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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.

LightSheer® Duet™ Laser Systems with LightSheer® ET™ Laser Handpiece is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. The LightSheer® Duet™ Laser System with LightSheer® ET™ Laser Handpiece is also intended for hair removal, permanent hair reduction, and the treatment of benign pigmented lesions and leg veins.

LightSheer® Duet™ Laser Systems with LightSheer® HS™ Laser Handpiece is intended for the treatment of benign vascular and pigmented lesions, hair removal, and permanent hair reduction.

The LightSheer Duet Laser System is a non-invasive aesthetic laser. The system delivers pulsed infrared laser light with a wavelength ranging from 790 - 950 nm (800 nm nominal) and has two unique treatment handpieces. One handpiece is the LightSheer® ET™ handpiece, which delivers laser energy through a 9 x 9 mm tip up to 90 J maximum. The settings for this handpiece are selectable pulse duration from 5 – 400 ms, selectable fluence from 10 - 100 J/cm2 and a pulse repetition rate up to 3 Hz maximum. The second handpiece is the LightSheer® HS™ handpiece, which delivers laser energy from a 22 x 35 mm diode array up to 45 J maximum. The settings for this handpiece are pulse duration from 10 - 30 ms, selectable fluence from 3 - 5.2 J/cm2 and multiple pulsing up to 3 pulses.

The complete system consists of a console and two handpieces connected to the system by umbilical cables. 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 LightSheer ET handpiece tip is watercooled to provide active skin cooling. The LightSheer HS handpiece tip uses vacuum and lower laser energy densities which reduces skin heating. The physician is able to control the settings of laser energy from the LCD display on the main console.

This section of the 510(k) submission for the Lumenis LightSheer® Duet™ Laser System is focused on establishing substantial equivalence to predicate devices, rather than presenting a study demonstrating new acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, device performance tables, sample sizes, expert involvement, and ground truth establishment is not present in the provided text.

Here's an analysis of the information that is available, and an indication of what is missing based on your request:

1. Table of acceptance criteria and the reported device performance:

• Not provided. This document does not detail specific performance acceptance criteria for the LightSheer Duet Laser System nor does it provide a table of reported device performance against such criteria. The submission aims to demonstrate "substantial equivalence" to predicate devices, implying that if the new device is sufficiently similar to an already cleared device, it doesn't need to meet new, separate performance criteria in the same way a novel device might.

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/Not provided. No specific test set or clinical study data is presented in this document to support new performance claims. The submission relies on demonstrating equivalence rather than new clinical proof.

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/Not provided. As no new clinical study data with ground truth establishment is presented, this information is not available.

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

• Not applicable/Not provided. See above.

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/Not provided. This device is a laser system, not an AI-powered diagnostic tool requiring human reader studies or AI assistance.

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

• Not applicable/Not provided. This device is a treatment system, not a standalone diagnostic algorithm.

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

• Not applicable/Not provided. See above.

8. The sample size for the training set:

• Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

• Not applicable/Not provided. See above.

Summary of what is provided in the text:

The provided text from the 510(k) submission for the Lumenis LightSheer® Duet™ Laser System focuses on describing the device and establishing its substantial equivalence to predicate devices already cleared by the FDA.

• Device Description: The document details the LightSheer Duet Laser System as a non-invasive aesthetic laser with two handpieces (LightSheer® ET™ and LightSheer® HS™) delivering pulsed infrared laser light. It describes their specifications (wavelength, fluence, pulse duration, spot size) and skin cooling mechanisms.
• Intended Use: The device is indicated for surgical, aesthetic, and cosmetic applications in general and plastic surgery, and dermatology, for all Fitzpatrick skin types (I-VI), including tanned skin. Specific indications for each handpiece include:
  • LightSheer® ET™: Treatment of vascular lesions (angiomas, hemangiomas, telangiectasia, other benign vascular lesions), pseudofolliculitis barbae, hair removal, permanent hair reduction, benign pigmented lesions, and leg veins.
  • LightSheer® HS™: Treatment of benign vascular and pigmented lesions, hair removal, and permanent hair reduction.
• Substantial Equivalence Claim: The core of this submission, as indicated by the "Substantial Equivalence" section, is that the specifications and indications for use of the LightSheer Duet Laser System are "the same or very similar" to those of its claimed predicate devices (Lumenis, Inc. LightSheer® Pulsed Diode Array Laser System and AesThera Corporation AIP™ Intense Pulsed Light System). The FDA's letter confirms that the device is deemed "substantially equivalent" for the stated indications for use.

