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Universal IPL with a spectrum of 400-1200nm (with different filters) is indicated for: Improvement of signs of Dry Eye Disease (DED) due to Meibomian Gland Dysfunction (MGD), also known as evaporative dry eve or lipid deficiency dry eve, in patients 22 years of age and older with moderate to severe signs and symptoms of DED due to MGD and with Fitzpatrick skin types I-IV. IPL is to be applied only to skin on the malar region of the face, from tragus to tragus including the nose (eyes should be fully covered by protective eyewear). IPL is intended to be applied as an adjunct to other modalities, such as meibomian gland expression, artificial tear lubricants and warm compresses.

The Lumenis Stellar M22 System incorporates a touch-screen control panel, power supply modules, cooling unit, switching module and service panel, monitored and controlled by its control software. Selected parameter treatment options and corresponding relevant user information are displayed on the monitor screen. The subject device (ophthalmic use) uses the spectrum range of 400-1200 nm. The cut-off filters used in the Lumenis presets for Universal IPL pigmented lesions treatment with the Stellar M22 system are the 515, 560, 590, 615, 640 or 695nm filters. Each filter cuts off all light with a wavelength shorter than the number indicated on the filter. The filter is inserted inside the handpiece and is exchangeable.

Universal IPL skin treatments with the Stellar M22 may use one of the three lightguides, 8x15, 15x35 mm rectangles and 6 mm round, which are supplied as accessories. Lightguides are made of sapphire and couple the optical energy from the module to the treatment site.

The provided text describes the regulatory acceptance of the Lumenis Stellar M22 for use in dry eye disease management, focusing on the clinical study that supports its effectiveness and safety. However, the document does NOT contain information about acceptance criteria for a device that uses AI/algorithm or any MRMC (Multi-Reader Multi-Case) comparative effectiveness study. Similarly, there's no mention of standalone algorithm performance or the sample size and ground truth establishment for a training set if an AI component were present.

The information primarily revolves around the performance of the IPL device itself, in conjunction with Meibomian Gland Expression (MGX), and is evaluated through clinical endpoints in human subjects.

Therefore, for aspects related to AI/algorithm performance, ground truth, and MRMC studies, the provided text does not contain the necessary details. I will answer the questions based on the information available in the text, and clearly state when information is not present.

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

Acceptance Criteria and Device Performance (Based on Clinical Study Outcomes)

The device's acceptance is primarily based on its clinical performance in improving a specific sign of Dry Eye Disease (DED) and its safety profile.

• IPL+MGX arm: Change in TBUT from baseline (BL) to follow-up (FU) was 1.99 ± 0.36 sec.
• Control (Sham+MGX) arm: Change in TBUT from BL to FU was 0.75 ± 0.34 sec.
• Between-group mean difference in TBUT: 1.24 ± 0.50 sec.
  Support for "meaningful clinical benefit" based on exploratory and post-hoc analyses (e.g., proportion of patients improving by two or more TBUT severity categories, proportion improving to non-MGD TBUT). |
  | Secondary Effectiveness Endpoints: Improvement in self-reported DED symptoms (OSDI questionnaire, Eye Dryness Score (EDS) VAS). | Not Met: The study did not demonstrate significantly greater benefit for the IPL device group with regard to self-reported dry eye symptoms (similar overall mean improvement in both groups, no statistically significant difference between groups).
• OSDI p=(b)(4), EDS VAS p=(b)(4).
  However, exploratory protocol-planned analysis of "OSDI responders" (OSDI (b)(4) interpreted as improvement to "mild or better") showed clinical benefit for active IPL treatment group ((b)(4)%) vs. control group ((b)(4)%). This outcome supports clinically meaningful benefit for a proportion of the study population. |
  | Supportive Effectiveness Endpoints (Signs of DED): Change in Meibomian Gland Score (MGS). | Clinical Benefit: Exploratory analysis of change in MGS showed clinical benefit for the IPL treatment group.
• Improvement of (b)(4) units in active arm vs. (b)(4) units in control arm.
• Between-group difference of (b)(4) units.
  This outcome supports clinically meaningful benefit for a subset of the study population. |
  | Safety: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events (UADEs). | Acceptable:
• No Serious Adverse Events (SAEs) or UADEs reported.
• AE incidence: 8.9% in IPL active treatment arm (2 ocular AEs, 2 skin AEs) compared to 20% incidence in the control arm.
• With proper eye protection, no ocular AEs attributed to the IPL system were reported. |
  | Other Non-Clinical Criteria (addressed through testing/declarations for device components):
• Thermal Safety
• Electrical Safety and Electromagnetic Compatibility (EMC)
• Biocompatibility
• Software Verification, Validation, and Hazard Analysis | Met:
• Thermal safety assessed (leveraging previous clearances).
• Complies with IEC 60601-1 and IEC 60601-1-2 (similar to previous K193500 device).
• Handpiece identical in materials and manufacturing to K193500, so previous biocompatibility assessments are applicable. Warnings for coupling gel eye contact included.
• Consistent with FDA guidance for software in medical devices; moderate Software Level of Concern (LOC); risks addressed by labeling and risk management process. |

