(93 days)
The Laser Dock is designed for use with Ho:YAG, CO2 and KTP laser systems when laser fibers are deployed.
Not Found
The provided text is a 510(k) Premarket Notification letter from the FDA regarding a device named "Laser Dock." This document is primarily concerned with establishing substantial equivalence to a legally marketed predicate device, allowing the manufacturer (Patient Pocket, LLC) to market the Laser Dock.
Crucially, this type of FDA document (510(k) clearance letter) for a Class II medical device like the Laser Dock does NOT typically include acceptance criteria, performance studies, or detailed data about the device's efficacy or accuracy.
510(k) clearance is based on demonstrating that the new device is as safe and effective as a legally marketed device (the predicate). It does not require a demonstration of de novo clinical effectiveness through extensive trials or performance studies with specific metrics like sensitivity, specificity, or reader improvement.
Therefore, I cannot provide the requested information from the given text. The text does not contain:
- A table of acceptance criteria and the reported device performance: This information is not part of a 510(k) clearance letter.
- Sample size used for the test set and the data provenance: Not applicable to a 510(k) clearance for this type of device.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
- If a standalone (algorithm only) performance was done: Not applicable, as this is a physical laser accessory, not an AI algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The "Laser Dock" is described as an accessory designed for use with specific laser systems (Ho:YAG, CO2, and KTP) when laser fibers are deployed. Its function would likely be related to safety or organization of laser fibers during surgical or dermatological procedures, not diagnostic accuracy or interpretation of medical images.
In summary, the provided document is insufficient to answer the detailed questions about acceptance criteria and study results, as this information is not typically part of a 510(k) clearance for a device of this nature.
§ 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.