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The Compex HD is intended to be used by a dentist or health care provider to warm and dispense dental composite materials contained in a compule or PLT (Pre Loaded Tip) to 155 degrees F (68 degrees C).

The Compex HD uses a heating device to elevate the temperature of dental composite material contained in a compule (PLT) to allow it to flow and be easily extruded. It utilizes a plastic housing in the shape of a traditional dispensing qun. The housing contains a heater element(s) and/or an electrically conductive plastic compule that itself acts as a heater when a current is applied. A control circuit board assembly and rechargeable lithium lon battery are used to apply power to the heater. A separate wall plug-in USB power supply is used to charge the battery. The unit will not function with the USB power supply connected to the unit.

The provided text describes the Compex HD device, a composite warmer for dental materials, and compares it to a predicate device, the Calset. It focuses on non-clinical performance data to demonstrate substantial equivalence, rather than a detailed AI algorithm performance study. Therefore, some of the requested information, particularly related to AI-specific metrics like human reader improvement with AI assistance, MRMC studies, or training set details, is not applicable to this device.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document refers to a "test set" in the context of comparing the Compex HD and Calset devices.

• Sample Size: The number of compules/PLTs tested is not explicitly stated. It mentions "testing was performed on both devices using thermocouples inserted into composite filled compules."
• Data Provenance: The tests were conducted internally by the manufacturer, AdDent, Inc. The data is retrospective, as it's part of the 510(k) submission. No country of origin for the data is specified beyond the company's location in Danbury, Connecticut, USA.

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

• Not Applicable. This device is a warming and dispensing tool, not an AI diagnostic or decision support system that requires expert interpretation for ground truth. The performance evaluation relies on physical measurements (temperature, flow, safety standards compliance) rather than expert consensus on diagnostic accuracy.

4. Adjudication Method for the Test Set

• Not Applicable. As the performance evaluation involves objective physical measurements and adherence to engineering standards, there is no need for an adjudication method typically used for subjective diagnostic interpretations.

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 device is not an AI-powered system, and no MRMC study or assessment of human reader improvement with AI assistance was conducted or is relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This device does not involve an algorithm for standalone performance evaluation in the context of AI. Its performance is evaluated mechanically and thermally.

7. The Type of Ground Truth Used

• The "ground truth" for the performance evaluation primarily consists of:
  • Direct Physical Measurements: Thermocouple readings to verify the composite temperature reached 155°F (68°C).
  • Engineering Standards Compliance: Successful adherence to international safety and EMC standards (ANSI/AAMI/IEC 60601-1 and ANSI/AAMI/IEC 60601-1-2).
  • Qualitative Assessment: Observation of improved flow of heated composite and ease of dispensing.

8. The Sample Size for the Training Set

• Not Applicable. This device is not an AI/machine learning device, so there is no "training set" in the conventional sense.

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

• Not Applicable. As there is no training set for an AI algorithm, no ground truth was established for it.

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The Tanda Pearl is an over-the-counter device intended for teeth bleaching. The Tanda Pearl uses low electrical current to accelerate the action of the bleaching agent to improve the whitened appearance of teeth.

The Tanda Pearl device consists of a double biting mouth tray made of silicone for fitting both the upper and bottom teeth simultaneously. A bleaching agent is applied to each side of the mouth tray. The device is battery operated and turned on using a button located on the handle. Once initialized, the device delivers low amounts of electrical current (4 to 15 mA) into the bleaching medium to accelerate the teeth whitening effect caused by the bleaching medium. Once the treatment cycle has been completed, the device is automatically shut off.

Here's an analysis of the provided text regarding the Tanda Pearl device's acceptance criteria and studies:

Summary of Acceptance Criteria and Device Performance for Tanda Pearl

The provided 510(k) summary for the Tanda Pearl device does not explicitly list quantitative acceptance criteria in a dedicated section with pass/fail thresholds. Instead, it describes performance testing conducted to support substantial equivalence and confirm that the Tanda Pearl performs as intended.

Based on the information, the implicit acceptance criteria are that the device:

• Meets relevant safety and performance standards (electrical, EMC, software, integrity, biocompatibility, risk management).
• Demonstrates clinical efficacy in teeth whitening.
• Demonstrates clinical safety with no significant concerns or severe adverse events.