Study Details:

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

   • The document mentions "Up to male or female subjects". It does not explicitly state the final enrolled sample size. However, it indicates:
     • Type I error of 0.05 (two-tailed test)
     • Type II error of (b)(4) (power = (b)(4))
     • 1:1 ratio of Treatment to Control
   • Data Provenance:
     • The study was a "multi-center, prospective, randomized, sham-controlled, superiority study."
     • Country of Origin: Not explicitly stated, but Lumenis Ltd. is based in Yokneam, ISR (Israel). Clinical trials are often multi-national, but this is not specified.
     • Retrospective or Prospective: Prospective.

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

   • The clinical study evaluates the device's effect on clinical endpoints directly measured or self-reported by patients (TBUT, OSDI, EDS, MGS). These are objective or subjective measures, not interpretations by experts needing to establish ground truth from, for example, images.
   • Therefore, the concept of "experts used to establish ground truth" in the typical sense (e.g., for image annotations) does not apply to this clinical trial design. Measurements like TBUT and MGS are taken by trained clinical personnel, and OSDI/EDS are patient-reported.

3. Adjudication Method for the Test Set:

   • Not applicable as the study relies on direct clinical measurements and patient self-assessment, not interpretive tasks requiring adjudication like image reads.

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

   • No, an MRMC comparative effectiveness study was not done. The study was a clinical trial evaluating a device's effect on physiological and symptomatic endpoints, not a study assessing the performance of human readers with or without AI assistance.
   • Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as no AI assistance was being evaluated for human readers.

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

   • No, this was not done. The product being evaluated is a medical device (IPL system), not an AI algorithm. The performance discussed is the direct effect of the device on patients.

6. The Type of Ground Truth Used:

   • The "ground truth" in this context refers to the clinical endpoints measured in the study:
     • Tear Break-up Time (TBUT): A direct physiological measurement (time from blink to tear film break-up).
     • Meibomian Gland Score (MGS): An objective clinical scoring system for meibomian gland function.
     • OSDI and EDS VAS: Patient-reported outcome measures (subjective symptoms).
   • These are considered the gold standard for evaluating DED and MGD in clinical trials. There is no mention of pathology or other external outcomes data beyond these clinical measures.

7. The Sample Size for the Training Set:

   • Not applicable. The document describes a clinical trial for a medical device, not the training of an AI model. Therefore, there is no "training set" in the context of an algorithm.

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

   • Not applicable. As there is no AI model training described, there is no "ground truth for a training set" to be established.

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The subject Lumenis M22 System has connection capability with the following available treatment handpieces, for multiapplication treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:
The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200nm (with 10 different filters) is indicated for:

• Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos
• Cutaneous lesions, including warts, scars and striae
• Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations
• Removal of unwanted hair from all skin types, and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
• Mild to moderate inflammatory Acne (Acne vulgaris)
  The Nd:YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd:YAG) is indicated for:
• The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias) and reticular veins (0.1 - 4.0 mm. diameter) of the leg
• The removal of unwanted hair from all skin types, and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
• The non-ablative treatment of facial wrinkles
  ResurFX module and handpiece. with wavelength of 1565 nm. is indicated for:
• Use in dermatological procedures requiring fractional skin resurfacing and coaqulation of soft tissue
  The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064nm is indicated for:
• Removal of dark tattoos
• Treatment of pigmented lesions
  *Note Permanent hair reduction is defined as 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 ResurFX System with wavelength of 1565 nm. is indicated for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.

The subject Lumenis M22 System is a multi-application, multi-technology platform with four (4) available treatment handpieces:

• Universal Intense Pulsed Light (IPL) handpiece:
• Multi-Spot Nd:YAG laser handpiece;
• ResurFX non-ablative laser handpiece;
• Q-Switched Nd:YAG laser handpiece.
  The following accessories are provided with and/or may be purchased independently for each of the four (4) available treatment handpieces of the M22 System:
• The Universal IPL handpiece has ten (10) different filters available: Cut-off filters of 515, 560, 590,615, 640, 695 and 755 nm, Notch Filters of 400-600 & 800-1200 nm and 530-650 & 900-1200 nm, and a Narrow band filter of 525-585 nm. Further, the IPL handpiece has three (3) sapphire cool light guides available with sizes of: 15mm x 35mm, 8mm x 15 mm, 6mm diameter.
• The Multi-Spot Nd:YAG handpiece has four (4) different light guides/tips available in sizes of: 2mm x 4mm, 6 mm, 9 mm and 1.5 mm.
• The ResurFX handpiece has two (2) different treatment tips available: SapphireCool and Precision tips.
• The Q-Switched Nd: YAG handpiece has both disposable and gold plated metal treatment tips available. The disposable treatment tips are available in four (4) different sizes of: 2, 2.5, 3.5, and 5 mm. The metal treatment tips are available in seven (7) different sizes of: 2, 2.5, 3.5, 4, 5, 6 and 8 mm.

