(159 days)
When used as an intervertebral body fusion device:
The CoRoent XLR-Standalone 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 non-fusion spinal surgery at the involved level(s). The CoRoent XLR-Standalone 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 XLR-Standalone System.
When used as a partial Vertebral Body Replacement (VBR):
The CoRoent XLR-Standalone System is a standalone system indicated for use in the thoracolumbar spine (T1-L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The CoRoent XLR-Standalone System is also indicated for treating fractures of the thoracic and lumbar spine. The CoRoent XLR-Standalone System is intended to be used with autograft or allograft.
The NuVasive CoRoent XLR-Standalone System is an implantable device manufactured from PEEK and titanium alloy that is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
The provided document is a 510(k) Summary for a medical device called the NuVasive CoRoent® XLR Standalone System. This type of submission focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than presenting a performance study with acceptance criteria in the same way a de novo or PMA submission might.
Therefore, the information typically found in acceptance criteria tables and detailed performance studies for AI/ML devices (like sensitivity, specificity, sample sizes for training/test sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies) is not present in this document.
Here's a breakdown of why and what information is available:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in this context. This document does not define specific clinical acceptance criteria (e.g., target true positive rate, false positive rate) that the device must meet, nor does it report performance against such criteria.
- Instead, it focuses on nonclinical testing for substantial equivalence:
- Acceptance Criteria (Implicit): The implicit acceptance criterion is that the device's mechanical performance (e.g., strength, durability, wear) must be "substantially equivalent" to or "meets or exceeds the performance of the predicate device" as determined by the specified ASTM standards and work items.
- Reported Device Performance:
Test Performed Reported Device Performance Static and dynamic torsion per ASTM F2077 Meets or exceeds the performance of the predicate device. Static and dynamic compression per ASTM F2077 Meets or exceeds the performance of the predicate device. Wear Debris per ASTM F2077 & ASTM F1877 Meets or exceeds the performance of the predicate device. Subsidence per ASTM F2267 Meets or exceeds the performance of the predicate device. Expulsion per ASTM Work Item Z8423Z Meets or exceeds the performance of the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document describes nonclinical, mechanical testing of physical implants, not testing on patient data or a "test set" in the context of AI/ML or clinical efficacy studies. Therefore, there's no "data provenance" related to patient data or sample sizes for clinical evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is a mechanical device, not an image analysis or diagnostic AI. "Ground truth" in this context refers to the defined parameters and methodologies of the ASTM standards themselves, which are established by expert consensus within their respective fields, but not in the same way as clinical "ground truth" for a diagnostic algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method is mentioned as this is not a diagnostic device or a study involving human interpretation of data. The "adjudication" is determined by whether the device's mechanical properties meet the specified ASTM standard thresholds.
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 intervertebral body fusion device, not an AI or imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This refers to a physical implant, not an algorithm. The "standalone system" in the device name refers to its ability to achieve fusion without requiring additional supplemental internal fixation, not to an algorithm operating independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Indirectly "Expert Consensus". The "ground truth" for nonclinical mechanical testing is implicitly established by the ASTM (American Society for Testing and Materials) standards themselves. These standards are developed through a consensus process involving engineers, scientists, and industry experts to define repeatable and reliable testing methodologies and performance benchmarks for medical devices.
8. The sample size for the training set
- Not Applicable. This document describes the 510(k) submission for a physical medical device. There is no "training set" in the context of machine learning or AI algorithms. The device itself is manufactured; it does not "learn" from 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 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.