(104 days)
The NuVasive® CoRoent® Thoracolumbar Implants are devices indicated for the following:
Intervertebral Body Fusion
The NuVasive CoRoent Thoracolumbar Implicated for intervertebral body fusion of the spine in sketally mature patients. The implants are designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation system cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
Thoracic Spine:
The CoRoent Thoracolumbar Implants are intended for use for thoracic interbody fusions at one or two contiguous levels in the thoracic spine from T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectory for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc hemiation (myelopathy and/or radiculopathy with or without axial pain).
Lumbar Spine:
The CoRoent Thoracolumbar Implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Partial Vertebral Body Replacement
The NuVasive CoRoent Thoracolumbar Implants may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T) to LS) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The implants are intended to be used with supplemental internal spinal fixation systems (e.g. pedicle screw system) that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft may be used at the surgeon's discretion.
The CoRoent Thoracolumbar Implants are manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026 or titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The PEEK device contains titanium alloy radiographic markers conforming to ASTM F136 or ASTM F1472. 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 thoracolumbar spine. This 510(k) is to expand the indications for use to include interbody fusion in the thoracic spine.
The provided text is a 510(k) Premarket Notification for the NuVasive® CoRoent® Thoracolumbar Implants, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a new, novel device.
Therefore, the document does not contain the detailed acceptance criteria or a study design to prove device performance against such criteria in the way one might expect for an AI algorithm or a device requiring a de novo pathway or PMA.
Instead, the document emphasizes the following:
- Substantial Equivalence: The core of the submission is to demonstrate that the NuVasive CoRoent Thoracolumbar Implants are substantially equivalent to previously cleared predicate devices (NuVasive CoRoent System (K071795), NuVasive CoRoent Titanium System (K120918), and NuVasive CoRoent Sterile Implants System (K132601)). This is crucial for 510(k) clearance.
- Expansion of Indications for Use: The current 510(k) specifically aims to expand the indications for use to include interbody fusion in the thoracic spine, in addition to the existing lumbar spine indications and partial vertebral body replacement.
- Clinical Performance Data to Support Expanded Indications: The document states, "To establish substantial equivalence with predicate devices for the expanded indications for use, clinical performance data is presented. These data demonstrate that there are no new types of safety or effectiveness questions for the device in the expanded indications for use in the thoracic spine."
Based on this, I can't provide the requested table and detailed study information as the document does not contain that level of detail for this type of device submission.
However, I can extract the relevant information regarding the "study" that supports the device, even if it's not a typical performance study with explicit acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
As noted, explicit, quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are not provided in this 510(k) summary because the submission relies on substantial equivalence to predicate devices rather than novel performance benchmarks.
The "performance" demonstrated is that the device is substantially equivalent to already cleared devices and introduces no new safety or effectiveness concerns for its expanded indications.
Acceptance Criteria (Implied for 510(k) Substantial Equivalence)
| Criterion | Reported Device "Performance" |
|---|---|
| Technological Characteristics: Comparable to predicate devices | The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison in areas including design, labeling/intended use, material composition, and function. (No design changes were made to the implants themselves). |
| Safety and Effectiveness for Expanded Indications: No new concerns | Clinical performance data are presented to demonstrate that "there are no new types of safety or effectiveness questions for the device in the expanded indications for use in the thoracic spine." (Details of this clinical data are not provided in the summary). |
| Material Conformance: Materials meet established standards | Manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026 or titanium alloy (Ti-6Al-4V) conforming to ASTM F136. PEEK device contains titanium alloy radiographic markers conforming to ASTM F136 or ASTM F1472. |
| Intended Use Alignment with Predicates: Broadly similar use cases | The intended uses (intervertebral body fusion in thoracic/lumbar spine, partial vertebral body replacement) are established as substantially equivalent to the predicate devices and align with their use in the thoracolumbar spine with supplemental fixation systems and bone graft. |
2. Sample size used for the test set and the data provenance
The document mentions "clinical performance data is presented," but does not specify the sample size, data provenance (country, retrospective/prospective nature), or any details of a 'test set.' In 510(k) submissions for implants, this "clinical performance data" might refer to a literature review, existing post-market surveillance data of similar devices, or a small clinical study, but these details are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. Given the nature of a medical implant and a substantial equivalence claim, the "ground truth" often relates to established clinical outcomes, material standards adherence, and biocompatibility, rather than expert interpretation of data for algorithmic performance.
4. Adjudication method
This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
This information is not provided and is highly unlikely to be part of a 510(k) submission for an implant of this type, which focuses on physical characteristics and material compatibility rather than diagnostic interpretation. An MRMC study is typically performed for AI or imaging devices that involve human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical thoracolumbar implant, not an algorithm.
7. The type of ground truth used
The "ground truth" in this context would likely refer to:
- Clinical Outcomes/Safety Data: Data reflecting the safety and effectiveness of the device (or its predicates) in surgical applications, including fusion rates, complication rates, and pain reduction. These specifics are not detailed in the summary.
- Material Standards Conformance: Verification that the materials (PEEK-Optima®, titanium alloy) meet relevant ASTM standards.
- Biocompatibility Testing: Data demonstrating that the materials are biocompatible.
- Mechanical Testing: Data on the mechanical properties (e.g., strength, fatigue) of the implants.
The document only broadly states "clinical performance data is presented" to demonstrate "no new types of safety or effectiveness questions."
8. The sample size for the training set
This is not applicable as the device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is not an AI algorithm.
§ 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.