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The Rodo Smilekey is intended to be used with the Rodo Abutment System for removing prostheses compatible with Smileloc Sleeve by using induction heating.

The Smilekey is an additional remover device intended for use with the predicate Rodo Abutment System (K160786). It is used to deliver induction energy to the Smileloc Sleeve. The Smilekey consists of a tip and handle that uses induction (alternating electromagnetic field) to deliver precise energy to the Smileloc. Only the end of the tip is inserted inside the patient's mouth while the handle is hand-held by the operator. The Smilekey is powered by a rechargeable lithium battery inside the handle. The handle also contains an electronic control board that regulates the entire operation, including LED indicators that let the operator know when energy is being applied to the Smileloc Sleeve and when the unlocking procedure has been completed.

The given text describes the Rodo Smilekey, a dental device intended for removing prostheses compatible with the Smileloc Sleeve using induction heating. The document focuses on demonstrating the substantial equivalence of the Rodo Smilekey to a predicate device, the Smileloc Activator, rather than establishing distinct acceptance criteria with specific performance thresholds for a novel diagnostic or treatment outcome.

Instead of traditional accuracy, sensitivity, or specificity metrics often seen in AI/ML performance studies, the performance data provided focuses on safety and functional performance compared to established standards and the predicate device.

Here's an attempt to structure the information based on your request, acknowledging that the nature of the device (a tool for heating/removing dental prostheses) means some of your requested categories may not have direct equivalents:

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

Since this is a 510(k) submission for a Class II medical device, the "acceptance criteria" are primarily related to safety, functional performance, and substantial equivalence to a predicate device, rather than diagnostic accuracy. No explicit numerical acceptance criteria are provided, but the document states compliance with relevant standards and demonstrates that performance meets safe limits and is equivalent to the predicate.

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

The document primarily describes bench testing (e.g., electrical safety, EMC, biocompatibility, cleaning, software V&V, battery, usability, thermal safety). These types of tests typically do not involve "test sets" of patient data in the way a diagnostic AI would.

• Sample size for test set: Not applicable in the context of patient data for diagnostic/prognostic evaluation. For bench tests, "samples" would refer to the number of devices or materials tested. This specific number is not provided, but the statement implies sufficient units were tested to meet the requirements of the standards.
• Data provenance: Not applicable. These are laboratory-based bench tests, not clinical data.

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)

Not applicable. The "ground truth" for these types of engineering and safety tests is adherence to established international standards (e.g., ISO, IEC, AAMI/ANSI) and regulatory guidance. Expert clinical opinion for ground truth in a diagnostic sense is not relevant for this device's performance claims.

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

Not applicable, as there is no "test set" of clinical cases 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 device is a tool for removing dental prostheses, not a diagnostic AI system assisting human readers.

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

This refers to the inherent performance of the device itself (e.g., its ability to heat the Sleeve safely and effectively). The entire "Performance Data" section describes standalone testing of the Rodo Smilekey. It functions as an algorithm itself in the sense of regulating energy delivery and time, and its performance was evaluated independently through bench testing.

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

The "ground truth" for the device's acceptable performance is defined by:

• Compliance with internationally recognized engineering and safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, ISO 10993-1, ISO 10993-5, IEC 62133, IEC 60601-1-6).
• Adherence to FDA guidance documents (e.g., for reprocessing, software validation).
• Demonstrating that thermal output (maximum implant/abutment temperature) remains below established safety limits determined by physiological studies (e.g., Eriksson, AR et al.).
• Substantial equivalence to a legally marketed predicate device (Rodo Abutment System K160786) based on similar intended use and demonstration that technological differences do not raise new safety or effectiveness concerns.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set of data. Its function is based on principles of induction heating and electronics, not learned patterns from data.

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

Not applicable, as no training set is used.

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