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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 LC100 diode laser system is indicated for hair removal and permanent hair reduction. Permanent hair reduction is defined as a long-term, stable reduction in the number of re-growing hairs after a treatment regime.

The LC100 is also indicated for photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, hemangioma, spider nevi, and other benign vascular lesions; photothermolysis of blood vessels (treatment of facial and leg veins); removal of benign pigmented lesions, including lentigines, nevi, chloasma, and café-au-lait; incision/excision, ablation and coagulation (homeostasis) of soft tissue.

The LC100 is indicated for use in patients with skin types I-VI, including tanned patients.

The LC100 delivers infrared laser light with a wavelength of 810 nm, a selectable pulse duration of 50 - 1000 ms. The corresponding fluence is delivered through a 12x12 or 12x6 mm handpiece tip. The laser pulses are generated at a maximum pulse repetition frequency of 3.3 Hz.

The complete system consists of a, chiller, a footswitch, and a handpiece containing diode bars connected to the power unit with an umbilical. In standard use, the handpiece is pressed against the patient's skin and a light pulse is delivered when the footswitch is depressed. The handpiece tip is water-Laser cooled to provide active skin cooling. parameters and other system features are controlled from the user interface panel on top of the laser unit, which provides an interface to the system computer.

The provided document is a 510(k) summary for the Palomar LC100 Diode Array Laser System, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission does not typically include the kind of detailed study data (like acceptance criteria tables, sample sizes for test/training sets, ground truth establishment, MRMC studies, or standalone performance) that would be present in a Clinical Study Report or a more extensive Premarket Approval (PMA) application.

The document primarily focuses on establishing substantial equivalence by comparing the LC100 to predicate devices (Palomar SLP 1000 Diode Laser and LightSheer Diode Array Laser) through a description of its system and intended use. It explicitly states: "The differences in the specifications of the LC100 laser and the predicate device do not result in different performance or raise new questions of safety or efficacy. Based on the foregoing, the LC100 Diode Conclusion: Array Laser System is substantially equivalent to the legally-marketed claimed predicate device."

Therefore, based solely on the provided text, I cannot provide the specific details requested in your prompt because they are not present in this 510(k) summary.

Here's what I can extract or infer based on the nature of a 510(k) submission:

• Acceptance Criteria and Reported Device Performance: Not explicitly stated in a quantitative table. The "acceptance criterion" for a 510(k) is typically substantial equivalence to a predicate device, meaning it performs as safely and effectively as the predicate without raising new questions of safety or efficacy. The "reported device performance" is essentially that it is considered substantially equivalent to the predicate devices for its stated indications for use.
• Study Proving Acceptance Criteria: The "study" is the submission itself, which argues for substantial equivalence by comparing the LC100's specifications and intended use to those of the predicate devices. This is generally a comparative analysis rather than a traditional clinical study with detailed performance metrics.
• Sample Size for Test Set and Data Provenance: Not applicable/not provided. This is not a study that involved a test set in the sense of a clinical trial.
• Number of Experts and Qualifications: Not applicable/not provided. Ground truth establishment with experts is not detailed for this type of submission.
• Adjudication Method: Not applicable/not provided.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable/not provided. These are complex studies not typically required or included in a 510(k) for a laser system.
• Standalone Performance: Not applicable/not provided as a distinct study. The comparison is against predicate devices.
• Type of Ground Truth Used: Not applicable/not provided as this is not a diagnostic device requiring external validation of its output against a 'ground truth.'
• Sample Size for Training Set: Not applicable/not provided. This device is not an AI/ML algorithm that would have a training set.
• How Ground Truth for Training Set was Established: Not applicable/not provided.

In summary, the provided document is a regulatory submission for substantial equivalence, not a detailed clinical performance study. The information requested regarding explicit acceptance criteria, detailed study design, sample sizes, and ground truth establishment is not typically found in this type of 510(k) summary.

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