(32 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 patients may also have up to Grade 1 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 or retrolisthesis 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 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 I spondylolisthesis or retrolistesis 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 I spondylolisthesis or retrolistesis 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 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 radios. 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 special 510(k) is intended to modify the sterilization of the Endoskeleton® system from non-sterile to sterile via gamma irradiation.
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. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).
The document provided does not describe a study that uses acceptance criteria to prove the device meets these criteria in the context of an AI/ML algorithm or a comparative effectiveness study. Instead, it is a 510(k) premarket notification for a medical device (Endoskeleton® System) that focuses on substantial equivalence to predicate devices, particularly regarding a change in sterilization method from non-sterile to sterile via gamma irradiation.
Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not present in this document.
However, I can extract the information that is available:
1. A table of acceptance criteria and the reported device performance:
The document focuses on substantial equivalence for a change in sterilization method. The "acceptance criteria" here are implied to be that the new sterilization method (gamma irradiation) effectively sterilizes the device without negatively impacting its other characteristics, thus maintaining substantial equivalence to the non-sterile predicate devices.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Device is sterile after processing | Sterilization validation was completed to verify that the subject devices are sterilized via gamma irradiation. |
| Device maintains substantial equivalence to predicate devices (indications for use, design, dimension, materials, surface treatment) | "There are no changes between the predicate devices and the subject devices with respect to indications for use, design, dimension, surface treatment and materials. The only difference to the currently marketed devices is the change in sterilization." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The document describes a 510(k) submission for a physical medical device (interbody fusion system) and a change in its sterilization method, not a study involving a test set for an AI/ML algorithm or data analysis. The "sterilization validation" would typically involve samples of the device and testing for sterility, but the specific sample size and detailed provenance of that testing are not provided in this summary.
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. No ground truth for a test set (in the context of AI/ML or diagnostic performance) is established in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method for a test set is mentioned.
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 document does not describe an AI/ML device or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This document does not describe an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the context of an AI/ML algorithm. For the sterilization validation, the "ground truth" would be the standard scientific and regulatory methods for proving sterility (e.g., microbial challenges, physical testing), but specific details are not provided.
8. The sample size for the training set:
Not applicable. This document is not about an AI/ML algorithm with a training set.
9. How the ground truth for the training set was established:
Not applicable. This document is not about an AI/ML algorithm with a training set.
§ 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.