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510(k) Data Aggregation
(29 days)
The Laser Peripherals bare laser fiber is intended for use in laser surgical procedures for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, KTP and Diode lasers have been cleared.
Laser Peripherals Bare Laser Fiber
This is an FDA Premarket Notification (510(k)) letter for the Laser Peripherals Bare Laser Fiber. It is a clearance letter, not a study report. The document states that the device is substantially equivalent to legally marketed predicate devices. Therefore, it does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement for a de novo or PMA submission.
The document essentially states that since the device is substantially equivalent to already cleared devices, a new study to prove device performance against acceptance criteria isn't required in the same way it would be for a novel device.
Therefore, I cannot provide the requested information from this document.
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(21 days)
The ScatterFree™ Lateral Emitting Fiber is intended for use in General, Urological, OB-GYN, Orthopedic and ENT laser surgical procedures for cutting, vaporizing or coagulating in any soft tissue application for which compatible Nd:YAG, KTP and Ho:YAG lasers have been cleared.
ScatterFree™ Lateral Emitting Fiber
The provided text is a 510(k) clearance letter from the FDA for the ScatterFree™ Lateral Emitting Fiber. It describes the device's intended use and states that it has been found substantially equivalent to predicate devices. However, this document does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, or details about ground truth, sample sizes, or expert adjudication.
Therefore, I cannot provide the requested information from the given input. The document is administrative in nature, confirming regulatory clearance, rather than a scientific study report.
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(90 days)
The LS-905 FiberChoice™ Adapter System is indicated for use for non-standard laser output ports for lasers manufactured by Laserscope. The LS-905 FiberChoice™ Adapter System is designed to allow owners of Laserscope lasers to connect Laser Peripherals, Inc. 510(k) cleared laser fibers to their lasers. The adapter may be used in each surgical specialty or procedure along with Laser Peripherals laser fibers for which compatible Laserscope lasers have received regulatory clearance.
Not Found
The provided document {0} - {2} is a 510(k) clearance letter for the LS-905 FiberChoice Adapter System. It states that the device is substantially equivalent to legally marketed predicate devices and outlines the general controls and regulations applicable to the device. However, it does not contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot generate the requested information based on the provided text.
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(41 days)
The Laser Peripherals Holmium Bare Fibers are indicated for a variety of surgical uses including open, laparoscopic or endoscopic ablation, coagulation, incision, excision, and vaporization. The delivery system may be used in each surgical specialty or procedure for which compatible Holmium and Nd: YAG lasers have received regulatory clearance.
Not Found
The provided document is a 510(k) clearance letter from the FDA for "Laser Peripherals Holmium Bare Fibers." This type of document establishes substantial equivalence to a predicate device but does not typically contain detailed acceptance criteria, study designs, or performance results in the same way a pre-market approval (PMA) application or a peer-reviewed study publication would.
Based solely on the provided text, I cannot answer the requested questions as the information is not present. The letter confirms market clearance but does not describe the specific studies or data used to demonstrate safety and effectiveness beyond stating substantial equivalence to a predicate device.
Therefore, I must state that the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) is not available in the provided document.
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(66 days)
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(65 days)
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