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The SpotLight / SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image cardiovascular and thoracic anatomies, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages (DLIR is limited for patient use above the age of 2 years). These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The system is indicated for x-ray Computed Tomography imaging of cardiovascular and thoracic anatomies that fit in the scan field-of-view.

The Low Dose CT Lung Cancer Screening Option for SpotLight / SpotLight Duo is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body or a professional medical society. Information from professional societies related to lung cancer screening can be found but is not limited to: American College of Radiology® (ACR) – resources and technical specification; accreditation American Association of Physicists in Medicine (AAPM) – Lung Cancer Screening Protocols; radiation management. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. The DLIR and ASIR-CV algorithms are not compatible with the Low Dose Lung Cancer Screening option.

The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.

The Low Dose Lung Cancer Screening (LD LCS) option indication for Arineta's SpotLight and SpotLight Duo scanners is being expanded to include small patients, as defined by AAPM (American Association of Physicists in Medicine). This expansion ensures comprehensive coverage of the intended lung cancer screening population, following the previous clearance of the LD LCS option for medium and large patients under K241200.

The proposed LD LCS option for the SpotLight and SpotLight Duo includes scan protocols with CTDI that comply with AAPM's requirements for the whole LD LCS population patient size groups, as detailed in the following table:

There are not any functional, performance, feature, or design changes required for the CT systems to which the option is applied.

The proposed full LD LCS protocols option, as the cleared K241200, will be activated by service or production personnel, with no additional installation required (option activation only).

This FDA 510(k) clearance letter describes the acceptance criteria and study proving the SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option (specifically for small patients) meets these criteria.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are largely based on image quality and nodule detectability being maintained at low dose levels, specifically for small patients (50-70 kg) within the AAPM guidelines for CTDI. The reported performance confirms these criteria are met.

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The SpotLight / SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image cardiovascular and thoracic anatomies, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages (DLR is limited for patient use of 2 years). These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The system is indicated for x-ray Computed Tomography imaging of cardiovascular and thoracic anatomies that fit in the scan field-of-view.

The Low Dose CT Lung Cancer Screening Option for SpotLight / SpotLight Duo is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols (for medium and large patients) that have been approved and published by a governmental body or a professional medical society. Information from professional societies related to lung cancer screening can be found but is not limited to: American College of Radiology® (ACR) - resources and technical specification American Association of Physicists in Medicine (AAPM) - Lung Cancer Screening Protocols; radiation management. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. The DLIR and ASIR-CV algorithms are not compatible with the Low Dose Lung Cancer Screening option.

The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.

The Low Dose Lung Cancer Screening (LD LCS) option is an indication being added to the existing Arineta scanners for SpotLight and SpotLight Duo, previously cleared by the FDA (K230370, K213465).

There are not any functional, performance, feature, or design changes required for the CT systems to which the option is applied.

This option includes scan protocols with CTDI that comply with AAPM's requirements for Low Dose Lung Cancer Screening.

No Hardware modifications and minor Software modifications (for compatibility with the Low-Dose Lung Cancer Screening protocols) are required for the subject device, which includes the following LD LCS protocol characteristics:

• Lung Cancer Screening protocols for medium and large patients according to AAPM's definitions.

· Lung Cancer Screening protocols option will be activated by service or production personnel (no need for additional installation, option activation only).

Here's a breakdown of the acceptance criteria and the study proving the device's performance, 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

• Test Set Sample Size:
  • Bench Testing: Not explicitly stated as a number of phantom scans, but described as "extensive bench testing" using "standard phantoms" and a "semi-anthropomorphic clinical simulation lung phantom."
  • Clinical Image Quality Assessment: Fourteen (14) cases.
• Data Provenance:
  • Bench Testing: Internal laboratory testing ("extensive bench testing").
  • Clinical Image Quality Assessment: Collected from two (2) U.S. sites. The text doesn't specify if it was retrospective or prospective, but the phrasing "were collected" often implies retrospective.

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

• Number of Experts: Two (2) U.S. board-certified radiologists.
• Qualifications: U.S. board-certified radiologists. No specific years of experience are mentioned.

