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The Profound Matrix System is intended for dermatological procedures, as follows:

The Matrix Pro applicator is indicated for general dermatological procedures for electrocoagulation and hemostasis. The Matrix Pro applicator is indicated for the percutaneous treatment of facial wrinkles in patients with Fitzpatrick Skin Types I-IV.

The Sublative RF applicator is indicated for dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. At higher energy levels greater than 62mJ/pin, the Sublative RF applicator is limited to Fitzpatrick Skin Types I-IV.

The Sublime applicator is indicated for non-invasive wrinkle treatment. At higher energy levels, greater than 100 J/cm³, the Sublime applicator is limited to Fitzpatrick Skin Types I-IV.

Profound Matrix is a system that combines three existing technologies and applications for dermatological procedures. Each respective technology is used in one of the three applicators designed for the Profound Matrix System. These three applicators are named: Matrix Pro, Sublative RF and Sublime.

The system console consists of a CPU, power supply, RF pulse generator, I/O board, splitter/distribution board and footswitch board. When the system is powered up, the user can select between user mode and service/maintenance mode. After selecting user mode and entering the required password, the user is requested to choose between the Matrix Pro, the Sublative RF or the Sublime applicators. Only one applicator can be used to treat a patient at any given time.

The user interfaces with the Profound Matrix System and applicators' settings through the 15″ touch screen. Each of the applicators have a finger trigger that can be used to activate the applicator or alternatively the end user can use the footswitch to activate the applicator.

Matrix Pro: The Matrix Pro applicator is designed to deliver bipolar, non-ablative radiofrequency energy through a 7x7 matrix/grid of sterile microneedles to the skin in a fractional manner. The microneedles can be set up to pulse up to a maximum of three depths during each insertion of the matrix/grid of microneedles with a maximum depth of up to 3.5mm. The Matrix Pro applicator delivers the right amount of energy at the precise depth, every time. The technology of the Matrix Pro applicator combines adjustable depth, energy, and real time impedance monitoring for customizable and consistent results. The Profound Matrix system monitors tissue impedance across the 3 modalities, in real-time, while simultaneously adjusting RF energy pulse duration and power output. The result is an accurate dose of RF energy delivery with every treatment application for consistent treatment outcomes, independent of patient-to-patient, body location, skin hydration, and procedural-related impedance variations.

Sublative RF: The Sublative RF applicator delivers bipolar radiofrequency (RF) to the skin surface in a fractional manner via an array of multi-electrode pin tips, which results in heating of both the demarcated spots to temperatures that ablate and resurface at contact points of the multi-electrode pins while also delivering heat in a wide diffuse manner to the dermis.

Sublime: The Sublime applicator uses a combination of an infrared (IR) light source and bipolar radiofrequency (RF) to bulk heat the dermis and affect dermal collagen in order to treat wrinkles. The bulk heating of the dermal layers refers to the gradual and gentle accumulation of heat with each additional pass performed.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Profound Matrix System with the Matrix Pro Applicator.

Context: The Candela Corporation sought clearance for a new indication for their Profound Matrix System (specifically the Matrix Pro applicator) – the percutaneous treatment of facial wrinkles in patients with Fitzpatrick Skin Types I-IV. This new indication builds upon existing clearances for general dermatological procedures and electrocoagulation/hemostasis for the Matrix Pro, and similar wrinkle treatment indications for other applicators within the Profound Matrix system (Sublative RF and Sublime) and a predicate device (Lutronic Infini).

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the new wrinkle treatment indication was the successful identification of post-treatment photographs by a majority of blinded evaluators, indicating an improvement in wrinkle appearance.

Additional Efficacy & Safety Metrics (Supporting Data, not explicit acceptance criteria but demonstrating effectiveness and favorable risk-benefit profile):

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Vbeam Prima is indicated for the following:
595 nm

• General Surgery:
• Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.
• Dermatology/Plastic Surgery:
  o For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars. striae and Psoriasis and the treatment of wrinkles.
• Treatment of Benign Epidermal Pigmented Lesions.
• Treatment of Inflammatory Acne Vulgaris.
• Gynecology:
  o Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.
• Podiatry:
  o Treatment of benign cutaneous lesions, such as warts.
• Pediatric Population
  o Treatment of cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas

1064 nm
The Vbeam Prima laser system is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, Venus lakes, leg veins, and poikiloderma of Civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), café-au-lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, and keratoses. The laser is also indicated for the treatment of wrinkles such as, but not limited to, peri-ocular and peri-oral wrinkles.

Vbeam Perfecta is indicated for the following:
595 nm

• General Surgery:
• Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.
• Dermatology/Plastic Surgery:
  o For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and Psoriasis and the treatment of wrinkles.
• Treatment of Benign Epidermal Pigmented Lesions.
• Treatment of Inflammatory Acne Vulgaris.
• Gynecology:
  o Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.
• Podiatry:
  o Treatment of benign cutaneous lesions, such as warts.
• Pediatric Population
  Treatment of cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas

The Candela Vbeam Family of Pulsed Dye Lasers includes both the Vbeam Prima and Vbeam Perfecta Laser Systems.
The Vbeam Prima Laser System has been previously cleared for both port wine stains, and hemangiomas under K183452.
The Vbeam Perfecta (Candela Family of Pulse Laser Systems) has been previously cleared for both port wine stains, and hemangiomas under K050673.
This 510(k) Premarket Notification is to expand the indications for use for the Candela Vbeam Family of Pulsed Dye Lasers for the Vbeam Prima Laser System and Vbeam Perfecta to include the pediatric population for treatment of cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas for the 595 nm wavelength. There is no new technology being introduced than what has been previously cleared Vbeam Prima Laser System under its predicate K183452 and Vbeam Perfecta under its predicate K050673.

The provided text from the FDA 510(k) summary (K230990 for Candela Vbeam Family of Pulsed Dye Lasers) does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. Instead, it details the substantial equivalence determination for an expanded indication (treatment of cutaneous capillary malformations and infantile/congenital hemangiomas in the pediatric population) for devices (Vbeam Prima and Vbeam Perfecta) that were previously cleared.

