Search Results

The Alma Q laser is intended for use in aesthetic and surgical applications requiring the ablation, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery.

a) LP1064nm

1. For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins.
2. The Alma Q laser system is also indicated for the treatment of wrinkles.
3. The Alma Q is also indicated for the removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB).
4. The Alma Q laser system is indicated for use on all skin types (Fitzpatrick IVI), including tanned skin.
5. The intended use of the integral cooling system in the Alma O laser handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.

b) OS 532nm

1. Tattoo removal
   -Red inks
   -Blue and light blue inks
   -Green inks
2. Treatment of benign vascular lesions
   -Telangiectasias
   -Spider angiomas
   -Cherry angiomas
   -Spider nevi
3. Treatment of benign pigmented lesions
   -Cafe-au-lait birthmarks solar lentigines
   -Solar lentigines
   -Becker's nevi
   -Freckles
   -Nevus spilus
   -Nevus of ota
4. Incision, excision, ablation, and vaporization of soft tissue in general dermatology

c) QS 1064nm
The Alma Q laser treatment system is intended for use:
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 dermal pigmented lesions (dermal melanocytosis); and
For tattoo removal (dark and blue inks).

The subject device, Alma Q Laser incorporates a flash lamp pumped Nd:Yag laser. The radiation emitted by this device has the ideal 1064nm wavelength. It also incorporates a built-in frequency conversion technology to obtain the 532nm (green) wavelength. The laser system is operated with an articulated arm system for transmitting the laser radiation with different size tips. Alma Q can operate in Q-switching mode and produce 1064nm wavelength beam. This beam can also be efficiently converted into 532nm wavelength beam using a KTP crystal. This laser can also operate in long-pulsed mode at 1064nm wavelength. The system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas.
The material that could contact the patient during device use is aluminum with limited-duration surface contact with intact skin. The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.

The provided document is a 510(k) Premarket Notification for the Alma Q Laser, a medical device. This type of FDA submission seeks to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective.

The document does not include data from a study designed to prove the device meets specific performance acceptance criteria for clinical efficacy. Instead, it relies on a comparison to predicate devices and non-clinical performance testing to establish substantial equivalence. Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study, nor specific details about expert-established ground truth or MRMC studies, as these types of studies were not deemed necessary for this particular submission.

Here's what the document states regarding performance and the justification for not conducting clinical studies:

• No Clinical Studies Deemed Needed: "Based on the similarities in the safety and effectiveness profiles of the subject and predicate devices, no animal or clinical studies were deemed needed to support this submission." (Page 12)
• Reliance on Substantial Equivalence: The primary method for proving the device's safety and effectiveness is by demonstrating its substantial equivalence to previously cleared predicate devices (Mydon and Naturalase). The submission details the technological characteristics and indications for use of the Alma Q Laser and compares them to the predicate devices.
• Non-Clinical Performance Testing: "In all instances, the Alma Q Laser functioned as intended and the results observed were as expected." (Page 12). This refers to non-clinical performance testing, likely related to engineering specifications, safety standards, and functional verification, to ensure the device performs according to its design. The document lists several IEC standards that were likely used for this testing (e.g., IEC 60601-1 for electrical safety, IEC 60825-1 for laser safety).

In summary, this document does not contain the information required to populate a table of acceptance criteria and reported device performance from a clinical study, as no such clinical study was conducted or required for this 510(k) submission.

Therefore, I will reiterate the key points from the provided text that explain why no such study details are available:

• No Clinical/Animal Studies: The submission explicitly states that "no animal or clinical studies were deemed needed to support this submission" due to the device's similarities to predicate devices in safety and effectiveness profiles.
• Method of Proof: The method of proof for this device's safety and effectiveness is Substantial Equivalence to predicate devices.
• Performance Testing: Refers to Non-clinical performance testing (e.g., electrical safety, laser safety, software verification and validation, biocompatibility) which ensured the device functioned as intended and met expected results.

Because the request specifically asks for information that is not present in the provided text (i.e., acceptance criteria and performance from a clinical study), I cannot fulfill all parts of your request based solely on this document.

