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Intended Use: Arthroscopes are rigid endoscopic devices introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. Arthroscopes are indicated for use in arthroscopic procedures performed in the hip, knee, shoulder, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release).

Altomec Arthroscopes are Non-deflectable rigid endoscopic devices, introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. The Altomec Rigid Arthroscope is a long tube containing a series of lenses. At the distal end, an objective lens captures the image of the object. Lens along the rod relay the image. At the proximal end, a proximal coupling lens relays the image to a CCD (Camera). The Altomec Arthroscope has 140mm working length with an outside diameter of 4.0mm. The inner or optical tube that holds the optical system has a diameter of 3.25mm. The Altomec Arthroscope has a 105 degree field of view and 30 degree direction of view. The direction of view enables viewing of different parts.

Operating site is magnified two to five times of its actual size, depending on the distance between the tip of the endoscope and the object that is inspected. Magnified image is viewed on a monitor by connecting device's eyepiece to a video coupler of a camera monitor system. Image size on the monitor also depends on the type of video coupler used with camera system. Image can be recorded in a variety of formats depending on the camera system used.

Light is transmitted through glass fibers running between inner and outer tubes from distal end to the light post. Light transmission is achieved by connecting one end of a light source and other end to the light post of the device. Device has no working channel. Sheaths with locking mechanism identical to predicate device, are used for irrigation.

The provided text describes a 510(k) submission for the Altomec Arthroscope, seeking to establish substantial equivalence to a predicate device (Stryker Arthroscope). However, the document does not contain the detailed acceptance criteria or results of a study as requested.

The document states:

• "The Altomec Arthroscopes met all specified design and performance requirements."
• "The technological differences between the Altomec Arthroscope and Stryker Arthroscopes do not raise new questions of safety or effectiveness."
• "The data within this submission demonstrates that there are no significant differences between the application device and the predicate, indicating that the application device is safe, effective and substantially equivalent for marketing in the U.S."

These statements suggest that performance testing was conducted, but the specifics of that testing (e.g., acceptance criteria, test results, sample size, ground truth, expert involvement) are not detailed within this 510(k) summary. The summary focuses on comparing the proposed device's technical characteristics (Field of View, Degrees Direction of View, Outer Diameter, Working Length, Reusability, Light Guide End Adapter) and materials to the predicate device to establish equivalence.

Therefore, I cannot provide the requested information based solely on the text provided. The document focuses on demonstrating substantial equivalence through technical and material comparison, not on presenting a standalone performance study with explicit acceptance criteria and results.

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