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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 or anchors 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. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). When using the ASTS-SA Interbody with fixation anchors, the device must be used with supplemental fixation.

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 or anchors are inserted through the anterior portion of the implant into adjacent vertebral bodies for bony fixation.

This looks like a 510(k) summary for a medical device called the "Anterior Spine Truss System - Stand Alone (ASTS-SA)". Unfortunately, this document does not provide the type of information you're asking for regarding acceptance criteria for a device performance study in the context of AI/ML.

Here's why and what's missing:

• Device Type: The ASTS-SA is an interbody fusion device, which is a physical implant used in spinal surgery. It's not an AI/ML-based diagnostic or therapeutic device. Therefore, performance studies for this device focus on mechanical properties, biocompatibility, and clinical outcomes related to fusion, not AI model performance metrics like sensitivity, specificity, AUC, etc.
• Performance Standards: The document lists performance standards such as ASTM F2077 (for mechanical testing) and ASTM F2267 (for subsidence testing), and expulsion testing. These are physical hardware tests, not software performance tests.
• No AI/ML Component: There is no mention of any artificial intelligence or machine learning component in the "Description," "Technological Characteristics," or "Performance Standards" sections.

Therefore, I cannot extract the requested information about acceptance criteria and AI model performance studies (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, training set details) because this document pertains to a physical medical implant, not an AI/ML-driven device.

The questions you are asking are highly relevant to AI/ML device submissions to regulatory bodies like the FDA, but they do not apply to this specific medical device summary.

Ask a specific question about this device

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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