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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 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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