Search Results

The Omnimax Device Series along with its optional Handpieces, uses IPL, IR, Laser and RF technologies and is intended for use in aesthetic and cosmetic applications and in selective treatments in medical specialties of dermatology, through the transmission of energy to human skin.

Intense Pulsed Light (IPL-DPC) with 415 – 1200 mm wavelengths (with and without contact-cooling) handpieces are indicated for:

• Hair removal and Permanent Hair Reduction in all skin types (I-V) to the Fitzpatrick scale - Recommended wavelengths in the range of 635-950 nm or 580-950 nm. * Flow Mode is suitable for Fitzpatrick skin types I-VI. Recommended wavelength: 635nm-950mm.
• Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (1-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 580-950 mm.
• Treatment of Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 535-950 nm.
• Treatment of Benign Pigmented Epidermal, Cutaneous and Vascular Lesions including warts; scars and striae in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 535-680 nm & 860-1200mm.
• Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale – Recommended wavelength in the range of 415-950 nm.

Infrared (IR) with 850 - 1750 nm wavelengths (with contact cooling) handpieces is indicated for:

• Dermatologic Treatment such as, but not limited to: photocoagulation of soft tissue (Scars, Wrinkles, Rhytids and Periorbital Wrinkles).

Radio Frequency (RF) handpieces are indicated for:

• Treatment of mild to moderate facial wrinkles and rhytids for all skin types.

Nd: Y AG Laser 1064 nm Long Pulse (LP) handpiece is indicated for:

• Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles.
• Removal or lightening of unwanted hair.
• Treatment of pseudofolliculitis barbae (PFB).
• Benign vascular lesions such as, but not limited to treatment of: Port wine stains: Hemangiomas; Warts, Superficial and deep telangiectasias (venulectasias); Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas.
• Benign cutaneous lesions, such as, but not limited to: Warts; Scars; Striae; Psoriasis.
• Benign pigmented lesions such as, but not limited to: Lentigos (age spots); Solar lentigos (sun spots); Cafe-au-lat macules; Sebortheic; keratoses; Nevi and nevus of Ota, Chloasma; Verrucae; Skin tags; Plaques.
• Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment and for patients with lesions that have not responded to other laser treatments.
• The non-ablative treatment of facial wrinkles, such as, but not limited to: Periocular wrinkles.
• Laser skin resurfacing procedures for the treatment of: Acne scars; Wrinkles.
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
• Indicated for use on all skin types (Fitzpatrick I-VI).

Nd:YAG 1064 nm O-Switched Laser with optional 532 nm Frequency Doubler (FD) handpiece indicated for:

• The removal of black, blue or green tattoos (significant reduction in the intensity of black tattoos); * Tattoo removal: Light blue; Yellow; Red; Green. * Benign pigmented lesions, such as, but not limited to: Cafe-au-lat (macules); Lentigines (senile and solar); Freckles (ephelides); Chloasma; Nevus spillus, Nevus of Ota; Becker's Nevi.
• Other pigmented cutaneous lesions, such as, but not limited to: Verrucae; Skin tags; Keratoses; Plaques.

Er: YAG Laser 2940 nm Long Pulse (LP), with standard and scanner accessory tips handpiece is indicated for: * Use in soft tissue (skin, cutaneous tissue) for Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars).

The Omnimax Device Series, which includes the Omnimax S3 and S4 devices, is a multiapplication, multi-technology platform designed for skin treatments and various aesthetic and dermatological applications. This is achieved by applying light energy (IPL, IR, and Laser) and Radio Frequency (RF) to the human skin. Each device in the series features the following technologies:

The Omnimax S4 incorporates IPL-DPC, IR, RF, and Laser technologies. The Omnimax S3 incorporates IPL-DPC, IR, and RF technologies.

The Omnimax Device Series modification enhances capabilities of the legally cleared Dermatological Treatment Device Family (K111303) by adding RF functionality with optional handpieces in addition to the previously cleared IPL, Laser and IR technology. The system consists of:

• a) Main unit (includes controller)
• b) Control Panel (UI)
• c) RF Module
• d) Display Unit
• e) Footswitch
• Trolley f)
• g) 14 Handpieces/applicators:
  • IPL-DPC 7 Handpieces ●
  • IR 2 Handpieces .
  • Laser 3 Handpieces ●
  • RF 2 Handpieces ●

The main unit is a platform system with embedded software, designed to support all treatment technologies and handpieces (i.e. IPL-DPC, IR, Laser and RF).

