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CS Model+ is intended for use as a front-end software tool for management of orthodontic models, detailed analysis, treatment simulation and virtual appliance design options, including dental casts and orthodontic appliances. These applications are based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.

The use of CS Model+ requires the user to have the necessary training and domain knowledge in the practice of orthodontics.

CS Model+ is a software that allows practitioners to apply software imaging tools for management of orthodontic models, detailed analysis, treatment simulation and virtual appliance design. CS Model+ allows design of virtual models, also known as virtual dental casts. Those can be exported as STL or PLY files which may be used for fabrication of orthodontic models (dental casts). Then, which may be used to fabricate sequential aligner trays or retainers. The production of physical models and the other fabrication processes, such as thermoforming of aligner, is out of scope of Carestream Dental's manufacturing process. Those fabrication processes are done by the user and is under their sole control and responsibility.

CS Model+ is intended to be used with the following Carestream Dental's digital imaging devices including:

• -Intraoral scanners;
• -Extraoral devices with 3D object modality.

CS Model+ allows healthcare professionals to do the following:

• -Display digital 2D or 3D views of digital 3D models;
• Adjust the color and opacity of digital 3D models; -
• -Make indicative measurements of digital 3D models;
• Print and export images of digital 3D models; -
• -In a digital model, automatically detect the teeth cervical margins, teeth numbering and mesio distal orientations;
• -Generate an orthodontic report;
• Create virtual setups; -
• -Automatically generate virtual setups suitable for aligners treatment;
• Make automatic and customizable export of virtual models; -
• -Manage the intermediate steps;
• -Make refinement during treatment.

The provided text is a 510(k) Summary for the medical device CS Model+. It outlines the device's indications for use and compares it to a predicate device, Ortho System™. However, the document explicitly states that clinical testing was not performed and is not a requirement for this submission.

Therefore, the input does not contain the information requested in your prompt regarding acceptance criteria, reported device performance from a study, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or ground truth types for training and testing sets.

The document focuses on nonclinical testing (software verification and validation) to establish substantial equivalence, stating: "Testing confirmed that CS Model+ is stable and operating as designed." and "All test results have been reviewed and approved, showing the CS Model+ software to be substantially equivalent to the primary predicate Ortho System™ (K171634)."

Without a clinical study, it's impossible to create the table and answer the detailed questions about acceptance criteria and device performance based on the provided text.

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The CS 9600 is extraoral system intended to produce two-dimensional digital X-ray images of the dento-maxillofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.

The CS 9600 can be upgraded to produce cephalometric digital X-ray images. This includes imaging the hand and wrist to obtain carpus image for growth and maturity assessment.

CS 9600 is an extraoral system intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxilofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.

The CS 9600 can be upgraded to produce cephalometric digital X-ray images. This includes imaging the hand and wrist to obtain carpus image for growth and maturity assessment.

CS 9600 is a cone-beam computed tomography (CBCT) x-ray system. It means CS 9600 rotates around the patient, capturing data using a cone-shaped x-ray beam. These data are used to reconstruct a two or a three-dimensional (3D) image of the following regions of the patient's anatomy: dental (teeth); oral and maxillofacial region (mouth, jaw and neck); ears, nose and throat region (ENT); cervical spine or wrist region.

Additional features such as low dose mode, scout image and metal artifact reduction are also provided by the CS 9600.

The CS 9600 can also be upgraded with cephalometric modality. The cephalometric modality of the proposed device CS 9600 is the same than the one available in the reference device K151087. The cephalometric mode works with a narrow beam linear scanning process called a "slot technique". The patient head is scanned in lines with a flat, fan-shaped x-ray beam.

The provided text describes the CS 9600 device, an extraoral system for producing 2D and 3D digital X-ray images, and its substantial equivalence to predicate devices. It specifically details the addition of an optional cephalometric modality.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of acceptance criteria with specific quantitative thresholds. Instead, it describes performance through comparison to predicate devices and general statements about clinical effectiveness. The core "acceptance criteria" appear to be met by demonstrating substantial equivalence to these predicate devices.

