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755 nm: The CLARITY II 755 nm Laser System is indicated for temporary hair reduction and stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime on all skin types (Fitzpatrick 1-VI) including tanned skin. The 755 nm laser is also indicated for treatment of benign pigmented lesions, vascular lesions and wrinkles.

1064 nm: The CLARITY II 1064 nm Laser System is indicated for stable long term or permanent hair reduction and for treatment of PFB (Pseudofolliculitis Barbae) on all skin types, Fitzpatrick I -VI, including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The 1064 nm laser is also indicated for coagulation and hemostasis of soft tissue, for hemostasis of vascular lesions such as but not limited to port wine stains, hemangiomna, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The 1064 nm laser system is also indicated for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, (significant reduction in the intensity of black and/or blue- black tattoos) and plaques. The 1064 nm Laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

The CLARITY II Laser System contains two separate resonators, an Alexandrite resonator and an Nd: YAG (Neodymium-doped Yttrium Aluminum Garnet) resonator which generates pulsed laser energy at the nominal wavelength 755 nm and 1064 nm, respectively. The outputs of each laser generator and the aiming beam are optically combined on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system for either the 755 nm or 1064 nm wavelength. It is a medical device, designed for specific clinical applications, emitting laser energy via a handpiece and controlled by the user with a handpiece finger switch or optional footswitch. The CLARITY II Laser System consists of a system main body with an LCD touch screen, optical fiber with an AC or ICD handpiece.

The provided text is a 510(k) summary for the CLARITY II Laser System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed performance studies with acceptance criteria, ground truth, or statistical analysis typical for a de novo or PMA submission of an AI-powered diagnostic device.

Therefore, the specific information requested in the prompt about acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training is not present in this document. The device in question is a laser system for dermatological treatments, not an AI diagnostic tool.

However, I can extract the information that is available and clarify what is missing based on your prompt.

Summary of Device Performance and Equivalence

The CLARITY II Laser System is being submitted as substantially equivalent to the CLARITY LPC Laser System (K130199) and the Elite + Laser (K141425). Substantial equivalence means that the device has the same intended use and technological characteristics as the predicate device, or if there are differences, they do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are inferred to be the characteristics of the predicate devices which the CLARITY II aims to match or demonstrate non-significant difference from, to achieve substantial equivalence. No explicit performance metrics or thresholds are stated as "acceptance criteria."

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

• Not Applicable / Not Provided. The submission states: "No performance data has been provided since the CLARITY II Laser System is equivalent to the previously cleared predicate devices with no new issues regarding safety and effectiveness." This indicates that no new clinical study with a test set was conducted for this 510(k) submission.

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

• Not Applicable / Not Provided. No clinical test set or ground truth determination is described in this submission.

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

• Not Applicable / Not Provided. No clinical test set or adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable / Not Provided. This device is a laser system and not an AI diagnostic tool that would typically undergo an MRMC study related to human reader performance with AI assistance.

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

• Not Applicable / Not Provided. This device is a physical laser system, not an algorithm, so "standalone performance" in the context of an algorithm is not relevant.

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

• Not Applicable / Not Provided. No clinical ground truth determination is described as no new clinical studies were submitted.

8. The sample size for the training set

• Not Applicable / Not Provided. This submission does not describe a training set as it's not an AI/ML algorithm submission.

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

• Not Applicable / Not Provided. As no training set is described, no ground truth establishment for it is mentioned.

Additional Information from the Document:

• Bench Testing: The device complies with applicable standards: ISO 13485:2016, ISO 60601-1 (electrical safety), and IEC 60601-1-2 (electromagnetic compatibility). These are considered part of the performance data to demonstrate safety and effectiveness for substantial equivalence.
• Clinical Testing: The document explicitly states: "No performance data has been provided since the CLARITY II Laser System is equivalent to the previously cleared predicate devices with no new issues regarding safety and effectiveness." This means the submission relies on the established safety and effectiveness of the predicate devices.
• Differences from Predicates: The CLARITY II includes a skin temperature monitoring feature (for informational purposes only) and an Intelligent Tracking Tip (ensures selectable overlap of contiguous pulses). The submission argues these differences "do not affect the safety and effectiveness of the subject device."

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Clarity Reveal is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning. Clarity Reveal is designed for use by healthcare professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.

