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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.

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)

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):

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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The Alma Hybrid Laser System, Delivery Devices, Applicators and Accessories are intended for use in surgical applications requiring the ablation, vaporization, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery).

HyLight-CO2

The Alma Hybrid CO2 non-fractional applicator, with wavelength of 10600 nm is cleared for use for the particular indications as follows:

Dermatology & Plastic Surgery

The ablation, vaporization, excision, 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) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts.

Pixel

The Alma Hybrid Pixel CO2 fractional applicator, with wavelength of 10600 nm is indicated for: The ablation, vaporization, and coagulation of soft tissue in dermatology and plastic surgery in the performance of skin resurfacing.

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 & indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.

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 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) ●

The provided text is a 510(k) Pre-Market Notification for the Alma Hybrid Laser System. Within this document, the main objective is to demonstrate substantial equivalence to predicate devices, rather than establishing new efficacy or safety criteria for the device itself. Therefore, it does not contain a typical "acceptance criteria" table for device performance against specific metrics, nor does it detail a clinical study designed to prove the device meets such criteria in the way one might expect for a novel device.

However, based on the document, we can infer some "acceptance criteria" through the comparisons made with predicate devices and the performance testing conducted. The study described focuses on histology testing on porcine animals to justify technical differences in some applicators.

Here's an attempt to extract and frame the information requested, with the understanding that the document's purpose is a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit acceptance criteria for efficacy in humans are not provided (as it's a substantial equivalence claim), the "acceptance criteria" are implied by demonstrating similar technical characteristics to the predicate devices and confirming tissue effects in an animal model meet expected physiological responses.

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

• Test Set (Histology Study): 3 Domestic female (Mixed Landrace & Large White) crossbred swine.
• Data Provenance: The study was implicitly prospective for the animal testing, conducted by Alma Lasers. The document does not specify the country of origin of the data beyond "Alma also performed histology testing on porcine animals."

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

The document does not specify the number of experts or their qualifications for evaluating the histology results. It states, "histology results complied with the FDA requirements." This implies interpretation by qualified individuals, but no details are given.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the animal histology results. It simply states that the "histology results complied with the FDA requirements" and "Re-epithelialization was observed three days after radiation in all specimens." This suggests a direct evaluation against predefined criteria rather than a consensus process among multiple independent reviewers.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "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." The study described is an animal histology study, not a human reader study.

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

This question is not applicable. The device is a laser system, not an AI or algorithm-based diagnostic tool. The performance described relates to the physical and biological effects of the laser, not a computational algorithm's performance.

7. The Type of Ground Truth Used

For the animal study, the ground truth was histology from punch biopsies taken from the radiated points at 0, 3, 7, and 14 days, examined for re-epithelialization and other tissue effects.

8. The Sample Size for the Training Set

This question is not applicable in the context of this 510(k) submission. The device is a physical laser system, not an AI or machine learning algorithm that requires a "training set" of data.

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

This question is not applicable for the same reasons as point 8.

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