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The THESSYS Multiscope is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as arthroplasty, nucleotomy, discectomy, and foraminotomy.

A multi-channel endoscope having working channel and/or irrigation channel(s), used to visualize the operative site.
The THESSYS MULTISCOPE consists of light transmitting optical fibers and an image transmitting fiber bundle and lens, or a rigid rod-lens transmitting images. It has one or two irrigation channels and a working channel contained within a rigid stainless steel envelope.

The provided text is a 510(k) summary for the THESSYS MULTISCOPE. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, studies, or performance data for the THESSYS MULTISCOPE itself.

The 510(k) process in the US is primarily a "substantial equivalence" pathway. This means a new device is compared to a legally marketed predicate device, demonstrating that it is as safe and effective as the predicate. It often relies on a comparison of technological characteristics and intended use, rather than extensive clinical performance studies or specific acceptance criteria for the new device's performance.

Therefore,Based on the provided text alone, it is not possible to complete the requested table and answer the study-related questions. The document focuses on establishing substantial equivalence to existing devices rather than presenting new performance data against specific acceptance criteria.

Reasoning for Absence of Information:

• 510(k) Process: The 510(k) premarket notification is generally not focused on demonstrating new clinical performance. Instead, it aims to show that a new device is "substantially equivalent" to a predicate device already on the market. This typically involves comparing technological characteristics, materials, and intended use.
• Device Type: The THESSYS MULTISCOPE is an arthroscope, a surgical visualization tool. Its primary function is to provide visualization. Performance metrics for such devices often relate to image quality, field of view, illumination, and mechanical integrity, which might be assessed through bench testing and verification/validation activities that are not typically summarized in detail within a 510(k) document unless a novel characteristic requires it.
• Document Content: The provided 510(k) summary explicitly details:
  • Submitter and device identification.
  • Predicate devices.
  • Device description and intended use.
  • Technological characteristics.
  • A "Substantial Equivalence Comparison Chart" (Table 1) comparing the THESSYS MULTISCOPE to its predicates based on features like rod-lens type, channels, reusability, material, and general intended use.

This comparison chart is the primary "proof" of meeting acceptance criteria for a 510(k) in this context: proving substantial equivalence to already approved devices. There are no explicit performance numbers, clinical study details, or ground truth establishment methods discussed because they were likely not required for this type of submission.

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