(90 days)
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 prior to treatment with 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.
Hyperlordotic Devices ≥16": The ENDOSKELETON® TAS Hyperlordotic Interbody Fusion Device (≥ 16") 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. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients should have received 6 months of non-operative treatment with the devices. The device is indicated to be used with autograft bone. The ENDOSKELETON® TAS Hyperlordotic Interbody Fusion Device must be used with a posterior supplemental internal spinal fixation that has been cleared by the FDA for use in the lumbar spine.
The Endoskeleton® TCS Interbody Fusion Device is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment with the device. The device is indicated to be used with autograft bone. The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine.
The Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device screws that are the subject of the present submission have been previously cleared as non-sterile. This Special 510(k) submission seeks clearance for the subject Endoskeleton® screws to be provided sterile by gamma irradiation. The current Endoskeleton family is an interbody and vertebral body system comprised of a variety of sizes and geometries to accommodate various patient anatomy and pathology. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI). The center of the implant is hollow and is to be filled with autograft material. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone.
I am sorry, but based on the text provided, I cannot provide the requested information about acceptance criteria and a study proving device performance. The document describes a 510(k) premarket notification for an interbody fusion device, focusing on substantial equivalence to predicate devices, particularly regarding a change in sterilization method (from non-sterile to sterile via gamma irradiation).
The document does not contain:
- A table of acceptance criteria and reported device performance metrics (e.g., accuracy, sensitivity, specificity for a diagnostic device, or specific physical performance thresholds for a therapeutic device).
- Details of a study proving the device meets specific performance criteria, as would typically be found in a clinical trial report or a detailed engineering test report.
- Information about sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or training set details, as these are typically associated with performance validation studies for AI/software devices or complex diagnostic tools.
Instead, the document focuses on:
- Identifying the device and its indications for use.
- Establishing substantial equivalence to predicate devices, primarily by demonstrating that the new sterilization method (gamma irradiation) for the screws does not alter the fundamental characteristics or safety/effectiveness of the device compared to the previously cleared predicate devices or an earlier clearance that also used gamma sterilization.
- Mentioning "sterilization validation and pyrogen testing" as performance testing related to the change in sterilization, and asserting biocompatibility based on material history and standards, rather than new, detailed performance studies for clinical effectiveness.
Therefore, I cannot fulfill your request as the information is not present in the provided text.
§ 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.