4. Adjudication Method for the Test Set

The provided text only states "a clinical image quality assessment was performed by two U.S. board-certified radiologists." It does not specify an adjudication method (e.g., 2+1, 3+1, none). It implies both radiologists performed the assessment, but not how disagreements (if any) were resolved or if their readings were merged.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs. without AI assistance

No MRMC comparative effectiveness study was mentioned. The study described focuses on whether the device's low-dose protocols produce diagnostic-quality images and maintain image quality compared to the predicate device, not on human reader performance with or without AI assistance.

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

The "device" in this context is the CT scanner itself with an added low-dose lung cancer screening option, which includes specific scan protocols and minor software modifications for compatibility. The "acceptance criteria" and "study" described are for the performance of the CT system under these low-dose conditions, as an image acquisition and reconstruction device. It is not an AI algorithm that provides diagnostic readings independently. Therefore, the concept of a "standalone" AI performance study is not directly applicable here. The performance evaluated is the image quality produced by the system.

7. The Type of Ground Truth Used

• Bench Testing: Phantom specifications or known values within the phantoms (e.g., specific nodule sizes, CT number values of materials). Comparison was also made against a "reference device" (GE Revolution CT).
• Clinical Image Quality Assessment: The "ground truth" for the clinical evaluation was the qualitative assessment by the two board-certified radiologists that the images were "diagnostic for the indications for use" and "enable the detection of findings relevant to LD LCS," including 2mm nodules. This is essentially expert consensus on clinical diagnostic utility. It does not refer to histopathological ground truth for nodules, for example.

8. The Sample Size for the Training Set

The document does not mention any training set size. This is because the submission describes an option for an existing CT system (SpotLight/SpotLight Duo) to perform Low Dose Lung Cancer Screening. It does not describe a new AI algorithm that requires a separate training set. The changes are primarily in scan protocols and minor software adjustments for compatibility. The core image reconstruction algorithms (Modified FDK, MBAF, MBAF2) are pre-existing.

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

As no training set is mentioned (since it's not a new AI algorithm being trained), this information is not applicable.

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SpotLight /SpotLight Duo (with DLIR option) is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data taken at different angles. The system has the capability to image cardiovascular and thoracic anatomies, in a single rotation. The system may acquire data using Axial, Cine, and Cardiac scan techniques from patients of all ages (DLR is limited for patient use above the age of 2 years). These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes.

The system is indicated for X-ray Computed Tomography imaging of cardiovascular and thoracic anatomies that fit in the scan field of view. The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.

The SpotLight / SpotLight Duo (with DLIR option) is a multi-slice (192 detector rows), dual tube CT scanner consisting of a gantry, patient table, operator console, power distribution unit (PDU) and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software and software for operator interface and image handling. The Deep Learning Image Reconstruction (DLIR) algorithm is a deep learning technology-based software sub-system that is integrated into the image reconstruction software. As in other CT scanners, a scanned subject is irradiated by X rays and a detector array measures attenuation data of X rays that have been attenuated by the subject from multiple view angles. This is achieved by rotation of the radiation source and the detector about the subject while acquiring the attenuation data. A computer is used to reconstruct cross sectional images of the subject from the attenuation data.

Here's a summary of the acceptance criteria and the study details for the SpotLight/SpotLight Duo (with DLIR option) CT system, based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list specific quantitative acceptance criteria in a table format. However, it indicates that the DLIR (Deep Learning Image Reconstruction) algorithm was evaluated to demonstrate non-inferiority to the predicate device's ASiR-CV noise reduction algorithm in terms of image quality. The performance tests focused on several image quality parameters:

2. Sample Size and Data Provenance for the Test Set

• Sample Size (Test Set): Not explicitly stated as a number of cases, but implied to be a collection of "clinical cases of different anatomies, using different types of scans, from patients with a wide range of BMIs and clinical features."
• Data Provenance: Retrospective clinical data acquired by SpotLight / CardioGraphe scanners. Collected from "multiple clinical sites with at least 50% of the cases performed in the US."

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Five (5) certified CT readers.
• Qualifications of Experts: 3 radiologists and 2 cardiologists. "4 out 5 are US board certified." Specific years of experience are not mentioned.

4. Adjudication Method

• Adjudication Method: The study was a "retrospective blinded image evaluation." Each exam was reviewed using both standard (ASiR-CV) and alternative (DLIR) methods. The data was "coded to avoid readers' bias." This suggests a comparative reading where readers likely assessed both image sets for the same patient without knowing which was which, and potentially without direct consensus discussions as a formal adjudication step, but rather an independent assessment that collectively informed the non-inferiority conclusion. No explicit "2+1" or "3+1" adjudication method is described.

