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The D1 LED Curing Light & accessories is intended to polymerize resinous dental materials, restorative composite materials, orthodontic brackets bonding and sealing materials that are photo-polymerized in the 430~490nm waveband of visible light.

D1 by DXM Co., Ltd. is classified as an Ultraviolet Activator for polymerization (21 CFR 872.6070) because it is a device intended for the photopolymerization light cured dental materials. The D1-Cordless is a universal photo-polymerization light curing source working in cordless conditions and producing visible blue light in the 430 to 490nm waveband of spectrum with a power density of 3,000mW/cm² (11-8mm light-guide). These power densities are sufficient for the product intended uses, namely, Photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) dental materials, restorative composite materials, and orthodontic brackets and orthodontic bonding and sealing materials.

D1 has two operating modes: Plasma Emulation/ Ortho mode: 3000 mW/cm² and High Power mode: 1500 mW/cm2.

Exposure timing intervals for Plasma Emulation mode is 1, 2, 3 seconds, Ortho: approximately 3 seconds on, 1 second off for 16 cycles and High Power mode: 5, 10, 20, 40 seconds.

The D1 Curing light is cordless and is powered by a rechargeable Lithium-lon battery which is charged by a Battery Charger Stand supplied with a certified AC/DC Adapter.

The provided text describes the 510(k) submission for the D1 LED Curing Light, which is a device intended to polymerize resinous dental materials. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a novel study.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it describes non-clinical bench tests performed to verify specific technical aspects of the device against established standards and expected performance for similar devices.

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

   The document does not specify a "test set" in the context of clinical data for performance evaluation in the way one would for a diagnostic or AI algorithm. Instead, it refers to non-clinical bench tests. For these bench tests, sample sizes are not explicitly stated. The data provenance is from non-clinical bench testing conducted in a lab setting, likely by DXM Co., Ltd. or a contracted testing facility. No country of origin for a clinical data set is applicable as no clinical studies were performed.

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

   Not applicable. No ground truth in the context of expert consensus on clinical cases was established, as no clinical studies were performed. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles and the specifications derived from the predicate devices and relevant standards.

4. Adjudication Method for the Test Set:

   Not applicable, as no clinical test set requiring expert adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   No MRMC comparative effectiveness study was done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a dental curing light device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   Not applicable. The D1 LED Curing Light is a physical device, not an algorithm. The "standalone" performance refers to the device's technical specifications and functionality, which were evaluated through bench testing.

7. Type of Ground Truth Used:

   The "ground truth" for this submission is based on engineering specifications, established international and national standards (e.g., IEC 60601-1, ANSI/AAMI/IEC 60601-1-2, ISO 10993-5, ISO 10993-10), and the performance characteristics of predicate devices. For example, the irradiance intensity of 3,000mW/cm² (Plasma Emulation/Ortho mode) and 1,500mW/cm² (High Power mode) would be a performance characteristic verified against the device's design specifications, which are implicitly derived from the requirements for effectively polymerizing dental materials and the performance of predicate devices.

8. Sample Size for the Training Set:

   Not applicable. There is no "training set" as this device does not involve machine learning or AI algorithms requiring data for training.

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

   Not applicable, as there is no training set.

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Indicated for the use of local anesthetics for infiltration and nerve block anesthesia administered prior to, or in conjunction with dental procedures.

Denjector is a gun type electronic dental anesthetic cartridge syringe. This device is used with injectable local anesthetics packaged in cartridge form. The device consists of: Injector gun, battery, battery charger stand, DC adapter for battery charger stand, Cartridge holder and Cartridge pushing/pulling pin. Standard needles may be used with the device.

This document is a 510(k) summary for the Denjector, an electronic dental anesthetic cartridge syringe. It indicates that no clinical tests were performed to establish its safety and effectiveness. Instead, the submission relies on non-clinical tests and a comparison to a predicate device to claim substantial equivalence. Therefore, the information requested regarding acceptance criteria and a study proving those criteria cannot be extracted from this document, as such a study was not conducted.

Here is a summary of the information that can be extracted, along with explanations for the missing data:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document explicitly states, "Clinical testing was not conducted." Therefore, there are no acceptance criteria derived from clinical performance and no reported device performance against such criteria. The substantial equivalence claim is based on non-clinical standards and comparison to a predicate.

