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Primescan 2 can be used as a diagnostic aid by licensed dentists for detection of caries on visible tooth surfaces, proximal caries, and tooth cracks.

The Primescan 2 is an intraoral scanner that records and generates digital images to provide caries diagnosis support using additional light sources at 405 nm and 850 nm and an optical filter to filter out the excitation light. By illuminating the tooth with these two wavelengths, two diagnosis support modes are realized, the fluorescence mode and the near-infrared mode. The acquired 2D data from the scanner can be viewed in the software in a live stream video during acquisition. The images are also stored in the cloud platform software for later patient communication.

In fluorescence mode, the tooth (or teeth) are illuminated with UV light (405 nm). This stimulates an autofluorescence of the enamel in the green wavelength range. In addition, the red fluorescence is stimulated in carious areas on the teeth. All stimulated fluorescence responses are significantly weaker in terms of their light intensity compared to the back-reflected excitation light. For this reason, the excitation light is filtered out with the aid of an optical filter. The dental professional can use the 2D image data of the fluorescence response (live stream video) as additional information for caries diagnosis.

For near-infrared mode (NIR mode), the tooth or teeth are illuminated with 850 nm. Enamel is partially transparent in this wavelength. The illumination can therefore penetrate the tooth and is reflected by structural defects such as cracks and cavities, as well as from the dentin core. The reflected light is picked up by the 2D sensor of the scanner.

When used, a sleeve is placed over the distal end of the scanner. This sleeve is the only patient contacting component and is offered as either a single-use disposable or a multi-use sleeve that is reprocessed.

Here's the breakdown of the acceptance criteria and study information for the Primescan 2 device, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance

The provided document does not explicitly state quantitative acceptance criteria or a specific table outlining them. However, it does mention that "in vivo bench tests demonstrated that Primescan-2 is effective as a diagnostic aid for occlusal caries using the fluorescence function and tooth cracks using the NIR function." This implies that the device met an unstated level of effectiveness for these diagnostic aids.

Since specific quantitative metrics (e.g., sensitivity, specificity, accuracy) are not provided in the summary, we cannot populate a detailed table with numerical acceptance criteria and performance outcomes.

Study Details

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

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: The study was "in vivo bench tests," implying data was collected from living subjects. The country of origin and whether it was retrospective or prospective is not explicitly stated.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not specified.

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

• MRMC Study: Not mentioned in the provided document. The study described is "Performance Validation Testing of the Caries diagnostic Aid - In vivo bench tests demonstrated that Primescan-2 is effective as a diagnostic aid..." This describes standalone device performance rather than human-in-the-loop improvement.

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

• Standalone Performance Study: Yes, a standalone performance study was done. The document states: "Performance Validation Testing of the Caries diagnostic Aid - In vivo bench tests demonstrated that Primescan-2 is effective as a diagnostic aid for occlusal caries using the fluorescence function and tooth cracks using the NIR function." This indicates the device's ability to provide a diagnostic aid on its own.

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

• Type of Ground Truth: Not explicitly stated. For "in vivo bench tests" related to caries and tooth cracks, ground truth would typically be established through a combination of visual-tactile examination by experienced clinicians, potentially supplemented by radiography or even histology (though less common for a diagnostic aid). However, the document does not specify the method used here.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable or not specified. This device appears to be a direct imaging and diagnostic aid rather than an AI/ML algorithm that requires a separate training set. The "diagnostic support" refers to the illumination and optical filtering techniques, not necessarily an AI algorithm trained on a dataset.

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

• Ground Truth for Training Set: Not applicable, as there's no indication of an AI/ML algorithm with a training set. The device operates on optical principles.

Key Observations and Limitations of Information:

• The provided 510(k) summary focuses highly on technological comparisons, safety, and regulatory compliance (electrical safety, biocompatibility, reprocessing, software, cybersecurity).
• While it mentions "Performance Validation Testing," it lacks specific quantitative results (e.g., sensitivity, specificity, accuracy, AUC) that are typically associated with diagnostic device clearances.
• The clinical study details, such as sample size, expert qualifications, and ground truth establishment methods for the performance validation, are not provided in this specific document. This information would typically be in a more detailed study report submitted to the FDA, but is summarized very broadly here.
• The device is described as providing "diagnostic support" using optical modes (fluorescence and NIR), rather than an explicit AI algorithm.

