(96 days)
VEO 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. VEO is designed to be used with autogenous graft and supplemental spinal fixation that is cleared for use in the lumbar spine.
VEO is a radiolucent PEEK interbody fusion implant comprised of various heights to accommodate individual patient anatomy and graft material size. It also interfaces with Class I access instruments and disc preparation instruments. The lateral access technique allows a large cage to be implanted similar to marketed lateral lumbar interbody fusion sized cages. It is designed for use to provide structural stability in skeletally mature individuals.
Here's a breakdown of the acceptance criteria and study information for the TranS1 VEO device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes a medical device, the TranS1 VEO, which is an intervertebral fusion device, and details its mechanical testing. The acceptance criteria are defined by various ASTM standards for mechanical testing. The reported device performance is that it met or exceeded these requirements.
| Test | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Static Compression | ASTM F2077-11 | Requirements established by ASTM F2077-11 | Met or exceeded requirements |
| Static Compression Shear | ASTM F2077-11 | Requirements established by ASTM F2077-11 | Met or exceeded requirements |
| Static Torsion | ASTM F2077-11 | Requirements established by ASTM F2077-11 | Met or exceeded requirements |
| Subsidence | ASTM F2267-04 | Requirements established by ASTM F2267-04 | Met or exceeded requirements |
| Expulsion | ASTM Draft F04.25.02.02 | Requirements established by ASTM Draft F04.25.02.02 | Met or exceeded requirements |
| Dynamic Compression | ASTM F2077-11 | Requirements established by ASTM F2077-11 | Met or exceeded requirements |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes confirmatory mechanical testing and does not refer to clinical studies with patient data. Therefore, information regarding "sample size used for the test set" (in terms of patient numbers), "data provenance" (country of origin, retrospective/prospective) is not applicable in this context. The "test set" in this case refers to the physical devices undergoing mechanical tests. The specific number of devices tested for each mechanical test is not provided in the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the study is a mechanical engineering test on a medical device, not a diagnostic or AI-driven evaluation that would require human expert ground truthing. The "ground truth" for these tests is the physical performance of the device against established engineering standards.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as above. Adjudication methods are typically relevant for clinical studies or image interpretation, not for mechanical device testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable. The document describes mechanical testing of an intervertebral fusion device, not a diagnostic or interpretative AI system where human readers would be involved or assisted by AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This information is not applicable. The device is a physical implant, not an algorithm.
7. Type of Ground Truth Used:
The ground truth used for these tests is the established requirements and specifications within the referenced ASTM (American Society for Testing and Materials) standards. These are engineering benchmarks for material properties, structural integrity, and performance under various loads.
8. Sample Size for the Training Set:
This information is not applicable. There is no "training set" as this is not an AI/machine learning study or a clinical trial with a patient training cohort. The device's design and manufacturing are based on established engineering principles and materials science.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as above. The "ground truth" for the device's design and manufacturing is derived from engineering principles and regulatory requirements for such implants.
§ 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.