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The Aurora system is a medical tool intended for use by appropriately trained healthcare professionals to aid detecting, localizing, diagnosing of diseases and in the assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors; and planning, guiding, and monitoring therapy, including the nuclear medicine part of theragnostic procedures.

GEHC's Aurora is a SPECT-CT system that combines an all-purpose Nuclear Medicine imaging system and the commercially available Revolution Ascend system. It is intended for general purpose Nuclear Medicine imaging procedures as well as head, whole body, cardiac and vascular CT applications and CT-based corrections and anatomical localization of SPECT images. Aurora does not introduce any new Intended Use.

Aurora consists of two back-to-back gantries (i.e. one for the NM sub-system and another for the CT subsystem), patient table, power distribution unit (PDU), operator console with a computer for both the NM acquisition and SmartConsole software and another for the CT software, interconnecting cables, and associated accessories (e.g. NM collimator carts, cardiac trigger monitor, head holder). The CT sub-system main components include the CT gantry, PDU, and CT operator console. All components are from the commercially available GEHC Revolution Ascend CT system.

Here's a breakdown of the acceptance criteria and study details for the Aurora system's deep-learning Automatic Kidney Segmentation algorithm, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Reported Device Performance

Study Details for Deep-Learning Automatic Kidney Segmentation Algorithm

1. Sample sized used for the test set and the data provenance:
* Sample Size: 70 planar NM renal studies.
* Data Provenance: Acquired using GEHC systems from:
* 2 hospitals in the United States
* 1 hospital in Europe
* Nature: Retrospective (the studies were "segregated, and not used in any stage of the algorithm development," implying they were pre-existing data).
* Diversity: Served a diverse patient population including a range of ethnicities and demographics, encompassing a range of dynamic renal clinical scenarios, detection technologies, collimators, tracers, scan parameters, and patient age.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Number of Experts for Bench Testing Ground Truth: One (1).
* Qualifications: "An experienced Nuclear Medicine physician."
* Number of Experts for Clinical Testing Evaluation: Three (3) qualified U.S. readers.
* Qualifications: "Qualified U.S. readers" (further specific qualifications like years of experience or board certification are not detailed).

3. Adjudication method for the test set:
* For Bench Testing Ground Truth: The ground truth contours were reviewed and confirmed by a single experienced Nuclear Medicine physician. This suggests a form of expert consensus, but without multiple experts, it's not a multi-expert adjudication like 2+1 or 3+1. It's best described as single expert confirmation.
* For Clinical Testing: The three qualified U.S. readers independently assessed the quality of segmentation using a 4-point Likert scale. There is no mention of an adjudication process among these three readers, implying their individual assessments contributed to the overall evaluation.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
* No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance vs. without AI assistance was not explicitly described.
* The clinical testing involved multiple readers evaluating the quality of the algorithm's segmentation itself, rather than assessing their own diagnostic performance with and without AI. The focus was on the utility and acceptability of the AI output for the readers.

5. Effect size of how much human readers improve with AI vs without AI assistance:
* This information is not provided as a comparative effectiveness study was not explicitly conducted. The study assessed the acceptability of the AI's output, not the improvement in human reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Yes, a standalone performance evaluation of the algorithm was done. This is described as "Bench Testing" where the algorithm's generated contours were compared directly against the ground truth (GT) contours using the DICE similarity score. The "clinical testing" involved human readers evaluating the AI output, but the bench testing was algorithm-only.

7. The type of ground truth used:
* Expert Consensus: The ground truth for the bench testing (GT contours) was established by an "experienced Nuclear Medicine physician." While only one physician is mentioned, it's considered an expert-derived ground truth.

8. The sample size for the training set:
* The document does not explicitly state the sample size used for the training set of the deep learning algorithm. It only mentions that the 70 test studies "were segregated, and not used in any stage of the algorithm development," which implies they were distinct from the training data.

9. How the ground truth for the training set was established:
* The document does not explicitly state how the ground truth for the training set was established. It is only mentioned for the test set.

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The SPHERICAL/ASPHERE Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The TORIC Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive error in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The MULTIFOCAL Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Daily wear replacement schedules may vary from patient to patient and should be decided by eye care practitioners in consultation with their patients.

Eye care practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.

The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lenses are fabricated from ocufilcon D, which is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% ocufilcon D and 55% water by weight when immersed in saline solution with polymeric wetting agents. The color additive (Pathalocyaninto(2-))Copper, Iron Oxide and Reactive Yellow 15 are added to the lens material to create a light yellow-green edge-to-edge color to make it easier to see when handling, and additionally, reduce transmittance of short wavelength light in the range of 380nm to 460nm. In addition, lenses contain a benzotriazole monomer to filter UVA and UVB radiation. The (ocufilcon D) name has been adopted by the United States Adopted Names Council (USAN).