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The Duoblade Plus SE (Models: DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH), and Duoblade Prime (Models: DB1P, DB1P-T, DB1P-H, DB1P-TH) are intended for general electrosurgical applications, including cutting and coagulation. These models are designed without shaft extension functionalities. The Model: DB1EP, DB1EP -T, DB1EP-H, DB1EP-TH are compatible with the smoke evacuation system, removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

The Electrosurgical Cutting and Coagulation Device and Accessories (Model: Duoblade Plus SE, Duoblade Prime) is a single-use, monopolar RF device designed to be used with a qualified Generator as part of the Surgery System. It uses high-frequency energy (RF Monopolar Energy) to generate heat for tissue cutting and coagulation. It can be operated using the integrated hand switch or a qualified Footswitch. The device's design simplifies functionality by excluding shaft extension features. The models of Duoblade Plus SE and Duoblade Prime are identified according to with/without a suction function (removing smoke), and a swivel function.

• Suction & swivel function (Duoblade Plus SE): DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH
• No Suction & swivel function (Duoblade Prime): DB1P, DB1P-T, DB1P-H, DB1P-TH
  The scope of the submission only includes the addition of model without functions, such as swivel function, shaft extension function and appearance change for marketing purpose.

The provided FDA 510(k) clearance letter and summary are for an electrosurgical device (Duoblade Plus SE, Duoblade Prime), not an AI/software device that would involve a test set, ground truth experts, or MRMC studies. The document primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of features, materials, and established non-clinical tests relevant to electrosurgical devices (e.g., biocompatibility, sterility, electrical safety, thermal effects on tissue).

Therefore, I cannot extract the information required by your prompt regarding acceptance criteria, test set details, ground truth establishment, or human reader effectiveness studies, as these concepts are not applicable to the type of device described in this 510(k) submission.

The document states:

• "No clinical studies were considered for this submission." This directly indicates that there was no human-in-the-loop performance study, nor any evaluation of "how human readers improve with AI vs without AI assistance" because there's no AI component.
• "The thermal effects of a subject device are the same as the predicate device." This highlights that the performance demonstration relies on equivalence to a previously cleared device, not on new independent performance metrics against a defined acceptance criterion of the type you've outlined. The non-clinical test mentioned ("Thermal effects on tissue") is a comparative study against a positive control device, not a test with a specific quantitative acceptance criterion for the new device on its own.

In summary, because this 510(k) submission is for a physical electrosurgical device and not an AI/software product, the requested information about acceptance criteria for AI performance, test sets, ground truth experts, and MRMC studies is not present in the provided text.

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The Excipio LV Prime Thrombectomy Device is indicated for the nonsurgical removal of emboli and thrombi from peripheral blood vessels.

The Excipio LV Prime Thrombectomy Device consists of a Thrombectomy Catheter to mechanically displace thrombus when used with an aspiration catheter. The device will be sold as a sterile, single use device.

The Thrombectomy Catheter is a mechanical thrombus displacement device with a nitinol braided component (basket) at the distal end that can be opened and closed via an activation wire that attaches to the distal end of the braid and attaches to a proximal handle. The operator can open the braided component to a diameter that best matches the target vessel (6-16 mm in diameter). The thickness of the basket wires enhances the radiopacity to facilitate visualization under fluoroscopy without the need for additional radiopaque markers.

Let's break down the information regarding the acceptance criteria and study for the Excipio LV Prime Thrombectomy Device, based on the provided FDA 510(k) clearance letter.

It's important to note that this document is a 510(k) clearance letter, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "study" described here is primarily a non-clinical bench testing campaign aimed at proving the new device performs similarly and meets a defined set of engineering and performance specifications. There is no clinical study involving human (or animal) subjects described in this document for the Excipio LV Prime Thrombectomy Device. Thus, concepts like "human readers," "AI assistance," "effect size," or "ground truth for training/test set" in the context of clinical outcomes or diagnostic accuracy are not applicable to this type of device and submission.

Acceptance Criteria and Reported Device Performance

The document describes non-clinical laboratory testing performed to support the substantial equivalence. The acceptance criteria for these tests are implicitly that the device met the criteria and functioned as intended, with a performance profile similar to predicate devices. Specific quantitative acceptance criteria or detailed reported performance values are not explicitly stated in this summary. Instead, it broadly states that the device "met all acceptance criteria" and "functioned as intended."

Table of Acceptance Criteria and Reported Device Performance:

Study Details: Non-Clinical Bench Testing

Since this is a thrombectomy device and the submission is for 510(k) clearance based on substantial equivalence, the "study" referred to is a series of in vitro bench tests.

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

   • The document does not explicitly state the specific number of units tested for each non-clinical test (e.g., how many devices were subjected to kink resistance or tensile testing). This level of detail is typically found in the full 510(k) submission, not the summary.
   • Data Provenance: All data is from in vitro bench testing conducted by the manufacturer, Contego Medical, Inc. The country of origin for this testing is not specified, but it would typically be conducted at the manufacturer's facilities or a contracted testing lab. This is by definition retrospective in the sense that the testing is performed before submission for clearance.

