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510(k) Data Aggregation
(147 days)
Endoskeleton TO Interbody Fusion Device (IBD)
The ENDOSKELETON® TO Interbody Fusion Device is indicated for use 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. Patients should have received 6 months of non- operative treatment prior to treatment with the device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
This traditional 510(k) is intended to add additional products to the Endoskeleton® TO System that have been additively manufactured from titanium alloy.
The Endoskeleton® TO Interbody Fusion Device implants are available in a variety of sizes for treatment in Posterior Lumbar Interbody Fusion (PLIF) to accommodate patient anatomy and are designed with a large hollow region in the center to house autograft bone material. The Endoskeleton® TO Interbody Fusion Device is offered with or without nanoLOCK® Surface Technology. The nanoLOCK® Surface Technology is identical to the previously cleared product (K141953), which is a microscopic roughened surface with nano-scale features. The version without nanoLOCK® Surface Technology has a macro surface roughness.
The implant system must be used with supplemental fixation for stabilizing the implants when placed in the interbody space.
The implants are composed of medical grade titanium alloy (Ti 6Al-4V ELI) per ASTM F136 and ASTM F3001.
The components included in this submission for additive manufacturing are sterile only.
The provided text describes a 510(k) premarket notification for a medical device, the Endoskeleton® TO Interbody Fusion Device (IBD). This document focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel safety and effectiveness through clinical trials with defined acceptance criteria and human performance metrics.
Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not applicable to this type of submission. The information provided primarily details mechanical testing to ensure the new manufacturing process (additive manufacturing) does not compromise the device's structural integrity compared to its predicate devices.
However, I can extract information related to the performance testing and its conclusions:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Strength | The additively manufactured Endoskeleton® TO Interbody Fusion Device implants must demonstrate mechanical strength equivalent to the predicate devices (Endoskeleton® TO IBD (K102067) and Endoskeleton® TO IBD with nanoLOCK® (K141953)) when subjected to various loading conditions according to relevant ASTM standards. | All mechanical testing (Static Axial Compression, Dynamic Axial Compression, Static Compression Shear, Dynamic Compression Shear, Static Torsion per ASTM F2077; Subsidence per ASTM F2267, and Expulsion) supported that the Endoskeleton® TO devices are adequate for the intended use and substantially equivalent to the predicate systems. |
| Biocompatibility | The device must be biocompatible according to international standards (ISO 10993). | Biocompatibility validations were completed in compliance with ISO 10993. |
| Cleaning Validation | The sterilization and cleaning process must be validated. | Cleaning validations were completed in compliance with ISO 10993. |
| Bacterial Endotoxin | The device must meet bacterial endotoxin limits according to AAMI ST72. | Bacterial endotoxin testing was conducted compliant to AAMI ST72. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each mechanical test. However, it indicates these were bench tests (mechanical, biocompatibility, cleaning, endotoxin) performed on physical device samples. Therefore, the "data provenance" is derived from these laboratory tests rather than patient data (e.g., country of origin of data, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This is not applicable as the submission relies on objective mechanical and material science testing against established standards, not interpretation by clinical experts to establish a "ground truth."
4. Adjudication Method
This is not applicable for the same reasons as #3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or mentioned. This type of study is typically relevant for diagnostic imaging devices where human interpretation is a key component. This device is an implantable surgical device.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
This is not applicable. The device is an implantable medical product, not an algorithm, and does not involve human-in-the-loop performance in the context of its function.
7. Type of Ground Truth Used
The "ground truth" used for this submission is based on:
- Established ASTM (American Society for Testing and Materials) standards for mechanical testing.
- ISO (International Organization for Standardization) standards (ISO 10993) for biocompatibility and cleaning validation.
- AAMI (Association for the Advancement of Medical Instrumentation) standard (AAMI ST72) for bacterial endotoxin testing.
The "ground truth" is that the new, additively manufactured device performs mechanically and biologically equivalently to the predicate devices as demonstrated by adherence to these industry and regulatory standards.
8. Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of an implantable medical device submission of this nature. Machine learning or AI models, which would require training sets, are not involved.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8.
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