Conclusion based on the provided text:

This 510(k) summary does not present new acceptance criteria or the results of a primary study to prove new performance claims. Instead, it relies on the FDA's "substantial equivalence" pathway, meaning the device is considered safe and effective because it is comparable to devices already legally marketed. Therefore, the detailed questions about study design, sample sizes, and ground truth establishment for a novel performance study are not addressed in this document.

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The LightSheer™ is intended to effect temporary hair reduction. The LightSheer™ is also intended to effect stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.

The LightSheer™ delivers pulsed infrared laser light with a wavelength of 800 nm, a selectable pulse duration of 5 - 30 ms, and a selectable pulse energy of 8 - 32 J. The corresponding fluence delivered through the 9 x 9 mm handpiece tip is 10 - 40 J/cm2. The laser pulses are generated at a maximum pulse repetition frequency of 1 Hz by an array of diode lasers located in the handpiece. The handpiece tip is water-cooled to provide active skin cooling.

The provided text describes the LightSheer™ Pulsed Diode Array Laser, which is intended for hair reduction. Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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

• Sample Size: The document does not specify the exact number of subjects or hair sites included in the clinical study. It only refers to "any subject."
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, given that it's a 510(k) submission for a new device claiming effectiveness for its intended use, it would typically be a prospective clinical trial conducted in the country of the applicant (USA, based on the address).

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 document. The clinical study describes "Observations of hair and skin responses were recorded," but it does not specify who made these observations or their qualifications.

4. Adjudication method for the test set

This information is not provided in the document.

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

An MRMC study was not done. This device is a laser for hair reduction, not an AI-assisted diagnostic tool for human readers.

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

This information is not applicable. The LightSheer™ is a physical medical device (laser system), not a software algorithm. Its performance is inherent in its operation, not in an algorithm that could be run standalone.

7. The type of ground truth used

The ground truth appears to be direct observation of hair regrowth and skin responses by unspecified personnel. The definition of "permanent hair reduction" also serves as a ground truth criterion. There is no mention of pathology or other objective outcome data, beyond visual assessment of hair and skin.

8. The sample size for the training set

This information is not applicable/provided. As a physical device, there is no "training set" in the context of machine learning. The device's parameters (wavelength, pulse duration, energy, fluence, etc.) are designed based on scientific principles and prior research into laser-tissue interaction for hair removal, rather than on a data-driven training process.

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

This information is not applicable/provided. As explained above, there is no "training set" for a physical laser device in the way there is for an AI algorithm. The scientific basis for its design would come from general knowledge of light absorption by melanin and tissue thermal damage, which is established through extensive scientific literature and research, not a specific "training set" with ground truth in the context of the regulatory submission.

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The LightSheer™ is intended to effect temporary hair reduction in skin types I-IV. The LightSheer™ is also intended to effect stable long-term, or permanent, hair reduction in skin types I-IV through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.

The LightSheer™ operates at a wavelength of 694.3 nanometers and the beam has a pulse duration of 3 and 20 milliseconds. Energy fluences of 10-60 J/cm² are achieved under conditions of intended use. A thermoelectrically cooled handpiece is held firmly against the treatment site.

The provided document is a 510(k) summary for the LightSheer™ Long Pulse Ruby Laser. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than detailing a specific clinical study with acceptance criteria and performance metrics in the way a traditional clinical trial report would.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, ground truth for training set) are not applicable or not provided by this type of regulatory submission.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics from a study designed to prove the device meets those criteria. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices for the specified indications for use.

