(30 days)
The Pioneer IBF/VBR System, when used as an IBF implant, is indicated for intervertebral body fusion of the spine in skeletally mature patients. Pioneer IBFs are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. Pioneer IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as the Quantum, Streamline, Contact ALP or SlimFuse systems.
The Cervical IBF device in intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment.
Lumbar IBFs are also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment.
The Pioneer IBF/VBR System, when used as a VBR implant, is intended for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. Pioneer VBRs are also indicated for treating fractures of the thoracic and lumbar spine. Pioneer VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with the Pioneer® Quantum Spinal Fixation System or supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5). Additionally, the Pioneer Vertebral Spacer implant is intended to be used with bone graft.
The Pioneer IBF/VBR System is an implantable device manufactured from PEEK and tantalum or titanium alloy that is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
The purpose of the submission was to add the CrossFuse II device to the system.
Here's an analysis of the acceptance criteria and study information for the Pioneer IBF/VBR System, based on the provided 510(k) summary:
This 510(k) summary describes a medical device (interbody fusion/vertebral body replacement system), and the "acceptance criteria" and "device performance" in this context refer to the mechanical and material properties of the implant, not diagnostic performance or accuracy in the sense of AI/image analysis. The study described is a non-clinical in vitro mechanical testing study, designed to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a physical implant, the "acceptance criteria" are implied by the mechanical tests performed, which aim to show that the device performs equivalently to previously cleared predicate devices. The document doesn't explicitly state numerical acceptance thresholds (e.g., "must withstand X N of compression"), but rather implies acceptance by conducting the tests and concluding substantial equivalence.
| Acceptance Criterion (Implied by Test) | Reported Device Performance | Comments |
|---|---|---|
| Withstand Static Compression | Performance data collected | Mechanical tests performed to demonstrate performance similar to predicate devices. |
| Withstand Static Torsion | Performance data collected | Mechanical tests performed to demonstrate performance similar to predicate devices. |
| Resist Subsidence | Performance data collected | Mechanical tests performed to demonstrate performance similar to predicate devices. |
| Resist Expulsion | Performance data collected | Mechanical tests performed to demonstrate performance similar to predicate devices. |
| Material Composition Equivalence | Composed of PEEK, tantalum, or titanium alloy (same as predicate device). | Directly stated as equivalent to the predicate. |
| Indication for Use Equivalence | Same indications for use as currently cleared predicate device. | Directly stated as equivalent to the predicate. |
| Dimensional Specifications | Differences not considered significant based on mechanical testing. | Mechanical testing likely validated that dimensional changes did not negatively impact performance. |
Overall Conclusion: "Based on the supporting documentation within this premarket notification, the subject device demonstrates substantial equivalence to the listed predicate devices." This statement is the ultimate "acceptance" of the device's performance relative to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. For mechanical tests of a physical device, the "sample size" would refer to the number of physical devices tested for each mechanical property. This information is typically detailed in the full test reports, which are not included in this summary.
- Data Provenance: The study is non-clinical mechanical testing. This means the data is not from patients (e.g., retrospective or prospective human data). It is in vitro laboratory testing of the implant itself. Country of origin for data is not applicable in the human data sense, but the testing would have been conducted in a specific lab (likely in the US or an accredited testing facility).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This study is non-clinical mechanical testing of a physical device. There is no "ground truth" to be established by human experts in radiology, pathology, or clinical outcomes. The "ground truth" is based on established engineering standards and validated mechanical testing methodologies.
4. Adjudication Method for the Test Set
- Not applicable. This study is non-clinical mechanical testing. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies among human readers or experts in diagnostic or clinical studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is a non-clinical mechanical testing study of a physical implant. MRMC studies are used to evaluate the diagnostic performance of imaging systems or AI algorithms with human readers. This type of study is not relevant to demonstrating the mechanical equivalence of a spinal implant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No. This is a non-clinical mechanical testing study. "Standalone performance" refers to the performance of an AI algorithm without human involvement in interpretation or decision-making. This concept is not applicable to a physical medical implant.
7. Type of Ground Truth Used
- Engineering Standards and Test Methodologies: The "ground truth" for the mechanical tests is based on established engineering principles, industry standards (e.g., ASTM standards for spinal implants), and validated test methods to measure properties like static compression, torsion, subsidence, and expulsion. The results are then compared against the performance of predicate devices, which are considered safe and effective.
8. Sample Size for the Training Set
- Not applicable. This is a non-clinical mechanical testing study and does not involve AI/machine learning algorithms that require training sets.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set (see point 8), there is no ground truth for a training set to be established.
Summary of Device Type and Study Context:
It is crucial to understand that this 510(k) summary is for a physical medical implant (Pioneer IBF/VBR System), not a diagnostic AI or imaging device. Therefore, many of the typical questions related to AI performance, human reader studies, and diagnostic ground truth are not applicable. The "study" described is a non-clinical mechanical testing report intended to demonstrate that the new device is substantially equivalent in terms of materials, intended use, and mechanical performance to existing, cleared predicate devices.
§ 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.