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Parallax® EZFlow™ Cement Delivery System is intended for use with Parallax Acrylic Resin with TRACERS or Parallax Acrylic Resin with TRACERS Ta for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Parallax® EZFlow™ Cement Delivery System is a delivery system for the Parallax Acrylic Resin with TRACERS and Parallax Acrylic Resin with TRACERS Ta. It is designed to provide surgeons with a means to inject Parallax Acrylic Resin with TRACERS or Parallax Acrylic Resin with TRACERS Ta for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. The EZFlow Cement Delivery System does not contain any bone cement material, as this system only consists of general instruments. All of the system components are manual, single-use disposable instruments.

The provided text is a 510(k) summary for the ArthroCare Corporation Parallax® EZFlow™ Cement Delivery System. This document does not contain information about acceptance criteria or a study proving the device meets said criteria in the way typically associated with AI/software devices (e.g., performance metrics, clinical trials).

Instead, this is a regulatory submission for a medical device that is a cement dispenser, which is a physical instrument, not a software or AI tool. The "study" mentioned here refers to the process of demonstrating "substantial equivalence" to a predicate device for regulatory clearance, not a performance study against specific acceptance criteria with quantifiable metrics like sensitivity, specificity, etc.

Therefore, most of the requested information regarding acceptance criteria, performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies is not applicable to this type of device and submission.

Here's a breakdown based on the information provided and what can be inferred about this type of device:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated in the document as quantifiable performance metrics (e.g., sensitivity, specificity, accuracy). For a physical medical device like a cement dispenser, acceptance criteria would typically involve engineering specifications, material compatibility, functional reliability (e.g., consistent flow rate, resistance to leakage, ease of use), and biocompatibility. These are usually established internally by the manufacturer and evaluated during product development and verification testing.
   • Reported Device Performance: The document states that "ArthroCare evaluated the indications for use, functional testing, and prospective clinical data to demonstrate equivalence to the predicate devices." This implies that the device performed adequately in these tests to demonstrate equivalence, but no specific performance statistics are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable/Not provided. The "test set" here would refer to the physical devices undergoing functional testing or perhaps patients in a clinical study if one was performed to demonstrate equivalence. The document mentions "prospective clinical data," but gives no details on the sample size or provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable/Not provided. For a physical device like this, "ground truth" establishment in the context of expert review (e.g., for image interpretation) is not relevant. If "clinical data" was used, the "ground truth" would likely be patient outcomes or physician assessments related to the procedure's success or safety.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable/Not provided.

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 is for a physical medical device, not an AI/software product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is for a physical medical device, not an AI/software product.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Based on "prospective clinical data," the ground truth likely involved outcomes data and/or physician assessments related to the successful fixation of fractures, absence of complications, and overall safety and efficacy in the context of vertebroplasty or kyphoplasty procedures.

8. The sample size for the training set:

   • Not applicable for a physical device. "Training set" refers to data used to train AI models.

9. How the ground truth for the training set was established:

   • Not applicable for a physical device.

Summary specific to this device:

The "study" that proves this device meets its requirements is the demonstration of substantial equivalence to existing predicate devices (specifically, the Parallax® Cement Injector Kit, K980064 and another unspecified "currently marketed device"). This involves:

• Indications for Use: Showing that the device serves the same purpose as the predicate.
• Functional Testing: Demonstrating that the device performs its intended mechanical functions (e.g., cement delivery) reliably and safely, similar to the predicate.
• Prospective Clinical Data: Potentially gathering data from actual use to confirm safety and performance outcomes, and similarity to the predicate device in a clinical setting.

The 510(k) clearance process focuses on whether the new device is "as safe and effective" as a legally marketed device, not on proving absolute efficacy against specific, quantifiable performance metrics in a de novo trial. The FDA's letter states they "have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence is the "proof" that the device met the regulatory requirements for market clearance as described in this document.

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