(196 days)
The Graft Containment Device, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.
The Graft Containment Device consists of a series of specialized shapes of surgical mesh made from commercially available polyester suture fibers. All sizes incorporate regions of reinforced holes to assist secure anchoring of the mesh to tissue. The devices are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
Bone screws intended for anchoring the graft containment device to bone, and made from PEEK, carbon-fiber reinforced PEEK, or titanium are also available.
The provided text describes a 510(k) summary for a medical device called the "Graft Containment Device." It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, many of the requested sections about acceptance criteria, study details, and expert involvement are not applicable or not present in the provided document.
Here's a breakdown of the information that can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Substantial equivalence to predicate devices in terms of design, materials, indications for use, and manufacturing characteristics. |
| Specific mechanical performance metrics (e.g., tensile strength, fatigue life, containment effectiveness) | "Mechanical testing was presented." (No specific results or acceptance criteria for mechanical tests are detailed). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable / Not specified. The submission relied on mechanical testing and comparison to predicate devices, not a clinical test set with human subjects.
- Data Provenance: Not applicable for a clinical test set. The data presented was from "Mechanical testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. No clinical test set requiring ground truth established by experts was described.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set was described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC study was not done. This device is a physical implant, not an AI-assisted diagnostic tool, so such a study is irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant; there is no "algorithm only" performance to be evaluated.
7. The Type of Ground Truth Used
- Not applicable for a clinical test set. The basis for the 510(k) clearance was "substantial equivalence" demonstrated through engineering drawings, labeling, and mechanical testing, comparing the device to already-cleared predicate devices. The "ground truth" here would be the established performance and safety profiles of the predicate devices.
8. The Sample Size for the Training Set
- Not applicable. No machine learning or AI training set was involved in the evaluation of this device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No machine learning or AI training set was involved.
Summary of the Study Proving Device Meets Acceptance Criteria (based on provided text):
The submission for the Graft Containment Device (K070148) sought to demonstrate substantial equivalence to existing legally marketed predicate devices. The "study" or evidence provided to meet this regulatory requirement included:
- Non-Clinical Tests: "Mechanical testing was presented." While the specific acceptance criteria and results are not detailed, the implication is that these tests demonstrated performance comparable to the predicate devices.
- Comparison to Predicate Devices: The submission included "Engineering drawings, labeling, and mechanical testing" to show that the subject device is "substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition, indications for use, and such other characteristics as may be associated with the manufacture of any medical device."
Key Takeaway: This 510(k) relies on a demonstration of substantial equivalence, which is a comparison to a legally marketed device, rather than a clinical study proving specific performance metrics against pre-defined acceptance criteria for a novel device. The document explicitly states "Summary of Clinical Tests: (Not Applicable)."
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.