(185 days)
The Yeung Endoscopic Spine System is indicated for the visualization and removal of herniated discs in the lumbar region.
The set consists of a telescope, forceps, sheath, obturator, adapter, tephine, punch, scissors, dilator, cannula, and caps. It is designed to be compatible with other available systems, but with increased emphasis on superior quality imaging. The scope system is designed to allow for clear visualization of spinal anatomy and pathology through its unique multichannel flow integrated system and working channels.
The provided document is a 510(k) premarket notification for the "Discoscope Set" (later referred to as the "Yeung Endoscopic Spine System") by Richard Wolf Medical Instruments Corp. This type of filing is for medical devices and generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance or efficacy against acceptance criteria through a clinical study with statistical endpoints.
Based on the content of the provided text, there is no information about acceptance criteria or a study designed to prove the device meets specific performance criteria. The submission explicitly states "Performance Data: None" and "Clinical Tests: None."
The document concludes that the device is substantially equivalent to predicate devices based on its intended use and technological characteristics.
Therefore, I cannot provide the requested information as it is not present in the given text.
Here's a breakdown of why each point cannot be addressed:
- A table of acceptance criteria and the reported device performance: This information is not provided. The document states "Performance Data: None."
- Sample size used for the test set and the data provenance: Not applicable, as no performance or clinical study was conducted.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment relevant to performance criteria is mentioned.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No. The document explicitly states "Clinical Tests: None."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this device is a physical endoscopic spine system, not an algorithm.
- The type of ground truth used: Not applicable, as no performance or clinical study was conducted.
- The sample size for the training set: Not applicable, as no training set for an algorithm is relevant to this device.
- How the ground truth for the training set was established: Not applicable.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. 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 § 888.9.