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The EUROPA™ Navigated Instruments are intended to be used in the preparation and placement of the EUROPA™ pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the stereotactic navigation system Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The EUROPA™ Navigated Instruments is intended to be used with the EUROPA™ Pedicle Screw System. The EUROPA™ Navigated Instruments are non-sterile, re-usable instruments including probes, taps, and drivers that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation ® System and are manufactured from Stainless Steel per ASTM F899.

The provided text does NOT include acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary for the "EUROPA™ Navigated Instruments."

This type of document primarily focuses on establishing substantial equivalence to already legally marketed predicate devices, rather than presenting a detailed clinical study with specific acceptance criteria, test sets, ground truth establishment, or human reader performance metrics. The information provided is high-level and generalized, stating that "Design validation testing included testing per ASTM F2554-18, and a one-to-one dimensional comparison to demonstrate substantially equivalent geometry that is critical to navigation accuracy. Testing, including anatomical and navigated simulated use and accuracy and reliability testing, has been conducted to verify that the EUROPA™ Navigated Instruments are appropriate for their intended use, to ensure functionality, accuracy, and compatibility with the Medtronic StealthStation® System using the NavLock Tracker, and to demonstrate substantial equivalence to the predicate instruments."

Therefore, I cannot fulfill your request for the specific details of acceptance criteria and the study that proves the device meets them from the provided text. The document does not contain the information required to construct the table or answer the specific questions about sample size, expert ground truth, adjudication, MRMC studies, standalone performance, or training set details.

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The IO™ Expandable Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Devices are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The IO™ Expandable Lumbar Interbody Fusion System is an expandable lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The IO™ Expandable Lumbar Interbody Fusion System consist of implants manufactured from titanium alloy (ASTM F136). Expansion mechanism components and the drive screw are manufactured from molybdenum rhenium (MoRe) alloy (ASTM F3273). The system is offered in various sizes to accommodate different patient anatomy requirements. Implants will be provided sterile and are intended for single use only.

This document describes the IO™ Expandable Lumbar Interbody Fusion System (K210800), a Class II medical device. The information provided outlines the performance data and equivalence to a predicate device, but it does not contain information related to software or AI performance, or any "acceptance criteria" or "study" that would involve a test set, ground truth, or expert review in the context of AI or diagnostic algorithms.

The performance data listed in the document refers to mechanical performance of the physical device, not the performance of an algorithm or software. Therefore, the requested information regarding acceptance criteria, sample size for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone studies, or ground truth for training sets cannot be extracted from this document.

The provided text focuses on the device's physical and mechanical properties and its substantial equivalence to a predicate device for FDA clearance.

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