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532mm
The ELEMENT-TL is indicated for coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lessons angiomas (port wine), telangiectasia (facial or extremities telangiectasias.venous anomalies, leg veins); benien pigmented lesions (nevi, lentigines, chloasma, cafk-au-lait, tattoos (red and green ink); verrucae; skin tags; keratoses; plaques; cutaneouslesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).

755 nm
The ELEMENT-TL is indicated for stable long-term, or permanent hair reduction which 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. It is used for all 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 ELEMENT-TL is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider 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, lentigos (age spots), safe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) 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 removal of unwanted hair, for the stable long term, or permanent hair reduction which 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 targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae (PFB).

The subject device is composed of the main body and a handpiece which is an irradiation device and as an accessory part, protective goggles for protection of the worker.

This equipment is controlled by a micro-processor interfaced to a LCD touch screen control panel. The computer controls start and stop of the treatment. When the key switch of the system is turned clockwise, the main power will be inputted, which will be conveyed to the hand piece through the control board.

Meanwhile, the control board connected to the touch screen is connected to the lamp of the handpiece and controls the same, and controls the whole system through the data connected to the touch screen control panel. When the switch of the hand piece is pressed, the lamp will laser.

This document describes a 510(k) premarket notification for the ELEMENT-TL medical laser system. The primary goal of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than to prove safety and effectiveness through clinical trials in the same way a PMA (Pre-Market Approval) would.

Therefore, the study supporting this submission is not a clinical study demonstrating improved human reader performance with AI, or a standalone algorithm performance study. Instead, it is focused on non-clinical performance data and a direct comparison to a predicate device to establish substantial equivalence.

Here's an analysis based on the provided text, addressing your questions where applicable, and noting where information is not present given the nature of a 510(k) submission for this type of device:

Device: ELEMENT-TL

Predicate Device: ORION by YERIM ENGINEERING Co., Ltd. (K161503)

Type of Study: This is a premarket notification (510(k)) which relies on demonstrating substantial equivalence to a predicate device through non-clinical performance testing, rather than a clinical trial or AI performance study with human readers.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly met by demonstrating compliance with recognized electrical safety, electromagnetic compatibility, usability, and laser safety standards, and by showing that the technical specifications are comparable to the predicate device. The performance data presented are primarily non-clinical, showing adherence to these standards.

Key Performance Data (Technical Comparison to Predicate):

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of clinical patient data here. The "test set" refers to the device itself being tested for compliance with standards and comparison to a predicate, not a dataset of patient images or outcomes.
• Data Provenance: Not applicable for patient data. The non-clinical testing was performed on the device itself. The origin of the predicate device (YERIM ENGINEERING Co., Ltd.) is Republic of Korea.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• This information is not provided and is generally not required for a 510(k) submission of a laser surgical instrument, which doesn't involve subjective interpretation of medical images by human experts. The "ground truth" here is compliance with engineering and safety standards, and functional equivalence to the predicate device's specifications.

4. Adjudication Method for the Test Set

• Not applicable. There is no adjudication of subjective interpretations as this is not a study involving human readers and interpretations of medical data. Performance is assessed against objective engineering standards and technical specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC study was not done. This device is a laser surgical instrument, not an AI-based diagnostic or assistive software. Therefore, there is no AI assistance for human readers, and no "effect size of how much human readers improve" to report.

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

• Not applicable. This is a hardware device, not a standalone algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is based on compliance with recognized international and national consensus standards (IEC standards for medical electrical equipment, laser safety, and usability) and direct comparison of the device's technical specifications and indications for use to a legally marketed predicate device. There is no reliance on expert consensus (e.g., radiology reads), pathology, or patient outcomes data in this 510(k) summary for establishing substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. See point 8.

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