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The maxMorespine Endoscope when used with recommended third party accessories/components, 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.

The maxMorespine Endoscope is a rigid, multi-channel endoscope comprised of a working channel, rod lens optical system to transmit light and images with irrigation channel(s) and stopcocks. The body is designed of an outer and inner tube of surgical grade stainless steel. The proximal end of the endoscope; eyepiece and light post is adaptable to industry standard endoscopic camera and light systems. The endoscope will be introduced into the patient via a minimally invasive access through a working cannula with various instruments introduced through the Endoscope working channel (maxMorespine System submitted sepatately - K090132).

This document is a 510(k) premarket notification for the maxMorespine Endoscope. It focuses on demonstrating substantial equivalence to predicate devices and does not contain information about a study to prove acceptance criteria for device performance. It's a regulatory submission for a medical device cleared in 2009.

Therefore, I cannot provide the requested information, which typically applies to AI/ML software as a medical device (SaMD) or devices with performance claims that require clinical or analytical validation studies.

Here's why the requested information isn't present in the provided document:

1. Nature of the Device: The maxMorespine Endoscope is a physical, rigid multi-channel endoscope. Its performance is primarily assessed through design specifications, material compatibility, and intended use, rather than complex algorithms requiring validation against ground truth data.
2. 510(k) Paradigm for this Device Type: For devices like endoscopes, substantial equivalence is usually demonstrated by comparing design, materials, sterilization, and intended use to existing predicate devices already on the market. This often doesn't involve formal performance studies with acceptance criteria in the same way an AI/ML diagnostic tool would.
3. Absence of Software: The document explicitly states, "No Software is needed for the maxMorespine Endoscope" (page 2), eliminating the need for AI/ML specific validation criteria.
4. Date of Submission: This submission is from 2009, prior to the widespread adoption and regulatory focus on AI/ML in medical devices that necessitated the detailed performance study information you're requesting.

In summary, the provided document does not contain any of the requested information regarding acceptance criteria or a study proving device performance because it pertains to a traditional medical device (an endoscope) for which such studies are typically not required for 510(k) clearance, particularly in 2009, and it has no AI/ML component.

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The maxMorespine System 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.

The maxMorespine System consists of basic cannulas, sheaths, dilators, drills, trephines, forceps, punches, mallet and quidewires which facilitate or compliment the maxMorespine Endoscope (submitted separately under K083552). The System is designed to provide the access and treatment of spinal anatomy and pathology.

This document is a 510(k) summary for the maxMorespine System, which is a spinal endoscopy system. It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria or a study demonstrating the device meets such criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on demonstrating equivalence to existing devices rather than presenting performance data against specific acceptance criteria.

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