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The TUTU ™ LED intraoral curing light is designed to polymerize visible light cure (VLC) dental materials including dental pit and fissure sealants, bonding adhesives, cements, restorative or luting materials

The TuTu7 is a LED curing light that is small and easy to use, vet powerful and swift in curing. It has a compact, lightweight hand piece, with a curved and contoured tip, to allow the light to be positioned and applied anywhere in the oral cavity. The TuTu has 3 different functioning modes, continuous, pulse and ramp. The device peeps every 3 seconds for precise timing of exposure, regardless of mode setting. The rechargeable battery is a Lithium lon, which at full charge can last up to 120 minutes. The TuTu is provided with a battery charger, which also acts as a storage holder for the device. A silicone sheath is provided to refract the light and protect the eyes of the operator.

Here's an analysis of the acceptance criteria and study information for the Invisible Technology TuTu 7 Dental Curing Light, based on the provided 510(k) summary:

This device (TuTu 7 Dental Curing Light) is a physical device, not an AI/Software as a Medical Device (SaMD). Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically applied to AI/SaMD (which involve performance metrics like sensitivity, specificity, F1 score, etc., against a ground truth) are not fully applicable in the same way.

For a physical medical device like a dental curing light, acceptance criteria generally relate to technical specifications, safety, and functional performance benchmarks that demonstrate substantial equivalence to predicate devices. The "study" here would be various tests and measurements conducted to show the device meets these technical specifications and performs its intended function safely and effectively.

Based on the provided text, the "acceptance criteria" are implied by the comparison to the predicate devices and the physical specifications of the TuTu 7. The 510(k) process primarily focuses on demonstrating substantial equivalence to a currently marketed predicate device, rather than proving efficacy through a large-scale clinical study in the way an AI/SaMD would.

Here's an attempt to structure the information as requested, adapting for a physical device:

Acceptance Criteria and Device Performance for Invisible Technology TuTu 7 Dental Curing Light

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

This information is not applicable in the context of an AI/SaMD's "test set" for performance evaluation against a dataset. For a physical device like a curing light, "testing" refers to laboratory bench testing, electrical safety tests, optical power measurements, etc. The 510(k) summary provided does not detail the specific sample sizes for these types of engineering tests, nor does it specify data provenance in terms of country of origin or retrospective/prospective studies. The "data" would be the results of the engineering and performance testing of the device itself.

3. Number of Experts and Qualifications for Ground Truth

This concept is not applicable as described for an AI/SaMD. There is no "ground truth" established by experts in the context of evaluating the predictive accuracy of a dental curing light. The performance is assessed through objective physical measurements and comparisons to established standards for power, wavelength, and functional operation.

4. Adjudication Method

This concept is not applicable for a physical device. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human annotators when establishing a "ground truth" for a dataset, which is not relevant here.

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

This is not applicable for a dental curing light. MRMC studies are designed to assess the impact of a diagnostic aid (like a CAD system) on human reader performance, which doesn't apply to a device that directly performs a therapeutic function (light curing).

6. Standalone (Algorithm Only) Performance Study

This is not applicable as the TuTu 7 is a physical device, not an algorithm or software. It does not have an "algorithm-only" mode separate from human interaction, nor does it generate diagnostic outputs that would be evaluated for standalone performance.

7. Type of Ground Truth Used

The "ground truth" for this type of device is implicitly defined by:

• Engineering specifications and standards: Wavelength range, power output, beam uniformity, heat generation, battery life.
• Performance of predicate devices: The TuTu 7 is compared against known, legally marketed predicate devices (SmartLite PS Pen-Style LED Curing Light and Elipar FreeLight) to demonstrate similar fundamental technology and performance characteristics.
• Material polymerization efficacy: While not explicitly detailed as a "study" in this summary fragment, the ability of the light to cure dental materials effectively to industry standards would be a critical aspect of its performance validation. This would typically involve testing with various depths/materials to ensure adequate cure.

8. Sample Size for Training Set

This is not applicable. The device is not an AI/SaMD that requires a training set.

9. How Ground Truth for Training Set was Established

This is not applicable as there is no training set for a physical device like this.

Summary of the "Study" (Demonstration of Substantial Equivalence):

The information provided indicates that the "study" for the TuTu 7 Dental Curing Light primarily involved demonstrating its substantial equivalence to two predicate devices, the Dentsply International SmartLite PS Pen-Style LED Curing Light (K041372) and the 3M ESPE AG Elipar FreeLight (K011154).

This demonstration relied on:

• Comparative Table of Technological Characteristics: Showing that the TuTu 7 shares the same product code, CFR, and fundamental technology (LED blue light curing) as the predicates.
• Specification Comparison: Comparing key performance parameters like wavelength range, power output (watts mW-cm), battery type, weight, and features (e.g., multiple curing times) to the predicates. The TuTu 7 often met or exceeded the specifications of its predicates (e.g., higher power output, comparable wavelength range).
• Intended Use Alignment: Confirming that the intended use of the TuTu 7 is identical to that of legally marketed predicate devices.
• General Controls Compliance: The device is subject to the general controls provisions of the Act, which include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

The FDA's review and determination of substantial equivalence (as indicated in the letter K062735) signifies that the device meets the necessary criteria for market entry, primarily by demonstrating that it is as safe and effective as a legally marketed predecessor device.

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