(112 days)
The NovaSpine Cement Restrictor device is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.
The NovaSpine Cement Restrictoris NOT intended for any spinal indications.
The NovaSpine Cement Restrictor "NSCR" is an implanted device for use as non-load bearing cement containment in orthopedic surgery. It will be used to contain standard bone cement such as Polymethylmethacrylate (PMMA) in the diaphysical canal of the femur or tibia.
The device is a straight or tapered rectangular hollow box construction with serrations on two opposite sides and flat surfaces on the remaining two sides. The device is fenestrated on all sides. The device is made in a variety of sizes the use of which will be determined by the responsible surgeon in accordance with the physical characteristics of each patient.
The NovaSpine Cement Restrictor is a Class II device intended for use as a non-load bearing cement containment in orthopedic surgeries, specifically within the diaphysical canal of the femur or tibia, to contain standard bone cement like Polymethylmethacrylate (PMMA).
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Intended Use | Use as non-load bearing cement containment in orthopedic surgery within the diaphysical canal of the femur or tibia. | Device is intended for use in orthopedic surgeries involving the femoral canal or the tibia to contain standard bone cement. | Meets criteria. |
| Material | Manufactured from 6-4 Titanium alloy as specified in ASTM F136 (latest version) or equivalent ISO 5832-3. | The NovaSpine Cement Restrictor is manufactured of a 6-4 Titanium alloy as specified in ASTM F136 (latest version) or equivalent ISO 5832-3. | Meets criteria. |
| Mechanical Testing (Performance Data) | Not required for non-load bearing Class II devices under CFR 21 878.3300. | "This is designated as a non-load bearing Class II device under CFR 21 878.3300 and no mechanical tests are required." | Meets criteria by exemption. |
| Substantial Equivalence | Demonstrated equivalency to legally marketed predicate devices. | Product found substantially equivalent to Medtronics Sofamore Danek USA, Inc. (K003718, K011443, K012255, K013014) and Spinal Concepts, Inc. (K022218, K021719, K031837, K03118). | Meets criteria. |
| Spinal Indication Limitation | Must include a warning explicitly stating that the device is NOT intended for any spinal indications. | "WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED." This warning is required to appear in the Warnings section of the device's package insert and on the product label. | Meets criteria as a required limitation. |
Based on the provided text, the following information is not available or not applicable:
2. Sample size used for the test set and the data provenance:
- The document describes a 510(k) submission, which primarily relies on substantial equivalence to predicate devices rather than a direct clinical study of the device itself. Therefore, a "test set" in the context of clinical performance data for this device is not detailed. The design controls and material specifications are the primary "test" here, which are checked against industry standards and predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as there's no mention of a clinical test set requiring expert ground truth assessment. The FDA's review process involves expert staff, but not in the context of establishing ground truth for a device's performance data as one would for an AI/diagnostic device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
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:
- Not applicable. This device is a cement restrictor, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's acceptance is its compliance with material standards (ASTM F136/ISO 5832-3), classification as a non-load bearing Class II device, and its substantial equivalence to previously cleared predicate devices. There's no clinical "ground truth" established through a specific study described here.
8. The sample size for the training set:
- Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.