Search Results

Source of illumination for curing photo-activated dental restorative materials and adhesives.

The Le'pen is a battery-powered cordless unit designed for curing VLC materials whose initiator systems are sensitive to light in the 385-480 nm wavelength range of the visible spectrum. The unit is based on violet and blue LED (light emitting diode) technology for light generation in the desired wavelength and Li-Ion rechargeable batteries.

The Le'pen includes:

• A cordless rechargeable handpiece with a focusing light emitted from a multi LED package tip and controlled by built-in control electronics
• A base unit that plugs into main power as the handpiece stand and charger
• A cap at probe tip to block light scattering
• Disposable disinfectant barrier sleeves on the tip probe
• User manual

The provided text is a 510(k) summary for the Le'pen dental curing light. It describes the device, its intended use, and arguments for its substantial equivalence to a predicate device (Ultradent Valo Cordless K110582).

However, the document does not contain the kind of detailed information about acceptance criteria, a study proving device performance against those criteria, or clinical study specifics (such as sample size for test sets, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance) that would be expected for a medical device cleared based on AI/ML or complex diagnostic capabilities.

The Le'pen is a dental curing light, a physical device used to cure photo-activated dental materials. Its clearance relies on benchtop testing demonstrating equivalent performance specifications (like radiometric power, wavelength range, depth of cure, thermal generation) and safety (electrical safety, EMC, software validation) compared to a predicate device, rather than on a study with human readers or AI-driven performance metrics.

Therefore, many of the requested items (e.g., related to AI/ML performance, ground truth establishment for test/training sets, expert adjudication, MRMC studies, effect size of human reader improvement) are not applicable to the information provided in this 510(k) summary.

Here's how to interpret the available information relative to your request:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a tabular format as you might see for an AI-based diagnostic. Instead, it describes various non-clinical tests conducted and confirms that the Le'pen's performance is either "similar to or greater" than the predicate device or meets relevant standards.

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

• Sample Size: Not explicitly stated as "sample size" in the context of a clinical study or data set. The document refers to "testing" on the device itself, materials, or simulated scenarios. For example, "several dental composite resins and shades" were used for Depth of Cure testing, but the exact number isn't quantified.
• Data Provenance: The tests are benchtop, non-clinical tests performed on the physical device and related materials. No specific country of origin for test data is mentioned; it's likely from the manufacturer's testing facilities or contract labs. The tests are prospective in nature as they evaluate the specific Le'pen device.

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

This is not applicable. The ground truth for this device's performance is established by objective physical measurements and compliance with engineering standards (e.g., ISO 4049:2009 for depth of cure, IEC 60601-1 for electrical safety), not by expert consensus on medical images or diagnoses.

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

This is not applicable. No human adjudication or consensus process is mentioned for these non-clinical, objective benchtop tests.

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:

This is not applicable. No MRMC study was done as this is a dental curing light, not an AI-assisted diagnostic tool requiring human reader studies.

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

This is not applicable. There is no algorithm performance being evaluated in this context.

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

The "ground truth" for this device's performance is based on objective physical measurements (e.g., light output readings, temperature measurements, material cure depth, electrical parameters) and adherence to specified industry standards (e.g., ISO 4049:2009, IEC 60601-1).

8. The sample size for the training set:

This is not applicable. There is no "training set" in the context of an AI/ML model for this device. The device's design is based on established engineering principles for dental curing lights.

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

This is not applicable. As there is no training set for an AI/ML model, there is no ground truth established for one. The device's functionality is proven through direct physical testing against established performance metrics and industry standards. The "existing literature on LED-based dental curing lights" also contributes to the understanding of safety and efficacy.

Ask a specific question about this device

The Pelton & Crane P50 series Dental Operative Units and Accessories are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. The Pelton & Crane P50 series Dental Operative Units and Accessories are designed for use by a trained professional in the field of dentistry.

