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This system is indicated to be used by a trained physician to provide illumination and visualization of an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures. Examples of surgical use include but are not limited to procedures on the knee, shoulder, ankle, elbow, wrist, temporomandibular joint (TMJ), spinal, ophthalmic, ENT, and the cervix.

The NeedleView CH is a rigid Fiberoptic scope with a working channel designed for single use. The product consists of a 17,000 pixel coherent silica fiber bundle, 30um diameter light fibers and a stainless steel channel encased in a stainless steel shaft. The effective field of view is 80° in air and 62° in water. The direction of view is 0°. The scope has retaining groves to incorporate a drape that will cover the camera and cord that connects to the Surg View System. The NeedleView CH Scope Kit consists of a fiber-optic based micro-endoscope (3.4mm Outer Diameter, 1.85mm Working Channel, 160mm Working Length), 12F Cannula (4mm Inner Diameter), 12F Dilator(4mm Diameter), 14Gx127mm Tuohy Needle, 18Gx152mm Tuohy Needle, #11 Scalpel, Guidewire (70cm Length), Hemostasis Valve Adapter (HVA), and a sterile drape. All of these items are disposable and for single-use only. The micro-endoscope is made to couple with a non-disposable system hand piece that contains a light source and camera, which is available separately.

This document is a 510(k) summary for the NeedleView CH™ Scope Kits, a medical device for arthroscopic and endoscopic procedures. The primary purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, thereby eliminating the need for extensive clinical trials.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on non-clinical performance and biocompatibility testing to demonstrate substantial equivalence. It does not provide specific numerical "acceptance criteria" or "reported device performance" in the format of a clinical trial outcome with metrics like sensitivity, specificity, or accuracy. Instead, it lists the types of performance tests conducted for various components of the NeedleView CH™ Scope Kit and states that these tests were "completed" or "utilized" specific standards. This implies that the device met the requirements of these standards for each test.

Since no specific numerical performance criteria or results are detailed in the provided text, a table like the one requested cannot be fully constructed with explicit numerical values. However, we can infer the categories of acceptance based on the tests conducted.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample sizes used for any of the performance tests. The data provenance is also not explicitly stated beyond the fact that these tests were performed by BioVision Technologies, LLC, for their device. This is typical for 510(k) submissions focusing on substantial equivalence through non-clinical bench testing, where detailed sample sizes for each specific test component are often included in the full test reports, not generally in the summary document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. This submission relies on performance testing against established engineering and biocompatibility standards, not on expert-adjudicated "ground truth" for diagnostic or clinical outcomes. There were no human experts evaluating the performance in a clinical context for the purpose of establishing ground truth for a test set in the way one would for an AI diagnostic device.

4. Adjudication Method for the Test Set:

Not applicable. As the tests described are physical, mechanical, and biological evaluations against standards, there is no "adjudication method" involving human reviewers in the context of clinical interpretation or diagnosis. The results of the tests would be pass/fail based on the specified standard's criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:

No. A MRMC comparative effectiveness study was not performed. This device is a physical medical instrument (an arthroscope/endoscope), not an AI-assisted diagnostic or interpretative system. The submission explicitly states: "Clinical testing was not used to prove substantial equivalence."

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This device is a physical instrument for visualization, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used:

For the performance and biocompatibility testing, the "ground truth" used is implicitly the established scientific and engineering standards (e.g., ISO 10993-1, ASTM F2096, ISO 11607-2, etc.). The device's components had to meet the performance specifications outlined in these standards. There is no pathology, outcomes data, or expert consensus serving as "ground truth" in the clinical sense for this type of submission.

8. The Sample Size for the Training Set:

Not applicable. Since this is not an AI/machine learning device, there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. No training set was used.

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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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