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

• Was an MRMC study done? Yes, a form of multi-reader evaluation was performed, comparing DLIR to ASiR-CV on clinical cases by five expert readers.
• Effect Size (human readers improve with AI vs. without AI assistance): The document states that "DLIR was found to provide diagnostic image quality that is not inferior to ASiR." It does not provide a specific quantitative effect size or a measure of improvement for human readers with AI (DLIR) vs. without AI (ASiR-CV, which is also an algorithm, a noise reduction one). The focus was on non-inferiority rather than an enhancement measurement for the readers themselves.

6. Standalone Performance Study

• Was a standalone study done? Yes, "DLIR bench tests were performed by applying DLIR and ASIR on phantoms." This represents a standalone evaluation of the algorithm's performance on objective image quality metrics using phantoms.

7. Type of Ground Truth Used

• For Bench Tests: Physical phantoms (water phantoms, CATPHAN, QA phantom) with known properties were used.
• For Clinical Evaluation: "Diagnostic image quality that is not inferior to ASiR" as determined by the expert readers serves as the ground truth/comparison metric. This is effectively expert consensus/opinion on diagnostic quality. There's no mention of pathology or outcomes data being used to establish ground truth for the clinical cases.

8. Sample Size for the Training Set

• The document does not specify the sample size used for training the Deep Learning Image Reconstruction (DLIR) algorithm.

9. How Ground Truth for the Training Set Was Established

• The document does not explicitly describe how ground truth for the training set was established. It only mentions that DLIR is a "deep learning technology-based software sub-system." For deep learning reconstruction, training typically involves pairs of noisy (or lower-dose) input images and corresponding high-quality (or higher-dose/reference standard) images, often reconstructed with a traditional full-dose, high-quality algorithm (not explicitly stated here, but common practice).

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The SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image whole organs, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes.

The system is indicated for X-ray Computed Tomography imaging of organs that fit in the scan field of view, including cardiac and vascular CT imaging. The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.

The SpotLight Duo is a multi-slice (192 detector rows), dual tube CT scanner consisting of a gantry, patient table, operator console, power distribution unit (PDU) and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software for operator interface and image handling. As in other CT scanned subject is irradiated by X rays and a detector array measures attenuation data of X rays that have been attenuated by the subject from multiple view angles. This is achieved by rotation source and the detector about the subject while acquiring the attenuation data. A computer is used to reconstruct cross sectional images of the subject from the attenuation data.

The provided text describes the regulatory clearance of a medical device, the "SpotLight Duo," and its substantial equivalence to predicate devices based on non-clinical performance testing. However, it does not include detailed acceptance criteria or the specific results of a study designed to prove the device meets these criteria in the format requested.

Here's a breakdown of the missing information and what can be inferred:

1. A table of acceptance criteria and the reported device performance: This information is not explicitly provided in a table format with specific quantitative criteria and corresponding performance metrics. The document mentions "performance specifications are met" but does not detail what these specifications are.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No information about sample size or data provenance is provided. The testing described is non-clinical performance testing using phantoms, not clinical data from patients.

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, as the testing described is non-clinical performance testing using phantoms. No human expert review for establishing ground truth is mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as the testing described is non-clinical performance testing using phantoms.

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: An MRMC comparative effectiveness study was not done. The device is a CT scanner, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done: The document describes non-clinical performance testing of the CT scanner hardware and software. It's essentially a standalone performance evaluation of the imaging system itself, independent of human interpretation for the purpose of demonstrating technical specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical performance testing, the ground truth would be established by the known physical properties and configurations of the phantoms used, as well as established metrology and physics principles for evaluating CT image quality and dose.

8. The sample size for the training set: Not applicable. The device is a CT scanner, and the "training set" concept is typically associated with machine learning or AI models, which is not the primary focus of this submission. The software adaptations mentioned are for supporting new detector configurations, reconstruction at larger FOV, and scan modes based on engineering modifications, not machine learning model training.

