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The Spirit Hair Removal laser Family intended for dermatological use. The devices are specifically indicated for hair removal, permanent hair reduction by using selective laser energy.

The Spirit Hair Removal laser Family is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin. Permanent reduction in hair regrowth is defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The Spirit Hair Removal laser Family has two models of the same device (916, & 918) and several trade names. The devices apply photothermal energy to human skin tissue to effect a desired change in the structure of the tissue. The energy is transmitted from a 810nm laser diode to the target tissue by a Treatment Handpiece that is in contact with the skin.

The 918 and 916 models have fully identical HW. The difference in the optical output power (6 -90J/cm² for the 918 model and 4.5 to 10J/cm² for the 916 model) is preset.

For the hair removal treatment, the devices utilized laser energy at the spectrum of 810nm (IR) which is absorbed by the Melanin which is located in the hair follicles. Once the energy is absorbed, it is turned into heat. The heat coagulates the hair follicles and removes the unwanted hair.

The Spirit Hair Removal laser Family was designed to comply with international standards and is constructed from metal, plastic a diode laser and other electronic components.

The provided text is a 510(k) premarket notification for the "Spirit Hair Removal Laser Family" (K153718). It focuses on demonstrating substantial equivalence to a predicate device (Soprano XL K112031) rather than presenting a study to prove a device meets specific acceptance criteria based on its own clinical performance for effectiveness.

Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria cannot be extracted directly from this document. The document primarily describes the justification for substantial equivalence through comparison with a previously cleared device and adherence to safety standards.

Here's a breakdown of the information that can be extracted, and where requested information is not available:

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

The document does not explicitly state "acceptance criteria" for clinical performance that the device itself must meet (e.g., a specific percentage of hair reduction to be considered effective). Instead, it establishes substantial equivalence by comparing its technological characteristics and intended use to a predicate device.

The tables provided compare features of the Spirit Hair Removal Laser Family to the predicate device, demonstrating they are technologically similar and perform comparably, which serves as the basis for substantial equivalence rather than fulfilling novel performance criteria.

The acceptance criterion for this submission is "substantial equivalence" to the predicate device. The performance shown is that the Spirit Hair Removal Laser Family's characteristics and safety comply with relevant standards and are comparable to those of the predicate.

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 mentions "Bench and clinical data demonstrate that the Spirit Hair Removal laser Family meet the required specifications." However, no sample size or specific details about a clinical test set are provided. The focus is on demonstrating equivalence through technical specifications and safety standards, rather than direct new clinical efficacy data for this specific device. The clinical data referred to might be from the predicate device or a general understanding, but details are absent for the Spirit Hair Removal Laser Family.

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. This document does not describe a study involving expert assessment to establish a "ground truth" for a test set.

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

Not applicable. No such study involving adjudication is described.

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 device that would involve human readers or AI assistance in interpretation.

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

Not applicable. This refers to an algorithm's performance, which is not relevant for a physical laser device. The "performance" of the laser is its ability to meet documented technical specs and operate safely.

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

Not applicable, as no specific clinical efficacy study is detailed for this device where a ground truth would be established. The document relies on the "ground truth" that the predicate device is safe and effective for its indicated use, and the new device is substantially equivalent. The definition of "Permanent reduction in hair regrowth" 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" could be considered an "outcomes data" ground truth for hair removal efficacy generally, but it's not a parameter measured in a new clinical study for this submission.

8. The sample size for the training set

Not applicable. This device is a physical laser system, not an algorithm that requires a training set.

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

Not applicable. This device is a physical laser system, not an algorithm that requires a training set.

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The Crystal , Record & Optima are generally intended for dermatological use. The device is specifically indicated for removal of hair by using selective light energy.

The Crystal & Record are two models of the same device. The Optima is an additional commercial name of the Record. The device applies photothermal energy to human skin tissue to effect a desired change in the structure of the tissue. The energy is transmitted from a light source to the target tissue by a Treatment Handpiece that is in contact with the skin.

The provided text describes a 510(k) submission for the Crystal, Record, and Optima photoepilation systems. However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics to fill out the table and answer all the requested questions.

The document states: "Bench and clinical data demonstrate that the Crystal, Record & Optima meet the required specifications." but does not elaborate on what those specifications are, how they were measured, or the results.

Therefore, many sections of your request cannot be fulfilled from the provided text. I will fill in what can be inferred or explicitly stated.

Here's a breakdown of what can and cannot be answered from the provided text:

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

• Cannot be fully provided. The document states "Bench and clinical data demonstrate that the Crystal, Record & Optima meet the required specifications," but it does not specify what those specifications are (the acceptance criteria) nor does it report the specific performance metrics achieved by the device.

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

• Cannot be provided. The document mentions "clinical data" but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective).

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

• Cannot be provided. The document does not describe how ground truth was established, nor does it mention any experts for this purpose.

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

• Cannot be provided. The document does not describe any adjudication method.

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:

• Cannot be provided. The device is a photoepilation system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study with AI assistance for human readers is not applicable or mentioned.

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

• Cannot be provided directly. The device, being a photoepilation system, operates as a standalone system by design (it's applied to the skin to remove hair). However, the document does not describe a formal "standalone performance study" in the context of diagnostic AI algorithms. It merely states that the device was tested.

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

• Cannot be provided. The document does not specify how "ground truth" (e.g., successful hair removal) was established for its clinical data.

8. The sample size for the training set:

• Cannot be provided. The document does not mention any training set, as it describes a medical device, not an AI model requiring a distinct training set.

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

• Not applicable. No training set is mentioned for this type of device.

Here is a summary of what can be extracted, and where information is missing:

The acceptance criteria and study data are explicitly not detailed in the provided 510(k) summary. The document states that "Bench and clinical data demonstrate that the Crystal, Record & Optima meet the required specifications" and that "No adverse affects have been detected." However, it does not list these specifications (acceptance criteria) or present the actual results from the bench and clinical studies that prove they were met.

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