(86 days)
The ACCUFUSE Cervical System (intervertebral body fusion device) is indicated for use as an intervertebral body fusion device in skeletally mature patients at one or two contiguous levels of the (C2-T1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The ACCUFUSE Cervical System implants are placed via an anterior approach using autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The ACCUFUSE Cervical System implants are to be used with supplemental fixation. Patients should have at least six weeks of nonoperative treatment prior to surgery.
The ACCUFUSE Cervical System (cervical plate/screws) is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spimal fusion in patients with:
•degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
•spondylolisthesis,
•trauma (i.e. fractures or dislocations),
•tumors,
•deformity (defined as kyphosis, lordosis, or scoliosis),
•pseudarthrosis,
•failed previous fusion,
•spinal stenosis
The ACCUFUSE Cervical System consists of intervertebral body fusion devices along with cervical plates and screws used to maintain disc space distraction in skeletally mature adults requiring an intervertebral body fusion. It is designed to be used in conjunction with supplemental spinal fixation instrumentation. The implant is available in a range of footprints and heights to suit each individual's pathology and anatomical conditions of the patient. The implant has a hollow center to allow placement of autogenous bone graft to promote intervertebral body fusion. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent implant migration and/or expulsion.
The ACCUFUSE Anterior Cervical Plate is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping or self-drilling bone screws using an anterior approach. Plates are available in a variety of lengths addressing single level and two levels of fixation.
This document is a 510(k) Premarket Notification from the FDA for a medical device. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the information requested in your prompt (especially regarding acceptance criteria, study design for proving performance, expert involvement, and clinical outcome measures) is not applicable to this type of submission.
Here's a breakdown based on the provided document:
Fundamental Point of the Document: This 510(k) submission for the ACCUFUSE Cervical System aims to demonstrate that its new device is substantially equivalent to legally marketed predicate devices. This means it has the same intended use, similar technological characteristics, and performs as safely and effectively as a legally marketed device. It is not a clinical trial report proving novel performance against predefined acceptance criteria.
Addressing Your Specific Questions (with explanations of why some are not applicable):
1. A table of acceptance criteria and the reported device performance
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Not Applicable in the traditional sense of a clinical performance study. This document demonstrates substantial equivalence through a comparison of technological characteristics and non-clinical (mechanical) testing.
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Implied "Acceptance Criteria": The acceptance criteria are implicitly that the device performs mechanically in a manner equivalent to the predicate devices when subjected to relevant ASTM standards.
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Reported Device Performance:
- Mechanical Testing Results (Summarized): The document states: "The results of these evaluations indicate that the ACCUFUSE Cervical System is equivalent to predicate devices." Specifically, it underwent:
- Static Axial Compression: Cage per ASTM F2077
- Dynamic Compression: Cage per ASTM F2077
- Static Torsion: Cage per ASTM F2077
- Dynamic Torsion: Cage per ASTM F2077
- Subsidence: Cage per ASTM F2267
- Static Axial Compression: Plate per ASTM F1717
- Dynamic Axial Compression: Plate per ASTM F1717
- Static Torsion: Plate per ASTM F1717
There is no table explicitly detailing "acceptance criteria" (e.g., minimum load bearing, maximum displacement) and then presenting measured performance values against them within this summary. The claim is simply that the device met the equivalence standard in these tests.
- Mechanical Testing Results (Summarized): The document states: "The results of these evaluations indicate that the ACCUFUSE Cervical System is equivalent to predicate devices." Specifically, it underwent:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable (for clinical data): "No clinical studies were performed."
- For Non-Clinical (Mechanical) Testing: The document does not specify the sample size (number of devices tested) for the mechanical tests. The provenance is internal to the manufacturer's testing or a contracted lab. It's prospective testing for the purpose of the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable: No clinical test set or ground truth (as in clinical diagnosis or outcome) was established by experts. The "ground truth" for the non-clinical testing is the performance of the predicate devices under the same test conditions and established engineering standards (ASTM).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No clinical test set requiring adjudication was performed.
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
- Not Applicable: This device is an intervertebral body fusion device and cervical plate/screws, not an AI-assisted diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical implantable medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For Non-Clinical Testing: The "ground truth" is based on established engineering standards (ASTM F2077, ASTM F2267, ASTM F1717) and the performance characteristics of previously cleared predicate devices in those same tests. There is no clinical "ground truth" in this submission.
8. The sample size for the training set
- Not Applicable: This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable: As above for question 8.
Summary of the Document's Approach:
This 510(k) submission relied primarily on non-clinical (mechanical) testing to demonstrate that the ACCUFUSE Cervical System is substantially equivalent to legally marketed predicate devices. This approach is common for devices where the technology is well-understood and there is a clear predicate that has demonstrated safety and effectiveness. No clinical studies were performed or required for this specific submission.
§ 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.