Ask a specific question about this device

The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano de, Soprano de and Soprano (5) is intended for use in dermatologic and general surgical procedures.

The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano ^', Soprano * and Soprano "CE] includes Diode Laser and NIR Modules

Diode Laser Modules:

The indications for use for the 810mm Modified Diode Laser Module 1.2 cm² include:

• The Hair Removal (HR) and Super Hair Removal(SHR) Mode is 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.
• The treatment of benign vascular and pigmented lesions.(The Laser Blanch (LB) Mode)
  . Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR. SHR and LB Modes)

Optional Tapered Light Guide: It is intended for the same use as the device.

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

• . The Hair Removal (HR) and Super Hair Removal(SHR) Mode is 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)

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

• The Hair Removal (HR) and Super Hair Removal(SHR) Mode is 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.
• The treatment of benign vascular and pigmented lesions.(The Laser Blanch Mode) 트
• Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR and Laser Blanch Modes) .

NIR Modules

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 joint pain and stiffness, 트
• The temporary relief of minor joint pain associated with arthritis,
• 프 The temporary increase in local circulation where applied, and
• 미 The relaxation of muscles; may also help muscle spasms, minor sprains and minor muscular back pain.

The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano XL, Soprano ™ and Soprano "CE] is a modification to previously cleared Soprano Family XL ™M Multi Application Platform [Soprano **] The relevant K number is K102716

Soprano 40, the new addition to the family has hand pieces with multiple wavelengths, spot sizes and supports both Diode Laser and Near Infrared (NIR) Technologies. The Soprano 40 comprises of the following major components:

1. The main console unit
2. Footswitch.

The provided document is a 510(k) premarket notification for a medical device (The Modified Alma Lasers Soprano XL Family of Multi-Application and Multi-Technology Platforms). It primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technical characteristics, and adherence to safety standards.

Crucially, this document does not contain information about acceptance criteria for device performance as typically understood for studies evaluating diagnostic or therapeutic efficacy (e.g., sensitivity, specificity, accuracy). Nor does it describe a study that proves the device meets such performance criteria by comparing it against a ground truth in a clinical setting.

Instead, the "acceptance criteria" and "study" described in this document are related to:

1. Substantial Equivalence: The primary "acceptance criterion" for a 510(k) submission is to demonstrate that the new device is as safe and effective as a legally marketed predicate device.
2. Safety and Performance Standards: The "studies" are tests conducted to ensure the device meets specified electrical, electromagnetic, and laser safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) and software development and risk management standards (IEC 62304, ISO 14971).

Therefore, I cannot populate the table and additional information based on the typical understanding of "acceptance criteria" for a device's clinical performance. The document focuses on showing the device is substantially equivalent to existing devices and safe according to engineering and manufacturing standards.

However, I can extract the information relevant to these types of "acceptance criteria" and "studies" as presented:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the specific questions about clinical study design for performance:

• 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. The document does not describe a clinical performance test set with human or biological data. The "tests" mentioned are engineering and software validation tests.
• 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. Ground truth for clinical efficacy is not discussed.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 platform, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies would be relevant in this context.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as detailed clinical performance is not assessed in this document. The "ground truth" for the engineering/software tests would be the requirements of the standards themselves.
• 8. The sample size for the training set: Not applicable. There is no machine learning or AI model being trained discussed.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, this regulatory document focuses on establishing the safety, essential performance, and substantial equivalence of a modified laser platform to existing devices, primarily through engineering tests and comparison of technical specifications, rather than clinical performance studies against a "ground truth" for efficacy.

Ask a specific question about this device

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 810nm Alma Diode Tabletop Laser include:

• The Alma 810nm diode tabletop laser is indicated for endovenous laser surgery for saphenous incompetent veins.

The indications for use for the 980 nm Alma Diode Tabletop Laser include:

-The Alma 980nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980nm diode tabletop laser is further indicated for laser assisted lipolysis.

The indications for use for the 1470nm Alma Diode Tabletop Laser include:

-The Alma 1470nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470nm diode tabletop laser is further indicated for laser assisted lipolysis.

