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The KMC Kyphoplasty System is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

KMC Kyphoplasty System consists of five components:

• Balloon Catheter .
• Tool Kit
• . Puncture Needle
• Balloon Catheter Syringe Pump .
• Kyphoplasty Multifunctional Tool .
  The Kyphoplasty Multifunctional Tool can be substituted for the Puncture Needle and Kyphoplasty Tool Kit.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

The KMC Kyphoplasty System is a medical device, and the information provided focuses on its 510(k) clearance process. For medical devices, "acceptance criteria" and "device performance" in the context of clinical studies often relate to the safety and effectiveness as defined by the "Indications for Use" and comparison to predicate devices, rather than specific numerical performance metrics like accuracy or sensitivity found in diagnostic AI. The primary goal of the studies for this type of device is to demonstrate that it performs as intended and is as safe and effective as legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of medical device, the "acceptance criteria" are implied to be the successful demonstration of safety and effectiveness for its stated Indications for Use, and substantial equivalence to predicate devices, without unexpected adverse events or failures. Device performance is measured by its ability to achieve these goals in a clinical setting.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Clinical Evaluation): A total of 25 patients.
• Data Provenance: The study was a "multicenter study" conducted at "two sites." The country of origin is not explicitly stated, but the submission is to the U.S. FDA by a company based in Shanghai, implying the study might have been international or conducted in the US (though the latter is less likely to be unnamed). The study is prospective, as it's a "clinical evaluation" of the system's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For a clinical evaluation of a medical device like a kyphoplasty system, "ground truth" would typically be established based on clinical outcomes assessed by treating physicians and potentially radiologists, but the number and qualifications of experts involved in data collection or assessment are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

• No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is typically relevant for diagnostic imaging AI devices, where the "reader" is a human interpreting images. The KMC Kyphoplasty System is a surgical device, not an AI diagnostic tool.

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

• No, this is not applicable. The KMC Kyphoplasty System is a physical medical device, not an algorithm. Therefore, a standalone algorithm performance study is irrelevant. The "performance" in this context refers to the device's physical and functional attributes, as well as its safety and effectiveness when used by a human surgeon.

7. The Type of Ground Truth Used

For the clinical evaluation, the "ground truth" would be the clinical outcomes observed in the 25 patients treated with the KMC Kyphoplasty System, as assessed by the treating clinicians in accordance with the study protocol. This includes the successful reduction and fixation of fractures, creation of a void in cancellous bone, and the device performing "per specification" when used according to instructions for use, without significant adverse events or complications that would indicate a failure of the device.

8. The Sample Size for the Training Set

• This information is not applicable/provided. The KMC Kyphoplasty System is a physical medical device; it does not involve machine learning or AI models that require a "training set" of data in the conventional sense. The "training" for the device would be its design, manufacturing, and preclinical testing phases.

9. How the Ground Truth for the Training Set was Established

• This information is not applicable/provided. As explained above, there is no AI training set for this device. The "ground truth" for its design and manufacturing would be established through engineering specifications, materials testing, and quality control processes.

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