(69 days)
The NuVasive CoRoent Small Interlock II System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. The CoRoent Small Interlock II System (lordotic angles of 7° to 15°) is a standalone system. The CoRoent Small Interlock II System (lordotic angles of 20° to 30°) must be used with supplemental fixation cleared by the FDA. The System is intended to be used with autogenous or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.
The NuVasive CoRoent Small Interlock II System is an anterior cervical interbody device consisting of a PEEK-OPTIMA® (poly-ether-ether-ketone) implant cage with commercially pure titanium coating, tantalum radiographic markers, titanium allov washers, and three (3) titanium alloy bone fixation screws. The devices are manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, commercially pure titanium conforming to ASTM F1580, titanium alloy conforming to ASTM F136 and tantalum conforming to ASTM F560 or ISO 13782. The implants are available in a variety of sizes to accommodate anatomical conditions.
The NuVasive CoRoent Small Interlock II System is an anterior cervical interbody fusion device. The provided text is a 510(k) summary for a medical device and does not contain information about an AI/ML powered device, therefore the vast majority of the requested information is not applicable.
Here's a breakdown of what can be extracted from the provided text according to your request, and why other parts are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes non-clinical performance testing for a physical implantable device, not an AI/ML algorithm. The acceptance criteria are implicit in the "meets or exceeds the performance of the predicate device" statement, and the "reported device performance" is a general statement that the device met these criteria. Specific numerical values for the tests are not provided in this summary.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Static and dynamic compression testing (per ASTM F2077) | Met or exceeded the performance of the predicate device |
| Static and dynamic torsion testing (per ASTM F2077) | Met or exceeded the performance of the predicate device |
| Wear debris/mass change analysis (per ASTM F1877 and ASTM F1714) | Met or exceeded the performance of the predicate device |
| Subsidence and push-out analysis | Met or exceeded the performance of the predicate device |
| Bacterial endotoxin testing (per ANSI/AAMI ST72:2011/(R)2016) | Met or exceeded the performance of the predicate device |
| No new risks introduced | No new risks introduced |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified for non-clinical testing. These tests are typically performed on a set number of physical devices (e.g., n=5 or n=10 per test) as per the ASTM standards.
- Data Provenance: Not specified. As this is non-clinical performance testing of a physical device, the concept of "country of origin of the data" or "retrospective/prospective" doesn't directly apply in the same way it would for clinical data or AI training data. The testing is performed in a lab setting.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
Not applicable. This is not an AI/ML study requiring expert ground truth for classification or diagnosis. The "ground truth" for these non-clinical tests is established by the defined ASTM standards and the physical properties/behavior of the device under specific loads.
4. Adjudication method for the test set:
Not applicable. There is no human adjudication needed for these types of mechanical and material tests.
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 device is a physical implant, not an AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical implant, not an AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance testing is based on established engineering and materials science standards (e.g., ASTM F2077, ASTM F1877, ASTM F1714, ANSI/AAMI ST72). The device's performance is compared against the requirements and typical performance of predicate devices as defined by these standards.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. As there is no AI/ML component, there is no training set or ground truth in that context.
§ 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.