(127 days)
The TiBow™ Expandable Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of nonoperative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.
The TiBow™ Expandable Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The device contains an expandable mechanism that allows it to achieve its final footprint in situ. The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration.
This document describes a spinal implant device, the TiBow™ Expandable Spacer System, and its clearance process with the FDA. It is a 510(k) premarket notification, which means the device is being cleared based on its substantial equivalence to a legally marketed predicate device, rather than a full premarket approval (PMA) which would typically require extensive clinical trials.
Therefore, the "study that proves the device meets acceptance criteria" refers to non-clinical performance testing to demonstrate this substantial equivalence to predicate devices, specifically regarding mechanical performance.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" for performance that are directly compared to "reported device performance" in a table format as might be found in a clinical study for diagnostic accuracy. Instead, the performance data section refers to standard tests and compares the device's performance to that of predicate devices, implicitly implying that meeting these standards and being comparable to the predicates constitutes acceptable performance.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: |
- Static compression strength
- Dynamic compression strength
- Shear strength
(In accordance with ASTM F2077 standards) | "Static compression, dynamic compression and shear testing in accordance with ASTM F2077, in addition to Finite Element Analysis and engineering rationale, was presented to demonstrate the substantial equivalency of The TiBow™ Expandable Spacer System."
Conclusion: "The TiBow™ Expandable Spacer System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance." Note: Specific numerical performance values are not provided in this summary. |
| Material Composition | Fabricated from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. |
| Design and Functionality | Expands in situ, hollow for bone graft, superior and inferior teeth for stability. Claimed to be substantially equivalent to predicate systems in terms of design and function. |
| Indications for Use | Intended for spinal fusion in skeletally mature patients with DDD at L2-S1, up to Grade 1 spondylolisthesis, after 6 months nonoperative treatment, with autogenous bone graft and supplemental fixation. Claimed to be substantially equivalent to predicate systems in indications for use. |
2. Sample Size Used for the Test Set and the Data Provenance
Given this is a 510(k) filing for a spinal implant, the "test set" refers to the mechanical testing performed on the physical device itself or simulations (Finite Element Analysis).
- Sample Size: The document does not specify the exact number of devices or simulations used for the mechanical testing (e.g., number of units tested for static compression).
- Data Provenance: The data is derived from non-clinical bench testing and Finite Element Analysis of The TiBow™ Expandable Spacer System. There is no mention of human clinical data (retrospective or prospective) in this regulatory summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to this 510(k) submission. "Ground truth" established by experts typically pertains to diagnostic device performance or clinical outcomes. For this device (an intervertebral body fusion device), the "truth" is established by adhering to recognized engineering standards (ASTM F2077, ASTM F136) and demonstrating substantial equivalence through mechanical testing and engineering rationale. The FDA's review division (Office of Device Evaluation, Division of Orthopedic Devices) comprises experts who review the submitted data to determine regulatory compliance.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1) refer to how discrepancies in expert opinions on clinical cases are resolved to establish a "ground truth." Since this submission relies on engineering standards and mechanical testing, such a method is irrelevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This question is not applicable. MRMC studies, AI assistance, and human reader improvement are relevant to diagnostic software or AI-enabled tools, not for an implantable spinal fusion device like The TiBow™ Expandable Spacer System.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This question is not applicable. This refers to the standalone performance of an algorithm or AI system, which is not relevant to an intervertebral body fusion device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance assessment is based on:
- Engineering Standards: Compliance with recognized ASTM standards for intervertebral body fusion devices (ASTM F2077 for mechanical testing, ASTM F136 for material composition).
- Substantial Equivalence: Comparison of the device's design, materials, indications for use, and mechanical performance to legally marketed predicate devices (The Longbow Spacer System K133717 and The Plateau Spacer System K130630). The "truth" is that its performance is equivalent to these already-cleared devices.
8. The Sample Size for the Training Set
This question is not applicable. "Training set" refers to data used to train machine learning models. This device is not an AI/ML-based product.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for an AI/ML model for this device.
§ 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.