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The COSMO TENS PF-990 Mini Digital Wireless Patch, a Transcutaneous Electrical Nerve Stimulator is indicated only for symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain relief. COSMO TENS PF-990 is indicated to be well attached to the skin by its patch before being turned on. It provides low frequency therapy that makes use of weak electrical currents applied to the body to directly stimulate nerve pathways.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving the device meets those criteria. The provided document is a 510(k) clearance letter from the FDA for a device called "COSMO TENS PF-990 Mini Digital Wireless Patch."

The letter primarily:

• Confirms that the device is substantially equivalent to legally marketed predicate devices.
• States the regulation number and class of the device.
• Outlines general requirements for marketing the device.
• Includes an "Indications for Use" statement.

There is no mention of:

• Specific acceptance criteria (e.g., performance metrics, thresholds).
• Details of any study conducted to demonstrate the device's performance against such criteria.
• Sample sizes, data provenance, expert qualifications, or adjudication methods.
• Standalone performance or comparative effectiveness studies.
• Ground truth details for training or testing sets.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study-related details based on the given text.

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