Search Results

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

2. Sample Sizes and Data Provenance

• Test Set (Pre-clinical Cadaveric):

  • Sample Size: Not explicitly stated as a distinct "test set" size. The text mentions "cadaveric vertebral bodies" for the equivalence study and "human cadaver fractured vertebral discs" for the comparative study.
  • Data Provenance: Human cadaveric material. Country of origin not specified, but typically conducted in the country of the research institution or manufacturer (implied US). Retrospective or prospective nature not specified for cadaveric studies, but generally considered pre-clinical, controlled experiments.

• Test Set (Pre-clinical Foam Bone):

  • Sample Size: Not explicitly stated, but implies a sufficient number of simulated human foam bone blocks were used for statistical comparison.
  • Data Provenance: Simulated human foam bone blocks.

• Test Set (Clinical Study):

  • Sample Size: Number of patients not explicitly stated, but the results describe "individual patients" and "four cases" with extravasation. The statement "In all cases, no patient complications were observed" suggests the study tracked outcomes for all enrolled patients.
  • Data Provenance: Clinical data from a "clinical study." Country of origin not specified, but implied to be
    a conventional clinical trial. Prospective, as it describes follow-up and outcomes.

3. Number of Experts and Qualifications for Ground Truth

• Pre-clinical Studies (Cadaveric & Foam Bone): The text does not mention the use of experts to establish a "ground truth" in the way it's typically understood for diagnostic AI. The outcomes here were quantitative measurements (void volume, cement volume) based on the device's physical interaction with the materials and subsequent measurement.
• Clinical Study: Not explicitly stated that experts established "ground truth" for the clinical outcomes (e.g., pain scores, extravasation, complications). These are direct patient outcomes or imaging observations. Clinical trials are typically evaluated by the treating physicians and study investigators, whose qualifications would be relevant clinicians (e.g., orthopedic surgeons, interventional radiologists).

4. Adjudication Method

Not applicable based on the provided text, as the studies described involve direct measurement of physical parameters and clinical outcomes rather than subjective interpretations requiring adjudication (e.g., diagnostic image interpretation).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The studies are focused on the device's physical performance, its ability to create a void, deliver cement, and its clinical safety and effectiveness in reducing pain. This is not a diagnostic device where human readers are interpreting images.

6. Standalone (Algorithm Only) Performance

No, this pertains to a physical medical device, not an algorithm, so a "standalone algorithm only" performance study is not applicable.

7. Type of Ground Truth Used

• Pre-clinical Studies: Quantitative measurements (e.g., volume of void created, volume of cement delivered) from cadaveric specimens and foam bone models.
• Clinical Study:
  • Patient Outcomes: Measured VAS pain scores, observation of complications, and imaging evidence (e.g., for PMMA extravasation). This combines objective and subjective patient-reported outcomes.

8. Sample Size for Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for a physical device.

Ask a specific question about this device