The P50 series Dental Operative Unit and Accessories serves as a base that includes components to deliver air, water, electrical power, and vacuum to dental handpieces, instruments, and accessories. The controls are contained in a Doctor's Unit, an Assistant's Unit, and a Cuspidor. Additional parts include mount arms, patient dental chair, foot control, and a junction box that houses a power supply and air/water regulators. The unit may also include a dental operating light and a monitor. Various handpieces, instruments, and accessories can be added to the P50 series Dental Operative Unit which Pelton & Crane does not manufacture but does provide a means to connect them to the P50 series Dental Operative Units. These include, but not limited to, pneumatic handpieces, electric motors with handpieces, scalers, intra-oral cameras, curing lights, air/water syringes, SE and HVE vacuum instruments. Water quality is maintained automatically by the preprogramed cleaning functions for the water lines, cuspidor spouts, and instrument hoses including motors and syringes. Instructions are provided for waterline treatment and suction cleaning agents. Water supply is available by either the municipal water supply or a self-contained water bottle.

The retrieved document is a 510(k) Pre-Market Notification for the Pelton & Crane P50 series Dental Operative Unit and Accessories. This notification focuses on demonstrating substantial equivalence to a predicate device rather than providing a study proving performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable or available in this type of submission.

However, I can extract the relevant information that is present:

1. A table of acceptance criteria and the reported device performance

The document does not present specific acceptance criteria in the form of a table with numerical thresholds for performance metrics. Instead, it provides a comparison table (Table 5.3) outlining technological characteristics between the proposed device (P50 series Dental Operative Unit and Accessories) and the predicate device (ESTETICA Dental Treatment Unit and Accessories, K161488). The document states that "The performance testing results provided in this submission supports that the proposed device performs as well as the predicate devices for its intended use" and that "Hence, the device is deemed to be substantially equivalent to the ESTETICA Dental Treatment Unit and Accessories (K161488)."

Here is a summary of the comparative characteristics, serving as the basis for "performance" as described in this 510(k) submission:

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

This information is not provided in the document. The submission relies on "Non-Clinical Test Data" to demonstrate substantial equivalence, which primarily involves performance bench testing against international standards and comparative performance testing of integrated accessories versus cleared stand-alone devices. There is no mention of a traditional "test set" in the context of clinical data for performance evaluation.

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)

This is not applicable as there was no clinical test set requiring ground truth establishment by experts for a specific performance metric.

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

This is not applicable as there was no clinical test set requiring adjudication.

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

This is not applicable. The device is a "Dental Operative Unit and Accessories" and is a physical medical device, not an AI-powered diagnostic or assistive tool for human readers. Its primary function is to provide power, air, water, and vacuum for other dental instruments.

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

This is not applicable. The device is a physical dental unit, not an algorithm.

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

For the non-clinical performance testing, the "ground truth" was adherence to established international standards (e.g., AAMI ES60601-1, IEC 60601-1-2, ISO 10993-1, etc.) and comparative performance to cleared stand-alone predicate devices for integrated accessories. Specific outcomes data or expert consensus on clinical findings are not mentioned as "ground truth" in this context.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device requiring a training set.

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

This is not applicable as this is not an AI/ML device requiring a training set.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "Non-Clinical Test Data" and primarily involves:

• Performance bench testing: Conducted according to international standards for dental operative units to determine conformance in regards to basic safety and essential performance. Relevant standards cited include:
  • AAMI ES60601-1:2005 +AC1; A2
  • IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)
  • IEC 60601-1-2 Edition 3: 2007-03 (EMC)
  • IEC 80601-2-60 Edition 1.0 2012-02 (Dental equipment specific)
  • ISO 9168 Third edition 2009-07-15 (Hose connectors)
  • ISO 14457 First edition 2012-09-15 (Handpieces and motors)
  • ISO 7494-2 Second edition 2015-04-01 (Air, water, suction)
  • ISO 7494-1 Second edition 2011-08-15 (General requirements)
• Biocompatibility testing: Completed for applicable components, referencing ISO 10993-1 and ISO 7405. Reference devices (Spirit - K143696 and ELECTROmatic - K163317) were used due to identical patient contacting parts.
• Software documentation: For moderate level of concern per FDA Guidance Document for Software Contained in Medical Devices, referencing IEC 62304.
• Comparative performance testing: The functions of the integrated accessories were compared to "cleared stand-a-lone device[s]."
• Risk Management: Compliance with ISO 14971:2007, with the Risk Management File reviewed by Intertek for 60601-1 certification.