The 510(k) summary states that:

• There are no new technologies being introduced.
• The device is identical in design, function, and intended use to its previously cleared Vbeam Prima Laser System (K183452) and Vbeam Perfecta (K050673) predicates.
• The expanded indications do not raise any new concerns of safety or effectiveness.

Therefore, the performance data provided relies on:

1. Bench testing: "based on the established testing previously cleared under Vbeam Prima Laser System under its predicate K183452 and Vbeam Perfecta under its predicate K050673. There are no changes in the design therefore the subject Candela Vbeam of Pulsed Dye Lasers is based on the established performance testing of the device's predicates." This implies that prior acceptance criteria for the predicate devices are considered met for the new device due to identical design. No specific quantitative acceptance criteria or results from this bench testing are provided in the document.

2. Clinical Performance: A systematic literature search was conducted to support the expanded pediatric indications. This is not a direct study proving the device meets an acceptance criterion "for the device itself," but rather a review of existing clinical evidence to support the safety and effectiveness of the treatment method (Vbeam 595-nm PDL) for the expanded indications.

Given this, I cannot fill in a table of acceptance criteria and reported device performance directly from this document, as the document explicitly states there are no changes to the device itself and it relies on the predicate's established performance. The "performance data" presented for the new indication is effectively a literature review.

However, I can extract information related to the clinical literature review used to support the new indication:

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

• Acceptance Criteria for Device (Implied): The device (Vbeam Prima and Vbeam Perfecta) must perform identically to its predicate devices, as no design changes were made. The performance is assessed on the safety and effectiveness of the 595-nm PDL for the target conditions based on existing literature. No specific quantitative performance metrics (e.g., laser fluence accuracy, pulse stability) are provided in this summary for the "acceptance criteria" of the device itself for this 510(k) submission, as it relies on the prior clearance of the predicate.
• Reported Device Performance (from literature review): The studies reviewed "support the intended indications for use of the Vbeam 595-nm PDL to treat cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas in the pediatric population." Details on specific outcome measures (e.g., percentage improvement in lesion appearance, adverse event rates) from these studies are not summarized or quantified in this 510(k) document, only that the literature generally supports the use.

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

• Test Set (Literature Review): A total of 33 articles were identified.
  • Total Patients: 7,725
  • Pediatric Patients (Hemangioma): 5,692 (4,782 IH, 910 congenital)
  • Pediatric & Adult Patients (PWS/Capillary Malformation): 1,354 pediatric and 679 pediatric and adult.
• Data Provenance: The studies were conducted globally, specifically listed as from the USA, UK, Europe, and Asia (including China, Japan, Taiwan, India, and the Middle East). The studies included randomized controlled, prospective, open label, evaluator-blinded clinical trials, or retrospective evaluator-blinded studies. The data is retrospective in the sense that it relies on previously published research.

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

• This information is not provided in the 510(k) summary. The ground truth for the efficacy and safety of the treatment would have been established by the methods within each of the 33 individual published studies (e.g., clinical assessment by dermatologists, photographic evaluation, patient-reported outcomes). The 510(k) summary only reviews the conclusions of these studies.

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

• This information is not provided as it's a literature review, not a de novo clinical study with a central adjudication panel. Adjudication methods would vary by individual study.

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 MRMC study was performed or referenced in this document. This submission is for a laser device, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a laser device for treatment, not an algorithm.

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

• The ground truth for the effectiveness of the treatment, as drawn from the literature review, is based on clinical outcomes data reported in peer-reviewed articles. This would typically include assessments of lesion clearance/improvement, photographic documentation, and safety outcomes (adverse events). Specific types of ground truth would vary by individual study design (e.g., some studies might use standardized scales for improvement, others might rely on subjective expert assessment).

8. The sample size for the training set:

• Not applicable. This is a laser device, not a machine learning algorithm requiring a "training set." The clinical literature review serves as the evidentiary basis for the expanded indication.

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

• Not applicable. As above, no training set for a machine learning model is involved.

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The PicoWay laser system is indicated for the following at the specified wavelength:

• · 532 mm: Removal of tattoos for Fitzpatrick Skin Types I-III to treat the following tattoo colors: red, yellow and orange.
• · 730 nm: Removal of tattoos for Fitzpatrick Skin Types II-IV to treat the following tattoo colors: green and blue.
• · 785 mm: Removal of tattoos for Fitzpatrick Skin Types II-IV to treat the following tattoo colors: green and blue.
  · 1064 nm: Removal of tattoos for all Fitzpatrick Skin Types to treat the following tattoo colors: black, brown, green, blue and purple.

The Pico Way laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V and for treatment of Melasma for Fitzpatrick Skin Types I-IV.

The Resolve handpieces (532 nm, and 1064 nm) are also indicated for the treatment of wrinkles in Fitzpatrick Skin Types I-IV.

The Resolve Fusion handpiece (532 nm) is indicated for benign pigmented for Fitzpatrick Skin Types I-IV.

The PicoWay laser system is indicated for the following at the specified wavelengths:

532 nm :

· Treatment of Melasma for Fitzpatrick Skin Types I-IV.

· Treatment of café au lait macules (CALMs) for Fitzpatrick Skin Types I-IV.

• · Treatment of Lentigines for Fitzpatrick Skin Types I-IV.
  730 nm:

· Treatment of Lentigines for Fitzpatrick Skin Types I-IV.

1064 nm:

• · Treatment of Melasma for Fitzpatrick Skin Types I-IV.
• · Treatment of Nevus of Ota for Fitzpatrick Skin Types III-IV.

The PicoWay Laser System is a solid-state laser capable of delivering energy at wavelengths of 1064 nm, 532 nm, or 730 nm, at extremely short duration in the range of 240-500 (ps). The laser system contains one 755 nm (Alexandrite) laser head which is used to 'pump' (create) the 1064 / 532nm wavelengths. The outputs of the two lasers are optically combined on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 532nm or 1064nm wavelengths. The 532nm or 1064nm output energy is delivered to the skin through an Articulated Arm and Zoom Handpiece (HP) delivery system. There are also 3 hand pieces (Resolve), one for 1064nm and two for 532nm (low energy and high energy), which deliver a 10 x 10 array of focused spots to the skin and 1 Axicon hand piece (Resolve Fusion) for 532nm, which delivers a 10 x 10 array of focused and ring spots to the skin.