9. How the ground truth for the training set was established: Not applicable for the reasons stated above.

In summary, the provided text describes a 510(k) premarket notification for a Computed Tomography X-ray System (SpotLight Duo). The "study" proving it meets acceptance criteria refers to a series of non-clinical performance tests using phantoms to demonstrate that the device's technical specifications - regarding image quality (spatial resolution, low contrast detectability, noise, uniformity, CT number accuracy) and dose performance - are met, and that it complies with relevant electrical safety and radiation protection standards.

The document does not contain information about clinical studies with human participants, expert review of images, or AI-specific performance metrics. It focuses on the physical and technical performance of the imaging device itself.

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ARISTE AB Mesh is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The non-absorbable polymer coating on the mesh contains the antimicrobial agents, rifampin and minocycline to help provide protection from microbial colonization of the device during surqical implantation.

ARISTE AB Mesh is intended for single patient one-time use only.

ARISTE AB Mesh is a non-resorbable sterile prosthesis designed to provide mechanical support for reconstruction of soft tissue deficiencies. The mesh is constructed of polypropylene fibers knitted together to form the mesh. The resulting structure is an implant which reinforces the tissue defect. The mesh is coated with a thiolene polymer. The coating acts as a carrier for antibiotic agents rifampin and minocycline in equal concentrations of approximately 171μg/cm² to help provide protection from bacterial colonization of the device during surgical implantation.

I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance as typically expected for an AI/ML device submission (e.g., performance metrics like sensitivity, specificity, accuracy, or AUC).

The document is a 510(k) clearance letter and summary for a surgical mesh (ARISTE AB Mesh), which is a physical medical device, not an AI/ML software device. The "performance testing" described refers to bench, animal, and biocompatibility testing for a physical implant, and the "acceptance criteria" for such devices are related to mechanical strength, biocompatibility, sterilization, and drug elution, rather than diagnostic accuracy or concordance with expert readers.

Therefore, I cannot provide the requested information in the format specific to AI/ML device evaluations.

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The KaVo NOMAD Pro 2 Handheld X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors.

KaVo NOMAD Pro 2 Handheld X-ray System is a battery-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-rays images utilizing either film or digital imaging techniques. The KaVo NOMAD Pro 2 Handheld X-ray System is designed for use in a dental office. It can also be used in other similar environments (orthodontic office, general practitioner's office, hospital ward, etc.) where appropriate safequards are implemented. The device uses a rechargeable battery to allow for the use of the KaVo NOMAD Pro 2 Handheld X-ray System where transportation or use of other x-ray devices might be prohibitive due to the other device's size and/or lack of mobility.

The KaVo NOMAD Pro 2 Handheld X-ray System is an X-ray device with a DC qenerator. The handheld device features a main unit (tube head), recharqeable battery (handset), charger, and charger AC/DC power supply. The power is supplied by a rechargeable Lithium Ion battery core pack built into a handset. This facilitates portability of the device. A beam-limiting cone is incorporated within the device. Internal and external shielding provide sufficient radiation protection to allow the clinician to remain in the operatory with the patient.

To make the system as simple as possible for the operator, KaVo NOMAD Pro 2 Handheld Xray System uses a fixed tube voltage of 60kV and a fixed tube current of 2.5mA. The only operator-adjustable parameter is the exposure time. This adjustment can be quickly accomplished through the user-friendly control panel.

Control buttons, display, and a trigger provide the primary operator interface. Exposures settings can be selected and displayed. Voltage (60 kV) and current (2.5 mA) are fixed with the exposure time varying based on patient type, detector type, and anatomical feature. Exposures can be completed using the trigger. The device can be used with three detector types: film, digital imaging intraoral sensors, and phosphor plates.

The KaVo NOMAD Pro 2 Handheld X-ray System is an extraoral source X-ray system. The document provided outlines the substantial equivalence to a predicate device, the NOMAD Pro X-ray System (K081664). This means that the device's performance is demonstrated by its adherence to recognized standards and by showing it functions comparably to an already approved device.

Here's the breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly demonstrated through compliance with various international standards and general performance characteristics that are "unchanged" or "same" as the predicate device, or show minor improvements. The table below highlights the key characteristics and indicates how performance is evaluated against the predicate.

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

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

Therefore, there was no "test set" of patient data or clinical samples used for the approval of this device. The evaluation was entirely based on non-clinical engineering and bench testing, demonstrating compliance with various national and international standards applicable to medical electrical equipment and X-ray systems.

