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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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MI Varnish is a fluoride varnish with Recaldent™ (CPP-ACP) that has a desensitizing action when applied to tooth surfaces. The application leaves a film of varnish on tooth and this may allow visual control and verification.

MI Varnish is a fluoride varnish (5% sodium fluoride with CPP-ACP) which has a desensitizing action when applied to tooth surfaces. The application leaves a film of varnish on tooth and this may allow visual control and verification. MI Vamish is packed in unit dose and can be applied on teeth with a disposable brush.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MI Varnish device, structured to answer your specific questions.

Acceptance Criteria and Device Performance Study for MI Varnish

Based on the provided 510(k) summary (K102808), the device MI Varnish is a fluoride varnish intended for desensitizing action when applied to tooth surfaces. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing direct clinical efficacy against predefined acceptance criteria for a novel device. Therefore, the "acceptance criteria" here are primarily around demonstrating comparable physical and chemical properties to legally marketed predicate devices, and the "study" is a summary of physical tests.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by demonstrating similarity to predicate devices. The reported device performance is presented as a comparison against these predicates.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state sample sizes for the individual physical tests (pH, consistency, total fluoride). It provides mean values with standard deviations (e.g., 39(2) for consistency), which implies that multiple measurements were taken for each parameter.

• Test Set Sample Size: Not explicitly stated, but implied to be multiple measurements for each physical property.
• Data Provenance: The tests were conducted "According to GC Corporation R&D test methods." The manufacturing origin of the device, GC America Inc. (Alsip, IL, USA), implies the tests were likely performed in a controlled R&D environment associated with the submitter. The document does not specify a country of origin for the data beyond that. The data is retrospective, as it refers to tests performed prior to the 510(k) submission date.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this 510(k) submission. The "ground truth" for the physical and chemical properties is established by direct measurement using specified test methods, not by expert consensus or interpretation against a test set. There were no human readers involved in evaluating the performance metrics provided.

4. Adjudication Method for the Test Set

Not applicable. The performance is based on direct physical and chemical measurements rather than requiring expert adjudication.

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. This is not a diagnostic imaging or AI device. It's a dental material (fluoride varnish), and the submission does not involve an MRMC study or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a dental material, not a software or AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance characteristics presented (pH, consistency, total fluoride) is based on instrumental and analytical measurements according to established R&D test methods. For the overall substantial equivalence claim, the ground truth is established by comparing the device's characteristics and intended use to those of legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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