Search Results

Type

Panel

Reference & Predicate Devices

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

Intended Use

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

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

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

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

Device Description

Not Found

AI/ML Overview

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

The letter primarily focuses on:

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

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

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

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

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

Without this information, I cannot fulfill your request.

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K Number

K233024

Device Name

Alma Harmony

Manufacturer

Alma Lasers, Inc.

Date Cleared

2024-02-08

(139 days)

Product Code

GEX,ILY,ONF

Regulation Number

Type

Panel

Reference & Predicate Devices

K231054,K230371,K230308,K203441,K072564,K170850

Intended Use

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

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

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

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

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

Iris VL / PL Applicator:
Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology.
The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait macules.
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations. Use on all skin types (Fitzpatrick I- VI).

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

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

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

Iris NIR Applicator: Intended to emit energy in the infra-red spectrum to provide topical heating for the purpose of elevating the tissue temperature.
For the temporary relief of minor muscle pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

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

Device Description

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

AI/ML Overview

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

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

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

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K Number

K230308

Device Name

Alma Harmony

Manufacturer

Alma Lasers, Inc.

Date Cleared

2023-03-01

(26 days)

Product Code

GEX,ILY,ONF

Regulation Number

Type

Panel

The Alma Soprano Titanium

Reference & Predicate Devices

K033946,K222064,K141237,K181298,K072564,K053604

Intended Use

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

Device Description

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

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

AI/ML Overview

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

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

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

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

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K Number

K230371

Device Name

Manufacturer

Date Cleared

2023-02-22

(9 days)

Product Code

GEX,ILY,OUG

Regulation Number

Type

Special

Panel

The Alma Soprano Titanium

Reference & Predicate Devices

K222064

Intended Use

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

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

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

810nm Applicator

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

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

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

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

755nm applicator

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

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

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

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

NIR Applicator

NIR Applicator intended use and indications for use

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

The indications for use for NIR Modules are:

· Elevating the tissue temperature for the temporary relief of minor muscle pain and stiffness,
· The temporary relief of minor joint pain associated with arthritis,
· The temporary increase in local circulation where applied, and
· The relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Device Description

The Alma Lasers Soprano Titanium Laser System consists of:

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

AI/ML Overview

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

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

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

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

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

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

The document states, "Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no clinical studies were deemed needed to support this submission." This indicates that there was no new clinical test set for this specific 510(k) submission. The device's safety and effectiveness are established through its substantial equivalence to the predicate device K222064.

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

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

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

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

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

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

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

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

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

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

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

8. The sample size for the training set:

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

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

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

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K Number

K222064

Device Name

Manufacturer

Date Cleared

2022-10-12

(91 days)

Product Code

GEX,ILY

Regulation Number

Type

Panel

The Alma Opus System, Colibri Applicator and Tips

Reference & Predicate Devices

K172193

Intended Use

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

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

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

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

Device Description

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

AI/ML Overview

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

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

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K Number

K201520

Device Name

Manufacturer

Date Cleared

2021-10-27

(506 days)

Product Code

GEI

Regulation Number

878.4400

Type

Panel

Harmony XL Multi-Application Platform

Reference & Predicate Devices

K121150

Intended Use

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

The Opus Plasma Applicator and Tips -

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

The Opus Colibri Applicator and Tips

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

Device Description

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

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

AI/ML Overview

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

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

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

Here's a breakdown of the available information:

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

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

The "acceptance criteria" here are implicitly related to:

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

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

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

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

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

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

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

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

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

No such study was performed or required, as this is not a diagnostic AI device designed to assist human readers. The submission explicitly states: "Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no clinical studies were deemed needed to support this submission."

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

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

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

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

8. The sample size for the training set

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

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

Not applicable.

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K Number

K181298

Device Name

Manufacturer

Date Cleared

2018-06-13

(28 days)

Product Code

ONF

Regulation Number

Type

Special

Panel

Modified Alma Lasers Soprano XL Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules

Reference & Predicate Devices

K072564,K141237

Intended Use

The Dye VL Handpiece (500-600 nm) is indicated for:

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

Device Description

The Harmony XL™ continues to be comprised of the identical console unit, footswitch, and a variety of handpieces. The main console of the Harmony XL™ continues to consist of the same control panel, system controller, power supply modules, cooling system, switching module, and isolation transformer.

