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The Monet Curing Laser is a source of illumination for curing photo-active materials and adhesives.

The Monet Curing Laser is a device for delivering light energy to dental restorative materials and adhesives, which utilize the light energy to affect a photopolymerization reaction. This energy is generated by a solid-state laser diode, which provides a consistent and reliable generation of laser energy at 450 ± 5nm for a maximum of 2.0 watts (2400 mW/cm²) of energy output. The laser energy is delivered to the dental material by means of an optical focusing lens that collimates the laser energy to a nearly parallel beam size that remains highly consistent regardless of distance to the target material. The device also includes a low-intensity aiming beam feature that allows the operator to see the delivery site of the energy without risk of premature polymerization of the material. The device features a metal construction with glass output window that contains all device electronics. The device features a simple on/off switch and set 3-second activation time. The device incorporates a detachable rechargeable battery which is recharged on an accompanying charging stand. The charging stand incorporates a basic radiometer to allow the user to confirm the output intensity of the emitted light.

The provided text describes the regulatory clearance for the "Monet Curing Laser" and offers information about its performance testing. However, it does not contain specific acceptance criteria tables or detailed study results in the manner requested for AI/software-based devices. The document is an FDA 510(k) clearance letter and summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical trial outcomes with statistical acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions related to sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details as these are not present in the provided document.

Information that CAN be extracted from the document:

1. Device Name: Monet Curing Laser
2. Regulation Number: 21 CFR 872.6070
3. Regulation Name: Ultraviolet activator for polymerization
4. Product Code: QNF, GEX
5. Regulatory Class: Class II

6. Indications for Use: The Monet Curing Laser is a source of illumination for curing photo-active materials and adhesives. For dental applications, this is specified as curing photo-activated dental restorative materials and adhesives.

7. Description of Submitted Device:

• Delivers light energy to dental restorative materials and adhesives to affect photopolymerization.
• Energy generated by a solid-state laser diode.
• Wavelength: 450 ± 5nm.
• Maximum energy output: 2.0 watts (2400 mW/cm²).
• Optical focusing lens collimates the laser energy to a nearly parallel beam.
• Includes a low-intensity aiming beam feature.
• Metal construction with glass output window.
• Simple on/off switch and set 3-second activation time.
• Detachable rechargeable battery.
• Accompanying charging stand with a basic radiometer to confirm output intensity.

8. Legally Marketed Predicate Device: Valo Grand, manufactured by Ultradent Products, Inc. (K160551)

9. Performance Data (as reported in the 510(k) Summary):

• ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY:
  • Complies with 21 CFR 1040.10 and 1040.11 (with permissible deviations relative to Laser Notice 50, dated June 24, 2007).
  • Complies with IEC 60601-2-22 Edition 3 and IEC 60825-1 Edition 2.
  • Complies with IEC 60601-1: Edition 3.1, IEC 60601-1-2 Edition 4, and IEC 60601-1-6 Edition 3.1.
• PERFORMANCE BENCH TESTING (Depth of Cure):
  • "Depth of cure testing was performed with the Monet and with the VALO curing light, assessing different popular brands of dental composite and lighter and darker shades of composite from each of these brands."
  • "Both light sources were activated for a single exposure of the same amount of time."
  • Reported performance: "The Monet is capable of achieving polymerization of the tested composites at a level that is generally equal to or better than the VALO while doing so with a lower light intensity."
• BIOCOMPATIBILITY:
  • Features the same nature of incidental patient contact as the predicate device.
  • Composed of similar materials to the predicate device.
• END-USER STERILIZATION:
  • Not intended to be sterilized by the end-user.
  • Includes single-use barrier sleeves for infection control (not sterile, not intended for end-user sterilization).

Summary of missing information based on your request:

• A table of acceptance criteria and the reported device performance: Specific quantitative acceptance criteria (e.g., "Depth of cure must be X mm with less than Y% variability") are not provided. The performance is qualitatively compared to the predicate ("equal to or better than").
• Sample sized used for the test set and the data provenance: No numerical sample sizes for depth of cure testing are mentioned. No information on data provenance (country, retrospective/prospective).
• Number of experts used to establish the ground truth... and qualifications: Not applicable. This is a physical device, not an AI/software device requiring expert ground truth for classification.
• Adjudication method: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI/software device that assists human readers.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For depth of cure, the "ground truth" would be the measured physical polymerization depth, but the method details are not provided.
• The sample size for the training set: Not applicable (not an AI/ML device).
• How the ground truth for the training set was established: Not applicable.

