(26 days)
The ArthroCare® Parallax® Contour® Vertebral Augmentation Device – enhanced when used with the access needle kits are indicated for use during kyphoplasty or vertebral augmentation procedures to create a void in the vertebral body and fill the void with Parallax® Acrylic Resin (bone cement). The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.
The ArthroCare Parallax Contour Vertebral Augmentation Device - enhanced is used to disrupt cancellous bone and create a void in the vertebral body and fill the void with Parallax Acrylic Resin (bone cement) during kyphoplasty or vertebral augmentation procedures.
Here's an analysis of the provided text regarding the ArthroCare Parallax Contour Vertebral Augmentation Device - enhanced, focusing on the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on a Special 510(k) submission, which means the device is a modification of an already cleared predicate device (K100479). For such submissions, the primary focus is to demonstrate that the changes do not significantly affect safety or efficacy and that the modified device performs comparably to the predicate. Therefore, the "acceptance criteria" here are largely related to maintaining the performance and characteristics of the predicate device.
| Acceptance Criteria (Inferred from 510(k) Scope) | Reported Device Performance |
|---|---|
| Mechanical Characteristics & Performance remain the same as the predicate device. Specifically, this includes: | Functional performance testing completed to demonstrate equivalence. This testing covered: |
| - Torque performance | - Torque |
| - Insertion and Withdrawal performance | - Insertion and Withdrawal |
| - Flexure performance | - Flexure |
| - Device Attachment/Deployment/Removal performance | - Device Attachment/Deployment/Removal |
| - Mechanical Displacement of Bone performance | - Mechanical Displacement of Bone |
| Indications for Use remain the same. | Indications for Use remain the same as the predicate device. |
| Technology remains the same. | Technology remains the same as the predicate device. |
| Principle of Operation remains the same. | Principle of Operation remains the same as the predicate device. |
| Sterilization method remains the same. | Sterilization method remains the same as the predicate device. |
| Modifications are not substantial and do not significantly affect safety or efficacy. | "The proposed modifications... are not substantial changes, and do not significantly affect the safety or efficacy of the device." |
Note on "Acceptance Criteria": In a 510(k) for a modified device, the "acceptance criteria" are not typically expressed as specific quantitative thresholds like "90% sensitivity" or "tensile strength > X N." Instead, the key criterion is demonstrating substantial equivalence to the predicate device, primarily through comparative testing that shows the modified device performs similarly or meets the same functional requirements.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the functional performance testing (test set). It only states that "Functional performance testing of the device included torque, insertion and withdrawal, flexure, device attachment/deployment/ removal, and mechanical displacement of bone have been completed."
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data. Given the nature of mechanical performance testing for a medical device submitted to the FDA in the US, it is highly likely that this testing was conducted in a controlled laboratory environment in the US (prospective testing for this submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this specific submission. The "ground truth" for mechanical functional testing is typically established by engineering standards, validated test methods, and direct measurement against known physical properties or the performance of the predicate device, not by expert medical opinion in the same way as, for example, image interpretation.
4. Adjudication Method for the Test Set
This is not applicable to the type of testing described. Adjudication methods (like 2+1, 3+1) are relevant for studies involving human interpretation or clinical endpoints where differing opinions need to be resolved. The testing mentioned (torque, insertion, etc.) is objective mechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size
No, an MRMC comparative effectiveness study was not done for this submission. MRMC studies are typically used to evaluate the impact of a diagnostic device (often image-based) on reader performance. This device is a surgical tool, and its evaluation focuses on mechanical performance and safety, not on improving human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual surgical instrument, not an algorithm or an AI system. Therefore, standalone performance (in the context of AI) is not relevant.
7. The Type of Ground Truth Used
For the functional performance testing, the "ground truth" would be established by:
- Engineering specifications and standards: The device must meet predefined mechanical strength, flexibility, and operational parameters.
- Performance of the Predicate Device: The modified device's performance is compared directly to the known and cleared performance characteristics of its predicate. The goal is to demonstrate that the new device performs within the acceptable range or equivalently to the predicate.
8. The Sample Size for the Training Set
Not applicable. This device is a physical surgical tool and does not involve AI or machine learning algorithms that would require a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”