The provided text is a 510(k) summary for the Omnimax Device Series. This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting the results of a specific clinical study with predefined acceptance criteria for a novel AI device. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not available in this document.

However, I can extract and infer some information based on the provided text, particularly regarding the rationale for not conducting new clinical performance studies for certain aspects of the device.

Here's a summary of the available and inferred information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to existing predicate devices. The "performance" is considered equivalent if the technological characteristics (wavelengths, fluence/power, pulse width, spot size, repetition rate, target population, materials, coolant method, anatomical sites) are comparable to the predicate devices.

The table below summarizes the comparison of key technical characteristics, which serve as the basis for the equivalence claim:

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

No new clinical or performance test sets were explicitly detailed for the Omnimax Device Series to establish performance for this specific 510(k) submission. The regulatory strategy is based on demonstrating substantial equivalence to predicate devices, leveraging their established safety and efficacy profiles.

For the RF function, which is an added capability compared to one of its predicates, the document states: "the safety and efficacy of radiofrequency devices emitting energy with a frequency of 1 MHz and power of 50W is well established in scientific research and clinical studies. Multiple studies with these and similar systems have shown safety in dermatologic therapy and the devices were cleared by the FDA for therapy of wrinkles and rhytids." This indicates that the "test data" for the RF component is derived from existing scientific literature and previous FDA clearances for similar devices, rather than a new study specific to Omnimax. This is an indirect, retrospective approach drawing from existing public domain and regulatory data.

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

Not applicable in the context of this 510(k) submission as no new, primary clinical test set with ground truth established by experts was conducted for the Omnimax Device Series. The assessment hinges on the existing body of evidence supporting the predicate devices and general scientific knowledge for the added RF function.

4. Adjudication Method for the Test Set:

Not applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No. This document does not describe an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. The Omnimax Device Series is a physical medical device (laser/light/RF system), not an AI algorithm.

7. The Type of Ground Truth Used:

For the IPL, IR, and Laser technologies: The "ground truth" is effectively the established safety and efficacy of the predicate device (Dermatological Treatment Device Family K111303), supported by its prior FDA clearance based on its own clinical, performance, and safety data.

For the RF technology: The "ground truth" is a combination of:

• Literature-based evidence: "well established in scientific research and clinical studies."
• Regulatory history: "devices were cleared by the FDA for therapy of wrinkles and rhytids."
• Comparison to predicate: "power and frequency of the Omnimax Device Series are within the range of previously cleared values" from the Apollo System (K111026).

This relies on existing outcomes data and expert consensus over time, published in scientific literature and incorporated into previous regulatory clearances.

8. The Sample Size for the Training Set:

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

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

Not applicable.

Ask a specific question about this device

Rapid Family systems and optional Hand-Pieces are intended for use in aesthetic and cosmetic applications and in selective treatments required in the medical specialties of dermatology.

Rapid Family systems and optional Hand-pieces with 420 – 1200 nm wavelengths (with and without contact-cooling) are indicated for:

• Hair removal and Permanent Hair Reduction in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelengths in the range of 635-950 nm, 730-950 nm or 580-950 nm
• Treatment of Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 535-950 nm
• Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale – Recommended wavelength in the range of 420-950 nm
• Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 580-950 nm
• Treatment of Benign Pigmented Epidermal, Cutaneous and Vascular Lesions including warts; scars and striae in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 535-680 nm & 860-1200nm

Rapid Family systems and optional Infrared (IR) Hand Pieces with 850 - 1750 nm wavelengths (with contact cooling) are indicated for:

• Dermatologic Treatment such as, but not limited to: photocoagulation of soft tissue (Scars, Wrinkles, Rhytids and Periorbital Wrinkles)

Rapid Family systems and optional Nd: YAG Laser 1064 nm Long Pulse (LP) Hand-Pieces are indicated for:

• Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles.
• Removal or lightening of unwanted hair (with and without adjuvant preparation)
• Treatment of pseudofolliculitis barbae (PFB)

Rapid Family systems and optional Nd:YAG Laser 1064 nm Long Pulse (LP) and Q-Switched Hand-Pieces are indicated for:

• Benign vascular lesions such as, but not limited to treatment of: Port wine stains; Hemangiomas; Warts, Superficial and deep telangiectasias (venulectasias); Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas
• Benign cutaneous lesions, such as, but not limited to: Warts; Scars; Striae; Psoriasis
• Benign pigmented lesions such as, but not limited to: Lentigos (age spots); Solar lentigos (sun spots); Cafe-au-lait macules; Sebortheic; keratoses; Nevi and nevus of Ota, Chloasma; Verrucae; Skin tags; Keratoses; The removal of black, blue or green tattoos (significant reduction in the intensity of blue/black tattoos); Plaques
• Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment and for patients with lesions that have not responded to other laser treatments.
• The non-ablative treatment of facial wrinkles, such as, but not limited to: Periocular wrinkles

Rapid Family systems and optional Nd:YAG Laser 1064 nm Long Pulse (LP) and Q-Switched Hand-Pieces are indicated for:

• Laser skin resurfacing procedures for the treatment of: Acne scars; Wrinkles
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
• Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

Rapid Family systems and optional Nd: YAG Laser 532 nm Frequency Dabbler (FD) Long Pulse (LP) and O-Switched Hand-Pieces are indicated for:

• Tattoo removal: Light blue; Yellow; Red; Green
• Vascular lesions: Hemangiomas (Port wine stains/birthmarks, cavernous, cherry, spider); hemangiomas; Angiomas (cherry, spider); Telangiectasia; Spider nevi
• Benign pigmented lesions, such as, but not limited to: Cafe-au-lait (macules); Lentigines (senile and solar); Freckles (ephelides); Chloasma; Nevi; Nevus spillus, Nevus of Ota; Becker's Nevi;
• Other pigmented cutaneous lesions, such as, but not limited to: Verrucae; Skin tags; Plaques

Rapid Family systems and optional Er: Y AG Laser 2940 nm Long Pulse (LP) Hand-Pieces, with standard and scanner accessory tips are indicated for:
Use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands) such as, but not limited to:

• 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)

NOTE Permanent hair reduction is defined as the 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

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the "Rapid Family" device. This document primarily outlines the regulatory approval for the device and lists its Indications for Use. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information based on the input text. The document focuses on regulatory equivalence and intended uses rather than detailed performance study results.

Ask a specific question about this device

The Dermatological Treatment Systems device family and optional Hand Piece family are intended for use in aesthetic and cosmetic applications and in selective treatments required in the medical specialties of dermatology.

The DTS device family is indicated for dermatological treatments such as, but not limited to:

• Hair removal in all skin types to the Fitzpatrick scale. Permanent Hair Reduction.
• Treatment of Vascular Lesions
• Treatment of Inflammatory Acne (acne vulgaris)
• Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae.
• Treatment of Wrinkles, rhytids and Periorbital Wrinkles
• Skin resurfacing (Acne scars)
• Treatment of Tattoos
• Treatment of Leg and Facial Vein Removal
• Treatment of photocoagulation of soft tissue in dermatologic applications
• Resurfacing of the skin, and for the treatment of facial wrinkles.

The Dermatological Treatment device family and optional Hand pieces with 415 -1200 nm wavelengths (with and without contact-cooling) are indicated for:

• Hair removal and Permanent Hair Reduction in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelengths in the range of 635-950 nm, 730-950 nm or 580-950 nm
• Treatment of Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 535-950 nm
• Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 415-950 nm
• Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 580-950 nm
• Treatment of Benign Pigmented Epidermal, Cutaneous and Vascular Lesions including warts; scars and striae in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 535-680 nm & 860-1200nm

The Dermatological Treatment device family and optional Infrared (IR) Hand Pieces with 850 - 1750 nm wavelengths (with contact cooling) is indicated for:

• Dermatologic Treatment such as, but not limited to: photocoagulation of soft tissue (Scars, Wrinkles, Rhytids and Periorbital Wrinkles)

The Dermatological Treatment device family and optional Nd: YAG Laser 1064 nm Long Pulse (LP) Hand Pieces is indicated for:

• Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles.
• Removal or lightening of unwanted hair (with and without adjuvant preparation)
• Treatment of pseudofolliculitis barbae (PFB)

The Dermatological Treatment device family and optional Nd:YAG Laser 1064 nm Long Pulse (LP) and Q-Switched Hand Pieces is indicated for:

• Benign vascular lesions such as, but not limited to treatment of: Port wine stains; Hemangiomas; Warts, Superficial and deep telangiectasias (venulectasias); Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas
• Benign cutaneous lesions, such as, but not limited to: Warts; Scars; Striae; Psoriasis
• Benign pigmented lesions such as, but not limited to: Lentigos (age spots); Solar lentigos (sun spots); Cafe-au-lait macules; Seborrheic; keratoses; Nevi and nevus of Ota, Chloasma; Verrucae; Skin tags; Keratoses; The removal of black, blue or green tattoos (significant reduction in the intensity of black and /or blue/black tattoos); Plaques
• Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment and for patients with lesions that have not responded to other laser treatments.
• The non-ablative treatment of facial wrinkles, such as, but not limited to: Periocular wrinkles; Perioral wrinkles
• Laser skin resurfacing procedures for the treatment of: Acne scars; Wrinkles
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
• Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The Dermatological Treatment device family and optional Nd:YAG Laser 532 mm Frequency Dabbler (FD) Long Pulse (LP) and Q-Switched Hand Pieces is indicated for:

• Tattoo removal: Light blue; Yellow; Red; Green
• Vascular lesions: Hemangiomas (Port wine stains/birthmarks, cavernous, cherry, spider); hemangiomas; Angiomas (cherry, spider); Telangiectasia; Spider nevi
• Benign pigmented lesions, such as, but not limited to: Cafe-au-lait (macules); Lentigines (senile and solar); Freckles (ephelides); Chloasma; Nevi; Nevus spillus, Nevus of Ota: Becker's Nevi;
• Other pigmented cutaneous lesions, such as, but not limited to: Verrucae; Skin tags; Keratoses; Plaques

The Dermatological Treatment device family and optional Er:YAG Laser 2940 nm Long Pulse (LP) Hand Pieces, with standard and scanner accessory tips is indicated for:
Use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands) such as, but not limited to:

• Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars);

The Dermatologic Treatment Systems (DTS) device family and optional hand pieces, including Intensive Pulse Light (IPL) Infrared light (IR) and Laser light technologies for dermatological treatments by delivery of energy to the human skin. The device family is a modification to the BeaMax/ ForMax family (K082876), pulsed light energy device based on a filtered, Xenon flashlamp.

The DTS device family modification enhances capabilities of the legally cleared Beamax/ Formax device family by adding new hand pieces that are now supporting Laser and IR technologies as well as the IPL technology.

The Basic unit is a platform system, designed to support all treatment technologies hand pieces (i.e. IPL, IR and Laser).

The embedded software is the heart of the control system which provides a control of all of the parameters to the relevant hand piece, where the operator has the access to modify some parameters via the touch screen and every hand piece has its own operating screen.

The provided text is a 510(k) summary for a medical device (K111303). It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, a detailed study proving the device meets specific acceptance criteria, as requested in your prompt, is not present in this document.

This 510(k) summary focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing a performance study with defined acceptance criteria and statistical analysis. The "Safety & Effectiveness" section states that "Based on the performance results provided (including test results and clinical data) and the analysis of similarities and differences presented above, SharpLight Technologies Ltd. believes that the proposed device family safe & effectiveness is substantially equivalent to the predicate devices without raising new safety and/or effectiveness issues." This implies that the performance data exists elsewhere (likely in the full 510(k) submission not fully provided here), but the summary itself does not detail specific acceptance criteria or the study that demonstrates compliance.

Therefore, I cannot populate the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not included in the provided text.

The information that is available related to this device's performance claim is:

• Claim of Substantial Equivalence: The manufacturer asserts that the device is substantially equivalent to predicate devices based on similarities in intended use, indications, technology, performance, and specifications.
• Wider Indications: The device family has "wider indications for use," enhancing its capability compared to predicate devices that support only partial treatments.
• General Performance Statement: The statement "Based on the performance results provided (including test results and clinical data)" indicates that some form of performance evaluation was conducted and submitted as part of the full 510(k) application, but the specifics are not detailed in this summary.

Conclusion: The provided 510(k) summary (K111303) does not contain the detailed acceptance criteria and the comprehensive study information required to answer your specific questions. The document focuses on demonstrating substantial equivalence rather than presenting a performance study with explicit acceptance metrics.

