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The Light Age EpiCare™ Alexandrite Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs re-growing after a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin.

It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

The Light Age EpiCare™ Alexandrite Laser has an Alexandrite crystal rod as a lasing medium. Pulsed energy is emitted at 755 nanometers in the near infrared portion of the spectrum. Energy from the laser is delivered to the target area via optical fiber with handpiece, which produces a circular beam on the skin. The EpiCare™ Alexandrite Laser is equipped with safety interlocks to protect patients and operators.

This 510(k) summary does not contain the detailed study results that would allow for a complete description of acceptance criteria and device performance in the format requested. The document primarily focuses on establishing substantial equivalence to predicate devices rather than providing a standalone clinical study report with specific acceptance criteria and detailed performance metrics.

However, based on the provided text, I can infer some information relevant to the request.

Here's an attempt to answer your questions based only on the provided text, with significant limitations due to the nature of the document:

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

The document does not explicitly state quantitative acceptance criteria or detailed performance results in the form of percentages, p-values, or confidence intervals. The basis for safety and effectiveness is stated as "essentially the same wavelength, the same operation principle, essentially the same fluence levels, and the same spot size" as predicate devices. The indication for "permanent hair reduction" typically implies a specific percentage of hair reduction over a defined period, but this is not quantified in the provided text.

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 does not mention any specific sample size for a test set or provide details on data provenance (e.g., country of origin, retrospective/prospective study design). This 510(k) summary relies on demonstrating substantial equivalence to pre-existing predicate devices, not on a new clinical trial with a defined test set.

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. The document does not describe a study involving human experts establishing ground truth for a test set.

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

Not applicable. The document does not describe a study involving adjudication of a test set.

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 medical treatments, not an AI diagnostic or assistance system.

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

Not applicable. This is a medical device (laser), not an algorithm.

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

Given the nature of a 510(k) for a laser device, the "ground truth" for its effectiveness would generally be based on clinical outcomes (e.g., observed hair reduction, visual improvement of lesions/wrinkles) from studies (either specifically for this device or, more likely in a 510(k), for the predicate devices) and expert clinical judgment. However, the document does not detail how "ground truth" was established for any specific study for this device. It primarily relies on the established safety and effectiveness of its predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device that requires a training set.

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The Light Age EpiCare™ Alexandrite Laser is intended for use in dermatology for the removal of dark, unwanted body hair.

The Light Age EpiCare™ Alexandrite Laser is a medical device capable of emitting an invisible pulsed treatment laser beam with a wavelength of 755 mm under the guidance of a visible aiming beam. This laser can be utilized in either a continuous or timed-exposure mode of operation.

The provided text describes a 510(k) summary for the Light Age EpiCare™ Alexandrite Laser, claiming substantial equivalence to a predicate device, the Sharplan Model 5000 Alexandrite Laser System.

Based on the provided text, the following information regarding acceptance criteria and studies is available:

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

   Acceptance Criteria	Reported Device Performance
   Substantial equivalence to predicate device (Sharplan Model 5000 Alexandrite Laser System) in design and clinical perspective.	The Light Age EpiCare™ Alexandrite Laser is stated to be of "identical design" and have the "same intended use" as the predicate device. Light Age, Inc. previously supplied internal components for the Sharplan Model 5000 and is now taking over final assembly, sales, and distribution without product changes or new indications.
   Intended use: removal of dark, unwanted body hair.	The device is intended "for use in dermatology for the removal of dark, unwanted body hair."
   Safety and effectiveness.	"The safety and effectiveness of the Light Age EpiCare™ Alexandrite Laser is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device..." The document asserts that "As the predicate and candidate devices are identical in design and overall performance characteristics, the Light Age EpiCare™ Alexandrite Laser should not raise any concerns regarding its overall safety or effectiveness."
   Wavelength: 755 mm.	The device emits an "invisible pulsed treatment laser beam with a wavelength of 755 mm."
   Operation mode: continuous or timed-exposure.	The device "can be utilized in either a continuous or timed-exposure mode of operation."

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

   The document does not describe a specific test set or clinical study conducted for the Light Age EpiCare™ Alexandrite Laser itself. Instead, it relies on the safety and effectiveness data of the predicate device, the Sharplan Model 5000 Alexandrite Laser System, which FDA reviewed under K973354 and K971874. A letter of authorization from ESC Medical Systems was provided to allow FDA access to this predicate data.

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

   Not applicable, as no new clinical study data for the Light Age EpiCare™ Alexandrite Laser is presented or described in this 510(k) summary. The determination is based on the previously established ground truth for the predicate device, which is not detailed here.

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

   Not applicable, as no new clinical study data for the Light Age EpiCare™ Alexandrite Laser is presented or described in this 510(k) summary.

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. The device is a medical laser for hair removal, not an AI-assisted diagnostic or imaging tool involving human readers.

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

   Not applicable. The device is a medical laser, not an algorithm. Performance is assessed based on its physical characteristics and equivalence to the predicate.

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

   For the Light Age EpiCare™ Alexandrite Laser, the "ground truth" for its safety and effectiveness is established by its substantial equivalence to the predicate device, the Sharplan Model 5000 Alexandrite Laser System, along with the safety and effectiveness data previously submitted for that predicate device (K973354, K971874). The specific types of ground truth (e.g., patient outcomes, clinical measurements) used in the predicate device's evaluation are not detailed in this summary.

8. The sample size for the training set:

   Not applicable. The device is a physical medical laser, not a machine learning model requiring a training set.

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

   Not applicable, for the same reason as point 8.

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