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1. Application of non-thermal radio frequency for relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
2. Application of ultrasound for non-invasive reduction in abdominal circumference on adults with a Body Mass Index (BMI) of 25 or greater.

The Ultimate Contour is a medical device that combines the technologies of radio-frequency energy and ultrasound in one convenient unit. The Ultimate Contour utilizes a single power source and control circuitry that directs the emission of energy based on which operating screen is selected and which applicator handpiece is attached to the unit's delivery cable. Based on the attached handpiece, the Ultimate Contour delivers to the handpiece of the appropriate energy intensity based on the settings selected.

Delivered radio frequency energy is accomplished with the multi-nodal RF handpiece that contains RF energy to the treatment area and works to gently heat the tissue to induce collagen contraction and increase local circulation. The elevated temperature further works to provide temporary relief from pain and muscle spasms. The unit features an interactive color LCD touchscreen for adjusting device settings, as well as for viewing onboard tutorial videos.

Delivered ultrasound is accomplished with a piezo transducer located in the ultrasound handpiece that is bonded to the handpiece contact surface. The handpiece is applied directly to the patient skin at the abdominal area and the emitted ultrasound energy focuses within the subdermal fatty tissue, causing reduction in waist circumference.

The unit features an interactive color LCD touchscreen for adjusting device settings, as well as for viewing onboard tutorial videos.

The device is presented as two model (005-00035) is an integrated free-standing system. The second model (005-00036) is a portable, table-top style units feature exactly the same internal electronics and components, the exact same software, the exact same attachments and accessories, and the exact same environment of use. The models differ only in the shape and dimensions of the mechanical enclosure of the control unit.

Here's an analysis of the provided text, focusing on acceptance criteria and the study proving device compliance, as requested:

Device: Ultimate Contour, Ultimate Contour Mini

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for performance in a tabular format. However, it implicitly defines the effectiveness acceptance criterion through the primary effectiveness endpoint of the clinical study.

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

• Sample Size for Test Set: 42 subjects completed the treatment regimen.
• Data Provenance: The study was a "single-site single-arm study." The country of origin or specific demographic details beyond "majority of study subjects were Caucasian females" are not explicitly stated. It was a prospective study as it involved treating subjects and then evaluating outcomes.

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

The document does not specify the number of experts used to establish a ground truth for the test set. For the primary effectiveness endpoint (waist circumference reduction), measurements were conducted by clinicians, but their specific qualifications or the number involved are not provided. The information only states: "Clinicians were blinded relative to measuring pre-treatment and post-treatment."

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It states that "Clinicians were blinded relative to measuring pre-treatment and post-treatment," implying that a single clinician or a group of clinicians performed measurements, but there's no mention of a consensus or adjudication process if discrepancies arose.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improving with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study involving AI assistance for human readers was not conducted or reported in this document. The device is a direct treatment device (radiofrequency and ultrasound for aesthetic/therapeutic purposes), not an AI diagnostic or assistive tool for clinicians interpreting data.

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

This question is not applicable to the device described. The "Ultimate Contour" is a physical medical device that applies energy (RF and ultrasound) directly to the patient, not an algorithm that functions standalone or with human-in-the-loop. Its performance is measured by its direct effect on the patient (e.g., waist circumference reduction).

7. The Type of Ground Truth Used

The ground truth for the effectiveness endpoint was established by clinically meaningful waist circumference reduction measurements. This was defined as "a value of at least 1 inch of waist circumference reduction of the treatment regimen," and this clinically meaningful value was "identified based on published studies utilizing other devices for the same purpose."

For safety, the ground truth was observed adverse events and serious adverse events reported by subjects and assessed by the study team.

8. The Sample Size for the Training Set

The document does not mention a training set in the context of device performance or clinical evaluation. The device is not an AI/ML product that typically requires a training set. The clinical study described involved direct treatment of subjects.

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

As no training set is mentioned as being applicable to this device or its evaluation, this question is not applicable.

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The Sterling Supreme Diode Laser is indicated for dentistry and oral soft tissue procedures of:

1. The removal of lesions, excision, incision, vaporization, hemostasis, and photocoagulation on soft tissues including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, gingivectomy, troughing, and removal of inflamed edematous tissue;

2. Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, temporary increase in local circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions;

3. Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.

