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The Straight Fire Holmium Laser Fiber is indicated for use in laser-based surgical applications, including, but not limited to endoscopic, laparascopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue. The Straight Fire Holmium Laser Fiber is designed for use with holmium (Ho:YAG) lasers with a standard.SMA-905 connector that have been cleared for surgical use.

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This is an unfortunate case of an XY problem. You've asked for details about acceptance criteria and a study proving a device meets them, but the document provided is a 510(k) clearance letter from the FDA for a medical device called "AccuMax™ Straight Fire Holmium Laser Fiber."

The provided document is a regulatory clearance, not a scientific study report describing acceptance criteria and performance data.

A 510(k) clearance signifies that the FDA has determined the device is substantially equivalent to a legally marketed predicate device. This process typically involves demonstrating that the new device is as safe and effective as the predicate, often through performance testing, but the detailed results and acceptance criteria from those tests are not included in the clearance letter itself.

Therefore, I cannot provide the information you requested based on the text. Here's why:

• No Acceptance Criteria or Performance Data: The clearance letter states the device's indications for use and confirms its substantial equivalence. It does not contain a table of acceptance criteria nor reported device performance against those criteria.
• No Study Details: There is no mention of a specific study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. This information would be found in a detailed study report or a different section of the 510(k) submission, not the clearance letter.

To obtain the kind of information you are looking for (acceptance criteria and study details), you would typically need to access:

• The full 510(k) submission: While some parts might be publicly available, the complete technical and performance data is often proprietary.
• Peer-reviewed publications: If a clinical study was conducted, its results and methodology might be published in a scientific journal.
• Device manufacturer's documentation: Manuals, technical specifications, or white papers might summarise performance characteristics, though usually not in the granular detail you're requesting.

In summary, the provided text does not contain the information necessary to fulfill your request.

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