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

   • Not Applicable. For non-clinical bench testing of a medical device, "ground truth" is established by engineering specifications, validated test methods, and industry standards (e.g., ISO standards). There are no "experts" establishing a clinical judgment ground truth in this context. The "experts" involved would be the design engineers, quality engineers, and test technicians who define the test protocols and interpret the results against the defined acceptance criteria.

3. Adjudication Method for the Test Set:

   • None Applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies or image interpretation studies where multiple human readers' opinions need to be reconciled to establish a ground truth. For bench testing, results are typically objective measurements compared directly against predetermined pass/fail criteria.

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

   • No, not done. An MRMC study is relevant to diagnostic imaging devices or other technologies where human interpretation is involved. This device is a mechanical thrombectomy device; its performance is evaluated by its physical characteristics and efficacy in removing thrombus in a lab setting, not by aiding human readers in diagnosis.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

   • Not Applicable. This device is an invasive medical device, not a software algorithm. Its use inherently involves a human operator (a clinician) and is not "standalone" in the sense of an unassisted algorithm making decisions.

6. Type of Ground Truth Used:

   • For the non-clinical testing, the "ground truth" is defined by:
     • Engineering specifications and design requirements: For dimensional, kink resistance, torsional strength, tensile, radial force, and corrosion testing.
     • Validated test methods and industry standards (e.g., ISO 10993-1): For biocompatibility, simulated use, and clot removal testing.
     • Manufacturer's internal quality standards.

7. Sample Size for the Training Set:

   • Not Applicable. The concept of a "training set" applies to machine learning algorithms. This device is a physical, mechanical medical device, not an AI/ML system.

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

   • Not Applicable. As above, there is no training set for this type of device.

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The Ulthera System is intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin.

The Ulthera System is indicated for use as a non-invasive dermatological aesthetic treatment to:

• Lift the eyebrow
• Lift lax submental (beneath the chin) and neck tissue, which can also affect the appearance of lax tissue in the submental and neck regions
• Improve lines and wrinkles of the décolleté
• Improve the appearance of skin laxity on the abdomen, anterior arms, and posterior arms

The Ulthera® System, in conjunction with the Ulthera® DeepSEE® transducer, allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal and subdermal layers of tissue to:

• Ensure proper coupling of the transducer to the skin
• Confirm appropriate depth of treatment such as to avoid bone

The Ulthera® System consists of the Ulthera® Control Unit (with system software), a handpiece with cable, and interchangeable transducers. The device produces controlled tissue coagulation below the skin surface (epidermis) within the first few millimeters of tissue (dermis) using highly focused, low-energy ultrasound deposition. The Ulthera® System directs micro-focused acoustic waves to the treatment area at desired depths without affecting or requiring a secondary action to protect the skin surface. The operator may also use the device's supplemental imaging capability to visualize the treatment area and aid in assuring full/proper skin contact of the Ulthera® System transducer to the skin in the target area.

The provided FDA 510(k) clearance letter for the Ulthera System describes changes to an existing device, primarily software updates to include wireless connectivity and a new treatment planning mode (SEE.PLAN.TREAT.®). It relies heavily on demonstrating substantial equivalence to a predicate device rather than presenting a de novo clinical study with specific acceptance criteria related to a new performance claim.

Therefore, the document does not contain the kind of detailed performance data and acceptance criteria that would typically be found for a device seeking clearance based on a new clinical effectiveness claim or a novel AI-driven diagnostic. The study described focuses on nonclinical performance testing to demonstrate that the minor software and hardware differences do not affect clinical functionality or performance specifications and that the device operates as intended and is as safe and effective as the predicate.

Below is an attempt to structure the information based on your request, highlighting what is present and what is absent from the provided text.

Analysis of Acceptance Criteria and Study to Prove Device Meets Criteria

Based on the provided FDA 510(k) clearance letter for the Ulthera System (UC-1 Control Unit PRIME Model 2.1), the device's acceptance criteria and the study proving it meets these criteria are primarily focused on demonstrating substantial equivalence to a previously cleared predicate device, especially concerning software and minor hardware changes. The performance data presented are nonclinical and focus on safety, electrical compatibility, software validation, usability, and cybersecurity, rather than specific clinical effectiveness endpoints.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a software update and minor hardware changes to an existing device, the acceptance criteria are not presented as traditional clinical performance metrics (e.g., sensitivity, specificity for a diagnostic device). Instead, they relate to the continued safe and effective operation of the modified device.

