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The LightSheer Family of Pulsed Diode Array Laser Systems (LightSheer Desire, LightSheer Desire Light and LightSheer Infinity) is indicated for use in surgical, aesthetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer Family of Pulsed Diode Array Laser Systems is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

Specific indications for each system and handpiece combination are listed in the document and include:

• Treatment of benign vascular lesions, including angiomas, telangiectasia and other benign vascular lesions and leg veins
• Treatment of pseudofolliculitis barbae (PFB)
• Hair removal, permanent hair reduction*
• Treatment of benign pigmented lesions, including age spots, solar lentigines, cafe-au-lait spots, nevi of Ota/Ito, melasma, Becker's nevi and other benign pigmented lesions
• Treatment of wrinkles

*Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The Lumenis LightSheer Family of Pulse Diode Array Laser Systems consists of four laser consoles that can be used with up to four different types of handpieces. The four laser consoles are: LightSheer Duet, LightSheer Infinity, LightSheer Desire, and LightSheer Desire Light. The laser consoles provide (1) a graphical user interface and software for control of the system, (2) the needed electronics to control and power the accessories, (3) handpiece connection port(s), (4) a vacuum pump (most models) and (5) cooling system.

Handpieces can be divided into two categories, depending on the technology applied to the skin during treatment: high speed (HS) Handpieces with vacuum technology (HIT™) or ET, XC and LR Handpieces with cooling technology (ChillTip), available with different sized tips. Some handpieces are universal, supporting different ChillTip sizes within a single handpiece. In addition, these handpieces either deliver pulsed diode laser light with wavelengths ranging from 790 - 950nm (805nm nominal) or 1040-1080nm (1060nm nominal), depending on the diode array type. The same LightSheer Handpieces are compatible with multiple systems (such as the LightSheer Duet, LightSheer Infinity, LightSheer Desire, and LightSheer Desire Light), in which case they differ only in terms of the mechanical connection to the console.

The provided text describes a 510(k) submission for the Lumenis LightSheer Family of Pulsed Diode Array Laser Systems. The purpose of the submission is to add 1060nm handpieces to the LightSheer Desire and LightSheer Desire Light Systems, which were previously cleared for use with other systems in the LightSheer Family. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving those criteria are met for the device's indications for use.

Therefore, the specific information requested in the prompt regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within this document. The document primarily details regulatory compliance and safety testing concerning substantial equivalence.

However, I can extract information related to the performance testing that was conducted to support the substantial equivalence claim, which can be interpreted as demonstrating the device meets general safety and effectiveness requirements.

Acceptance Criteria and Reported Device Performance (General Safety and Effectiveness)

While explicit "acceptance criteria" in the format of specific clinical metrics are not provided, the document states performance testing was conducted to verify that the modifications did not raise "different questions of safety and effectiveness." The reported performance is that the device conforms to relevant safety and performance standards.

Information Not Available in the Document:

1. Sample size used for the test set and the data provenance: The document does not describe a clinical "test set" with patient data or its provenance for demonstrating the device's clinical efficacy against specific acceptance criteria.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed clinical testing with expert-established ground truth is not described.
3. Adjudication method for the test set: Not applicable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a laser system, not an AI-assisted diagnostic tool for human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: Not explicitly stated beyond conformance to engineering and safety standards. There is no mention of expert consensus, pathology, or outcomes data for a clinical ground truth.
7. The sample size for the training set: Not applicable, as this is a laser and not a machine learning algorithm.
8. How the ground truth for the training set was established: Not applicable.

Summary of Study Described:

The study referenced in the document is a regulatory "performance testing" conducted internally by Lumenis to demonstrate that the modifications (adding 1060nm handpieces) to the LightSheer Desire and LightSheer Desire Light Systems, and other system modifications, do not raise new questions of safety or effectiveness. This testing primarily involved:

• Risk Analysis: Performed according to ISO 14971.
• Electrical and Laser Safety and Electromagnetic Compatibility (EMC) Testing: Conformance to international standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22).
• Software Verification and Validation: Ensured the software functions as intended and meets requirements.

The document asserts that based on these activities, the device is "substantially equivalent" to its legally marketed predicates. This type of submission relies on demonstrating that the new device or modification is as safe and effective as a predicate device, rather than proving a set of specific clinical performance claims with clinical trials against acceptance criteria.

