(215 days)
The ArthroCare® Parallax® Contour® Vertebral Augmentation Device 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 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 acceptance criteria and supporting studies for the ArthroCare® Parallax® Contour® Vertebral Augmentation Device, structured according to your request.
Please note: The provided text primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria in a quantitative, pass/fail manner. The "reported device performance" are observations and outcomes from the studies conducted to support this equivalence.
Acceptance Criteria and Study Findings for ArthroCare® Parallax® Contour® Vertebral Augmentation Device
The information provided within the 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through functional performance testing, pre-clinical cadaveric studies, and a clinical study. The "acceptance criteria" are implied by the successful outcomes of these studies and the finding of substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence | Functional performance testing showed successful torque, insertion/withdrawal, flexure, device attachment/deployment/removal, and mechanical displacement of bone, demonstrating mechanical characteristics equivalent to the predicate. |
| Void Creation Volume (Pre-clinical) | In simulated human foam bone blocks, void volumes were similar between the Contour and predicate devices, with no statistically significant differences. |
| Cement Delivery Volume (Pre-clinical) | In cadaveric vertebral bodies, the Contour and predicate devices demonstrated equivalence in the volume of Parallax PMMA bone cement delivered. |
| Increased Cement Delivery vs. Standard Vertebroplasty (Pre-clinical) | Use of the Contour device prior to cement augmentation allowed significantly more cement delivery into the vertebral body compared to standard vertebroplasty procedure (control group where Contour was not used). |
| Clinical Void Volume | Range of void creation from 0.33 to 2.02 cc for individual patients. |
| Clinical PMMA Instillation Volume | Range of PMMA instillation from 2.9 to 8.5 cc. |
| Clinical Safety (Extravasation) | Four cases demonstrated imaging evidence of PMMA extravasation into paravertebral veins; all four cases were asymptomatic. |
| Clinical Effectiveness (Pain Reduction) | Mean VAS pain score was significantly reduced (dependent t-test, p |
§ 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.”