The Alma Diode Tabletop Laser is comprised of the following major components:

• 1. The main console unit
• 2. Footswitch.
• 3. Accessories

This is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with acceptance criteria in the way a de novo or PMA submission would. Therefore, the document does not contain the detailed performance study information requested for an AI/ML device.

Here's an analysis based on the provided text, highlighting what is and isn't available:

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

The document does not provide a table of acceptance criteria and reported device performance in the context of clinical efficacy or specific accuracy metrics from a study. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to the predicate device by matching technical characteristics and indications for use.

The tables in sections 8-VI (Tables 1, 2, and 3) compare the "Alma Diode Tabletop Laser" (K13) to the "Quanta Diode Laser Family" (K100558) across several technical parameters. The "reported device performance" in this context is the Alma device meeting these technical specifications and having similar indications for use.

Similar tables exist for the 980nm and 810nm modules, with minor differences in wavelength, max power (30W for 980nm/810nm), and aiming beam wavelength (635nm vs 650nm for predicate).

The study that proves the device meets the acceptance criteria:

The "study" cited is the comparison to predicate devices and adherence to recognized electrical and laser safety standards. There are no clinical performance studies, accuracy metrics, or AI/ML specific evaluations described in this 510(k) summary.

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

Not applicable. This is a 510(k) for a laser device, not an AI/ML diagnostic. There are no test sets of patient data mentioned for performance evaluation. The device was tested to meet specific safety and electrical standards.

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. This type of information is not relevant to this 510(k) submission, which focuses on substantial equivalence of a physical laser device.

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

Not applicable. No test set requiring adjudication in this context.

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 not an AI/ML product designed to assist human readers.

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

Not applicable. This device is not an algorithm.

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

The "ground truth" for this submission is implicitly the established safety and performance profile of the predicate device and adherence to international electrical and laser safety standards.

The device was tested by a certified laboratory according to:

• IEC 60601-1: 1988+A1:1991+A2:1995: Medical Electrical Equipment Part 1: General Requirements for basic safety and essential performance
• IEC 60601-1-2: Medical electrical equipment: Part 1-2: General requirements for safety-Collateral Standard: Electromagnetic compatibility - Requirements and tests (2001 + A1(4))
• IEC 60601-2-22:1995 Medical electrical equipment- Part 2-22: Particular requirements for the safety of diagnostic and therapeutic laser equipment 1995.
• IEC 60825-1:2007 (2nd edition) Safety of Laser Products-Part 1: Equipment Classification and Requirements

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Ask a specific question about this device

The Alma Lasers ALEX755 Module to be used with the Harmony XL™ Multi-Application Platform is indicated for permanent hair reduction. Also indicated for the treatment of vascular lesions and benign pigmented lesions.

The Alma Lasers ALEX755 Module is an additional module to the existing Alma Lasers. Ltd. Harmony XLTM Multi-Application Platform (previously cleared under K072564). The pistol-shaped Alex755 laser module incorporates a solid state Alexandrite rod laser medium and a xenon flash lamp as the heart of the optical bench. The flash lamp pumped Alexandrite rod emits light through an aperture located on the module tip. The laser beam is delivered when the operator presses both the footswitch, and the handpiece trieger. The Alma Lasers ALEX755 Module is comprised of the following components; An 'umbilical' cable and connector, that is permanently attached to the ALEX755 module body and semi-permanently attached to the laser system. Electrical cables (to provide power to the light source and to connect to a memory device that identifies the module). A supply and return water line (to remove the heat generated). Module body (shells) housing the module internals and connecting to the umbilical. The operator holds the handpiece by its handle in order to position the module tip against the patient's skin. Optional air-cooling can be provided.

This 510(k) summary describes a medical device, the Alma Lasers ALEX755 Module. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. The document focuses on regulatory approval based on substantial equivalence to predicate devices, rather than performance studies with defined acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or what is explicitly missing:

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

• Cannot be provided. This document does not describe specific acceptance criteria (e.g., a certain percentage of hair reduction, lesion clearance rate) or any performance data from a study. The approval is based on substantial equivalence, implying that its performance is expected to be similar to its predicates without explicit new performance data provided in this summary.