The Sterling Supreme Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 3 watts of energy output. The laser energy is delivered to surgical site by means of an optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The device features some user definable settings, including a switchable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options.

The working end of the delivery fiber is contained within a metal handpiece with a disposable single-use tip. This handpiece system is incorporated into the device. The activation of the working beam diodes is completed by use of a foot-actuated switch.

The provided text does not describe a study involving an AI/ML medical device, clinical performance metrics, or a comparative effectiveness study. It pertains to a 510(k) premarket notification for a medical device called the "Sterling Supreme Diode Laser."

This submission describes changes to the device's labeling and the method of delivering single-use tips (now non-sterile, requiring end-user sterilization) compared to a previously cleared predicate device. It addresses electrical safety, electromagnetic compatibility, performance bench testing, biocompatibility, and end-user sterilization verification and validation.

Therefore, I cannot extract the information required to answer your request about acceptance criteria and a study proving the device meets them, specifically regarding AI/ML performance, ground truth, expert consensus, or multi-reader multi-case studies.

The document states:

• "No new risks or concerns regarding device performance are raised in modifying the device to provide the single-use tips to the market in a non-sterile state. No performance characteristics or specifications of the device are modified."
• "The modifications consist only of changes to the device labeling and instructions for use for the end-user to be aware of the present condition of the tips and to properly prepare the tips for use. All other aspects of the device, including indications for use, are not affected by this change."
• The performance data sections focus on ensuring that the non-sterile delivery of tips and subsequent end-user sterilization do not negatively impact the device's safety or efficacy.

To answer your specific questions in the context of this document, here's what can be inferred or explicitly stated regarding the closest equivalent "acceptance criteria" and "study":

Acceptance Criteria (Implied for the Change):
The primary acceptance criterion for this 510(k) submission regarding the change from sterile to non-sterile tips is that the modification does not introduce new risks or adversely affect the safety and effectiveness of the device, and that end-user sterilization is effective.

Reported Device Performance (for the change):
The testing confirmed that:

• The device still complies with relevant electrical safety (21 CFR 1040.10, 1040.11, IEC 60601-2-22, IEC 60825-1, IEC 60601-1: 3rd Edition, IEC 60601-1-2, IEC 60601-1-6).
• No performance characteristics or specifications of the device were modified.
• No new risks or concerns regarding device performance were raised.
• Biocompatibility was not affected as no materials were modified.
• End-user sterilization of tips with an approved liquid chemical sterilant is capable of achieving a log 6 reduction in bioburden without adversely impacting performance or specifications.
• Rinsing after sterilization adequately removes residual sterilant.

Given this context, I will provide a table and address your points based on the closest applicable information in the document, acknowledging that it's not an AI/ML clinical performance study.

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

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

The document does not detail specific sample sizes for electrical safety, EMC, performance bench testing, or biocompatibility, as these are typically standard engineering and material tests, not clinical studies with patient populations. The tests pertain to the device itself and the sterilization process for the tips. The data provenance is internal testing performed by the manufacturer, CAO Group, Inc. (U.S.A.). The tests are likely retrospective, as they apply to a modified product seeking clearance.

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

This information is not applicable to the type of tests described (electrical safety, EMC, performance bench testing, biocompatibility, sterilization validation). These tests rely on established engineering standards and laboratory protocols, not human expert interpretation for "ground truth" in the way it's used for AI/ML image analysis.

4. Adjudication method for the test set

Not applicable. There is no mention of human-in-the-loop assessment or expert adjudication for the technical tests performed.

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 diode laser, not an AI/ML diagnostic system. No MRMC study was performed or is relevant to this submission.

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

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used

For electrical safety and EMC, the "ground truth" is adherence to recognized international and federal standards (e.g., IEC 60601 series, 21 CFR 1040).
For performance bench testing and biocompatibility, the "ground truth" is the device's original validated performance and material safety profile, which the modifications must not adversely affect.
For end-user sterilization, the "ground truth" for efficacy is a "log 6 reduction in bioburden," which is a standard microbiological criterion for sterilization, and proof of adequate residual sterilant removal.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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The Pioneer Elite Diode Laser is indicated for dentistry and oral soft tissue procedures of:

1. The removal of lesions, excision, incision, vaporization, hemostasis, and photocoagulation on soft tissue including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, frenectomy, troughing, and removal of inflamed edematous tissue.
2. Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions;
3. Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.