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The LightSheer pulsed diode array laser systems are indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer pulsed diode array laser systems are intended for use on all skin types (Fitzpatrick skin types I – VI), including tanned skin.

The LightSheer Desire Light Laser System with LightSheer ET/XC Laser Handpiece is indicated for the treatment of vascular lesions, including angiomas, telangiectasia and other benign vascular lesions, the treatment of Pseudofolliculitis Barbae (PFB). The LightSheer Desire Light Laser System with LightSheer ET/XC Laser Handpiece is also indicated for hair removal, permanent hair reduction* and the treatment of benign pigmented lesions and leg veins.

• Note: 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.

The modified LightSheer Desire Light Laser System is a non-invasive aesthetic laser system that delivers pulsed infrared laser light with a wavelength ranging from 790-830 nm (805 nm nominal). The system consists of a laser console and two optional handpieces, ET or XC, which can be connected to the console, one at a time, via a universal plug-in connector and an umbilical cable.

The ET handpiece; delivers laser energy through a 9mm tip up to 81 J maximum. The settings for this handpiece are selectable pulse duration from 5-400 ms, selectable fluency from 10-100 J/cm² and a pulse repetition rate up to 3 Hz maximum. The XC handpiece; delivers laser energy through a 12mm x 12mm tip up to 58 J maximum. The settings for this handpiece are selectable pulse duration from 5-400 ms, selectable fluency from 10-40 J/cm² and a pulse repetition rate up to 3 Hz maximum

The laser system delivers pulsed infrared laser light from the diode array in the ET or XC handpiece to the treatment area. In standard use, the handpiece is pressed against the patient's skin and a pulse of light is delivered. To initiate energy output, the system requires redundant activation of the handpiece enable button and the handpiece trigger button while the system is in the Ready mode.

The ET and XC handpieces include a chilled sapphire tip that is water-cooled to provide active skin cooling. The physician is able to control the settings of laser energy from the LCD display on the main console.

The provided text describes the 510(k) premarket notification for the "LightSheer Desire Light Laser System." This document establishes substantial equivalence to a predicate device rather than focusing on specific performance metrics against pre-defined acceptance criteria for a new device. Therefore, it does not contain the detailed information necessary to fully answer all aspects of your request as it pertains to acceptance criteria and a study proving those criteria.

However, based on the information provided, here's what can be extracted and inferred:

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

The document does not present specific quantitative acceptance criteria or a table of performance metrics in the way one might expect for a study proving device performance against such criteria. Instead, it states that "Test results indicated that the subject LightSheer Desire Light Laser System performs in accordance with its requirements and specifications, in similarity to its predicate device."

The "performance" in this context refers to demonstrating that the modified device functions comparably to its predicate and meets safety standards. The categories of testing performed are:

The ultimate "acceptance criterion" for this 510(k) submission is that the device is "substantially equivalent" to the predicate device in terms of safety and effectiveness, and the document concludes that it meets this.

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

The document does not specify a "test set" in the context of clinical data for performance evaluation. The testing described (electrical, software, environmental, system) suggests a regulatory/engineering testing approach rather than a clinical study with a patient sample size. There is no mention of country of origin of data or whether it was retrospective or prospective, as no clinical data set is referenced.

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

Not applicable. This type of information is generally relevant for clinical studies involving expert interpretation of medical images or outcomes, which is not the primary focus of the performance testing described here. The "ground truth" for electrical safety, software function, etc., is based on engineering specifications and regulatory standards.

4. Adjudication method for the test set

Not applicable, as no human-reviewed data sets or adjudications are mentioned.

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 device is a laser system, not an AI-powered diagnostic or assistive tool for human readers.

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

This refers to the performance of the device itself as a physical system, rather than an algorithm. The "System testing" mentioned (e.g., energy measurements, handpiece cooling, safety controls) represents the standalone performance evaluation of the device's functional aspects. The document implies these tests were performed to ensure the device operates according to its specifications.

7. The type of ground truth used

The "ground truth" for the tests performed are primarily the engineering specifications, design requirements, and international safety standards (e.g., EN 60601-1, EN 60825-1, ISO 14971) against which the device's electrical, laser, mechanical, and software functionality were evaluated. For example, for "energy measurements," the ground truth would be the expected energy output within a specific tolerance, as defined by the device's design specifications.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this device is not an AI/machine learning system that requires training data.

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

Not applicable for the same reason as #8.

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