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

• Cannot be provided. No test set or clinical study data is reported in this document.

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

• Cannot be provided. No test set or ground truth establishment is described.

4. Adjudication method for the test set

• Cannot be provided. No test set or adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Cannot be provided. This device is a laser module for treatment, not an AI-assisted diagnostic or interpretation system. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.

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

• Cannot be provided. This device is a hardware laser module operated by a human. The concept of "standalone algorithm performance" doesn't apply.

7. The type of ground truth used

• Cannot be provided. No ground truth is described as no performance study is detailed.

8. The sample size for the training set

• Cannot be provided. No training set is described as no new algorithm development or performance study is detailed.

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

• Cannot be provided. No training set or ground truth establishment is described.

In summary, the provided text is a 510(k) summary for regulatory clearance based on substantial equivalence, not a report of a device performance study with acceptance criteria.

Ask a specific question about this device

The SOPRANO XL™ Multi-Application Platform includes a Diode Laser Module and an optional NIR Module.

The Diode Laser Module:

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

The NIR Module is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The SOPRANO XL™ Multi-Application Platform is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

The Soprano XL Multi-Application Platform features an additional indication for the treatment of benign vascular and pigmented lesions introduced to its Diode Module compared to the existing Alma Lasers, Ltd. (former MSq., Ltd.) Soprano Diode Laser System, previously cleared under K052874 for hair removal and long-term hair reduction. The Soprano XL system is indicated for use on all skin types (Fitzpatrick Skin Types I-VI), including tanned skin.

The Soprano XL Multi-Application Platform is a multi-application, multi-technology platform that supports the following technologies:

· Diode laser technology
· Near-infrared light technology (NIR)

Both the Soprano and Soprano XL systems consist of a console, a diode module and a footswitch. The module is pressed against the patient skin and a laser pulse is delivered when the module trigger and the footswitch are activated. The module tip is cooled by the cooling system.

Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system micro-controller through an LCD touch-screen.

The provided document is a 510(k) summary for the Alma Lasers Soprano XL Multi-Application Platform. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through novel studies.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving device performance against those criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truth methodologies for new data.

The core argument for clearance is based on the device having "the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate devices."

Below is a breakdown of why each specific point you requested cannot be found in this document:

1. A table of acceptance criteria and the reported device performance: This document does not present specific quantitative acceptance criteria or results from a performance study designed to meet them. It relies on the equivalence to previously cleared devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set data is described. The clearance is based on comparison to predicate devices, not on new clinical performance data from a test set.

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): No ground truth establishment for a test set is discussed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set or corresponding adjudication method is mentioned.

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: This device is a laser platform, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and
   AI assistance metrics are not applicable and are not present.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This device is a physical laser system, not an algorithm. Standalone algorithm performance is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): As no new performance study is detailed, no ground truth methodology for such a study is provided.

8. The sample size for the training set: No training set is mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established: Not applicable, as there's no training set.

In summary, this 510(k) submission is a "me-too" application, seeking clearance based on substantial equivalence to existing, legally marketed devices. It does not present new performance data against a defined set of acceptance criteria, nor does it involve AI or algorithmic performance evaluation.

Ask a specific question about this device

Intended Use: The Accent UniForm Massager handpiece/module is intended to be used with the Alma Lasers Family of Accent™ RF Systems for use in dermatologic and general surgical procedures.

Indications for Use: The massage component of the Alma Lasers Accent UniForm Massager Handpiece/Module is intended for use with the Alma Lasers Family of Accent RF Systems to provide: Temporary reduction in the appearance of cellulite. Simultaneous application of RF energy and mechanical manipulation of the skin by the Alma Lasers Accent UniForm Massager Handpiece/Module is intended for use with the Alma Lasers Family of Accent RF Systems to provide: Temporary reduction in the appearance of cellulite.

