(33 days)
The Tera Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion.
The Tera Lumbar Interbody Fusion System is 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 I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
The Tera Lumbar Interbody Fusion System is intended to be used with supplemental spinal fixation system cleared for use in the lumbosacral spine.
The Tera Lumbar Interbody Fusion System consists of intervertebral body fusion devices intended for lumbar interbody fusion using a transforaminal lumbar interbody fusion surgical approach (TLIF), an oblique transforaminal interbody fusion surgical approach (Oblique TLIF), or a posterior lumbar interbody fusion surgical approach (PLIF). The devices are intended to improve stability of the spine while supporting fusion. The Tera Lumbar Interbody Fusion System cages are intended for use at one or two contiguous levels in the lumbar spine (L2-S1). The components are offered in different shapes and sizes to meet the requirements of the individual patient's anatomy and are provided sterile.
Tera Lumbar Interbody Fusion System cages are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion. All cages are manufactured using the L-PBF (laser powder bed fusion) additive manufacturing method. L-PBF allows for the formation of solid, non-porous cages with a layered porous lattice structure on the surfaces of the components, including the surfaces of the interior graft window. This intricate structure facilitates bone in-growth by providing a larger surface of implant/bone contact than a buffed surface. The cages are also titanium anodized to allow for identification of various heights by color.
Tera-T Ti Interbody cages, Tera-O Ti Interbody cages, and Tera-P Ti Interbody cages are also available with a Promimic HAnano Surface (hydroxyapatite (HA) coating). Cages are coated with a 20nm HA layer composed of crystalline hydroxyapatite particles that mimic human bone tissue through shape, composition, and structure. This surface treatment increases implant anchoring by facilitating osseointegration and enhancing early bone growth. All Tera Lumbar Interbody Fusion System implants are only available sterile packaged.
Non-sterile, reusable surgical instruments to support implantation of the system are provided for use with Tera Lumbar Interbody Fusion System devices are provided in steam sterilization trays.
The provided text describes a 510(k) clearance for a medical device called the "Tera Lumbar Interbody Fusion System." This document is a regulatory approval for a physical medical device (an implant used in spinal fusion surgery), not a software or AI-driven diagnostic device.
Therefore, the requested information about acceptance criteria for AI/software performance, such as MRMC studies, ground truth establishment, training set details, or expert adjudication, is not applicable to this document. The clearance is based on mechanical performance testing and substantial equivalence to a predicate device.
Here's a breakdown of the relevant information provided in the document regarding the device's acceptance and testing:
Acceptance Criteria and Device Performance for Tera Lumbar Interbody Fusion System
The Tera Lumbar Interbody Fusion System is a physical medical device. Its acceptance criteria and performance are based on mechanical testing to demonstrate substantial equivalence to previously cleared predicate devices, rather than AI or software performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets and reported values. Instead, it states that the device was tested against recognized ASTM standards, and its performance met the acceptance criteria of these standards.
| Acceptance Criteria Category | Standard / Reference | Reported Device Performance |
|---|---|---|
| Mechanical Strength | ASTM F2077 | Demonstrated substantial equivalence to predicate devices under various loading conditions. Performance met required criteria for intended use. |
| - Static Axial Compression | ASTM F2077 | Passed / Met Criteria |
| - Static Axial Compression Shear | ASTM F2077 | Passed / Met Criteria |
| - Dynamic Axial Compression | ASTM F2077 | Passed / Met Criteria |
| - Dynamic Axial Compression Shear | ASTM F2077 | Passed / Met Criteria |
| Subsidence | ASTM F2267 | Passed / Met Criteria |
| Material Properties | ASTM F3001 | Passed / Met Criteria (Tensile, Microstructure, Chemical Composition) |
| Biocompatibility | N/A (Standard implied) | Testing conducted, results satisfactory |
| Sterilization & Packaging | N/A (Standard implied) | Validation conducted, results satisfactory |
Note: The document states, "Performance equivalence demonstrated that the subject device met the acceptance criteria of the standards and is substantially equivalent to the predicate devices." This indicates that the established acceptance criteria were the thresholds defined by the respective ASTM standards for intervertebral body fusion devices.
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "mechanical performance testing" and "worst-case analysis and resulting worst-case configuration mechanical testing." It doesn't specify a precise numerical sample size for the physical devices tested (e.g., "N units were tested"). However, typically, mechanical performance testing of medical implants involves a statistically sufficient number of samples to ensure robust results, often following specific sample size recommendations within the testing standards.
- Test Set Sample Size: Not explicitly stated as a number of devices (e.g., "10 units"). However, "worst-case configuration mechanical testing" implies selected configurations representative of the most challenging conditions.
- Data Provenance: The data is generated from in-vitro (laboratory) mechanical testing of the manufactured device. It is not patient or clinical data. No country of origin for data or retrospective/prospective status is applicable as it's not a clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable for this type of device clearance. Ground truth, in the context of AI/software, refers to human expert annotations or pathological diagnoses. For mechanical devices, "ground truth" is defined by the performance requirements of the relevant engineering standards (e.g., ASTM F2077, ASTM F2267, ASTM F3001). The "experts" in this context would be the engineers and technicians performing the tests and validating the results against the standard requirements.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in human expert annotations for AI ground truth. For mechanical testing, the results are quantitative measurements against predefined thresholds in the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC study was NOT done. MRMC studies are specific to evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a physical implant, not a diagnostic AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This question is not applicable. This device is not an algorithm. The "standalone" performance here refers to the device's mechanical integrity on its own without human interaction during the test (other than setting up the test). The mechanical tests performed (static/dynamic compression, shear, subsidence) are essentially "standalone" evaluations of the device's physical properties.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance validation is defined by the acceptance criteria specified in the relevant ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices and titanium alloys. These standards define the mechanical properties and performance thresholds that the device must meet.
8. The Sample Size for the Training Set
This question is not applicable. This device is a physical implant, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for a physical medical 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.