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The intended use of the dental instrument heater - The Down Pak - is to provide continuous heat and/or vibration at the tip of a dental instrument. The Down Pak is designed for processing gutta percha (softening, spreading, compacting) and cutting plastic handles of obturators during a root canal treatment. The device may only be operated by dentists and endodontists.

The device is a battery-operated dental instrument heater which is designed to provide continuous heat and/or vibration at the tip of a dental instrument. The low frequency vibration stimulates the transformation of gutta percha in a solid mass. The temperature is regulated by the type of tip attached to the handpiece and it automatically maintains a preset temperature for consistent results. The cordless handpiece is easily operated by a single button and can be recharged by placing the handpiece in a charger. The tips are autoclavable and the handpiece can be disinfect with 80% alcohol.

The provided text describes a 510(k) summary for the "Down Pak" dental instrument, which is a battery-operated heater designed to provide continuous heat and/or vibration to the tip of a dental instrument for endodontic procedures. The document primarily focuses on demonstrating substantial equivalence to a predicate device ("EndoTwinn") and compliance with recognized consensus standards.

Based on the provided text, the following information can be extracted regarding acceptance criteria and device performance:

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

The document states compliance with several international standards but does not provide specific quantitative acceptance criteria or detailed device performance metrics within the context of these standards. It generally asserts that the device "complies with the requirements of recognized consensus standards."

It's important to note: The document does not provide specific numerical or qualitative performance results (e.g., "device maintained temperature within X range for Y duration") for any of these standards. It only states general compliance.

2. Sample size used for the test set and the data provenance:

The document does not specify a sample size for a test set that would typically be associated with clinical performance or direct device efficacy studies. The "Device Testing Results" section refers to compliance with consensus standards, which are often tested on individual units or small batches of devices for design verification rather than a large clinical test set.

Data provenance (country of origin, retrospective/prospective) is not mentioned in relation to any specific testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Since a clinical test set with human subject outcomes or expert-adjudicated results is not described in this 510(k) summary, information regarding the number and qualifications of experts for ground truth establishment is not available.

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

As no clinical test set requiring expert adjudication is described, the adjudication method is not applicable and therefore not mentioned.

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:

This document describes a dental instrument heater, not an AI-assisted diagnostic or interpretative device. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and not mentioned.

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

This device is a hardware instrument, not an algorithm or software. Therefore, a standalone algorithm performance study is not applicable and not mentioned.

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

For the standards compliance mentioned (IEC, ISO), the "ground truth" would be the successful demonstration that the device design and manufacturing meet the technical specifications and safety requirements outlined in those standards (e.g., electrical parameters, biocompatibility test results). This is not typically "expert consensus," "pathology," or "outcomes data" in the clinical sense, but rather engineering and laboratory test results against established performance criteria within the standards.

8. The sample size for the training set:

The concept of a "training set" is relevant for machine learning or AI models. This document describes a physical medical device, not a software algorithm. Therefore, information regarding a training set sample size is not applicable and not provided.

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

As there is no training set mentioned (given the nature of the device), this information is not applicable and not provided.

In summary:

The provided 510(k) summary for the "Down Pak" dental instrument focuses on demonstrating substantial equivalence to a predicate device and compliance with established international consensus standards for medical devices (electrical safety, EMC, risk management, biocompatibility). It does not include details of clinical studies, expert-adjudicated test sets, or AI/algorithm performance metrics, as these are not relevant to the type of device being described. The "Device Testing Results" section refers to general compliance with these standards rather than specific quantitative performance criteria.

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