Clarity Reveal is a software-only device that allows clinicians to review CT and MR image data in three-dimensional (3D) format and/or stereoscopic 3D format (commonly known as virtual reality, or VR). The 3D and VR images are accessible through the Clarity Reveal mobile application which is used by clinicians for preoperative planning.

Clarity Reveal includes two main software-based user interface components, the Processing Interface and Viewer Interface. The Processing Interface is hosted on a cloud-based, virtual workstation and only accessed by authorized personnel, such as an imaging technician. The Processing Interface contains a graphical user interface where an imaging technician can select DICOM-compatible medical images, segment such images, and initiate processing into a 3D format. The Viewer Interface is a mobile application that is accessible via a compatible, touchscreen enabled, off-the-shelf mobile device to allow for clinicians to review the medical images in 3D and/or VR formats. Only when the compatible mobile device is used in conjunction with a compatible off-the-shelf VR headset can the surgeon view medical images in the VR format.

The product is intended to be used by trained medical professionals, including imaging technicians and clinicians/surgeons, and is used to assist in clinical decision making.

This document describes the Ceevra Clarity Reveal device, a software-only medical imaging system. The provided text is a 510(k) summary submitted to the FDA, detailing the device's intended use, description, and comparison to a predicate device. However, it does not contain specific acceptance criteria or the study data proving the device meets those criteria.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications
• Adjudication method
• MRMC comparative effectiveness study details
• Standalone performance details
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

The document only states the following regarding performance:

• Performance Data (Section 7): "Safety and performance of Clarity Reveal has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Additionally, the software validation activities were performed in accordance with IEC 62304:2006/AC: 2008- Medical device software - Software life cycle processes, in addition to the FDA Guidance documents, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' and 'Content of Premarket Submission for Management of Cybersecurity in Medical Devices.'"

This statement indicates that verification and validation were performed to ensure the device met software specifications and applicable performance standards, and that the process followed relevant international standards and FDA guidance. However, it does not disclose the specific performance metrics, acceptance criteria, or the results of those tests.

The 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device (EchoPixel True3D Viewer K142107) based on intended use, technological characteristics, and general safety/performance verification, rather than providing detailed clinical study results or quantitative performance criteria.

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Clarity® is indicated for use in external beam radiation therapy. It provides 3D ultrasound and hybrid imaging of soft tissue anatomy to aid in radiation therapy simulation and planning, and to guide patient positioning prior to the delivery of treatment (Image Guided Radiation Therapy).

When configured with an autoscan probe kit for transperineal ultrasound (TPUS) imaging, Clarity® may be used to continuously track and monitor the prostate and to accurately and precisely guide patient positioning during the delivery of treatment (Intrafractional Position Tracking and Monitoring).

When configured with a gating option, Clarity® may also interface with radiation delivery systems equipped with a compatible external gating control device. With this option, while in tracking and monitoring mode, Clarity® can signal the radiation delivery system to automatically impose a beam-hold when the tracked anatomy has exceeded pre-defined monitoring (tracking) limits, and signal again to release the tracked anatomy returns to a position within those limits (Exception gating has been shown to be compatible with radiation delivery systems equipped with Elekta's Response™ Gating Control System.

The Clarity® system integrates medical diagnostic ultrasound, real-time optical position tracking and proprietary software to acquire and reconstruct 3D images of soft-tissue anatomy for use in external beam radiation therapy. Clarity® offers a non-invasive, non-ionizing means for accurate and precise localization of anatomical structures and patient positioning relative to the treatment isocenter.

The Clarity® system (Model 310C00) is configured around a mobile image acquisition station with an integrated ultrasound scanner, high-resolution touch screen, and high-performance computer system running the Clarity® software. It may be used at the patient's side in the CT-Sim room (Clarity® Sim) and the treatment room (Clarity® Guide) when equipped with a ceiling-mounted optical tracking system, patient/couch position tracking tools and, optionally, remote control and treatment monitoring equipment. With the gating option, the Clarity® Guide acquisition station may interface with radiation delivery systems equipped with a compatible external gating control device.

Each acquisition station is configured with up to three optically-tracked ultrasound probes: one or two hand-held probes for manual scanning and a motorized (autoscan) probe for automated scanning. The user can select the probe and scanning method that is most appropriate for the target anatomy and the patient's clinical presentation. The autoscan probe remains in contact with the patient for continuous imaging of the prostate and surrounding anatomy using specifically designed positioning apparatus for transperineal ultrasound (TPUS); it is operated from the acquisition station's remote control and monitoring equipment interface (touch-screen identical to that on the mobile acquisition station).