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

The document does not explicitly state the sample size for the test set. It mentions "clinical images representative of the range of the different cephalometric radiological exams were taken." This implies a set of images was used, but the exact number is not provided. The data provenance (country of origin, retrospective/prospective) is also not stated.

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

The document states that "The cephalometric images were reviewed by a qualified expert." It indicates a single expert was used. The specific qualifications of this expert are not detailed beyond "qualified expert."

4. Adjudication Method for the Test Set:

No adjudication method is described. The review was conducted by a single "qualified expert."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No MRMC comparative effectiveness study was mentioned. The study focused on technical comparisons and single-expert clinical review, not on comparing human reader performance with and without AI assistance.

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

The device described is an X-ray imaging system, not an AI algorithm. Therefore, a standalone performance study of an algorithm independent of human interaction is not applicable in this context. The "performance testing" was for the imaging system itself.

7. The Type of Ground Truth Used:

For the cephalometric images, the ground truth was established through expert consensus (or rather, the opinion of a single "qualified expert") who "evaluated [the images] to be of acceptable clinical effectiveness for the proposed indications for use" and "deemed to be of a clinically usable diagnostic quality."

8. The Sample Size for the Training Set:

The document describes performance testing for an imaging device, not an AI algorithm. As such, there is no mention of a "training set" in the context of machine learning. The device's performance is established based on its physical characteristics, image quality, and regulatory compliance, rather than by training on a dataset.

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

As mentioned above, the concept of a "training set" for an AI algorithm is not applicable to the information provided for this medical imaging device.

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The CS 9600 is extraoral system intended to produce two-dimensional digital X-ray images of the dento-maxillofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.

CS 9600 is an extraoral system intended to produce two-dimensional digital X-ray images of the dento-maxilofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
CS 9600 is cone-beam computed tomography (CBCT) x-ray system. It means CS 9600 rotates around the patient, capturing data using a cone-shaped x-ray beam. These data are used to reconstruct a two or a three-dimensional (3D) image of the following regions of the patient's anatomy: dental (teeth); oral and maxillofacial region (mouth, jaw and neck); ears, nose and throat region (ENT); cervical spine or wrist region.
Additional features such as low dose mode, scout image, metal artifact reduction are also provided by the CS 9600.

The provided text describes the 510(k) summary for the CS 9600 device. However, it does not include specific acceptance criteria with numerical targets, nor does it detail a study that rigorously proves the device meets such criteria in terms of clinical performance or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Planmeca ProMax 3D Max, K160506) through technical comparisons and general performance testing.

Here's a breakdown of the information requested, based on the provided text, and highlighting what is not present:

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

The document does not explicitly state numerical acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy for specific diagnostic tasks). Instead, it states that "The images were reviewed by a qualified expert and were evaluated to be of acceptable clinical effectiveness for the proposed indications for use. The CS 9600 set of images were deemed to be of a clinically usable diagnostic quality." This is a qualitative statement of performance rather than a quantitative comparison against defined criteria.

A comparison of technical specifications between the CS 9600 and its predicate device is provided, which implicitly serves as a form of "performance" comparison to demonstrate similarity.

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 mentions "The performance testing for imaging applications was carried out taking clinical images representative of the range of the different radiological exams available." It does not specify the sample size of these clinical images, their provenance (country of origin), or whether they were collected retrospectively or prospectively.

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)

The document states: "The images were reviewed by a qualified expert." It refers to a singular "expert" and provides no details about their number, specific qualifications (e.g., years of experience, subspecialty), or how ground truth was established beyond a general review.

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

The document does not describe any specific adjudication method for establishing ground truth from multiple experts. It only mentions review by "a qualified expert."