The subject change is to add a version of the 515-950 nm SVL515 Module AFT handpiece ("SVL515") provided in the company's cleared Harmony XL™ (K072564) to the Harmony XL™ system. The modified handpiece has a narrowed wavelength range of 500-600 nm as compared to the SVL515 handpiece that has a wavelength of 515-950 nm. In addition, the modified handpiece is named the "Dye VL handpiece." Further, the identification color of the distal end of the handpiece is being changed from turquoise to light green.

AI/ML Overview

The provided text is a 510(k) summary for the Alma Lasers Harmony XL™ Multi-Application Platform with the Dye VL Handpiece. This document is a regulatory submission to the FDA for demonstrating substantial equivalence to a predicate device, not a detailed scientific study on device performance against specific acceptance criteria. Therefore, the information required to fully answer your request regarding acceptance criteria and a study proving the device meets them is limited and largely not present in the provided text.

Here's an analysis based on the available information:

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

The document does not provide a table with specific acceptance criteria (e.g., in terms of clinical efficacy metrics like lesion reduction percentage, or safety metrics like adverse event rates) and reported device performance against those criteria.

The "Performance Data" section states:

"Software verification and validation was performed, and demonstrates that the software performs as intended."
"Electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) was established."
"Biocompatibility of patient-contacting components was established per ISO 10993."
"In all instances, the subject device functions as intended and meets all the same acceptance criteria as the predicate devices."

This indicates that the acceptance criteria are based on fulfilling engineering and safety standards, and that device functions as intended. However, the specific quantitative or qualitative criteria are not detailed.

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

The document does not mention any clinical test set, sample size, or data provenance (country of origin, retrospective/prospective). The performance data cited refers to engineering verifications and validations (software, electrical safety, EMC, biocompatibility), which typically do not involve human subjects or clinical data in the same way as a clinical trial.

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

This information is not applicable and not available in the document, as no clinical test set requiring expert ground truth establishment is described.

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

This information is not applicable and not available, as no clinical test set requiring 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

There is no mention of an MRMC comparative effectiveness study, nor is there any AI component described in the device. The device is a laser/light platform, not an imaging analysis or diagnostic AI device. Therefore, this question is not applicable to the provided document.

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 physical laser/light therapy platform, not an algorithm.

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

For the engineering performance data mentioned, the "ground truth" would be established by the relevant engineering standards (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility) and the functional specifications of the device. There is no mention of clinical ground truth (like pathology or outcomes data) because the document focuses on demonstrating substantial equivalence based on technological characteristics and safety, rather than presenting new clinical efficacy data.

8. The sample size for the training set

The document does not mention any training set. This device is not described as an AI/ML device that would require a "training set" in the context of machine learning.

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

Not applicable, as no training set for an AI/ML component is mentioned.

Summary of what is present:

The document is a 510(k) summary for a medical device (Harmony XL™ Multi-Application Platform with Dye VL Handpiece). It aims to demonstrate substantial equivalence to existing predicate devices, not necessarily to prove new clinical efficacy.

Acceptance Criteria (Implied): The device is stated to meet the "same acceptance criteria as the predicate devices" for software, electrical safety, electromagnetic compatibility, and biocompatibility. These criteria are based on established engineering and safety standards (IEC 60601-1, ISO 10993) and the device's functional specifications. Specific quantitative or qualitative performance targets are not listed.
Study: The "studies" conducted are non-clinical:
- Software verification and validation.
- Electrical safety testing (IEC 60601-1).
- Electromagnetic compatibility testing (IEC 60601-1-2).
- Biocompatibility testing (ISO 10993).
Sample Size/Data Provenance/Experts/Adjudication/MRMC/Standalone Performance/Ground Truth (for clinical data or AI): These details are not provided because the 510(k) submission primarily relies on demonstrating that the modified device's technological characteristics and intended use are substantially equivalent to a cleared predicate, and that it conforms to relevant engineering and safety standards. It does not describe a clinical performance study using patient data and expert review.

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K Number

K172193

Device Name

Manufacturer

Date Cleared

2018-01-09

(172 days)

Product Code

GEX,ILY

Regulation Number

Type

Panel

Reference & Predicate Devices

K050779,K140009,K170626

Intended Use

Intended Use: The device is intended for use in dermatologic and general surgical procedures.
Indications for Use:
The Soprano trio Diode Laser Module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio Diode Laser Module include:

Benign vascular and vascular dependent lesions removal.
The indications for use for the Soprano1064nm Diode Laser Module include:
The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
Treatment of Pseudo folliculitis Barbae (PFB)
Use on all skin types (Fitzpatrick I-VI), including tanned skin.
The indications for use for the 810nm Modified Diode Laser Module 1.2 cm' include:
. The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
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 cm include:
The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)
The indications for use for the 755nm Diode Laser Module include:
The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
The treatment of benign vascular and pigmented lesions.(The Laser Blanch Mode)
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,
. 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 minor muscular back pain.