Ask a specific question about this device

The BEAMAX/ FORMAX Pulsed Light Device Family and optional Handpies family are intended for use in aesthetic and cosmetic applications and in selective treatments required in the medical specialties of dermatology.

The BEAMAX/ FORMAX Pulsed Light Device Family and optional Handpies family with 415 - 950 nm wavelengths (with and without contact-cooling) are indicated for:

• Hair removal in all skin types (I-VI) to the Fitzpatrick scale. Permanent Hair Reduction. - Recommended wavelengths in the range of 635-950 nm or 580-950 nm
• Treatment of Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale -Recommended wavelength in the range of 535-950 nm
• Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 535-950 nm
• Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 415-950 nm

The proposed BEAMAX/ FORMAX family system is a pulsed light energy device based on a filtered, Xenon flashlamp.

The total emission spectrum of a Xenon flashlamp is from around 300 nm in the UV to 1000 nm in the near IR. The light emitted from the lamp is collected by a reflector and focused into a rectangular, waveguide. Prior to entering the waveguide, the light is transmitted through a longpass optical filter which blocks all wavelengths below the "cut-off" wavelength of the filter. Thus when a 635nm filter is used, only light of wavelengths above 635 nm is emitted. Since the lamp is surrounded by a water cooling jacket, actual wavelength emission is up to about 950 nm, due to water absorption of longer wavelengths.

The BEAMAX/FORMAX family system is equipped with four different handpieces which can be attached for different clinical applications. These handpieces differ in the optical filter applied, hence in the optical spectrum emitted, as well as in the time duration of the pulses emitted. A microprocessor based system controller is used to monitor and direct all system functions and Man Machine Interface.

The provided document is a 510(k) summary for the BEAMAX/ FORMAX Pulsed Light Device Family. This document focuses on demonstrating substantial equivalence to predicate devices rather than conducting a new clinical study to establish acceptance criteria and device performance from scratch. Therefore, many of the typical elements of a study that prove a device meets acceptance criteria are not present.

However, based on the information provided, here's an attempt to answer the request by interpreting "acceptance criteria" as the criteria for substantial equivalence, and "study" as the comparison to predicate devices:

Acceptance Criteria and Device Performance Study for BEAMAX/FORMAX Pulsed Light Device Family

Overview

The BEAMAX/FORMAX Pulsed Light Device Family sought 510(k) clearance by demonstrating substantial equivalence to legally marketed predicate devices, as opposed to conducting a de novo clinical trial with new performance acceptance criteria. The "acceptance criteria" here therefore refer to the criteria for substantial equivalence, and the "reported device performance" is framed by its similarity to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a substantial equivalence submission, the "acceptance criteria" are the conditions under which the device is considered substantially equivalent to already cleared devices. The "reported device performance" is essentially that it matches or is comparable to these predicate devices for the specified indications.

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

• Sample Size for Test Set: Not applicable in the context of a 510(k) substantial equivalence submission, as direct human clinical outcome data from a "test set" for the new device is not provided. The "test" here is the comparison against the characteristics and established safety/effectiveness of predicate devices already on the market.
• Data Provenance: The "data" for comparison comes from the regulatory filings and established performance of the identified predicate devices, which are already marketed in the US. There is no mention of country of origin for new clinical data, nor is there a distinction between retrospective or prospective data for a newly conducted study for this submission.

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

• Number of Experts: Not applicable. Ground truth, in the context of a 510(k) for substantial equivalence, is established by the FDA's prior clearance of the predicate devices based on their safety and effectiveness. No new expert consensus panel was convened for this specific submission to establish a "ground truth" for a new test set.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Since there's no new test set with human subject data requiring expert review and adjudication for this submission, no adjudication method like 2+1 or 3+1 was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The documentation focuses on technological and indications-for-use equivalence rather than human reader performance with or without AI assistance. The device is a pulsed light system, not an AI diagnostic tool that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable. This device is an energy-based medical device (pulsed light system), not an algorithm or AI system. Its performance is inherent in its physical operation and energy delivery for therapeutic purposes.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The new device's characteristics, intended use, and indications are compared against these established "truths" to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.

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

• How Ground Truth for Training Set Was Established: Not applicable. As there is no training set for an AI/ML algorithm for this device, there is no ground truth established for such a set.

Ask a specific question about this device