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

• Sample Size: Not applicable (No clinical test set was used).
• Data Provenance: Not applicable (No clinical data was used).

Explanation: As no clinical testing was performed, there is no test set or associated data provenance.

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

• Number of Experts: Not applicable (No clinical test set requiring ground truth established by experts).
• Qualifications: Not applicable.

Explanation: Without clinical testing, there was no need for experts to establish ground truth for a test set.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable.

Explanation: No clinical test set means no adjudication method was necessary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study Done: No.
• Effect Size: Not applicable.

Explanation: An MRMC comparative effectiveness study involves human readers and clinical cases. Since no clinical testing was done, no such study was conducted.

6. Standalone (Algorithm Only) Performance Study:

• Standalone Study Done: No.

Explanation: The "Denjector" is a hardware device (an electronic dental anesthetic cartridge syringe), not a software algorithm. Therefore, a standalone algorithm-only performance study is not relevant. The testing mentioned (EN 60601-1, EN 61000-3-2, and EN 61000-3-3) refers to electrical safety and electromagnetic compatibility standards for medical devices, which are not performance studies in the clinical sense.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not applicable.

Explanation: There are no clinical outcomes or diagnostic assessments to establish ground truth for, as no clinical study was performed.

8. Sample Size for the Training Set:

• Sample Size: Not applicable.

Explanation: The Denjector is a hardware device, not an AI/ML algorithm that requires a training set.

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

• Method: Not applicable.

Explanation: As no training set was used, no ground truth needed to be established for it.

In summary, the provided 510(k) submission for the Denjector explicitly states that no clinical trials were conducted. The device's safety and effectiveness were established through non-clinical testing against recognized standards (EN 60601-1, EN 61000-3-2, EN 61000-3-3) and a comparison to a predicate device (CC:3; computer controlled syringe by DENTSPLY Midwest Professional Ltd., K983105) to demonstrate substantial equivalence.

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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 430-490 nm waveband of visible light.

Cybird by DXM Co., LTd is classified as an Ultraviolet Activator for polymerization(21 C.f.r.872.6070) because it is a device intended for the photo-polymerization light cured dental materials. The Cybird is a universal photo-polymerization light curing source working in cordless conditions and producing visible blue light in the 440 to 490nm waveband of spectrum with a power density comprised 1,000W/cm², 11-8mm light-guide).These power densities are sufficient for the product intended uses ,namely, Photopolymerization in the 440-490 nm waveband of visible light cured (VLC) dental materials , Photo – polymerization in the 440-490nm waveband of visible light cured(VLC) restorative composite materials, and Photo-polymerization in the 440-490 nm waveband of visible light cured (VLC) orthodontic brackets and orthodontic bonding and sealing materials. Exposure times can be set for 5,10,15, or 20 seconds.

The DXM Co., Ltd. Cybird LED Curing Light is a device intended for the photo-polymerization of light-cured dental materials. The submission states that no clinical testing was conducted to establish its safety and effectiveness. Instead, the device's substantial equivalence to a predicate device, the Satelec Mini L.E.D (K032465), was demonstrated through non-clinical testing.

Therefore, the following information cannot be extracted from the provided text: A table of acceptance criteria and the reported device performance, sample size used for the test set and data provenance, number of experts for ground truth and qualifications, adjudication method, MRMC comparative effectiveness study results, standalone performance, type of ground truth used, sample size for training set, and how ground truth for the training set was established.

However, based on the provided text, the following details regarding the acceptance criteria and the study that "proves" the device meets them can be summarized:

Non-Clinical Acceptance Criteria and Reported Performance (via equivalence to a predicate device):

The acceptance criteria for the Cybird LED Curing Light were not explicitly stated as quantitative thresholds for performance metrics. Instead, the device's acceptability was based on demonstrating substantial equivalence to a legally marketed predicate device (Satelec Mini L.E.D, K032465) through non-clinical testing. This implies that the device's performance, as measured by these non-clinical tests, should be comparable to or within acceptable limits relative to the predicate device and established safety standards.