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

• Sample Size: The document does not specify a "test set" sample size in terms of patient data or clinical cases. The testing reported is nonclinical.
  • For Usability Testing, it mentions "clinicians" and a "simulated use study," implying a small group of human participants, but no specific number is provided.
• Data Provenance: Not applicable as the testing is nonclinical (electrical, software, usability simulation, cybersecurity). There is no mention of patient data (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable: This type of information (experts establishing ground truth for a clinical test set) is not relevant for the nonclinical tests performed to support this 510(k). The "ground truth" for the nonclinical tests is compliance with engineering standards and proper software operation.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are used for establishing clinical ground truth, typically in the context of reader studies or clinical trials, which were not detailed or the focus of this 510(k) summary for software/hardware updates.

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

• No: The document does not mention any MRMC comparative effectiveness study. The focus is on demonstrating that the device itself (with updated software) is safe and effective through nonclinical means, and that its changes do not negatively impact the clinical functionality of the predicate. There is no claim about human readers improving with or without AI assistance, as the device is a therapeutic/aesthetic system, not an AI-driven diagnostic aid for human interpretation.

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

• Not Applicable in the traditional sense: The Ulthera System is a therapeutic device with an imaging component for guidance. Its "performance" is whether it delivers focused ultrasound energy as intended and the new software features (like SEE.PLAN.TREAT.®) function correctly. It's not an algorithm producing a diagnostic output that would have a standalone performance metric like AUC, sensitivity, or specificity. The testing performed confirms the system's standalone operational integrity (electrical, software V&V, cybersecurity) rather than algorithmic diagnostic performance.

7. The Type of Ground Truth Used

• Engineering Specifications and Standard Compliance: For the nonclinical tests, the "ground truth" is adherence to established engineering specifications, international electrical safety standards (IEC 60601-1, IEC 60601-1-2), usability standards (IEC 62366-1), and FDA guidance for software and cybersecurity.
• Functional Verification: For the new software features, the ground truth is whether the features operate as designed and intended (e.g., wireless connectivity functions, SEE.PLAN.TREAT.® mode works).

8. The Sample Size for the Training Set

• Not Applicable: This document describes a 510(k) clearance for software/hardware updates to an existing device. It does not refer to the development of a new AI algorithm requiring a training set in the sense of machine learning on clinical data. The "software" in question is the operating system and treatment planning interface, not an independently learning AI model.

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

• Not Applicable: As there is no mention of a training set for an AI algorithm, this information is not provided. The development of the software features would have followed standard software development life cycle (SDLC) practices, with requirements defining the intended function.

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The SIGNA Prime Elite is a whole body magnetic resonance scanner designed to support high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.

Depending on the region of interest being imaged, contrast agents may be used. The images produced by SIGNA Prime Elite reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance.

These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

SIGNA Prime Elite is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan time. The system uses a combination of time-varying magnet fields (Gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences, imaging techniques and reconstruction algorithms. The system features a 1.5T superconducting magnet with 60 cm bore size. The system is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

The document does not provide a table of acceptance criteria and reported device performance. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative performance metrics against pre-defined acceptance criteria.

Here's an analysis of the provided information concerning acceptance criteria and study details:

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

The document does not contain a specific table outlining quantitative acceptance criteria and corresponding reported device performance metrics. It indicates that the SIGNA Prime Elite's image quality performance was compared to the predicate device through bench and clinical testing and found to be "substantially equivalent."

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 states: "The subject of this premarket submission, the SIGNA Prime Elite, did not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission."

Therefore, there is no formal test set sample size mentioned for a specific clinical performance study. The "sample clinical images" are used to demonstrate acceptable diagnostic image performance, but details about their sample size, provenance (country of origin), or whether they are retrospective or prospective are not provided.

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)

Since no formal clinical study with a defined test set and ground truth establishment is described, this information is not provided. The document mentions that images "when interpreted by a trained physician yield information that may assist in diagnosis," but it doesn't specify expert review for a test set.

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

As there is no formal test set described for a clinical performance study, an adjudication method is not applicable and 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

The document states that the SIGNA Prime Elite is a "whole body magnetic resonance scanner." There is no mention of AI assistance or a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The submission is for an imaging device, not an AI-powered diagnostic tool.

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

This question is not applicable as the device is a magnetic resonance scanner, not an algorithm that operates standalone without human interpretation.

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

Given that clinical studies were not required and only "sample clinical images" were included to demonstrate acceptable diagnostic image performance, there is no mention of a formally established ground truth type (e.g., expert consensus, pathology, outcomes data) for a test set. The images are expected to be interpreted by a "trained physician."

