(254 days)
The Innovasis Ax Stand-Alone ALIF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system such as the Innovasis® Excella® Spinal System. The Ax Stand-Alone interbody implants with a lordotic angle less than 20°, when used with the internal fixation screws, do not require use of supplemental fixation.
The Innovasis Ax Stand-Alone ALIF implant will be provided in two configurations. The first is an HA PEEK caqe with an integrated titanium faceplate. The second is an all titanium version of the same implant. Both designs will feature screws, a locking mechanism, and instruments. The implant is a stand-alone anterior intervertebral body fusion device indicated for use in patients with degenerative disk disease (DDD) at one or two contiquous levels from L2 to S1. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s).
The interior of the device will be packed with autograft.
Intended to support restoration of the sagittal balance.
It is intended to be used with bone screws and will not require additional supplementary fixation for implants with a lordotic angle less than 20°.
Implants with a lordotic angle ≥20° are indicated for use with supplementary fixation, such as the Excella Spinal System.
It is intended for use with the standard anterior approach
The provided document is a 510(k) premarket notification from the FDA for a medical device called the Ax™ Stand-Alone ALIF System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data with acceptance criteria for device performance in terms of diagnostic accuracy or clinical outcomes.
Therefore, the document does not contain the information requested for acceptance criteria and the study that proves the device meets those criteria, specifically:
- A table of acceptance criteria and reported device performance (in terms of diagnostic metrics).
- Sample size used for a test set and data provenance.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method for a test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Information on a standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the document details non-clinical performance data (mechanical testing) demonstrating substantial equivalence to predicate devices.
Here's what the document does provide regarding performance data and substantial equivalence:
1. Acceptance Criteria and Device Performance (Non-clinical):
| Acceptance Criteria (based on predicate equivalence) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (K121211, K151785, K123045) in: | Ax Stand-Alone ALIF is substantially equivalent to predicates per performance testing. |
| - Mechanical strength (Static Axial Compression, Dynamic Axial Compression, Subsidence, Expulsion, antibackout testing) per ASTM F2077-14 and F2267-04. | Performance testing per ASTM F2077-14 and F2267-04 for Static Axial Compression, Dynamic Axial Compression, Subsidence, Expulsion, and side-by-side antibackout testing indicates that the Ax Stand-Alone ALIF is substantially equivalent to the predicates. |
| - Materials (biocompatibility profile and processing) | Materials are substantially equivalent to predicate device. |
| - Technology | Technology is substantially equivalent to predicate device. |
| - Design | Design is substantially equivalent to predicate device. |
| - Sizes | Sizes are substantially equivalent to predicate device. |
| - Bone graft window/cavity | Bone graft window/cavity is substantially equivalent to predicate device. |
| - Indications for use | Indications for use are substantially equivalent to predicate device. |
2. Sample size used for the test set and the data provenance: Not applicable. The document discusses non-clinical mechanical testing, not a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. 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/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical testing, the "ground truth" is defined by the established industry standards (ASTM F2077-14 and F2267-04) and the performance of the predicate device.
8. The sample size for the training set: Not applicable.
9. 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.