(62 days)
CancelleX Porous Titanium Lumbar Interbody System devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non- fusion spinal surgery at the involved spinal level(s). The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation. The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the CancelleX device.
CancelleX Porous Titanium Lumbar Interbody System devices are being added to the Lumbar Interbody System. The CancelleX Porous Titanium Interbody devices are generally box shaped with surface teeth and a central channel for packing autogenous bone. These implants are available in a range of shapes and sizes to accommodate variations in patient anatomy. The devices are manufactured from Commercially Pure (Unalloyed) Titanium (ASTM F1580). The system also includes instruments manufactured using polyacrylamide (PARA-IXEF-GY51) polymer and stainless steel per ASTM F899.
The provided text describes the regulatory clearance of the CancelleX Porous Titanium Lumbar Interbody Device. It does not contain information about the acceptance criteria or a study proving the device meets said criteria in the context of AI/ML device performance.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data (bench testing and biocompatibility). It explicitly states that animal and clinical performance data were not required to determine substantial equivalence.
Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI/ML or answer most of the requested questions.
Here's what can be extracted based on the provided document:
1. Table of Acceptance Criteria and the Reported Device Performance (as much as applicable):
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance/Conclusion |
|---|---|---|
| Biocompatibility | ISO 10993-1:2009 analysis | Biological effects considered based on FDA Guidance. (Implies compliance, as no issues were raised to prevent clearance) |
| Bench Testing | Static and dynamic axial compression (ASTM F2077) | Substantial equivalence supported by evaluation. |
| Compression shear testing (ASTM F2077) | Substantial equivalence supported by evaluation. | |
| Subsidence testing (ASTM F2267) | Substantial equivalence supported by evaluation. | |
| Expulsion testing | Substantial equivalence supported by evaluation. | |
| Overall Equivalence | Comparison to predicate devices for design, materials, operating principle, indications for use | Subject device has equivalent technological characteristics and at least equivalent performance. |
The following questions cannot be answered based on the provided document as they relate to AI/ML device performance, which is not discussed:
- 2. Sample sized used for the test set and the data provenance
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- 4. Adjudication method for the test set
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- 7. The type of ground truth used
- 8. The sample size for the training set
- 9. How the ground truth for the training set was established
Summary of what the document does indicate:
The device's clearance was based on its substantial equivalence to previously cleared predicate devices, supported by non-clinical (biocompatibility and bench) testing. No AI/ML components or associated studies are mentioned.
§ 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.