(126 days)
The aprevo™ Transforaminal interbody device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo™ Personalized Interbody device is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches.
The aprevo™ Transforaminal IBF, including the aprevo™ transforaminal curved lumbar interbody fusion (TLIF-C) and the aprevo™ transforaminal oblique lumbar interbody fusion (TLIF-O), are designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo™ devices incorporate patient specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient. The individualized surgical correction plan and device configurations are developed using patient CT scans. The aprevo™ devices are manufactured from Titanium Alloy (Ti-6Al-4V) per ASTM F3001. The aprevo™ TLIF-C and aprevo™ TLIF-O devices have a cavity intended for the packing of bone graft.
The provided text describes a medical device, the aprevo™ Transforaminal IBF, and its regulatory clearance. However, it does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria related to its performance in a clinical or diagnostic setting. Instead, the document focuses on mechanical testing and a "Clinical Evaluation of Transforaminal Implant Usability, Fit, and Accuracy" to demonstrate substantial equivalence to predicate devices for regulatory purposes.
Therefore, I cannot provide a table of acceptance criteria and reported device performance related to diagnostic accuracy, nor can I describe studies that prove the device meets such criteria based on the provided text.
The closest information provided related to "performance data" is for mechanical testing and usability, not for a diagnostic or clinical performance study.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
- Cannot provide. The document only lists "test modes" for mechanical testing (Static axial compression per ASTM F2077, Static compression shear per ASTM F2077, Dynamic axial compression per ASTM F2077, Dynamic compression shear per ASTM F2077, Subsidence per ASTM F2267) and one "TR-056 Clinical Evaluation of Transforaminal Implant Usability, Fit, and Accuracy." It states, "The results of this non-clinical testing show that the mechanical performance of the aprevo™ Transforaminal IBF is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." No specific quantitative acceptance criteria or numerical performance results are provided for any of these tests.
2. Sample size used for the test set and the data provenance:
- Cannot provide. The document mentions a "TR-056 Clinical Evaluation of Transforaminal Implant Usability, Fit, and Accuracy" but provides no details on the sample size (number of patients/cases), data provenance (country, retrospective/prospective), or methodology of this "clinical evaluation."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot provide. This information would typically be part of a clinical or diagnostic performance study, which is not detailed here.
4. Adjudication method for the test set:
- Cannot provide. This information would typically be part of a clinical or diagnostic performance study, which is not detailed here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Cannot provide. This document describes an interbody fusion device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical implant, not an algorithm, although its design involves patient CT scans for personalization. The document refers to the device being tested, not an algorithm.
7. The type of ground truth used:
- Cannot provide. For mechanical testing, the "ground truth" would be the standard test parameters. For the "Clinical Evaluation of Transforaminal Implant Usability, Fit, and Accuracy," the nature of the "ground truth" for "usability, fit, and accuracy" is not specified (e.g., surgical observation, post-operative imaging, patient outcomes).
8. The sample size for the training set:
- Not applicable. This document describes a physical medical device (Transforaminal IBF), not an AI algorithm that would have a "training set." While the device design uses patient CT scans for personalization, this is part of the manufacturing process for a patient-specific device, not an AI model training a diagnostic algorithm.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" in the context of an AI algorithm described in this document.
§ 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.