(88 days)
For photocoagulation during ophthalmic surgery. To be used with (specified equipment).
For photocoagulation during ophthalmic surgery. This device delivers laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.
The Peregrine Straight Laser Probe is an ophthalmic laser delivery device. By its design, it does not generate, intensify or significantly reduce energy. It consists of a connector that is plugged into an existing laser source, a glass fiber with PVC jacket, a Delrin handpiece and 304 stainless needle. The specific laser source to which the probe is connected will be specified in the "Indications for Use."
The provided text is a 510(k) Premarket Notification summary for the Peregrine Straight Laser Probe. It describes the device, its intended use, and its substantial equivalence to predicate devices, focusing on manufacturing and materials rather than performance data from a clinical study. Therefore, the document does not contain the information required to populate the acceptance criteria and study details as requested. This type of submission typically focuses on demonstrating equivalence to an already approved device through design, materials, and intended use, rather than presenting novel performance data from human or extensive animal studies.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Details on sample sizes, data provenance, or the nature of any test sets.
- Information about experts, ground truth establishment, or adjudication methods for performance evaluation.
- Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Standalone (algorithm-only) performance data.
- Details on the type of ground truth used for performance evaluation, beyond inferring that the probe is intended to achieve photocoagulation.
- Information on training set sample sizes or how their ground truth was established, as this is not an AI/ML device submission.
The closest relevant information is about sterility, where it states:
- Acceptance Criteria (Implied): The device will be ETO Sterilized to achieve sterility.
- Study (Method): The method used to validate the sterilization cycle is the AAMI Overkill Method. This is a standard validation method for sterilization, but no specific performance data (e.g., sterility assurance level achieved) is reported in this summary.
In summary, the provided text describes a medical device in the context of a 510(k) submission, which focuses on device description, indications for use, and substantial equivalence to predicate devices. It does not contain the detailed performance study data requested in your prompt.
§ 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.