The ResurFX System is an advanced computer-controlled laser emission system operating at a wavelength of 1565 nm, and is intended for Fractional Non-Ablative Skin Resurfacing application when using a dedicated handpiece.
The following accessories are provided with and/or may be purchased independently for the ResurFX System:

• Two (2) different treatment tips: SapphireCool and Precision tips.
• Footswitch.

The provided document is a 510(k) summary for the Lumenis M22 and ResurFX Systems, which are laser surgical instruments. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria through studies involving human-in-the-loop or standalone algorithm performance.

Therefore, many of the requested details about acceptance criteria, study types, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory document. This document details engineering and performance bench testing to ensure the modified device functions as intended and safely, similar to its predicate.

Here's an analysis of the information that can be extracted from the document:

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

The document doesn't present a table of specific clinical acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy for a diagnostic or AI-driven device. Instead, the "acceptance criteria" are implied by the performance bench testing ensuring the device meets safety and operational standards and functions as intended, similar to the predicate devices. The "reported device performance" is essentially that it passed these engineering and safety tests.

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

Not applicable. This is a 510(k) for a device modification, focusing on engineering verification and validation (V&V) and safety testing. There is no "test set" in the context of clinical data for an AI algorithm. The V&V activities involve testing the physical device and its components.

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. No "ground truth" was established by clinical experts for a test set, as this is not a study of an AI or diagnostic device's clinical performance.

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

Not applicable. No clinical test set requiring adjudication was used.

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 document is not about an AI-assisted diagnostic device, but rather a laser surgical instrument. Therefore, no MRMC study was conducted or reported.

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

Not applicable. This device does not have a standalone algorithm in the sense of a diagnostic or image interpretation AI. Its "standalone" characteristic refers to the ResurFX system being made available as a separate unit rather than just a module of the M22. This is a hardware device for treatment, not an algorithm for analysis.

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

Not applicable. The ground truth for this device's performance is its physical and electrical specifications, and its ability to function safely and effectively within those parameters as demonstrated by engineering bench testing and compliance with recognized standards.

8. The sample size for the 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

Not applicable.

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The Medicam Evolux, Evostar and Evolight pulsed light systems (and included accessories) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue. It is intended for use for: Removal of unwanted hair from all skin types (640nm to 1200nm); Treatment of benign pigmented lesions including dyschromia, hyper pigmentation, melasma, ephelides (freckles) (510nm to 1200nm); Removal of benign cutaneous vascular lesions including port wine stains, hemangiomas, rosacea, erythema, leg veins(485 nm to 1200nm); and Treatment of benign cutaneous lesions including warts, scars and striae (420nm to 1200nm). The Medicam Evolase pulsed light system (and included accessories) is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue. It is intended for use for: Treatment of benign pigmented lesions including dyschromia, hyper pigmentation, melasma, ephelides (freckles) (1064nm to 1200nm); and Removal of benign cutaneous vascular lesions including port wine stains, hemangiomas, rosacea, erythema, leg veins (532nm to 1200nm). The devices are intended for prescription use.

Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light Systems emit intense wide spectrum emission with wavelength of 420 - 1200 nm. It includes the following main components: A system console (including software and electronic control boards); A control and color touch screen; and Hand piece with cooling system.

The provided document is a 510(k) summary for the Medicam Evolux, Evostar, Evolight, and Evolase Pulsed Light Systems. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria through performance data.

Therefore, many of the requested sections (Table of acceptance criteria, sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for test/training sets, and training set sample size) cannot be directly extracted from this document as it does not contain such detailed study information.

Here's an analysis based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a table of specific numerical acceptance criteria or reported device performance metrics in the way that would typically be found in a clinical study report. The substantial equivalence argument relies on the device having the "same indications for use, similar design and functional features" as the predicate devices, implying that their performance is expected to be comparable.

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

Not applicable. The document does not describe a clinical study with a test set. This submission is based on substantial equivalence to predicate devices, referencing their established safety and effectiveness.

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

Not applicable. No new clinical study data with ground truth establishment is described.

4. Adjudication Method for the Test Set

Not applicable. No new clinical study data is described.

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

No, an MRMC comparative effectiveness study is not mentioned or described in this document. The submission focuses on substantial equivalence based on indications for use and technological features.

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

Not applicable. This device is a pulsed light system, not an algorithm. Performance is assessed through its physical characteristics and intended use, primarily compared to predicate devices.