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

As no clinical testing was performed, there were no clinical experts (like radiologists) involved in establishing ground truth for a test set. Evaluation was based on engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

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

No, an MRMC comparative effectiveness study was not done. The approval is based on substantial equivalence to a predicate device and compliance with non-clinical performance and safety standards.

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

Yes, in a sense. The "performance" of the device was assessed in a "standalone" non-clinical manner, meaning its physical and electrical characteristics, and its compliance with safety and performance standards for X-ray devices, were tested independently of human operators or clinical outcomes. The device itself is an X-ray system, not an AI algorithm, so the concept of "algorithm only" or "human-in-the-loop" isn't directly applicable in the way it would be for AI software. Its functionality as an X-ray generator was validated through engineering tests.

7. The Type of Ground Truth Used

The "ground truth" for this device's approval is primarily established through compliance with recognized international and national standards for medical electrical equipment and diagnostic X-ray systems (e.g., IEC 60601 series, 21 CFR 1020.30, 1020.31), and by demonstrating substantial equivalence in technological characteristics and indications for use to a legally marketed predicate device. This involves engineering measurements and testing to ensure the device meets specified performance thresholds and safety requirements.

8. The Sample Size for the Training Set

Not applicable, as this is hardware (an X-ray system), not a software algorithm that requires a training set.

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

Not applicable, as this is hardware (an X-ray system), not a software algorithm that requires a training set.

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The SpotLight CT Computed Tomography X-ray is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles. The system has the capability to image whole organs, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes.

The system is indicated for X-ray Computed Tomography imaging of organs that fit in a 25cm field of view, including cardiac and vascular CT imaging. The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.

The SpotLight CT is a third generation rotate-rotate CT scanner, designed and built based on technologies and principles of operation of the predicate device and other legally marketed CT scanners. The SpotLight CT is a multi-slice (192 detector rows), dual tube CT scanner consisting of a gantry, patient table, operator console, power distribution unit (PDU) and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software for operator interface and image handling.

The provided document describes the Arineta Ltd. SpotLight CT device and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance." Instead, it describes various performance specifications and how the device performed against them. I've re-framed the reported performance metrics as if they were acceptance criteria.

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

• Test Set (Clinical Testing): 38 subjects
• Data Provenance: Not explicitly stated, but the study was conducted at "one site," and the readers were "US certified." This suggests the data was collected in the US.
• Retrospective or Prospective: The clinical testing describes "data were collected," which could mean either. However, the phrase "The study protocol was designed to test the scanner across different patient populations, clinical scenarios and scan techniques" implies a prospective study design for collecting new data specifically for this evaluation.

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

• Number of Experts: Four (4)
• Qualifications: "US certified readers who are qualified radiologists or cardiologists." Specific years of experience are not mentioned.

4. Adjudication Method for the Test Set

The document states, "The images were evaluated and rated by four US certified readers." It does not specify an adjudication method like 2+1 or 3+1 for resolving discrepancies. It implies independent evaluation by each reader.

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

• Was an MRMC study done? No, a multi-reader multi-case (MRMC) comparative effectiveness study (comparing human readers with and without AI assistance) was not done. The clinical testing focused on evaluating the device's diagnostic image quality for standalone performance.
• Effect size of human readers with AI vs without AI assistance: Not applicable, as no such study was conducted or reported.

6. Standalone (Algorithm Only) Performance

• Was a standalone study done? Yes, the described "Non-clinical Performance Testing" and "Clinical Testing" primarily focus on the standalone performance of the SpotLight CT system. The image quality, temporal resolution, dose performance, and diagnostic quality evaluations are all measures of the device's inherent capabilities without human intervention during the image generation or initial analysis phase. The "clinical diagnostic value and image quality" evaluated by the readers are also assessing the output of the device itself.

7. Type of Ground Truth Used

• Non-clinical/Phantom Testing: The ground truth for these tests would be objective physical measurements and known parameters of the phantoms used to evaluate image quality metrics (e.g., spatial resolution targets, known low contrast objects, CT number uniformity).
• Animal Testing: The "diagnostic quality" evaluation in animal models likely used established veterinary diagnostic criteria and potentially post-mortem examination or other correlative imaging as ground truth.
• Clinical Testing: The "clinical diagnostic value and image quality" in human subjects were evaluated by "qualified radiologists or cardiologists" against established clinical diagnostic criteria. While not explicitly stated as "expert consensus ground truth," the assessment by multiple, qualified experts serves as the de-facto ground truth for evaluating diagnostic utility. It does not mention pathology or long-term outcomes data for ground truth.

