(88 days)
This device will be used in the same manner as all: (a) surgical microscopes are used and (b) as all lasers are used in ENT and general surgery not requiring photocoagulation. The device is primarily intended to allow surgeons to perform tissue ablation with minimal peripheral thermal effects. More specifically, the device can be used for: general surgery which does not require photocoagulation; and in ENT applications, including microsurgery in the middle ear, stapedoplasty, for preparation of sites for osteosynthesis, microsurgery on ossicles, tympanic membrane, ablative surgery on soft tissues (for example: ligament severance of the stapes muscle), and removal of exostosis.
The OPMI® TwinER Surgical Microscope is a surgical microscope with an integrated solid-state Er: YAG (Erbium Yttrium aluminum garnet) laser. The Er:YAG laser is used for the ablation of biological tissue. The OPMI® TwinER is designed for use in general surgery where coagulation is not required, and otology, rhinology, and laryngology ("ENT") applications. Because the Er: YAG laser operates in the 2,940 nm wavelength and is absorbed very well by water, it causes minimal damage to the peripheral tissues from thermal absorption. This makes the Er: YAG particularly effective in traditional and microsurgery in the ear.
The therapy beam is a Class IV laser with adjustable power output between 10 mJ and 100 mJ. The OPMT® TwinER also uses an aiming beam to position the therapy beam, which operates in the 660-680 nm wavelength. The aiming beam is a Class IIIA laser with adjustable power output between 0.2 mW and 3 mW.
The therapy and aiming beams are delivered to the surgical field via a micromanipulator. A mirror, which can be finely adjusted using a joystick, allows the exact positioning of the laser beam.
The provided text describes the OPMI® TwinER Surgical Microscope, a device combining a surgical microscope with an integrated solid-state Er:YAG laser. It discusses the device's intended use, its substantial equivalence to predicate devices, and the underlying technology. However, the text does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria.
The document is a 510(k) summary and the subsequent FDA clearance letter, which focuses on demonstrating substantial equivalence to pre-market cleared devices rather than providing detailed performance studies against specific acceptance criteria.
Therefore, most of the requested information cannot be extracted from the given text.
Here's a breakdown of what can be inferred or stated based on the provided text, and what cannot:
Information that CANNOT be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: This level of detail about specific performance metrics and their acceptance thresholds is not present.
- Sample size used for the test set and the data provenance: There is no mention of a specific "test set" or a study performed with a defined sample size.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment for a specific test set is not discussed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: No information is available regarding adjudication.
- 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: This is irrelevant as the device is a surgical microscope with a laser, not an AI-assisted diagnostic tool for "human readers."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not discussed in the context of a specific study for this device.
- The sample size for the training set: Not applicable as it's not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
Information that CAN be inferred or stated from the provided text:
While a formal "study" proving acceptance criteria isn't detailed, the document makes a claim based on existing literature:
"Numerous studies have proven that the Er: YAG laser, such as that used by the OPM10 TwinER, is safe and effective. Studies indicate that the Er. YAG laser is in fact safer and more effective than CO2 lasers for certain ENT applications."
This statement serves as the general "proof" for the underlying technology's safety and effectiveness. The acceptance criteria, therefore, are implicitly tied to the general understanding and regulatory acceptance of Er:YAG lasers for the stated applications.
In summary, the provided document focuses on regulatory approval through substantial equivalence to predicate devices, rather than presenting a detailed study with specific acceptance criteria for the OPMI® TwinER Surgical Microscope itself. The safety and effectiveness are established by referencing existing knowledge and studies on Er:YAG lasers in general.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.