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 MRMC comparative effectiveness study is mentioned. This device is an imaging system (CBCT scanner), not an AI-assisted diagnostic tool, so such a study would not be applicable in this context. The testing described is focused on the inherent imaging quality and clinical usability of the system itself, not its impact on human reader performance.

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

This question is not applicable as the CS 9600 is a CBCT imaging system, not an AI algorithm. Its "performance" refers to the quality of the images it produces for human interpretation, not an automated diagnostic output.

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

The ground truth was established by "a qualified expert" who "evaluated [images] to be of acceptable clinical effectiveness for the proposed indications for use." This implies an expert opinion/review rather than a definitive histological (pathology) or patient outcomes-based ground truth.

8. The sample size for the training set

This device is an imaging system, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI model development described in the document. The performance testing involves clinical images, but these are for testing the device's output, not for training an algorithm within the device.

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

As there is no training set mentioned for an AI model, this question is not applicable.

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CS Imaging is digital imaging software intended to be used with Carestream Dental's digital imaging devices by healthcare professionals to display, adjust, make measurement, print, export and store digitized images to support image diagnosis in medical care, predominantly in dentistry.

Not Found

Unfortunately, the provided text does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods for proving device performance.

The document is a 510(k) clearance letter from the FDA for a device called "CS Imaging." It primarily addresses the administrative details of the clearance, the device's classification, general regulatory requirements, and its indications for use. It confirms that the device is substantially equivalent to legally marketed predicate devices.

There is no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets, data provenance, or the number of experts.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance studies.
• The type of ground truth used or how it was established for either test or training sets.

The "Indications for Use" section (page 3) describes what the software is intended to do (display, adjust, measure, print, export, and store digitized images to support image diagnosis in dentistry), but it doesn't detail any performance metrics or studies to validate these functions beyond the general determination of substantial equivalence.

Therefore, I cannot fulfill the request using only the provided text.

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The RejuvatoneMD is intended for facial stimulation and is indicated for over-the-counter cosmetic use.

The RejuvatoneMD device is a non-invasive at-home facial stimulation device intended for cosmetic use. The device works by delivering low-level electrical microcurrent impulses through dual contact spheres to strategic locations on the face and allows users to adjust the output level for personalized comfort.

Here's an analysis of the provided text regarding the RejuvatoneMD device's acceptance criteria and studies, organized according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative format for performance of the device in its intended cosmetic use (e.g., "90% of users report improved skin tone"). Instead, the "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to a legally marketed predicate device and compliance with relevant safety and manufacturing standards.

The table below summarizes the technical characteristics comparison between the RejuvatoneMD (Subject Device) and its predicate (NuFACE® Mini Device). For performance specifications like maximum output voltage/current, pulse duration, frequency, etc., the "acceptance" is implied by demonstrating values that are similar to and within an acceptable range of the predicate device, and crucially, comply with IEC 60601-2-10 requirements.

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

• Usability/Label Comprehension Study:
  • Sample Size: 30 participants
  • Data Provenance: Not explicitly stated (e.g., country of origin). The document implies it was a prospective study conducted specifically for this device validation.
• Other Testing (Electrical Safety, Performance, EMC, Biocompatibility): These tests are typically laboratory-based and use technical samples of the device and its components, not human subjects, except for biocompatibility which is tested on materials. No sample size of specific user data is applicable here. The data provenance is laboratory testing against recognized standards.

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

• For the Usability/Label Comprehension Study, the ground truth was based on the participants' ability to correctly self-select, comprehend instructions, and use the device. This "ground truth" is a measure of user understanding and performance, not a clinical diagnosis or expert consensus on clinical outcomes. No external "experts" (like radiologists) are mentioned as establishing ground truth for this usability study. The study itself assesses whether lay users can achieve the intended "truth" of understanding and proper use.
• For the technical standards compliance (Electrical Safety, Performance, EMC, Biocompatibility), the "ground truth" is the established requirements and limits defined by the international consensus standards (IEC, ISO). The experts involved would be the engineers and technicians performing the tests and the standard-setting bodies, not individual experts assessing specific cases.

