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The MIRAMATIC Box Sharps Container is intended for use in dental offices for collection and disposal of contaminated wastes and sharps. Indicated for use as an aid in minimizing needle stick injuries during needle disposal. For use with 25, 27 and 30 gauge long and short dental needles.

The Cap Trap Needle Re-capper is intended for use in dental offices during uncapping/recapping procedures. Indicated for use as an aid in minimizing needle stick injuries during re-capping and needle disposal.

The MIRAMATIC Box Sharps Container is designed for use with the MIRAMATIC cartridge syringe to enable single-handed disengagement, ejection and disposal of needles during dental procedures.

The Cap Trap Needle Re-capper is a mechanical re-capper designed to allow single-handed re-sheathing so that the needle is re-sheathed without directing it toward any part of the body. It consists of a base, carrier plate and activation plate.

This document, K061933, describes two separate devices: the Hager MIRAMATIC Box Sharps Container and the Cap Trap Needle Re-capper. The provided text discusses the general characteristics, intended use, and preliminary testing activities for these devices, but it does not contain the specific details required to answer the questions about acceptance criteria and a study that proves the device meets those criteria.

The document states that "Testing activities were conducted to establish the performance and reliability characteristics of the accessories. Testing included mechanical testing, cleaning and sterilization efficacy and simulated use evaluation." However, it does not provide:

• Specific acceptance criteria: No numerical targets (e.g., "must reduce needle sticks by X%") or qualitative benchmarks are listed.
• Reported device performance: No results from the mentioned testing activities are presented.
• Details of the study: Information on sample size, data provenance, ground truth establishment, expert involvement, or adjudication methods is absent.

Therefore, for each of your specific questions, the answer based on the provided text is that the information is not available in this document.

Summary of Missing Information:

1. A table of acceptance criteria and the reported device performance: Not provided. The document mentions "testing activities were conducted to establish the performance and reliability characteristics," but it does not list the criteria or the results.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided. The document generally refers to "testing activities" and "simulated use evaluation" without detailing the study design or sample size.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. The document does not mention the involvement of experts in establishing ground truth for any testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
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: Not applicable. These devices are mechanical, not AI-driven diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. These are mechanical devices, not algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided. The document vaguely mentions "simulated use evaluation" but doesn't specify what constituted the "ground truth" for evaluating performance (e.g., actual needle stick reduction, measured force, etc.).
8. The sample size for the training set: Not applicable (not an AI/algorithm). If interpreted as a sample size for an initial testing or development phase, it is not provided.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, this 510(k) summary provides an overview of the medical devices and their intended use, but it does not contain the detailed study results or acceptance criteria that you are requesting.

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