The Pioneer Elite Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 3 watts of energy output. The laser energy is delivered to surgical site by means of an optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The device features some user definable settings, including a switchable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options. The working end of the delivery fiber is contained within a metal handpiece with a disposable single-use tip. This handpiece system is incorporated into the device. The activation of the working beam diodes is completed by use of a foot-actuated switch.

The provided text is a 510(k) summary for the Pioneer Elite Diode Laser, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, specifically noting a change in the sterilization delivery of the single-use applicator tips.

Therefore, the context of the document is not a study to prove a device meets acceptance criteria through clinical performance metrics like sensitivity, specificity, or reader improvement. Instead, it's a regulatory submission demonstrating that a modified version of an already cleared device is still safe and effective, primarily by ensuring that the change in sterilization delivery does not negatively impact performance and that the device still meets relevant safety and performance standards.

As such, many of the requested points for describing an acceptance criteria study (e.g., sample size for test set, ground truth experts, MRMC study, training set details) are not applicable to this type of regulatory submission. The "acceptance criteria" here are compliance with recognized standards and verification/validation testing related to the specific modification.

Here's a breakdown based on the information provided:

Acceptance Criteria and Device Performance (Not a typical clinical performance study)

The acceptance criteria and device performance described in this document relate to the safety and fundamental functional compliance of the modified device, particularly concerning the change in sterilization of the single-use tips, rather than clinical efficacy metrics.

Study Details (Specific to the demonstrated change in sterilization delivery)

1. Sample size used for the test set and the data provenance: Not applicable in the traditional sense for clinical performance. The testing mentioned (End-User Sterilization) would have involved a sufficient number of samples of the single-use tips to demonstrate sterilization effectiveness and tip integrity, but specific numbers are not provided in this summary. The data provenance would be from laboratory testing conducted by or for the manufacturer.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of submission. "Ground truth" here is established via standard microbiological (bioburden reduction) and material/performance testing protocols.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Standard laboratory testing protocols would be followed, typically with independent verification.
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 document is not about AI or human reader performance.
5. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This is a laser device, not an algorithm.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the sterilization effectiveness testing, the "ground truth" would be established by validated microbiological methods (e.g., direct bioburden measurement, sterility testing after sterilization, assays for residual sterilant) and physical/functional property testing of the tips.
7. The sample size for the training set: Not applicable. This is not a machine learning or AI device.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The document describes a regulatory submission (510(k)) for a previously cleared device, the Pioneer Elite Diode Laser. The primary "study" or demonstration of compliance pertains to a specific modification: the single-use applicator tips are now delivered to the end-user in a non-sterile condition, rather than pre-sterilized.

The manufacturer conducted verification and validation testing to ensure that this change did not compromise the safety or effectiveness of the device. This testing focused on:

• Electrical Safety and Electromagnetic Compatibility: Ensuring continued compliance with relevant international and national standards (e.g., IEC 60601 series, 21 CFR 1040).
• Performance Bench Testing: Confirming that the act of changing the sterilization delivery method did not alter any original performance characteristics or specifications of the device.
• Biocompatibility: Verifying that no material changes were made and that the modified delivery method (requiring end-user sterilization) did not introduce new biocompatibility risks, provided instructions were followed.
• End-User Sterilization: Crucially, performing tests to demonstrate that:
  • Treatment of the tips with an approved liquid chemical sterilant can achieve a "log 6 reduction in bioburden" (a standard measure of sterilization efficacy).
  • This sterilization process does not adversely impact the performance or specifications of the tips.
  • Rinsing the tips after sterilization adequately removes residual sterilant.

Conclusion of the demonstration: The manufacturer concluded that these modifications and associated testing confirm that the device remains safe and effective, and substantially equivalent to the predicate device, with the change consisting only of labeling and instructions for use regarding the end-user sterilization of the tips.

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The Precise SHP Diode Laser is indicated for dentistry and oral soft tissue procedures of:

1. The removal of lesions, excision, incision, vaporization, hemostasis, and photocoagulation on soft tissue including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, frenectomy, troughing, and removal of inflamed edematous tissue.

2. Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions;

3. Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.

The Precise SHP Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 3 watts of energy output. The laser energy is delivered to surgical site by means of an optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The device features some user definable settings, including a switchable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options.