Study Information (Non-Clinical Equivalence Study):

1. Sample size used for the test set and the data provenance: Not applicable in the traditional sense of a clinical trial. The "test set" consisted of the Cybird LED Curing Light itself, undergoing various engineering and electrical safety tests. The "data provenance" is from these specific non-clinical tests performed on the device by DXM Co., Ltd. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of human subjects.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in this context, was established by compliance with international and national standards for electrical safety and electromagnetic compatibility (e.g., EN 60601-1, EN 61000 series, EN 55011). These standards themselves are established by expert consensus in their respective fields, but no specific number or qualification of experts for this particular device's testing is mentioned beyond the presumption that the company performing the tests had qualified personnel.

3. Adjudication method: Not applicable. The process was one of compliance testing against defined standards. Either the device met the standard (passed) or it did not (failed). There was no independent adjudication of test outcomes by multiple parties mentioned.

4. 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 for human readers. No MRMC study was performed.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a standalone hardware product for polymerization, not an algorithm.

6. The type of ground truth used: The ground truth for proving the device's safety and effectiveness was based on compliance with established international and national standards for electrical safety (EN 60601-1), electromagnetic compatibility (EN 60601-1-2, EN 61000 series, EN 55011), and demonstration of functional equivalence (power output, wavelength) to the predicate device for its intended use.

7. The sample size for the training set: Not applicable. There was no machine learning model or algorithm to train.

8. How the ground truth for the training set was established: Not applicable, as there was no training set.

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The Hawk Intraoral Camera and Accessories are indicated for use to provide a view of mouth to assist the dentist in describing dental procedures and to show the patient the mouth before and after dental procedures.

Hawk Intraoral Camera composed of light (25g), small (185 x10mm) hand piece along with docking station. The hand piece consists of a focusing mechanism to assist the doctor in taking video of the patient's mouth. The hand piece connects to docking station via cable. The docking station attaches directly to monitor, TV, or computer via standard composite connection. It uses high definition imaging (480 lines) to capture images at 78 degrees field of view. Hawk Intraoral Camera includes also footswitch.

The provided 510(k) summary for the "Hawk Intraoral Camera and Accessories" does not describe any acceptance criteria or a study proving the device meets them. This type of submission, especially for a Class I device seeking substantial equivalence, generally relies on demonstrating equivalence to a predicate device through non-clinical testing of safety and performance against recognized standards, rather than clinical efficacy studies with specific performance metrics.

Here's why the requested information cannot be extracted from this document:

• No Acceptance Criteria: The document does not define specific metrics (e.g., sensitivity, specificity, accuracy, image resolution thresholds, field of view clarity) that the device must achieve to be considered effective.
• No Performance Study: There is no study described that measures the device's performance against predefined acceptance criteria. The document explicitly states: "Clinical testing was not conducted."
• Reliance on Substantial Equivalence: The approval is based on demonstrating substantial equivalence to a predicate device (Veracan Intraoral camera and accessories, K021083) in terms of intended use, operation, safety, and function, supported by non-clinical testing against electrical and medical device safety standards (EN 60601-1, EN 60601-2, EN 61000-3-2 and EN 61000-3-3).

Since the specific information requested about acceptance criteria and a performance study is not present in the provided text, the table and other details cannot be filled as requested. The available information primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Explanation of Missing Elements:

1. Table of acceptance criteria and reported device performance: Not present. The submission focuses on meeting safety standards and equivalence to a predicate, not specific performance metrics.
2. Sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, type of ground truth, training set sample size, how ground truth for training was established: All these elements are relevant to performance studies, especially those involving AI or diagnostic devices, which were not conducted for this camera. The device is a viewing tool, not a diagnostic one requiring such detailed performance evaluation.

Summary of available relevant information:

• Intended Use: To provide a view of the mouth to assist the dentist in describing dental procedures and to show the patient the mouth before and after dental procedures.
• Predicate Device: Veracan Intraoral camera and accessories (K021083).
• Non-Clinical Testing Standards: EN 60601-1, EN 60601-2, EN 61000-3-2, and EN 61000-3-3. These are safety and electromagnetic compatibility standards, not performance criteria for diagnostic accuracy or image quality exceeding basic functionality.
• Clinical Testing: Not conducted.
• Conclusion: Substantially equivalent to the predicate and safe and effective for its intended use based on non-clinical testing against standards.

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