(90 days)
The Curiteva Porous PEEK Standalone ALIF devices are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral 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 Grade I spondylolisthesis or retrolisthesis at the involved level(s). The system spacers are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.
The Curiteva Porous PEEK Standalone ALIF spacer is an interbody fusion device to be used with three titanium alloy screws or anchors. When used with screws, the system is a standalone interbody fusion device. When used with anchors, the system is intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (>20° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).
The Curiteva Porous PEEK ALIF devices are intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The system spacers are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral 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 Curiteva Porous PEEK Standalone ALIF System implants are provided sterile or non-sterile, are single-use devices, and available in a variety of different footprints, styles and sizes to accommodate the individual pathology and anatomical conditions of the patient. The subject system consists of interbody spacer implants that are generally box-shaped with an open central corridor to permit packing with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The system also provides screws and anchors that can be inserted through the anterior portion of the spacers into adjacent vertebral bodies for bony fixation.
The Curiteva Porous PEEK Standalone ALIF System implants are manufactured from implant-grade PEEK (per ASTM F2026), Titanium alloy (per ASTM F136), and Tantalum (per ASTM F560). All Porous PEEK interbody spacers are additionally surface treated with a hydroxyapatite (HA) coating that is approximately 20nm thick.
The provided FDA 510(k) Clearance Letter for the Curiteva Porous PEEK Standalone ALIF System does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria, as typically found for devices involving AI/ML and diagnostic performance.
This document describes a traditional medical device (an intervertebral body fusion device) primarily evaluated through non-clinical performance testing (mechanical testing) for substantial equivalence to predicate devices. Therefore, many of the requested categories are not applicable to the information provided in this regulatory submission.
Here's an assessment based on the provided text, indicating where information is not present or not applicable:
Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:
The Curiteva Porous PEEK Standalone ALIF System is an intervertebral body fusion device. Its clearance is based on demonstrating substantial equivalence to legally marketed predicate devices through comparison of design, intended use, material composition, function, range of sizes, and non-clinical performance testing.
The "acceptance criteria" in this context are related to the mechanical performance and safety of the implant, demonstrating that it is as safe and effective as existing cleared devices. The "study" proving this involves a series of in-vitro biomechanical tests.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit from Testing) | Reported Device Performance (Summary from Document) |
|---|---|---|
| Mechanical Strength | Static Axial Compression (ASTM F2077) | Sufficient for intended use; substantially equivalent to predicates |
| Dynamic Axial Compression (ASTM F2077) | Sufficient for intended use; substantially equivalent to predicates | |
| Static Compression-Shear (ASTM F2077) | Sufficient for intended use; substantially equivalent to predicates | |
| Dynamic Compression-Shear (ASTM F2077) | Sufficient for intended use; substantially equivalent to predicates | |
| Stability | Subsidence (ASTM F2267) | Sufficient for intended use; substantially equivalent to predicates |
| Expulsion Resistance | Expulsion Testing | Sufficient for intended use; substantially equivalent to predicates |
| Material/Wear | Particle Characterization (ASTM F1877) | Sufficient for intended use; substantially equivalent to predicates |
Note: The document states that the results "demonstrate that the strength and performance... is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." Specific numerical acceptance values or detailed performance data are not provided in this summary, as is typical for 510(k) summary documents which focus on the conclusion of substantial equivalence rather than raw data.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: This information is not provided in the document. For biomechanical testing, sample sizes are typically specified per test (e.g., n=6, n=10 per group).
- Data Provenance: The testing is described as "non-clinical testing" and performed on the "subject Curiteva Porous PEEK Standalone ALIF System." This indicates in-vitro (benchtop) testing of the device itself, not human or patient data. Therefore, country of origin or retrospective/prospective classification is not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts
- Not Applicable. This type of device (a physical implant) does not involve AI/ML or diagnostic image interpretation where expert ground truth establishment for a test set would be relevant. The "ground truth" for mechanical testing is established by the specified ASTM standards and the physical properties of the material and design.
4. Adjudication Method for the Test Set
- Not Applicable. As there is no ground truth established by experts, an adjudication method is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study is relevant for diagnostic devices (e.g., AI for image interpretation) to compare human performance with and without AI assistance. This device is an implantable surgical device, so an MRMC study was not performed, nor is it applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
- Not Applicable. This concept applies to AI/ML algorithms, not to a physical implantable device.
7. The Type of Ground Truth Used
- For the non-clinical performance testing, the "ground truth" is defined by the established engineering and biomechanical principles and standards (e.g., ASTM F2077, ASTM F2267, ASTM F1877). These standards define acceptable methodologies and performance metrics for intervertebral fusion devices.
8. The Sample Size for the Training Set
- Not Applicable. This device is not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, there is no ground truth to be established for it.
§ 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.