7. The Type of Ground Truth Used

Not applicable. The submission is based on substantial equivalence, implying the "ground truth" for its safety and effectiveness is derived from the established history and performance of the predicate devices for their stated indications.

8. The Sample Size for the Training Set

Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.

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

Not applicable. As above, this is a medical device, not an algorithm requiring a training set.

Summary of Substantial Equivalence Claim (as per document):

The document asserts that the Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light Systems are substantially equivalent to the legally marketed predicate devices (Profile BBL System K032460 and Quantum, Models SR, HR, DL K020839).

The basis for this claim is:

• Indications for Use: The devices share the "same indications for use" as the predicate systems.
• Design and Features: They have "similar design and functional features."
• Technological Equivalence: "Technologically, the Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light Systems are substantially equivalent to the listed predicate devices."

Therefore, the conclusion states: "the risks and benefits for Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light System are comparable to the predicate devices." The acceptance criteria, in this context, are met by demonstrating this substantial equivalence to already cleared devices. No new, independent performance study with explicit numerical acceptance criteria is detailed in this 510(k) summary.

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The Lumenis One Family of Systems (and the delivery accessories that are used with them to deliver light and/or laser and/or RF energy) is indicated for use in surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology as follows:

Intense Pulsed Light (IPL) Wavelengths (515 - 1200 nm):
The 515-1200 nm intense pulsed light wavelengths are indicated for:

• The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
• The treatment of tattoos;
• The treatment of cutaneous lesions, including warts, scars and striae;
• The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
• The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction in skin types I-V through selective targeting of melanin in hair follicles.

Nd:YAG Laser Wavelength (1064 nm):
The 1064 nm wavelength produced by the Nd: YAG laser is indicated for:

• The coagulation and hemostasis of vascular lesions and soft tissue, including:
• Treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg:
• The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction in skin types I-V through selective targeting of melanin in hair follicies;
• The non-ablative treatment of facial wrinkles.

LightSheer Diode Laser Wavelength (800 mm):
The 800 nm wavelength produced by the LightSheer diode laser is indicated for:

• The removal of unwanted hair, and to effect stable long-term, or permanent', hair reduction through selective targeting of melani, in hair follicles;
• The treatment of vascular lesions, including angiomas, hemangiomas telangiectasia and other benign vascular lesions;
• The treatment of leg veins;
• The treatment of benign pigmented lesion;
• The treatment of pseudofolliculitis barbae;

The LightSheer diode laser is intended for use on all skin types (Fitzpatrick skin types 1 - VI), including tanned skin.

Aluma RF Energy (468 kHz):
The Aluma 468 kHz energy is indicated for:

• The Aluma Skin Renewal System is intended for use in Dermatologic and General Surgical procedures for the non-invasive treatment of wrinkles and thytids.

Lumenis One systems are comprised of the following main components:

• System console;
• Control and Display;
• One or more delivery handpieces, the Treatment Heads (up to three attached out of four handpieces available for each system);
• Skin cooling technology integrated into the handpiece (as applicable);
• Trigger button integrated into the handpiece; an additional safety button integrated into the laser handpieces;
• Remote interlock connector (disables pulse emission when treatment room door is opened).

This 510(k) summary explicitly states that no clinical data was provided for the Lumenis One Family of Systems. The device's substantial equivalence to predicate devices was based on shared indications for use and similar or identical technical specifications, not on new performance studies.

Therefore, the following information cannot be found or accurately described from the provided text:

• A table of acceptance criteria and reported device performance
• Sample sizes used for test sets
• Data provenance for test sets
• Number of experts used to establish ground truth
• Qualifications of experts
• Adjudication methods
• MRMC comparative effectiveness study results
• Standalone performance results
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

The document makes a direct statement that is crucial for understanding why these details are absent:

"Clinical data therefore was not provided." (Section VII, page 2)

The rationale for not providing clinical data is that:
"The Lumenis One Family of Systems share the same indications for use and the same or similar technical specifications as the currently marketed predicate Lumenis Family of Intense Pulsed-Light (IPL) and IPL Nd: Y AG Laser Systems (K020839, K024093, K030342, K030527), the LightSheer Pulsed Diode Array Laser System (K973324, K974346, K982940, K001746, K003614), and the Aluma Skin Renewal System (K051214). The small differences that exist in certain technical specifications are not significant and they do not alter the safety or effectiveness of the Lumenis One Family of Systems." (Section VII, page 2)

In summary, the device's acceptance criteria were implicitly met by demonstrating substantial equivalence to already cleared predicate devices, without the need for new clinical performance studies or establishing new acceptance criteria and demonstrating compliance.