The provided document describes the Candela PicoWay Laser System (K220853) and its substantial equivalence to a predicate device (K191685). The primary difference is the addition of new indications for benign pigmented lesions. The document does not refer to the device as an "AI device" or an "algorithm," but rather a laser system. Therefore, some of the requested information regarding AI device testing (e.g., human-in-the-loop performance, effect size of human improvement with AI, training set details, expert qualifications for ground truth in a test set, adjudication methods) is not directly applicable.

However, based on the information provided, here's a summary of the acceptance criteria and the study that supports the expanded indications for the PicoWay Laser System, focusing on the clinical evidence for the new indications.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the expanded indications are implied by the clinical studies demonstrating the safety and effectiveness of the PicoWay Laser System for these conditions. The reported device performance is derived from the outcomes of these clinical studies.

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Nordlys system is intended to be used in dermatology as listed below:

Nordlys System + Intense pulse light applicators:

• Permanent Hair Reduction (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) (overall 600 - 950 nm).
• Treatment of Telangiectasias (530-750 nm or 555-950 nm)
• Treatment of Port Wine Stains (530-750 nm or 555-950 nm)
• Treatment of Benign Pigmented Lesions (eg Mottled Pigmentation. Ephelides) and Benign Vascular Lesions (ex Diffiuse Redness) (530-750 nm or 555-950 nm)
• Treatment of Rosacea (530-750 nm or 555-950 nm)
• Treatment of Poikiloderma of Civatte (530-750 nm or 555-950 nm)
• Treatment of Benign Epidermal Pigmented Lesions (eg Solar Lentigines ) (400-720 nm)
• Treatment of Inflammatory Acne Vulgaris (530-750 nm)

Nordlys System + Nd: Y AG Laser (1064 nm):
*Treatment of Leg Vessels (0.1-3.0 mm diameter).

• Treatment of Benign Vascular Lesions.
• Treatment of Venous Lakes.
• Treatment of Port Wine Stains.
• Treatment for Clear Nail defined as: Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
• Treatment of benign cutaneous lesions, such as warts.
  Podiatry (ablation, vaporization, incision, and coagulation of soft tissue), including:

• Matrixectomy
• Periungal and subungal warts
• Plantar warts.

Nordlys System + Frax 1940 Laser (1940 nm):

• The Frax 1940 is indicated for use in dermatological procedures requiring the coagulation of soft tissue and for skin resurfacing procedures.
  Frax 1940 is indicated for treatment of benign pigmented lesions, such as but not limited to lentigines (age spots), solar lentigines (sunspots), and ephelides (freckles) for Fitzpatrick Skin Types I-IV.

Nordlys System + Frax 1550 Laser (1550 nm):

• The Frax 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

Frax Pro system (Y dun) is intended to be used in dermatology, as listed below:

Frax Pro System + Frax 1940 (1940 nm)
*The Frax 1940nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.
Frax 1940 is indicated for treatment of benign pigmented lesions, such as but not limited to lentigines (age spots), solar lentigines (sunspots), and ephelides (freckles) for Fitzpatrick Skin Types I-IV.

Frax Pro System + Frax 1550 (1550 nm)
*The Frax 1550nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

The Frax 1940 applicator is used with the Nordlys and Frax Pro system (previous called Ydun).

The Nordlys and Frax Pro systems consist of a console containing power unit and control electronics with control and display panel, including software. The Frax 1940 applicator connects to the systems and has built in Laser diodes emitting 1940 nm light in a fractional pattern.

This document describes a 510(k) premarket notification for a medical device called "Frax 1940 for Nordlys and Frax Pro Systems." This device is a laser system intended for dermatological procedures.

However, the provided document DOES NOT contain the specific information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it does not include:

1. A table of acceptance criteria and reported device performance: This document only states that "results of the clinical studies demonstrated favorable safety and effectiveness profile," but no specific metrics or comparison to acceptance criteria are provided.
2. Sample sizes used for the test set and data provenance: No details about the number of subjects in the clinical studies, their demographics, or where the data was collected are given.
3. Number of experts used to establish ground truth and qualifications: The document mentions "clinical studies" but not how ground truth was established, or the qualifications of any experts involved in that process.
4. Adjudication method for the test set: Not mentioned.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: This is not a study type relevant to this type of laser device (which treats skin directly) and is typically used for diagnostic or imaging AI.
6. Standalone (algorithm only) performance: Not applicable as this is a physical laser device, not an AI algorithm.
7. Type of ground truth used: Not specified, beyond "effectiveness profile" for "benign pigmented lesions removal."
8. Sample size for the training set: Not applicable, as this is a physical device, not an AI algorithm requiring a training set in the typical sense. The "clinical studies" mentioned are for validation/testing, not training.
9. How the ground truth for the training set was established: Not applicable.

What the document does state about "performance data" (Section 9):

• Performance Standards: The device has been tested according to and complies with several IEC and EN standards related to medical electrical equipment and laser safety:
  • IEC 60601-1 (General requirements for basic safety and essential performance)
  • IEC 60601-1-2 (Electromagnetic Disturbances)
  • EN 60825-1 (Safety of laser products Equipment classification and requirements)
  • IEC 60601-2-22 (Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment)
• Clinical Testing: "Two clinical studies were conducted on the Frax 1940 to support the new indications of benign pigmented lesions."
• Clinical Study Results: "The results of the clinical studies demonstrated favorable safety and effectiveness profile for the Frax 1940 nm laser system for the indicated use for benign pigmented lesions removal after 1-3 treatment sessions."

In summary, this document confirms that clinical studies were performed to demonstrate safety and effectiveness for the stated indications. However, it does not provide the detailed methodology or quantitative results of these studies, which would be necessary to answer the specific questions about acceptance criteria and how they were met.

To provide the information you requested, you would typically need access to the full 510(k) submission, specifically the sections detailing the clinical study protocols and results, which are often redacted or not publicly available in the FDA 510(k) summary.

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The PROFOUND MATRIX SYSTEM is intended for dermatological procedures, as follows:

The MATRIX PRO applicator is indicated for general dermatological procedures for electrocoagulation and hemostasis.