The Accent UniForm Massager handpiece/module is a cleanable, reusable radiofrequency (RF) energy delivery and skin mechanical manipulation/massage device (accessory) intended for use with the Alma Lasers Family of Accent RF Systems. The Accent UniForm Massager handpiece/module is comprised of the following main components: Handpiece Tip with Massage Ring, Handpiece Body (Handle used for holding the handpiece, A RF emission indicator - blue LED illuminates prior to- and during the RF energy emission, A Thermo-electric cooler - integrated within the handpiece, provides contact cooling, A Umbilical cable - contains hot and cold water tubes (cooling system), RF-power cable and the communication cable that controls the operation of the handpiece, A Handpiece connector - connects the handpiece to its port. It incorporates an integrated impedance matching network (IMN) and a memory chip (i-button) that stores information about the handpiece and the parameter settings. It also houses the water tube quick-connectors.)

The provided text is a 510(k) summary for the Alma Lasers Accent UniForm Massager Handpiece/Module. It establishes substantial equivalence to predicate devices and describes the intended use and indications for use. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document states:
"The review of the indications for use and technical characteristics provided demonstrates that the Accent UniForm Massager handpiece/module is substantially equivalent to the predicate devices."
And:
"The Accent UniForm Massager handpiece/module was found to be substantially equivalent to the predicate devices."

This indicates that the submission relies on demonstrating similarity to already approved devices rather than presenting a de novo study with specific performance metrics and acceptance criteria. Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

The Alma Lasers ThermoXEL™ CO2 Laser System and Delivery Device 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 (knec).

The Alma Lasers ThermoXEL™ CO2 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 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.

Dermatology & Plastic Surgery, continued
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, sebortheic 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;

Dermatology & Plastic Surgery, continued

• 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 matrixectorny.

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 o 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 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;

Otolaryngology (ENT), continued

• laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue;
• Zenker's Diverticulum/pharyngoesophageal diverticulum Jendoscopic 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, trachcobronchial/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 UPP):
• 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, perincal, 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;

GYN Laparoscopy, continued

• 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;

General/Thoracic Surgery, continued

• 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;

Dental/Oral Surgery, continued

• 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 ThermoXEL™ CO2 Laser System Pixel Handpieces are indicated for use in soft tissue for:

Dermatology & Plastic Surgery

• Skin resurfacing

The Alma Lasers ThermoXEL™ CO2 Laser System and delivery device accessories consist of the following major components:

• 1. 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)
  • a. LCD control panel
  • b. Keypad
• 2. 7-joint articulated arm
• 3. Footswitch
• 4. Variety of Delivery Device Handpieces (single spot, scanner, pixel)

This submission is a 510(k) premarket notification for the Alma Lasers ThermoXEL™ CO2 Laser System and Delivery Device Accessories. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)). The FDA's substantial equivalence determination for this device is primarily based on its similarity in indications for use, operation, and technical/functional capabilities to predicate devices already on the market.

Therefore, this document does not contain information about specific acceptance criteria or an independent study to prove that the device meets those criteria. Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices. Consequently, I am unable to provide the detailed information requested in your prompt regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or specific study designs.

The relevant sections of the document are:

• Section VII. Safety and Effectiveness Information: This section states that "The review of the indications for use and technical characteristics provided demonstrates that the Alma Lasers ThermoXEL™ CO2 Laser System and Delivery Device Accessories are substantially equivalent to the predicate devices." This is the core of their "proof" of effectiveness and safety, relying on comparison to already approved devices rather than a de novo study.
• Section III. Predicate Devices: This lists the devices to which Alma Lasers ThermoXEL™ is claiming substantial equivalence.

Without a direct study of the device against predefined acceptance criteria, I cannot complete the table or answer the specific questions about study design, sample sizes, ground truth, or expert involvement as those details are not provided in a 510(k) submission focused on substantial equivalence.

Ask a specific question about this device

The Alma Lasers Family of Thermo-XEL Handpieces is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue for compatible CO2 and 2940 nm Er:YAG laser systems cleared for use in the medical specialty of Dermatology and Plastic Surgery to which they are attached.

