(125 days)
The Space Vision® PLIF (Posterior Lumbar Interbody Fusion® TLIF (Transforaminal Lumbar Interbody Fusion) and Space Vision® OLIF (Oblique Lumbar Interbody Fusion) systems are intervertebral body fusion devices indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two continuous 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 I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least 6 months of non-operative treatment prior to treatment with Space Vision® PLIF, SpaceVision® TLIF systems. These devices are to be filled with autogenous bone graft material. These devices can be implanted via posterior or transforaminal approaches. SpaceVision® PLIF, SpaceVision® TLIF or SpaceVision® OLIF systems must be used in combination with supplemental internal spinal fixation which has been cleared by the FDA for use in the lumbar spine.
The SpaceVision® PLIF system (Posterior Lumbar Interbody Fusion), the SpaceVision® OLIF system (Oblique Lumbar Interbody Fusion) and the SpaceVision® TLIF system (Transforaminal Lumbar Interbody Fusion) are intended as an internal spacer between the vertebral bodies of the lumbar (L2-S1) spine to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain. The design of the cages is adapted to the vertebral anatomy. SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF systems consist of cages differentiated by their approach, with varying dimensions and ancillary products for placement of the cages. The systems are supplied sterile or non-sterile. The SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF cages are made from PEEK Optima (Invibio, Inc.) ASTM F2026 and ASTM F560 Tantalum wire. X-ray markers system on the cages permits the identification of cage position and allows post-operative assessment. SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF implants are supplied with their specific instrumentation and trial spacers.
The provided document describes the SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF systems, which are intervertebral body fusion devices. This is a 510(k) premarket notification, indicating the device's substantial equivalence to legally marketed predicate devices, not requiring extensive clinical trials to demonstrate effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. This is primarily achieved through mechanical testing to show comparable properties.
| Acceptance Criteria (Demonstrates Substantial Equivalence in Mechanical Properties) | Reported Device Performance |
|---|---|
| Conformity to Class II Special Controls Guidance Document: Intervertebral Body Fusion Device (June 12, 2007) | Conformity affirmed. The device states it "conforms to Class II Special Controls Guidance Document: Intervertebral Body Fusion Device- Document issued on: June 12, 2007." |
| Mechanical testing according to ASTM F2077-14 (Static Axial Compression, Dynamic Axial Compression, Static Compression Shear, Dynamic Compression Shear) | Testing performed and results demonstrated comparability. "Mechanical testing includes static axial compression, dynamic axial compression, static compression shear, dynamic compression shear, performed according to ASTM F2077-14." |
| Subsidence testing according to ASTM F2267-04 | Testing performed and results demonstrated comparability. "subsidence testing performed according to ASTM F2267-04." |
| Expulsion testing according to DRAFT ASTM F-04.25.02.02 (ENDOLAB PI-52 protocol) | Testing performed and results demonstrated comparability. "expulsion testing performed according to DRAFT ASTM F-04.25.02.02 (ENDOLAB PI-52 protocol)." |
| Overall Mechanical Properties Comparable to Predicate Device | Affirmed comparability. "Results demonstrate comparable mechanical properties to the predicate device." The conclusion states, "SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF Devices are substantially equivalent to the primary predicate Phantom PLIF (K082801 - US Spine) in terms of intended use, material, design, mechanical properties and function." And also "substantially equivalent to the additional predicates BAK-L (P950002 - Zimmer) and Brantigan Cage (P960025 - DePuy Spine) in terms of intended use and mechanical properties." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a test set or data provenance in the context of typical clinical studies for performance evaluation. For a 510(k) submission based on substantial equivalence, the "test set" primarily refers to the physical devices undergoing mechanical testing, not a patient cohort.
- Sample Size: Not specified for the mechanical testing. For physical device testing, usually a statistically appropriate number of devices are tested, but the exact count isn't in this summary.
- Data Provenance: Not applicable in the sense of retrospective or prospective patient data from a specific country, as "No clinical data has been presented." The data provenance for the mechanical testing would be the testing facility (ENDOLAB PI-52 protocol is mentioned) and the specific ASTM standards used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as "No clinical data has been presented." The "ground truth" here is the adherence to mechanical performance standards and comparability to predicate devices, not clinical diagnoses made by experts.
4. Adjudication Method for the Test Set
This information is not applicable as "No clinical data has been presented" and no human expert review or adjudication of a "test set" in the clinical sense was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states, "No clinical data has been presented." Therefore, there is no effect size reported for human readers improving with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone (algorithm only) performance study was not done. This device is a physical intervertebral body fusion system, not a diagnostic algorithm or AI-powered tool. The concept of "algorithm only" performance is not relevant to this type of medical device submission.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the established mechanical performance standards (ASTM standards) and the mechanical properties of the legally marketed predicate devices. The goal is to demonstrate that the SpaceVision® systems meet these standards and are comparable. There is no expert consensus, pathology, or outcomes data used as ground truth for this specific submission, as clinical data was not presented.
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical implant, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As there is no training set mentioned, the method for establishing its ground truth is irrelevant.
§ 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.