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INTRAcel RF Microneedle System is indicated for use in dermatological and general surgical procedures for electrocoagulation, hemostasis and the percutaneous fractional treatment of the skin in monopolar and bipolar mode.

The INTRAcel RF Microneedle System comprises of two primary components; an RF Generator with User Interface Software and a disposable Electrode Insertion Device with an integrated cable.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the INTRAcel RF Microneedle System:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a "test set" in the context of clinical images or patient data that would require sample sizes and data provenance like country of origin or retrospective/prospective nature. The studies described are primarily non-clinical, focusing on device performance, electrical safety, biocompatibility, and software validation.

• Animal Performance Testing (Wound Healing): The "study was conducted to see the wound healing response following FRM treatment for both human and porcine skin." While human skin is mentioned, the detailed procedural description (biopsy time points, H&E, HSP47, RT-PCR) is for "Micro-pig covering 10 weeks." The specific number of human or porcine subjects is not provided. The study appears to be prospective as it involves active treatment and observation over time.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The studies detailed are technical (electrical, biocompatibility, software) or animal studies for wound healing, which do not typically involve human expert adjudication for ground truth establishing in the sense of medical image interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/provided for the types of studies performed (technical bench testing, software validation, animal studies). There's no indication of a test set requiring adjudication in the context of expert consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

A MRMC comparative effectiveness study was not performed or reported in this document. The device is an electrocoagulation and microneedling system; therefore, its performance is assessed directly through physical and electrical properties, biological safety, and tissue response, rather than as an aid to human interpretation like an AI diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to the INTRAcel RF Microneedle System in the way it's usually applied to AI diagnostic algorithms. The device itself is an active treatment device, not a diagnostic algorithm. The software validation mentioned is for the control and functionality of the device, implying a "standalone" software performance in terms of controlling the hardware as intended, rather than interpreting medical data.

7. Type of Ground Truth Used

• For Electrical Safety & EMC: Ground truth would be defined by the specifications and pass/fail criteria of the referenced international standards (IEC 60601 series).
• For Performance Testing: Ground truth would be defined by the device's design specifications and expected functional outputs (e.g., specific power output, tip count accuracy).
• For Biocompatibility Testing: Ground truth is established by the results of standardized biological tests (cytotoxicity, sensitization, intracutaneous reactivity) against acceptance criteria for biocompatible materials.
• For Sterilization & Shelf Life: Ground truth is established by the ability to achieve sterility (e.g., meeting sterility assurance levels) and maintain device integrity/functionality over time via accelerated aging.
• For Software Verification & Validation: Ground truth is the established "Software Design Specifications" — the software's ability to operate the device as programmed and safely (per the "moderate" level of concern).
• For Animal Performance Testing (Wound Healing): Ground truth is established through histological examination (H&E, HSP47 stain) and molecular analysis (RT-PCR for mRNA changes in collagen, HSPs, MMPs) of biopsied tissue, documenting physiological wound healing responses at different time points and energy levels.

8. Sample Size for the Training Set

This information is not provided and is specifically irrelevant as the document describes a physical medical device, not an AI/ML algorithm that requires a training set of data. The software mentioned handles device control, not predictive modeling or classification.

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

This information is not applicable as there is no "training set" in the context of an AI/ML model for this device.

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