The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are available tinted for visibility, and tinted to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: Reactive Yellow 15, Rutile TiO2, Iron Oxide, (Pathalocyaninto(2-))Copper, Carbazole Violet, Phthalocyanine Green.

When producing the color lenses, the manufacturing process changes the specifications to the light yellow-green contact lens by pad-printing the color pigment(s)—entrapping the colorants in the interpenetrating network of the contact lens material in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a clear pupil diameter of 6.0 mm.

The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) incorporate a UV absorbing monomer. The lenses filter >95% in the UVB range (280nm - 315nm), and >80% in the UVA range (315nm - 380nm).

The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are manufactured in the sphere/asphere, toric, and multifocal design configurations.

The provided FDA 510(k) clearance letter and associated summary pertain to a contact lens device, the Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color). It's important to note that this document describes the device as a "Soft (Hydrophilic) Contact Lens," which is a device type, not an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study parameters related to AI/ML device performance (such as sensitivity, specificity, MRMC studies, ground truth establishment for AI/ML, etc.) are not applicable to this type of medical device submission.

The "acceptance criteria" for a contact lens device primarily revolve around its physical, chemical, and biological properties, as well as its safety and functionality for human use, established through non-clinical (laboratory) testing and comparisons to predicate devices. The study proving these criteria are met is typically a combination of non-clinical bench testing and demonstrating substantial equivalence to an already marketed predicate device.

Here's the information based on the provided document, restructured to address your points where applicable:

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

For a contact lens, explicit "acceptance criteria" are often derived from recognized standards (like ANSI Z80.20 mentioned) and the performance of predicate devices. The reported device performance is compared against these and is generally expected to be within acceptable tolerances or equivalent to the predicate.

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The AURORA Surgiscope System is intended for use in neurosurgery and endoscopic neurosurgery and pure neuroendoscopy (i.e. ventriculoscopy) for visualization, diagnostic, and/or therapeutic procedures, such as ventriculostomies, biopsies and removal of cysts, tumors, and other obstructions.

The Aurora Surgiscope System consists of two components: (1) a sterile, single use, Sheath with integrated illumination LEDs and camera, with an Obturator, and (2) a non-sterile, reusable control unit, Image Control Box (ICB).

The Sheath is intended to provide access to the surgical site by acting as the insertable portion of the device, as well as the instrument channel to accommodate other surgical tools. Depth markers are present along the length of the Sheath for user reference. The proximal end of the Sheath also incorporates a Tab, which serves as the location for fixation arm to hold the device.

At the proximal end of the Sheath is the Imager, which comprises the following components: LEDs (light emitting diodes), camera (and optical components), and focus knob.

• The LEDs provide illumination to the surgical field by directing light down the Sheath, along the working channel.
• The camera captures videos of the surgical field.
• The focus knob allows the user to adjust the focus of the camera to obtain the desired image quality.

To facilitate insertion of the Sheath into the surgical site, an Obturator is provided with the device. During device insertion, the Obturator is fully inserted into the Sheath, and the entire AURORA Surgiscope is advanced to the desired surgical location. The distal end of the Obturator is conical in shape to minimize tissue damage during device insertion. In addition, the proximal handle of the Obturator is designed to accommodate various stereotactic instruments for neuronavigation, which can further aid in device placement. The Obturator is removed after insertion.

The ICB is a non-sterile device that provides three main functions in the AURORA Surgiscope System:

• To power the LEDs and camera of the AURORA Surgiscope.
• To relay the video feed captured by the AURORA Surgiscope camera to a connected Medical Grade Surgical Monitor for real-time image visualization.
• To allow the user to make adjustments to the displayed video feed (e.g., contrast, brightness), and to vary the light output of the LEDs.

The user interface is a membrane keypad with buttons located on the ICB that can be depressed for image adjustment, such as zoom, contrast, and brightness. The connection ports to the AURORA Surgiscope, Medical Grade Surgical Display Monitor, and Power are located on the side of the ICB, along with the ON/OFF switch.

The provided FDA 510(k) clearance letter for the AURORA Surgiscope System (K250752) does not contain the detailed information necessary to fully answer all the questions regarding acceptance criteria and the study that proves the device meets them.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K201840) based on technological characteristics and functional requirements. It explicitly states that "No clinical test/studies were required or performed as all conducted performance tests appropriately support a determination of substantial equivalence compared with the predicate device (K201840)."

Therefore, for many of the requested points, the answer will be that the information is not available in the provided text.

Here's a breakdown of what can and cannot be answered based on the input:

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

The document mentions "functional requirements" and "performance tests" but does not detail specific acceptance criteria or quantitative performance results. It only states that the device meets these requirements after sterilization, environmental, and transit conditioning, and equivalent to a 1-year shelf-life.