A multimodality imaging phantom is used to calibrate Clarity® to the room coordinate system and to verify system integrity for sub-millimeter target localization accuracy and precision within each room (daily and monthly QC).

A dedicated high-performance server and workstation computer system running the Clarity® software is connected to Clarity® acquisition stations through the hospital's local area network. The server houses the central database and web server, and provides for interoperability with other imaging and treatment planning/simulation systems via the DICOM 3/RT protocol. The workstation is used for multimodality image fusion and review, soft-tissue structure definition, approval of patient positioning references, setup of monitoring parameters, and review of treatment and QC data. Optionally, additional Clarity® workstations may be connected to the central Clarity® server.

The Clarity® software is designed to step the user through a radiation therapy workflow or "course" and QC procedures. Different courses are defined to help classify patients in the database and to present the user with reminders, default choices and configuration settings tailored to the target anatomy (e.g., prostate, bladder, liver, uterus & cervix, breast, head & neck). Such configurations include probe type, imaging (scan) presets, contouring and assisted segmentation tools, alert values for target misalignment, and prostate monitoring (tracking) parameters.

The typical use of the system for a radiation therapy course begins with the acquisition of a baseline 3D ultrasound (3DUS) scan with the patient in the planning position. The planning CT is imported, registered and fused with the 3DUS on the Clarity® workstation to verify the alignment of the target anatomy. The structures of interest are then defined and a baseline positioning reference including, if applicable, monitoring (prostate tracking) parameters are approved. Optionally, the 3DUS and related contours may be exported via DICOM to a third-party virtual simulator or treatment planning system.

To assist with patient positioning prior to each treatment session, a new 3DUS scan is acquired and used to determine target displacement relative to the baseline planning-day position. Optical tracking of couch position allows for accurate and precise patient repositioning relative to the treatment isocenter (Image Guided Radiation Therapy).

Automatic image analysis identifies a soft-tissue structure such as the prostate in successive transperineal 3DUS images, which are acquired continuously during treatment, and allows Clarity® to track its motion and assist with patient repositioning (Intrafractional Position Tracking and Monitoring). When configured with the gating option, while in tracking and monitoring mode, Clarity® can signal the radiation delivery system to automatically impose a beam-hold when the tracked structure position has exceeded pre-defined monitoring (tracking) limits, and signal again to release the beam-hold when the structure returns to a position within those limits (Exception Gating).

Clarity® may optionally be configured to send calculated couch shifts for patient repositioning to the operator at the couch control user interface using the MOSAIQ® Workflow Manager.

A web-based interface is available for remote review and approval of positioning references and other treatment parameters, and review of completed treatment session and QC procedure data.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in a quantitative format. Instead, it generally states that the device fulfills its design and risk management requirements and localization accuracy and precision specifications were verified.

However, based on the narrative, we can infer some implied performance expectations:

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

The document does not explicitly state the sample size for a "test set" in terms of patient data. The testing primarily focuses on device verification and validation using phantoms and simulated conditions.

• Sample Size: Not explicitly stated for patient data. The document mentions "multimodality phantoms" for accuracy and precision verification and "simulated treatment conditions" for exception gating validation. It also mentions "representative end-users" for human factors evaluations.
• Data Provenance: Not applicable in the context of patient data for performance claims, as the testing described is primarily focused on phantom studies and simulated use, not clinical performance studies with patient data.

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

This information is not provided. The ground truth for the device's accuracy and precision was established using "multimodality phantoms" and validated against their known properties. For usability, "representative end-users" were involved, but their qualifications are not detailed beyond "end-users."

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the described testing (phantom studies, simulated conditions), a formal adjudication method for a test set of clinical cases is unlikely to have been employed or documented here.

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 involving human readers and AI assistance is mentioned. The device, Clarity®, is presented as an image-guidance system, not an AI-assisted diagnostic tool for human readers.

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

Yes, standalone performance was assessed for the core functions of the device.

• Localization Accuracy and Precision: Verified using "multimodality phantoms." This implies testing the device's ability to localize targets against a known physical ground truth independent of human interpretation during the measurement phase.
• Exception Gating: "Validated with Elekta's Response™ Gating Control System under simulated treatment conditions." This suggests the algorithm's ability to trigger beam-holds based on defined limits was tested in an automated, standalone manner.