4. Adjudication Method for the Test Set

• For the Usability/Label Comprehension Study, the "adjudication method" was based on whether participants could "correctly" perform specific tasks. This would have been predetermined criteria defined in the study protocol (e.g., "User correctly identifies appropriate use for the device" or "User correctly selects power level"). It's not an expert adjudication in the sense of clinical disagreement.
• For technical testing, compliance is typically determined by measurements falling within specified ranges or passing defined test procedures. There is no "adjudication" in the clinical sense.

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 MRMC study was done. This device is a direct-to-consumer microcurrent facial stimulator, not an AI-powered diagnostic imaging tool. Therefore, the concept of "human readers improving with AI vs. without AI assistance" is not applicable.

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

• A standalone performance was done, but not in the context of an "algorithm." The core of the submission relies on the standalone electrical and mechanical performance of the device as measured against international safety and performance standards (IEC, ISO). The device's technological characteristics are compared directly to the predicate device. The usability study is also a form of standalone performance assessment – how well does a human user interact with the device as designed.

7. The Type of Ground Truth Used

• Usability/Label Comprehension Study: User performance and comprehension against pre-defined correct actions and understanding gleaned from the labeling.
• Technical Performance (Electrical Safety, EMC, Biocompatibility): Compliance with international consensus standards (IEC, ISO) and comparison of technical specifications to the legally marketed predicate device. This is primarily objective, measurable physical parameters.
• Substantial Equivalence: Comparison to the technological characteristics, intended use, and safety profile of a legally marketed predicate device (K133823 – NuFace Mini).

8. The Sample Size for the Training Set

• Not applicable. This device is hardware for electrical stimulation. There is no "training set" in the machine learning sense. The device's design and parameters are based on established electrical engineering principles and the specifications of predicate devices.

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

• Not applicable, as there is no training set. The "ground truth" for the device's design parameters is derived from engineering principles, safety standards, and established performance of similar predicate devices.

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The HairMD is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa-V and for both, Fitzpatrick Classification of Skin Phototypes of I-IV.

The HairMD consists of 21 red, visible-light, continuous wave diode lasers operating at 650 nanometers and 30 super luminescent light emitting diodes (LEDs), operating at 650 nanometers that are configured within a protective inner liner and outer helmet. The HairMD is physically similar to the iGrow Hair Growth System, except that it does not contain earphones or inner liner spacers. The use of these specific number of diode lasers and LEDs, provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. This is achieved by a safety interlock. At the beginning and end of a therapy session, audible tones are delivered to the user, indicating that therapy has begun (2 beeps) or ended (one long beep). The system is powered by line voltage, operating at 110/220 volts.

The provided text describes a 510(k) premarket notification for the HairMD device, an infrared lamp intended to promote hair growth. However, it explicitly states that "No clinical trial data for the HairMD was submitted for this 510(k)." Therefore, a study proving the device meets acceptance criteria, as well as several of the requested data points (like sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, and training set details), are not available in this document.

The submission focuses on demonstrating substantial equivalence to predicate devices (iGrow Hair Growth System and Hairmax Lasercomb) based on technological characteristics and intended use.

Here's a breakdown of what can be extracted and what cannot:

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

The document does not provide specific acceptance criteria or clinical performance data for the HairMD device. It states: "No clinical trial data for the HairMD was submitted for this 510(k)."

However, it does mention that the device was tested for conformance with safety standards.

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

• Sample Size for Test Set: Not applicable, as no clinical trial data was submitted.
• Data Provenance: Not applicable, as no clinical trial data was submitted.

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

• Not applicable, as no clinical trial data was submitted and thus no ground truth for a test set was established.

4. Adjudication method for the test set

• Not applicable, as no clinical trial data was submitted.

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 MRMC comparative effectiveness study was done. This device is not an AI-assisted diagnostic tool; it's a therapeutic device.