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

• Sample size for test set: Not specified. The document states "non-clinical testing was performed" but does not detail the number of units tested.
• Data provenance: Not specified. The nature of the testing (functional performance, sterilization effects) suggests it would be laboratory testing rather than patient data.

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

• Not applicable / Not specified. Since no clinical studies were performed, there was no need for expert review of clinical data to establish ground truth. The "ground truth" here would be the successful function of the device in engineering tests.

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

• Not applicable / Not specified. No clinical data was being adjudicated.

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. The document explicitly states: "No clinical test/studies were required or performed". This device is a surgical endoscope, not an AI-assisted diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant to its clearance.

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

• Not applicable. This is a physical medical device (endoscope), not a standalone algorithm.

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

• For the non-clinical performance tests mentioned, the "ground truth" would be the engineering specifications and functional integrity of the device. This is typically verified through direct measurement, visual inspection, and functional tests (e.g., image quality assessment, illumination intensity, camera function, mechanical integrity) against predefined specifications. It is not based on clinical "ground truth" like pathology or expert consensus.

8. The sample size for the training set

• Not applicable. This notice does not describe an AI/machine learning device that requires a training set.

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

• Not applicable. No training set was involved for this device.

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The Aurora system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in the assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors; and planning, guiding, and monitoring therapy, including the nuclear medicine part of theragnostic procedures.

· NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT), Imaging modes include single photon, multi-isotope, and multi-peak, with data stored in frame/list mode. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring.

· CT System: produces Cross sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head, whole body, cardiac and vascular X-Ray Computed Tomography applications.

· NM + CT System: Combined, hybrid SPECT and CT protocols, for CT-based SPECT attenuation corrected imaging as well as functional and anatomical mapping (localization, registration, and fusion).

The Aurora system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include digital processing of data and images, including display, quality check, transfer, and processing, to produce images in a variety of trans-axial and reformatted planes. The images can also be post processed to obtain additional images, imaging planes, analysis results and uptake quantitation. The system may be used for patients of all ages.

GEHC's Aurora is a SPECT-CT system that combines an all-purpose Nuclear Medicine imaging system and the commercially available Revolution Ascend system. It is intended for general purpose Nuclear Medicine imaging procedures as well as head, whole body, cardiac and vascular CT applications and CT-based corrections and anatomical localization of SPECT images. Aurora does not introduce any new Intended Use.

Aurora consists of two back-to-back gantries (i.e. one for the NM sub-system and another for the CT subsystem), patient table, power distribution unit (PDU), operator console with a computer for both the NM acquisition and SmartConsole software and another for the CT software, interconnecting cables, and associated accessories (e.g. NM collimator carts, cardiac trigger monitor, head holder). The CT sub-system main components include the CT gantry, PDU, and CT operator console. All components are from the commercially available GEHC Revolution Ascend CT system. The CT gantry has been adapted for use with predicate device's NM portion. CT PDU, CT Console Keyboard and CT operator console are the same as in Revolution Ascend Plus.

The provided document does not contain details about specific acceptance criteria, a study proving device performance against those criteria, or the various methodological details requested regarding sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance.

The document is a 510(k) summary for the Aurora system, indicating that it is a modification of a predicate device (Discovery NM/CT 670) and incorporates components from other cleared devices. The filing emphasizes that, due to the nature of these modifications (primarily replacing a 16-slice CT with a 64-slice CT and other workflow enhancements, while the NM system is largely carried over), clinical testing was deemed unnecessary to demonstrate substantial equivalence.

The document states:

• "Because the changes associated with Aurora do not change the Indications for Use from the predicate and reference devices, and represent equivalent technological characteristics, this type of change supports using scientific, established / standardized, engineering / physics-based performance testing, without inclusion of clinical images for determining substantial equivalence."
• "Given the above information and the type and scope of changes, particularly that the NM imaging component is identical to the predicate, and the CT component is the commercially available Revolution Ascend CT system, clinical images are not included in this submission. Clinical images are not needed to demonstrate substantial equivalence."

Instead of a clinical study, the submission relies on:

• Design control testing per their quality system (21CFR 820 and ISO 13485): including Risk Analysis, Required Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), Simulated use testing (Validation).
• Conformance to standards: IEC 60601-1 and its applicable Collateral and Particular Standards (IEC 60601-1-2, 60601-1-3, 60601-2-44), as well as performance testing per NEMA NU-1.
• Additional engineering bench testing (non-clinical testing): This was performed to support substantial equivalence, demonstrate performance, and substantiate product claims. Evaluated areas included applicability of cleared lesion detectability and dose/time reduction claims, quantitation accuracy, IQ performance with low dose CT for attenuation correction, and workflow.

