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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.

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

The document does not specify a "test set" in the context of an AI/ML algorithm for image analysis or diagnostics. Instead, the "testing" refers to a series of non-clinical (laboratory) studies:

• Toxicology: "All non-clinical toxicology tests were conducted in accordance with the GLP regulation." This includes In-Vitro Cytotoxicity, Systemic Toxicity, and Acute Ocular Irritation tests. The sample sizes for these biological tests would be defined by the relevant ISO standards (ISO 10993-5, ISO 10993-11, ISO 10993-23) but are not explicitly reported in this summary.
• Shelf Life: Testing was performed to evaluate stability, sterility, and package integrity. Sample sizes are not specified for this summary.
• Physicochemical & Mechanical Properties: Tests for refractive index, water content, Dk, % transmission, tensile strength, modulus, % elongation to break, specific gravity, and polymerization residuals. Sample sizes are not specified.

Data Provenance: The studies were non-clinical, implying laboratory-based testing rather than patient data from a specific country. They were conducted under "Good Laboratory Practice (GLP) regulations," indicating a controlled, high-quality laboratory environment. There is no mention of retrospective or prospective patient data from a clinical test set.

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

This information is not applicable as the device is a contact lens, not an AI/ML diagnostic or image analysis device requiring expert-established ground truth on a test set of images or clinical cases. The ground truth for device properties is established by scientific measurement and adherence to defined standards.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical or image-based studies, which are not described here.

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

This information is not applicable. An MRMC study is relevant for AI/ML diagnostic devices where human readers (e.g., radiologists) interpret cases with or without AI assistance. This device is a contact lens. The document explicitly states: "Clinical testing is not required. The clinical performance of soft (hydrophilic) contact lenses manufactured from (ocufilcon D) materials has been demonstrated previously."

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

This information is not applicable. This device is a contact lens, not an AI/ML algorithm.

7. The type of ground truth used

For this contact lens device, the "ground truth" (or basis for evaluation) comes from:

• Established scientific standards and methodologies: For physicochemical properties (e.g., water content, Dk, light transmission) and mechanical properties (e.g., tensile strength, modulus).
• Biological safety standards: Adherence to ISO 10993 series for biocompatibility (cytotoxicity, systemic toxicity, ocular irritation).
• Comparison to a legally marketed predicate device: "Substantial equivalence" is demonstrated by showing that the new device has the same fundamental scientific technology, materials, and performs comparably to a predicate device, which itself has established safety and effectiveness.

8. The sample size for the training set

This information is not applicable. This device is a contact lens, not an AI/ML algorithm that requires a "training set."

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

This information is not applicable for the same reason as point 8.

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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 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 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): < 1.0 mm VRMS over 20 cm DSV
       • Reported Performance: Implied to meet this target.

2. Sample sizes used for the test set and the data provenance: Not mentioned. The testing described appears to be engineering/verification testing, not a clinical study with patient samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.

4. Adjudication method for the test set: Not mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not mentioned. The document describes a comparison to a predicate device based on technological characteristics and compliance with safety standards, not a comparative effectiveness study involving human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly mentioned in a clinical context. The "software verification testing" mentioned is general for software functionality and safety, not a performance evaluation of a specific algorithm (like an AI algorithm) for a clinical task. The device described is a radiation therapy system, not an AI diagnostic tool.

7. The type of ground truth used: Not specified in the context of clinical performance. For the engineering performance parameters listed (e.g., dose accuracy, geometric accuracy), the "ground truth" would be established by physical measurements and phantom studies against known standards.

8. The sample size for the training set: Not applicable, as this document does not describe the development or testing of an AI algorithm in the way the prompt implies. It's a hardware medical device with integrated software.

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

In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device primarily through technical specifications and compliance with general medical device safety and quality standards, rather than presenting clinical study data with specific acceptance criteria and detailed performance results for user-facing outcomes.

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The AURORA Evacuator +Coag is a powered instrument with a handpiece intended for removal of soft tissue and fluids, and coagulation of tissue under direct visualization may include laparoscopic, pelviscopic, pelviscopic, endoscopic, percutaneous, and open. Applications include those when access to the surgical site is limited, such as neurosurgical.