Device Description

The subject device, Alma Lasers Soprano Trio Diode Laser Module is an additional hand piece intended to be used with previously cleared Soprano platforms. Consistent with the previous clearance the system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas, and its major components are still the main console unit, foot switch, and individual modules. No change has been made to the main console unit except for incorporation of the software needed to run the new module and adding a new device name (Soprano 100 Platinum) to the Soprano family name for marketing purposes. The footswitch and pre-existing modules are also unmodified from those cleared in K140009 and K170626.
The module's operation involves emission of laser (diode) energy through the hand piece to the patient's skin. The materials that could contact the patient during device use are as cleared in the predicate. The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, which is primarily a regulatory submission to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study designed to prove acceptance criteria in the typical sense of a clinical trial for a novel device. Therefore, much of the requested information (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, specific ground truth for training data) is not applicable or not provided in this type of regulatory document.

However, I can extract the relevant information regarding performance testing and the conclusion of safety and effectiveness.

Acceptance Criteria and Device Performance

The acceptance criteria here are implicitly tied to demonstrating substantial equivalence to predicate devices, ensuring that the modified device functions as intended and does not raise new safety or effectiveness concerns.

Acceptance Criteria (Implicit)	Reported Device Performance
Adherence to relevant medical electrical equipment and laser safety standards.	The device was tested and found to comply with:

IEC 60601-1 (General Requirements for safety)
IEC 60601-1-2 (General Requirements for basic safety and essential performance - EMC)
IEC 60601-2-22 (Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment)
IEC 60825-1 (Safety of laser products - Part 1: Equipment Classification, requirements and user's guide) |
| Software functions as intended and is validated. | Software verification and validation testing was performed. |
| Biocompatibility established for patient-contacting materials. | Biocompatibility was established, as the materials contacting the patient are the same as those cleared in the predicate device. |
| No new safety or effectiveness issues raised by the modification (combining wavelengths into a single handpiece). | Animal histology testing was performed comparing the histology of individual wavelengths to the histology of combined wavelengths over a range of energies. Testing showed no significant differences between the individual tissue effects and the combined wavelength tissue effects.
"In all instances, the Soprano Trio Diode Laser Module functioned as intended and the results observed were as expected." |
| Equivalence in safety and effectiveness to predicate devices. | The conclusion states: "The Soprano Trio Diode Laser Module is as safe and effective as the primary predicate [...] and reference predicate [...]. The proposed Trio diode laser module has similar intended use and indications, similar technological characteristics, and same principle of operation as its predicate device. Combining different wavelengths in one module does not alter the intended use of the device and does not affect its safety and effectiveness when used as labeled. Thus, the Soprano Trio Diode Laser Module is substantially equivalent." No clinical studies were deemed needed due to similarities in safety and effectiveness profiles with predicate devices. |

Detailed Study Information (as applicable to this 510(k) submission):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No specific "test set" in the context of clinical data for algorithmic performance is mentioned. The performance testing described includes adherence to international standards and animal histology.
- For animal histology, the sample size is not specified, nor is the country of origin or whether it was retrospective/prospective. The text only states "animal histology testing was performed".
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. The ground truth for device performance here is based on compliance with engineering standards and direct observation of tissue effects in animal models by the manufacturer or testing facility, not expert consensus on diagnostic interpretations.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No diagnostic interpretation or human reader-based assessment requiring adjudication is described.
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 device is a laser surgical instrument, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device, not a standalone algorithm. Its performance is assessed through compliance with standards and tissue effects, not an algorithmic output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the animal histology study, the "ground truth" would be the observed histological changes and tissue effects, likely evaluated by a histopathologist, although this is not explicitly stated. The comparison was to the effects of individual wavelengths.
- For compliance with standards, the ground truth is the engineering specifications and safety requirements defined by the standards themselves.
The sample size for the training set:
- Not applicable. No machine learning training set is mentioned as this is a laser device.
How the ground truth for the training set was established:
- Not applicable.

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K Number

K171242

Device Name

Alma LipoFlow System

Manufacturer

Date Cleared

2017-07-14

(78 days)

Product Code

MUU

Regulation Number

878.5040

Type

Panel