The document explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product."

Ask a specific question about this device

Source of illumination for curing photo-activated dental restorative materials and adhesives.

The Valiant Curing Light is a visible light activator for polymerization of dental materials and adhesives, such as dental resins and composites. The Valiant Curing Light is composed of a cordless handpiece, a charging base, disposable barrier sleeves, a light attenuating shield, and an instruction for use. The cordless handpiece is made of medical grade aluminum, electronic elements, glass lenses, and medical grade plastic elements. A plastic rotation switch provides an interface to switch between various modes of the cordless handpiece. Once a mode is selected, an ON/OFF button activates and executes the selected mode. The unit is battery operated and contains a removable and rechargeable Li ion battery. The charging base allows for placement and inductive charging of the handpiece when not in use. The light attenuating shield absorbs emitted light from the cordless handpiece to minimize ocular radiation to the patient and user. The Valiant Curing Light is provided non-sterile. Disposable barrier sleeves (510(k) number K132953, TIDI Shield, Model 21102, by TIDI Products) assist in mitigating patient contamination; additionally, the handpiece, charging base and light attenuating shield can withstand common surface disinfectants. Also included in the Valiant Curing Light is an instructions for use. The instructions for use details the function and four independently operable settings of the device: 1) standard curing mode, 2) ramp curing mode, 3) boost curing mode, and 4) white light mode (visualizing of dental anatomy). The white light mode can be used for intraoral illumination to aid in the visualization of dental anatomy (i.e. equivalent to a class I dental operating light, CFR 872.4630). The curing light modes 1-3 provide broad spectrum blue light (400 - 500mm, with peaks at 410nm and 475nm) to cure a variety of dental restorative materials and adhesives utilizing the most common photoinitiators (CQ and PPD). The white light mode 4 provides an aid for illuminating dental anatomy.

The document describes the Valiant Curing Light, a dental device for curing photo-activated dental restorative materials and adhesives. The submission aims to demonstrate substantial equivalence to a predicate device, the Valo Cordless (K110582).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for performance in a table format with pass/fail thresholds. Instead, it demonstrates performance by comparing the Valiant Curing Light to its predicate device, the Valo Cordless, and asserting "statistically similar" or "equivalent" performance in various non-clinical tests.

However, based on the non-clinical performance testing sections, we can infer the implied acceptance criteria:

Study Details

The document relies solely on non-clinical (benchtop) performance testing to demonstrate substantial equivalence. No clinical studies were deemed necessary.

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

• Sample Size: Not explicitly stated for each test (e.g., number of composite pucks, number of light measurements). The descriptions refer to "testing concluded," "measurements obtained," or "comparison testing" without specifying the number of samples or repetitions beyond general terms.
• Data Provenance: The studies were non-clinical, likely conducted in a laboratory setting by Inter-Med / Vista Dental Products. There is no mention of country of origin of the data as it's not patient data, nor is it retrospective or prospective in the clinical sense.

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

• This question is not applicable as the studies were non-clinical benchtop tests comparing physical properties and performance against a predicate device and engineering design specifications. The ground truth would be established by scientific measurement and engineering validation, not expert consensus in a clinical context.

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

• This question is not applicable as there were no human readers or expert adjudications involved in establishing ground truth for these non-clinical tests.

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:

• This question is not applicable. This is a dental curing light, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

• This question is not applicable. This device is a physical tool (a curing light), not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

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

• The "ground truth" for the non-clinical tests was established through objective physical measurements and engineering validation, comparing the device's performance against its own design specifications and against the measured performance of a legally marketed predicate device (Valo Cordless). For example, microhardness measurements would be taken using standardized laboratory techniques.

8. The sample size for the training set:

• This question is not applicable. The Valiant Curing Light is a physical device, not an AI algorithm that requires a training set.