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The Omnilux Revive and Blue Combination is intended to emit energy in the red and blue region of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

The Omnilux Revive and Blue is a combination of two sources of high spectral purity. They provide uniform or "hot-spot" headwidth. The output pre-tuned to one wavelength with a narcow spectral bandwidth: Rlue is 415 + 2 wavelength of Omnilux Revive is 63 + 5 mm, and Omnilux Blue is 415 + 5m. The Omnilux base unit contains the III I FD hose same attached to the end of the arms and then positioned for patient to the lesting. The user interface an LCD and keyboard together with the control devices functions an LCD and Reyboard together while the reasonal control all device functions.

This 510(k) summary does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a definitive study proving the device meets those criteria. The document explicitly states:

"Based upon an analysis of the overall performance characteristics for the device, Photo Therapeutics Limited believes that no significant differences exist between Photo Therapeutics Eamined an' and the previously approved the Onlinex Revive (K030426) and Omnilux Blue (K030883) devices and their Omnilux Revive (R050+20) and Onlines Revive and Blue Combination raises no new issues of safety or effectiveness."

This statement indicates that the submission relies on the substantial equivalence to previously approved devices (Omnilux Revive and Omnilux Blue), rather than presenting a new, dedicated clinical study with defined acceptance criteria for the combination device. Therefore, a table of acceptance criteria and the performance of this specific combination device against those criteria is not provided in this document.

However, I can extract the available information and indicate where details are not present:

Here's a breakdown of the information provided, or where it's absent:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of acceptance criteria or performance metrics for the Omnilux Revive and Blue Combination device in the context of a new study designed for this specific combination. Instead, it asserts substantial equivalence to previously approved Omnilux Revive and Omnilux Blue devices. Therefore, the "reported device performance" for this combination is inferred to be similar to its predicate devices for their respective indications.

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

• Sample Size: Not applicable/not stated. The document doesn't detail a new clinical test set for the Omnilux Revive and Blue Combination. It relies on the performance characteristics of its predicate devices.
• Data Provenance: Not applicable/not stated for a new study. The predicate devices were likely approved based on data (country of origin, retrospective/prospective) from their respective submissions (K030426 and K030883), but those details are not provided here for reference.

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

• Not applicable/not stated, as no new test set is described for this combination device.

4. Adjudication Method for the Test Set:

• Not applicable/not stated, as no new test set is described for this combination device.

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

• No, an MRMC comparative effectiveness study is not mentioned or implied for the Omnilux Revive and Blue Combination device. The submission focuses on substantial equivalence.

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

• Not applicable. This is a light therapy device, not an AI or algorithm-based diagnostic tool. "Standalone performance" in this context would refer to the device's physical output and direct therapeutic effect, not an algorithmic assessment.

7. The Type of Ground Truth Used:

• Not applicable/not stated for a new study. For the predicate devices, "ground truth" for acne treatment would typically be clinical assessment by dermatologists, possibly using standardized photographic scales or lesion counts. However, this is not detailed for the combination device here.

8. The Sample Size for the Training Set:

• Not applicable/not stated, as this is not an AI/machine learning device that involves a "training set."

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

• Not applicable/not stated, as this is not an AI/machine learning device.

Summary of Device and Indication:

• Device Name: Omnilux Revive and Blue Combination
• Indication for Use: "To emit energy in the red and blue region of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris."
• Mechanism: Combines two sources of high spectral purity light:
  • Omnilux Revive: Wavelength of 633 ± 5 nm (red light)
  • Omnilux Blue: Wavelength of 415 ± 5 nm (blue light)
• Basis for Approval: Substantial equivalence to previously approved Omnilux Revive (K030426) and Omnilux Blue (K030883) devices. The manufacturer asserts that "no significant differences exist" and that "the Omnilux Revive and Blue Combination raises no new issues of safety or effectiveness."

To find detailed performance data and acceptance criteria, one would need to review the 510(k) submissions for the individual predicate devices: K030426 (Omnilux Revive) and K030883 (Omnilux Blue).

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The Q-switched Nd: YAG Laser Treatment Head for the Quantum series is intended for use in the medical specialties of plastic surgery and dermatology for applications requiring selective photothermolysis and photo-acoustic effects in target chromophores.

The Q-switched Nd: YAG Laser Treatment Head for the Quantum series is indicated for:

• Removal of dark tattoos
• Treatment of pigmented lesions

The Lumenis Quantum series of IPL/Nd: YAG systems are intense pulsed-light (IPL) and Nd: Y AG laser devices. Each Quantum system is comprised of three main components:

• A system console (including software and control electronics, key-operated power control switch, power-on indicator, emergency shut-off knob and a remote interlock connector);
• A control and display panel;
• One or more delivery handpiece(s), the Treatment Heads.

The Q-switched Nd: Y AG Treatment Head for the Quantum series is a pulsed laser operating at a wavelength of 1064 nanometers. It is an upgrade that can be installed on any Quantum system.

The Q-switched Nd: YAG Laser Treatment Head is a hand held device comprised of the laser head and optics, trigger circuit, safety components and cooling circuit. The Qswitched Nd: YAG Laser Treatment Head is connected to the Quantum console via an umbilical cable and connector.

