(171 days)
Sclerostomy for the treatment of primary open- angle glaucoma where maximum tolerated medical therapy and trabeculoplasty have failed.
The entire electronic system of Fugo Blade for thermocauterization in glaucoma is equivalent to the predicate system. The only difference in the two systems is the geometry of the disposable incision tips as delineated in detail above.
The provided text is a 510(k) Premarket Notification Summary for "The Fugo Blade for Thermocauterization in Glaucoma." It details the device's name, intended use, and its equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, device performance data, sample sizes, ground truth establishment, or clinical study details.
The document's primary purpose is to demonstrate substantial equivalence to a legally marketed predicate device, which is a regulatory pathway for approval rather than a detailed performance study. Therefore, I cannot extract the requested information from the provided text.
Specifically, the following information is not available in the provided document:
- Table of acceptance criteria and reported device performance: No performance metrics or criteria are mentioned.
- Sample sizes used for the test set and data provenance: No test sets, sample sizes, or data origins are described.
- Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth establishment or expert involvement is discussed for performance evaluation.
- Adjudication method for the test set: Not applicable as no test set evaluation is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study information: No MRMC study or human-in-the-loop performance is mentioned.
- Standalone (algorithm only) performance study details: Not applicable as the device is a surgical instrument, not an algorithm.
- Type of ground truth used: Not applicable as no performance evaluation study is detailed.
- Sample size for the training set: Not applicable as it's not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
The document focuses on:
- Device Name: The Fugo Blade for Thermocauterization in Glaucoma.
- Intended Use: Sclerostomy for the treatment of primary open-angle glaucoma where maximum tolerated medical therapy and trabeculoplasty have failed.
- Predicate Device: The Fugo Blade for anterior capsulotomy.
- Equivalence Basis: The electronic system of the device is identical to the predicate device, producing the same electronic output signal characteristics, thus reacting identically with tissue. The only difference is the geometry of the disposable incision tips.
§ 886.4100 Radiofrequency electrosurgical cautery apparatus.
(a)
Identification. A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.(b)
Classification. Class II.