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The SkinStylus SteriLock® MicroSystem is intended to be used as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older. The SkinStylus SteriLock® MicroSystem is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, and III in patients aged 22 years and older.

The SkinStylus SteriLock® MicroSystem is a handheld device that creates channels as well as microinjuries into the skin, by virtue of a 1A DC motor that rapidly reciprocates an array of 32 gauge microneedles that are no longer than 2.5mm. The device consists of a power source, a motor body with depth adjustment, a removable nosecone interface, and a disposable, single use cartridge containing an array of microneedles. The power source consists of two separate systems. One option is a rechargeable lithium-ion battery that delivers no more than 5 volts DC and 1 amp of current to power the motor. The other option consists of an AC wall adaptor that converts 110v AC into 5v DC. A power cord connects the wall adaptor to the device via a USB connector and a standard 1/8" headphone plug on the device side. The motor body is comprised of anodized aluminum with a dial mechanism that controls the depth of penetration of the microneedles from 0.0 mm to a maximum of 2.5mm. The removable nosecone interface provides the SkinStylus® the unique ability to have an interface between the motor and the cartridge to ensure there is a secondary control preventing any fluid from entering the motor body. The removable nosecone is autoclave sterilized after every use. The SkinStylus® disposable cartridge is designed in a 36-needle array with all needles at 2.5mm. The needle array is housed in a specially designed and patented cartridge housing that prevents liquids from entering the motor body via the inside lumen of the cartridge. The SkinStylus SteriLock® microneedles are composed of 304 18/8 surgical steel tested and certified as biocompatible under GLP testing conditions that conform to ISO 10993-10, and 10993-11.

The provided text is a 510(k) summary for the SkinStylus SteriLock® MicroSystem. This document primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed report of a clinical performance study with specific acceptance criteria and results.

Therefore, I cannot provide the requested information about acceptance criteria and device performance based on the given text.

The document explicitly states: "A new clinical trial was not conducted to support the additional indications for use and overall safety of the device." (Page 5). This means the 510(k) submission relies on non-clinical testing and comparison to a predicate device to demonstrate substantial equivalence, rather than a prospective study with human subjects designed to measure a specific level of clinical performance against pre-defined acceptance criteria.

The information provided covers:

• Non-Clinical Test Reports: This section lists various tests performed (biocompatibility, sterilization validation, reprocessing validation, fluid ingress validation, shelf-life testing, electrical safety, depth penetration validation, needle reciprocal rate validation, clinician usability study). These are engineering and safety tests, not clinical performance studies with acceptance criteria for device efficacy in improving appearance.
• Summary of Substantial Equivalence: This section compares the subject device to a predicate device (Collagen P.I.N. System) and a reference device (SkinStylus SteriLock® MicroSystem). The comparison focuses on technological characteristics like indications for use, mode of action, power source, needle length, geometry, speed, and safety features. The conclusion states that the device "raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate device."

Without a clinical trial designed to establish efficacy against specific performance metrics, the other requested details such as sample size, data provenance, expert adjudication, MRMC studies, standalone performance, and ground truth establishment are not applicable or cannot be extracted from this document.

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