(185 days)
The Curiteva Lumbar Interbody Fusion is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 - S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Implants are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) and supplemental spinal fixation systems that have been cleared for use in the lumbar spine. Patients should receive at least six (6) months of non-operative treatment prior to treatment with the device.
The Curiteva Lumbar Interbody Fusion System implants are available in a variety of different footprints, styles and sizes to accommodate surgical approach, and the individual pathology and anatomical conditions of the patient.
The implants are generally rectangle-shaped with an open central chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device.
The Curiteva Lumbar Interbody Fusion System implants are manufactured from PEEK (per ASTM F2026) with Tantalum markers (per ASTM F560), or Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. The PEEK implants are available with or without a medical grade commercially pure titanium (CpTi) plasma coating (per ASTM F1580) on the superior and inferior surfaces.
Here's an analysis of the provided text regarding acceptance criteria and study information for the Curiteva Lumbar Interbody Fusion System:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, the acceptance criteria and performance data are entirely focused on mechanical testing, as this is a 510(k) submission for an intervertebral body fusion device, which typically relies on demonstrating substantial equivalence to predicates through physical and mechanical properties.
| Acceptance Criteria (General for Intervertebral Body Fusion Devices) | Reported Device Performance (Curiteva Lumbar Interbody Fusion System) |
|---|---|
| Sufficient strength for intended use (e.g., maintaining spinal stability). | "The strength and performance... is sufficient for its intended use." |
| Demonstrated performance under static axial compression as per ASTM F2077. | Mechanically tested for static axial compression per ASTM F2077. |
| Demonstrated performance under dynamic axial compression as per ASTM F2077. | Mechanically tested for dynamic axial compression per ASTM F2077. |
| Demonstrated performance under static compression-shear as per ASTM F2077. | Mechanically tested for static compression-shear per ASTM F2077. |
| Demonstrated performance under dynamic compression-shear as per ASTM F2077. | Mechanically tested for dynamic compression-shear per ASTM F2077. |
| Resistance to subsidence as per ASTM F2267. | Mechanically tested for subsidence per ASTM F2267. |
| Resistance to expulsion. | Mechanically tested for expulsion. |
| Characterization of wear debris as per ASTM F1877. | Mechanically tested for wear debris characterization per ASTM F1877. |
| Substantial equivalence to legally marketed predicate devices. | "is substantially equivalent to legally marketed predicate devices." |
2. Sample Size Used for the Test Set and the Data Provenance
This document describes non-clinical mechanical testing of the device prototypes. Therefore:
- Sample size used for the test set: Not explicitly stated numerically for each test, but it would involve multiple samples of the device undergoing the specified mechanical tests. For medical device mechanical testing, typically a sufficient number of samples (e.g., n=5 or more per test condition) are used to ensure statistical validity and representativeness, but no specific numbers are given here.
- Data provenance: As this is non-clinical testing, the data provenance is from laboratory testing performed by the manufacturer (Curiteva, LLC) or a contracted testing facility. It is not patient-derived data (e.g., no country of origin or retrospective/prospective clinical study applies here).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to the data presented. Ground truth and expert consensus are concepts relevant to clinical studies involving human interpretation or pathology. The study described here is purely mechanical testing of a physical device. The "ground truth" for these tests are the established ASTM standards and the physics of material behavior.
4. Adjudication Method for the Test Set
This question is not applicable as there is no "adjudication" in the context of mechanical testing. The results are quantitative measurements against predefined standards (ASTM F2077, F2267, F1877).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study evaluates human reader performance, typically with medical images, both with and without AI assistance. The provided document describes mechanical testing of a physical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical implant, not a software algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for the performance data in this submission is derived from established engineering and material science standards (ASTM) and the objective measurements obtained from laboratory mechanical testing. It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of mechanical testing of a physical device. Training sets are relevant to machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above; there is no training set mentioned or implied in this document.
§ 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.