(90 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 T1, for treatment of cervical degenerate disc disease (DDD is defined as 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 nonoperative treatment.
The Reliance Cervical IBF System is comprised of implant 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 is made of PEEK Optima LT1 with Tantalum markers.
The provided text describes the Reliance Cervical IBF System, an intervertebral body fusion device, and its a 510(k) submission (K120396). The submission focuses on demonstrating substantial equivalence to already marketed predicate devices through mechanical testing.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Equivalence: PEEK Optima LT1 with Tantalum markers | The Reliance Cervical IBF System is comprised of implant 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 is made of PEEK Optima LT1 with Tantalum markers, demonstrating material equivalence to predicate devices. |
| Intended Use Equivalence: Intervertebral body fusion of the spine in skeletally mature patients at one level (C3 to T1) for DDD, with autogenous bone graft and supplemental fixation. | The Indications for Use for the Reliance Cervical IBF System closely match the intended use of predicate devices: "The RELIANCE CERVICAL IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients... intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerate disc disease (DDD)... used with autogenous bone graft to facilitate fusion... intended to be used with legally cleared supplemental spinal fixation." |
| Levels of Attachment Equivalence: C3-T1 | The device is "intended for use at one level in the cervical spine, from C3 to T1," demonstrating equivalence in levels of attachment. |
| Size Range Equivalence | The document explicitly states equivalence to predicate devices in "size range." However, specific size ranges for the device or the predicate devices are not provided. |
| Use with Supplemental Fixation Equivalence | The device "implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level," indicating equivalence in this regard. |
| Static Compression Testing (ASTM F2077-03) | Performed on the "worst case Reliance Cervical IBF device." The device was found to be "substantially equivalent to the predicate devices." No specific numerical outcomes of the testing are provided. |
| Dynamic Compression Testing (ASTM F2077-03) | Performed on the "worst case Reliance Cervical IBF device." The device was found to be "substantially equivalent to the predicate devices." No specific numerical outcomes of the testing are provided. |
| Subsidence Testing (ASTM F2267-04) | Performed on the "worst case Reliance Cervical IBF device." The device was found to be "substantially equivalent to the predicate devices." No specific numerical outcomes of the testing are provided. |
| Static Push-out Testing (ASTM Draft F-04.25.02.02) | Performed on the "worst case Reliance Cervical IBF device." The device was found to be "substantially equivalent to the predicate devices." No specific numerical outcomes of the testing are provided. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document refers to testing performed on "the worst case Reliance Cervical IBF device," implying a limited sample size, likely representative units for mechanical testing. No specific number of devices tested is provided.
- Data Provenance: The mechanical testing was performed following ASTM Standards (F2077-03, F2267-04, and Draft F-04.25.02.02). The context suggests this was conducted by the manufacturer (Reliance Medical Systems, LLC) as part of their 510(k) submission, likely in a laboratory setting. The country of origin of the data is not explicitly stated but is implied to be within the United States, given the FDA submission. This is a prospective test in the sense that the testing was carried out specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This device, an intervertebral body fusion system, does not involve a test set for diagnostic accuracy or human interpretation. Therefore, there are no "experts" in the sense of clinicians establishing ground truth on patient data.
- The determination of what constitutes "worst case" for mechanical testing would have been based on engineering principles and potentially input from mechanical engineers or materials scientists.
4. Adjudication Method for the Test Set
- Not applicable. The study is mechanical testing, not a diagnostic study requiring adjudication of expert interpretations. The "adjudication" in this context would be the interpretation and comparison of the mechanical test results against the established ASTM standards and data from predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is used for diagnostic devices to assess the performance of human readers with and without AI assistance. This submission is for a physical implantable medical device and relies on mechanical testing to demonstrate substantial equivalence, not diagnostic accuracy.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This isn't a software algorithm or AI-driven diagnostic device. The performance evaluated is the mechanical integrity of a physical implant.
7. Type of Ground Truth Used
- The "ground truth" for this type of submission is defined by established engineering standards (ASTM Standards) for mechanical performance and the mechanical performance data of legally marketed predicate devices. The device's performance is compared against these benchmarks to demonstrate substantial equivalence.
8. Sample Size for the Training Set
- Not applicable. This is not a study involving machine learning or AI, so there is no "training set." The device itself is the "product" being evaluated, not a system that needs to be trained on data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, there is no ground truth established for one. The "truth" for the product's performance is established through adherence to mechanical testing standards and comparison to predicate device performance.
§ 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.