(193 days)
The CoRoent No-Profile System is a standalone system indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient 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 nonfusion spinal surgery at the involved level(s). The CoRoent No-Profile System is intended for use with autograft.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the CoRoent No-Profile System.
The NuVasive CoRoent No-Profile Standalone System is manufactured from PEEK-Optima LT1, titanium alloy, and Nitinol SE508 alloy. The implants are available in a variety of sizes to suite the individual pathology and anatomical conditions of the patient. The CoRoent No-Profile Standalone System is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
Here's an analysis of the provided text regarding the NuVasive CoRoent No-Profile System:
Acceptance Criteria and Study Details for NuVasive CoRoent No-Profile System
This document describes the premarket notification (510(k)) for the NuVasive CoRoent No-Profile System. The "acceptance criteria" here refer to demonstrating substantial equivalence to predicate devices through
various nonclinical performance tests, rather than a clinical study with statistical endpoints.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Must be comparable to predicate devices to demonstrate safe and effective performance for intended use. | Passed All Tests: Results demonstrated substantial equivalence to predicate devices. |
| Static Axial Compression | ASTM F2077-03 Compliance | Performed per ASTM F2077-03; results indicate equivalence. |
| Dynamic Axial Compression | ASTM F2077-03 Compliance | Performed per ASTM F2077-03; results indicate equivalence. |
| Static Torsion | ASTM F2077-03 Compliance | Performed per ASTM F2077-03; results indicate equivalence. |
| Dynamic Torsion | ASTM F2077-03 Compliance | Performed per ASTM F2077-03; results indicate equivalence. |
| Expulsion | Compliance with Draft standard, work item Z8423Z | Performed per Draft standard Z8423Z; results indicate equivalence. |
| Subsidence | ASTM F2267-04 Compliance | Performed per ASTM F2267-04; results indicate equivalence. |
| Wear Debris | ASTM F2077 & ASTM F17877 Compliance | Performed per ASTM F2077 & ASTM F17877; results indicate equivalence. |
| Axial Screw Pullout | ASTM F543 Compliance | Performed per ASTM F543; results indicate equivalence. |
| Screw Push-out Testing | Implied standard for screw retention | Performed; results indicate equivalence. |
| Screw Push-through Testing | Implied standard for screw retention | Performed; results indicate equivalence. |
| Static Separation Testing | Implied standard for construct integrity | Performed; results indicate equivalence. |
Note: The document explicitly states: "The results of these studies, as well as the descriptive information presented, demonstrates that the subject CoRoent No-Profile System is substantially equivalent to the performance of the predicate devices, and the device was therefore found to be substantially equivalent."
2. Sample Size Used for the Test Set and Data Provenance
The study described is focused on nonclinical performance testing of a medical device, not a human clinical trial. Therefore, the concept of a "test set" in the context of human subjects or data provenance (e.g., country of origin, retrospective/prospective) does not apply here. The "test sets" would refer to the physical samples of the device components manufactured and tested in a laboratory setting. The document does not specify the exact number of physical samples used for each nonclinical test, but it implies a sufficient number were used to meet the requirements of the specified ASTM standards and draft work items.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable as the study is a nonclinical, mechanical performance evaluation of a device, not a diagnostic or clinical study requiring expert ground truth assessment.
4. Adjudication Method for the Test Set
This section is not applicable as the adjudication method is relevant for expert review in clinical or diagnostic studies. Nonclinical performance testing results are typically evaluated against predefined engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This section is not applicable as the submission is for a medical device (spinal implant) and not an imaging or diagnostic AI system that would typically undergo an MRMC study.
6. Standalone (Algorithm Only) Performance
This section is not applicable as the submission is for a physical medical device (spinal implant), not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" for this nonclinical study is the established performance criteria and specifications defined by the relevant ASTM standards (e.g., ASTM F2077-03, ASTM F2267-04, ASTM F543, ASTM F17877) and a draft standard (Z8423Z). The device's performance was compared to these benchmarks and to the known performance characteristics of the predicate devices.
8. Sample Size for the Training Set
This section is not applicable as this is a nonclinical device performance study, not a machine learning model, and therefore has no "training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as above.
§ 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.