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

• Not applicable. This device is a therapeutic device, not an algorithm.

7. The type of ground truth used

• Not applicable, as no clinical trial data was submitted. The substantial equivalence argument relies on the established safety and efficacy of the predicate devices and the HairMD's comparable technological characteristics.

8. The sample size for the training set

• Not applicable, as no clinical trial data was submitted for the HairMD device itself. The device is not based on a machine learning model that requires a training set.

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

• Not applicable (see point 8).

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The CS 8100SC and the CS 8100SC Access are intended to produce complete or segmented tomographic digital panoramic and cephalometric digital X-ray images to be used at the direction of healthcare professionals of the dentomaxillofacial region of the human anatomy as diagnostic support for pediatric and adult patients. This includes imaging the hand and wrist to obtain carpus image for growth and maturity assessment.

In addition, the CS 8100SC is provided with the panoramic radiological exam option which allows the display of one determined segment of the dental structures using the capability of the system to explore each slice during an exam.

Not Found

This document is a 510(k) summary for the CS 8100SC and CS 8100SC Access dental X-ray systems. It primarily describes the FDA's substantial equivalence determination and the indicated uses of the device.

Unfortunately, the provided document does not contain the requested information about acceptance criteria, specific study details, sample sizes for test or training sets, expert qualifications, or ground truth establishment. This type of detailed performance testing data for novel algorithms or specific diagnostic claims is typically found within the 510(k) submission, not in the FDA's decision letter or "Indications for Use" statement.

The document states that the devices are "intended to produce complete or segmented tomographic digital panoramic and cephalometric digital X-ray images... as diagnostic support... This includes imaging the hand and wrist to obtain carpus image for growth and maturity assessment." This indicates the general purpose, but not the quantitative performance metrics or the studies proving those metrics.

To answer your questions, the relevant information would need to be extracted from the full 510(k) submission, specifically the sections detailing performance testing and clinical evaluations, which are not included in this extract.

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CS 3D Imaging is digital imaging software intended to be used with Carestream's 3D extra-oral X-ray equipment by healthcare professionals to display, make measurement, print, export and store 2D and 3D views of the dento-maxillofacial and ENT (Earn, Nose and Throat) region of the human anatomy as diagnostic support.

It is also a software application used for the management of the implant library and the virtual placement of dental implants.

It can be used as stand-alone software in a standard computer and does not perform any radiographic image acquisition.

CS 3D Imaging is digital imaging software intended to be used with Carestream's 3D extra-oral X-ray equipment by healthcare professionals to display, make measurement, print, export and store 2D and 3D views of the dento-maxillofacial and ENT (Earn, Nose and Throat) region of the human anatomy as diagnostic support.

It is also a software application used for the management of the implant library and the virtual placement of dental implants.

It can be used as stand-alone software in a standard computer and does not perform any radiographic image acquisition.

I apologize, but the provided text from the FDA 510(k) summary for "CS 3D Imaging" is a general notification letter and an "Indications for Use" statement. It does not contain any information regarding acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

To answer your request, I would need a detailed performance study report or a section of the 510(k) submission specifically describing the validation studies and their results.

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The Rejuvalite MD is an Over the Counter device that is intended for the treatment of full face wrinkles.

The Rejuvalite MD, is a tabletop device that contains 120 LEDs split evenly into 4 different wavelengths. The total power density for combined wavelengths is approximately 62 mW/cm2 at a distance of 4" from the illuminating surface of the device. The labeling requires Users to maintain the distance between the illuminating surface and the treatment site at 4"during the treatment. There is a 4" distance limiting arm attached to the device to help users on determining and maintaining the 4" distance between the device's illuminating surface and the treatment site. The Rejuvalite MD system components include the tabletop unit consisting of the base, arm, and swivel head containing the LED module , 4" distance limiting arm, timer, internal UL approved power adapter, and goggles. The device incorporates a power adapter mounted inside of the lamp base that converts the AC to DC voltage. The power switch is operated to turn the device on or off. The unit is designed to be placed on a table for easy exposure to the face to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Over the Counter (OTC).

