(64 days)
The Sustain Spacer is a vertebral body replacement device 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 Sustain Spacer is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material.
The Sustain Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The Sustain Spacer is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of each device will grip the endplates of the adjacent vertebrae to resist expulsion.
The Sustain Spacer devices are made from commercially pure titanium or titanium alloy as specified in ASTM F67, F136 and F1295.
The Sustain Spacer is a vertebral body replacement device. The provided text indicates that its acceptance criteria and performance were established through mechanical testing.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | In accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000 | "Mechanical testing... was presented." (Details of specific results are not provided in the summary, but the general statement confirms testing against the guidance.) |
| Material Compatibility | Made from commercially pure titanium or titanium alloy as specified in ASTM F67, F136 and F1295 | "The Sustain Spacer devices are made from commercially pure titanium or titanium alloy as specified in ASTM F67, F136 and F1295." |
2. Sample size used for the test set and the data provenance:
The provided text details mechanical testing and material specifications. This type of testing typically involves physical samples of the device components. The document does not specify the sample size used for the mechanical tests, nor does it explicitly mention data provenance in terms of country of origin or whether the data was retrospective or prospective. Such details are usually found in the full test report, not the 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
For mechanical testing, "ground truth" is typically established by engineering standards and validated testing protocols, not by expert medical review. Therefore, this section is not applicable in the context of the provided information, which focuses on mechanical and material properties. The standard mentioned, "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", sets the technical benchmark.
4. Adjudication method for the test set:
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes. For mechanical testing, the "adjudication" is inherent in the objective, quantitative nature of the tests and their alignment with established engineering standards. Therefore, this section is not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The provided information focuses on the mechanical and material equivalence of the Sustain Spacer to predicate devices through engineering testing, not on clinical effectiveness with human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is typically relevant for AI/software devices. Since the Sustain Spacer is a physical medical implant, the concept of "standalone (algorithm only)" performance without human-in-the-loop is not applicable.
7. The type of ground truth used:
The ground truth used for demonstrating the device's performance is based on engineering standards and specifications. Specifically, the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000, and ASTM material standards (F67, F136, F1295) serve as the benchmarks against which the device's mechanical and material properties are measured.
8. The sample size for the training set:
The concept of a "training set" is relevant for machine learning algorithms. Since the data described pertains to mechanical and material testing of a physical implant, a "training set" in the machine learning sense is not applicable.
9. How the ground truth for the training set was established:
As mentioned above, the concept of a "training set" is not applicable here. The "ground truth" for the device's performance was established by recognized industry standards and guidance documents for spinal implants, which dictate the required mechanical properties and material composition.
§ 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.