7. The Type of Ground Truth Used

• Localization Accuracy and Precision: Ground truth was established using multimodality phantoms with known, precise physical properties.
• Exception Gating: Ground truth was established through simulated treatment conditions which would have defined parameters for when a beam-hold should be triggered.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of a machine learning or AI model that requires training data. Clarity® appears to be an image guidance system based on established ultrasound and optical tracking technologies, not a system that relies on a large dataset for machine learning training.

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

Not applicable as no "training set" is mentioned or implied for a machine learning component. The system's functionality is based on physics, engineering, and software development, with calibration and verification against known physical standards.

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755mm: The CLARITY LPC Laser System is indicated for temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. On all skin types (Fitzpatrick I-VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

1064nm: The CLARITY LPC Laser System is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles.

The CLARITY LPC Laser System contains two separate laser resonators, an Alexandrite resonator and an Nd: YAG (Neodymium-doped Yttrium Aluminum Garnet) resonator which generates pulsed laser energy at the nominal wavelength 755 nm and 1064 nm, respectively. The outputs of each laser generator and the aiming beam are optically combined on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system for either the 755 nm or 1064 nm wavelength. The control panel is equipped with an LCD touch screen so that users can easily adjust parameters for optimal settings. The software included provides all the function which is necessary to use the device. The CLARITY LPC laser system is configured with an ICD (Intelligent Cooling Device) skin cooling device. The CLARITY LPC Laser System delivers laser energy with various pulse durations from 0.35 milliseconds to 300 milliseconds. The output of this laser is delivered to the area of treatment by means of a lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end. A trigger switch (finger switch or footswitch) is used to control the delivery of laser pulses. The user may choose to deliver a single pulse each time the trigger switch is depressed, or pulses may be delivered repetitively as long as the switch is depressed, at repetition rates up to 10 pulses per second (depending on the chosen pulse duration). The laser output energy is delivered via an optical fiber to a handpiece which produces circular beams with diameters from 2 to 20 millimeters on the skin. Operators of the laser select parameters such as desired energy density (fluence) level and repetition rate and monitor operation via a touch screen and display panel. The touch screen panel can also be used to enable or disable the triggering of the laser, to initiate the calibration feature and to obtain feedback from the system.

The provided document is a 510(k) summary for the Lutronic Corporation CLARITY LPC Laser System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving clinical efficacy through extensive studies with specific acceptance criteria in the same way a PMA (Pre-Market Approval) or clinical trial would.

Therefore, the document explicitly states: "7. Performance Data None presented."

This clearly indicates that the submission does not contain a detailed study proving the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity. Instead, the submission relies on demonstrating substantial equivalence to a previously cleared device (Candela Corporation GentleMAX Family of Laser Systems, K112715) by comparing technological characteristics (wavelengths, laser source, indications for use, treatment parameters, etc.).

Given this explicit statement, I cannot provide the requested information about acceptance criteria, a study proving it, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text.

The document's purpose is to show that the new device is as safe and effective as the predicate device without needing new clinical performance data, as the technological characteristics and intended uses are highly similar.

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Clarity® is indicated for use in external beam radiation therapy, to provide 3D ultrasound and hybrid imaging of soft-tissue anatomy to support radiation therapy simulation and planning, and to guide patient positioning prior to the delivery of treatment.

Clarity® may also be used with an Autoscan Probe for transperineal ultrasound (TPUS) imaging, to continuously monitor the motion of the prostate and to accurately guide patient positioning during the delivery of treatment (i.e., intra-fractionally).

Clarity® integrates medical diagnostic ultrasound and a real-time optical measurement system, which determines the 3D position of the ultrasound probes, to acquire and reconstruct 3D images of soft-tissue anatomy for use in external beam radiation therapy. During the course of treatment, non-ionizing 3D ultrasound imaging and optical tracking of couch position with Clarity® offers a noninvasive means for accurate localization of anatomical structures and patient positioning.

