(125 days)
The nv is intended for spinal fusion procedures at one level, from C2-T1, in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. One device is to be used per intervertebral space. Patients should receive six weeks of non-operative treatment with an intervertebral body fusion device. The ny' devices must be used with supplemental fixation and are designed for use with autograft bone to facilitate fusion. The devices are to be implanted via an anterior approach.
The nv is an intervertebral body fusion device used in the cervical spine following discectomy. All devices are manufactured from PEEK Optima® LT1 per ASTM F2026 and include tantalum markers per ASTM F560 for radiographic visualization.
The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow centre to accommodate bone graft. The devices are implanted via an anterior (ACIF) surgical approach. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability and prevent back out.
The provided document is a 510(k) premarket notification for a medical device called "nvC," an intervertebral body fusion device. This type of regulatory submission typically focuses on demonstrating "substantial equivalence" to a predicate device, rather than conducting a full clinical study with specific acceptance criteria as might be seen for novel technologies or PMA applications. As such, the document details mechanical testing to support substantial equivalence rather than a study against a pre-defined performance acceptance criteria for a diagnostic or AI-driven device.
Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets acceptance criteria (as would be typical for an AI/diagnostic device) are not directly applicable or available in this submission. This 510(k) primarily demonstrates the device's mechanical performance is comparable to an existing device, implying it meets the safety and effectiveness standards already established for such devices.
Here's an attempt to address your request based on the available information, noting where information is not present in the document.
Description of Acceptance Criteria and Proving Study for the nvC Intervertebral Body Fusion Device
The nvC device, a PEEK Optima® LT1 intervertebral body fusion device, established its substantial equivalence to predicate devices through a series of mechanical performance tests, rather than a clinical study with traditional acceptance criteria for diagnostic accuracy or clinical outcomes. The "acceptance criteria" here are implicitly the performance levels demonstrated by the predicate devices in the same standardized mechanical tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicitly from Predicate Devices) | Reported nvC Device Performance |
|---|---|
| Static Axial Compression: Performance comparable to predicate device per ASTM F2077 | Passed; results demonstrated substantial equivalence to the predicate device |
| Dynamic Axial Compression: Performance comparable to predicate device per ASTM F2077 | Passed; results demonstrated substantial equivalence to the predicate device |
| Static Torsion: Performance comparable to predicate device per ASTM F2077 | Passed; results demonstrated substantial equivalence to the predicate device |
| Dynamic Torsion: Performance comparable to predicate device per ASTM F2077 | Passed; results demonstrated substantial equivalence to the predicate device |
| Subsidence: Performance comparable to predicate device per ASTM F2267 | Passed; results demonstrated substantial equivalence to the predicate device |
| Expulsion: Performance comparable to predicate device (no specific standard cited for this) | Passed; results demonstrated substantial equivalence to the predicate device |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of test samples (e.g., individual device units) used for each mechanical test. Mechanical testing typically uses a specific number of samples (e.g., n=5 or n=6) per test condition.
- Data Provenance: The tests were conducted internally or by a testing laboratory as part of the regulatory submission process. There is no information regarding country of origin or whether the data is retrospective or prospective, as these terms are not applicable to material mechanical testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This information is not applicable to mechanical testing of an intervertebral body fusion device. Ground truth and expert consensus are relevant for diagnostic devices or those involving interpretation of medical images/data. The "ground truth" for mechanical testing is established by the test standards themselves and measured physical properties.
4. Adjudication Method for the Test Set
- This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or expert review processes, not in standardized mechanical testing.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers interpret results, and an AI's impact on their performance is evaluated. The nvC is a physical implant, not a diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
- No standalone performance study of an algorithm was done. This device does not involve an algorithm or AI. The tests performed are for the physical properties of the implant itself.
7. Type of Ground Truth Used
- The "ground truth" for this device's evaluation is primarily based on engineering and material science standards, specifically the mechanical performance requirements outlined in ASTM F2077 and ASTM F2267, as well as general expectations for expulsion resistance. The performance of the predicate devices in these tests serves as the benchmark for substantial equivalence.
8. Sample Size for the Training Set
- Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in the context of data-driven models. The device's design is likely based on engineering principles and prior experience with similar implants.
9. How Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an algorithm, there is no ground truth to establish for it.
Summary of the Study:
The study conducted for the nvC device was a series of non-clinical mechanical performance tests. These tests were performed in accordance with recognized ASTM standards (F2077 for axial compression and torsion; F2267 for subsidence) and also included an expulsion test. The purpose of these tests was to demonstrate that the mechanical properties and performance of the nvC device were substantially equivalent to those of its predicate devices: X-Spine Calix™ Cervical Interbody Spacer (K083637) and Genesys Spine Apache™ Cervical Interbody System (K103034). The conclusion of the submission is that the device's technological characteristics and performance are comparable to the predicate devices, thereby supporting its substantial equivalence for the stated indications for use.
§ 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.