(63 days)
The Creaspine SupStance Small Vertebral Body Replacement System is a vertebral body replacement system intended to replace a vertebral body. The SupStance Small VBR System is designed for use in the thoracolumbar spine (T1- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance Small VBR System is intended to be used with supplemental internal fixation systems. Anterior thoracolumbar plates and screws or pedicle screw and rod systems are among the options for the surgeon to use.
The use of allograft and/or autograft with the SupStance Small VBR System is optional.
The Creaspine SupStance Small Vertebral Body Replacement System is a vertebral body replacement system intended to replace a vertebral body. The SupStance Small VBR System consists of the SupStance Small VBR implants and the instrumentation required for implantation of the device. The SupStance Small VBR implant is a cage composed of fused hollow trapezoidal tubes with open sides and integral end caps. The SupStance Small VBR cages are available in three sizes (12mm, and 16mm) and cover a range of heights from 18mm to 50mm.
Like the sides of the cages, the SupStance Small VBR end caps have large openings for introduction of allograft and/or autograft and evenly spaced round serrations for fixation to the vertebral endplates. The end caps have a various (total) sagittal angle of 0°, 5°, and 8° to accommodate spinal anatomy.
The SupStance Small VBR cages are fabricated from poly-ether-ether-ketone (PEEK) with 6% BaSO4 contrast filler. The implants are provided non-sterile and may be implanted via an anterior approach or a costo-tranverse approach.
Here's an analysis of the provided text regarding the Creaspine SupStance Small Vertebral Body Replacement System, focusing on acceptance criteria and the supporting study:
The provided text is a 510(k) Summary for a medical device. It does not describe a study involving human or animal subjects, or an AI/algorithm-based device, in the typical sense of testing diagnostic accuracy or clinical effectiveness with patient data.
Instead, this document focuses on mechanical performance testing to demonstrate substantial equivalence to predicate devices. The "acceptance criteria" and "device performance" are related to mechanical properties, not diagnostic or clinical outcomes in a biological system.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, MRMC study, standalone performance, training set) are not applicable to this type of regulatory submission.
Here's the breakdown based on the provided document:
Description of the Acceptance Criteria and Supporting Study for the Creaspine SupStance Small Vertebral Body Replacement System
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical Performance: | ||
| (Standardized Testing) | Mechanical properties of the device should be comparable to those of legally marketed predicate devices for similar spinal vertebral body replacement systems. This is implicitly based on "FDA Guidance for Industry and FDA Staff, Spinal System 510(k)s" (issued May 3, 2004), which recommends specific tests. | "The data collected confirms that the mechanical properties of the proposed SupStance Small VBR System are comparable to those of the predicate devices." |
| Specific Mechanical Tests: | The device must successfully pass, and exhibit comparable properties in, the following types of mechanical tests as recommended by FDA guidance: |
- Static compression testing
- Dynamic compression testing
- Static torsion testing
- Dynamic torsion testing
- Expulsion testing | The document states, "Performance testing included the types of mechanical testing recommended... (static and dynamic compression testing, static and dynamic torsion testing, and expulsion testing)." While specific quantitative results aren't provided in this summary, the conclusion is that the data confirms comparability. |
| Intended Use Equivalence: | The device's intended use must be substantially equivalent to that of predicate devices. | The device "share[s] the same intended use... as that of the predicate devices." (Paragraph 2, "Statement of Technological Comparison") |
| Design Concepts & Materials Equivalence: | The device's basic design concepts and materials must be substantially equivalent to those of predicate devices. | The device "share[s] the same... basic design concepts, and materials as that of the predicate devices." (Paragraph 2, "Statement of Technological Comparison") The material (PEEK with 6% BaSO4) and design (fused hollow trapezoidal tubes with open sides and integral end caps) are described. |
| Substantial Equivalence to Predicate Devices (Overall): | The device must demonstrate substantial equivalence to legally marketed predicate devices in terms of safety and effectiveness, meaning it is as safe and effective as a legally marketed device that is not subject to premarket approval. | "The information and data collected support a claim of substantial equivalence for the proposed SupStance Small VBR System to the specified predicate devices." This conclusion is affirmed by the FDA's 510(k) clearance letter. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The "test set" in this context refers to the number of physical device units or samples subjected to mechanical testing. The FDA guidance for such devices typically specifies the number of samples per test.
- Data Provenance: The testing was conducted by Creaspine or their contracted laboratories to support the 510(k) submission. The exact country of origin for the testing itself isn't specified, but the applicant company (Creaspine) is based in France. The data is prospective in the sense that the testing was performed specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For mechanical performance testing of a physical device, "ground truth" isn't established by human expert consensus or clinical observation. The ground truth is determined by the physical properties measured according to standardized engineering test methods (e.g., ASTM standards or ISO standards for medical devices).
4. Adjudication method for the test set:
- Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies among human readers/experts in clinical or image interpretation studies. For mechanical testing, the results are quantitative measurements, and reconciliation would involve engineering analysis of test setup, measurement precision, and adherence to protocols.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No. This type of study (MRMC) is relevant for evaluating the performance of diagnostic tools (e.g., AI with radiologists) where human interpretation is a key component. This submission is for a physical implantable device, not a diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used:
- Engineering Measurement & Standardized Test Methods: The "ground truth" for mechanical testing is established by objective, verifiable measurements obtained from standardized tests (static/dynamic compression, torsion, expulsion) conducted according to established engineering and regulatory guidelines (e.g., FDA guidance, ASTM/ISO standards). The performance is compared against known characteristics of predicate devices.
8. The sample size for the training set:
- Not Applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. (See point 8)
Summary Takeaway:
The provided document details a regulatory submission for a physical medical device (vertebral body replacement system). The "study" referenced is a series of mechanical performance tests designed to demonstrate the device's physical properties are substantially equivalent to already-approved predicate devices, thereby establishing its safety and effectiveness for its intended mechanical function within the human body. The acceptance criteria are largely implicit in the FDA guidance for such devices, requiring performance comparable to established benchmarks or predicate devices under specified test conditions.
§ 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.