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DefineRF is a monopolar radiofrequency device that delivers up to 50W to the chosen location of the single needle tip. The device is equipped with touchscreen user interface, a footswitch, a handpiece, a needle type RF electrode, and an FDA cleared single use neutral electrode pad (K092761). The needle tip is single use and provided sterile. The system is designed for use in a clinical environment for use on adults.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "DefineRF Microneedling System." It primarily focuses on demonstrating substantial equivalence to a predicate device, Agnes (K160469), rather than presenting a detailed clinical study for acceptance criteria.

While it mentions performance testing and biocompatibility, it explicitly states: "Clinical Evidence – N/A. No clinical studies were conducted as part of this submission."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them based on clinical evidence, because such a study was not conducted or submitted for this 510(k). The regulatory pathway chosen (510(k)) relies on demonstrating substantial equivalence to a legally marketed predicate device, often through non-clinical performance data and technical comparisons, rather than de novo clinical trials to prove efficacy and safety in the same way a PMA would.

However, I can extract the non-clinical performance testing details described in the document, which serve as evidence for substantial equivalence, and frame them in the context of what would typically be considered "acceptance criteria" for a non-clinical evaluation.

Here's a breakdown of the available information and why some requested points cannot be answered:

Acceptance Criteria and Reported Device Performance (Non-Clinical):

Acceptance Criteria (Implied Non-Clinical)	Reported Device Performance (Non-Clinical)
Electrical Safety & EMC Conformance: Adherence to relevant IEC 60601 standards for medical electrical equipment, including general safety (60601-1), radiofrequency surgical equipment (60601-2-2), and electromagnetic disturbances (60601-1-2).	Tests performed in accordance with IEC 60601-1: 2005, IEC 60601-2-2: 2017/AMD2:2020, and IEC 60601-1-2: 2014/AMD1:2020. (Implicitly passed, as clearance was granted).
Biocompatibility: Patient-contacting materials must be biocompatible according to ISO 10993 standards (e.g., cytotoxicity, irritation, sensitization).	Biocompatibility tests performed according to ISO 10993-1: 2009, ISO 10993-5: 2009, and ISO 10993-10: 2010. "all patient contacting materials were determined to be biocompatible."
Software Verification & Validation: Software must meet FDA's guidance for medical device software life cycle processes and risk management.	Software V&V testing conducted and documentation provided in accordance with IEC 62304:2006+A1:2015 and EN ISO 14971:2019+A11:2021. (Implicitly passed).
Sterility & Packaging: Sterilization process, biological indicator efficacy, residuals, and packaging integrity must meet ISO standards.	Tests performed in accordance with ISO 11135: 2014, ISO 11138-2: 2006, ISO 10993-7: 2008, ISO 11607-1: 2006, ISO 11607-2:2019, and ISO 11737-2:2019. (Implicitly passed).
Functional Performance (Thermal Effect/Coagulation): Device should produce desirable clinical treatment effect (coagulation micro zones) at target depths across different tissue types and power levels, comparable to expectations for electrocoagulation.	Testing on three ex vivo tissue types (kidney, muscle, skin) at 37°C. Treatment settings included low, medium, and maximum power levels. "Treatments produced clearly detectable Coagulation Micro Zones in all treated tissues at the target depths. The Test device were consistent in all test tissue." "The study concluded that treatment by the device possessed a desirable clinical treatment effect."
Equivalence to Predicate Device: Overall design, principle of operation, technical specifications, and indications for use must be substantially equivalent to the predicate.	The document extensively details comparisons, highlighting similarities in indications, operation, frequency, modality, and even slightly higher safety features (impedance monitoring, needle scanning). Despite some differences in power, needle length, and voltage, these were addressed by performance testing and deemed not to impact safety or efficacy, leading to a strong conclusion of substantial equivalence.

Information Not Available / Not Applicable (as per the document):

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for the ex vivo tissue performance testing. The document mentions "three different tissue types" and "all specimens" but no specific case count.
- Data Provenance: Ex vivo tissue testing. Country of origin not specified, but typically conducted in a controlled lab environment. The document describes it as "ex vivo kidney, muscle, and skin". It is a non-clinical, prospective test for the device's performance within a controlled lab setting, not using human patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as there was "no clinical studies" and "no human-in-the-loop performance." The "ground truth" for the ex vivo performance testing was the observation of "clearly detectable Coagulation Micro Zones" via methods like histopathology, which would be evaluated by lab personnel or pathologists, but not "experts" in the context of clinical interpretation like radiologists for AI.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no human adjudicated clinical test set was used.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an electrosurgical tool, not an AI or imaging diagnostic device that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical electrosurgical system, not an algorithm. The "performance testing" described is the device's direct physical interaction with tissue.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the ex vivo performance testing, the "ground truth" was likely established through histopathology analysis of the treated tissue samples to confirm the presence and nature of "coagulation micro zones." This is a laboratory/pathological assessment, not expert consensus in a clinical context or outcomes data.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. (No training set).

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