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The Fugo Blade ® for peripheral iridotomy is indicated for intraocular creation of iridotomies.

The intended use of the device is to create an opening or iridotomy in iris tissue where lasers are not capable or desirable, thereby surgical intervention is required.

The Fugo Blade for PI is an electrosurgical device that is powered by the electromagnetic (EM) energy from flashlight size batteries. This energy is conditioned, tuned (9,8 x 10 6 Hz) and focused on a thin, blunt cutting filament. Moreover, 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, tunes (9.8 x 10 6 ) and focuses this EM energy into a 50-100 micron column of EM energy surrounding a blunt 100 micron diameter cutting filament at the end of the Fugo Blade hand piece. This column of EM field energy is capable of reacting with iris tissue. This column of EM field energy causes the molecular bonds in the iris tissue which comes in contact with the EM field to ionize momentarily and thereby break apart, a condition that physicists refer to as a momentary "plasma formation". In this way, the molecular lattice of the iris is broken down, thereby creating a peripheral iridotomy.

The provided text describes a 510(k) premarket notification for the "Fugo Blade for Peripheral Iridotomy, Model M300", submitted by MediSURG Ltd. The submission claims substantial equivalence to existing predicate devices.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly state quantitative "acceptance criteria" for the Fugo Blade for Peripheral Iridotomy in the manner of specific thresholds (e.g., "sensitivity must be > 90%"). Instead, the acceptance is based on demonstrating substantial equivalence in safety and effectiveness to predicate devices. The performance is reported in terms of achieving this equivalence.

*Note on Technological Equivalence: The Fugo Blade for PI is declared technologically equivalent to the Fugo Blade for Capsulotomy because they share the same electronic system. Its equivalence to the ND:Yag Laser for PI is based on functional and outcome equivalence, despite different technological mechanisms, both resulting in "plasma formation" to break down iris tissue.

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

• Test Set Description:
  • Clinical Study: 25 subjects with acute angle closure glaucoma and 25 subjects with phakic IOL insertion.
  • Preclinical Study: Porcine eye models (specific number not provided).
• Data Provenance:
  • Clinical Study: Prospective clinical data, likely from the study conducted by MediSURG Ltd. The country of origin is not specified but is implied to be within the scope of the FDA submission (likely USA).
  • Historical Controls: Retrospective data obtained from "peer-reviewed literature" and "8 separate ND: Yag PI studies on angle closure patients published in Index Medicus peer-reviewed journals."

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

The text does not explicitly state the number of experts used to establish ground truth or their specific qualifications for either the preclinical or clinical studies.

• For the clinical study, assuming standard medical practice, ophthalmologists would have assessed the outcomes (safety and effectiveness of iridotomy creation and prevention/elimination of angle closure). Their qualifications are implied by their role as treating/evaluating physicians.
• For the preclinical porcine eye studies, researchers/veterinarians with expertise in ocular anatomy and histology would have performed endothelial cell imaging and heat generation measurements.

4. Adjudication Method for the Test Set

The text does not specify an adjudication method (such as 2+1, 3+1, or none) for the clinical or preclinical test sets. Outcomes were compared to historical controls.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as described in the text.
• The study design involved comparing the Fugo Blade for PI's clinical outcomes to historical controls from the peer-reviewed literature for the predicate ND:Yag laser. This is a comparison of device performance to existing published data, not an MRMC study where human readers' performance with and without AI assistance is directly measured and compared.

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

• Yes, a standalone performance evaluation was implicitly done, as the Fugo Blade is a surgical device, not an AI algorithm.
• The preclinical studies (endothelial cell damage and heat generation in porcine eyes) and the clinical trial (on human subjects) assessed the device's direct performance and safety without considering "human-in-the-loop" improvements, other than the surgeon utilizing the device. The device's performance as a standalone tool for creating iridotomies was the focus.

7. Type of Ground Truth Used

• Preclinical Study: Direct measurements (endothelial cell count, temperature increase) in porcine eye models.
• Clinical Study: Clinical outcomes observed in subjects (creation of iridotomies, prevention/elimination of angle closure), assessed by treating clinicians. This represents outcomes data and expert assessment of safety and efficacy.
• Historical Controls: Published clinical outcomes from peer-reviewed literature, representing established clinical efficacy and safety of the predicate device.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to this submission, as it describes a physical electrosurgical device and its clinical/preclinical evaluation, not a machine learning model.

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

As the concept of a training set is not applicable, this question is also not relevant to the provided text.

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