The SUBLATIVE RF applicator is indicated for dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. At higher energy levels greater than 62mJ/pin, the Sublative RF applicator is limited to Fitzpatrick Skin Types I-IV.

The SUBLIME applicator is indicated for non-invasive wrinkle treatment. At higher energy levels, greater than 100 J/ cm3, the Sublime applicator is limited to Fitzpatrick Skin Types I-IV.

The Profound Matrix System combines three existing technologies and applications for dermatological procedures. Each respective technology is used in one of the three applicators designed for the Profound Matrix System. These three applicators are named: Matrix Pro, Sublative RF and Sublime.

The Matrix Pro applicator is designed to deliver bipolar, non-ablative radiofrequency energy through a 7x7 matrix/grid of sterile microneedles to the skin in a fractional manner. The microneedles can be set up to pulse a maximum of three depths during each insertion of the matrix/grid of microneedles with a maximum depth of up to 3.5mm.

The Sublative RF applicator delivers bipolar radiofrequency (RF) to the skin surface viaan array of multi-electrode pin tips. The applicator delivers bipolar RF energy to the skin, which results in heating of demarcated spots to temperatures that ablate and resurface at contact points of the multi-electrode pins.

The Sublime applicator uses a combination of an infrared (IR) light source and bipolar radiofrequency (RF) to bulk heat the dermis and affect dermal collagen in order to treat wrinkles. The bulk heating of the dermal layers refers to the gradual and gentle accumulation of heat with each additional pass performed.

Here's a breakdown of the acceptance criteria and study information for the Profound Matrix device, based on the provided text:

Important Note: The provided document is a 510(k) Summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results for a novel device. As such, information regarding acceptance criteria for a new clinical performance study, multi-reader multi-case studies, and detailed ground truth establishment for a training set are largely not applicable or not provided in this context. The document explicitly states that "no clinical or animal studies were needed to support this 510(k) Premarket Notification."

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" for a new clinical performance study with specific metrics like sensitivity or specificity. Instead, the "acceptance criteria" are implied by demonstrating that the device's technical characteristics and performance are comparable to the legally marketed predicate device, and it meets relevant safety and performance standards.

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

• Test Set Sample Size:
  • For the Ex-Vivo Thermal Damage Evaluation, the sample size was not explicitly specified numerically, but it involved "excised abdominal skin tissue." The samples were treated with "four RF energy levels (1), 2J, 3J and 4J) and included three treatment depths using two depth configurations (dense and spread)."
  • For other bench tests (electrical safety, EMC, software, etc.), the "sample size" refers to the device units tested, which is typically a smaller number to demonstrate compliance with engineering standards.
  • No clinical test set was required or used for this 510(k) submission.
• Data Provenance:
  • Ex-Vivo Thermal Damage Evaluation: The tissue was "ex-vivo, excised abdominal skin tissue." The country of origin is not specified, but it was likely laboratory bench testing.
  • For other tests like electrical safety, EMC, and software, the data provenance would be internal laboratory testing by Candela Corporation.
  • Retrospective or Prospective: All testing described is prospective bench testing.

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

• Not Applicable / Not Provided in this context. Since no clinical studies were performed, there was no need for experts to establish ground truth on patient data. The "ground truth" for the ex-vivo thermal damage evaluation would be the observed histological changes, interpreted by the researchers conducting the bench test.

4. Adjudication Method for the Test Set

• Not Applicable / Not Provided in this context. As there were no clinical studies and no expert interpretation of patient data for performance metrics, no adjudication method was mentioned.

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

• No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The 510(k) summary explicitly states, "Based on the similarities of the device specifications, intended use, indications for use between the Profound Matrix and its predicate device, no clinical or animal studies were needed to support this 510(k) Premarket Notification."

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

• Yes, in the context of device function. The "performance" described pertains to the standalone device functionality and its components (applicators, software, electrical systems) rather than an AI algorithm. The Ex-Vivo Thermal Damage Evaluation and other bench tests evaluate the device's inherent performance. There is no mention of an AI algorithm in the traditional sense (e.g., for diagnosis or prediction) and therefore no standalone algorithm performance in that context.

7. The Type of Ground Truth Used

• For Ex-Vivo Thermal Damage Evaluation: Histological observation of "collagen denaturation consistent with tissue heating" and "voids consistent with broken fat cells membranes and a surrounding layer of compressed fat cells" were the "ground truth" for evaluating the thermal effects. This is a type of laboratory/experimental observation.
• For other bench tests: The "ground truth" is adherence to established engineering and safety standards (e.g., electrical parameters, software functionality).

8. The Sample Size for the Training Set

• Not Applicable. As no clinical or animal studies were performed and no machine learning algorithm for diagnostic or predictive purposes was described, there was no training set in the typical sense for a medical AI device. The device's "training" would be its design and engineering based on existing knowledge and predicate devices.

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

• Not Applicable. See point 8.

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755mm: Temporary hair reduction. Stable long-term or permanent reduction targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas).

1064nm: Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment hair reduction is defined as the long-term. stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for pigmented 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. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles. Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)

The GentleMax Pro Plus contains two separate laser heads (Alexandrite and Nd:YAG), which produce laser light outputs of 755 nm and 1064 nm, respectively. The output of each laser head is optically combined on the laser rail, so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either 755 nm or 1064 nm wavelengths. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat. The Dynamic Cooling Device (DCD) protects the upper layers of the skin with a cooling burst of cryogen.

This document is a 510(k) premarket notification for the Candela GentleMax Pro Plus laser system, which is a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies. As such, the information you're asking for, particularly regarding acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/algorithm-driven medical device, is not directly applicable to this submission.

This document pertains to a laser surgical instrument, not an AI or algorithm-based diagnostic/therapeutic device. Therefore, the concepts of "test set," "ground truth," "expert consensus," "MRMC studies," and "standalone performance" as they relate to AI model validation are not present here.

However, I can extract the relevant information about how this device's performance and safety were evaluated to demonstrate substantial equivalence.

Here's an analysis based on the provided text, addressing your points where applicable and explaining why others are not relevant:

Device Type: Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology (Product Code GEX). This is NOT an AI/algorithm-driven device requiring traditional AI model performance evaluation.

