(101 days)
The ENDOSKELETON® TA 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 to treatment with the device. The device may be used with supplemental fixation. These DDD pattents may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
The Endoskeleton® TAS 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 with the devices. The device is a standalone system intended to be used with the bone screws provided and requires no additional supplementary fixation. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is indicated to be used with autograft bone.
The Endoskeleton® TO IBD 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 with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is indicated to be used with autograft bone.
The Endoskeleton® TT IBD 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 and radiographic studies. Patients should have received 6 months of non-operative treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is indicated to be used with autograft bone.
The Endoskeleton® TC is indicated for use for anterior cervical interbody fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C-3 to C-7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device. The Endoskeleton® TC is indicated to be used with supplemental fixation and autograft bone.
The Endoskeleton® TL IBD is indicated for use in spinal fusion procedures 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 is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients with non-fusion spinal surgery at the involved level(s) may be treated with the device. It is indicated to be used with autograft bone.
The ENDOSKELETON® TA VBR is for use in the thoracolumbar spine (T1 – L5) to replace all or part of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The ENDOSKELETON® TA VBR is intended for use with supplemental internal spinal fixation systems. The ENDOSKELETON® TA VBR may be used with bone graft material or bone graft substitute.
This traditional 510(k) is intended to modify the surface treatment of Endoskeleton devices.
The Endoskeleton system is an interbody and vertebral body system comprised of a variety of implant sizes and geometries to accommodate various patient anatomy and pathology. The modified surface technology provides a microscopic roughened surface with nano-scale features. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).
The provided text describes a 510(k) premarket notification for the Endoskeleton® System, which includes various interbody fusion devices and a vertebral body replacement device. This submission focuses on a modification to the surface treatment of existing devices, rather than a new device with novel indications for use. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily related to demonstrating that the modified device is substantially equivalent to the predicate devices, particularly regarding its mechanical performance, biocompatibility, and integrity.
The document does not detail specific acceptance criteria in the form of numerical thresholds for metrics like sensitivity, specificity, or accuracy, as would be typical for an AI/ML device. Instead, the "acceptance criteria" are implied by the regulatory requirement to demonstrate substantial equivalence to previously cleared devices. The "study" refers to the performance testing conducted to show that the new surface treatment does not negatively impact the device's safety and effectiveness compared to the predicate devices.
Here's a breakdown of the requested information based on the provided text, recognizing the context of a medical device modification rather than an AI/ML diagnostic tool:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength: Device must maintain adequate mechanical strength for intended use, comparable to predicate devices. (Demonstrated by ASTM F2077) | Axial fatigue testing performed per ASTM F2077. The testing indicated that the Endoskeleton® devices are adequate for the intended use and substantially equivalent to the predicate systems. |
| Surface Integrity: New surface treatment must maintain integrity over time and under conditions of use. | Surface specific characterization and integrity testing were completed. (Implicitly, these tests supported the conclusion of substantial equivalence). |
| Biocompatibility: Device with new surface must be biocompatible, comparable to predicate devices. (Demonstrated by ISO 10993-1) | Biocompatibility per ISO 10993 was established through ISO 10993-1 assessment and an implantation animal model. The testing indicated that the Endoskeleton® devices are adequate for the intended use and substantially equivalent to the predicate systems. (This implies that the new surface treatment did not introduce new biocompatibility concerns and met the standard). |
| Wear Characteristics: Wear properties should be acceptable and comparable to predicate devices. (Demonstrated by modified ASTM F1160) | Wear testing was done using a modified protocol of ASTM F1160 with particulate characterization. (Implicitly, the results supported the conclusion of substantial equivalence). |
| Substantial Equivalence: All modified devices must remain substantially equivalent to predicate devices with respect to indications for use, design, dimension, and materials (except for the surface treatment). | The subject Endoskeleton® device is identical to the predicate devices with respect to indications for use, design, dimension, and materials. The only difference to the currently marketed devices is the change in surface treatment. "The testing indicated that the Endoskeleton® devices are adequate for the intended use and substantially equivalent to the predicate systems." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to mechanical and biocompatibility testing rather than a clinical "test set" in the context of diagnostic accuracy.
- Sample Size: Not explicitly stated. For mechanical and biocompatibility testing of medical devices, sample sizes are typically determined by relevant ISO/ASTM standards (e.g., ISO 10993, ASTM F2077, ASTM F1160) and statistical power analysis specific to the test type. They would refer to the number of device components or animal subjects tested, not patient data.
- Data Provenance: Not applicable in the sense of country of origin of patient data. The provenance of the testing would be controlled laboratory environments where the mechanical and biocompatibility tests were conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not a study involving expert review of diagnostic data to establish ground truth. The "ground truth" for this submission is established by the specifications of the device itself and the requirements of the standards (ASTM, ISO) for mechanical properties and biocompatibility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication method is used for establishing ground truth in clinical/diagnostic studies, which is not the nature of the testing described here.
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
Not applicable. This submission is for a physical medical device (intervertebral body fusion device), 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 submission is for a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device modification, the "ground truth" is a combination of:
- Engineering Specifications and Standard Requirements: The acceptance criteria are based on established ISO and ASTM standards for the mechanical properties and biocompatibility of implantable devices. The device must meet these standards to ensure safety and effectiveness.
- Predicate Device Performance: The primary "ground truth" for demonstrating substantial equivalence is the known, cleared performance of the predicate devices. The modified device must perform comparably to these established devices.
8. The sample size for the training set
Not applicable. This type of "training set" is relevant for AI/ML algorithms, not for the physical device modification described.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm.
§ 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.