(107 days)
The aprevo® Cervical ACDF Interbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kvphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. The aprevo® Cervical ACDF Interbody System must be used with supplemental fixation systems. For hyperlordotic corrections (≥20 lordosis), the system must be used with at least an anterior cervical plate as supplemental fixation.
The aprevo® Cervical ACDF-X Interbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. When used as a standalone system, the aprevo® Cervical ACDF-X Interbody implant with integrated screw fixation is intended for use at multiple contiguous levels, or up to two levels when used in trauma, deformity or failed previous fusions. Deformity procedures to correct coronal anqulation or any use of hyperlordotic correction (>20°) must include supplemental fixation such as posterior cervical screw fixation or anterior plating.
The aprevo® Cervical ACDF System, which includes the aprevo® Cervical ACDF Interbody, aprevo® Cervical ACDF-X Interbody, and the aprevo® Cervical ACDF-X (no cam) Interbody are designed to stabilize the cervical 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 and include an aperture for the packing of bone graft.
The aprevo® Cervical ACDF System interbodies are additively manufactured from Ti-6AI-4V ELI titanium alloy per F3001, while the screw are machined from Ti alloy per ASTM F136. The devices are accompanied by an inserter instrument which facilitates the placement of the interbodies. Both the interbody devices and the instrument are provided to the end-user as single use, sterile-packed products.
I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving device conformance. The text is a 510(k) summary for a medical device (aprevo® Cervical ACDF System) and primarily focuses on establishing substantial equivalence to predicate devices, rather than outlining specific acceptance criteria or an in-depth study with the requested details.
Here's a breakdown of why I cannot fulfill your request based on the provided text:
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Table of acceptance criteria and reported device performance: The document states that "All testing demonstrated substantial equivalence between the subject and predicate devices," but it does not specify what those acceptance criteria were (e.g., specific thresholds for static compression in N, or dynamic compression cycles) nor does it provide the reported performance values against those criteria. It only lists the types of tests performed (e.g., Static and Dynamic axial compression per ASTM F2077).
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Sample sizes for test set and data provenance: This information is not present in the document.
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Number of experts and qualifications for ground truth: This information is not present in the document. The testing described is bench testing, not clinical studies involving expert assessment of patient data.
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Adjudication method for the test set: Not applicable as there's no mention of human-reviewed test sets for AI/software.
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Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. The device described appears to be an implantable interbody fusion device, not an AI or imaging diagnostic software. Therefore, there would not be a study with human readers improving with AI assistance.
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Standalone performance (algorithm only): Not applicable, as this is a physical medical device.
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Type of ground truth used: For the bench testing, the "ground truth" would be the predetermined mechanical standards (e.g., ASTM standards) and measurements, not expert consensus, pathology, or outcomes data in a clinical sense.
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Sample size for the training set: Not applicable, as this is a physical medical device, not a machine learning model.
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How ground truth for the training set was established: Not applicable for the same reason as above.
In summary, the provided document is a regulatory submission for a physical medical device and discusses bench testing to demonstrate substantial equivalence, not a study of an AI/software device with the characteristics you've requested.
§ 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.