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• CO2 LASER Part: Fractional mode is indicated only for ablative skin resurfacing. Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.
• HF electrosurgical Part : The FRAXIS DUO is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis

FRAXIS DUO is a combination of two separate systems: CO2 laser and HF electrosurgical system. The Laser and High Frequency(=Radio frequency) can not be used simultaneously. FRAXIS DUO's CO2 laser includes the system main body, different handpieces(Fractional type, Non-fractional type), footswitch and an LCD Touch screen control panel. FRAXIS DUO's CO2 laser utilize a CO2 RF tube to generate a laser beam with a wavelength of 10,600nm and use different handpiece(Fractional type, Non-fractional type) for different indications for use. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different handpiece. The laser are supplied with different handpieces depending upon the device configuration. FRAXIS DUO's High Frequency(=Radio Frequency) includes the system main body, a Bipolar handpiece equipped with disposable micro-needle electrodes, footswitch and an LCD touch screen control panel. The HF energy is delivered using disposable micro-needle electrodes.

The provided text describes the FRAXIS DUO device and its predicates, but it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

Instead, the document details a substantial equivalence determination by the FDA for the FRAXIS DUO to legally marketed predicate devices. This determination is based on a comparison of technological characteristics, indications for use, and performance data. The performance data provided is primarily non-clinical and animal testing to demonstrate safety and similar tissue effects to the predicate devices.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria with quantitative metrics and their corresponding reported device performance values for the FRAXIS DUO. Instead, it relies on demonstrating comparable performance and safety to predicate devices through a series of tests.

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

• Sample Size for Test Set: Not explicitly stated in terms of a specific number of cases or individuals for a clinical test set. The "test set" here refers to animal models for safety and histological evaluation.
  • Laser Part Animal Testing: "In vivo animal testing using micropig models was also conducted..." (Number of micropigs not specified).
  • HF Electrosurgical Part Animal Testing: "In vivo animal testing using micropig models was also conducted..." (Number of micropigs not specified).
• Data Provenance: The animal studies were "In vivo animal testing using micropig models." The country of origin of the data is not specified, but the manufacturer is ILOODA CO LTD. from South Korea. The studies are prospective in nature, as they involve conducting tests on live animals to gather data.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: The histological evaluations were performed to assess "depth and zone of ablation and thermal damage." It is implied that qualified personnel (e.g., veterinary pathologists or dermatopathologists) conducted these evaluations, but their specific qualifications (e.g., "radiologist with 10 years of experience") are not mentioned.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not described. The text mentions "Histologic evaluation was done by H&E for immediately after procedure" and that "Histologically, both FRAXIS DUO and predicate device created tissue coagulation in the dermis and show similar coagulated pattern." This implies a single assessment for each sample, rather than a multi-reader adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical and animal testing for safety and technological equivalence, not on human reader performance or improvements with AI assistance. The device is a physical instrument, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. The FRAXIS DUO is a laser and electrosurgical instrument for therapeutic use, not an algorithm, so a standalone algorithm performance study is irrelevant to this device.

7. Type of Ground Truth Used:

• For the animal studies, the "ground truth" was established through histological evaluation (H&E staining) of tissue samples from the micropigs, assessing the "depth and zone of ablation and thermal damage." This is a form of pathology-based ground truth for observable tissue effects.

8. Sample Size for the Training Set:

• Not applicable. This device is a therapeutic medical instrument, not a machine learning or AI model that requires a training set. The performance data is based on engineering tests and animal studies.

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

• Not applicable, as there is no training set for this device.

Summary regarding "Acceptance Criteria and Study":

The document details the FDA's 510(k) clearance process based on substantial equivalence to predicate devices. This means the FRAXIS DUO demonstrated that it is as safe and effective as existing legally marketed devices.

The "study" that supports this is a combination of:

• Biocompatibility testing (ISO10993-1;2009 for patient contact materials).
• Non-clinical testing for electrical safety (IEC 60601-1, IEC 60601-1-2) and laser safety (EN 60825-1, EN 60601-2-22).
• In vivo animal testing using micropig models to histologically evaluate the depth and zone of ablation and thermal damage immediately, 7 days, and 14 days post-treatment for both the CO2 laser part and the HF electrosurgical part. An additional preclinical test compared 2MHz and 1MHz high-frequency characteristics on tissue.

The "acceptance criteria" were implicitly met by demonstrating that the device fulfilled the requirements of the specified standards and that the animal study results showed the fractional and non-fractional modes were "safe for use and effective" and produced "similar coagulated pattern[s]" to the predicate device in histological evaluations. There were no explicit numerical cut-offs or performance targets presented as "acceptance criteria" in this summary.

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