products. Instead, the performance testing described relates to the functionality of the new temperature sensor.

Acceptance Criteria (Inferred from testing)	Reported Device Performance
Demonstrate time required for temperature sensor to register tissue temperature and notify user.	Performed (details not explicitly quantified in this summary)
Demonstrate accuracy of temperature detection in an ex vivo porcine model.	Performed (details not explicitly quantified in this summary)
Demonstrate relationship between tissue temperature at thermistor and temperature at a specified distance from the thermistor (in ex vivo porcine model).	Performed (details not explicitly quantified in this summary)
Meet general safety and performance standards for medical electrical equipment and laser products.	Passed (compliant with IEC 60601-1, -1-2, -2-22; IEC 60825-1; ISO 17665-1; ISO 10993)
Software Validation & Verification Test	Passed
Biocompatibility evaluation	Passed

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

The document mentions "ex vivo porcine model" for performance testing of the temperature sensor.

Sample Size: Not specified (e.g., number of porcine samples or measurements).
Data Provenance: Ex vivo porcine model (experimental, not human clinical retrospective or prospective data). The country of origin for the data is not specified.

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

Not applicable. The ground truth for the performance of a temperature sensor is typically established by calibrated reference instruments, not expert human readers or consensus, especially in an ex vivo setting.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human readers in diagnostic studies, which is not relevant here.

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

No. An MRMC study was not conducted. This device is a surgical laser, and the testing described is not related to human diagnostic performance or AI assistance in interpretation.

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

No. This is not an AI/ML algorithm or diagnostic device tested for standalone performance. The testing involved the functional performance of a physical component (temperature sensor) within a laser system.

7. The Type of Ground Truth Used

The ground truth for the temperature sensor's performance would be derived from calibrated temperature measurement devices in the ex vivo porcine model, comparing the thermistor's readings against these reference measurements. This is a type of "bench testing" or "experimental setup" ground truth, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product that undergoes a training phase with a dedicated dataset.

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

Not applicable, as there is no training set for this device.

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K Number

K201520

Device Name

Manufacturer

Alma Lasers Inc.

Date Cleared

2021-10-27

(506 days)

Product Code

GEI

Regulation Number

878.4400

Type

Panel

The Alma Hybrid Laser System

Reference & Predicate Devices

K121150

Predicate For

K233760

Intended Use

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

The Opus Plasma Applicator and Tips -

The Opus Plasma Tips (Focus and Glide), when used with the unipolar applicator, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.

The Opus Colibri Applicator and Tips

The Opus Colibri Tips, when used with the unipolar Opus Collbri applicator, are indicated for dermatological procedures requiring resurfacing of the skin.

Device Description

The new Colibri handpiece with two tips incorporates the unipolar RF-based technology and delivers radiofrequency energy via the designed tips that creates micro-plasma causing controlled ablation micro-perforations and a thermal injury zone in the skin, surrounding the perforations.

The new Colibri RF fractional tips are made of the same material as the existing cleared RF tips. The purpose of the Colibri tips is to treat very small areas of skin.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "The Alma Opus System, Colibri Applicator and Tips." This is a regulatory submission demonstrating substantial equivalence to a legally marketed predicate device, not a study evaluating specific acceptance criteria for performance with numerical results against a ground truth for a diagnostic AI device.

Therefore, many of the requested elements for an AI device (like reported device performance against acceptance criteria, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not available in this document.

However, I can extract information related to what was tested and the conclusions drawn for safety and effectiveness.

Here's a breakdown of the available information:

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

This document does not provide a table of acceptance criteria with numerical performance targets and reported values for classification or detection tasks, as it's not a diagnostic AI device. Instead, it focuses on demonstrating safety and functionality.

The "acceptance criteria" here are implicitly related to:

Compliance with electrical safety standards.
Demonstration of expected tissue effects through histology.
Absence of unexpected adverse events.

Acceptance Criteria (Implicit from testing)	Reported Device Performance
Compliance with IEC 60601-1-2 (Electromagnetic Compatibility)	Performed and presumably complied (implied by clearance).
Compliance with IEC 60601-2-2 (High-Frequency Surgery Equipment Safety)	Performed and presumably complied (implied by clearance).
Compliance with IEC 60601-1 (General Electrical Safety)	Performed and presumably complied (implied by clearance).
Software Verification and Validation	Performed and presumably successful (implied by clearance).
Histological demonstration of controlled ablation/resurfacing in porcine model	"Testing was performed safely on the test animals, and the histology results complied with the FDA requirements at 0, 3, 7 and 14 days."
"Reepithelialization was observed three days after radiation in all specimens."
"No adverse events or unexpected complications have been detected in the swine."
"The damage was found to be very superficial and limited."
"The Alma Opus System Delivery Devices (Colibri Applicator Tips) and Accessories functioned as intended and the results observed were as expected."
No new questions of safety or effectiveness compared to predicate	"These differences do not raise new questions of safety or effectiveness, as the operation of the device and technological parameters are substantially equivalent to the predicate." (Section VI)
As safe and effective as the predicate device (K121150)	"The Alma Opus System, Colibri Applicator and Tips is as safe and effective as the predicate K121150. The proposed system has the similar indications, similar technological characteristics, and same principle of operation as its predicate device." (Section IX)

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

Sample Size for Non-Clinical Performance Testing (Histology): Three (3) Domestic female (Mixed Landrace & Large White) crossbred swine were used.
Data Provenance: The study was conducted on porcine animals, typically domestic. The document does not specify the country of origin for the animals or if the study was prospective/retrospective, but preclinical animal studies are inherently prospective.

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)

This is not applicable as this is not a diagnostic AI device requiring expert ground truth for classification/detection. The assessment of histology slides (which would typically be performed by a veterinary pathologist) is implied by the "histology results complied with the FDA requirements" statement, but no specific number or qualifications of experts are given.

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

Not applicable, as this is not a diagnostic AI device involving human interpretation of results 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

No such study was performed or required, as this is not a diagnostic AI device designed to assist human readers. The submission explicitly 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."

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

Not applicable, as this is a medical device for skin ablation and resurfacing, not a standalone diagnostic algorithm.

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

For the non-clinical performance testing, the "ground truth" was established through histology on porcine tissue. This is a direct pathological assessment of tissue changes post-treatment.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device that requires a training set.

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

Not applicable.

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K Number

K203441

Device Name

Manufacturer

Alma Lasers, Ltd.

Date Cleared

2021-07-02

(221 days)

Product Code

GEX,ONG

Regulation Number

Type

Panel