Here's a table summarizing the reported device performance in relation to these implicit criteria:

Detailed Information about the Studies:

1. A table of acceptance criteria and the reported device performance: (Provided above)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size (Test Set): The document states "the results of a single site IRB clinical study". While it confirms a clinical study was performed, the exact sample size for this clinical study is not provided in the given text.
   • Data Provenance:
     • Country of Origin: Not explicitly stated, but the original technology developer is "Fluorinex Active Ltd.", which could be an indicator but is not definitive for the study location.
     • Retrospective or Prospective: "single site IRB clinical study" indicates it was a prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Number of Experts: Not mentioned.
   • Qualifications of Experts: Not mentioned.
   • The "Vita Shade scores and the Vita Shade Delta-E scores" typically rely on standardized shade guides and visual assessment, which implies trained assessors, but their number and qualifications are not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Adjudication Method: Not mentioned. It's unclear how discrepancies in Vita Shade scoring, if any, were handled.

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:

   • MRMC Study: No, there is no indication of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This device is not an AI/imaging diagnostic device that would typically involve human readers interpreting images. The study rather compares the device to a control for tooth whitening efficacy.
   • Effect Size of AI Assistance: Not applicable, as no AI assistance is mentioned or evaluated in the context of human readers.

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

   • Standalone Study: The clinical study evaluated the device (Tanda Pearl) against a control, demonstrating its efficacy and safety. This can be considered a "standalone" evaluation of the device's performance, but not in the context of an "algorithm only" as typically applied to AI/software as a medical device. The device is a physical product directly used by humans.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Type of Ground Truth: The efficacy ground truth was established by objective measurements of tooth whitening using "Vita Shade scores and the Vita Shade Delta-E scores." These are widely accepted clinical metrics for tooth shade changes. Safety involved tracking "reported events" and their severity to resolution. This aligns with clinical outcomes data based on standardized clinical assessments.

8. The sample size for the training set:

   • Sample Size (Training Set): Not applicable. This device is not an AI/machine learning device that typically involves a distinct "training set" in the context of model development. The provided clinical study is a performance study to demonstrate the device's function, not to train an algorithm.

9. How the ground truth for the training set was established:

   • Ground Truth (Training Set): Not applicable, as there is no training set for an AI algorithm.

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The Absolute White Light emits visible blue light in the 400 nanometer spectrum and is intended to provide a light source for bleaching teeth.

The Absolute White Light is intended for use by the end consumer. The Absolute White Light is a battery operated, hand held device that contains a hun vosible light in the 400 nanometer spectrum, which can penetrate the tooth and activate the photoactive substances within the tooth yielding a minimal amount of heat. Built in safety features include automatic light shut off after two minutes and "Light Guard" that prevents light exposure to the user's eyes.

The provided document describes the Absolute White Light, a device intended to provide a light source for bleaching teeth. However, it does not include a study that proves the device meets specific acceptance criteria in terms of efficacy or performance on human subjects for tooth whitening. Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and safety standards.

Here's a breakdown based on your request, highlighting what is present and what is absent:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of clinical performance (e.g., a specific percentage improvement in tooth shade) for the Absolute White Light. Instead, it relies on demonstrating that the device is "substantially equivalent" to a legally marketed predicate device (Dentovations Luster Whitening System) in terms of its intended use and technical characteristics.

The "performance data" section primarily refers to compliance with quality system regulations and safety standards, not clinical efficacy data.

Table of Comparison with Predicate Device (acting as the basis for "performance" as substantial equivalence):

Additional "Performance Data" (Compliance, not clinical efficacy):
The device is manufactured in compliance with:

• Quality System Regulations (21 CFR 820)
• DIN EN ISO13485:2003
• DIN EN ISO 9001:2000
• EN 61000-6-1 Electromagnetic compatibility (EMC) Part 6-1: Immunity standard for residential, commercial and light-industrial environments
• EN61000-6-3 Electromagnetic compatibility (EMC) Part 6-3: Emission standard for residential, commercial and light-industrial environments

Study Details (or lack thereof)

Based on the provided text, there is no specific clinical study or performance study presented that directly proves the device's efficacy in terms of tooth whitening (e.g., changes in shade). The submission relies on demonstrating substantial equivalence to a predicate device, implying that since the predicate device is already cleared for use, a device with similar characteristics and intended use is also safe and effective.

Therefore, the following points cannot be addressed with the provided text, as no such study is described:

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, no clinical test set described for efficacy.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical test set described for efficacy.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, no clinical test set described for efficacy.
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 is not an AI/imaging diagnostic device. No MRMC study was conducted.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is not an AI/imaging diagnostic device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, no clinical ground truth for efficacy was established or reported. The "ground truth" for regulatory clearance was the substantial equivalence to the predicate device based on technical specifications and safety standards.
7. The sample size for the training set: Not applicable, no machine learning model or training set is described.
8. How the ground truth for the training set was established: Not applicable, no machine learning model or training set is described.