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Rejuvalite MD device. Please note that the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo clinical study with strict acceptance criteria for a novel device. Therefore, some of the requested information, particularly regarding detailed clinical acceptance metrics and their achievement, may not be explicitly stated in the context of this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the document, the "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device, particularly regarding safety, effectiveness, and key technical specifications. There are no explicit quantitative clinical performance acceptance criteria listed.

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

• Test Set Description: The primary "test set" described is for a Usability/Label Comprehension Study.
• Sample Size: 36 participants.
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. Given it's a usability study for an OTC device being submitted for FDA clearance, it would almost certainly be a prospective study conducted within a population relevant to the U.S. market.

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

This type of information is generally not applicable to a usability/label comprehension study. The "ground truth" for this study is essentially the participants' ability to understand instructions and use the device. There's no clinical "ground truth" (e.g., presence of a disease) being established by experts in this context.

4. Adjudication Method for the Test Set

Not applicable to a usability/label comprehension study as described. The outcomes (comprehension percentage, successful use percentage) are direct observations of participant interaction.

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, an MRMC comparative effectiveness study was not done.
• This device is a light therapy device for wrinkles, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and "human readers improve with AI vs without AI assistance" are not relevant to this submission.

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

Again, this question is not applicable to
the Rejuvalite MD device. It is a physical light therapy device, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the usability study, the "ground truth" was directly observed user performance and self-reported comprehension. For the broader claim of effectiveness for wrinkle treatment, the device relies on substantial equivalence to a predicate device (LightStim for Wrinkles, K120775) which was presumably established through its own clinical data or literature at the time of its clearance. The Rejuvalite MD itself did not perform independent clinical outcomes data to establish de novo effectiveness.

8. The Sample Size for the Training Set

Not applicable. The Rejuvalite MD is a physical device, not an AI/algorithm 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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Carestream's Dental Imaging Software is intended to be used with Carestream's dental digital imaging devices by healthcare professionals to display, adjust, measure, print and store 2D digital images of the dento-maxillofacial region of the human anatomy to support image diagnosis.

Dental Imaging Software

The provided documents (K141607) contain an FDA 510(k) clearance letter for "Dental Imaging Software" and its "Indications for Use." However, these documents do not describe acceptance criteria, a study that proves the device meets acceptance criteria, or any of the detailed information requested regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.

The 510(k) clearance process primarily demonstrates substantial equivalence to a legally marketed predicate device, not necessarily detailed performance metrics against specific acceptance criteria.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be said based on the provided text, and what cannot:

Information that CANNOT be found in the provided document:

• A table of acceptance criteria and the reported device performance: This document does not detail specific performance metrics, such as sensitivity, specificity, accuracy, or any quantitative acceptance criteria.
• Sample sized used for the test set and the data provenance: No test set information is provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment details are provided.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: No adjudication method is described.
• 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 MRMC study or AI assistance is mentioned. The device is described as "Dental Imaging Software" for display, adjustment, measurement, print, and storage of images, implying a viewing and processing tool rather than an AI diagnostic aid.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone performance is discussed, as the device is for use "by healthcare professionals to display, adjust, measure, print and store."
• The type of ground truth used (expert concensus, pathology, outcomes data, etc): No ground truth type is specified.
• The sample size for the training set: No training set information is provided.
• How the ground truth for the training set was established: No training set ground truth establishment details are provided.

Information that CAN be inferred or directly stated from the provided document:

The primary "acceptance criterion" for this 510(k) clearance, as stated in the letter, is substantial equivalence to a legally marketed predicate device. The letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

The study that "proves" this equivalence is the 510(k) submission itself, which typically includes comparisons to predicate devices regarding technological characteristics, safety, and effectiveness. However, no details of this submission are present in the provided text.

Summary based on available information:

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