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The mJoule 1064 laser systems and accessories is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastic, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.

Dermatology:
Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lake, leg veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café 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 lasers are indicated for pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Removal of unwanted hair, for the stable long term. or permanent hair reduction through selective of melanin in hair follicles, and for the treatment for pseudo folliculitis barbae (PFB). The mJoule 1064 laser system and accessories is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The mJoule 1064 laser system and accessories is indicated for the treatment of facial wrinkles.
Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and T.
mentagrophytes, and/or yeasts Candida albicans, etc.).
Treatment of Aphthous Ulcers.
Excision and Vaporization of Herpes Simplex I and II.
Laser assisted uvulopalatoplasty (LAUP).
Laser assisted lipolysis.
Treatment of mild to moderate inflammatory acne vulgaris.

Surgical Applications:
Incision/excision and cutting, ablation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastic, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g., menorrhagia) and urology.

The mJOULE 1064nm Laser System consists of a console and laser delivery accessories. It uses focusing optics to deliver optical energy to the treatment site. The control console houses the power supply, cooling system, fiber arm delivery system with a handpiece. The user activates laser emission by means of a footswitch.

1. Acceptance Criteria and Device Performance:

The provided document does not explicitly present a table of acceptance criteria and reported device performance in the typical format of quantitative metrics (e.g., sensitivity, specificity, accuracy) against predefined thresholds. Instead, it demonstrates substantial equivalence to predicate devices based on shared technical characteristics and indications for use.

The "acceptance criteria" are implied by the substantial equivalence determination process itself. The device (mJOULE System) is deemed to meet the acceptance criteria because its specifications and performance are comparable to legally marketed predicate devices, and it has successfully passed various recognized safety and performance standards.

Here's a table summarizing the comparative technical specifications that serve as the basis for demonstrating equivalence:

The study that proves the device meets the acceptance criteria is the non-clinical performance testing outlined in the "Summary of Non-clinical Tests" section. This testing demonstrates that the mJOULE System is safe and effective and performs comparably to its predicate devices.

2. Sample Size for the Test Set and Data Provenance:

The document describes non-clinical performance and safety testing against recognized consensus standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1) and biocompatibility testing (ISO-10993-1).

• Sample Size: For instrument performance and safety tests, the "sample size" typically refers to the number of devices or components tested. The document does not specify the exact number of mJOULE systems or components tested for each standard. This is common for this type of submission, as the focus is on demonstrating compliance with recognized standards rather than a broad statistical analysis of device performance across a large population. For biocompatibility, it mentions evaluating the sapphire window and gold frame of the ClearV handpiece.
• Data Provenance: The testing was prospective in the sense that it was conducted on the mJOULE system and its accessories specifically to demonstrate compliance for this submission. The "country of origin of the data" is not explicitly stated, but it would have been generated in a controlled testing environment, likely at the manufacturer's facilities or accredited testing laboratories.

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

This information is not applicable in this context. The "ground truth" for non-clinical performance and safety testing is established by recognized international standards (e.g., IEC, ISO) and regulatory requirements (e.g., basic safety, essential performance, EMC, usability). The device's performance is measured against these established engineering and safety benchmarks, not against expert interpretation of clinical outcomes for a specific disease or condition.

For biocompatibility, the ground truth is established by the ISO 10993-1 standard, which outlines methods for evaluating biological reactions to medical devices. This involves expert toxicologists and material scientists interpreting the results against established safety thresholds.

4. Adjudication Method for the Test Set:

This is not explicitly applicable in the context of non-clinical device testing. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or patient outcomes, where there might be inter-reader variability.

For performance and safety testing, the results are objectively measured against predefined criteria within the standards. Any discrepancies or failures would lead to further investigation and design modifications until compliance is achieved. There isn't a "consensus" process for interpreting a test result being within or outside a specification, but rather an objective verification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was NOT done.

This type of study is specifically designed to evaluate the impact of a medical device (often AI-assisted) on the diagnostic accuracy or treatment decisions of human readers. The mJOULE System is a laser system for surgical and aesthetic applications, not an AI-driven diagnostic or interpretative device that assists human readers. The submission focuses on demonstrating substantial equivalence in terms of technical characteristics and existing indications for use, without introducing new clinical claims that would necessitate an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This concept is not directly applicable. The mJOULE system itself is a physical laser device operated by a human. While it has software ("Software verification and validation testing documents are provided..."), the "standalone performance" of the algorithm is integrated into the device's overall function and assessed through the mentioned performance and safety standards. There isn't an "algorithm only" performance that produces clinical outputs independent of the human operator and the device hardware, as might be the case for an AI diagnostic algorithm. The software is part of the control system that ensures the device operates safely and as intended.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is multi-faceted, based on:

• Compliance with Recognized Consensus Standards: The primary ground truth is established by international standards such as IEC 60601 series, IEC 60825-1, and ISO 10993-1. These standards define the acceptable limits for electrical safety, electromagnetic compatibility, usability, essential performance, laser safety, and biocompatibility.
• Predicate Device Equivalence: A significant part of the submission relies on demonstrating that the mJOULE System's technical characteristics and indications for use are substantially equivalent to legally marketed predicate devices. The "ground truth" here is the established safety and effectiveness of those predicate devices, as previously cleared by the FDA.
• Software Verification and Validation: For software, the ground truth is compliance with specified software requirements and successful execution of test cases as per "Guidance for the content of premarket submissions for software contained in medical devices."

8. The Sample Size for the Training Set:

This information is not applicable. The mJOULE System, as described, is a physical laser device and does not appear to employ machine learning or artificial intelligence in a way that would require a "training set" for an algorithm. The software mentioned is for control, safety, and usability, which typically undergoes traditional software verification and validation, not machine learning model training.

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

This information is not applicable because there is no mention of a training set or machine learning algorithm in the provided document.

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