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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.

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.

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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

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