8. The sample size for the training set

The document describes the SIGNA Prime Elite as a new 1.5T MR system. It is a hardware device with associated software, not a machine learning model. Therefore, the concept of a "training set" in the context of machine learning is not applicable and not mentioned.

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

As the device is an MR scanner and not an AI/ML model requiring a training set, this information is not applicable and not provided.

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The Gentuity® HF-OCT Imaging System with Vis-Rx® Prime Micro-Imaging Catheter is intended for intravascular imaging and is indicated for use in coronary arteries in patients who are candidates for transluminal interventional procedures. The Vis-Rx Prime Micro-Imaging Catheter is intended for use in vessels 1.3 to 6.0 mm in diameter. The Vis-Rx Prime Micro-Imaging Catheter is also intended for use prior to or following transluminal interventional procedures. The Vis-Rx Prime Micro-Imaging Catheter is not intended for use in a target vessel that has undergone a previous bypass procedure.

The Gentuity® HF-OCT Imaging System provides images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The system utilizes fiber-optic technology to deliver near-infrared light and receive light reflected from coronary tissue to produce high resolution, real-time images. The Gentuity HF-OCT Imaging System consists of the following components:

1. The Gentuity Imaging Console: A mobile system that houses the Optical Engine, the Computer and application software, and the Probe Interface Module (PIM). It also includes two monitors, keyboard, mouse, and cord storage as well as external interfaces to the system. The PIM provides the interconnection between the Gentuity Imaging System and the Vis-Rx® Prime Micro-Imaging Catheter.
2. Vis-Rx Prime Micro-Imaging Catheter: The Vis-Rx Prime Micro-Imaging Catheter is a sterile, single-use catheter that consists of an external sheath and an optical imaging core. The external sheath facilitates placement of the device into the coronary artery and houses the optical imaging core. An optical fiber and lens assembly rotates inside the optical imaging core. The optical fiber and lens deliver near-infrared light to the tissue and receive reflected light. The Vis-Rx Prime Micro-Imaging Catheter is a rapid exchange design, compatible with an 0.014" guidewire. The catheter attaches to the PIM, which is mounted outside the sterile field on the table bed rail. A sterile 3 ml purge syringe is provided with the Vis-Rx Prime Micro-Imaging Catheter.
3. Optional Gentuity Review Station: The Gentuity Review Station (GRS) is an optional standalone computer with the Gentuity application software that provides analysis and review capabilities similar to what may be performed on the Gentuity Console. The GRS allows physicians to review images for research, presentation and publication preparation outside the catheterization lab without the Gentuity Console.

This FDA 510(k) summary does not contain the detailed performance study information typically found in acceptance criteria and validation studies for medical devices, particularly those involving AI or imaging interpretation. This document primarily describes the device, its intended use, and substantial equivalence to a predicate device based on bench and animal testing.

Therefore, many of the requested points cannot be answered from the provided text.

Here is what can be extracted and what cannot:

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

The document does not provide a table of acceptance criteria with corresponding reported device performance metrics. Instead, it lists the types of performance testing conducted and states that "All [type of test] validation results met applicable acceptance criteria." without specifying what those criteria or results were.

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 an "Animal Study" which was a GLP (Good Laboratory Practice) nonclinical laboratory study. It does not specify the sample size (number of animals) used, nor does it detail the specific data collected from this study in a way that would relate to device performance metrics, image quality, or diagnostic accuracy. There's no information about human test sets, data provenance, or retrospective/prospective nature.

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

This information is not provided. The document does not describe any studies involving human experts interpreting images or establishing ground truth.

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

This information is not provided.

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

There is no mention of an MRMC study and no indication that this device involves AI assistance for human readers in its primary function as described in this 510(k) summary. The device is an imaging system (Optical Coherence Tomography) for intravascular imaging.

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

This information is not provided. The document focuses on the hardware and basic system functionality, not on advanced algorithmic performance or automated interpretation.

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

For the animal study, the "ground truth" would likely be the direct physiological and histological findings from the animals, but the document does not specify this or link it to any performance claims. For other tests (biocompatibility, particulate, sterilization), the ground truth is against established standards and validated methods.

8. The sample size for the training set

This is not applicable as the document does not describe any machine learning or AI components requiring a training set.

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

This is not applicable.

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Ormco™ EtchFree Bonding Primer is a bonding primer intended to bond orthodontic appliances such as metal brackets, ceramic brackets, and aligner attachments to enamel, in conjunction with an orthodontic sealant/enhancer, such as Ormco's Ortho Solo™ and an adhesive/cement without etching.

