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The InMode SR IPL Device wavelengths (515-1200nm) are indicated for use for the following treatments:

• . The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
• The treatment of benign cutaneous vascular lesions, including port wine stains, . facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, superficial leg veins and venous malformations.

The InMode SR IPL device is designed to deliver optical energy to the skin via a pre-cooled sapphire block. The good optical contact between sapphire block and skin is achieved by using water based gel. The device provides individual adjustment of light fluence and pulse duration to achieve maximum efficiency and safety for each patient. The hand piece has integrated skin cooling to enhance safety and comfort of the treatment.
The InMode SR IPL device consists of an AC/DC power supply unit, water cooling system, controller, user interface including a LCD screen and functional buttons and IPL hand piece. The IPL hand piece is connected to the console via a cable. The hand piece comprises a flash lamp, reflector, water flow tube and cooled sapphire output window (10 x 30 mm).

Here's a breakdown of the acceptance criteria and study information for the InMode SR IPL Device based on the provided text:

Important Note: The provided 510(k) summary explicitly states "Clinical Performance Data: Not Applicable." This means no clinical study was conducted by InMode MD to demonstrate the device's efficacy or safety on human subjects for this submission. The device received clearance based on substantial equivalence to a predicate device, which is a common pathway for medical device approval. Therefore, many of the typical questions about study design, sample sizes, and ground truth generation will not be applicable in this context.

Acceptance Criteria and Device Performance

Since no clinical study was performed for this 510(k) submission, there are no specific performance-based acceptance criteria or reported device performance metrics in the typical sense (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance criteria" are based on demonstrating substantial equivalence to a legally marketed predicate device (Sciton Profile BBL) and compliance with voluntary recognized standards.

Table of Acceptance Criteria (as demonstrated by substantial equivalence and standards compliance):

Study Details (or lack thereof, as applicable):

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

   • Not Applicable. No clinical test set involving human subjects was used for this 510(k) submission. The device gained clearance through substantial equivalence to a predicate device and compliance with recognized standards.

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

   • Not Applicable. As no clinical test set was created or used, there was no need for experts to establish ground truth.

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

   • Not Applicable. No clinical test set was used, so no adjudication method was employed.

4. 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 is a medical device, specifically an IPL (Intense Pulsed Light) device. It is not an AI/software as a medical device (SaMD) that assists human readers in diagnosis. Therefore, no MRMC comparative effectiveness study was conducted with human readers or AI assistance.

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

   • Not Applicable. This is a physical medical device, not an algorithm. The device's performance is assessed by its physical specifications, safety, and equivalence to a predicate, not by algorithmic standalone performance.

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

   • Not Applicable. Since no clinical study was performed for this 510(k) submission, there was no ground truth established from expert consensus, pathology, or outcomes data for the InMode SR IPL device itself. The basis for clearance relies on the established safety and efficacy of the predicate device (Profile BBL) and the InMode SR's demonstrated equivalence to it.

7. The sample size for the training set:

   • Not Applicable. As this is not an AI/machine learning device, there was no "training set" in the context of algorithm development.

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

   • Not Applicable. See point 7.

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