Conclusion from the document:

The regulatory approval (K110888) was granted based on the determination of "substantial equivalence" of the Absolute White Light to the predicate device (Dentify Luster Whitening System, K042153). This means the FDA concluded that the new device has the same intended use and similar technological characteristics to a device already on the market and does not raise different questions of safety and effectiveness. The "performance data" provided focuses on manufacturing quality systems and adherence to electromagnetic compatibility (EMC) standards, not on clinical performance demonstrating tooth whitening efficacy in human subjects.

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BriteWhite Teeth Whitening System is intended to emit light in the 400 nanometer spectrum to provide a light source for the bleaching of teeth.

The BriteWhite Teeth Whitening System device that utilizes Light Emitting Diodes to provide a tooth whitening system, the whitening light source is a mouth piece which is placed inside the mouth, using barrier sleeves, which emits a biologically safe and effective level of blue visible light. The general wavelength for the mouth piece is 400 nanometer spectrums to provide a selected wavelength which activates the whitening gel to bleach the teeth without the aide of heat. To ensure user safety when operating the light, the system has a built in feature to eliminate any risk for the end user and professional. The light automatically shuts off after a specified period of time. Secondly, the light source in placed inside the mouth, so there is no need for safety glasses for the patient and professional. No contact with the eyes is in this area of treatment and prevents penetrations of blue wavelength and protects the vision of the patient and professional.

The provided text is related to a 510(k) submission for the BriteWhite Teeth Whitening System. This document focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study with specific acceptance criteria and performance data in the format of a clinical trial or performance study.

Therefore, many of the requested elements regarding acceptance criteria, study design, sample size, expert ground truth, and comparative effectiveness are not available in this type of regulatory document.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific, quantifiable acceptance criteria (e.g., a certain percentage improvement in tooth shade) or comparative performance data (e.g., measured whitening effectiveness). The clearance is based on substantial equivalence to predicate devices.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. The document does not describe a test set used for performance validation in a clinical study format. The clearance is based on comparison to predicate devices' established safety and effectiveness.
• Data Provenance: Not applicable. No specific performance data from a new study is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. There is no mention of a test set with expert-established ground truth.

4. Adjudication method for the test set:

• Not applicable. No test set requiring expert adjudication is described.

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 device is a tooth whitening system, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical medical device (light source), not a software algorithm.

7. The type of ground truth used:

• Not applicable in the context of a performance study. The "ground truth" for regulatory clearance is the established performance and safety of the predicate devices. The claim of "substantial equivalence" implies that the new device meets the same standards as the legally marketed predicates.

8. The sample size for the training set:

• Not applicable. This device does not involve machine learning or a training set.

9. How the ground truth for the training set was established:

• Not applicable. This device does not involve machine learning or a training set.

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The QuickSmile light is intended to emit light in the 600-700 nanometer spectrum to provide a heat source for bleaching teeth.

The QuickSmile light is intended for use by a dental professional as a tooth whitening system. The whitening light heat source is a stand alone unit which emits a biologically safe and effective level of red visible light, which can penetrate the tooth and activate the photoactive substances within the tooth yielding a minimal amount of heat. The general wavelength is 600-700 nanometers. The LED light emits approximately 1º-3º C heat against the tooth surface. To ensure user safety when operating the light, the light has built in features to eliminate any risk for the end user and dental professional. First, the light automatically shuts off after a specified period of time designated by the dental professional. Secondly, the light is supplied with specially designed safety glasses for the patient and dental professional that stop the penetration of the red/orange wavelength and protect the vision of the patient and dental professional.

The provided text does NOT currently contain information about acceptance criteria, device performance, sample sizes used, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for the QuickSmile Whitening Light.

The document is a 510(k) Pre-Market Notification for the QuickSmile Whitening Light, which focuses on demonstrating substantial equivalence to a predicate device, the South Beach Smile Light Whitening System. It describes the device, its intended use, and technological characteristics. The FDA's response letter in the document primarily confirms the substantial equivalence determination for the light source component but explicitly states that the determination does not apply to the whitening component(s) of the device (specifically mentioning malachite green oxalate) because the regulatory status of such tooth whitening preparations was unresolved at the time.