The provided text describes the Q-switched Nd:YAG Laser Treatment Head for the Lumenis Quantum series. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the device "shares the same indications for use, same principle of operation, same wavelength, same or similar fluence range and spot sizes as the predicate devices." It also notes that a "Clinical Evaluation Report demonstrated the safety and effectiveness of the Q-switched Nd: YAG laser for the claimed indications for use." However, specific quantitative acceptance criteria (e.g., a certain percentage of tattoo removal, reduction in lesion size) and their corresponding performance metrics are not explicitly stated in the provided document. The document relies on substantial equivalence to predicate devices rather than establishing new, specific performance criteria.

• Removal of dark tattoos
• Treatment of pigmented lesions | Reported Performance: "A Clinical Evaluation Report demonstrated the safety and effectiveness of the Q-switched Nd: YAG laser for the claimed indications for use."
  (No specific numerical performance metrics were provided in this document as the basis for substantial equivalence). |
  | Technical specifications (wavelength, fluence range, spot sizes) comparable to predicate devices | "The technical specifications of the Q-switched Nd: YAG Laser Treatment Head for the Quantum series are similar or identical to those of the predicate MedLite C3 Q-switched Nd: YAG laser system (K011677), the Q-Clear laser system (K033259) and the Q-YAG 5 / Clear Light (K003460)." |

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

The document mentions "A Clinical Evaluation Report" but does not provide details about the sample size used for the test set, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective nature).

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 given text.

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

This information is not provided in the given text.

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

A multi-reader multi-case (MRMC) study is not mentioned in the document. The device is a laser treatment head, not an AI-assisted diagnostic or interpretative tool, so an MRMC study related to human reader improvement with AI would not be applicable here.

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

The device is a laser treatment head, which is a physical instrument used for medical procedures, not a standalone software algorithm. Therefore, a "standalone algorithm-only" performance study is not applicable. The "standalone" performance would be its inherent treatment efficacy, which the clinical evaluation report broadly addressed.

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

The document refers to a "Clinical Evaluation Report" which demonstrated "safety and effectiveness." This implies that clinical outcomes data (e.g., visual assessment of tattoo removal, reduction in lesion pigmentation, adverse event rates) would have been used as the ground truth. However, the exact methods for defining and measuring this ground truth are not detailed.

8. The sample size for the training set

The document does not mention a training set. This is consistent with a medical device submission focused on substantial equivalence to existing predicate devices, where extensive de novo training data for an algorithm might not be required or relevant in the same way it would be for an AI-powered diagnostic tool. The "Clinical Evaluation Report" would likely involve a test or validation set of patients, not a separate training set as understood in machine learning.

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

As no training set is mentioned or implied, this information is not applicable.

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The StarLux pulsed light system is intended for the treatment of inflammatory acne (acne vulgaris) and for the treatment of benign pigmented epidermal and cutaneous lesions, including warts, scars and striae.

The StarLux Pulsed Light System is a broad spectrum light-based medical device designed for a wide range of clinical applications. The StarLux offers 5 handpieces with Palomar's patented contact cooling technology, each specifically designed for the optimal treatment of specific clinical indications.

The provided text is a 510(k) summary for the Palomar StarLux™ Pulsed Light System. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results for a new, novel function.

Therefore, many of the requested categories for a study proving device acceptance and performance cannot be directly extracted from this document, as it outlines a regulatory submission process based on equivalence.

However, I can extract information related to the device's intended use and the general conclusion of the 510(k) submission.

Here's a summary based on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not applicable/Not provided. This submission relies on demonstrating equivalence to predicate devices rather than a de novo clinical trial with a test set.
• Data Provenance: Not applicable/Not provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable/Not provided. Ground truth in the context of equivalence is not established by expert consensus on a test set, but rather by the regulatory acceptance of the predicate devices.

4. Adjudication Method for the Test Set

• Not applicable/Not provided.

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

• No. The document does not describe an MRMC study comparing human readers with and without AI assistance. This type of study is not relevant to a pulsed light system's regulatory submission based on substantial equivalence to existing devices.

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

• Not applicable. This device is a pulsed light system, not an algorithm. Its performance is inherent in its physical operation and effect on tissue, not in an independent algorithmic output.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is the established safety and efficacy of the legally marketed predicate devices (Palomar EsteLux (K040081), Palomar StarLux (K033549), Palomar SpaLight (K003886), Lumenis IPL (K020839)) for their respective indications. The StarLux™ is deemed substantially equivalent to these devices.

8. The Sample Size for the Training Set

• Not applicable/Not provided. This is not an AI/ML device that requires a training set in the conventional sense.

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

• Not applicable/Not provided.