The AURORA Evacuator +Coag device is provided sterile, for single use only. It is a disposable, handheld, battery powered instrument that combines the ability to remove fluids and soft tissue, apply bipolar energy for the coagulation of tissue, and apply irrigation directly to clear the surgical site during minimally invasive surgical procedures. It consists of a wand and handle with connection ports for a bipolar electrode cable, vacuum source (for aspiration) and irrigation line. At the distal tip of the wand, a side aspiration window with an internally rotating whisk is provided to break up and aspirate soft tissue and fluids. The battery and motor that powers the whisk is contained in the device handle. Bipolar electrodes are located at the distal tip of the wand and can be activated to coagulate tissue when connected to an electrosurgical generator. When desired, an irrigation line may be connected to the handle and saline can be delivered to clear the surgical field as a procedural aid. Bipolar electrosurgical generator/cables, vacuum source, and irrigation source are not provided with the device. Prior to use, the device is to be connected to electrosurgical generator, external vacuum source (i.e. operating room suction) and irrigation source (i.e. drip). A green power indicator light is located on the top portion of the handle to show that power is available to the device. A suction control vent for the user to control vacuum pressure and a button for activating the whisk are located conveniently on the handle.

This document is a 510(k) Premarket Notification from the FDA regarding the AURORA Evacuator +Coag device. It describes the device, its intended use, and a comparison to predicate devices, and a summary of non-clinical testing. However, it does not contain information related to software or AI/ML components. Therefore, I cannot provide an answer based on the prompt's request for acceptance criteria and studies related to a device's AI/ML performance.

The document lacks the following information which are critical to answer your request:

• Acceptance criteria for AI/ML performance: The document details acceptance criteria for the physical device's performance (e.g., biocompatibility, electrical safety, sterilization, in-vitro verification, ex-vivo tissue studies), but not for any AI/ML components.
• Study that proves the device meets acceptance criteria for AI/ML: No studies related to AI/ML performance are mentioned.
• Sample size used for the test set and data provenance (AI/ML): Not applicable as no AI/ML component is discussed.
• Number of experts used to establish ground truth (AI/ML): Not applicable.
• Adjudication method (AI/ML): Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study (AI/ML): Not applicable.
• Standalone (algorithm only) performance study (AI/ML): Not applicable.
• Type of ground truth used (AI/ML): Not applicable.
• Sample size for the training set (AI/ML): Not applicable.
• How the ground truth for the training set was established (AI/ML): Not applicable.

Therefore, no table of acceptance criteria and reported device performance for an AI/ML component can be created from this document. The document focuses on regulatory approval for the physical medical device and its electrosurgical, aspiration, and irrigation functionalities.

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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 serves as the location for the fixation arm to hold/fix 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 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.

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 text describes the AURORA Surgiscope System, a neurological endoscope. However, it does not contain specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) or details of a study designed to demonstrate them.

The document discusses various non-clinical tests performed to demonstrate the device's safety and substantial equivalence to a predicate device. These tests fall under general medical device regulatory requirements rather than specific performance outcomes for an AI/algorithm-driven device.

Therefore, for almost all of the requested information, the answer is that the data is not available in the provided text.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes non-clinical testing for the device (biocompatibility, electrical safety, software V&V, mechanical testing), but does not mention a "test set" in the context of diagnostic performance or AI model evaluation.

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

N/A. The document does not describe a study involving expert review for establishing ground truth related to diagnostic performance.

4. Adjudication method for the test set

N/A. No test set for diagnostic performance is described.

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

No. The document does not describe an MRMC study or any study evaluating human reader improvement with AI assistance. The device is a surgical endoscope, not an AI diagnostic tool.

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

No. The document does not describe a standalone algorithm performance study.

7. The type of ground truth used

N/A. The concept of "ground truth" in the context of diagnostic or AI performance is not relevant to the non-clinical testing described. The "truth" in these tests relates to engineering specifications, material properties, safety standards, and software functionality.

8. The sample size for the training set

N/A. No training set for an AI/algorithm is described. The software validation mentioned (point 4 in "SUMMARY OF NON-CLINICAL TESTING") refers to the software controlling the endoscope's functions, not an AI algorithm for diagnostic purposes.

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

N/A. No training set is described.

Summary of what the document DOES describe regarding "studies" and "performance":

The document outlines a series of non-clinical tests that demonstrate the device's safety and functional performance in accordance with regulatory standards for a medical device (neurological endoscope). These include:

• Biocompatibility testing: MEM Elution (cytotoxicity), Sensitization (Kligman Maximization), Irritation (Intracutaneous Injection), Systemic Toxicity (Systemic Injection), Hemolysis (Indirect), Materials Mediated Pyrogenicity. The device sheath with LEDs and camera is considered tissue-contacting for less than 24 hours. The ICB (Image Control Box) has no patient contact.
• Electrical safety and electromagnetic compatibility (EMC): Compliance with IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-18.
• Software verification and validation testing: Conducted as per FDA Guidance for "major level of concern" software (meaning failure could cause serious injury or death). This ensures the software controlling the device functions correctly.
• Mechanical and other testing: Dimensional, imaging (visualization, resolution), illumination, tensile strength, simulated use (clinician evaluation), instrument compatibility, particulate testing (USP <788>), sterilization (ISO 11135-1 for SAL of 10-6), packaging and shelf-life (ISTA 2A and ASTM F1980).