Clarity® comprises the following functional components:

• The Clarity® Acquisition Station is configured around an ultrasound console, which may be suspended from an articulated arm or mounted on a cart, with an integrated computer system and high-resolution touch screen. Acquisition stations are placed in the CT-Sim room (Clority® Sim) and the treatment room (Clority® Guide), with a celling-mounted optical measurement system and patient/couch position tracking tools.
• Each acquisition station is equipped with optically-tracked ultrasound probes; one or two hand-held probes for manual scanning and a motorized (Autoscan) probe for automated scanning. The user can select the probe and scanning method that is most appropriate for the given target anatomy and the patient's clinical presentation. The Autoscan probe includes a positioning apparatus that is specifically designed for transperineal imaging. The Autoscan probe remains in place during a CT-Sim scan and during radiation treatment; scanning is controlled from a remote console interface.
• A multimodality phantom is used for image calibration to the room's coordinate system that is defined by the corresponding room lasers, and for daily verification of system integrity for sub-millimeter target localization accuracy within each room.
• One or more dedicated workstation computer systems, connected to the hospital's local area network, are used for multimodality image fusion and review, soft-tissue structure definition, approval of patient positioning references, and review of treatment sessions.
• A dedicated central server computer system (typically combined with a workstation) houses the patient database and provides for interoperability with other imaging and treatment planning/simulation systems using the DICOM 3/RT protocol.

The Clarity® software is designed to step the user through a radiation therapy workflow or "course." Different courses are defined (e.g., "Prostate", "General", "QC") to help classify patients in the database and to present the user with default choices and settings, tailored for the target anatomy (e.g., prostate, bladder, liver, uterus & cervix, breast, head & neck) and daily QC. Such configurations include probe type, scan settings, contouring and assisted segmentation tools, and alert values for target misalignments.

At the time of CT-Simulation, a 3D ultrasound (3DUS) scan is acquired with the patient in the planning position. At the Workstation, the planning CT is imported and fused with the 3DUS, the structure of interest is defined, and a baseline positioning reference is approved. The 3DUS may be exported via DICOM to a third-party virtual simulator or treatment planning system (TPS),

In the treatment room, a 3DUS scan is used to determine target displacement relative to the baseline planning-day position, and to guide patient positioning prior to treatment.

When used with the Autoscan probe, Clarity® allows for continuous imaging of the prostate and surrounding anatomy to enable precise motion management during the delivery of treatment (i.e., intra-fractionally).

To assist with the clinical workflow, Clarity® can be configured to send calculated couch shifts to the operator at the couch control user interface.

A web-based software interface is available with Clarity® for remote review of treatment session data and positioning references.

Given the provided text, the device in question is Clarity®, a patient positioning system for ultrasound, indicated for use in external beam radiation therapy, and specifically for continuous monitoring of prostate motion during treatment with an Autoscan Probe.

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

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

The document does not explicitly state quantitative acceptance criteria in a clear, tabulated format. However, it mentions qualitative statements about performance and verification.

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 for Test Set: The document mentions "actual patients" for the prostate motion tracking study, but does not specify the number of patients or the sample size.
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Not explicitly stated, but the description "continuous monitoring sessions with actual patients under simulated treatment conditions" suggests a prospective observational study. The usability study was a "simulated use" study.

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

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set.

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

The document does not specify any adjudication method for the test set.

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

The document describes a "side-by-side comparison with the Calypso® 4D Localization System" concerning "clinical performance for prostate motion tracking." This comparison is mentioned as a way to demonstrate the device's performance, but it is not described as an MRMC comparative effectiveness study where human readers improve with AI vs without AI assistance. The Clarity® device itself performs the "automatic image analysis and contouring of soft-tissue structures" to track motion, rather than assisting human readers in a diagnostic or interpretive task where improvement metrics like effect size would be quantified in the manner described.

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

Yes, a standalone performance assessment was done for the algorithm's capability.
The text states: "4D monitoring with Clarity® is based on automatic image analysis and contouring of soft-tissue structures, such as the prostate, in transperineal 3DUS images, which are continuously acquired during treatment. This is an expanded capability over the predicate Clority® OBP System, in that the Clority® software is now able to identify the soft-tissue target and track its motion over successive 3DUS images." This description clearly indicates an algorithm-only function (automatic image analysis and contouring, tracking motion over successive images).

Additionally, "Localization accuracy and precisions have been verified with multimodality phantoms," which would typically be a standalone performance test.

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

The document mentions a "side-by-side comparison with the Calypso® 4D Localization System" for prostate motion tracking. In this context, the Calypso® 4D Localization System (which tracks electromagnetic signals from implanted markers) likely served as the reference or "ground truth" for the prostate motion, against which Clarity's performance was evaluated.