Ormco™ EtchFree Adhesive is a light-curing adhesive that is intended to be used for the attachment of orthodontic appliances to teeth such as metal bracket, ceramic brackets, and aligner attachments.

The Ormco™ Bonding System consists of a primer, a sealant, an adhesive, and bonding accessories.

· Ormco™ Bonding Primer is intended to bond orthodontic appliances such as metal brackets, and aligner attachments to enamel, in conjunction with an orthodontic sealant/enhancer, such as Ormco's Ortho Solo™ and an adhesive/cement. The primer is a clear liquid that conditions the surface of the application of a bonding sealant/enhancer. Ormco Bonding Primer is designed to be used as a system along with Ortho Solo and Ormco" Bonding Adhesive. The primer is offered in single-use vials which will be sold in kits and separately.

· Ormco™ Adhesive is a light-curing composite that is intended to be used with metal and ceramic brackets for orthodontic treatment and can also be used as aligner attachment. It is a convenient off-white paste providing aesthetics when used as aligner attachments or beneath a bracket. The adhesive is designed to be used as a system along with Ormco Bonding Primer and Ortho Solo. The adhesive is offered in syringes for multi-patient use, which will be sold in kits and separately.

This document describes the Ormco™ EtchFree Bonding System, comprising the Ormco™ EtchFree Bonding Primer and Ormco™ EtchFree Adhesive, and its substantial equivalence to predicate devices. The information provided focuses on non-clinical performance bench testing rather than clinical studies related to human reader performance or detailed AI-specific metrics.

Here's an analysis of the provided text in relation to your questions:

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

The document does not explicitly present acceptance criteria in a table format with corresponding reported device performance values. It lists the international and FDA-recognized consensus standards against which non-clinical performance bench testing was conducted. It generally states that "All results were deemed acceptable."

However, based on the mentioned tests, we can infer the areas of performance evaluated:

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 primarily discusses non-clinical performance bench testing. It does not mention clinical studies or human test sets. Therefore, details regarding sample size for test sets, country of origin, or retrospective/prospective data are not applicable in this context. The "test set" refers to materials or samples used in laboratory bench tests. The specific number of samples for each bench test (e.g., how many specimens for shear bond strength) is not provided.

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

This information is not applicable as the document describes non-clinical bench testing of a dental adhesive system. There is no mention of experts or ground truth establishment in the context of human assessment or interpretation of results for a test set. The "ground truth" for these tests would be the measurement results against established scientific standards.

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

This is not applicable as there is no mention of a human-centric test set requiring adjudication in the provided text.

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

This is not applicable. The device described is a dental adhesive system, not an AI-powered diagnostic tool or image analysis system. There is no mention of AI assistance or human reader studies.

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

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

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

For the non-clinical bench tests, the ground truth is established by the scientific and engineering principles and methodologies outlined in the referenced international and FDA-recognized consensus standards (e.g., ISO 29022 for shear bond strength, ISO 11405 for adhesion, ISO 10993 series for biocompatibility). The "truth" is whether the material properties or biological responses meet the specifications or thresholds defined by these validated tests.

8. The sample size for the training set

This is not applicable. The device is a physical product, not an AI model or algorithm that requires a training set.

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

This is not applicable for the same reason as above (physical product, not AI).

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TopCEM Ceramic Primer Ceramic Coupling Agent serves as priming agent and is used to create a durable adhesion between luting composites and glass/oxide ceramic, metal, composite and fiberreinforced composite restorations.

TopCEM Ceramic Primer Ceramic Coupling Agent is common oral cementation repair auxiliary materials. In the process of using the product, TopCEM Ceramic Primer Ceramic Coupling Agent is placed between the prosthesis and resin adhesives, which can form the bonding layer of tooth tissue - light cure dental adhesive layer - resin cement layer - ceramic coupling agent - prosthesis, so as to achieve better bonding effect. TopCEM Ceramic Primer Ceramic Coupling Agent does not have direct contact with tooth tissue during use. TopCEM Ceramic Primer Ceramic Coupling Agent is mainly composed of silane coupling agent, acid acrylate and volatile organic solvent.

The provided document is a 510(k) Premarket Notification from the FDA for a dental bonding agent. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

However, the document does not contain any information about a study that proves the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or accuracy, as would be expected for an AI/ML medical device. The device described is a "Ceramic Primer Ceramic Coupling Agent," which is a chemical product used in dentistry, not an AI/ML-driven diagnostic or prognostic device.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance (e.g., sensitivity, specificity, accuracy).
• Sample sizes for test sets or data provenance.
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on non-clinical testing of physical properties and biocompatibility for a chemical product. It states:

• "Summary of Non-clinical testing": "The physical properties of the subject device, including Appearance, Solid Content, Bond Strength (MPa), Whether there are traces left on the glass panel surface, Packing Amount Tolerance and Detection of Infrared Characteristic Peaks, were determined and tested according to Internal standard SOP of the company, and the test results demonstrated the qualification and substantial equivalence when compared to the predicate device."
• "Summary of Clinical testing": "Clinical test is not applicable."

