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The NuVasive Spinal Arthroscope, consisting of a rigid diagnostic arthroscope with outer sheath, is intended to achieve percutaneous vizualization of, and/or to assist in performing percutaneous surgical procedures on, the spinal nerve root, foramina, intervertebral disc, and the surrounding tissues of the spine via uniportal or biportal posterior or posterolateral approach, where anatomic restrictions permit percutaneous access. The device is intended for use in conjunction with the NuVasive Guided Spinal Arthroscopy System under real-time radiographic visualization via image-intensified C-arm fluoroscopy, but may also be employed independent of that system where it is compatible in diameter and length with other commercially available arthroscopic instruments, and with surgical need.

The subject Spinal Arthroscope is a rigid diagnostic arthroscope with outer sheath. The diagnostic scope is available in three (3) models, consisting of arthroscopes with 0°, 30°, and 70° viewing angles, each of which has a working length of 400 +0.5 mm. The field of view for each is 105°. The device employs a rod lens imaging system and a fiberoptic light guide for illumination. The standard eyepiece permits use of the subject device with various commercially-available video systems. While the device is manufactured with an ACMI-type illumination sidearm, it is supplied with both Richard Wolf-, and Storz-type adaptors which permit connection to many commercially-available light sources. The outer sheath has a 5.0 mm outer diameter and is equipped with a standard luer lock stopcock to permit irrigation through the sleeve. The subject Spinal Arthroscope is provided non-sterile, and is reusable.

The provided 510(k) summary for the NuVasive Spinal Arthroscope (K992782) does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

This 510(k) submission is for a medical device (arthroscope) that is an instrument rather than a diagnostic AI/ML algorithm. For such devices, the regulatory pathway focuses on demonstrating substantial equivalence to a predicate device based on design, materials, indications for use, and functional characteristics. It does not typically involve the kind of performance metrics and studies (e.g., sensitivity, specificity, MRMC studies) that are associated with AI/ML-driven diagnostic devices.

Therefore, the requested information elements (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size, and ground truth establishment for training) are not applicable or not present in this particular 510(k) summary.

Here's a breakdown of what is available in the document, which pertains to the regulatory pathway for this specific type of device, not an AI/ML algorithm:

• Device Type: Rigid diagnostic arthroscope.
• Regulatory Pathway: 510(k) premarket notification, demonstrating substantial equivalence to predicate devices.
• Key Argument for Equivalence: Similar indications for use, materials, design features, method of use, and functional characteristics, raising no new safety or effectiveness issues.
• Non-Clinical and Clinical Tests: The document explicitly states "Not applicable" for both "Summary of Non-Clinical Tests" (G) and "Summary of Clinical Tests" (H), and "Conclusions of Non-Clinical and Clinical Tests" (I). This reinforces that performance data of the type expected for AI/ML devices is not part of this submission.
• Acceptance Criteria: Not defined or reported in the document.
• Study Proving Acceptance Criteria: No such study is mentioned or summarized.

In summary, for the NuVasive Spinal Arthroscope (K992782), this 510(k) summary does not provide the information relevant to AI/ML device performance acceptance criteria and studies.

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