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

• This question is not applicable as there is no training set for this device.

Ask a specific question about this device

The ESTETICA Dental Treatment Unit and Accessories are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. The ESTETICA Dental Treatment Unit and Accessories are designed for use by a trained professional in the field of general dentistry.

The ESTETICA Dental Treatment Unit and Accessories serves as a base that includes components to deliver air, water, electrical power, and vacuum to dental handpieces, instruments, and accessories. The device includes a patient chair, foot control, dentist element, assistant element and a water unit. The unit may also include a dental operating light and a monitor. Various handpieces and accessories can be added to the ESTETICA Dental Treatment Unit and Accessories. These include, but not limited to, pneumatic handpieces, electric motors with handpieces, scalers, intra-oral cameras, curing lights, air/water syringes and SE and HVE vacuum instruments.

The provided text describes the 510(k) premarket notification for the ESTETICA Dental Treatment Unit and Accessories. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not present specific acceptance criteria in a table format with corresponding reported device performance metrics in the way one might see for a diagnostic AI device (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly defined by conformance to various international and national standards for dental operative units and medical electrical equipment. The "reported device performance" is broadly stated as "Performance bench testing according to international standards for dental operative units has been conducted to determine conformance" and "the performance of the ESTETICA Dental Treatment Unit and Accessories has been verified utilizing the following standards."

Here's an interpretation based on the provided text, outlining the areas of conformance:

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

The document does not detail specific sample sizes for particular performance tests. It refers to "Performance bench testing" and "Comparative performance testing" but does not specify the number of units or test subjects used in these tests. The provenance of the data (country of origin, retrospective/prospective) is also not specified, as these are non-clinical bench tests, not clinical studies.

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)

This product is a dental treatment unit, not an AI or diagnostic device that requires expert-established ground truth for its performance evaluation in the typical sense of medical image analysis. The "ground truth" here is adherence to engineering and safety standards, verified through bench testing. Therefore, there were no experts used to establish ground truth in the context of clinical interpretation or diagnosis.

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

Not applicable. As a device undergoing non-clinical bench testing for conformance to standards, there is no "adjudication method" in the clinical sense (e.g., for conflicting expert opinions). Performance is evaluated against documented technical specifications and standard requirements.

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 dental operative unit, not an AI-assisted diagnostic or interpretative tool. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed.

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

This device does not involve an "algorithm only" component for diagnostic or interpretative tasks. It is a physical medical device that provides power and functions for dental procedures. Performance evaluations were done on its physical and electrical characteristics according to relevant standards.

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

The "ground truth" for the performance evaluation of the ESTETICA Dental Treatment Unit and Accessories is the set of specifications and requirements outlined in the international and national standards listed (e.g., ISO 7494-1, IEC 60601-1). Performance is assessed based on whether the device operates within the parameters defined by these standards. No expert consensus, pathology, or outcomes data were used for establishing ground truth in this context.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product and does not involve a "training set" for an algorithm.

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

Not applicable. There is no training set for this device.

Ask a specific question about this device

The dental treatment unit with accessories is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The dental treatment unit is intended for use in the dental clinic environment and is used by trained dentists and/or dental assistants.

The motors serve as drives for rotating and oscillating straight and contra-angle hand pieces in connection with a dental treatment unit. They are used for endodontic and general dental purposes.

The SPRAYVIT M multifunctional syringe is used for dental treatment with unheated air and heated water. It is also used to illuminate the preparation field.

The TENEO dental treatment unit is a dental operating system. The device includes a patient chair, foot control, dentist element, assistant element and a water unit. The unit may also include a dental operating light, and a monitor.

