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The E-PEN is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years and older.

The E-PEN is a microneedling device that mechanically creates microscopic punctures in the epidermal and dermal layers of the skin by means of micro-needles in a reciprocating cartridge head. The E-PEN is comprised of a reusable pen body, a sterile, single use microneedling cartridge, and a power adapter. The microneedling cartridge is attached to the pen body and activated with an On/Off button. The depth of needle penetration can be adjusted by the user depending on the condition of the skin being treated. Charging is accomplished by attaching the E-PEN pen body to the power adapter.

This document is a 510(k) clearance letter for the E-pen microneedling device. It contains regulatory information and a summary of performance data. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of clinical effectiveness or performance as an AI/software device. This type of information is typically found in clinical study reports, scientific publications, or more detailed regulatory submissions for AI-powered devices, which are not present in this 510(k) clearance letter for a microneedling device.

The provided information focuses on:

• Regulatory Classification: The device is a Class II microneedling device for aesthetic use (21 CFR 878.4430).
• Intended Use: To improve the appearance of facial acne scars in adults aged 22 years and older.
• Technical Specifications: Comparison with a predicate device (SkinPen Precision System, DEN160029) showing similar design, materials, and operating parameters (e.g., number of needles, needle gauge, penetration depth, speed).
• Non-Clinical Performance Data: Biocompatibility, sterilization validation, sterility/shipping/shelf-life, EMC (Electromagnetic Compatibility), electrical safety, software validation (moderate level of concern), and bench testing (needle length, penetration depth, speed, prevention of re-use).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving clinical effectiveness or AI performance based on this document. The document primarily demonstrates substantial equivalence to a predicate device based on technical and safety specifications, not a new clinical performance study against specific acceptance criteria for a health outcome based on AI.

If this were a submission for an AI-powered device, the information requested (AI performance, ground truth, experts, etc.) would be crucial and would typically be provided in a different section or supplementary documentation.

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The RM STAR EX with RMS Needle is intended for use in dermatologic procedures for electrocoagulation and hemostasis.

The RM STAR EX with RMS Needle includes a system main device and a handpiece equitable with a bipolar electrode. The RF signal is generated from the main device which is then delivered to the handpiece and then to bipolar electrode. The RF signal is delivered to the target tissue using penetrating needle electrodes in the consumable tip. The bipolar electrode is placed in light contact with the epidermis while the handpiece is being held at right angles to the target tissue. As the RF signal passes through the skin, it generates an electrothermal reaction which is capable of coagulating the tissue. Using the consumable tip, RM STAR EX with RMS Needle creates heat within the target skin tissue via needle electrodes from the bipolar electrode.

The provided document describes a 510(k) premarket notification for the "RM STAR EX with RMS Needle" device. This device is an electrosurgical cutting and coagulation device and accessories, intended for use in dermatologic procedures for electrocoagulation and hemostasis. The submission aims to demonstrate substantial equivalence to the predicate device "SYLFIRM X" (K213612).

However, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set (clinical data related to accuracy/performance against a ground truth).
• Data provenance for a test set.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone performance (algorithm only without human-in-the-loop performance).
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set (as this is not an AI/ML device in the context of diagnostic interpretation).
• How ground truth for the training set was established.

The document primarily focuses on demonstrating the substantial equivalence of the RM STAR EX with RMS Needle to its predicate device through non-clinical performance data. This includes:

• Biocompatibility Testing: Conducted according to ISO 10993-1, covering cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity.
• Sterilization Validation Test: Performed using the biological indicator (BI) overkill method following ISO 11135 guidelines to confirm a sterility assurance level of 10^-6 for EO sterilization.
• Shipping, Packaging, and Shelf Life: Included pyrogen tests (USP , ), package integrity testing (ASTM D4169-22), and sterile barrier packaging testing (ASTM F88/F88M-15, F1929-15). Shelf life validated using ASTM F1980-21.
• Electrical Safety and EMC Test: Evaluated according to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC TR 60601-4-2, EN 55011, and IEC 61000-3-2.
• Software Validation Test: Performed for a device with a moderate level of software concern.
• Pre-clinical Test (Animal Study): This is the closest to a performance study, assessing the safety and effectiveness on tissue.

Pre-clinical Test (Animal Study) Details:

• Study Design: Radiofrequency (RF) microneedling was applied to liver, kidney, muscle, and skin of rabbits. Animals were euthanized at 3 hours, 5 days, and 22 days post-treatment.
• Tissue Reactions:
  • Internal organ models: Minimal hemorrhage and fibrosis, no significant gross lesions.
  • Skin model: Mild dermal necrosis initially, good recovery with minimal fibrosis by Day 22.
• Histological Findings: Localized and well-controlled tissue damage, signs of healing and regeneration, no major adverse reactions.
• Conclusion: Demonstrated controlled tissue interaction, no adverse effects, and effective healing in both skin and internal organ models, confirming safety and effectiveness.

Differences with Predicate Device and Justification (related to performance):

The document highlights differences in Conduction Time, Depth, and Number of Electrodes compared to the predicate. For each, the differences are argued not to raise new questions of safety and effectiveness, supported by the animal test (Doc. No. NT24-00035, NT24-00036).

• Conduction Time: Subject device (100-200 ms and continuous) shorter than predicate (120-300 ms). Argued not to raise different questions of safety and effectiveness because shorter conduction time.
• Depth: Subject device (0-2.0 mm) less than predicate (0.3-4.0 mm). Argued not to raise different questions of safety and effectiveness because depth is not greater.
• Number of Electrodes: Subject device (13 pins) less than predicate (25 pins). Argued not to raise different questions of safety and effectiveness because fewer electrodes.

Summary of missing information requested:

The request asks for details typically associated with clinical studies or AI/ML performance evaluations (e.g., test set sample size, expert consensus ground truth, MRMC studies). The provided text describes a submission for an electrosurgical device based on engineering and pre-clinical animal studies, not a diagnostic device relying on human interpretation or AI algorithms requiring clinical validation of diagnostic accuracy metrics. Therefore, the specific criteria for "acceptance criteria and study that proves the device meets the acceptance criteria" in the context of diagnostic performance (as implied by the specific questions) are not applicable or present in this 510(k) summary.

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