(46 days)
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.
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.
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):
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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.
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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.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set was used requiring adjudication.
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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.
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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.
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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.
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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.
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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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.