(122 days)
The Spinal Elements Cervical Intervertebral Body Fusion System is a stand-alone interbody fusion device intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with these devices.
The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.
Spinal Elements' Cervical Intervertebral Body Fusion System is composed of an implant body and fixation screws. The implant body is a generally box-shaped device with holes through its body for the placement of graft material. Additionally, it has teeth located on its superior and inferior external surfaces to help keep the device from migrating once placed in its desired location. There are also screw holes located in the implant body. Each screw hole is lined in its internal surface with a titanium ring insert.
Screws pass through screw holes of the implant body and affix to bone to help prevent implant migration. When fully seated, the screw head rests on the titanium insert of the screw hole.
Device implant bodies are made from either titanium alloy (Ti-6A1-4V) conforming to ASTM F 136 or ISO 5832-3 or polyetheretherketone conforming to ASTM F 2026.
Screws are made from Ti-6AI-4V per ASTM F 136 or ISO 5832-3 with certain subcomponents manufactured from nitinol conforming to ASTM F2063.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Cervical Intervertebral Body Fusion System:
The document provided is a 510(k) summary for a medical device seeking clearance, not a peer-reviewed study report. Therefore, it focuses on demonstrating substantial equivalence to previously cleared devices rather than a standalone clinical study with detailed acceptance criteria and performance metrics in the way a clinical trial for a new drug or novel high-risk device might.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria described are primarily related to mechanical performance and substantial equivalence to predicate devices. The document does not explicitly state numerical "acceptance criteria" in the format of, for example, "Sensitivity >= X% and Specificity >= Y%." Instead, it states that the device must perform as intended based on comparison to cleared devices.
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance | Comments |
|---|---|---|---|
| Mechanical Performance | Static Compression (ASTM F 2077-03) | "All test results indicate the device will perform as intended based on a comparison to devices cleared for similar or identical indications for use." | This implies the device met or exceeded the performance of the predicate devices in these tests. No specific numerical thresholds or results are provided. |
| Static Torsion (ASTM F 2077-03) | (Same as above) | ||
| Dynamic Compression (ASTM F 2077-03) | (Same as above) | ||
| Dynamic Torsion (ASTM F 2077-03) | (Same as above) | ||
| Subsidence Testing (ASTM F 2267-04) | (Same as above) | ||
| Substantial Equivalence | Equivalence in Indications for Use | "virtually the same" to predicate devices K071833 and K083389 | |
| Equivalence in Intended Use | "virtually the same" to predicate devices K071833 and K083389 | ||
| Equivalence in Surgical Technique | "virtually the same" to predicate devices K071833 and K083389 | ||
| Equivalence in Materials | "virtually the same" to predicate devices K071833 and K083389 (Ti-6A1-4V or PEEK) | ||
| Equivalence in Technological Characteristics | "virtually the same" to predicate devices K071833 and K083389 |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical mechanical testing. For such testing, the "test set" would refer to the number of physical devices or components subjected to the mechanical tests. The document does not specify the sample size (N) for these mechanical tests. It also does not involve human data, so discussions of country of origin or retrospective/prospective data are not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable. For mechanical testing of implantable devices, "ground truth" is established by engineering standards (e.g., ASTM F2077, ASTM F2267) and laboratory measurements rather than expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
This section is not applicable as it pertains to human-based assessment or clinical trials, not mechanical testing.
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
There was no MRMC study conducted or described. This type of study is relevant for diagnostic AI devices, not for a spinal implant primarily evaluated through mechanical performance and substantial equivalence.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
There was no standalone algorithm performance study as this is a physical medical device, not an AI-driven diagnostic or therapeutic algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance claim is based on established engineering standards (ASTM) for mechanical testing and the performance profiles of predicate devices that have already received regulatory clearance. The "ground truth" is that the device meets the mechanical robustness requirements as defined by these standards and performs comparably to or better than similar predicate devices.
8. The Sample Size for the Training Set
This section is not applicable. There is no "training set" in the context of mechanical testing for substantial equivalence of a physical medical device. The "training" for the device's design and manufacturing is based on established engineering principles, material science, and the designs of previously successful devices.
9. How the Ground Truth for the Training Set was Established
This section is not applicable for the same reasons as #8. The "ground truth" (i.e., how optimal design and performance were determined) for the device's development would be based on biomechanical principles, material properties, and the historical performance and safety of similar devices already on the market.
§ 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.