The Alma Lasers Family of Thermo-XEL Handpieces is indicated for use in soft tissue for: DERMATOLOGY AND PLASTIC SURGERY: Skin resurfacing

The Alma Lasers Family of Thermo-XEL Handpieces is comprised of the following main components: Thermo-XEL Handpiece body. Adapter attachments: CO2 laser adapter attachment, as required, to attach the handpiece body to the qualified CO2 or Er: Y AG laser system Er:YAG laser adapter attachment, as required, to attach the handpiece body to the qualified Er: Y AG laser system

The Alma Lasers Family of Thermo-XEL Handpieces are provided as a non-sterile, cleanable, multiple use laser energy delivery device (accessory). The proximal end of the handpiece is designed to be attached, using the laser adapter, to the distal end of the articulated arm of compatible CO2 (10.6 um) or Er.YAG (2940 nm) laser systems as qualified by Alma Lasers for use with the Thermo-XEL Handpiece.

This document is a 510(k) premarket notification for the Alma Lasers Family of Thermo-XEL Handpieces, submitted to the FDA in 2008. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that defines and met specific acceptance criteria for a new, novel device performance claim. Therefore, much of the requested information regarding acceptance criteria and performance studies is not present in this type of submission.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable for this 510(k) submission.

This document is a "substantial equivalence" claim. For devices pursuing substantial equivalence, the primary "acceptance criterion" is that the device is as safe and effective as a legally marketed predicate device. This is typically demonstrated through comparing indications for use, operating principles, technological characteristics, and performance data if relevant to the comparison, rather than establishing and meeting novel performance metrics.

The document states: "The Alma Lasers Family of Thermo-XEL Handpieces shares the same or similar indications for use, operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices." It also explicitly mentions: "The review of the indications for use and technical characteristics provided demonstrates that the Alma Lasers Family of Thermo-XEL Handpieces is substantially equivalent to the predicate devices."

Therefore, the "reported device performance" is implicitly that it performs equivalently to the listed predicate devices in terms of its intended use (ablation, vaporization, and coagulation of soft tissue for skin resurfacing) when attached to compatible CO2 and Er:YAG laser systems. No specific quantitative performance metrics or acceptance criteria are defined or reported.

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

Not applicable/Not provided in this 510(k) submission.

This submission does not detail specific "test sets" or clinical studies with human subjects, as it relies on substantial equivalence to predicate devices. The "data provenance" mentioned would refer to the characteristics and performance of the predicate devices already on the market.

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

Not applicable/Not provided in this 510(k) submission.

There is no mention of a test set requiring ground truth established by experts.

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

Not applicable/Not provided in this 510(k) submission.

There is no mention of a test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable.

This device is a laser handpiece, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

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

Not applicable.

This device is a physical medical instrument (laser handpiece), not a software algorithm.

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

Not applicable/Not provided in this 510(k) submission.

As no specific study with a test set requiring ground truth is described, this information is not present. The "ground truth" for a substantial equivalence determination largely rests on the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable/Not provided in this 510(k) submission.

There is no mention of a "training set" as this is not an AI/machine learning device. The design and validation of this device would rely on engineering principles, materials testing, and performance testing against established safety standards rather than a data-driven training set.

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

Not applicable/Not provided in this 510(k) submission.

As there is no training set, this information is not available.

Summary of this 510(k) context:

This 510(k) submission (K072182) for the Alma Lasers Family of Thermo-XEL Handpieces is a regulatory filing that seeks to demonstrate "substantial equivalence" to pre-existing, legally marketed predicate devices. This pathway does not typically require the detailed clinical studies, acceptance criteria, and performance metrics that would be associated with a novel device or an AI/software device. Instead, the manufacturer compares the new device's indications for use, design, and technological characteristics to those of predicate devices to establish that it is "as safe and effective" as those already on the market. Therefore, the specific types of performance data, test sets, and ground truth methodologies you've requested are generally not found in this type of submission.

Ask a specific question about this device

The Alma Lasers Harmony XL™ Multi-Application Platform is intended for use in dermatologic and general surgical procedures. The Harmony XL™ Multi-Application Platform is intended for use in aesthetic, cosmetic, and surgical applications requiring the ablation, vaporization, excision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, oral surgery, ophthalmology (skin around the eyes), orthopedics, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications.