The working end of the delivery fiber is contained within a metal handpiece with a disposable single-use tip. This handpiece system is incorporated into the device. The activation of the working beam diodes is completed by use of a foot-actuated switch.

This submission (K181601) is for a labeling change to the previously cleared Precise SHP Diode Laser (K123443). The key change is that the disposable applicator tips will now be delivered non-sterile, and the end-user will be responsible for sterilization. Therefore, the "device performance" in terms of clinical efficacy of the laser itself is not re-evaluated or specifically measured against acceptance criteria in this document. The focus of the "study" described here is to demonstrate that the new labeling and the end-user sterilization process do not negatively impact safety or effectiveness.

Here's an analysis based on the provided text, addressing your points:

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

Since this is a labeling change and not a re-evaluation of the laser's primary performance, the "acceptance criteria" are related to the safety and efficacy of the sterilization process for the tips and the laser's continued compliance with safety standards.

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: The document does not specify the exact sample size for the "verification and validation testing" performed on the tips for sterilization efficacy or performance. It simply states "Verification and validation testing indicate..."
• Data Provenance: Not specified. The document outlines a submission to the US FDA by a US-based company (CAO Group, Inc., West Jordan, Utah, U.S.A.). However, the location/country where the testing was performed is not mentioned, nor is it explicitly stated if the data is retrospective or prospective, though it would logically be prospective testing conducted specifically for this submission.

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

Not applicable. This submission concerns a labeling change and the effect of end-user sterilization on a device component. It does not involve establishing ground truth based on expert clinical or radiological reviews. The "ground truth" here is objective laboratory testing against established sterilization standards.

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

Not applicable. This type of adjudication method is used in studies involving human interpretation or decision-making (e.g., image reading). The testing performed here (sterilization efficacy) is objective laboratory testing.

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 document does not describe an MRMC study or any AI component.

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

Not applicable. This document does not describe any algorithm or AI performance.

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

The "ground truth" for the sterilization efficacy testing would be objective laboratory standards for sterilization, specifically achieving a Log 6 reduction in bioburden, as measured by standard microbiological assays. For tip performance, it would be instrumental measurements against predefined performance specifications.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning study.

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

Not applicable. There is no "training set."

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Application of non-thermal radio frequency for relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

The Ultimate Contour is a body sculpting device that combines the technologies of radio-frequency in one convenient unit. The Ultimate Contour utilizes a single power source and control circuitry that directs the emission of energy based on which operating screen is selected and which applicator handpiece is attached to the unit's delivery cable. Based on the attached handpiece, the Ultimate Contour delivers to the handpiece the appropriate energy intensity based on the settings selected. Delivered radio frequency energy is accomplished with the multi-nodal RF handpiece that contains RF energy to the treatment area and works to gently heat the tissue to induce collagen contraction and increase local circulation. The elevated temperature further works to provide temporary relief from pain and muscle spasms. The unit features an interactive color LCD touchscreen for adjusting device settings, as well as for viewing onboard tutorial videos. The device is presented as two model (005-00035) is an integrated free-standing system. The second model (005-00036) is a portable, table-top style units feature exactly the same internal electronics and components, the exact same software, the exact same attachments and accessories, and the exact same environment of use. The models differ only in the shape and dimensions of the mechanical enclosure of the control unit.

This document is a 510(k) Summary for a medical device called "Ultimate Contour" and "Ultimate Contour Mini." It does not describe an AI/algorithm-based device, but rather a physical device that uses radio frequency for therapeutic purposes.

Therefore, many of the requested criteria for AI/algorithm acceptance and study details (such as sample size for test/training sets, ground truth establishment for AI, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document.

However, I can extract information related to the device's performance testing and general acceptance criteria as described in the document.

Here's the closest interpretation of the requested information based on the provided document, with notes indicating why certain points are not applicable:

Device Name: Ultimate Contour, Ultimate Contour Mini
Regulation Number: 21 CFR 878.4400 (Electrosurgical Cutting and Coagulation Device and Accessories)
Regulatory Class: Class II
Product Code: PBX
Indications for Use: Application of non-thermal radio frequency for relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

Acceptance Criteria and Reported Device Performance

The document describes performance testing rather than explicitly stating acceptance criteria in a quantitative sense for each indication. However, it implicitly aims to demonstrate the device's ability to achieve the stated therapeutic effects or safety parameters.