Therefore, the requested information cannot be extracted from this document as a clinical validation study demonstrating performance against specific acceptance criteria with human-in-the-loop or standalone performance was not part of the submission for substantial equivalence.

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Aurora is a Software as a Medical Device (SaMD) that establishes sleep quality. Aurora automatically analyzes, displays, and summarizes Photoplethysmogram (PPG) data collected during sleep using compatible devices. Aurora is intended for use by and by order of a healthcare professional to aid in the diagnosis of sleep disorders including sleep apnea in adults.

The Aurora output, including automatically detected respiratory events and parameters, may be displayed and edited by a qualified healthcare professional. The Aurora output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional.

Aurora is not intended for use with polysomnography devices.

Aurora is a Class II Software as a Medical Device (SaMD), intended to aid in the evaluation of sleep disorders, where it may inform or drive clinical management. Aurora is a software application that is indicated for use on a general-purpose computing platform. It is a cloud-based software-as-a-medicaldevice (SaMD) with a user interface that runs in a web browser.

Aurora automatically analyzes and displays photoplethsmography (PPG) signal data including SPO2 and pulse/heart rate only from compatible FDA-cleared medical purpose pulse oximeters that meet Aurora's data acquisition requirements for sampling rate, digital resolution, measurement range, and accuracy range.

Following upload of a compatible PPG study to the cloud software, the algorithm functions by verifying minimum signal quality, study length, and technical adequacy requirements, preprocessing the data including normalization, digital filtration, and artifact detection/rejection procedures, applying machine learning algorithms including multiple deep neural network machine learning models, statistical signal processing analyses including time-domain and time-frequency domain analyses over multiple time and resolution scales, and other analyses output a detected set of events and derived signals for the PPG study that are post-processed and logically filtered according to algorithm rules based on the American Academy of Sleep Medicine (AASM) recommended scoring event, desaturation, and association rules. Aurora algorithm outputs, including scored respiratory events, sleep stages, Aurora Apnea-Hypopnea Index (eAHI), Total Sleep Time (TST), Sleep Efficiency (SE), Sleep Latency (SL), Wake After Sleep Onset (WASO), and Oxygen Desaturation Events Index (ODI) measures, are stored and made available for display, editing, and review in Aurora by qualified healthcare professionals.

Aurora reports results of the automated data analysis based on AASM guidelines, including the Aurora output Apnea-Hypopnea Index (eAHI) and total sleep time (TST). The algorithm outputs are graphical and numerical displays and reports of sleep latency, sleep quality, and sleep pathologies including sleep disordered breathing. The Aurora displays and reports are for the order of physicians, trained technicians, or other healthcare professionals to evaluate sleep disorders where it may inform or drive clinical management taking into consideration other factors that normally are considered for clinical management of sleep disorders for adults.

The clinician can view raw data for interpretation, edit events, write clinical notes, and customize sleep reports for the patient.

Aurora output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional.

The document provides detailed information about the performance evaluation of the Aurora device, a Software as a Medical Device (SaMD) intended to aid in the diagnosis of sleep disorders.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for Aurora are implied by the performance metrics reported, demonstrating its accuracy in detecting Apnea Hypopnea Index (eAHI) and performing sleep staging against polyomnography (PSG) ground truth. While explicit numerical "acceptance criteria" tables are not provided, the reported sensitivity, specificity, and regression/Bland-Altman statistics serve as the evidence of meeting performance expectations for substantial equivalence.

Table of Performance Data (Implied Acceptance Criteria)

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

• Test Set Sample Size:
  • For eAHI performance (sensitivity/specificity): 158 adult patients.
  • For Sleep Staging:
    • Wake: 52,622 epochs
    • Light NREM: 69,438 epochs
    • Deep NREM: 10,195 epochs
    • REM: 14,459 epochs
• Data Provenance: The document does not explicitly state the country of origin but implies clinical settings where PSG (Polysomnography) and HSAT (Home Sleep Apnea Test) recordings are collected. The study involved simultaneous PSG and HSAT recordings, suggesting a prospective collection of data for testing purposes to facilitate direct comparison.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Three registered polysomnographic technologists were used for manual scoring, and one board-certified sleep physician reviewed each PSG.
• Qualifications of Experts:
  • Scorers: Registered polysomnographic technologists.
  • Reviewer/Confirmer: Board-certified sleep physician.

4. Adjudication Method for the Test Set

• Adjudication Method: A 2+1 consensus method. For an event to be officially scored or reported, a consensus of at least two-thirds among the three scorers was required. Additionally, each PSG was reviewed by a board-certified sleep physician to provide clinical confirmation of scoring and technical adequacy, serving as a final adjudication layer.

