(129 days)
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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.