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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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755mm:

The Elite iQ PRO Laser System is indicated for stable long-term or permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 or 12 months after the completion of a treatment regime. It is used for skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

1064nm:

The Elite iQ PRO Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lakes, leg veins and porkiloderma of Civatte; and treatment of beingn cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigines (age spots), solar lentigines (sunspots), cafe au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

Additionally, the laser is indicated for the treatment of pseudo follicultis barbae (PFB) and for stable long-term or permanent hair reduction. Permanent hair reduction is defined as 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 Skintel Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot starting fluence.

The Elite iQ™ PRO workstation is a dual wavelength system that delivers laser energy in both the Nd:YAG (1064-nm) and Alexandrite (755-nm) wavelengths. Through various spot sizes, fluences and repetition rates, the system offers hair removal treatment and aesthetic treatments across all skin types. An Alexandrite standalone workstation is also available for purchase. The Elite iQ PRO delivers the laser energy through a lens-coupled optical fiber with a wide range of interchangeable, quick-release laser handpieces with electronic spot recognition. The Elite iQ PRO also includes the Skintel® Melanin Reader for objective measurement of the melanin content of skin.

The locking casters allow this stand-alone laser system to be secured in place, as well as to be conveniently moved or transported. When not in use, handpiece components and other system components can be stowed in the storage area located in the side drawer. All system connections, such as the foot switch and remote interlock connections, are located on the rear of the laser. This includes all applicable device labels. User-selectable controls and functions are located on the front of the laser.

Elite iQ PRO software features include a Windows® operating system, LCD touch screen and a state-of-the-art graphic user interface. The software of the device was changed to update the fluence levels for the handpieces in order to support the new 30mm handpiece. The new 30 mm handpiece is also part of the DEKA AGAIN PRO device (K233090). The new fluence levels are within range of the previously approved ranges in the Elite iQ device (K193426). The software was also updated to reflect the Elite iQ PRO branding.

There are no changes to the principle of use of the device compared to the predicates Elite iQ Laser System (K193426) and DEKA AGAIN PRO (K233090).

The labeling of the device has been updated to reflect the name of the device Elite IQ PRO Laser System.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Elite iQ PRO (M122K1) device.

Key Observation: The provided 510(k) summary primarily focuses on establishing substantial equivalence to predicate devices (Elite iQ Laser System (K193426) and DEKA AGAIN PRO (K233090)) through comparison of technical characteristics and intended uses. It does not contain details about a clinical study with acceptance criteria for device performance in terms of efficacy or diagnostic accuracy (e.g., sensitivity, specificity, accuracy) for its intended indications (hair reduction, vascular lesions, etc.).

Instead, the "acceptance criteria" and "study" described are in the context of verification and validation activities against recognized electrical and laser safety standards, and comparing technical specifications to predicate devices.

1. Table of acceptance criteria and the reported device performance

Based on the provided text, the "acceptance criteria" appear to be compliance with established safety and performance standards for medical electrical and laser equipment, as well as maintaining similar technical characteristics to predicate devices. The "reported device performance" is implicitly that the device meets these standards and maintains comparable technical specifications.

Note: The document explicitly states: "The following verification and validation activities have been performed on the modified device." This indicates that the studies performed were primarily focused on demonstrating compliance with these technical and safety standards, rather than clinical efficacy.

Regarding Device Performance (from comparison tables):

The device's performance is described in terms of its technical specifications, which are compared to predicate devices. The key updates for the Elite iQ PRO are:

• Repetition Rate: Up to 12 Hz (compared to 10 Hz for Elite iQ and 12 Hz for DEKA AGAIN PRO).
• Handpiece (Spot) Size: Addition of a 30mm handpiece, similar to DEKA AGAIN PRO (Elite iQ had up to 24mm).
• Software update to reflect new fluence levels for the 30mm handpiece and Elite iQ PRO branding.

These are considered performance improvements or equivalences rather than demonstrating achievement of specific clinical acceptance criteria through a trial.

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 a clinical test set sample size, data provenance, or whether it was retrospective or prospective. The studies appear to be technical verification and validation, not clinical trials on patients.

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)

This information is not provided in the document. As no clinical efficacy or diagnostic accuracy study is described, there's no mention of experts establishing ground truth for a patient test set.

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

This information is not provided, as the document does not describe a clinical test set requiring adjudication.

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

There is no mention of an MRMC comparative effectiveness study, nor any AI assistance/human-in-the-loop performance data. The device is a laser system and a melanin reader; it does not appear to incorporate AI for interpretation or diagnosis that would necessitate such a study.

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

This is not applicable as the device is a laser system and a melanin reader, not an AI algorithm performing diagnostic tasks.

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

Since the studies described are for technical verification and validation against standards, the "ground truth" would be the specifications and requirements of those engineering and safety standards. For the Skintel Melanin Reader accuracy, the ground truth would be established by reference measurements or calibrated instruments. There is no mention of clinical ground truth (e.g., pathology, outcomes data) for the efficacy of hair removal or lesion treatment.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML device that requires a training set in the conventional sense.

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

This is not applicable for the same reason as above.

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