(93 days)
When used as a Vertebral Body Replacement: When used as a vertebral body replacement, the Novel® Spinal Spacer System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The Novel® Spinal Spacer System is intended for use with supplemental spinal fixation system. Specifically the Novel® Spinal Spacer System is to be used with Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System. Furthermore the Novel® Spinal Spacer System is intended for use with allograft.
When used as a Lumbar Intervertebral Body Fusion: When used as a lumbar Intervertebral Body Fusion, the Novel® Spinal Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Novel® Spinal Spacer System is to be used with a supplemental fixation system and autogenous bone graft.
When used as a Cervical Intervertebral Body Fusion: When used as a cervical intervertebral body fusion device, the Novel® Spinal Spacer System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone graft. These patients should have had six months of non-operative treatment. The Novel® Spinal Spacer System is to be used with a supplemental fixation system.
The Novel® Spinal Spacer System is an implantable device manufactured from PEEK and titanium alloy that is available in a variety of different shapes and sizes to suit individual pathology and anatomical conditions of the patient.
The provided text describes the Novel® Spinal Spacer System, a medical device. Based on the document, here's an analysis of the acceptance criteria and supporting study:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Structural integrity and mechanical performance | "The test results demonstrate that the mechanical performance of the Novel® Spinal Spacer System is substantially equivalent to the predicate device." |
| Substantial Equivalence to Predicate Device | "Data was provided which demonstrated the Novel® Spinal Spacer System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, design, material and function." This implies that by meeting the substantial equivalence criteria, the device is considered to have acceptable performance. |
| Compliance with Indications for Use | The device must meet the specific indications for use as a vertebral body replacement (thoracolumbar spine), a lumbar intervertebral body fusion device (L2-S1), and a cervical intervertebral body fusion device (C2-T1). The FDA's 510(k) clearance signifies acceptance of these indications in comparison to the predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify a sample size for a test set. This submission is for a 510(k) clearance, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than new clinical trials with a test set of patients. The "Performance Data" section specifically refers to "test results" for mechanical performance, implying laboratory or bench testing, not patient data. The provenance of this mechanical testing data (e.g., country of origin, retrospective/prospective) is also not mentioned.
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):
This information is not applicable as the clearance is based on substantial equivalence, primarily supported by mechanical testing, not a study involving human experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for the same reasons as point 3.
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:
This information is not applicable. The device is an implantable spinal spacer, not an AI-powered diagnostic tool, so an MRMC study or AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the "Performance Data" concerning mechanical performance, the implicit "ground truth" would be engineering standards and benchmarks for intervertebral body fusion devices, against which the Novel® Spinal Spacer System's mechanical properties were evaluated. For the overall substantial equivalence, the "ground truth" is the performance and safety profile of the predicate devices.
8. The sample size for the training set:
This information is not applicable. As a physical implant, the Novel® Spinal Spacer System does not have a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as point 8.
§ 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.