For "localization accuracy and precisions," the ground truth was derived from multimodality phantoms, which have known, precise target locations.

8. The sample size for the training set

The document does not provide any information about the sample size used for a training set. This is not uncommon for 510(k) summaries, which often focus on verification and validation studies rather than detailed development data.

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

The document does not provide any information on how ground truth was established for a training set, as it does not mention a training set.

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The Clarity™ OBP System is intended for use in external beam radiation therapy, to provide 3D ultrasound and hybrid imaging of soft-tissue anatomy to support radiation therapy simulation and planning, and to guide patient positioning prior to the delivery of treatment.

The Clarity™ OBP System integrates medical diagnostic ultrasound and optical position tracking to acquire and reconstruct three-dimensional ultrasound (3DUS) images of soft-tissue anatomy for use in external beam radiation therapy. During the course of radiation therapy, the Clority™ OBP System offers a non-ionizing means for daily localization of target anatomical structures.

The Clarity™ OBP System comprises the following functional components:

• The 3DUS imaging station (typically one in the CT-simulation room and one in the treatment . room}, including the 3DUS console with an integrated computer system and opticallytracked ultrasound probes, patient/couch position tracking tools, and a ceiling-mounted optical tracking system.
• . A multimodality phantom, for 3DUS image calibration to the room's coordinate system defined by the corresponding room lasers, and for daily verification of system integrity.
• . One or more dedicated workstation computer systems for multimodality image fusion and review, soft-tissue structure definition, approval of patient positioning references, and monitoring of treatment progress.
• . A dedicated central server computer system (typically combined with a workstation), which houses the patient database and provides for interoperability with other imaging and treatment planning/simulation systems using the DICOM 3/RT protocol.

All networked Clarity™ OBP System stations are configured to run the same software version. The software interface is designed to 'walk' the user through a sequence of steps (or "course") to acquire 3DUS scans in the planning position, import planning CT data and fuse with 3DUS, define the structure of interest and approve a baseline positioning reference, acquire another 3DUS in the treatment position to determine target displacement relative planning-day position, and adjust patient positioning prior to treatment. The 3DUS data may be exported through DICOM to a third-party virtual simulator or treatment planning system (TPS).

Different courses are defined in the software (e.g., "Prostate", "General", "QC") to help classify patients in the database and to present the user with default choices and settings, tailored for the target anatomy (e.g. prostate, bladder, liver, uterus & cervix, breast, head & neck) and daily QC tasks. Such configurations include probe type, scan settings, contouring and assisted segmentation tools, and alert values for large target misalignments.

The Clarity™ OBP System provides the option for hand-held ultrasound scanning or automated scanning with a motorized probe. The user can select the probe and scanning method that is most appropriate for the given target anatomy and the patient's clinical presentation. The autoscan probe comes with a probe holder apparatus and a remote control console, specifically designed to facilitate transperineal imaging of the prostate and surrounding soft tissues.

The Clarity™ OBP System also includes an optional web-based interface for remote review of treatment session data and positioning reference images.

The provided text does not contain specific acceptance criteria or details of a study with reported device performance metrics in tabular or descriptive form. The document is a 510(k) summary for the Clarity™ OBP System, primarily focusing on its intended use, device description, comparison to predicate devices, and a general statement about verification and validation testing.

Here's what can be extracted based on the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific acceptance criteria or reported device performance metrics (e.g., accuracy, precision, sensitivity, specificity) are provided in the document. The text only states that "The verification test results demonstrate that this next-generation device fulfills design and risk management requirements, and performs well in accordance with established specifications for its intended use."

2. Sample Size for Test Set and Data Provenance:

The document broadly mentions "clinical settings under conditions of simulated use" for testing but does not specify any sample sizes (e.g., number of patients, number of images) for a test set. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth:

This information is not provided in the document.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

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

The document does not mention an MRMC comparative effectiveness study or any effect sizes related to human readers' improvement with or without AI assistance. The Clarity™ OBP System is described as a patient positioning system utilizing 3D ultrasound and optical tracking, not an AI-assisted diagnostic or interpretive tool in the context of human reader performance.

