(114 days)
When used with the bone screws, the Theken Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material.
When used with the SpinPlate, the Theken Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material. When used with the SpinPlate, the Theken Spine Vu aPOD Intervertebral Body Fusion Device is intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System.
The Theken Spine Vu aPOD Intervertebral Body Fusion Device, when used with bone screws, is a stand alone device. If the Theken Spine Vu aPod Intervertebral Body Fusion Device is used with the SpinPlate then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. The SpinPlate and bone screws are not intended to be used together. This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
The Vu aPOD Intervertebral Body Fusion Device consists of lumbar spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Vu aPOD spacers are manufactured from PEEK OPTIMA LT1 polymer per ASTM F2026 while the bone screws and SpinMate are comprised of Titanium alloy (Ti-6Al-4V ELI) per ASTM F136. Radiographic markers present with the Vu aPOD spacers are comprised of tantalum per ASTM F560. The Vu aPOD Intervertebral Body Fusion Device is for lumbar spinal use at one or two contiguous levels from the L2-L3 to L5-S1 disc levels.
This document pertains to the 510(k) summary for the Theken Spine Vu aPOD Intervertebral Body Fusion Device, a spinal implant, not an AI/ML powered device. As such, concepts like "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (e.g., sensitivity, specificity, F1 score) are not directly applicable.
The document describes the preclinical testing performed to demonstrate the device's substantial equivalence to predicate devices, focusing on mechanical performance.
Here's an interpretation of the requested information based on the provided text, re-framing "acceptance criteria" to refer to the mechanical performance standards:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Standards per ASTM) | Reported Device Performance |
|---|---|
| ASTM F2077: Static Axial Compression | Met (indicating substantial equivalence to predicate devices) |
| ASTM F2077: Static Compression-Shear | Met (indicating substantial equivalence to predicate devices) |
| ASTM F2077: Static Torsion | Met (indicating substantial equivalence to predicate devices) |
| ASTM F2077: Dynamic Axial Compression | Met (indicating substantial equivalence to predicate devices) |
| ASTM F2077: Dynamic Compression-Shear | Met (indicating substantial equivalence to predicate devices) |
| ASTM F2077: Expulsion | Met (indicating substantial equivalence to predicate devices) |
| ASTM F2267: Static Subsidence | Met (indicating substantial equivalence to predicate devices) |
Explanation: The document states that "Preclinical testing has been performed per ASTM F2077 (static axial compression, static compression-shear, static torsion, dynamic axial compression, dynamic compression-shear, expulsion) and ASTM F2267 (static subsidence) indicating that the Vu aPOD Intervertebral Body Fusion Device is substantially equivalent to predicate devices." This implies that the device successfully met the performance requirements outlined in these ASTM standards, thus proving its mechanical integrity and equivalence to existing, cleared devices.
Regarding the remaining points (2-9), these are relevant to AI/ML device evaluations and are not applicable to this physical medical device. The document does not contain information on:
- Sample size used for a test set (as there is no "test set" in the AI/ML sense)
- Data provenance for a test set
- Number of experts used to establish ground truth or their qualifications
- Adjudication method for a test set
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone (algorithm only) performance
- Type of ground truth (e.g., pathology, outcomes data) for an AI/ML model
- Sample size for a training set
- How ground truth for a training set was established
This 510(k) summary focuses on demonstrating mechanical and material equivalence of a surgical implant to previously cleared devices through preclinical bench testing, rather than evaluating the performance of an AI/ML algorithm.
§ 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.