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• CO2 LASER Part:
  Fractional mode is indicated only for ablative skin resurfacing.

Non-fractional mode (Impulse 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.

The Fractional CO2 Laser Machine uses a CO2 laser with the emission wavelength of 10600nm to emit focal spots through a high focus lens. The target is water in skin tissue. A certain amount of thermal stripping, more thermal coagulation and obvious thermal effect are produced at the part directly penetrated by the focal spot.

The Fractional CO2 Laser Machine has two operational modes, fractional mode and impulse mode.

• Fractional mode includes three modes: normal, random and midsplit;
• Impulse mode includes three modes: single, continuous and impulse.

The Fractional CO2 Laser Machine has 5 modules: Control display panel module, Main control power module, Light guide arm module, Fan cooling module, Laser module.

The provided FDA 510(k) clearance letter describes a "Fractional CO2 Laser Machine" (K250782) and its substantial equivalence to a predicate device, the "Ilooda Fraxis CO2 Laser" (K172096).

However, the document primarily focuses on demonstrating substantial equivalence through non-clinical performance and safety comparisons rather than detailing specific acceptance criteria for a study that proves the device meets those criteria, particularly in the context of device performance outcomes for intended use. The clearance is based on the device being as safe and effective as its predicate through these comparisons and compliance with relevant standards.

Therefore, many of the requested sections regarding the study that proves acceptance criteria (especially clinical study details, ground truth, expert involvement, and reader studies) cannot be extracted from this document as such studies are explicitly stated to be not included.

Here's an analysis of what can and cannot be extracted:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence and Standards Compliance)

The acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device and compliance with recognized safety and performance standards. The "reported device performance" is presented through direct comparison with the predicate.

Table of Acceptance Criteria and Reported Device Performance

Study Information (Based on the provided document)

As per Section 10, "No clinical study is included in this submission," and Section 9 "Non Clinical Test Conclusion," the device relies on non-clinical testing and substantial equivalence to a predicate. Therefore, the following sections cannot be fully addressed with the provided text for a clinical study proving acceptance criteria.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable (N/A) for clinical outcomes given no clinical study was performed. For non-clinical tests, specific sample sizes (e.g., number of units tested for electrical safety, number of samples for biocompatibility) are not detailed in this summary, but are typically defined by the referenced standards.
   • Data Provenance: N/A for clinical data. For non-clinical compliance testing, the provenance is from manufacturer-conducted tests or accredited labs demonstrating adherence to international standards (e.g., IEC, ISO).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. No clinical study for which ground truth would be established by experts is described.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • N/A. No clinical study with adjudicated outcomes is described.

4. 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:

   • N/A. Such a study would be relevant for devices involving image interpretation or AI assistance, which this laser device is not described as having.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • N/A. This is not an AI/algorithm-driven diagnostic device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • N/A. For non-clinical tests, the "ground truth" is defined by the passing criteria of the referenced international standards (e.g., specific thresholds for electromagnetic compatibility, absence of cytotoxicity).

7. The sample size for the training set:

   • N/A. No algorithm or AI component requiring a training set is mentioned.

8. How the ground truth for the training set was established:

   • N/A. No algorithm or AI component requiring a training set is mentioned.

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