This indicates that the "acceptance criteria" and "proof" in this context relate to chemical and physical properties, and biocompatibility, as evaluated through internal SOPs and comparison to a predicate device, rather than the performance metrics typically associated with AI/ML diagnostic tools.

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Superflow Prime Treatment System is used in the removal and destruction of skin lesions and coagulation of tissue.

AIMIRA SFP consists of Three modules, the main body, a multi-spectral skin camera, and a plasma skin treatment handpiece. The main body includes a main cabinet, a touch screen display, a vacuum system, computer control system and power supply unit. The system runs on AiMIRA SFP software ASP-1M. The skin camera consists of multi-spectral imaging optics, and an electronic control circuit. The plasma skin treatment handpiece consists of high voltage plasma discharge circuit, high precision control electronics, a single patient use treatment probe unit, rechargeable battery system for power supply, and a wireless communication circuit to communicate with the computer in main body. A vacuum and illumination system are integrated into AIMIRA SFP to facilitate the treatment process. A multi-spectral imaging (MSI) camera is also into AIMIRA SFP system. The purpose of the MSI camera is to provide the doctor an imaging tool to record the patient's skin conditions before and after treatments as part of the patient's treatment data record.

The provided text is an FDA 510(k) Premarket Notification document for the "Superflow Prime Treatment System (ASP-1M)". This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of specifications.

Crucially, the document explicitly states "No clinical study is included in this submission." This means there is no data presented regarding acceptance criteria, device performance from a clinical study, sample sizes, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment methods for a clinical test set.

Therefore, I cannot provide the requested information from this document for a study that proves the device meets acceptance criteria in a clinical setting, as no such study is presented within the provided text.

The closest information available related to "acceptance criteria" would be the performance and safety specifications that were tested non-clinically to demonstrate substantial equivalence to the predicate device. However, these are engineering and technical specifications, not acceptance criteria for clinical performance regarding efficacy or diagnostic accuracy.

Here's what can be extracted regarding the device's technical specifications and the non-clinical testing performed:

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

As no clinical study performance is reported, I will present the technical specifications and the conclusion that the non-clinical tests confirmed compliance with established safety and performance standards. These standards implicitly set the "acceptance criteria" for the non-clinical tests.

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

• Sample Size: Not applicable as no clinical test set is used. The tests were non-clinical/bench testing.
• Data Provenance: Not applicable for a clinical study. The non-clinical tests were conducted internally or by accredited labs to verify compliance with standards.

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 study for efficacy or diagnostic performance was conducted. The "ground truth" for non-clinical testing is adherence to international standards and internal design specifications.

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

• Not applicable as no clinical study was conducted.

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 study was not done. The device is an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic imaging device for human readers.

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

• Not applicable as the device is not an AI algorithm. It is a medical device for physical intervention (skin lesion removal).

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

• For the non-clinical tests, the "ground truth" is compliance with recognized international standards (IEC, ISO, AAMI) and the device's technical specifications, as compared to a legally marketed predicate device.

8. The sample size for the training set:

• Not applicable. The device is not an AI/ML system that requires a training set in the typical sense. Its functionality is based on established physical principles of electrosurgery.

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

• Not applicable.

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The Youlaser PRIME family laser devices (Youlaser PRIME, Youlaser PRIME CO2, Youlaser PRIME MT) and accessories are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery).

Surgical Handpieces
Youlaser PRIME CO2, Youlaser PRIME and Youlaser PRIME MT with a wavelength of 10600nm used in combination with surgical handpieces are indicated for use for the particular indications as follows:

Dermatology & Plastic Surgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:

• · laser skin resurfacing
• · laser derm-abrasion
• · laser burn debridement.

Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts.

OptiScan PRIME Scanner
Youlaser PRIME CO2, Youlaser PRIME and Youlaser PRIME MT with a wavelength of 10600nm used in combination with OptiScan PRIME scanner are indicated for:
·Laser skin resurfacing (ablation and/or vaporization) of soft tissue

Youlaser PRIME and Youlaser PRIME MT with wavelength of 1550nm used in combination with OptiScan PRIME scanner, are indicated for:
· Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue

Youlaser PRIME MT with wavelengths of 10600nm & 1550nm used in combination with OptiScan PRIME is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.