6. Standalone (Algorithm Only) Performance:

The document describes the Clarity™ OBP System as an integrated system involving hardware and software for acquiring and reconstructing 3D ultrasound images to guide patient positioning for radiation therapy. It does not present a standalone algorithm performance study. The system provides tools for image fusion, contouring, and defining positioning references, but the document does not detail an "algorithm only" performance separate from the overall system's function with a human in the loop (the user).

7. Type of Ground Truth Used:

The document mentions "definition of a positioning reference" and "define the structure of interest" as part of the system's function. The "ground truth" implicitly refers to the accurate localization of target anatomical structures for radiation therapy. However, the exact method for establishing this ground truth for validation purposes (e.g., expert consensus based on other imaging modalities like CT, pathology, or direct outcome data) is not explicitly stated.

8. Sample Size for the Training Set:

This information is not provided in the document. The system uses "predefined "courses" tailored for the target anatomy" and "assisted segmentation tools," which implies some form of training data or rules, but no details on size are given.

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

This information is not provided in the document.

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Clarity™ Advanced Ceramic Brackets are intended for use in orthodontic treatment. The brackets are affixed to teeth so that pressure can be exerted on the teeth.

Clarity Advanced Ceramic Brackets are intended to teeth, upon which an orthodontic wire is used to move the teeth to new positions. Clarity Advanced Ceramic Brackets consist of a translucent alumina body and a glass-grit bonding base. The bracket is either uncoated or coated with a thin film of stabilized zirconia. The brackets incorporate a watersoluble color placement indicator system that marks archwire and vertical slots to aid in bracket positioning and color codes tie wing(s) to facilitate bracket identification.

The provided text describes the 510(k) summary for the Clarity™ Advanced Ceramic Brackets, focusing on substantial equivalence to predicate devices through non-clinical performance testing.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes "nonclinical performance testing."

• Sample Size for Test Set: Not explicitly stated in the provided text. The text only mentions "The test results showed that..." for each test, implying a sample was used but not quantifying it.
• Data Provenance: The data is based on bench testing conducted by the manufacturer, 3M Unitek Corp, a US-based company. The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate performance. There is no indication of external data sources or retrospective analysis of patient data.

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

This question is not applicable to this type of submission. The "ground truth" for the non-clinical performance tests (bond strength, bracket strength, friction, debonding) is established by the physical and mechanical properties of the materials and device and measured through standardized engineering tests, not through expert human interpretation or consensus.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, the "truth" for these physical performance tests is directly measured by instruments, not human review or adjudication.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This device is a physical orthodontic bracket, not an AI-powered diagnostic or treatment planning tool that involves human readers or interpretation of medical images. No MRMC study was conducted.

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

Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used:

The "ground truth" for these non-clinical tests is based on objective, quantitative measurements of physical properties, such as force (bond strength, debond strength, bracket strength) and coefficients of friction, using standardized testing methodologies.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance data is generated through physical bench testing.

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

Not applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant to the device described.

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Clarity Modified Ceramic Bracket is intended for use in orthodontic treatment.

Not Found

I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device named "Clarity™ Modified Ceramic Brackets," which primarily discusses regulatory aspects and substantial equivalence to legally marketed predicate devices. It does not include details about device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information in the table format.

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To detect or image the distribution of radionuclides in the body or organ, using the following techniques:

• Multiplanar Reconstruction (MPR)
• Maximum/Minimum Intensity Projection (MIP) .
• . Image Contrast Manipulation
• Image Zoom Manipulation .
• Automatic registration with Mutual Information Technique .

Clarity Fusion is an option within the Clarity PET system so the end-user may differentiate between the two different applications within the same software program. This viewing of fused images is the ability to see the same datasets, as if they were being viewed independently, overlapped with each others. These fused images will allow a physician to look at two different datasets from different modalities. This is common medical practice that has now been computerized.

The provided text is a 510(k) summary for the Clarity Fusion device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the specific information required to answer your request about acceptance criteria, device performance, study details (sample sizes, ground truth establishment, expert qualifications, adjudication methods), or multi-reader multi-case studies.

This submission is a "Special 510(k)", which typically streamlines the review process for modifications to a legally marketed device if the changes do not affect the device's fundamental scientific technology or intended use. In such cases, extensive new clinical performance studies are often not required, and instead, the focus is on verification and validation that the modifications meet the original safety and effectiveness requirements and maintain substantial equivalence.