To answer your request, the provided input would need to contain a study report or clinical trial data presenting performance metrics against specific acceptance criteria. This document does not include such a study.

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The SonX 35 Ultrasonic Bleaching System is used to accelerate the action of a tooth bleaching medium by introducing energy into said medium in the form of ultrasonic vibrational impulses at a frequency cycled between 25000 and 30000 hertz, improving the appearance of teeth.

The SonX 35 Ultrasonic Bleaching System is a device used in the application of dentifrice compositions for the purpose of whitening teeth. This device aids in the performance of these compositions by providing energy in the form of ultrasonic wave energy. Transducers that are fully encased in the portion of the tray external to the patient generate the ultrasonic energy at a frequency that is sinusoidally cycled between 25,000 and 30,000 hertz. Electrical pulses of a voltage not exceeding 7VDC and 300mA current are supplied to the transducers by means of a separate power source unit, which delivers the energy by means of insulated conductors attached to an appendage of the tray device. All electrical connections are external of the patient, and the transducer electrical supply is electrically isolated from the main power supply.

The provided text is a 510(k) summary for the SonX 35 Ultrasonic Bleaching System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The document states: "Performance Standards: The SonX 35 Ultrasonic Bleaching System complies with the performance requirements of 21 CFR 1050, and the electrical safety requirements of IEC 60601-1 and IEC 60601-2-5." It also mentions "Clinical Performance Data See Part 7: Performance Data" but Part 7 is not included in the provided text.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and the study that proves the device meets those criteria from the given text.

The available information only states that the device is compliant with certain general performance and electrical safety standards, and refers to a "Part 7: Performance Data" which is not provided. No clinical study details (sample size, ground truth, expert qualifications, etc.) are present in the extract.

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The Dentovations South Beach Smile Light Whitening System is intended for use as a light source for bleaching teeth.

The South Beach Smile Light Whitening System is intended for use by the consumer and sold either over the counter or by a dental professional as a yooth whitening system. The System consists of a handheld, battery operated light theat source) device, a whitening gel and preconditioning mouth wash. The Whitening Light heat source is a hand held device that contains a biologically safe and effective level of blue visible light, which can penetrate the tooth and activate the photoactive substances within the tooth yielding a minimal amount of heat. The general wavelength is 350 -700 nm. The xenon light emits approximately 1 - 3 ° C heat agginst the tooth surface. To insure user safety when operating the light, the light has built in features that will eliminate any risk for the end user (1) light automatically shuts off after two minutes of use and (2) the light head acts a light automatouny shuts on and light from accidentally being exposed to the users eyes.

The provided text is a 510(k) Premarket Notification Summary for the "South Beach Smile Light Whitening System." It focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance data from a specific study with acceptance criteria.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted because such a study is not presented in the provided document. The document describes the device, its intended use, and compares its technical characteristics to predicate devices. It states that the device has been tested and proven to be safe for the consumer to use, but it does not detail the specific tests, acceptance criteria, or their results in a quantitative manner as requested.

Here's an attempt to answer based on the available information, with many points noted as "Not provided in the text":

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

Not provided in the text. The document states "The Whitening Light has been tested and proven to be safe for the consumer to use," but no details on the sample size or provenance of this testing are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The document describes device characteristics and safety features, not a diagnostic or classification task requiring expert ground truth for a test set.

4. Adjudication method for the test set

Not applicable, as no test set requiring ground truth adjudication is described.

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 device is a light source for tooth whitening, not an AI-powered diagnostic tool.

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

This concept is not relevant to the described device, which is a physical light system. The closest equivalent is the device's inherent performance characteristics as described in point 1.

7. The type of ground truth used

Not applicable. The "ground truth" for the device's performance relates to its physical output (e.g., light wavelength, heat generation) and safety features, which would be measured against engineering specifications or known safety standards, not an expert-derived ground truth or pathology.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that would involve a training set.

9. How the ground truth for the training set was established

Not applicable. This is not a machine learning or AI device that would involve a training set.

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The Light Tip is intended to concentrate the energy and guide the beam to the bottom of the preparation when curing composite materials. The deep composite will therefore be cured first which strengthens the filling, creates contact points and reduces the contraction gap.

Not Found

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental device called "Light Tip." It discusses regulatory aspects, such as substantial equivalence to a predicate device, and general controls, but it does not include any performance study data, acceptance criteria, sample sizes, expert qualifications, or ground truth information. It only provides the indications for use of the device.

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