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The IsoelasticU™ is indicated for joint replacement arthroplasty of the ulnar head at the distal radioulnar joint (DRUJ) for the following indications

• -Rheumatoid arthritis with or without tendon ruptures
• -Degenerative arthritis or post traumatic arthritis
  • 1. Arthrofibrosis of the DRUJ o
  • 2. Reconstruction of the distal ulna post tumor resection o
  • 3. Failed Ulnar Head Resection 0
  • 4. Distal ulna instability with xray or bone scan evidence of arthritic or inflammatory O changes
  • 5. Revision following failed ulnar head arthroplasty O
• Ulna stems are intended for uncemented use -

The IsoelasticU ulnar head implant allows for replacement of the distal ulnar head much like the predicate metallic and silicone elastomer distal ulnar head implants.

This document is a 510(k) summary for a medical device (IsoelasticU™ wrist joint ulnar prosthesis). It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way described in your request (e.g., performance metrics, sample sizes, expert ground truth, MRMC studies, standalone algorithm performance, or training set details).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (SBI Uhead Implant). This is a different regulatory pathway than proving performance against specific acceptance criteria for a novel device or AI/software.

Here's a breakdown of why the requested information cannot be extracted from this document:

1. No Acceptance Criteria or Reported Device Performance Table: The document explicitly states that the device is "substantially equivalent" to the SBI Uhead Implant. The table provided compares features and indications for use between the IsoelasticU and the predicate device, not performance metrics against acceptance criteria.
2. No Study Described: There is no description of a clinical study, algorithm performance study, or any kind of test set evaluation to demonstrate the IsoelasticU™ meets specific performance metrics.
3. No AI Mentioned: The device is a physical prosthesis, not an AI or software device. Therefore, concepts like "test set," "training set," "ground truth," "MRMC study," or "standalone algorithm performance" are not applicable to this document.
4. Regulatory Approach: The 510(k) process for this device relies on demonstrating that it is as safe and effective as a legally marketed predicate device, not on proving new performance against predefined quantitative criteria through a performance study.

In summary, the provided text does not contain the information required to answer your prompt because it is a 510(k) summary for a physical medical device (a prosthesis) that demonstrates substantial equivalence, not a performance study for an AI/software device or a novel device proving specific acceptance criteria.

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