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The Cybird LED Curing Light is intended to polymerize resinous dental materials, restorative composite materials and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 400-480 nm waveband of visible light.

Cybird is a LED curing light intended for polymerization of light-cured materials by dental professionals. This product is effective on various light-cured materials. Cybird's body is made from industrial-grade aluminum which is a durable material intended to ensure heat dissipation. The Cybird features multiple curing modes to ensure functionality.

The provided text describes the 510(k) summary for the Cybird LED Curing Light (Model: Cybird WPT) and its comparison to a predicate device. It explicitly states that clinical testing was not required to demonstrate substantial equivalence, meaning a study proving the device meets specific acceptance criteria based on clinical outcomes or human reader performance was not performed or provided.

Instead, the submission relies on non-clinical tests and a comparison of technical specifications to a previously cleared predicate device. Therefore, it's not possible to provide all the requested information, specifically points 2 through 9, as they pertain to clinical or human-reader studies.

Here's a breakdown of what information can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal "acceptance criteria" table with specific thresholds that the device had to meet to be deemed effective in a clinical context. Instead, it compares the performance attributes of the Cybird WPT to its predicate device, the Cybird LED Curing Light (Model: Gold & XD, K173876). The "acceptance criteria" here implicitly relates to demonstrating that the new device performs "similar or better" than the predicate in non-clinical tests and that the differences do not "represent significant issues to clinical evaluation."

Summary of Acceptance: The Cybird WPT LED Curing Light was deemed substantially equivalent based on:

• Identical intended use.
• Demonstration through non-clinical performance and material testing that differences in device design (wireless charger, adjusted curing times for black light guides) and resulting light intensity do not negatively impact the device's ability to achieve polymerization of dental materials, and that the depth of cure is similar to the predicate.
• Compliance with voluntary standards for biocompatibility, electrical safety, EMC, and software verification/validation.

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

• Not applicable. No clinical test set data was used. Non-clinical tests were performed on the device itself and material samples. The text does not specify the sample sizes for these non-clinical tests (e.g., how many devices were tested for irradiance intensity or depth of cure) nor the country of origin of this testing 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. No clinical "ground truth" established by experts was used, as clinical testing was not required for this submission.

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

• Not applicable. No clinical test set requiring adjudication was used.

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 an LED curing light, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.

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

• Not applicable. This device is hardware for polymerization; it does not involve an algorithm with standalone performance in the context of diagnostic or interpretive tasks. Software verification and validation were done for its internal operation.

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

• For the non-clinical tests, the "ground truth" or reference for performance would be established by:
  • Validated laboratory methods and standards: Such as those for measuring irradiance intensity, spectral output, and depth of cure (e.g., ADA Specification No. 48).
  • Predicate device performance: The performance of the predicate device (Cybird Gold / XD) served as the benchmark for comparison for most attributes.
  • Material specifications: For biocompatibility, materials were tested against ISO standards (ISO 10993-5, 10993-10).

8. The sample size for the training set

• Not applicable. This device does not use machine learning or AI models that require a training set.

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

• Not applicable. No training set was used.

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