Summary of the Study (as described in the 510(k) document):

The "study" presented in this 510(k) submission is a comparison and analysis of the StarLux™ Pulsed Light System against legally marketed predicate devices. The approach is to demonstrate substantial equivalence rather than to conduct a de novo clinical trial with specific performance metrics.

The conclusion of the submission states: "Based on the foregoing, the StarLux™ pulsed light system is substantially equivalent to the legally marketed claimed predicate devices." This means the device met the regulatory acceptance criteria by showing that its specifications and intended uses are comparable to those of already approved devices, and it does not raise new questions of safety or efficacy.

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NaturaLight IPL System (intense pulsed light) is indicated for: The removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction. The treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait. treatment of vascular lesions, including port wine stains, hemangiomas, telangiectasias, rosacea, facial and leg veins.

The Focus Medical NaturaLase LP Laser System and the NaturaLase LP+ System when used in Laser Mode is indicated for: General Surgical Applications: Incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue dermatology/plastic surgery, endoscopic/laparoscopic general surgerv. in gastroenterology, general surgery, gynecology, head and neck/ otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery, and urology.

Dermatology/Plastic Surgery: Coagulation and hemostasis of benign vascular lesions such as port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins. In addition, the NaturaLase LP is intended for the treatment of benign pigmented 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, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The NaturaLase LP Laser is also indicated for 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. Cutting, incision, excision, hemostasis, coagulation, vaporization and ablation of soft tissue in dermatology and plastic surgery. The NaturaLase LP Laser is also indicated for the treatment of facial wrinkles and wrinkles such as, but not limited to, periocular and periorbital wrinkles. The NaturaLase LP Laser is indicated for the removal of unwanted hair, for the stable long tem, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The NaturaLase LP Laser is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The NaturaLase LP Laser is indicated for use on all skin types (Fitzpatrick I - VI) including tanned skin.

Endoscopic/Laparoscopic Surgery: The Natural.ase LP Laser is also indicated for use in a variety of surgical procedures in several surgical specialties. These include, but not limited to, cholecystectomy, appendectomy, vagotomy, and pyloromyomotomy where its abilities to incise, excise, coagulate, vaporize, or ablate soft tissue may be applied.

Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstruction including squamous cell carcinoma and adenocarcinoma, gastrointestinal hemostasis including varices, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastric erosions, gastrointestinal tissue ablation including benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, and hemorrhoids.

General Surgery: Incision, excision, vaporization, ablation, and hemostasis of soft tissue general surgery applications, skin incisions, tissue dissection, excision of external turnors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation, tonsillectomy, and hemorrhoids.

Gynecology: Treatment of menorhagia by photocoagulation of the endometrial lining of the uterus. ablation of endometrial implants and/or peritoneal adhesions, soft tissue excisional procedures such as excisional conization of the cervix, intrauterine gynecologic procedures where cutting, ablation, and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, and uterine septum.

Head and Neck/Otorhinolaryngology (ENT): Tissue incision, excision, ablation, and vessel hemostasis.

Hemostasis During Surgery: Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscopic) and open procedures.

Neurosurgery: Hemostasis for pituitary tumor, meningioma, hemagioblastoma, AVMs. glioblastoma, astrocytoma, oligodendroglioma.

Oculoplastics: Incision, excision, vaporization, and/or coagulation of tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of biopsv or orbital tumors, enucleation on eyeball, exteneration of orbital contents.

Orthopedics: Cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications.

Pulmonary Surgery: Palliative treatment of benign and malignant pulmonary airway obstructions, including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granilo mas, and benign strictures.

Thoracic Surgery: Cutting (incision/excision), coagulating, and vaporization of soft tissue. Thoracic applications including, but not limited to, isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets, vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (thoracoscopy).

Urology: All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures and lesions of the external genitalia (including condyloma acuminata).

The Focus Medical NaturaLase LP and NaturaLight Family of Products consists of the NaturaLase LP Nd: YAG Laser System, the NaturaLight IPL System and the NaturaLase LP+ a simple combination of the NaturaLase LP and the NaturaLight.

This document is a 510(k) premarket notification for a medical device submitted to the FDA in 2004. It outlines the device's summary and indications for use, but does not contain information regarding acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to predicate devices, not on performance studies with specific acceptance criteria.

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The Profile BBL (and the light and/or laser delivery accessories) is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.
It is intended for use for:
• The treatment of tattoos;
• The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
• The treatment of cutaneous lesions including warts, scars and striae;
• The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, engiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
• Treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis; and
• The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction.
The integral thermo-electric cooler is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
• Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
• Reduce discomfort during and/or associated with light or laser treatment:
• Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation;
• Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and
• Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

Profile BBL System emits intense wide spectrum emission with wavelength of 500-1400 nm. It consists of a system console, internal computer, control panel and display, and a treatment head comprised of a light guide with cooling capability and a pushbutton switch.

