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The Fugo Blade system is intended for incision, excision, ablation, vaporization and hemostasis of oral soft tissue e.g. excisional and incisional biopsies; exposure of unerupted teeth; fibroma removal; frenectomy and frenotomy; gingival troughing for crown impressions; gingiyoplasty: gingivectomy; gingival incision and excision; hemostasis; implant recovery; incision and drainage of abscess; leukoplakia; operculectomy; oral papillectomies; pulpotomy; pulpotomy as an adjunct to root canal therapy; reduction of gingival hypertrophy; soft tissue crown lengthening; secular debridement; treatment of aphthous ulcers; vestibuloplasty; biopsy incision and excision; and lesion (tumor) removal.

The Fugo Blade for dentistry is an electrosurgical device that is powered by the electromagnetic (EM) energy from flashlight size batteries. This energy is conditioned, tuned (9.8+/- 2.0 x 106 Hz) and focused on a thin blunt cutting filament. Moreover, the EM energy from flashlight size (C cell) batteries is fed into a proprietary electronic network system which is activated by the surgeon with an on/off switch. This electronic system is fed EM energy from the battery energy supply source, then conditions it in a proprietary fashion and transfers it to the surgeon cutting filament. This column of EM energy is capable of reacting with tissue. This column of EM energy causes the molecular bonds in the tissue which come in contact with the EM field to ionize and thereby break apart, a condition that plasma physicists refer to as "plasma formation". In this way, the molecular lattice of the tissue is broken into micro-fragments, thereby creating an incision, excision, ablation, vaporization, and hemostasis of oral soft tissue.

The provided 510(k) summary for the "Fugo Blade for Dentistry" is a pre-market notification to establish substantial equivalence to a predicate device, not a report on a study proving the device meets specific acceptance criteria in the manner typically seen for novel efficacy claims. This document primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device (Wallach Quantum 500 electrosurgical generator for surgery, K000768) and other previously cleared Fugo Blade products (K001498, K041019, K050933) for ophthalmic use.

Therefore, the acceptance criteria and study details are interpreted in the context of demonstrating substantial equivalence rather than novel performance claims against predefined metrics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, specific acceptance criteria in terms of numerical performance thresholds (e.g., sensitivity, specificity, accuracy) for the dental application are not explicitly stated in this document. Instead, the "acceptance criteria" are implied to be the established safety and efficacy of the predicate devices. The "reported device performance" refers to the demonstration that the Fugo Blade for Dentistry shares the same technological characteristics and clinical effects as these predicate devices.

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

• Sample Size: The document does not explicitly state a sample size for a new test set specifically for the Fugo Blade for Dentistry. Instead, it references studies performed for previous 510(k) submissions for ophthalmic applications (K001498, K041019, K050933). The sample sizes for those specific studies are not provided in this summary.
• Data Provenance: The data provenance for the supporting clinical studies is:
  • K001498: University of South Carolina (presumably prospective clinical studies, though not explicitly stated).
  • K041019: Louisiana State University (presumably prospective clinical studies, though not explicitly stated).
  • K050933: No specific institution mentioned for clinical studies, but states "statistical significance for safety and efficacy."
  • The preclinical studies on plasma formation were conducted under the supervision of Dr. Michael Brown, director of the Swarthmore College Plasma Lab, Swarthmore, PA.

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

This information is not provided in the 510(k) summary. The document refers to "studies at the University of South Carolina" and "studies at Louisiana State University," but does not detail the specific methodology for establishing ground truth, the number of experts, or their qualifications for those studies.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Given the nature of electrosurgical device studies (often involving direct observation of tissue effects, histological analysis, or functional outcomes), adjudication methods like 2+1 or 3+1 for image interpretation would typically not be applicable.

5. 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

No, an MRMC comparative effectiveness study involving human readers with or without AI assistance was not done. The Fugo Blade is an electrosurgical device, not an AI-driven diagnostic or imaging aid.

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

The Fugo Blade is a medical device for direct surgical use, not an algorithm. Therefore, a standalone algorithm-only performance study is not applicable. The "standalone performance" of the device itself is demonstrated through its physical and functional characteristics (e.g., generating a plasma field, cutting tissue, achieving hemostasis), which are supported by the referenced studies.

7. The Type of Ground Truth Used

Based on the descriptions:

• K001498 (Lens Capsule): Implied ground truth would be based on histological analysis of incision walls for structural integrity and biomechanical testing for strength characteristics.
• K041019 (Scleral Tissue): Implied ground truth would be based on histological analysis for tissue trauma adjacent to the incision and possibly direct observation of incision characteristics (resistance-free).
• K050933 (Vascular Uveal Layer): Implied ground truth would involve assessment of hemostasis, likely through direct observation and potentially histological confirmation of coagulation without excessive damage.
• Preclinical Plasma Field Studies: Ground truth was established by plasma physicists at Swarthmore College, involving direct observation and analysis of the generated plasma field, possibly using microscopy and other analytical techniques.

8. The Sample Size for the Training Set

The concept of a "training set" as typically understood in machine learning or AI is not applicable here. This device involves direct physical interaction with tissue, and its "training" or development would involve engineering design, bench testing, and in vitro and in vivo studies to refine its physical parameters and performance characteristics. The document does not provide sample sizes for any studies used in the development of the device.

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

As above, the concept of a "training set" in the AI sense does not apply. The ground truth for the underlying scientific principles and performance characteristics of the electrosurgical technology was established through scientific investigation, experimental observation, and analysis (e.g., plasma physics studies at Swarthmore College). For the previous clinical studies referenced, ground truth would have been established through expert assessment, histological analysis, and objective measurements of tissue effects and outcomes, as described in point 7.

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