• Temporary hair reduction in skin types I-IV
• Stable long-term, or permanent, hair reduction in skin types I-IV through selective targeting of melanin in hair follicles. (Permanent hair reduction defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.) | The 510(k) cleared the device for these specific Indications for Use. | Clearance implies the FDA found sufficient evidence (through substantial equivalence) that the device can achieve these intended effects. |

Study Details (Based on available information)

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

   • Not provided. The document states "Clinical Data: None required," indicating that a separate clinical efficacy study with a test set was not submitted for this 510(k) clearance. Clearance was based on substantial equivalence to predicate devices and engineering/performance data (though not detailed here).

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

   • Not applicable / Not provided. As no clinical efficacy study with a test set was required/submitted, there was no need for experts to establish ground truth for such a set.

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

   • Not applicable / Not provided. No clinical efficacy study with a test set.

4. 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 for hair reduction, not an AI-assisted diagnostic imaging device that would typically involve human "readers" or an MRMC study.

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

   • Not applicable. This is a medical device (laser system), not an algorithm or AI. Its performance is inherent to its physical operation, not an automated interpretation without human involvement. Humans operate the device.

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

   • Not explicitly stated as generated for this submission. The regulatory decision is based on a determination of substantial equivalence to predicate devices which presumably had their effectiveness established historically, potentially through clinical outcomes data or other means suitable for their time of clearance. For this specific 510(k), no new "ground truth" for a performance study was generated.

7. The sample size for the training set:

   • Not applicable. This device is hardware (laser system), not a machine learning algorithm that requires a "training set."

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

   • Not applicable. No training set was used.

Summary of Regulatory Approach:

This 510(k) submission for the LightSheer™ Long Pulse Ruby Laser gained market clearance through the "substantial equivalence" pathway. This means the manufacturer demonstrated that their device is as safe and effective as a legally marketed predicate device (in this case, other LightSheer™ models and the EpiLaser® Normal Mode Ruby Laser). This pathway often does not require new clinical efficacy studies if the technological characteristics and indications for use are sufficiently similar to the predicate. The statement "Clinical Data: None required" confirms this approach for this particular submission.

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The LightSheer™ is intended to effect hair removal of patients with skin types 1 - 4 through selective targeting of melanin in hair follicles. The LightSheer™ is a prescription device (12 CFR 801.109)

LightSheer™ laser is a long pulse ruby laser which delivers its energy to the treatment site via two quartz fiber optics. The beam exits from a chilled hand piece which is held in firm contact with the skin at the treatment site.

The provided text is a 510(k) summary for the LightSheer™ Long Pulse Ruby Laser. It outlines the device's intended use and claims substantial equivalence to a predicate device, the EpiLaser®. However, it explicitly states "None required" for performance data. This means a study specifically proving the device meets acceptance criteria was not conducted or reported in this submission because the FDA deemed it unnecessary due to the substantial equivalence claim.

Therefore, many of the requested details about acceptance criteria and a detailed study are not available in this document.

Here's what can be extracted based on the provided text, with clarifications where information is missing:

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

Since "Performance Data: None required" is explicitly stated, there are no specific numerical acceptance criteria or reported device performance metrics from a study to present in a table. The basis for clearance is substantial equivalence to the predicate device, not a new performance study.

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

• Sample Size for Test Set: Not applicable, as no performance data study was conducted or reported.
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable, as no performance data study was conducted or reported.

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

• Not applicable, as no performance data study was conducted or reported.

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 for hair removal, not an AI-assisted diagnostic tool that would involve human readers.

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

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

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

• Not applicable, as no performance data study was conducted or reported.

8. The sample size for the training set

• Not applicable, as no performance data study was conducted or reported.

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

• Not applicable, as no performance data study was conducted or reported.

Summary of Device Acceptance:

The LightSheer™ Long Pulse Ruby Laser was accepted based on a substantial equivalence claim to the legally marketed predicate device, the EpiLaser®. The 510(k) summary argues that "The specifications, performance and intended use of the LightSheer™ are the same or similar as the EpiLaser®" and "The differences between the lasers are not significant in terms of the performance or intended use of the LightSheer™." Therefore, the FDA did not require a new performance study to prove the device meets specific acceptance criteria.

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