The provided text is a 510(k) Summary for the Sirona Dental Systems TENEO Dental Treatment Unit and Accessories. It focuses on demonstrating substantial equivalence to predicate devices, and as such, it does not contain the information requested about acceptance criteria and a study proving the device meets those criteria for software or AI performance.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document primarily discusses:

• Intended Use and Device Description: What the device does and its components.
• Technological Characteristics Comparison: A detailed table comparing the TENEO device to two predicate devices (C8+ and A-DEC 200) across various features like dentist element, assistant element, chair, water unit, and general characteristics. This comparison is to establish substantial equivalence.
• Performance Data (General): It mentions a "clinical assessment has been conducted for the TENEO by a dentist," that a "test concept along with the acceptance criteria have been provided," and that "Additional information concerning system and component tests and traceability analysis has been provided." It also references sterilization and biocompatibility tests, and compliance with various international and national performance standards (ISO, AAMI, IEC, EN, DIN) related to dental units, biocompatibility, risk management, electrical safety, usability, software lifecycle, photobiological safety, and sterilization.

However, it does not provide the actual acceptance criteria values or the specific results of a study demonstrating fulfillment of those criteria in a quantitative manner. It certainly does not mention anything related to AI, machine learning, or algorithms.

Ask a specific question about this device

CONELOG® Titanium base CAD/CAM

• Implant-prosthetic titanium abutment for CONELOG® implants with connection, as a bonding base for hybrid abutments.
• The Titanium base CAD/CAM for implant Ø 3.3 mm is designed only for hybrid abutments in the area of the upper lateral incisors and lower central and lateral incisors.

CONELOG Titanium base CAD/CAM is an abutment designed to be used with the Sirona CAD/CAM System in Coris ZI meso L and meso S to fabricate a hybrid abutment with an angle up to 20°.The Titanium base CAD/CAM is available in four implant platform sizes (3.3 mm 3.8 mm, 4.3 mm, and 5.0 mm), two gingival heights (0.8 mm or 2.0 mm) and is supplied with the corresponding screw. All design parameters are according to the cleared Sirona CAD/CAM System parameters.

This document is a 510(k) summary for the CONELOG® Titanium base CAD/CAM. It describes the device, its intended use, and the data submitted to demonstrate substantial equivalence to legally marketed predicate devices.

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria. Instead, it relies on performance testing designed to demonstrate mechanical integrity under relevant dental conditions.

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

The document does not specify the exact sample size for the non-clinical testing. It only states that "non-clinical testing data submitted" was used. The provenance of the data (country of origin, retrospective/prospective) is not mentioned.

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)

This is a medical device submission for a physical implant component, not an AI or imaging-based diagnostic tool. Therefore, there is no "ground truth" in the diagnostic sense, and no experts were used to establish such. The "ground truth" for this type of device is its mechanical robustness and compliance with established standards.

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

Not applicable, as this is not an imaging or diagnostic study requiring adjudication for ground truth.

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 submission for a physical dental implant component, 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 submission for a physical dental implant component, not an algorithm.

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

The "ground truth" in this context is the successful completion of established mechanical performance tests (ISO 14801) designed to simulate in-vivo conditions. The device is expected to withstand specified static and dynamic forces without failure, demonstrating its structural integrity and safety.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no training set in the conventional sense.

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

Not applicable. See point 8.

Ask a specific question about this device

The device is used to provide light for endoscopic devices. Those devices can be connected directly to the light source or by fiber bundles or single fibers. The device is intended for prescription use only.

The cold light sources of the PS series consist of short arc metal-halide or xenon lamps, driven by electronic ballasts. Optical components such as mirrors, lenses, filters and coatings focus the light to a small diameter of typically 1.5-4mm. Fiber light guides (single or bundles) transmit the light to the application such as endoscopes.

The provided text is a 510(k) summary for a medical device called the "PS series" light source with fiber. This submission focuses on establishing substantial equivalence to predicate devices rather than demonstrating performance through a clinical study with acceptance criteria.

Therefore, the document explicitly states: "No performance data is required for this Class II device nor requested by FDA (ODE)."

This means most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this particular 510(k) submission.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

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

• Not applicable. No test set performance data was provided or required for this 510(k) submission.

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)

• Not applicable. No ground truth establishment was performed as no test set data was provided.

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

• Not applicable. No test set data was provided for adjudication.

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, not an AI-powered diagnostic device. No MRMC study was performed.

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

• Not applicable. This device is a light source, not an algorithm. No standalone performance study was conducted.

