(70 days)
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.
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.
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 510(k) summary for the Novel® Spinal Spacer System does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically described for AI/ML devices or diagnostic accuracy studies.
Instead, this document is a 510(k) premarket notification for a spinal implant device, a hardware medical device. For such devices, acceptance criteria and performance are typically evaluated through mechanical testing, biocompatibility testing, and a demonstration of substantial equivalence to a predicate device, rather than diagnostic accuracy metrics.
Here's an analysis based on the provided text, highlighting what is and is not available:
1. A table of acceptance criteria and the reported device performance
The document states:
- Acceptance Criteria (Implied): The mechanical performance of the Novel® Spinal Spacer System should be "substantially equivalent to the predicate device."
- Reported Device Performance: "The test results demonstrate that the mechanical performance of the Novel® Spinal Spacer System is substantially equivalent to the predicate device."
Table:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantially equivalent mechanical performance to predicate device | Mechanical performance demonstrated to be substantially equivalent to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified. Mechanical testing typically involves a set number of samples per test type (e.g., fatigue, static compression, expulsion), but the exact number is not detailed in this summary.
- Data provenance: Not specified. As mechanical testing is performed in a lab setting, "country of origin of the data" in the context of patient data is not applicable here.
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 is not applicable to the evaluation of this device. Mechanical performance testing does not rely on expert interpretation of imaging or clinical data for ground truth. Instead, it relies on standardized test methods and engineering measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to the evaluation of this device. Adjudication methods are typically used in clinical or diagnostic studies involving human interpretation.
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 is not applicable to the evaluation of this device. An MRMC study is relevant for diagnostic devices or AI algorithms that assist human readers, not for mechanical spinal implants.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable to the evaluation of this device. Standalone performance refers to the performance of an algorithm without human intervention, which is not relevant for a spinal implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For mechanical testing, the "ground truth" would be defined by the validated standards and test methods (e.g., ASTM or ISO standards for spinal implants) and the measured physical properties and behaviors of the device under specific loads. These are objective engineering measurements, not clinical or pathological ground truth as understood in diagnostic studies.
8. The sample size for the training set
This is not applicable. There is no concept of a "training set" for a spinal implant device undergoing mechanical testing and substantial equivalence review.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this type of device submission.
In summary:
This 510(k) summary focuses entirely on demonstrating substantial equivalence for a physical medical device (spinal implant) through mechanical performance testing and material comparisons. It does not involve any AI/ML, diagnostic accuracy, or clinical reader studies. Therefore, most of the requested information (related to test sets, experts, adjudication, MRMC, standalone performance, training sets, and clinical ground truth) is not present because it is not relevant to the type of device and regulatory submission presented. The primary "study" proving acceptance criteria is the mechanical performance testing that demonstrated substantial equivalence to a predicate device.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.