Table of Acceptance Criteria (Inferred from Performance Testing) and Reported Device Performance:

Study Details

Many of these points are not applicable as this is not an AI/algorithm-based device being submitted for a clinical study to prove algorithmic accuracy. It's a physical device seeking substantial equivalence based on technical characteristics and limited clinical performance testing.

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

   • For Clinical Performance Testing (heating skin tissues): "a single-site study on 5 human patients with varying skin pigmentation".
   • Data Provenance: Not explicitly stated, but clinical testing implies prospective data collection from human subjects. The document is part of a US FDA submission, so the study would likely have been conducted, or data collected, in North America, but this is not specified.

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

   • N/A. This document describes a physical medical device. The "ground truth" for the clinical performance testing was the direct measurement of skin tissue temperature, not an expert assessment of an image or diagnostic output for an algorithm. There is no indication of experts establishing a "ground truth" label in the sense of an AI model's training or testing.

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

   • N/A. This concept applies to human reader studies often used to establish ground truth for AI algorithms or assess reader performance. The testing for this device involved direct physical measurements (temperature) and engineering verification (electrical safety, RF power), not qualitative assessments requiring adjudication.

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 does not involve AI or human-in-the-loop assistance for interpretation. It's a direct therapeutic device.

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

   • N/A. This is not an algorithm/AI device. The "standalone" performance here would refer to the device itself operating as intended. Bench testing and the limited clinical performance testing (heating tissues to a specific temperature range) serve this purpose for the physical device.

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

   • For the Clinical Performance Testing: The ground truth was direct physiological measurement (skin tissue temperature, measured to be within 40-45°C). It was not based on expert consensus, pathology, or broader outcomes data for the described study.
   • For other tests (electrical safety, RF power), the "truth" was compliance with engineering standards and design specifications.

7. The sample size for the training set:

   • N/A. This refers to AI/machine learning models. There is no mention of an AI training set for this device.

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

   • N/A. As there is no AI training set, this question is not applicable.

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The Sterling Supreme Diode Laser is indicated for dentistry and oral soft tissue procedures of:

1. The removal of lesions, excision, incision, vaporization, hemostasis, and photocoagulation on soft tissues including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, gingivectomy, troughing, and removal of inflamed edematous tissue;

2. Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, temporary increase in local circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions;

3. Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.

The Sterling Supreme Diode Laser is a device for delivering laser energy to human soft tissue for a variety of dental and oral procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 3 watts of energy output. The laser energy is delivered to the surgical site by means of an optical fiber fully ensheathed within a coated steel coil terminated in a handpiece assembly, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The target tissues absorb the laser energy converting it to heat. Depending on the intensity or power output of the laser, the heat so generated can cause hemostasis, ablation, or vaporization. The device features some user definable settings, including a selectable 650nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options. The device allows for selection of factoryestablished presets for common dental and oral care procedures, and allows for the operator to save desired settings for quick-reference.

Laser energy is transmitted through the fixed length of optical fiber to the distal end of the handpiece assembly. The handpiece assembly consists of a reusable, removable, sterilizable handpiece sleeve, and for surgical procedures is terminated with a single-use disposable tip. The operator uses the handpiece assembly to position and direct the laser energy to the intended treatment site. The activation of the working beam diodes is accomplished by use of a wireless foot-actuated switch.

The provided text is a 510(k) summary for the Sterling Supreme Diode Laser, a medical device. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it does not contain the detailed acceptance criteria and study data typical of a clinical trial or a performance validation study for a new, non-substantially equivalent device.

The document's purpose is to establish substantial equivalence based on technological characteristics and performance specifications compared to a predicate device, not to provide a standalone clinical study proving the device meets specific acceptance criteria in the manner one might expect for a novel AI or diagnostic device.

Therefore, many of the requested sections (sample size for test/training set, ground truth methods, expert qualifications, MRMC studies, effect size, etc.) are not applicable or not provided in this type of regulatory submission for this specific device.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

The document defines "acceptance criteria" through conformance to standards and internal performance verification against labeled specifications. The predicate device's performance is used as a benchmark for "substantial equivalence" but not as formal "acceptance criteria" that the new device must meet to prove its own efficacy by objective performance metrics.

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The Sterling Diode Laser is indicated for: Dental soft tissue indications:

Dental, oral and soft tissue surgery including:

Sulcular debridement of diseased or fibrous tisue, excision and biopsy, gingivectory and gingivoplasty, lesion (tumor) removal, fibroma removal, tissue retraction (troughing), aphthous ulcers, gingival hyperplasia (excision and recontour), crown lengthening, operculectomy, frenectomy, and photocoagulation.

