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The Callaly Tampliner is inserted into the vagina and used to absorb menstrual fluid.

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The provided document is a 510(k) premarket notification letter from the FDA regarding the Callaly Tampliner (super plus absorbency). This document is typically issued for medical devices and focuses on substantial equivalence to predicate devices, regulatory compliance, and a brief "Indications for Use" statement.

Crucially, this document DOES NOT contain information regarding device performance studies, acceptance criteria, or any details related to AI/algorithm performance. Therefore, I cannot extract the requested information based on this text.

The document discusses:

• The device name: Callaly Tampliner (super plus absorbency)
• Regulation Number: 21 CFR § 884.5470 (Unscented menstrual tampon)
• Regulatory Class: II
• Product Code: HEB
• Approval for Over-The-Counter Use
• Standard FDA compliance requirements (registration, listing, labeling, GMP, adverse event reporting)

Since the original text does not contain any of the requested information regarding AI/algorithm acceptance criteria or performance studies, I cannot fill out the requested table or answer the specific questions.

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The Callaly Tampliner is inserted into the vagina and used to absorb menstrual fluid.

Not Found

{
  "1. A table of acceptance criteria and the reported device performance": null,
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": null,
  "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": null,
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": null,
  "5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": null,
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": null,
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": null,
  "8. The sample size for the training set": null,
  "9. How the ground truth for the training set was established": null
}

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The Callaly Tampliner is inserted into the vagina and used to absorb menstrual fluid

Not Found

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (Callaly Tampliner). It confirms the device's substantial equivalence to legally marketed predicates and outlines regulatory requirements.

However, the document does not contain any information regarding specific acceptance criteria, device performance metrics, clinical study design, sample sizes, expert qualifications, or ground truth establishment for proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

Ask a specific question about this device