(129 days)
The RELIANCE CERVICAL IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.
The RELIANCE CERVICAL IBF System is intended for use at one level in the cervical spine, from C3 to TI, for treatment of cervical disc disease (defined at neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The RELIANCE CERVICAL IBF System is to be used in patients who have six weeks of non-operative treatment.
The Reliance Cervical IBF System is comprised of implants and instrument components. The implant component, the Reliance Cervical IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the cervical spine. The spacer may be made of PEEK Optima LT1 with Tantalum markers. The Reliance Cervical IBF System may also include bone screws to secure the device to the vertebral body.
The provided text is a 510(k) Summary for the Reliance Cervical IBF System, which is a medical device for intervertebral body fusion. The document focuses on demonstrating substantial equivalence to already marketed predicate devices rather than providing detailed performance data from a clinical study with acceptance criteria.
Therefore, many of the requested categories for device performance and acceptance criteria are not applicable or not explicitly stated in this type of regulatory submission. This 510(k) summary primarily relies on mechanical testing and comparison of material, intended use, levels of attachment, size range, and use with supplemental fixation to predicate devices.
Here's the breakdown of the information that can be extracted and what cannot:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Set by Regulation/Standard or Sponsor) | Reported Device Performance (from Study) |
|---|---|
| Mechanical Performance: |
- Compliant with ASTM F-2077
- Compliant with ASTM F-2267
- Compliant with ASTM Draft F-04.25.02.02 | Mechanical Performance:
- The Reliance Cervical IBF System was found to be substantially equivalent to the predicate devices with regard to mechanical performance, as demonstrated by testing per ASTM F-2077, ASTM F-2267, and ASTM Draft F-04.25.02.02. |
| Biocompatibility: - Substantially equivalent to predicate devices | Biocompatibility:
- The Reliance Cervical IBF System is substantially equivalent to the predicate devices in terms of biocompatibility. |
| Sterilization: - Substantially equivalent to predicate devices | Sterilization:
- The Reliance Cervical IBF System is substantially equivalent to the predicate devices in terms of sterilization. |
| Material Equivalence | The device is comprised of PEEK Optima LT1 with Tantalum markers, similar to predicate devices. |
| Intended Use Equivalence | The intended use is for intervertebral body fusion in the cervical spine (C3-T1) for cervical disc disease, consistent with predicate devices. |
| Levels of Attachment Equivalence | One device per intervertebral space, C3-T1, consistent with predicate devices. |
| Size Range Equivalence | Sizes are equivalent to predicate devices. |
| Use with Supplemental Fixation Equivalence | Intended for use with legally cleared supplemental spinal fixation, consistent with predicate devices. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not applicable/Not specified for a clinical test set. The performance data discussed refers to mechanical testing. For mechanical testing, the "sample size" would refer to the number of devices or components tested, which is not provided.
- Data Provenance: Not applicable for clinical data. The performance data is based on laboratory mechanical testing, not human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. This document describes mechanical and material equivalence testing, not a clinical study requiring expert ground truth for interpretation of patient data.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Not applicable. This is not a clinical study involving human readers or interpretation of clinical data.
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
- No. An MRMC study was not conducted as this is a submission for a physical medical device (intervertebral body fusion system), not an AI/software device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. For mechanical testing, the "ground truth" would be the engineering specifications and performance limits defined by the ASTM standards, which the device's performance is compared against to demonstrate compliance/equivalence.
8. The Sample Size for the Training Set
- Not applicable. This device is hardware, not an AI/software device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set is used for this type of device.
§ 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.