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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 ORABLU Oral Lesion Marking System is a three component swab system intended to be used by a dentist as an adjunct to traditional oral examination by incandescent light, combined with further examination with one of three oral examination lights manufactured by AdDent, Inc. The Microlux DL (K041614), Microlux BLU (K072309), and Bio/Screen (K082668). The ORABLU Oral Lesion Marking System is used as an aid to enhance the visualization of oral mucosal irregularities by physically marking areas of oral mucosa that may warrant further investigation.

The ORABLU Oral Lesion Marking System is a three component swab system.

This document is a 510(k) premarket notification decision letter from the FDA for the ORABLU Oral Lesion Marking System. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms substantial equivalence to a predicate device and states that the device can be marketed.

Therefore, I cannot provide the requested information based on the provided text.

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The Bio-Screen is intended to be used by a dentist or health care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities and aid in defining lesion borders

This device uses an array of short wave blue LED's in the technique of biofluorescence to demonstrate abnormal oral tissue It employs a built in optical filter to improve contrast between healthy and abnormal tissue and improve visualization

This 510(k) submission (K082668) for the Bio-Screen device provides very limited information regarding detailed performance studies and acceptance criteria. This summary will extract all available information, but it is important to note that many of the requested data points are not present in the provided text.

Based on the provided text, the Bio-Screen device is compared to predicate devices like Velscope, Microlux/DL, and Microlux/Blu, relying on the principle of biofluorescence for visualizing oral mucosal abnormalities. The submission primarily focuses on establishing substantial equivalence to these existing devices rather than presenting a standalone study with defined acceptance criteria and detailed performance metrics unique to the Bio-Screen.

1. Table of Acceptance Criteria and Reported Device Performance

No explicit table of acceptance criteria or quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for the Bio-Screen device is provided in the document. The submission states that the Bio-Screen uses a built-in optical filter "to improve contrast between healthy and abnormal tissue and improve visualization." This qualitative statement about improved visualization is the closest the document comes to defining a performance characteristic.

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

The provided text does not mention any specific test set, its sample size, or the provenance of any data used for evaluating the Bio-Screen. The submission relies on a comparison to predicate devices, implying that their performance characteristics are adopted or assumed through equivalence.

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

Since no specific test set or study is described, there is no information provided regarding the number of experts used or their qualifications to establish ground truth.

4. Adjudication Method for the Test Set

As no specific test set or study is described, there is no information provided regarding an adjudication method.

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

The provided text does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done for the Bio-Screen device. The submission focuses on substantial equivalence to predicate devices, not on quantifying human reader improvement with or without AI assistance (which is not relevant as this is a medical device, not an AI).

6. Standalone Performance Study

The provided text does not describe a standalone performance study (algorithm only, without human-in-the-loop performance) for the Bio-Screen. The device is intended to be used "by a dentist or health care provider as an adjunct to traditional oral examination," indicating a human-in-the-loop design.

7. Type of Ground Truth Used

Since no specific study is detailed, the type of ground truth used is not mentioned. For devices like this intended to visualize abnormalities, ground truth would typically come from biopsy and pathology results, or expert clinical consensus.

8. Sample Size for the Training Set

The provided text does not mention any training set or its sample size. This is understandable given the nature of the device (an optical examination light) and the focus on substantial equivalence rather than a machine learning algorithm.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned, no information is provided on how its ground truth was established.

Conclusion:

The K082668 submission for the Bio-Screen is a 510(k) premarket notification primarily focused on establishing substantial equivalence to already-marketed predicate devices (Vizilite, Microlux/DL, Microlux/Blu, Velscope). The document does not describe a detailed, standalone clinical study with explicit acceptance criteria, performance metrics, and detailed information about test sets, ground truth establishment, or expert involvement. The core argument for market clearance appears to be that the Bio-Screen shares similar technology and intended use with existing, legally marketed devices.

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The Microlux Transilluminator is a device used upon initial examination of the dental patient to help locate crown fractures, posterior and anterior caries.

The Microlux Transilluminator is a screening device used to help locate caries and crown fractures. It also functions as an auxiliary light source to aid in operative procedures and preventive dentistry.

The Microlux Transilluminator consists of a battery powered, high output L.E.D. light source, (three 'N" size batteries are included) and a fiber-optic glass light guide with either a 3mm or 2mm tip. The fiber-optic glass light guide snaps into the light source. The fiber-optic light guide is autoclaveable. The light source can be wiped with disinfectant. Disposable custom fitted sleeves are also available the cover the entire unit to prevent cross contamination.

