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For light activated polymerization of dental materials such as composites, luting cements, adhesives, and sealants using visible and near-UV light.

The Ascent 3D is a polymerization light source device for delivering light energy to polymerizable dental materials applied to human teeth in conjunction with a variety of procedures and treatments. This energy is generated by solid-state light-emitting diodes (LEDs), which provide a consistent and reliable generation of light energy at 390-520nm with an average optical output of 1600 milliwatts. The LEDs are positioned at the terminal end of the device, allowing for direct illumination of the treatment site without the use of light pipes or other optically conductive appendages. The device features three LEDs that are spatially positioned to illuminate three surfaces or planes of the tooth simultaneously. The device controls allow the operator to select which combination of LEDs are active and the emission time. Emission is initiated by pressing a button, and can be interrupted by pressing the same button or by allowing the selected emission time to expire. The device is constructed of a biocompatible plastic such as ABS, and coated aluminum. The device is powered from an internal rechargeable battery that is charged from an external power supply when not in use.

The provided text describes a 510(k) premarket notification for a dental device, the Ascent 3D. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the specifics of a study proving the device meets those criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (Palmlight 10) through a comparison of technical characteristics and compliance with general safety and performance standards. It mentions "bench testing on an evaluation sample" and lists various internal test reports and compliance with IEC standards, but these are general statements of testing performed, not a detailed study fulfilling the criteria you've outlined (like specific metrics, sample sizes, expert involvement, and ground truth establishment).

Based on the provided text, here's what can be extracted and what information is missing:

Information Present:

• Device Name: Ascent 3D
• Intended Use: For light activated polymerization of dental materials such as composites, luting cements, adhesives, and sealants using visible and near-UV light.
• Predicate Device: Palmlight 10 (K061341)
• General Performance Characteristics (Comparison to Predicate): Wavelength, Optical Output Intensity, Optical Output Fluence, Cooling System, Emission Patterns, Light Source, Cycle Times, Battery Specifications, Input Power Requirements, Power Supply Specifications, Enclosure Materials of Construction, Dimensions, Weight.
• Conformity to Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-57, IEC 62304.
• Mentioned Bench Tests: "Ascent 3D Depth of Cure Analysis" (according to ISO 4049:2009), "QAC-I03481 Final process inspection of Ascent 3D Probe," "QAC-103482 Final process inspection of Ascent 3D Handpiece," "Ascent 3D Sensor Verification Test," "Ascent 3D Main and Safety Specification Verification Test."

Information NOT Present (and therefore cannot be provided from this text):

• A specific table of acceptance criteria and reported device performance beyond the general technical specifications. The document implies compliance with standards and equivalence to the predicate, but not explicit acceptance thresholds for a study as you describe.
• Sample sizes used for the test set (other than "an evaluation sample").
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth for any test set.
• Qualifications of experts.
• Adjudication method for any test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human readers. This is a device for curing dental materials, not an AI diagnostic tool, so such a study would be highly unlikely and irrelevant to this submission.
• If a standalone (algorithm only) performance study was done. This is not an AI algorithm.
• The type of ground truth used (e.g., pathology, outcomes data). The "Depth of Cure Analysis" would imply a physical measurement of cured material, which could be considered a form of ground truth for that specific performance aspect.
• The sample size for the training set. This is not an AI/ML device that requires a training set.
• How the ground truth for the training set was established. (Not applicable as it's not an AI/ML device).

Given the nature of the device (an ultraviolet activator for polymerization, a dental curing light) and the context of a 510(k) submission, the "study" proving it meets acceptance criteria would primarily involve bench testing to demonstrate performance specifications (e.g., light intensity, wavelength, energy delivery, depth of cure) and compliance with established electrical and safety standards (IEC). These submissions typically do not involve clinical trials with human subjects in the way an AI diagnostic device would, nor do they involve experts establishing ground truth for diagnostic accuracy, as the device's function is purely physical/chemical.

The "acceptance criteria" for a device like this are generally:

1. Meeting its stated performance specifications (e.g., optical output intensity, wavelength range).
2. Being safe for its intended use (electrical safety, EMC, biocompatibility of materials).
3. Demonstrating substantial equivalence to a legally marketed predicate device in terms of indications for use, technological characteristics, and safety/effectiveness.

The document states, "Bench testing on an evaluation sample of the submitted was performed consistent with internal requirements," and lists specific internal test procedures as well as the ISO 4049:2009 standard for Depth of Cure Analysis. This implies that the 'study' performed was a series of in-house verification and validation tests against established performance metrics and safety standards, rather than a clinical trial or AI model validation study.

Summary Table of Available Information (from the document):

In summary, the provided document does not contain the detailed study information as typically requested for AI/ML or diagnostic devices. Instead, it demonstrates performance through compliance with engineering standards and direct comparison of technical specifications to a predicate device, which is typical for electromechanical medical devices like a dental curing light.

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