Therefore, many of the details you're asking for (like specific acceptance criteria performance data, sample sizes of test/training sets, expert qualifications, or MRMC studies) are not present in this type of 510(k) summary. These types of details would typically be found in a Traditional 510(k) submission where a new device is being introduced.

Here's what can be extracted and what cannot:

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

• Cannot provide. This information is not present in the provided text. The submission relies on demonstrating substantial equivalence to a predicate device (Clarity PET) and states that "software validation/verification and a Declaration of Conformity were submitted to demonstrate substantial equivalence." It does not provide specific acceptance criteria or performance metrics for the Clarity Fusion itself beyond its functionalities listed.

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

• Cannot provide. This information is not present.

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)

• Cannot provide. This information is not present. Ground truth methodology and expert involvement are not detailed.

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

• Cannot provide. Adjudication methods are not mentioned.

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 mentioned. The device described is an image processing system that fuses images from different modalities and provides tools like MPR, MIP, contrast manipulation, and automatic registration. It's not presented as an AI-enabled diagnostic aid that would typically be evaluated with MRMC studies comparing human readers with and without AI assistance. It "serv[es] primarily as an aid in image display" and is "not intended to replace the final interpretation of physicians."

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

• Not applicable/Cannot provide. The device is an image display and processing tool, not an AI algorithm performing a diagnostic task independently. Its function is to enhance diagnostic image quality and aid in image display for a physician, not to operate as a standalone diagnostic algorithm.

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

• Cannot provide. The method for establishing ground truth is not described in this document.

8. The sample size for the training set

• Cannot provide. This information is not present.

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

• Cannot provide. This information is not present.

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To detect or image the distribution of radionuclides in the body or organ, using the following techniques:

• Multiplanar Reconstruction (MPR) .
• Maximum/Minimum Intensity Projection (MIP) .
• Image Contrast Manipulation .
• Image Zoom Manipulation .
• Automatic registration with Mutual Information Technique .

Clarity PET is PET intage review software. Clarity PET offers a comprehensive software solution for medical imaging tasks and applications. Clarity PET is a medical diagnostic workstation designed for display, review, 3D MPR, communication and archiving of medical images

This 510(k) submission (K032866) for the Clarity PET device does not contain a study demonstrating that the device meets specific acceptance criteria based on its performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices already on the market.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no table of acceptance criteria or reported device performance metrics in the provided document. The submission relies on establishing equivalency rather than meeting new performance benchmarks.

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

Not applicable. No new performance study (test set, data provenance) is conducted for this 510(k) submission.

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

Not applicable. No new performance study is conducted that involved establishing ground truth with experts.

4. Adjudication Method:

Not applicable. No new performance study requiring adjudication is conducted.

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

No, an MRMC comparative effectiveness study was not done. The submission does not present a study comparing human reader performance with and without AI assistance, as the device is image review software, not an AI-assisted diagnostic tool in the sense of providing automated interpretations.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone performance study was not done. The Clarity PET is described as image review software and thus its "performance" is implicitly tied to its ability to display and manipulate images, similar to predicate devices. It's not an algorithm providing a diagnostic output independently.

7. Type of Ground Truth Used:

Not applicable. No ground truth for a new performance study is established or used in this submission.

8. Sample Size for the Training Set:

Not applicable. The provided document does not describe a training set for an algorithm, as the device is image review software, not a machine learning model.

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

Not applicable.

Summary of the K032866 Submission's Approach:

The K032866 submission for Clarity PET establishes substantial equivalence by demonstrating:

• Equivalent Indications for Use: The device can "detect or image the distribution of radionuclides in the body or organ, using the following techniques: Multiplanar Reconstruction (MPR), Maximum/Minimum Intensity Projection (MIP), Image Contrast Manipulation, Image Zoom Manipulation, Automatic registration with Mutual Information Technique." These are explicitly stated as equivalent to the Medical Image Merge™ device.
• Equivalent Technological Characteristics, Performance Characteristics, and Instructions for Use: The submission asserts that Clarity PET shares these equivalencies with the Medical Image Merge™ device and other predicate devices like Syngo Multi-Modality Workstation, ADAC Laboratories Image Fusion and Review System, and GE Advantage Windows Workstation.

The core of this 510(k) is a comparison to legally marketed predicate devices, asserting that Clarity PET performs the "same functions" and has "equivalent" characteristics, rather than providing new performance data against a specific set of acceptance criteria. The FDA's letter confirms that they reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use.

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