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The KYPHON Xpander™ II Inflatable Bone Tamp is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures) hand, tibia, radius and calcaneus.

The KYPHON Xpander™ II Inflatable Bone Tamps are designed for reduction of fractures. The main components are the shaft, Y-Adapter and the inflatable balloon located at the distal tip.

Here's a breakdown of the acceptance criteria and study information for the KYPHON Xpander™ II Inflatable Bone Tamp, based on the provided text:

Important Note: This device is a physical medical instrument (inflatable bone tamp), not an AI/software device. Therefore, many of the questions related to AI performance metrics (like human reader improvement with AI, standalone AI performance, training/test set provenance, expert ground truth for imaging, MRMC studies) are not applicable to this type of submission. The provided text details engineering and biocompatibility testing, not clinical performance studies involving interpretation of data by humans or AI.

Acceptance Criteria and Reported Device Performance

Study Details (Applicable to this device type)

1. Sample size used for the test set and the data provenance:

   • The document does not specify sample sizes for each individual test (e.g., how many tamps were subjected to fatigue testing, how many units were tested for balloon compliance).
   • The testing described is in vitro (bench testing) and in vivo (biocompatibility). Data provenance would be from laboratory experiments conducted by the manufacturer. No country of origin for data is specified for these tests, though the manufacturer is US-based.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. For this type of physical device, "ground truth" is established by engineering specifications, material standards, and validated test methods, not by expert consensus on clinical data interpretation. The "experts" would be the engineers, material scientists, and testers involved in conducting and verifying the performance tests, whose qualifications are inherent in their roles within a medical device manufacturer.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for disagreements in human interpretation of data/images, often in clinical or diagnostic studies. This is a report of engineering and biocompatibility testing. The "adjudication" for these tests comes from the test protocols, acceptance criteria, and quality control processes of the manufacturer.

4. 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 device is a manual surgical instrument, not an AI or imaging-related device that would involve human readers or AI assistance in interpretation.

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

   • Not applicable. This device is a manual surgical instrument and does not incorporate an algorithm or AI.

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

   • For the functional and mechanical testing: Engineering specifications and validated test methods/standards. The device's performance is measured against predefined physical parameters and tolerances.
   • For biocompatibility: International standard ISO-10993 (Part 1), which defines the biological evaluation of medical devices.

7. The sample size for the training set:

   • Not applicable. There is no "training set" for this type of physical medical device. Training sets are relevant for machine learning algorithms.

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

   • Not applicable. As above, no training set exists for this device.

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