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The Anterior Spine Truss System - Stand Alone (ASTS-SA) Interbody Fusion Device is a stand-alone interbody fusion device indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbosacral spine at one or two contiguous disc levels. Each interbody fusion device is intended to be used with three titanium alloy screws which accompany the implant. Hyperlordotic implants (>20° lordosis) are intended to be used with supplemental fixation (e.g. posterior fixation). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. ASTS-SA Interbody Fusion Devices are used as an adjunct to fusion in the lumbosacral spine and are placed via an anterior approach at the L2 to S1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes to accommodate the patient's anatomy. Screws are inserted through the anterior portion of the implant into adjacent vertebral bodies for bony fixation.

This document is a 510(k) Premarket Notification from the FDA regarding the "Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device." It confirms the substantial equivalence of the device to legally marketed predicate devices.

Based on the provided text, the document primarily addresses regulatory clearance through substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed device performance results (e.g., sensitivity, specificity, accuracy).

Therefore, I cannot extract the information required for a study proving the device meets acceptance criteria as the provided document does not contain such a study report. It focuses on the regulatory approval process based on comparison to existing devices.

The document states:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
• "4WEB, Inc. has compared these devices to the previously cleared predicate devices in regards to indications for use, materials, function, sizes and mechanical test results. These comparisons demonstrate substantial equivalence to the predicate devices."
• "4WEB, Inc. concludes that the ASTS-SA devices are substantially equivalent to the predicate devices and raise no new questions of safety or effectiveness."

It lists "Performance Standards" (ASTM F2077, ASTM F2267-04, Expulsion testing, and MR Conditional testing standards) but does not provide the results of these tests or specific acceptance criteria with corresponding numerical performance metrics for the ASTS-SA device. It only states that "Performance testing has been completed per the following standards."

Therefore, I am unable to fill out the requested table and answer the specific questions about device performance against acceptance criteria, sample sizes, ground truth establishment, or human reader studies, as this information is not present in the provided FDA 510(k) clearance letter.

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