The provided text is a 510(k) summary for the Microlux Transilluminator, a device used to aid in visualizing caries and crown fractures. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The 510(k) summary focuses on establishing substantial equivalence to legally marketed predicate devices, primarily highlighting the difference in light source technology (LED vs. halogen/incandescent lamps). It does not describe any performance studies or clinical trials with acceptance criteria, sample sizes, ground truth establishment, or expert evaluations.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them based on the given input.

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Intended Use: The Calset unit is used to warm dental composite materials and whitening bleach to130°F (54°C) or 155°F (68°C). It is also used to warm anesthetic carpules to 98°F (37°C) (body temperature).

The Calset is a warming device used to heat dental materials prior to their use in the mouth. It consists of a base unit that contains a heating element a temperature control circuit with LED indicators, a removable metal tray that is designed to hold different materials and a low voltage wall transformer that provides power to the unit.

Here's an analysis of the provided text regarding the Calset Composite Heater, focusing on the acceptance criteria and study information:

The provided text is a 510(k) summary for a medical device called the "Calset Composite Heater." This document is used to demonstrate substantial equivalence to a predicate device, not to provide detailed study results for performance acceptance criteria in the way one might find for a novel, high-risk device requiring extensive clinical trials.

Therefore, many of the typical questions about AI/ML algorithm studies (like training set size, ground truth for training, MRMC studies, specific performance metrics for algorithms) are not applicable to this type of submission. The focus here is on demonstrating the device functions as intended and is safe, primarily through comparison to an already-approved predicate device and basic performance testing.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the intended use and the comparison to the predicate device. The performance is reported directly in the description.

Study that Proves the Device Meets Acceptance Criteria:

The document describes the device and its intended uses, and implicitly relies on the technical specifications and comparison to the predicate device to prove it meets the criteria. It does not provide a detailed "study" in the sense of a clinical trial or a performance study with a separate test set, ground truth, or statistical analysis. This is typical for Class I or Class II devices undergoing 510(k) clearance, where substantial equivalence is the primary focus.

The "study" here is more of an engineering verification that the device achieves the stated temperatures.

Additional Requested Information:

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

   • N/A. The document does not describe a "test set" in the context of clinical data or image data. The performance claims are based on the device's engineering specifications. There is no indication of clinical data provenance.

2. 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):

   • N/A. Ground truth for a diagnostic or AI algorithm is not relevant here. The ground truth for device performance would be a calibrated thermometer measuring the actual temperature achieved by the heater.

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

   • N/A. Not applicable, as there is no test set in the context of diagnostic or AI-driven performance.

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:

   • N/A. This device is a composite heater, not an AI-assisted diagnostic tool. Therefore, MRMC studies are not applicable.

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

   • N/A. This is a hardware device; there is no embedded algorithm in the sense of AI/ML that would have standalone performance. Its "performance" is its ability to heat to specified temperatures, which is a physical characteristic.

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

   • For the temperature claims, the ground truth would be physical measurement with calibrated instruments (e.g., thermometers). This is not explicitly stated but is implicitly assumed for any device that makes temperature claims.

7. The sample size for the training set:

   • N/A. There is no training set mentioned or implied, as this is not an AI/ML device.

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

   • N/A. No training set exists.

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This device is used as an aid to improve the visualization of oral lesions. It is designed to be used by a dentist or health care provider, in combination with a traditional examination by incandescent light.

The Microlux/DL is used to enhance dental examination of lesions of the oral mucosa. The device consists of a battery powered light source that uses a blue-white LED, a rigid diffused fiber optic light guide. It is used in conjunction with a non-toxic dilute (1%) acetic acid rinse for the viewing of oral lesions. The fiber optic illuminator itself is non-tissue contacting, and is classified as a 510(k) Exempt FDA Device.

This submission for the Microlux/DL device (K041614) does not include a study with acceptance criteria and device performance results. The document is a 510(k) summary for a premarket notification for a dental device, establishing substantial equivalence to a predicate device rather than presenting a detailed performance study against specific acceptance criteria.

The submission primarily focuses on comparing the Microlux/DL to its predicate device, the Speculite/OraLite (also sold as Visilite), based on its description and intended use.

Here's a breakdown of why the requested information cannot be provided from the given text:

• No specific acceptance criteria or tabulated performance data are present. The document states that "The Microlux DL compares favorably and is substantially equivalent to another legally marketed device." This is a general statement of equivalence, not a report of performance against predefined metrics.
• No study details are provided. The submission does not describe a clinical or performance study that would involve sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established for training or testing sets. The general statement of equivalence implies that the device is expected to perform similarly to the predicate, but no empirical data is presented to demonstrate this.

In summary, the provided text is a 510(k) premarket notification for substantial equivalence, which does not typically include the detailed performance study data requested. The FDA's letter concurs with the substantial equivalence claim, allowing the device to be marketed based on its similarity to existing cleared devices, rather than requiring a detailed performance study with specified acceptance criteria in this specific submission.

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