Acceptance Criteria and Reported Device Performance (as relevant for a laser system):

The "acceptance criteria" for this device are primarily based on demonstrating substantial equivalence to a predicate device (Candela GentleMAX Family of Lasers System, K140122) in terms of design, technological characteristics, intended use, and indications for use. The performance data provided are therefore related to safety and functional equivalency.

• Wavelengths (755 nm & 1064 nm)
• Laser Medium (Flashlamp-excited, Solid state Alexandrite and Nd:YAG laser)
• Aiming Beam (Green diode laser)
• Maximum Fluence (400 J/cm2 (ALEX), 520 J/cm2 (YAG))
• Accuracy of Output (± 20%)
• Operating Modes (Pulse)
• Energy Delivery (Footswitch & finger switch)
• Beam Delivery (Lens-coupled optical fiber)
• Skin Cooling (Cryogen DCD)
• System Cooling (Ambient Air)
• Software/GUI/Touch Screen (Yes)
• Dimensions & Weight
• Power Supply

Minor Differences (not raising new safety/effectiveness questions):

• Maximum Energy (J): Modified: 68 J ALEX; 90 J Nd:YAG (Predicate: 53 J ALEX; 80 J Nd:YAG). This indicates increased power.
• Spot Size (mm): Modified: 1.5, 3, 3x10, 5, 6, 8, 10, 12, 15, 18, 20, 22, 24, 26 (Predicate: 1.5, 3, 3x10, 5, 6, 8, 10, 12, 15, 18). New, larger spot sizes added.
• Repetition Rate (Hz): Modified: 1-10 Hz (Predicate: 1-10 Hz). Text notes "faster repetition rate" but table shows same range. This likely refers to increased maximum repetition rate within the 1-10Hz range for specific parameters, not a change in the overall range.
• Pulse Duration (ms): Modified: 0.25 - 100 ms (new 2ms) (Predicate: 0.25 - 100 ms). This indicates the addition of a specific 2ms pulse setting option. |
  | Same Intended Use & Indications for Use | The Intended Use/Indications for Use Statement is unchanged from the predicate device (K140122). |
  | Compliance with Electrical Safety and EMC Standards | Complies with IEC 60825-1, IEC 60601-1-2, IEC 60601-1, IEC 60601-2-22. |
  | Biocompatibility | Established based on predicate devices and results of ISO 10993-5 and ISO 10993-10 series of testing (acceptable). |
  | Software Verification & Validation | Testing conducted and results were found acceptable for software release, performed per FDA's guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices". |

Since this is not an AI/algorithm-driven device, the following points are not applicable and are not discussed in the provided 510(k) summary:

• 2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" in the context of an AI model. Performance evaluation for this laser is primarily functional and safety testing.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No image-based "ground truth" or expert review process as would be needed for an AI diagnostic algorithm.
• 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 is not an AI-assisted device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable. There's no AI model involved that requires a "training set."
• 9. How the ground truth for the training set was established: Not applicable.

Summary of Device Evaluation for Substantial Equivalence:

The manufacturer asserted that the GentleMax Pro Plus is substantially equivalent to its predicate (Candela GentleMAX Family of Lasers System, K140122) because:

• It has the same intended use and indications for use.
• It shares similar design and technological characteristics. While some specifications like maximum energy, pulse duration (new 2ms option), and spot sizes (new larger ones) have changed, the manufacturer states these "minor differences do not raise any new types of safety or effectiveness questions because the GentleMax Pro Plus parameters are similar to the predicates."
• It meets all relevant electrical safety and electromagnetic compatibility standards (IEC 60825-1, IEC 60601-1-2, IEC 60601-1, IEC 60601-2-22).
• Its biocompatibility was established using existing predicate data and ISO 10993 testing.
• Its software underwent verification and validation testing in accordance with FDA guidance, with acceptable results.
• No clinical studies were needed to support this 510(k) due to the strong similarities in device specifications, intended use, and indications for use with the predicate device.

In essence, the "study that proves the device meets the acceptance criteria" for this 510(k) submission is the demonstration, through comparison to a predicate and adherence to relevant safety standards, that the new device is as safe and effective as a device already on the market. This is a common pathway for medical device clearances that are not introducing fundamentally new technologies or indications.

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The PicoWay laser system is indicated for the following at the specified wavelength:

532 nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

730 nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.

785 nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.

1064 nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.

The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.

The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.

The Resolve handpieces (532 nm HE, 532 nm, 1064 nm) are also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV

The Resolve Fusion handpiece (1064 nm) is indicated for the treatment of wrinkles as well as benign pigmented lessons in Fitzpatrick Skin Types I-IV

The Resolve Fusion handpiece (532 nm) is indicated for the treatment of benign pigmented lesions in Fitzpatrick Skin Types I-IV

The PicoWay System has been previously cleared (K170597, K162454, K160607, K150326, K142372 and K153527) for tattoo removal and treatment/removal of benign pigmented lesions as well as treatment of acne scars and wrinkles. There are minor modifications to the current system to add four (4) new handpieces, minor system specifications, and new wavelengths. The additional new handpieces will work in the same way as the currently cleared PicoWay handpieces as in they will operate in the same manner as the predicate devices.

The PicoWay Laser System is a solid-state laser capable of delivering energy at wavelengths of 1064 nm, 532 nm, 730 nm (new) or 785 nm at extremely short duration in the range of 240-500 ps. The laser system contains one 755 nm (Alexandrite) laser head which is used to 'pump' (create) the 1064 nm picosecond wavelength. The 1064 nm wavelength can be frequency-doubled to 532 nm as desired. The outputs of the two lasers are designed to be co-linear on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 532 nm or 1064 nm wavelengths. The current 785 nm and new 730 nm wavelength contain a Ti:Sapphire laser rod that is pumped with the 532 nm energy. All these energies are delivered through an articulated arm and corresponding handpiece. Currently there are two cleared Resolve handpieces (1064 nm and 532 nm), a 785 nm handpiece and a Zoom handpiece that works on two wavelengths (532 nm and 1064 nm).

