(126 days)
The NuVasive® CoRoent® Sterile Implants System is a device system indicated for the following: Intervertebral Body Fusion The NuVasive CoRoent Sterile Implants System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion. The NuVasive CoRoent Sterile Implants System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. Partial Vertebral Body Replacement The NuVasive CoRoent Sterlie Implants System may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by turnor or fracture, to restore height of a collapsed vertebrail body, and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.
Device Desert Sterile Implants are manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026 and titanium alloy conforming to ASTM F136 and ISO 5832-3. The implants are offered gamma sterilized. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
The information provided describes a 510(k) premarket notification for the NuVasive® CoRoent® Sterile Implants System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than fulfilling specific acceptance criteria through a clinical study in the way an AI/ML device would.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of device and submission.
Here's a breakdown of the relevant information from the document in the format requested, with an explanation of why other sections are not applicable:
Acceptance Criteria and Device Performance Study for NuVasive® CoRoent® Sterile Implants System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated) | Reported Device Performance |
|---|---|
| Material Properties (PEEK-Optima LT-1): Gamma sterilization does not negatively affect mechanical properties. | Test data provided as evidence that gamma sterilization does not negatively affect mechanical properties of PEEK-Optima LT-1. |
| Sterilization Validation: Successful validation of the gamma sterilization process. | Gamma sterilization validation was performed. |
| Sterile Packaging Performance Validation: Successful validation of sterile packaging. | Sterile packaging performance validation was performed. |
| Integrity of Sterile Barrier Over Time Validation: Successful validation of sterile barrier integrity over time. | Integrity of the sterile barrier over time validation was performed. |
| Substantial Equivalence to Predicate Devices: Device is substantially equivalent to legally marketed predicate devices in terms of design, labeling/intended use, material composition, and function. | The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate device (NuVasive CoRoent System K071795 and Alphatec Spine Epicage Interbody Fusion Device K130548) through comparison in areas including design, labeling/intended use, material composition, and function. This was confirmed by the FDA's "Substantial Equivalence" determination. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable. This submission is for a physical implantable medical device, not an AI/ML device or diagnostic test that would typically involve a "test set" of patient data for performance evaluation in the way the question implies. The "test data" referenced pertains to material and sterilization validation, not clinical outcomes from a patient-based test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. As above, this type of submission does not involve expert-established ground truth on patient cases/data. The "ground truth" here is compliance with material specifications and sterilization efficacy.
4. Adjudication Method for the Test Set
- Not Applicable. No test set in the conventional sense (patient data requiring expert review) was used for this type of device.
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 a physical implantable device, not a diagnostic imaging or AI system that involves human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical implantable device, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's acceptance was:
- Material Specifications: Compliance with ASTM F2026 for PEEK-Optima® LT-1 and ASTM F136 / ISO 5832-3 for titanium alloy.
- Sterilization Standards: Validation of gamma sterilization processes to achieve sterility.
- Packaging Integrity Standards: Validation of sterile packaging performance and barrier integrity over time.
- Comparison to Predicate Devices: Demonstrating equivalence in design, materials, function, and intended use as assessed against legally marketed devices.
8. The Sample Size for the Training Set
- Not Applicable. This device is not an AI/ML system that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As above, no training set was used.
§ 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.