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

• The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to assess how much human readers improve with AI vs. without AI assistance. The study focuses on the standalone performance of the Aurora algorithm against expert-scored ground truth. The device output may be displayed and edited by a qualified healthcare professional, suggesting a human-in-the-loop workflow, but the study described does not quantify the effect of AI assistance on human reader performance.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The reported sensitivity, specificity, Deming regression, and Bland-Altman analyses directly evaluate the algorithm's performance (Aurora) against the expert-scored PSG as ground truth, without a human in the loop for the performance metrics themselves.

7. Type of Ground Truth Used

• The type of ground truth used was expert consensus from manual scoring of Polysomnography (PSG) data. Specifically, PSG recordings were manually scored by three registered polysomnographic technologists using guidelines following the 3% desaturation guidance. This was further reviewed and confirmed by a board-certified sleep physician.

8. Sample Size for the Training Set

• The document does not specify the sample size for the training set. The provided details pertain exclusively to the test set used for performance validation.

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

• The document does not specify how the ground truth for the training set was established. Information regarding the training data, its collection, or annotation methods is not included in this summary.

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The Facet Aurora Reusable Lancet Base (commonly referred to as a lancing device) is a non-sterile reusable device which provides a spring-loaded mechanism to quickly eject and retract a lancet of proprietary design to effect a lancing event for the purpose of obtaining a droplet of capillary blood for diagnostic testing in children, adolescents, and adults in a home setting.

The device is designed to be cleaned and disinfected between uses on a single patient.

The Facet Aurora Reuseable Lancet Base is a blood sampling device used in conjunction with a lancet blade of proprietary design to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients.

The lancing device has been in commercial distribution in the United States for over 10 years. There have been no significant design changes over the life of the device.

The provided text describes a 510(k) premarket notification for the "Facet Aurora Reusable Lancet Base." However, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing of its mechanical properties and materials. It does not contain information about:

• Acceptance criteria related to the performance of a device that uses AI/algorithm, such as sensitivity, specificity, or AUC.
• A study proving the device meets acceptance criteria for an AI/algorithm.
• Sample sizes for AI/algorithm test sets or data provenance.
• Details about experts establishing ground truth or adjudication methods for an AI/algorithm's performance evaluation.
• MRMC studies or standalone AI performance.
• Training set details for an AI/algorithm.

The device in question is a mechanical lancing device, not an AI or algorithm-based device. The non-clinical testing listed (e.g., Endcap Removal Force, Depth of Puncture, Life Cycle Test) are standard mechanical and durability tests for such a device.

Therefore, based on the provided text, I cannot describe acceptance criteria and a study that proves the device meets those criteria in the context of an AI/algorithm, as the information is not present. The document focuses on physical and mechanical properties and biocompatibility.

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The Aurora Surgiscope System is intended for use in neurosurgery and endoscopic neurosurgery and pure neuroendoscopy (i.e. ventriculoscopy) for visualization, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.

The Aurora Surgiscope System consists of two components: (1) a sterile, single use, sheath with integrated illumination LEDs and camera, with an obturator, and (2) a non-sterile, reusable control unit, Image Control Box (ICB).

The sheath is intended to provide access to the surgical site by acting as the insertable portion of the device, as well as the instrument channel to accommodate other surgical tools. Depth markers are present along the length of the sheath for user reference.

At the proximal end of the sheath is the imager, which comprises the following components: LEDs (light emitting diodes), camera (and optical components), and focus knob.

• The LEDs provide illumination to the surgical field by directing light down the sheath, along . the instrument channel.
• The camera captures video image of the surgical field. ●

The proximal end of the sheath also contains a tab, which may be used to manually hold the device. To facilitate insertion of the surgical site, an obturator is provided with the device. During insertion, the obturator is fully inserted into the sheath, and the entire unit is advanced to the desired location. The distal end of the obturator is conical in shape to minimize tissue damage. In addition, the proximal handle of the obturator is designed to accommodate various stereotactic instruments for neuronavigation. Once inserted, the obturator is removed. Two sterile, single use accessories optional for use are provided with the Aurora Surgiscope System: an Irrigation Device and 12 French Suction Device.

The ICB is a non-sterile device that provides three main functions in the Aurora Surgiscope System:

• To power the Surgiscope LEDs and camera
• . To relay the video feed captured by the Surgiscope camera to a display monitor for real-time image visualization
• . To allow the user to make adjustments to the displayed video feed (e.g., contrast, brightness), as well as vary the LED light output.

The user interface is a membrane keypad with buttons located on the ICB that can be depressed for image adjustment, such as zoom, contrast, brightness, and orientation. The ICB is supplied with two cables: A power cable for connection to an AC wall outlet, and a display cable for connection to a high definition surgical monitor.