The provided document is a 510(k) summary for the Candela PicoWay Laser System (K191685). It focuses on adding new handpieces and wavelengths to an already cleared device. This type of submission relies heavily on demonstrating substantial equivalence to a predicate device rather than presenting a de novo clinical study with specific acceptance criteria for a novel AI device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, as one would expect for an AI/ML medical device. Specifically, it lacks:

• A table of acceptance criteria and reported device performance for an AI/ML algorithm. The document primarily addresses the safety and performance of laser hardware.
• Sample size and data provenance for a test set to evaluate an AI/ML algorithm.
• Details on experts used to establish ground truth or adjudication methods for an AI/ML test set.
• Information on MRMC comparative effectiveness studies or standalone AI performance.
• Details on training set sample size or ground truth establishment for an AI/ML algorithm.

The document primarily discusses:

• Device Description: The PicoWay Laser System and the new handpieces/wavelengths.
• Technological Characteristics: Highlighting their similarity to the predicate device.
• Performance Data (for hardware safety and function):
  • Electrical Safety and Electromagnetic Compatibility
  • Biocompatibility
  • Software (V&V for updated functionality, not an AI algorithm)
  • Bench Testing (for hardware specifications)
  • Ship Testing (for packaging integrity)
• Clinical Data: Explicitly states, "The PicoWay Laser System did not require clinical performance data." This further confirms the absence of clinical studies evaluating performance against acceptance criteria for an AI solution.

In summary, the provided text describes a submission for a laser system where the substantial equivalence argument is based on hardware modifications and engineering verification/validation, not on the performance of a new AI algorithm against pre-defined clinical acceptance criteria.

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1,064nm:

The Vbeam® Prima Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus, spider veins, and poikiloderma of civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), cafe au lait manules, sebortheic keratoses, nevi, chloasma, verrucea, skin tags, and keratoses. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

595 nm:

General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.

Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangioma, spider angioma, poikiloderma of civatte, and benign cutaneous lesions, such as warts, scars, striae, psoriasis and the treatment of benign epidermal pigmented lesions. Treatment of inflammatory acne vulgaris.

Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.

Podiatry: Treatment of benign cutaneous lesions, such as warts.

The Vbeam Prima Laser system is designed as a transportable device that delivers laser energy at wavelengths of 595 nm (pulse-dye) or 1064 nm (Nd: YAG). The device is comprised of a main console, power supply, controlled electronics, firmware, software, cooling system, and handpieces. There is also an internal calibration port with an internal meter located in the system. The handpiece offers a set of distance gauges available in the following spot ranges: 3-7 mm, 11-15 mm, and 3 X 10 mm. The user selects treatment settings, such as fluence, number of pulses, and spot size selection via a color touch screen. The handpiece incorporates a Dynamic Cooling Device (DCD) into its handpiece that is designed to cool the skin surface during treatment, which consists of an electrically controlled spray nozzle, cryogen reservoir canister and an electronic control circuitry. The Vbeam Prima Laser System also offers an optional EverCool Delivery System Handpiece for skin cooling during treatment.

The Vbeam Prima Laser System (K183452) is a laser surgical instrument. As stated in section 9, "no clinical studies were needed to support this 510(k) Premarket Notification." Therefore, no specific acceptance criteria or "study that proves the device meets the acceptance criteria" in terms of clinical performance are provided in the document.

The document focuses on demonstrating substantial equivalence to predicate devices (Candela Vbeam Prima Laser System (K180593) and Candela GentleMAX Family of Pulse Dye Laser Systems (K140122)) through non-clinical performance data.

Here's a breakdown of the information requested, based on the provided text:

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

Since no clinical acceptance criteria or performance metrics were reported for this specific 510(k), this table cannot be populated as requested. The document emphasizes equivalence to predicate devices based on:

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, as no clinical human subject test set was used for this 510(k) submission. Performance data primarily comes from engineering and software testing.

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 clinical human subject test set requiring expert ground truth assessment was conducted.

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

Not applicable, as no clinical human subject test set was conducted.

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, as the device is a laser system, not an AI diagnostic tool, and no clinical studies, including MRMC studies, were performed for this submission.

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

Not applicable, as the device is a laser system, not an algorithm.

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

Not applicable, as no clinical studies with a defined ground truth were provided in this 510(k). The "ground truth" for the non-clinical performance data would be adherence to established engineering and software standards.

8. The sample size for the training set

Not applicable, as no machine learning algorithm was evaluated, and therefore no training set was used.

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

Not applicable, as no training set was used.

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The CO2RE is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee).

The CO-RE is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.

The Standard Handpiece of the CO2RE System is indicated for the following:

Dermatology & Plastic Surgery
The ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:

• laser skin resurfacing
• laser dermabrasion
• laser burn debridement.

Laser skin resurfacing (ablation and/or vaporization) for the treatment of:

• wrinkles, rhytids, and furrows (including fines lines and texture irregularities)
  Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen.

Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:

• keratoses, including actinic and sebortheic keratosis, sebortheic wart, and verruca sebortheica;
• 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 granuloma pyogenicum/granuloma telagiectaticum):
• tattoos;
• telangiectasia:
• removal of small skin tumors, including periungual (Koenen) and subungual fibromas;
• superficial pigmented lesions;
• adenosebaceous hypertrophy or sebaceous hyperplasia;
• rhinophyma reduction;
• cutaneous papilloma (skin tags);
• milia;
• debridement of eczematous or infected skin;
• basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions;
• nevi, including spider, epidermal and protruding;
• neurofibromas:
• laser de-epithelialization;
• tricoepitheliomas;
• xanthelasma palpebrarum;
• syringoma

Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy. Vaporization of:

• benign/malignant vascular/avascular skin lesions;
• Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual warts.

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:

• leukoplakia, including oral, larynx, uvula, palatal, upper latera pharyngeal tissue;
• nasal obstruction;
• adult and juvenile papillomatosis polyps;
• polypectomy of nose and nasal passages; lymphangioma removal;
• removal of recurrent papillomas in the oral cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords;
• superficial lesions of the ear, including chondrodermatitis nodularis chronica helices/Winkler's disease;
• rhinophyma;
• verrucae vulgares (warts);

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, vulvar, perineal, and Bowen's disease, (Erythroplasia of Quevrat) and Bowenoid papulosa (BP) lesions;
• leukoplakia (vulvar dystrophies);
• herpes vaporization;
• urethral caruncle vaporization;
• cervical dysplasia:
• benign and malignant tumors;

Dental/Oral Surgery
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:

• treatment of ulcerous lesions, including aphthous ulcers;
• excision and ablation of benign and malignant lesions;
• leukoplakia:

Genitourinary
Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:

• benign and malignant lesions of external genitalia;
• condyloma;
• erythroplasia

The Fractional Handpiece of the CO2RE System is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.

