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For dental clinics treatment to irradiate polymer-based restorative materials to cure them. The instrument must only be used in hospital environments, clinics or dental offices, by qualified practitioners.

The LED Curing Lights (Model: DB686 HALO) is an oral device for repairing teeth. It uses the principle of light curing to make the dental repair resin material solidify rapidly under the action of light wave in the specific wavelength range (385~515nm), so as to fill the tooth cavity or bond the bracket. It is a cordless pen-style device, and consists of handpiece, LED cure tip, charging base, power adapter, eyes protector, eye protector unit and disposable protective sleeve. The LED Curing Lights protects the handpiece and LED cure tip from gross contamination and prevent cross infection between patients by applying the disposable protective sleeve. The disposable protective sleeve (patient contact part) is made of PP material.

The provided FDA 510(k) clearance letter and summary for the LED Curing Light (DB686 HALO) describes a device that uses light to cure dental materials. It is crucial to understand that this submission primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance and safety data, rather than conducting a comparative effectiveness study with human readers or presenting clinical trial data.

Therefore, many of the requested points, particularly those related to clinical studies, human reader performance, expert consensus, and ground truth establishment from patient data, are not applicable to this type of 510(k) submission for a non-diagnostic, non-AI device. The device is a direct energy device (light source) that acts on materials, not a diagnostic AI device that interprets images.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)

The "acceptance criteria" here are implicitly the standards and specifications that the device must meet to demonstrate substantial equivalence to its predicate devices. The "reported device performance" are the results of the non-clinical tests proving compliance with these standards.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details (Focus on Non-Clinical Demonstrations)

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

• For a device like an LED curing light, the "test set" and "data provenance" refer to the physical devices and materials tested in the non-clinical studies.
• The document does not specify the exact sample size (number of devices or material samples) used for each non-clinical test. This information would typically be detailed in the full test reports submitted to the FDA, but is summarized in the 510(k) summary.
• Data Provenance: The tests are described as "Non-clinical data" and "All nonclinical testing performed on new devices." This implies that the tests were conducted on the manufacturer's own (proposed) devices and materials as part of their design verification and validation activities. The country of origin for the data generation (testing laboratories) is not explicitly stated, but the applicant is based in China. The testing would be considered prospective in the sense that it was conducted specifically for this 510(k) submission.

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

• Not Applicable. This device is an active medical device (light source) for material polymerization and caries detection, not a diagnostic imaging AI algorithm. Therefore, there is no "ground truth" based on expert image interpretation or patient outcomes in the context of diagnostic accuracy, nor were human experts involved in establishing a "ground truth" for the performance testing of the device's physical parameters (e.g., light intensity, wavelength, electrical safety, biocompatibility, curing efficacy as measured by ISO standards). The "ground truth" for these tests is defined by the technical specifications and standards themselves.

4. Adjudication Method for the Test Set:

• Not Applicable. As there are no human readers or expert interpretations involved in the stated non-clinical performance and safety testing, there is no adjudication method required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No. An MRMC study is designed to evaluate how AI assistance impacts human reader performance (e.g., radiologists interpreting images). This device is a light curing unit, not a diagnostic AI system. Its clearance is based on demonstrating substantial equivalence in its ability to cure dental materials and meet safety standards, not on improving human diagnostic accuracy.

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

• Not Applicable. This is not an algorithm or software-only device. Its performance is measured as a standalone physical device (its light output, safety, biocompatibility, and ability to cure materials as per ISO standards).

7. The Type of Ground Truth Used:

• The "ground truth" for this device's acceptance is based on engineering and performance standards (e.g., ISO 10650, ISO 4049 for curing performance; IEC 60601 series for electrical safety; IEC 62471 for photobiological safety; ISO 10993 series for biocompatibility). The device's measured parameters must fall within acceptable ranges defined by these standards, and its performance must be comparable to the predicate devices.
• For the Caries Detection Mode (EAQ product code), while it's a diagnostic aid, the document doesn't detail specific "ground truth" for its diagnostic performance, rather it implies functional equivalence based on violet light emission for fluorescent reaction.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/machine learning device that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. As there is no training set for an AI model, this question is irrelevant to this device.

In summary, the 510(k) for the LED Curing Light (DB686 HALO) is a traditional submission focused on demonstrating technical conformity to established safety and performance standards and substantial equivalence to existing predicate devices through non-clinical testing. It does not involve AI, diagnostic image interpretation, multi-reader studies, or clinical trials for comparative effectiveness.

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