The models of the Youlaser PRIME family are medical laser emitting at 10600nm (CO2 laser source), 1550nm, plus combined configurations.

The 1550nm laser source is a fiber laser, this wavelength lies in the invisible infrared part of the electromagnetic spectrum.

The CO2 laser source is an RF driven sealed gas tube emitting laser radiation both in continuous and pulsed mode in the invisible far-infrared part of the electromagnetic spectrum (10600nm).

The beam delivery system is an articulated arm with a handpiece or a scanner on its end.

The laser device is equipped with a display with a graphical user interface (GUI) for user-device interaction (e.g. laser parameters settings).

The scanner is also provided with a touchscreen display to select the scan pattern, shape, dimension,...etc. Laser emission is controlled via the external footswitch has an activation pedal which enables laser emission.

The provided text describes a 510(k) premarket notification for a laser surgical instrument. It details the device's technical specifications and compares them to predicate devices to demonstrate substantial equivalence. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of a human-in-the-loop or algorithm-only performance study as typically seen for AI/ML-based medical devices.

The "study" mentioned is an in vivo animal study (on minipigs) for the 1550nm fiber laser source to demonstrate safety and effectiveness, specifically regarding its ability to cause ablation and coagulation in tissue. This is a pre-clinical safety/performance study, not a clinical study assessing diagnostic or assistive performance against ground truth and acceptance criteria in the way an AI/ML device would be evaluated.

Therefore, most of the requested information regarding acceptance criteria, performance metrics, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance is not present in the provided document.

Here's what can be extracted and what is missing:

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

• Acceptance Criteria: Not explicitly stated as quantifiable performance goals for a diagnostic algorithm. The document focuses on demonstrating substantial equivalence to predicate devices in terms of technical characteristics and intended use, and safety and effectiveness through non-clinical (animal) testing.
• Reported Device Performance:
  • In vivo minipig study (for 1550nm fiber laser):
    • Outcome: "Testing was performed safely on the test animals, and the histology results complied with the FDA requirements, from 0 to 14 days."
    • "Re-epithelization was observed three days after radiation in all specimens."
    • "Slight erythema was noted as the primary side effect in higher energy settings, but it was transient and resolved within days."
    • "No cases of oedema were observed, and overall, the healing process was uncomplicated."
    • "Histologic analysis performed with H&E staining at various time points (days 1, 4, and 14) revealed predictable levels of ablation and coagulation depending on the energy settings used, with the fiber laser causing predominantly coagulation while the CO2 laser focused on ablation."
    • "By day 4, re-epithelization of the skin was already evident, and by day 14, the skin had fully healed."
  • Conclusion: "The Youlaser PRIME device demonstrates predictable and controlled skin ablation and coagulation, ensuring patient safety and clinical efficacy." and "The findings confirm that the device is equivalent to other approved technologies, with precise control over energy output and microspot density to facilitate rapid healing and minimize side effects."

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

• Test Set (for the in vivo study): "Three animals were used in this study."
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It's an in vivo animal study, not human clinical data.

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

• Experts: Not explicitly stated. The document mentions "histologic analysis performed with H&E staining," which implies expert pathological assessment, but the number and qualifications of the pathologists are not provided.
• Ground truth context: For this type of device, "ground truth" would be the observed biological effects (ablation, coagulation, healing) in the animal tissue, as assessed histologically.

4. Adjudication method for the test set

• Not applicable/Not mentioned, as this was an evaluation of physical effects on tissue, not a diagnostic decision process requiring adjudication.

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

• No. This type of study is for AI-assisted diagnostic devices. The Youlaser PRIME is a laser surgical instrument, and the evaluation presented is a non-clinical (animal) study of its physical effects, not a human-reader study.

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

• No. This is not an AI/algorithm-only device. The "study" refers to the laser's physical interaction with tissue.

7. The type of ground truth used

• For the in vivo animal study: Histology results (e.g., H&E staining at various time points) examining ablation, coagulation, and re-epithelialization in minipig skin tissue.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. No training set for an AI/ML model.

Summary of Device and its Evaluation:

The Youlaser PRIME family devices are laser surgical instruments. The "study" mentioned in the document is an in vivo non-clinical study on minipigs designed to demonstrate the safety and effectiveness of the 1550nm fiber laser source by evaluating the biological response (ablation, coagulation, healing) in animal tissue. This type of evaluation is standard for surgical devices that interact directly with tissue, focusing on physical parameters and biological outcomes rather than diagnostic performance or human-AI interaction. The document's primary purpose is to establish substantial equivalence to legally marketed predicate devices, which is achieved by comparing technical specifications and demonstrating comparable safety and effectiveness through non-clinical testing.

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