(298 days)
When used as a vertebral body replacement, the NUBIC devices are indicated for use in skeletally mature patients to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The NUBIC device may be implanted singularly or in pairs and may be used with allograft or autograft.
When used as an intervertebral fusion device, the NUBIC devices are intended for use in skeletally mature patients at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The devices are designed for use with autograft to facilitate fusion and intended for use with supplemental internal fixation. One NUBIC device is used per intervertebral space. A connecting screw is available which allows the NUBIC device (without strut) to be physically attached to the SIGNUS TOSCA II anterior cervical plate systems if desired.
When used as a vertebral body replacement, the RABEA devices are indicated for use in skeletally mature patients to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The RABEA device is intended to be implanted in pairs and may be used with allograft or autograft.
When used as an intervertebral fusion device, the RABEA devices are intended for use in skeletally mature patients at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The devices are designed for use with autograft to facilitate fusion and intended for use with supplemental internal fixation. One RABEA device is used per intervertebral space.
The basic shape of the NUBIC device is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the Signus TOSCA II anterior cervical plate if the surgeon so chooses.
The basic shape of the RABEA device is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.
This is a medical device submission (510(k)) for the NUBIC™ and RABEA™ devices, which are spinal vertebral body replacement and intervertebral fusion devices. The FDA has determined the devices are substantially equivalent to previously cleared devices.
Based on the provided text, there is no information about acceptance criteria or a study that specifically proves the device meets acceptance criteria in the typical sense of a performance study with metrics like sensitivity, specificity, or accuracy. This document is a 510(k) summary for a medical device. For devices like these (implants), "acceptance criteria" and "studies" usually refer to biocompatibility, mechanical testing (e.g., fatigue, compression, expulsion), sterilization validation, and often a demonstration of substantial equivalence to a predicate device. The provided text primarily focuses on the latter.
Here's an analysis of what information is available, formatted to address your questions:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The submission focuses on demonstrating substantial equivalence to predicate devices rather than presenting specific quantitative acceptance criteria and performance data from a clinical trial or a machine learning model.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is not a study testing a diagnostic algorithm or a similar device that would have a "test set" in the context of machine learning. The "testing" for these devices would be mechanical and biocompatibility testing, which are referenced indirectly through adherence to ASTM standards and substantial equivalence claims.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There is no mention of experts establishing a ground truth as would be relevant for a diagnostic or AI-driven device.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is not applicable to an implantable medical device like a spinal cage.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is an implant, not an algorithm.
7. The Type of Ground Truth Used
Not applicable in the context of typical AI/diagnostic device evaluation. For this type of device, ground truth would be related to biocompatibility (e.g., validated materials), mechanical integrity (e.g., strength, durability against specified loads), and clinical outcomes (e.g., fusion rates, adverse events), none of which are detailed in this summary. The "ground truth" for substantial equivalence is that the device's design, materials, and intended use are equivalent to legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of Device Acceptance and "Study" Information from the Provided Text:
The "study" or justification for acceptance of the NUBIC™ and RABEA™ devices is based on demonstrating "Substantial Equivalence" to previously cleared predicate devices.
The key points from the provided text regarding this:
- Substantial Equivalence Basis: "Documentation was provided which demonstrated the NUBIC to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in basic design, intended use, indications, anatomic sites and performance." (Identical text is provided for both NUBIC and RABEA devices).
- Material Standards: The devices are made of materials conforming to ASTM standards (PEEK-OPTIMA® LT1, Invibio™ as described by ASTM F2026; titanium alloy (Ti-6Al-4V) as described by ASTM F136). Adherence to these standards implies certain material performance characteristics have been met, often acting as "acceptance criteria" for material properties.
- FDA Determination: The FDA reviewed the 510(k) submission and "determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."
Therefore, the acceptance criteria primarily revolved around demonstrating that the new devices (NUBIC and RABEA) are as safe and effective as existing legally marketed devices, by showing equivalence in:
- Basic design
- Intended use
- Indications for use
- Anatomic sites
- Performance (implied through design, materials, and comparison to predicates)
The "study" proving this is the submission of documentation for substantial equivalence, which would include detailed comparisons to predicate devices and evidence of material conformity to relevant ASTM standards. These documents are not fully provided here, but their successful review by the FDA constitutes the acceptance.
§ 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.