8. Sample Size for the Training Set

The document does not provide any information about a training set since this is a hardware device (CT scanner) with associated imaging software, not typically an AI/ML algorithm that requires a distinct "training set" in the common sense. The image reconstruction algorithm is described as "Stereo CT reconstruction algorithm based on common algorithms used in single source scanners that are modified to combine the data acquired from the two sources." This implies an engineered algorithm, not one trained on a dataset.

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

Not applicable, as there is no mention of an AI/ML algorithm requiring a training set in the document. The device uses an engineered image reconstruction algorithm.

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Aria Bio's Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The Aria Bio Dental Implant System consists of two stage endosseous form dental implants, hexagonal and conical implants and hexagonal and conical abutments; cover screws and healing caps; abutment systems and superstructures and surgical instruments.

The provided document describes a 510(k) premarket notification for Aria Bio's Dental Implant System, asserting its substantial equivalence to predicate devices. The document does not describe acceptance criteria for particular performance metrics nor does it present detailed study results proving a device meets specific acceptance criteria in the format requested.

Instead, the document focuses on demonstrating substantial equivalence through:

• Comparison of indications for use and technological characteristics with predicate devices.
• Reporting that a series of performance tests (fatigue, surface analysis, biocompatibility, sterilization, shelf life) were performed and that "All results are supporting Aria Bio's labeling claims in order to establish substantial equivalency." However, it does not provide the specific acceptance criteria for these tests, nor the detailed results.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details regarding sample sizes for training/test sets, ground truth establishment, or specific study types like MRMC, as this information is not present in the provided text.

The document states:

• "A series of performance tests and evaluations were performed to demonstrate that Aria Bio's Dental Implant System does not raise any new issues that may affect its substantial equivalency with its predicate devices. These evaluations include fatigue (ISO 14801), surface analysis by SEM/EDS and XPS, biocompatibility in accordance with ISO 10993-1, sterilization validation (ISO 11137-2, AAMI TIR 33, ISO 17665-1) and shelf life validation (ISO 11607-1) in order to assure maintaining of SAL 10° along the shelf life."
• "All results are supporting Aria Bio's labeling claims in order to establish substantial equivalency."

This indicates that these tests were conducted, and their outcomes were deemed acceptable based on established industry standards (e.g., ISO 14801 for fatigue testing, ISO 10993-1 for biocompatibility). However, the specific quantitative acceptance criteria or the actual performance results (e.g., specific fatigue limits, exact sterilization validation parameters, detailed surface analysis findings) are not provided in the document beyond stating that they were performed and supported substantial equivalence.

Without these specific details, I cannot construct the requested table or answer most of the specific questions about the study design and results.

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The NOMAD MD is a handheld and portable general purpose X-ray system. The device uses a fixed tube current and voltage (kVp) and, therefore, is limited to taking diagnostic X-rays of extremities.

It is intended to be used by a qualified and trained clinician on both adult and pediatric patients. It is not intended to replace a radiographic system with variable tube current and voltage (kVp) which may be required for full optimization of image quality and radiation exposure for different exam types.

The NOMAD MD is a handheld, general purpose X-ray system that operates on 14.4 V DC supplied by a rechargeable NiCd battery pack. The X-ray tubehead, X-ray controls, and power source are assembled into a single hand-held enclosure. The package includes a spare battery, a Charging Cradle, and an AC-to-DC Power Supply.

The provided text describes the safety and effectiveness testing for the NOMAD MD Handheld X-ray System, as part of its 510(k) premarket notification. Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" for diagnostic image quality in a quantitative, pass/fail table format. Instead, it states the objective was to demonstrate substantial equivalence to the predicate device (MinXray HF 100H+) for diagnostic image quality.

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

• Sample Size: The document mentions "radiographic images of foot, knee, elbow, and hand phantoms" were used. It does not specify the exact number of phantoms or the number of images taken.
• Data Provenance: Not specified, but likely obtained in a controlled laboratory or testing environment by the manufacturer (Aribex, Inc., located in Orem, UT, USA). The study appears to be prospective as it involved taking new images for comparison.