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

• Not applicable. No ground truth was established as no performance study was conducted.

8. The sample size for the training set

• Not applicable. No training set was used as this device is a light source, not a machine learning algorithm.

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

• Not applicable. No training set or associated ground truth was used for this device.

Summary of Device Safety and Effectiveness Demonstration:

Instead of performance criteria, the submission focuses on demonstrating safety and effectiveness through:

• Substantial Equivalence: Comparing the PS series to legally marketed predicate devices (Isolux and Cogent/WelchAllyn light sources and cables) in terms of use, design, and function.
• Safety Standards Compliance: The device is designed to and fully meets several international safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, UL2601-1, CAN/CSA-C22.2 No. 601-1-M90, 47 CFR Ch.1 Part 15 (FCC), IEC 60601-2-41).
• Technological Characteristics: Describing the components (short arc metal-halide or xenon lamps, electronic ballasts, optical components) and how they function to focus white light into fiber light guides for endoscopic applications. The short arc lamp is cited as improving effectiveness of focusing, similar to the predicate device.

The conclusion states that the technological differences to the predicate devices do not affect the safety or efficacy of the submitted devices, leading to the determination of substantial equivalence.

Ask a specific question about this device

The AC-powered dental operating light, which can be attached via optical fibers to a surgical headlight, is a device intended to illuminate oral structures and operating areas.

The cold light sources of the PS series consist of short arc metal-halide or xenon lamps, driven by electronic ballasts. Optical components such as mirrors, lenses, filters and coatings focus the light to a very small diameter of typically 1.5-3mm, Fiber light guides (single or bundles) transmit the light to the application such as headlights, endoscopes or other lighted tools.

Based on the provided text, the device described is a "Xenon/Metal halide light source with fiber and headlight" (PS series) intended as an "AC-powered dental operating light." The document explicitly states:

"No performance data is required for this Class I device nor requested by FDA (ODE)."

Therefore, a detailed study proving the device meets specific acceptance criteria, as one might find for a more complex medical device, was not necessary or provided in this 510(k) submission. The submission primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to safety standards.

Here's an breakdown based on your requested information, acknowledging the limitations due to the device's classification:

Acceptance Criteria and Device Performance

Study Details (or lack thereof)

Since "No performance data is required" for this Class I device, the following points are largely not applicable or indicate that a specific "study" as you might define it for a complex AI/diagnostic device was not performed.

1. Sample size used for the test set and the data provenance: Not applicable. No performance data was required.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No performance data was required.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No performance data was required.
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 device is a light source, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a light source, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth was established for performance data as it was not required.
7. The sample size for the training set: Not applicable. This device is a light source, not a machine learning model.
8. How the ground truth for the training set was established: Not applicable.

Summary of the "Proof"

The "proof" that this device meets its "acceptance criteria" (which in this case are primarily substantial equivalence and safety compliance) is demonstrated through:

• Comparison to Predicate Devices: The submission argues that the PS series light source is "similar in use, design and function" to several legally marketed predicate devices (Cogent/WelchAllyn Solartec Source ST270, Micro Link endoscopic fiber cable; Isolux America 1300 XSBP, 1125 XSB, Fiber optic surgical headlight, fiberoptic cable).
• Adherence to Safety Standards: The document lists a comprehensive set of international and national safety standards that the device "fully meets." This is a critical component for FDA clearance, especially for devices where extensive performance testing might not be mandated.
• Technological Description: The detailed description of how the device produces and channels light (e.g., short arc lamps, optical components, improved focusing into small fibers) serves to explain how it achieves its intended illumination function, and implicitly, how it is equivalent or even potentially an improvement in focusing effectiveness compared to older technologies (though this isn't framed as a strict performance claim with quantitative data).

In essence, for this Class I device, the regulatory pathway did not require the type of extensive performance study you've outlined for AI or diagnostic devices. The acceptance criteria were primarily met through demonstrating safety compliance and substantial equivalence to established predicate devices.

Ask a specific question about this device

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.

Ask a specific question about this device