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HTF Plus (HTF with non-essential amino acids) is used as a holding media and a supplement for human gametes and embryos for assisted reproduction.

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I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for a medical device called "HTF Plus - HTF with non-essential amino acids," indicating that the device has been deemed substantially equivalent to a legally marketed predicate device.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This means the submission primarily focused on demonstrating equivalence to an existing device, rather than providing detailed acceptance criteria or a specific study proving performance against such criteria.

The document includes:

• Trade/Device Name: HTF Plus - HTF with non-essential amino acids
• Regulation Number/Name: 21 CFR 884.6180, Reproductive media and supplements
• Regulatory Class: II
• Product Code: 85 MQL
• Indications for Use: HTF Plus (HTF with non-essential amino acids) is used as a holding media and a supplement for human gametes and embryos for assisted reproduction.
• 510(k) Number: K022334
• Date of Clearance: August 28, 2002

It does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
• Information about standalone algorithm performance studies.
• Details on the type of ground truth used.
• Sample size or ground truth establishment for a training set.

Therefore, I cannot fulfill your request based on the provided text.

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