The Surgical Handpiece of the CO2RE System is indicated for the following:

Dermatology & Plastic Surgery
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:

• vermillionectomy of the lip;
• cutaneous horns;
• removal of small skin tumors, including periungual (Koenen) and subungual fibromas;
• rhinophyma reduction;
• basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions;
• neurofibromas;
  Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy. Vaporization/coagulation of:
• benign/malignant vascular/avascular skin lesions;
• Moh's Surgery;
• Lipectomy;
• Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual warts.

Laser incision and /or excision of soft tissue for the performance of upper and lower evelid blepharoplasty.

Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation.

Podiatry
Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of:

• verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts;
  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,
• nasal obstruction:
• adult and juvenile papillomatosis 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, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords;
• laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue;
• Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser-assisted esophagodivertuculostomy (ELAED)];
• stenosis, including subglottic stenosis;
• tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy;
• pulmonary bronchial and tracheal lesion removal;
• benign and malignant nodules, tumors and fibromas (larynx, trachea, tracheobronchial/endobronchial);
• benign and malignant lesions and fibromas (nose and nasal passages);
• benign and malignant tumors and fibromas (oral);
• stapedotomy/stapedectomy; acoustic neuroma in the ear;
• superficial lesions of the ear, including chondrodermatitis nodularis chronica helices/Winkler's disease:
• telangiectasia/hemangioma of larynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue);
• cordectomy, cordotomy (for the treatment of vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea;
• myringotomy/tympanostomy (tympanic membrane fenestration);
• uvulopalatoplasty (LAUP, laser UPPP);
• turbinectomy and turbinate reduction; 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, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions;
• incision and drainage (1&D) of Bartholin's and nubuthian cysts;
• benign and malignant tumors;
• hemangiomas.

GYN Laparoscopy
Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic surgery, including GYN laparoscopy, for treatment of:

• endometrial lesions, including ablation of endometriosis;
• excision/lysis of adhesions;
• salpingostomy
• oophorectomy/ovariectomy; fimbrioplasty;
• metroplasty:
• microsurgery (tubal);
• uterine myomas and fibroids;
• ovarian fibromas and follicle cysts;
• uterosacral ligament ablation;
• hysterectomy.

Neurosurgery
Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of: Cranial

• posterior fossa tumors;
• peripheral neurectomy;
• benign and malignant tumors and cysts (e.g. gliomas (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;
• chondromalacia:
• chondroplasty;
• ligament release (lateral and other);
• excision of plica;
• partial synovectomy.

General

• debridement of traumatic wounds;
• debridement of decubitus and diabetic ulcers;
• microsurgery:
• artificial joint revision;
• PMMA removal.

General/Thoracic Surgery
Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include:

• debridement of decubitus ulcers, stasis, diabetic and other ulcers;
• mastectomy;
• debridement of bums;
• rectal and anal hemorrhoidectomy;
• breast biopsy;
• reduction mammoplasty;
• cytoreduction for metastatic disease;
• laparotomy and laparoscopic applications;
• mediastinal and thoracic lesions and abnormalities;
• skin tag vaporization;
• atheroma;
• cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips;
• pilonidal cyst removal and repair;
• abscesses:
• other soft tissue applications.

Dental/Oral Surgery

• Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:
• gingivectomy- removal of hyperplasias;
• gingivoplasty:
• incisional and excisional biopsy;
• incision of infection when used with antibiotic therapy;
• frenectomy (frenum release);
• excision and ablation of benign and malignant lesions;
• homeostasis;
• operculectomy;
• crown lengthening;
• removal of soft tissue, cysts and tumors;
• oral cavity tumors and hemangiomas;
• abscesses;
• extraction site hemostasis;
• salivary gland pathologies;
• preprosthetic gum preparation;
• 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 CO₂RE System is a computer controlled radio-frequency (RF) excited carbon dioxide (CO2) laser system that delivers CO2 energy to the target treatment area at 10,600 nm. The CO2RE Laser System is comprised of multiple components, including the control unit and six handpieces. Laser is transmitted to the tissue via a series of lenses integrated into the articulated arm. The CO2 laser energy is absorbed by water in tissue to achieve its intended treatment effects.

Here's an analysis of the provided FDA 510(k) summary relating to the CO2RE Laser System, focusing on the requested acceptance criteria and study details.

Important Disclaimer: The provided document is a 510(k) Summary, not a full 510(k) submission. A 510(k) Summary focuses on demonstrating substantial equivalence to a predicate device, and often relies on existing knowledge of the technology rather than extensive novel clinical studies. Therefore, many of the requested details about acceptance criteria, human reader studies, and detailed ground truth establishment might not be explicitly present or required for a 510(k) submission for this type of device. The information provided below is extracted directly from the given text.

Acceptance Criteria and Device Performance for CO2RE Laser System (K181523)

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a "test set" in the context of typical AI/software performance validation involving patient data. For this laser device, the "testing" refers to engineering and quality assurance tests on the device itself.

• Sample Size: Not applicable in the traditional sense of a clinical test set for diagnostic accuracy. Testing was conducted on the device's components and system.
• Data Provenance: Not applicable. The "data" here refers to measurements from electrical safety, EMC, software, biocompatibility, and sterilization tests. These are internal lab tests, not patient data.

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

• Number of Experts: Not applicable. Ground truth, in the context of a medical laser device for surgical and dermatological procedures, typically relies on established medical knowledge, clinical outcomes, and the device's physical/electrical parameters meeting specified standards. It doesn't involve "experts" labeling a test set of images or patient data for an algorithm.
• Qualifications of Experts: Not applicable for the type of testing described.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The device's performance is demonstrated through adherence to engineering standards and technical specifications, not through a diagnostic assessment requiring expert adjudication of results.

