(215 days)
The STALIFTM TT Intervertebral Body Fusion System is indicated for use with autogenous bonc graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.
The STALIFTM TT is a stand alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
The STALIFTM TT system may be used with bone grafting material (autograft only).
The Surgicraft STALIF"M TT is a radiolucent intervertebral body fusion device and unicortical cancellous bone screws and is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIFTM TT is similar to that of the vertebral body endplate with a central cavity than can be packed with bone graft (autograft). The STALIFTMTT IBF System consists of varying sizes to include different widths, heights and hole positions to accommodate individual pathology and anatomical conditions.
This is a 510(k) premarket notification for the STALIF™ TT Intervertebral Body Fusion System. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria through clinical studies. Therefore, many of the requested data points related to clinical study design and performance metrics are not applicable in this context.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This section is Not Applicable in the traditional sense of a clinical performance study with predefined acceptance criteria and measured device performance against those criteria. For medical devices pursuing 510(k) clearance, the "acceptance criteria" revolve around demonstrating substantial equivalence to a legally marketed predicate device.
The study presented here asserts that the STALIF™ TT system meets the "acceptance criteria" of being substantially equivalent to its predicates based on:
| Acceptance Criteria (for Substantial Equivalence) | Reported Device "Performance" (Demonstration of Substantial Equivalence) |
|---|---|
| Similar Indications for Use (The device should be intended for the same or similar patient population and clinical use cases as the predicate.) | The STALIF™ TT system is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, including those with up to Grade 1 Spondylolisthesis or retrolisthesis. It's intended as a stand-alone system with bone screws and may be used with autograft. This aligns with the general indications for intervertebral body fusion devices, suggesting similarity to the predicate devices. |
| Similar Design Features (The device should have analogous structural and functional characteristics.) | The device is described as a radiolucent intervertebral body fusion device and unicortical cancellous bone screws. Its cross-section profile is similar to the vertebral body endplate with a central cavity for bone graft. It comes in varying sizes (widths, heights, hole positions). The submission asserts that engineering drawings confirm similar design features to predicates. |
| Similar Operational Principles (The device should function in a comparable manner to the predicate.) | As an intervertebral body fusion device, its operational principle is to provide stabilization and promote fusion within the intervertebral space. This fundamental principle is inherent to all devices in this product classification and is assumed to be similar to its predicates. The submission states that operational principles are similar. |
| Similar Material Composition (The materials used in the device should be the same or result in equivalent performance and biocompatibility as the predicate.) | While specific material composition is not detailed in the provided text, the submission states that the subject device is "substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition..." This implies that the materials used are either the same or have been assessed to be equivalent to those of the predicate devices. |
| Acceptable Performance via Non-Clinical Testing (Mechanical, biocompatibility, sterilization, and other relevant non-clinical tests demonstrating safety and effectiveness comparable to the predicate.) | Mechanical Testing: The STALIF™ TT was tested according to:ASTM F 2077-03 – Static and Dynamic TestsASTM F 2267-04 – Subsidence Test |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission relies on engineering drawings and non-clinical mechanical testing, not a clinical "test set" of patient data.
- Data Provenance: Not applicable for a clinical test set. The mechanical testing standards (ASTM F 2077-03 and ASTM F 2267-04) are international standards. The origin of the actual test samples would likely be from the manufacturer (Surgicraft Limited, UK). The study is not retrospective or prospective in the clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is Not Applicable as no clinical test set with ground truth established by medical experts was used or described. The "ground truth" in 510(k) for mechanical testing is adherence to the specified ASTM standards.
4. Adjudication Method for the Test Set
- Not Applicable. No clinical test set requiring expert adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a medical device clearance, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Not Applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used
- For the non-clinical testing, the "ground truth" is defined by the ASTM standards (ASTM F 2077-03 for static and dynamic tests, and ASTM F 2267-04 for subsidence tests). The device's mechanical performance is compared against the requirements and typical performance characteristics for intervertebral fusion devices as outlined in these standards and generally accepted for substantial equivalence to predicate devices. There is no pathology, outcomes data, or expert consensus used as ground truth in the clinical sense for this submission.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not a machine learning or AI device. The physical device is manufactured based on design specifications and then tested.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8.
§ 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.