(36 days)
The DePuy Synthes T-PAL Ti Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacers should be packed with autogenous bone graft (i.e. autograft).
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.
The T-PAL Spacers are intended to be used with DePuy Synthes supplemental fixation.
The DePuy Synthes T-PAL Ti Spacer is an interbody fusion device used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy. Previously, only T-PAL Spacers manufactured from PEEK (With TAN marker pins) material were available. The subject T-PAL Ti spacers will be manufactured entirely of TAN per ASTM F1295. The T-PAL Ti Spacer is available in two footprints and a range of heights and is angulated 5° to accommodate the lordotic curve (except for the smallest height of each footprint, which does not have a lordotic angle). Pyramidal teeth that assist in stabilization of the construct are located on the inferior and superior surfaces of the spacers. These teeth are oriented along a contour that follows the curve of the implant to assist in implantation. A bullet-nose design also facilitates self-distraction and ease of insertion. The open architecture of the devices allows them to be packed with autogenous bone graft material, i.e. autograft.
This document is a 510(k) premarket notification decision letter from the FDA regarding the DePuy Synthes T-PAL Ti Spacer. It is not a study demonstrating acceptance criteria or device performance in the context of an AI/algorithm-driven medical device.
Therefore, I cannot provide the requested information, such as:
- A table of acceptance criteria and the reported device performance: This document does not contain performance metrics that would be applicable to an AI device. The "performance data" mentioned (Section H) refers to a Finite Element Analysis of the physical implant, not an AI algorithm's performance.
- Sample size for the test set and data provenance: No such data is presented.
- Number of experts and qualifications for ground truth: Not applicable to this type of device submission.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not conducted as this is a physical implant, not an AI device.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: No training data for an algorithm is mentioned.
- How the ground truth for the training set was established: Not applicable.
Summary of what the document does provide:
The document concerns the regulatory clearance (510(k)) of a new version of an existing intervertebral body fusion device, the DePuy Synthes T-PAL Ti Spacer. The key aspects are:
- Device: DePuy Synthes T-PAL Ti Spacer (an intervertebral body fusion device).
- Changes from predicate: The main changes are a material change (from PEEK to Ti-6Al-7Nb (TAN) ASTM F-1295 titanium alloy), a sterilization modality change, and a minor design modification.
- Intended Use: For patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, requiring interbody fusion with supplemental fixation. The spacers must be packed with autogenous bone graft. DDD is defined by back pain of discogenic origin, confirmed by history and radiographic studies, in skeletally mature patients who have had six months of non-operative treatment.
- Predicate Device: Synthes T-PAL Spacer (K100089) and Patriot Signature® Ti Spacer (K122097).
- Demonstration of Equivalence: The submission asserts that the new device is substantially equivalent to the predicate devices because the intended use, performance, and technology remain "identical" despite the material and minor design changes.
- Performance Data (for the physical implant): A Finite Element Analysis (FEA) simulating static/dynamic axial compression and compression shear was performed to demonstrate that the proposed modifications do not introduce a "new worst case" regarding the physical implant's mechanical performance. This is not performance data for an AI algorithm.
- Conclusion: The FDA determined substantial equivalence based on the unchanged intended use and similar technological characteristics, with FEA and post-market data supporting that the changes do not raise new questions of safety and effectiveness.
In essence, this document is a regulatory approval letter for a medical implant, not a study of an AI device's performance against acceptance criteria.
§ 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.