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

• MRMC Study: No. This is a laser surgical instrument, not an AI-assisted diagnostic tool where human readers compare performance with and without AI. The submission focuses on demonstrating the device's technical specifications and safety/effectiveness equivalence to a predicate, not improving human reader performance.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This device is a directly operated laser system, not an artificial intelligence algorithm that operates independently or provides diagnostic output. It does not have an "algorithm only" mode in the sense of AI performance evaluation. The "software" mentioned refers to the operating software of the physical device.

7. The Type of Ground Truth Used

• Type of Ground Truth: For this type of device, "ground truth" is established by:
  • Engineering Specifications and Benchmarks: The device's output (e.g., laser power, wavelength, pulse duration) must meet design specifications.
  • Industry Consensus Standards: Compliance with recognized standards like IEC 60601-1 for electrical safety and electromagnetic compatibility.
  • Predicate Device Performance: The primary ground truth for a 510(k) is the demonstration of substantial equivalence to a legally marketed predicate device, implying that if the predicate is safe and effective, the new device with similar characteristics and performance also is.
  • Biocompatibility Data: Established guidelines for material safety.
  • Sterilization Validation: Demonstrated ability to be safely sterilized.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not use machine learning with a "training set" of data in the typical sense. Its functionality is based on established physical principles of laser operation.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no "training set" for an AI algorithm.

Summary of 510(k) Specifics for CO2RE Laser System:

This 510(k) submission for the CO2RE Laser System (K181523) is an example of a substantial equivalence determination for a medical device that is not an AI/ML-driven diagnostic or therapeutic tool. Its 'acceptance criteria' and 'study' are primarily centered around:

• Predicate Equivalence: Demonstrating that the new device has the same intended use and similar technological characteristics, indications, and principles of operation as a previously cleared device (K151655).
• Performance Testing: Laboratory and engineering tests to ensure the device meets declared technical specifications, electrical safety, EMC, biocompatibility, and sterilization requirements.
• Software Validation: Ensuring the embedded software controls the device appropriately and safely.

The framework for evaluating AI/ML devices with detailed criteria like MRMC studies, expert adjudication, and distinct training/test sets is not applicable to a device like the CO2RE Laser System.

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The PicoWay laser system is indicated for the following at the specified wavelength:

532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

785nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.

1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.

The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.

The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.

The Resolve handpieces are also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.

The PicoWay Laser System is a solid state laser capable of delivering energy at wavelengths of 1064 nm, 785 nm, or 532 nm at short durations of 240–750 picoseconds (ps) at repetition rates up to 10 Hz (1064 nm, 532 nm) or 5 Hz (785 nm). The device system is comprised of a system console, an articulated arm, and an attached handpiece. The laser output at each wavelength is generated within the laser chassis and delivered to the skin through an articulated arm delivery system terminated by a handpiece. The light-weight and ergonomic handpieces allow the spot size on the skin to be easily adjusted. A range of spot sizes is available for the PicoWay System (up to 10 mm). The system includes an internal calibration port with an internal meter located on the control panel of the system console, which is used to verify the transmission of the articulated arm. The PicoWay system control panel enables the user to select the desired energy density level and repetition rate. The control panel is also used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.

The provided text describes the FDA 510(k) summary for the PicoWay Laser System, primarily focusing on its expansion of indications for use to include the treatment of wrinkles.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: PicoWay Laser System
Expanded Indication: Treatment of wrinkles using the Resolve handpieces (532nm or 1064nm wavelengths)

Acceptance Criteria and Reported Device Performance

• Investigator assessments: 92% improvement rate at 12-week follow-up.
• Mean elastosis score improvement: 1.44 ± 0.83.
• Investigator satisfaction rate: 88%.
• Subjects' satisfaction rate: 74% at the last visit.
• Very positive safety profile with no adverse events (though 2 subjects reporting severe pain were counted as AEs out of caution, but resolved next day without intervention).
• Anticipated treatment responses (erythema, edema, tingling, crusting, acne breakout) observed and resolved within days without medical intervention.
• Most subjects reported low levels of pain during treatment and discomfort in the week following treatment, indicating good tolerability. |

Study Details:

1. Sample Size and Data Provenance:

   • Test Set Sample Size: A total of 74 subjects were enrolled, and 72 subjects were treated.
   • Data Provenance: The study was a "multicenter study conducted at 4 sites in the United States." The data is prospective.

2. Number and Qualifications of Experts for Ground Truth:

   • Number of Experts: Two blinded evaluators.
   • Qualifications: Not explicitly stated beyond "blinded evaluators." It's common in dermatology/cosmetic studies for these to be board-certified dermatologists or plastic surgeons, but the document does not specify.

3. Adjudication Method for the Test Set:

   • The assessment was performed by "2 blinded evaluators." The text implicitly suggests consensus or independent agreement was sought for the "correct identification of the post treatment photograph and assessment of at least one Elastosis Score unit." However, a formal adjudication process like 2+1 or 3+1 is not explicitly described. It simply states "as assessed by 2 blinded evaluators," implying their combined assessment formed the ground truth for the primary endpoint.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC study was conducted for human readers with and without AI assistance. This device is a laser system, not an AI diagnostic tool that assists human readers. The clinical study was a direct evaluation of the device's effect on wrinkles.

5. Standalone Performance (Algorithm Only):

   • N/A. This is a hardware device (laser system) used for treatment, not an algorithm for diagnosis or image analysis. The "performance" here refers to the clinical efficacy and safety of the physical device.

6. Type of Ground Truth Used:

   • The ground truth for the primary endpoint was established by expert assessment ("2 blinded evaluators") based on "correct identification of the post treatment photograph and assessment of at least one Elastosis Score unit." This is a subjective, observer-reported outcome measure in a clinical setting.
   • Additional ground truth indicators included investigator assessments, subject satisfaction, and adverse event reporting.

7. Sample Size for the Training Set:

   • N/A. This is a medical device (laser system), not a machine learning algorithm that requires a separate training set. The study describes a clinical trial evaluating the device's performance directly on human subjects.

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

   • N/A. (See point 7).

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