The provided FDA 510(k) clearance letter and summary for the Aurora Surgiscope System do not contain information typically found in a clinical study report or performance evaluation for an AI/software device. The document focuses on demonstrating substantial equivalence to a predicate device, which means proving that the new device is as safe and effective as a legally marketed device, rather than rigorously quantifying performance against defined acceptance criteria in a study setting.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance related to a diagnostic or AI function.
• Sample sizes for test sets or data provenance for AI model validation.
• Details about expert readers, ground truth establishment, or adjudication methods for AI performance.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance data.
• Training set details for an AI model.

The "testing" mentioned in the document pertains to traditional medical device testing for hardware, biocompatibility, electrical safety, and mechanical aspects. While it states "Software verification and validation testing" was conducted and "documentation provided as recommended by the FDA Guidance Content of Premarket Submissions for Device Software Functions," it does not provide any specific performance metrics or acceptance criteria for software functionality that would typically be associated with an AI/ML-driven device's diagnostic performance. The "Image Control Box" software mentioned focuses on image adjustment and display, not diagnostic interpretation.

Therefore, based solely on the provided text, it is not possible to describe the acceptance criteria and the study proving the device meets those criteria from an AI/ML perspective. The device, as described, appears to be a neurological endoscope system for visualization, diagnostic, and therapeutic procedures, with software for image display and adjustment, not an AI-powered diagnostic tool.

If this were an AI-powered device, the information requested would be crucial for its evaluation. Without it, I cannot fulfill the request for AI-related performance criteria.

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The Enhanced AURORA™ Medical Diode system and related accessories is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis, eczema, and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.

The Enhanced AURORA™ Medical Diode system and related accessories is designed to allow a clinician to easily apply UVA or UVB light to the patient's affected skin. The clinician selects the desired treatment type (UVA or UVB light) and applies the light through the appropriate handpiece by pointing the exit aperture towards the affected skin area.

The device is comprised of four main components:

• A base station
• A touchscreen where the user can enter system commands
• Two handpieces connected to the base by power cables. One handpiece contains diode emitters that, when activated, emit UVA light. The other handpiece emits UVB light. Either handpiece will only operate if the appropriate wavelength is selected, so a user cannot accidentally activate the incorrect handpiece. Activation of energy occurs on depression of a trigger in the handpiece.
• A printer accessory that can print out verification of treatment parameters for hard copy records.

The document describes the acceptance criteria and study for the Enhanced AURORA™ Medical Diode system.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a 'test set' in the context of clinical data or patient samples. The performance data is based on bench testing only. Therefore, there is no sample size for a test set of patient data, nor is there information about data provenance (country of origin, retrospective/prospective).

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

Not applicable. The performance data is derived from bench testing of the device's output, not from expert interpretation of medical images or patient data requiring ground truth establishment by experts.

4. Adjudication method for the test set

Not applicable, as a test set requiring adjudication by experts (e.g., for diagnostic accuracy) was not conducted. The assessment was based on physical measurements during bench testing.

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

Not applicable. This device is a phototherapy system, not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

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

Not applicable. This device is a medical phototherapy system, not an algorithm. Its performance is assessed by its physical output characteristics during bench testing, not by an algorithm's standalone performance.

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

The "ground truth" for this device's performance was the user-selected power settings, against which the actual UVA and UVB energy dosage output was measured. This is a technical performance measurement, not a clinical ground truth.

8. The sample size for the training set

Not applicable. This document describes a medical device for phototherapy, not a machine learning model requiring a training set.

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

Not applicable, for the same reason as above.

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The RoughRider America™ RoughRider Aurora™ Manual Wheelchair is indicated to provide mobility to persons restricted to a seated position up to a weight capacity of up to 250 lb / 114 kg.

The RoughRider America™ RoughRider Aurora™ Manual Wheelchair (Aurora) is a user propelled, manually operated folding wheelchair. The Aurora is designed for everyday use and to help its rider move around easily, safely, and without the restrictions imposed by much of the terrain encounter in daily life. The Aurora is expected to perform well:

• Indoors and outdoors; ●
• Over smooth, rough, and uneven ground; ●
• Over soft and hard surfaces; ●
• Over small obstacles, like door jams; and ●
• Up, down and across slopes. ●
  The Aurora utilizes primarily aluminum tubing that is bent, fastened, and/or welded to create a frame. The frame is comprised primarily of side frame, X-brace, foot rest, and caster fork subassemblies. Upholstery is made from fire-resistance fabric. The rear wheels of the Aurora can be removed making the wheelchair lighter for lifting or carrying.
  The side frames have three axle holes that allow the rear wheel position to be adjusted forward and backward. Wheel position affects the rider's forward and backward stability by changing wheel axle position relative to the person's center of gravity. The position of the rear wheel relative to the rider's center of gravity also affects the amount of the rider's weight that is distributed onto the front casters, and allows the rider to maximize maneuverability and control.
  The Aurora side frame fenders act as fixed arm rests and enable transferring in and out of the wheelchair. The side frame also includes the backrest tubes and push handles. The backrest tubes can be adjusted up and down to meet basic support requirements of the rider and/or their companion. Wheel locks attach to the side frame and prevent the rear wheels from turning. The locks keep the wheels from moving during transfers or when a stationary position is necessary.
  An X-Brace connects the side frames of the wheelchair together, determines the chair width, and allows the frame to fold. With the X-Brace in the unfolded position, the chair performs much like a typical X-Brace folding wheelchair. The Aurora can be easily folded for stowage or storage and fits easily into the cargo carrying areas of most vehicles.
  The seat upholstery fastens to the top surface of each X-brace seat tube and provides support for the rider to sit. The angled, sling-style seat and tension-adjustable back fabric offers seating suitable for many different riders. The tilted seat helps keep the rider slightly reclined to reduce the chances of tipping forward and out of the chair. The back fabric can be adjusted to increase or reduce back fabric tension. The seat width of the Aurora is determined by the size of the x
  brace and the seat fabric and fixed at the point of fabrication, based on the customer order. The seat can be used with a range of wheelchair and flotation (pressure relief) cushions.
  The footrests are not easily removable and support the rider's lower legs or feet. The footrests are independently adjustable up and down to position the rider's legs appropriately. The footrests are hinged and can be folded up to enable easier transfers into and out of the Aurora. When the Aurora is unfolded, and the rider is sitting in the chair, the footrest design can give the rider added protection for their toes from doors or other obstacles.
  The casters include the caster wheels (hubs and tires) and a caster fork. The caster is mounted to the front of the side frame using the caster barrel. The casters can turn freely 360°. The casters of the Aurora are positioned approximately five inches further forward than most hospital- or boxstyle wheelchair designs. This additional distance gives the rider of the Aurora a stable ride, in terms of forward stability.
  To prevent unintended changes to the chair configuration and reduce risk to the rider, most adjustment (footrest and backrest height) require access to basic tools.
  The maximum weight capacity of the chair is 250 lb (114kg).
  The Aurora is based on and substantially equivalent to the established and tested design, of the Whirlwind RoughRider. This design has been refined with input from thousands of wheelchair riders around the world after over 15 years of use. The Aurora is easy to clean and uses a range of standardized components that are easy to maintain and replace.

The provided text is a 510(k) Summary for a manual wheelchair, the "RoughRider America™ RoughRider Aurora™ Manual Wheelchair." It primarily focuses on demonstrating substantial equivalence to a predicate device, the "Whirlwind RoughRider Wheelchair," by comparing technological characteristics and presenting performance data based on recognized consensus standards.

This document does not describe a study involving an AI/algorithmic device or its acceptance criteria based on human-in-the-loop performance, expert ground truth establishment, training sets, or adjudication methods. The "device" in question is a physical manual wheelchair.

Therefore, for the specific questions related to AI/algorithmic device validation (acceptance criteria, test set details, expert ground truth, adjudication, MRMC studies, standalone performance, training set details, etc.), the provided text does not contain the information needed to answer them.

The document does discuss performance data for the wheelchair in terms of meeting specific ISO standards. If the intent was to understand the "acceptance criteria" and "study" for a physical device based on this document, here's an interpretation:

Acceptance Criteria and Supporting Study for a Manual Wheelchair (Physical Device)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the RoughRider America™ RoughRider Aurora™ Manual Wheelchair are primarily framed in terms of meeting the requirements and passing the tests outlined in a set of FDA-Recognized Consensus Standards (ISO standards). While specific numerical acceptance thresholds within each ISO standard are not detailed in this summary, the general criterion is "The applicable tests described in these standards were passed."

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

For a physical device like a wheelchair, "test set" typically refers to the number of physical units subjected to testing, rather than a dataset of clinical images. The document does not specify the number of wheelchair units tested. The data provenance is implied to be from laboratory testing conducted by the manufacturer or a contracted testing facility, as per the mentioned ISO standards. It is not clinical data (retrospective or prospective).

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

This question is not applicable to the validation of a physical manual wheelchair. "Ground truth" in this context would be derived from physical measurements and mechanical stress tests according to standardized protocols, not expert clinical interpretation.

4. Adjudication Method for the Test Set

This question is not applicable. The "tests" here are standardized engineering and mechanical performance tests, not subjective interpretations 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

This question is not applicable. The device is a manual wheelchair, not an AI or imaging 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 not an algorithm. The "standalone performance" of the wheelchair refers to its ability to meet the stated ISO standards and functional specifications independently.