The provided text is a 510(k) summary for the Sciton Profile BBL System. It establishes substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

This document focuses on the regulatory aspects of device clearance, asserting equivalence based on similar indications for use, design features, and functional features compared to previously cleared devices. It does not present novel performance data or detail any studies designed to meet specific acceptance criteria for the Sciton Profile BBL System itself.

Therefore, the requested information, such as a table of acceptance criteria and device performance, sample sizes, expert qualifications, ground truth details, or MRMC study results, cannot be extracted from the provided text.

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The Lumenis Family of Intense Pulsed-Light (IPL) systems and combination IPL/Nd:YAG laser systems (and the delivery accessories that are used with them to deliver light and/or laser energy) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows:

Intense Pulsed Light Energy / Wavelengths (515 - 1200 nm):

• The treatment of tattoos and benign pigmented epidermal and cutaneous lesions * including warts, scars and striae;
• • The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
• • The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent1, hair reduction in skin types I-VI through selective targeting of melanin in hair follicles;

Nd:YAG Laser Wavelength (1064 nm):

• • The coagulation and hemostasis of vascular lesions and soft tissue, including:
    • • Treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg;
• • The non-ablative treatment of facial wrinkles.

The Real Time Chiller is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:

• • Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
• Reduce discomfort during and/or associated with light or laser treatment; *
• • Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyperand/or hypopigmentation;
• • Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and
• • Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems are comprised of the following main components:

• • A light/laser system console (including software and control electronics);
• A control and display panel; and *
• • One or more attached hand-piece(s), which may have integrated skin cooling components.

This is a pre-market notification for a laser system, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies (such as MRMC, standalone performance, ground truth, and sample sizes) is largely not applicable in the context of AI/ML device evaluation.

Here's a breakdown of why this information isn't present in the provided text for an AI/ML context:

• Device Type: The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems are medical devices that physically interact with tissue for surgical, aesthetic, and cosmetic applications. They are not software-based AI/ML devices that provide diagnostic or prognostic insights.
• Approval Process: The document is a 510(k) submission, indicating a substantial equivalence pathway. This pathway compares the new device to existing legally marketed predicate devices to demonstrate that it is as safe and effective. It does not typically involve the rigorous performance metric evaluations (like sensitivity, specificity, AUC) associated with AI/ML devices.
• "Acceptance Criteria" in this context: For this type of device, "acceptance criteria" primarily refer to demonstrating that the device's technical specifications and performance (e.g., fluence, pulse rate, spot size) are comparable to predicate devices and that clinical data supports its safety and effectiveness for its intended use. There are no "reported device performance" metrics in the sense of AI/ML model output.

However, I can provide the available information relevant to the device's evaluation, reinterpreting "acceptance criteria" and "study" for this non-AI/ML context:

1. Table of Acceptance Criteria and Reported Device Performance (Reinterpreted for a Laser System)

Since this is a 510(k) for a laser system, the "acceptance criteria" are implied by its comparison to predicate devices across various technical and functional specifications, and the "reported device performance" is its demonstrated capability to meet those same specifications and achieve the intended clinical effects.

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

• The document states: "Clinical data was provided to demonstrate that the Lumenis Family of IPL and IPL/Nd:YAG laser (1064 nm) systems are safe and effective..."
• No specific sample size, data provenance, or retrospective/prospective nature of the clinical data is provided in this summary. This level of detail is typically found in the full study reports, not necessarily in the high-level 510(k) summary.

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

• Not Applicable. For a laser system, "ground truth" isn't established by experts interpreting outputs in the way it is for AI/ML diagnostic tools. The "truth" would be the observed clinical outcome (e.g., hair reduction, lesion clearance, wrinkle reduction) directly from the treatment.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling expert disagreements in AI/ML performance evaluation, which is not relevant here.

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 a laser treatment device, not an AI diagnostic/assistant tool. MRMC studies are for evaluating scenarios where humans are interpreting outputs (e.g., medical images) with or without AI assistance, which is not the function of this device.

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

• Not Applicable. Again, this is a physical laser device, not an algorithm. Its performance is always "standalone" in the sense that it performs its function without an AI element, but it requires a human operator for application.

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

• For a medical treatment device like this laser system, the "ground truth" for demonstrating safety and effectiveness would primarily be clinical outcomes data. This includes:
  • Observed clinical efficacy: e.g., photographic evidence of lesion clearance, hair reduction, wrinkle improvement.
  • Patient feedback: on pain reduction, discomfort.
  • Adverse event reporting: to assess safety.
  • These outcomes would be assessed by clinicians.

8. The sample size for the training set

• Not Applicable. This device does not use a "training set" in the AI/ML sense. Its operational parameters are designed and validated through engineering principles and clinical studies, not by training an algorithm on a dataset.

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

• Not Applicable. As there is no training set for an AI/ML model, there is no ground truth established in this context.

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