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The SER Pen Carain MicroSystem is intended for use as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I - III, aged 22 years and older and as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.

The SER Pen Carain MicroSystem (MP1209SP) is a handheld device that creates channels as well as microinjuries into the skin, by virtue of a DC motor drive system that rapidly reciprocates an array of 12 needles and 36 needles that are no longer than 2.5mm. The device consists of a power source, a motor body with depth adjustment, and a disposable, single use cartridge containing an array of needles. The power source consists of a rechargeable lithium-ion battery that delivers no more than 5 volts DC and 1 amp of current to power the motor. 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 SER Pen Carain MicroSystem's disposable cartridge is designed in two configurations, a 12-needle array and a 36-needle array. The needle array is housed in a specially designed cartridge housing with a silicon spring that prevents liquids from entering the motor body via the inside lumen of the cartridge. The SER Pen Carain MicroSystem biolock sleeve is a one end elastic opening PE bag to protect the whole system from cross contamination from the outside during the operation procedure. The SER Pen Carain MicroSystem microneedles are composed of 304 18/8 surgical steel tested and certified as biocompatible under GLP testing conditions that conform to ISO 10993-5, 10993-10, and 10993-11. A metallurgical analysis under GLP testing conditions that conform to ASTM E1019-11(Method A)(C/S Analyzer) was also completed and is attached. Each lot of cartridges are individually packaged and then gamma ray sterilized by TUV Sud accredited facility under procedure code P1501314 with a minimum dose of 25kGy. Certifications on file with the Sponsor and available for review.

This document describes the SER Pen Carain MicroSystem (MP1209SP), a microneedling device cleared via a 510(k) submission (K241355) by demonstrating substantial equivalence to predicate devices, rather than through a direct study proving specified acceptance criteria.

The submission specifically states: "The Sponsor intends to rely on the same performance data submitted in Collagen P.I.N. (K222199) and SkinStylus (K200044 and K231073) devices and not include any clinical data." This means that acceptance criteria and performance data are inferred from the predicate devices through a comparison of technological characteristics, rather than direct testing of the SER Pen Carain MicroSystem against pre-defined acceptance criteria with a dedicated study.

Therefore, the following information is based on the provided document and the nature of a 510(k) submission relying on predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission relying on predicate devices, explicit "acceptance criteria" and "reported device performance" in the context of a de novo clinical study are not directly presented for the SER Pen Carain MicroSystem. Instead, the "acceptance criteria" are implied by meeting the same performance and safety standards demonstrated by the predicate devices, and "device performance" is established by showing identical or highly similar technological characteristics and performance to those predicates.

Based on the document, the "performance" of the SER Pen Carain MicroSystem is derived from its substantial equivalence to the predicate devices across various technological characteristics.

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

• Sample Size for Test Set: This information is not provided as the submission relies on existing data from predicate devices. There was no specific "test set" for the SER Pen Carain MicroSystem in the context of a new clinical study.
• Data Provenance: The document explicitly states the "Sponsor intends to rely on the same performance data submitted in Collagen P.I.N. (K222199) and SkinStylus (K200044 and K231073) devices and not include any clinical data." Therefore, the data provenance would be from the studies conducted for these predicate devices, which are not detailed in this document. Information on country of origin or whether the data was retrospective or prospective is not available in this document.

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

• This information is not applicable as no new clinical study with a "test set" requiring expert ground truth was conducted for the SER Pen Carain MicroSystem. The data used for establishing substantial equivalence comes from pre-existing regulatory submissions for the predicate devices.

4. Adjudication Method for the Test Set

• This information is not applicable as no new clinical study with a "test set" requiring adjudication was conducted for the SER Pen Carain MicroSystem.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. The submission explicitly states "not include any clinical data," indicating a reliance on non-clinical data and comparison to predicate devices for substantial equivalence.

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

• No, this is a microneedling device, not an AI algorithm. "Standalone performance" in the context of an algorithm is not applicable.

7. The Type of Ground Truth Used

• As no new clinical studies were conducted for the SER Pen Carain MicroSystem, the concept of "ground truth" in this context is not directly applicable. The basis for clearance is established through demonstrating similar technological characteristics and performance to predicate devices that were previously cleared by the FDA based on their own evidence (which may have included clinical data, expert consensus, etc., but that information is not present here). For the non-clinical tests (biocompatibility, sterilization, etc.), the "ground truth" is adherence to established international and national standards (ISO, ASTM, USP).

8. The Sample Size for the Training Set

• This information is not applicable as there was no AI algorithm or "training set" for this device.

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

• This information is not applicable as there was no AI algorithm or "training set" for this device.

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