7. The Type of Ground Truth Used

For this medical device, the "ground truth" is established by:

• Standardized Test Protocols: The specific methodologies and measurements defined within the cited ISO 7176 series standards.
• Physical Measurements and Mechanical Performance: Quantitative outcomes from these standardized tests, such as stability angles, dimensions, mass, and resistance to force (fatigue, impact).
• Material Properties: Verification that the aluminum frame meets material strength and durability specifications to support increased weight capacity.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of validating a physical manual wheelchair. The design refinements over 15 years, informed by "thousands of wheelchair riders around the world," represent an iterative design and improvement process, but not an algorithmic training set.

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

Not applicable, as there is no training set as defined for an AI device. The design evolution was based on real-world use and feedback, leading to refinements in features like the adjustable backrest and material choice (aluminum for lighter weight and higher capacity).

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The Aurora-RT, with magnetic resonance imaging capabilities, is intended to provide precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Aurora-RT is a medical device for image-guided radiation therapy (IGRT) that combines magnetic resonance imaging (MRI) with radiotherapy technology. It combines a 6 MV medical linear accelerator (Linac) and 0.5 T cryogenless superconducting MRI system mounted in a rotating gantry frame. The MR imaging capability is utilized for positioning the patient at the start of radiation therapy in place of computed tomography (CT) imaging that is commonly used in radiation therapy. MR imaging offers superior soft tissue contrast compared to CT and does not utilize ionizing radiation as with CT images.

This document is a 510(k) Premarket Notification from MagnetTx Oncology Solutions Ltd. for their Aurora-RT device. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (ViewRay MRIdian Linac System). The document focuses on regulatory compliance and technical specifications rather than clinical study data for device performance against specific acceptance criteria.

Therefore, the provided text does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and the study that proves the device meets them. Specifically, the prompt asks for a table of acceptance criteria and reported device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types. This information is typically found in a clinical study report or a more detailed performance evaluation section of a 510(k) submission, which is not present in this summary document.

The document does mention "Summary of Performance Testing" (Section 5.9), stating that:

• "Comprehensive performance testing has shown that the few differences in technological characteristics between Aurora-RT and the predicate device do not affectiveness of Aurora-RT for its intended use."
• "Design control procedures applied to the development of Aurora-RT, including verification and validation testing, are in compliance with 21 CFR 820 FDA Quality System Regulation, ISO 13485 Medical devices – Quality management systems – Requirements for requlatory purposes, and ISO 14971 Medical devices – Application of risk management to medical devices."
• "The performed testing demonstrated conformance to design requirements and recognized consensus standards and ensured all identified risks and hazards were mitigated."
• "Software verification testing was conducted and documented in accordance with the FDA's 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' for devices that pose a major level of concern."
• "Basic safety and essential performance have been satisfied through conformance with device-specific recognised consensus standards, as well as applicable general and collateral safety and essential performance standards for medical devices."

However, these statements are high-level summaries of compliance with general medical device regulations and standards (IEC 60601 series, IEC 61217, IEC 62304, IEC 62366-1) rather than a detailed breakdown of specific performance acceptance criteria and results for the device's clinical claims (e.g., precision radiotherapy for lesions, tumors).

Based on the provided text, the following information can be inferred or explicitly stated, but much of the requested detail is missing:

1. A table of acceptance criteria and the reported device performance:
   • No specific clinical acceptance criteria for "precision radiotherapy" are provided in the context of device performance data.
   • The document primarily compares technological characteristics (Max Dose Rate, Static Dose Accuracy, MLC characteristics, Isocenter Accuracy, MRI Field Strength, Field Homogeneity, Geometric Accuracy, SNR) between the proposed device (Aurora-RT) and the predicate device (ViewRay MRIdian Linac System). These are design specifications and technical performance parameters, not necessarily clinical 'acceptance criteria' tied to patient outcomes or a specific clinical study evaluation described in the way the prompt asks.
   • For example:
     • Static Dose Accuracy for Linac:
       • Acceptance Criteria/Target (Aurora-RT): 90% of the points evaluated in a treatment volume pass a gamma criteria of 3%/3mm.
       • Reported Performance: Implied to meet this target, as the document states "The performed testing demonstrated conformance to design requirements and recognized consensus standards."
       • (Predicate Device: 90% of points pass relative gamma 3%/3mm AND high dose, low gradient absolute point measurement within 5% of planned dose.)
     • Isocenter Accuracy:
       • Acceptance Criteria/Target (Aurora-RT): 1 mm diameter
       • Reported Performance: Implied to meet this target.
     • Geometric Accuracy (MRI):
       • Acceptance Criteria/Target (Aurora-RT):

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