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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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755mm:
The Elite iQ Laser System 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 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 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 poikiloderma of Civatte; and treatment of benign 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 folliculitis 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™ 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 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 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 software features include a Windows® operating system, LCD touch screen and a state-of-the-art graphic user interface.

The provided FDA 510(k) summary for the Cynosure Elite iQ laser system primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance and safety testing. It does not involve an AI/ML-driven device, clinical studies to evaluate diagnostic performance (like those for AI-driven image analysis), or human-in-the-loop performance studies. Therefore, many of the requested categories (e.g., sample size for test/training sets, expert ground truth adjudication for AI, MRMC studies) are not applicable to this submission.

The "Performance Testing - Bench" section describes a validation study related to the "Hair Removal Treatment Guidance Mode" (which provides starting settings based on user input, not an AI algorithm) for safety. This is the closest aspect to "acceptance criteria and study that proves the device meets acceptance criteria" within the provided text, but it's not an AI/ML context.

Here's a breakdown based on the provided document, acknowledging the non-AI/ML context:

Device: Cynosure Elite iQ Laser System

Purpose of Submission (K193426): To demonstrate substantial equivalence to legally marketed predicate devices for indications related to hair reduction, vascular lesions, pigmented lesions, and wrinkle treatment, and for the Skintel Reader which measures skin melanin content.

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

The document states that "Performance testing showed no complications from using the recommended settings, thus confirming the treatment parameters set forth in the Hair Removal Treatment Guidance Mode are a safe starting point for practitioners performing test spots." It also mentions "Results showed no undesirable or unexpected AEs from test spots."

While explicit numerical acceptance criteria (e.g., "no more than X% of patients experience AE") are not presented in this summary section, the implicit acceptance criterion for the "Hair Removal Treatment Guidance Mode" validation was that the recommended settings would lead to no undesirable or unexpected adverse events (AEs) when applied as test spots.

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

• Test Set Sample Size: Not explicitly stated as a number of subjects. The document refers to "The subjects chosen were at the high end of the recommended skin type range."
• Data Provenance: The validation study was performed by E. Victor Ross MD, affiliated with Scripps Green Hospital in San Diego, CA (USA). It appears to be a prospective validation study, as it describes patients being "evaluated 48-72 hours post treatment."

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

• Number of Experts: One expert is explicitly mentioned: E. Victor Ross MD.
• Qualifications of Experts: Affiliated with Scripps Green Hospital in San Diego, CA. (Specific domain experience like "dermatologist with X years experience" is not detailed in this summary).

4. Adjudication method for the test set:

Not applicable in the context of this safety validation. The expert (E. Victor Ross MD) performed the study and evaluated the outcomes. There's no mention of multiple reviewers or an adjudication process for what would typically be an AI ground truth dataset in an AI/ML context.

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 system and a skin melanin reader; it does not involve AI assistance for human readers or interpretation of medical images.

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

Not applicable in the context of AI/ML. The "Hair Removal Treatment Guidance Mode" provides recommendations, but those are based on pre-programmed settings and user inputs, not an AI algorithm performing alone.

7. The type of ground truth used:

For the "Hair Removal Treatment Guidance Mode" validation, the "ground truth" was the observed absence of undesirable or unexpected adverse events (AEs) on patients following treatment with the system's recommended settings. This is akin to outcomes data related to safety.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. The "Hair Removal Treatment Guidance Mode" settings were "created based on previous user experience with the Elite+ Laser System," rather than being derived from a formal training dataset for an AI model.

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

Not applicable, as there was no formal "training set" in the context of an AI/ML algorithm. The settings were derived from "previous user experience" with an earlier product (Elite+ Laser System), suggesting historical clinical observations and expert consensus from practical application over time.

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