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

• Number of Experts: "A board-certified radiologist" (singular) was used.
• Qualifications of Experts: "Board-certified radiologist." No further details on years of experience are provided.

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

Based on the description "reviewed by a board-certified radiologist who determined that images from both devices were of diagnostic quality and, therefore, substantially equivalent," there was no formal adjudication method described involving multiple readers. It was a single-reader assessment.

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

• No MRMC study was done. The described study was a comparison of image quality between two X-ray devices, not an assessment of human reader performance with or without AI assistance.
• No AI component is mentioned in this device or its evaluation.

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

• Not applicable. The NOMAD MD is an X-ray imaging device, not an AI algorithm. Its performance was evaluated based on the diagnostic quality of the images it produced, assessed by a human expert.

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

The ground truth for image quality was expert assessment/consensus by a single board-certified radiologist. The images were of phantoms, simplifying the "ground truth" to the radiologist's determination of "diagnostic quality."

8. The sample size for the training set:

• Not applicable. This device is an X-ray emitter, not an AI or imaging processing algorithm that typically requires a training set. The descriptions relate to hardware performance, radiation safety, and image generation capabilities.

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

• Not applicable, as there was no training set for an AI algorithm.

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The Arion Dialysis Water System is for use in multi-patient hemodialysis. The system consists of pretreatment, reverse osmosis, post-treatment and distribution equipment. The sizing of the system is consisting with the demand of water needed for patients. The water produced will meet the minimum requirements of ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications (RD52:2004 and RD62:2006/A1:2009) and the CMS End Stage Renal Disease (ESRD) Program Interpretive Guidance (based on 42 CFR 494) when used as directed. RO and Pretreatment design is based off of feed water quality to meet the stated specifications. This system is intended to be used in hospitals, dialysis centers, and dialysis clinics.

The Arion Dialysis Water System is comprised of water purification equipment used to purify water for hemodialysis.

The Arion Dialysis Water System (K112331) is a high-purity water system used for hemodialysis. The device's performance relies on its ability to produce water that meets specific quality standards.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

The document does not specify a distinct "test set" in the context of typical clinical or algorithm performance studies. Instead, the device's performance is verified through a series of non-clinical tests conducted at installation and on an ongoing basis. Each installed system acts as its own "test subject."

• Sample Size: Each individual Arion Dialysis Water System installed.
• Data Provenance: Prospective (at the time of installation and quarterly thereafter) as the device is put into use. The country of origin for the data is not explicitly stated, but the applicant (Arion Water, Inc.) is based in Massachusetts, USA, suggesting the testing would primarily occur in facilities within the USA.

3. Number of Experts and Qualifications:

The document does not mention the use of external experts to establish ground truth for this type of device. The ground truth for water quality is established by objective, verifiable laboratory tests against recognized industry standards (ANSI/AAMI).

4. Adjudication Method:

Not applicable. The performance is assessed based on objective water quality measurements and equipment functionality against defined standards, not subjective interpretations requiring adjudication.

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

Not applicable. This device is a water purification system, not an imaging or diagnostic algorithm that would typically involve human readers.

6. Standalone Performance:

Yes, the performance data presented is for the standalone performance of the Arion Dialysis Water System. The device's ability to produce water meeting the required standards is assessed independently.

7. Type of Ground Truth Used:

The ground truth used is based on objective measurements and verifiable compliance with established industry standards and regulations. Specifically:

• Chemical Contaminant Levels: Measured and compared against the maximum acceptable levels specified in ANSI/AAMI RD52:2004 and RD62:2006/A1:2009.
• System Design and Functionality: Compliance with ANSI/AAMI equipment and design regulations, and verification of safe mechanical and electrical operations.

8. Sample Size for the Training Set:

Not applicable. This device is a physical water purification system, not a software algorithm that undergoes a "training" phase with a dataset. Its design and manufacturing are based on engineering principles and compliance with established standards.

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

Not applicable, as there is no "training set" in the context of an algorithm. The design and manufacturing processes are guided by the "ground truth" of established engineering principles and the requirements outlined in ANSI/AAMI RD52:2004, RD62:2006/A1:2009, and CMS ESRD Program Interpretive Guidance.

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