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MOTUS PRO family is a medical laser family intended for:

Alexandrite 755nm laser source:

• Temporary hair reduction.

• Stable long term or permanent hair reduction through selective targeting of melanin in hair follicles.

• 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 on all skin types (Fitzpatrick I-VI) included tanned skin.

• Treatment of benign pigmented lesions.

• Photocoagulation of benign dermatological vascular lesions (such as port wine stains, hemangiomas, telangiectasias).

Nd:YAG 1064nm laser source:

• Removal of unwanted hair for stable long term or permanent hair reduction and for treatment of PFB. The laser are indicated on all Skin Types Fitzpatrick I-VI including tanned skin.

• Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to, port wine stains, hemangioma, warts, teleangiectasias, rosacea, venus lake, leg veins and spider veins.

• Coagulation and hemostasis of soft tissue.

• Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafè au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.

• The laser is indicated for benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patient with lesions that have not responded to other treatments.

The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

• Treatment of wrinkles.

MOTUS PRO family is a medical laser family equipped with Alexandrite 755mm laser and Nd:YAG 1064nm laser. The laser sources deliver the laser output through a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition. The device available with Alexandrite source only has the brand name MOTUS PRO AX.

The modifications to the device respect to DEKA Motus AZ (K211821) consist of a restyling of the device (chassis, cover plastic and GUI) and on modification to spot size ranges (new spot size available), pulse duration, 755mm maximum fluence and maximum pulse repetition rate. The modified specifications are within the range of the already cleared reference device (K233090).

The intended use of modified device, as described in the labelling has not changed as a result of the modifications. Labelling itself has been updated also to include general improvements that have been implemented since clearance of predicate device and reference device and considered as minor changes.

This FDA 510(k) Premarket Notification document for the MOTUS PRO Family laser device outlines the basis for substantial equivalence to predicate devices, but does not contain a detailed study report with specific acceptance criteria and performance data in the format typically used for AI/ML device evaluations.

The provided document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (DEKA Motus AZ (K211821) and DEKA AGAIN PRO family (K233090)) based on identical or within-range technical specifications and indications for use.

Therefore, I cannot extract the specific information requested in the prompt regarding a detailed study with acceptance criteria and device performance metrics, sample sizes, ground truth establishment, or expert involvement as these details are not present in the provided text.

However, I can provide what is available regarding performance data and testing:

Summary of Performance Data (as reported in the document):

The document mentions that electrical safety, electromagnetic compatibility (EMC), and software verification and validation testing were conducted.

There is no specific clinical study data provided in this document that would allow for the construction of a "table of acceptance criteria and reported device performance" in the context of clinical efficacy or diagnostic accuracy. The substantial equivalence is based on the device's technical specifications and intended use being comparable to existing devices.

Regarding the specific questions you asked:

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

   • Not provided in the document. The document details technical specifications of the device and compares them to predicate devices, stating they are "identical" or "within the range" of the reference device. It does not present a formal table of clinical acceptance criteria and the device's performance against them.

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

   • Not provided in the document. The document does not describe a clinical test set or its characteristics.

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 provided in the document. No information about ground truth establishment or expert involvement for a test set is mentioned.

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

   • Not provided in the document. No information about adjudication methods is 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 provided in the document. This document is for a laser device, not an AI/ML device for interpretation, so an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned.

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

   • Not applicable. This device is a laser surgical instrument, not an algorithm.

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

   • Not provided in the document. No information about ground truth for clinical efficacy is mentioned. The "performance data" section focuses on engineering safety and software validation, not clinical outcomes.

8. The sample size for the training set:

   • Not applicable/provided. As this is a laser device and not an AI/ML algorithm, there isn't a "training set" in the conventional sense of machine learning.

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

   • Not applicable/provided.

What the document does state regarding performance data:

• Electrical safety and electromagnetic compatibility (EMC): Tested according to AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1. This ensures the device meets fundamental safety and performance requirements for medical electrical equipment and laser products.
• Software Validation and Verification Testing: Conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submission for Device Software Functions." This ensures the software components of the device are reliable and function as intended.

Conclusion stated by the manufacturer:

Based on the comparison of indication for use and the technological characteristics (which are identical or within the range of predicate devices), the manufacturer concludes that the MOTUS PRO family device is safe, effective, and performs as well as the legally marketed predicate devices. This implies that compliance with the listed safety standards and software validation are sufficient for demonstrating substantial equivalence given the nature of the modifications (restyling, modifications to spot size ranges, pulse duration, maximum fluence, and maximum pulse repetition rate, all within the range of already cleared devices).

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