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The Rejuvapen NXT is a microneedling device and accessories intended to be used as a treatment to improve the appearance of periorbital wrinkles in Fitzpatrick skin types I-IV. The Rejuvapen NXT is intended for use on adults at least 22 years of age.

Device Description

The Rejuvapen is a handheld instrument that contains a Single Use micro needle cartridge containing 12 stainless steel microneedles in a circular arrangement with an adjustable microneedle depth of up to 2.5 mm. The needles create very small punctures in the epidermal and dermal layers of the skin. The device is powered by a medical grade wall plug-in supply. An adjustment is provided for a variable speed motor that controls the frequency of the puncture process with a

AI/ML Overview

Here's an analysis of the acceptance criteria and study findings based on the provided text, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with quantitative thresholds for effectiveness as a primary endpoint. Instead, the effectiveness is demonstrated through a clinical study where improvement in periorbital wrinkles is observed. The acceptance criteria for safety are primarily qualitative observations and adherence to international standards.

Acceptance Criteria Category	Specific Criteria/Standard Adhered To	Reported Device Performance
Safety - Biocompatibility	ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-11, USP 40 part 151, ISO 10993-12	Biocompatibility evaluation performed, indicating compliance with standards. (Implied successful given broader conclusion of substantial equivalence).
Safety - Sterilization	ISO11135-1:2007, ISO/TS11135-2:2008, ISO11737-1:2006	Shelf life (2 years) verified; sterilization validation reports in accordance with standards.
Safety - Reprocessing	Cleaning and low-level disinfection validation, use of protective sleeve required.	Cleaning and low-level disinfection validations performed.
Safety - Electrical	IEC / ES60601-1, IEC60601-1-2, IEC60601-1-6	EMC testing and electrical safety testing performed, complying with standards.
Performance - Needle Protrusion Accuracy	Maximum needle protrusion setting of 2.5 + 0.25 mm.	Bench testing demonstrated accuracy of needle penetration depth and maximum permissible depth within set tolerance (± 0.25mm) at depths of 0.5mm and 2.5mm. Device maintained functional integrity with aged cartridges and devices.
Performance - Puncture Frequency Accuracy	Maximum puncture frequency of 110 Hz + 2%.	Bench testing demonstrated accuracy of puncture rate within set tolerance (± 2%) at frequencies of 80 Hz and 110 Hz. Device maintained functional integrity with aged cartridges and devices.
Performance - Cross-Contamination	Safety features to protect against cross-contamination (e.g., fluid ingress protection, safety membrane).	Testing of the safety membrane/seal under worst-case scenario (maximum puncture rate and needle penetration depth) did not result in penetration of viral particles, protein, or hemoglobin markers.
Effectiveness (Periorbital Wrinkles)	Not explicitly stated as a quantitative threshold in the provided text, but implied as significant improvement.	Physician Assessment: For 37 subjects with consistent grading, mean improvement in Lemperle scale was 0.57. 19 out of 45 subjects (42%) had at least a one-grade improvement according to both assessors.
Subject Assessment: 37/46 (80%) of subjects graded their treatment response as "slight to somewhat noticeable improvement in periorbital wrinkles."
Adverse Events	Not explicitly stated as a quantitative threshold or maximum allowed percentage, but events should be mild and self-limiting.	20 adverse events in 12/52 subjects (23%), all judged mild, self-limiting, and requiring no intervention. 14/20 (70%) were bruising, 2/20 (10%) swelling, 1/20 (5%) blotchy skin/bruising, 1/20 (5%) 'watery eyes'/allergic response.
Erythema (Physician)	Not explicitly stated as a quantitative threshold; generally expected to be mild/moderate and transient.	Immediately post-treatment: predominantly minor or mild (83-93% across treatments), with 2-10% moderate. No severe erythema was observed.
Erythema (Subject)	Not explicitly stated as a quantitative threshold; generally expected to be transient.	Immediately post-treatment: 26% severe, 52% moderate, 22% mild/minor.
One day post-treatment: 11% severe.
By evening Day 3: 96% mild, minor, or absent.
By Day 8: 96% none, 4% minor, 2% mild.
Pain/Discomfort (Subject)	Not explicitly stated as a quantitative threshold; generally expected to be low and transient.	Mean pain score during treatment: 2.1 (range 0-7) on a 0-10 scale.
Mean discomfort score during treatment:

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