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The Dentist In A Box™ Dental Emergency Kit Plus Tooth Trauma Care Kit provides immediate, temporary relief from common dental problems, accidents and trauma until a dentist can be seen. For use by trained professionals.

For temporary relief from a lost filling, chipped tooth, or irritation by orthodontic wire or denture clasp or for temporary stabilization of a loosened or knocked out permanent tooth. Used by persons in remote areas such as during military field service when access to a dentist or dental equipment and facilities are not available for an extended period of time and effective treatment is necessary to prevent discomfort or delay in treatment may aggravate the injury.

Dentist In A Box intends to assemble U.S. FDA regulatory cleared and/or exempt devices into a convenience kit for the U.S. market.

The kit components are either (1) legally marketed pre-Amendments devices, (2) exempt from premarket notification (consistent with the exemption criteria described in the classification regulation(s) and the limitation of exemptions for Section 510(k) of the act (e.g., 862.9), or (3) have been found to be substantially equivalent through the premarket notification process for the use(s) for which the kit is to be intended (i.e., not claiming or causing a new use for the component(s)).

The components are purchased in finished form, i.e., they are packaged, labeled, etc., consistent with their pre-Amendments, exemption, or premarket notification criteria and status.

Components:
Hand-held mouth mirror
Sterile Cotton-tipped swabs
Temporary filling material
Tooth splinting material
Sterile unbuffered Saline Solution 0.9%, 5ml unit dose
Sterile Disposable gloves

The provided text describes a 510(k) submission for a convenience kit, not a study evaluating a device's performance or acceptance criteria in the manner requested. The submission is for the "Dentist In A Box™ Dental Emergency Kit Plus Tooth Trauma Care Kit".

Therefore, I cannot extract the information you requested about acceptance criteria and a study proving device performance because no such study was performed or is referenced in the provided text.

Here's why and what the document does provide:

• No Clinical Study/Non-Clinical Test Summaries: The document explicitly states "Non-Clinical Test Summaries: N/A" and "Clinical Study Summary: N/A". This means no studies were conducted to assess the performance of the kit as a whole or its individual components beyond their existing regulatory status.
• Substantial Equivalence: The basis for this 510(k) clearance is "substantial equivalence" to a predicate device (Cavit-W temporary crown and bridge resin K875133) for the only Class II device component in the kit, and the fact that other components are either pre-Amendments, exempt, or previously cleared devices.
• Convenience Kit: The device is a "convenience kit," an assembly of already cleared or exempt devices. The regulatory approach for such kits often focuses on the components' individual clearances and the kit's intended use not introducing new questions of safety or effectiveness.

To directly answer your numbered requests based on the provided text, using "N/A" where the information is not present:

1. A table of acceptance criteria and the reported device performance:

   Acceptance Criteria	Reported Device Performance
   N/A	N/A
   (The submission does not present specific performance criteria or data, as it relies on substantial equivalence of its components.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size (Test Set): N/A (No test set mentioned)
   • Data Provenance: N/A (No data from a test set mentioned)

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):

   • Number of Experts: N/A
   • Qualifications of Experts: N/A

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Adjudication Method: N/A

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:

   • MRMC Study Done: No.
   • Effect Size: N/A

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Standalone Performance Study: No.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Type of Ground Truth: N/A

8. The sample size for the training set:

   • Sample Size (Training Set): N/A

9. How the ground truth for the training set was established:

   • Ground Truth Establishment: N/A

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