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Subcutaneous injection of Copaxone®.

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The provided text is a 510(k) clearance letter from the FDA for a device called "Copaxone (Glatiramer Acetate for Injection) EZ-Ject from Shared Solutions." This letter primarily discusses the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

However, the document does NOT contain information regarding:

• Acceptance criteria: Specific performance metrics or thresholds the device needed to meet.
• A study proving the device meets acceptance criteria: There is no description of any clinical trial, bench test, or other study.
• Reported device performance: No data on accuracy, precision, reliability, or any other performance metric is provided.
• Sample size for test set or training set.
• Data provenance.
• Number or qualifications of experts.
• Adjudication method.
• MRMC comparative effectiveness study or human reader improvement.
• Standalone algorithm performance study.
• Type of ground truth used.
• How ground truth was established for training set.

The letter is a regulatory document confirming substantial equivalence, not a summary of a performance study. It states the "Indications for Use" for the device, which is "Subcutaneous injection of Copaxone®." This is a functional description, not a performance criterion.

Therefore,Based on the provided text, I cannot describe the acceptance criteria or the study that proves the device meets the acceptance criteria as this information is not present in the document. The document is a 510(k) clearance letter from the FDA, which confirms the device's substantial equivalence to a predicate device but does not detail the technical performance criteria or the studies conducted to establish them.

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