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The device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended for single use only.

The Orthodontic Ceramic Brackets are bonded to teeth to apply forces to the tooth, transmitted, to alter the tooth position. The force is introduced by a flexible orthodontic wire, which is attached to Orthodontic Ceramic Brackets. The ceramic bracket has both, aesthetic and self ligating qualities. The bracket design enables easier orthodontic wire placement and removal through self-ligating properties.

The provided text describes a 510(k) premarket notification for "TruKlear Orthodontic Ceramic Brackets." This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its own performance against new acceptance criteria.

Therefore, the document does not contain information on the following:

• A table of acceptance criteria and reported device performance (beyond compliance with ISO standards for material and mechanism).
• Sample size used for a test set or its data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a clinical study.
• Sample size for a training set.
• How ground truth for a training set was established.

Instead, the submission for the TruKlear Orthodontic Ceramic Brackets relies on non-clinical data (bench testing) and biocompatibility testing to demonstrate substantial equivalence to a previously cleared predicate device (Orthodontic Ceramic Brackets, K090933) from the same manufacturer.

Here's a summary of the information that is available regarding the device's acceptance criteria and the "study" (bench testing and biocompatibility) proving it meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document details compliance with established standards rather than specific performance metrics against novel acceptance criteria.

The "Rational for Substantial Equivalence" states: "The testing completed in the previously cleared submissions along with the additional testing completed demonstrates that the new TruKlear bracket exhibits comparable mechanical and functional characteristics to the predicate devices in addition to being biocompatible acceptable." This implies that meeting these standards and showing comparability to the predicate device's performance was the acceptance criterion.

2. Sample size used for the test set and the data provenance:
Not applicable for this type of submission. The evaluation was based on bench testing of the device itself and biocompatibility testing, not on clinical data from a "test set" of patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically understood for clinical studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for the device's performance was established via adherence to engineering and biocompatibility standards.

4. Adjudication method for the test set:
Not applicable.

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 is a medical device (orthodontic bracket), not an AI/software device involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device.

7. The type of ground truth used:
For the non-clinical and biocompatibility tests, the "ground truth" was derived from predefined values and methodologies specified in the respective ISO and DIN standards. For example, for material strength, the 'ground truth' is the material's ability to withstand certain forces as per the standard; for biocompatibility, it's the absence of adverse biological reactions as defined by ISO 10993.

8. The sample size for the training set:
Not applicable. There is no concept of a "training set" for physical device bench testing or biocompatibility analysis in the context of this 510(k) submission.

9. How the ground truth for the training set was established:
Not applicable.

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The intended use of the Amico iCE LED series surgical lights are to provide high intensity, shadow free illumination to the patient surgical field during surgical procedures.

The intended use of the Amico Mira LED series minor surgery lights is to provide high intensity, shadow free illumination to the patient surgical field during minor surgery procedures.

Amico iCE series consists of 3 models - iCE-30-6, iCE-25-6, & iCE-25-3. These are major surgical luminaires that provide illumination in a surgical suite allowing doctors to operate on a patient.. The device comes with several built-in fail safe's preventing any single fault from creating a hazardous situation. These lamps are a Class 2 device (under FDA) providing max illumination of 160,000 lx, 160.0001x, and 130.000 Ix respectively. These surgical lights are coupled with ceiling mounted suspension systems supporting horizontally articulating extensions arms and horizontally and vertically articulating spring arms. Both arms can rotate either 340 degree (with stop) or infinitely without a stop. The spring arms vertically articulate 50° downwards and 45° upwards. This allows for ease of movement of the lamp head to any given position. The lamp housing is made of high quality plastic wrapped around an aluminum structure. The front clear glass is made of high quality polycarbonate material. The yoke connecting the lamp head to the spring arms is made of steel. The lamps also have a built-in mechanical focusing system that is controlled using the center Aluminum and/or plastic handle. Rotating this handle allows the user to expand and contract the lighted field as per the user's requirement. The lamps can also be sold with an optional in-light camera that doubles as a focusing handle. This provides the user with the option to record/display small areas of a surgical site on a large display allowing for greater detail and accuracy during surgeries. A separate remote control is used to control the various functions of the camera.

Amico Mira LED series consists of 3 models - Mira LED 90, Mira LED 65 & Mira LED 50. These are minor surgical luminaires that provide illumination in a surgical suite allowing doctors to perform minor surgical procedures on a patient. These lamps are a Class 2 device (under FDA) providing max illumination of 90.000 1x. 65.000 Ix, and 50.000 Ix respectively. These surgical lights are coupled with ceiling mounted suspension systems supporting horizontally articulating extensions arms and horizontally and vertically articulating spring arms. Both arms can rotate either 340 degree (with stop) or infinitely without a stop. The spring arms vertically articulate 50° downwards and 45° upwards. This allows for ease of movement of the lamp head to any given position. The lamp housing is made of high quality plastic which connects to the front clear glass is made of high quality polycarbonate material. The yoke connecting the lamp head to the spring arms is made of steel. The lamps also have a built-in electronic focusing system that is controlled using the center Aluminum/plastic handle. Rotating this handle allows the user to expand and contract the lighted field as per the user's requirement.

This K131893 submission is for surgical lights (Amico iCE LED Series and Amico Mira LED Series Minor Surgical Lights). The study provided is non-clinical performance testing. Therefore, many of the typical categories for AI/algorithm-based medical devices are not applicable.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance (Non-Clinical)

The acceptance criteria for these surgical lights are based on meeting established electrical safety and performance standards for medical electrical equipment and surgical luminaires. The reported device performance indicates that the devices passed these tests.

Study Details for Device Acceptance

It's important to note that this submission describes non-clinical performance testing for surgical lights, not a clinical study involving patients or an algorithm-based device. Therefore, many of the typical questions for AI/ML device studies are not applicable.

1. Sample size used for the test set and the data provenance: Not applicable. This was testing of the physical device's electrical safety and performance, not a test on a dataset.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for electrical and performance standards is established by the specifications in the international standards, not by expert consensus in the context of an algorithm. The testing would be conducted by qualified engineers/technicians in an accredited lab.
3. Adjudication method for the test set: Not applicable. The testing involves objective measurements against predefined thresholds within the standards.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this was not an MRMC study. This device is a surgical lamp, not an AI or imaging device that would typically undergo such a study.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
6. The type of ground truth used: The "ground truth" for this type of device and testing is defined by the requirements and thresholds set forth in the international electrical safety and performance standards (IEC 60601-1, IEC 60601-2-41, IEC 60601-1-2).
7. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

Conclusion from Non-Clinical Testing:

The electrical safety testing concludes that the Amico Clinical Solutions Corp. iCE LED Series and Amico Lights Corp. - Mira LED Series Minor Surgical Lights have been proven to be safe and effective and pose no foreseen hazards, having passed all specified IEC standards tests.

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