Laser periodontal procedures, including:

Laser soft tissue curettage; laser removal of diseased, infected and necrosed soft tissue within the periodontal pocket; removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium.

The Sterling Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 10nm for a maximum of 5 watts of energy is delivered to the surgical site by means of an optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The target tissues absorb the laser energy converting it to heat. depending on the intensity or power output of the laser, the heat so generated can cell hemostasis, ablation, or vaporization. The device features some user definable settings, including a selectable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options.

The optical fiber is stored within the device and dispensed to the desired length according to the clinician's need. A fiber is passed through a reusable, sterilizeable handpiece assembly and terminated with a single-use disposable tip. The operator uses the handpiece to position and direct the laser energy to the intended treatment site. The activation of the working beam diodes is accomplished by use of a foot-actuated switch.

The provided document is a 510(k) premarket notification for the Sterling Diode Laser, seeking substantial equivalence to a predicate device. This type of regulatory submission focuses on comparing a new device to an existing legally marketed one, rather than presenting a detailed study proving the device meets specific performance acceptance criteria in the manner described for an AI/ML medical device.

Therefore, the information requested, which is typically relevant to AI/ML device studies, cannot be fully extracted or is not applicable to this document.

However, I can provide the available information that aligns with your request categories:

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

The document doesn't explicitly define "acceptance criteria" in the sense of quantitative performance metrics for a study to prove the device meets them. Instead, it demonstrates substantial equivalence to a predicate device by comparing technical specifications and performance characteristics.

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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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The Pilot Pro Diode Laser is indicated for the procedures of removal of lesions, excision, incision, vaporization, hemostasis, and photocoagulation on soft tissue in the fields of otolaryngology (ear, nose, and throat), dentistry and oral surgery, arthroscopy, dermatology, podiatry, plastic surgery, urology, and gynecology.

The Pilot Pro Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 5 watts of energy output. The laser energy is delivered to the surgical site by means of an optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The device features some user definable settings, including a switchable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous emission or pulse emission options. The working end of the delivery fiber is contained within a metal handpiece with a disposable single-use tip. This handpiece system is removable from the optical fiber system for cleaning and sterilization in between uses. The activation of the working beam diodes is completed by use of a foot-actuated switch.

The provided text is a 510(k) Summary of Safety and Effectiveness for the Pilot Pro Diode Laser. It explicitly states that the device is substantially equivalent to a legally marketed predicate device (DenLaser 800 Plus, K062619). The primary method used to demonstrate this substantial equivalence is via bench testing to confirm the device meets design criteria for essential performance and satisfies performance requirements indicated in 21 CFR 1010 and 21 CFR 1040.

Here's a breakdown of the requested information based on the provided text. It's important to note that since this is a 510(k) for substantial equivalence and not a de novo premarket approval, the level of detailed clinical study information (like MRMC studies, specific expert qualifications, or ground truth establishment methods for large datasets) is often less comprehensive or simply not required in the same way.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of specific, quantifiable acceptance criteria with corresponding performance data in the typical sense of a clinical trial. Instead, it relies on demonstrating equivalence to a predicate device and adherence to regulatory standards and design specifications.

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

• Sample Size: The document mentions "an evaluation sample of the current device." It does not specify the exact number of devices tested. This implies a limited number of devices used for bench testing, sufficient to demonstrate compliance with design and regulatory requirements.
• Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting. There is no information about country of origin of data or whether it was retrospective or prospective, as it pertains to device performance testing, not patient data.

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

Not applicable. The study described is bench testing of a laser device's physical performance and safety features, not a diagnostic or clinical study requiring expert-established ground truth on patient data.

4. Adjudication method for the test set:

Not applicable. This was bench testing, not a study requiring adjudication of expert 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:

No. This document describes a laser surgical instrument, not an AI-assisted diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

Not applicable. This is a hardware device (diode laser) and not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device's performance is based on:

• Engineering specifications and design criteria: The device was tested against its own design parameters for essential performance.
• Regulatory standards: It was evaluated against the requirements of 21 CFR 1010, 21 CFR 1040, IEC 60601 series, and IEC 60825-1.
• Predicate device characteristics: The predicate device's established performance and safety served as a key benchmark for substantial equivalence.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI-driven device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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