The Alma Lasers Harmony XL™ Multi-Application Platform is comprised of the following main components: The main console unit that incorporates the touch-screen control panel, power supply modules, cooling system, switching module, service panel and isolating transformer. Variety of handpieces and attachment accessories. Footswitch.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for the Harmony XL™ Multi-Application Platform, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting performance criteria and a study to meet them.

The text outlines:

• General information about the device and submitter.
• A list of predicate devices.
• A product description.
• Extensive indications for use for various modules and handpieces in dermatologic and general surgical procedures.
• A rationale for substantial equivalence.
• A conclusion of substantial equivalence.

It does not contain details regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used in a study.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document is a regulatory submission for substantial equivalence, not a scientific publication detailing performance studies against specific acceptance criteria.

Ask a specific question about this device

The Alma Lasers NIR Module is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The Alma Lasers NIR Module is an additional module to the existing Alma Lasers, I.td. (former MSq.) Soprano Diode Laser System cleared under K052874.

The Alma Lasers NIR Module is comprised of the following components:

• An 'umbilical' cable and connector, that is permanently attached to the NIR module body and semi-permanently attached to the laser system that houses:
• Electrical cables (to support the thermoelectric coolers (TFC) associated with the chilled sapphire window, to provide power to the pulsed light source (quartz tube), and to connect to a memory device that identifies the module)
• A supply and return water line (to remove the heat generated by the infrared lamp and thermoelectric cooler)
• Module body (shells) housing the module internals and connecting to the umbilical.

The light source emits a pulse when it is activated by pressing the footswitch. The light passes through an aperture with a filter, into a lightguide that is located on the module tip. The operator holds the handpiece by its handle in order to position the lightguide against the patient's skin.

The module tip is TEC-cooled to provide contact skin cooling. The module contact cooling mechanism can be turned on or off by touching the appropriate soft-key in the bottom-left corner of the LCD control panel. The temperature at the skin surface does not exceed 40°C.

The NIR module is operated only by pressing the footswitch.

The proximal end of the umbilical is semi-permanently attached to the laser system console and the distal end is permanently attached to the body of the NIR delivery module. The Alma Lasers NIR Module is removable by either the user or an authorized filed service engineer for replacement at the proximal end.

This document (K080318) is a 510(k) summary for the Alma Lasers NIR Module, which is an additional module for the existing Alma Lasers Soprano Diode Laser System. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than proving specific device performance criteria against pre-defined acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted because such a study is not part of this 510(k) submission. The FDA clearance for this device is based on substantial equivalence to existing legally marketed devices, not on the presentation of new clinical trial data demonstrating performance against specific numerical endpoints.

Here's a breakdown of why each requested point cannot be addressed from the provided text:

1. Table of acceptance criteria and reported device performance: Not provided. The submission states the device shares the same indications for use, operation, technical and functional capabilities with predicate devices, implying similar performance, but it doesn't quantify specific performance metrics or acceptance criteria for those metrics.
2. Sample size used for the test set and data provenance: No test set or associated data is described as part of a performance study in this document.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable, as no such study is described.
4. Adjudication method for the test set: Not applicable, as no such study is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or described in this submission.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a laser module for therapeutic heating, not an AI or algorithm-driven diagnostic device.
7. Type of ground truth used: Not applicable, as no performance study with ground truth establishment is described.
8. Sample size for the training set: Not applicable, as this is a hardware device where "training sets" in the context of AI/algorithm development are not relevant.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

Conclusion based on the provided document:

The Alma Lasers NIR Module obtained 510(k) clearance (K080318) on March 7, 2008, by demonstrating substantial equivalence to predicate devices (Palomar LuxIR Handpiece, Cutera Titan Tabletop Product, Altus Medical Optional Infrared Handpiece). The basis for this equivalence is that the device shares the same indications for use, the operation, technical and functional capabilities with these predicate devices.

The indications for use are: "The Alma Lasers NIR Module is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain."

No specific clinical studies with defined acceptance criteria for device performance were presented or required for this 510(k) submission, as it relied on the established safety and effectiveness of the predicate devices.

Ask a specific question about this device