(105 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 nonoperative treatment prior to treatment with the device may 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 use with autograft bone.
The Endoskeleton TA® Interbody Fusion Device is comprised of a variety of implant sizes to accommodate various patient anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).
The provided text is a 510(k) summary for the Endoskeleton TA® Interbody Fusion Device. It details the device's indications for use, description, and predicate devices. However, it does not contain specific acceptance criteria, detailed study results, or information about AI/ML algorithm performance.
Here's a breakdown of why I cannot fulfill your request based on the provided text, and what information is present:
Missing Information (and why it's missing from a 510(k) summary of this type):
- Acceptance Criteria and Reported Device Performance Table: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It typically doesn't include detailed performance criteria and results in the same way a clinical trial report or a PMA (Premarket Approval) application would. The summary states: "The pre-clinical testing performed indicated that the Endoskeleton TA® Interbody Fusion Device is adequate for the intended use," but no specific metrics are given.
- Sample Size for Test Set and Data Provenance: This information is not typically part of a 510(k) summary for a spinal implant. The "testing" mentioned is likely mechanical/bench testing rather than clinical data involving a "test set" in the context of an AI/ML algorithm.
- Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable to this type of device and submission.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This device is an interbody fusion device, not a diagnostic imaging AI tool.
- Standalone (algorithm only) Performance: Not applicable as it's not an AI/ML device.
- Type of Ground Truth Used: Not applicable.
- Sample Size for Training Set: Not applicable.
- How Ground Truth for Training Set was Established: Not applicable.
Information that is present:
- Device Name: Endoskeleton TA® Interbody Fusion Device
- Indications for Use: For skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1, with or without Grade I spondylolisthesis/retrolisthesis, who have received 6 months of nonoperative treatment. To be used with supplemental fixation and autograft bone.
- Device Description: Comprised of various implant sizes manufactured from medical grade titanium alloy (Ti6Al4V-ELI) and associated instrumentation.
- Predicate Devices: BAK Interbody Fusion Device (Spine-Tech, P950002), Inter Fix Threaded Fusion Device (Sofamor Danek, P970015), Ray Threaded Threaded Cage (Surgical Dynamics, P950019), and Titan Spine Endoskeleton TA® VBR (K032812).
- Performance Testing (General Statement): "The pre-clinical testing performed indicated that the Endoskeleton TA® Interbody Fusion Device is adequate for the intended use."
Conclusion:
This 510(k) summary for the Endoskeleton TA® Interbody Fusion Device demonstrates substantial equivalence to predicate devices based on design, function, materials, and indications for use. It mentions pre-clinical testing, but does not provide the specific detailed performance metrics, acceptance criteria, or study methodologies that would be relevant for an AI/ML device as outlined in your request. The request's format (e.g., ground truth, training/test sets, experts, MRMC studies) is specifically tailored for AI/ML or diagnostic devices, which this interbody fusion device is not.
§ 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.