(121 days)
Synthes T-PAL 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 Spacer 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 non-operative treatment.
*The T-PAL Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, Synthes USS (including Matrix, USS Small Stature Click'X, Pangea, USS Polyaxial, USS Iliosacral, and ClampFix).
The Synthes T-PAL Spacer is a radiolucent interbody fusion device used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy. The T-PAL Spacer is available in two footprints and a range of heights, and is angulated 5º 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.
The provided 510(k) summary describes a spinal intervertebral body fusion device, not an AI or imaging device. Therefore, many of the requested criteria related to AI or digital imaging performance metrics (like sample size for test/training set, expert qualification, MRMC studies, standalone performance, etc.) are not applicable and thus, no information is available in the provided text for those points.
This submission focuses on the mechanical and structural performance of the T-PAL Spacer, comparing it to predicate devices through non-clinical performance tests.
Here's the available information based on the provided text:
Acceptance Criteria and Device Performance
| Criteria | Description / Reported Performance |
|---|---|
| Non-Clinical Performance Tests | Synthes determined the T-PAL Spacer is substantially equivalent to predicate devices based on the following tests: |
| Static Axial Compression | Performed (conclusion: substantially equivalent) |
| Dynamic Axial Compression | Performed (conclusion: substantially equivalent) |
| Subsidence | Performed (conclusion: substantially equivalent) |
| Expulsion | Performed (conclusion: substantially equivalent) |
| Static Compression Shear | Performed (conclusion: substantially equivalent) |
| Clinical Performance | Not needed for this device. |
| Substantial Equivalence to Predicates | The device is considered substantially equivalent to similar previously cleared predicate devices in terms of design, function, performance, material, and intended use as determined by the non-clinical performance tests. This is the primary acceptance criterion for 510(k) clearance for this type of device, indicating it performs as safely and effectively as a legally marketed device. |
Study Details (where applicable for a non-AI/imaging device)
- Sample size used for the test set and the data provenance: Not applicable. The performance evaluation was based on non-clinical (mechanical) testing of the device itself, not on processing a defined "test set" of data or images.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical performance typically comes from engineering specifications and testing standards, not expert clinical consensus in this context.
- Adjudication method for the test set: Not applicable.
- 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 is not an AI/imaging device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/imaging device.
- The type of ground truth used: The "ground truth" for this type of device is established by engineering standards and validated mechanical testing protocols. The goal is to demonstrate that the device meets or exceeds the mechanical properties and safety profiles of its predicate devices when tested under specified conditions.
- The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no training set in the conventional sense.
- How the ground truth for the training set was established: Not applicable.
§ 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.