These tests are designed to show the device is safe and performs its intended function (visualization, diagnostic/therapeutic procedures using an endoscope), and that it is substantially equivalent to a predicate device based on its technical characteristics. It does not involve AI or diagnostic performance metrics typically requested for such systems.

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The AURORA Evacuator +Coag is a powered instrument with a handpiece intended for removal of soft tissue and fluids, and coagulation of tissue under direct visualization. Types of direct visualization may include laparoscopic, pelviscopic, endoscopic, percutaneous, and open.

The subject device, AURORA Evacuator +Coag, is provided sterile, for single use only. It is a disposable, handheld, battery powered instrument that combines the ability to remove fluids and soft tissue, apply bipolar energy for the coagulation of tissue, and apply irrigation directly to clear the surgical site during minimally invasive surgical procedures.

It consists of a wand and handle with connection ports for a bipolar electrode cable, vacuum source (for aspiration) and irrigation line. At the distal tip of the wand, a side aspiration window with an internally rotating whisk is provided to break up and aspirate soft tissue and fluids. The battery and motor that powers the whisk is contained in the device handle. Bipolar electrodes are located at the distal tip of the wand and can be activated to coagulate tissue when connected to an electrosurgical generator. When desired, an irrigation line may be connected to the handle and saline can be delivered to clear the surgical field as a procedural aid.

Bipolar electrosurgical generator/cables, vacuum source, and irrigation source are not provided with the device. Prior to use, the device is to be connected to electrosurgical generator, external vacuum source (i.e. operating room suction) and irrigation source (i.e. drip).

A green power indicator light is located on the top portion of the handle to show that power is available to the device. A suction control vent for the user to control vacuum pressure and a button for activating the whisk are located conveniently on the handle.

The provided text describes the AURORA Evacuator +Coag device, its indications for use, and a comparison to predicate and reference devices. It then lists a summary of non-clinical testing conducted to demonstrate its safety and effectiveness.

Here's an analysis of the text in the context of your request:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a structured format. However, it describes several tests performed and states that the device was found to be "substantially equivalent" or demonstrated "comparable" effects.

Here's an interpretation of potential "acceptance criteria" and "reported device performance" based on the text:

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

• Sample Size:
  • For the ex-vivo tissue studies, the sample size is only specified as "porcine heart, liver, and kidney". The number of individual samples or replicates is not provided.
  • For other tests like biocompatibility, electrical safety, etc., no specific sample sizes are mentioned.
• Data Provenance: The studies are described as "ex-vivo tissue studies" and "non-clinical testing." This implies laboratory-based testing rather than clinical data from human patients. There is no information regarding the country of origin of the data. Given it's non-clinical, the terms "retrospective" or "prospective" don't directly apply in the same way they would to human clinical trials.

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

The document does not mention the use of experts to establish "ground truth" for the non-clinical tests. Non-clinical tests typically rely on standardized methods and measurements rather than expert consensus on subjective interpretations. For tests like thermal damage assessment, the ground truth would be based on scientific measurements and comparative analysis with a predicate device.

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

No information is provided about any adjudication methods. This is consistent with non-clinical testing where subjective expert interpretation and adjudication are generally not primary components.

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 conducted or mentioned. The device is a surgical instrument (Electrosurgical Cutting and Coagulation Device and Accessories), not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI assistance are not relevant here.

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

Not applicable. The AURORA Evacuator +Coag is a physical medical device intended for surgical use. It is operated by a human and is not an algorithm. Therefore, "standalone" performance in the sense of an algorithm operating independently doesn't apply. Its performance is evaluated in conjunction with human operation.

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

For the non-clinical tests, the "ground truth" would be established by:

• Comparability to Predicate Device: For thermal damage, the ground truth was the established performance of the predicate device under the same conditions.
• Standardized Test Methods: For biocompatibility, electrical safety, sterilization, etc., the ground truth is defined by the specific parameters and requirements of the referenced ISO standards (e.g., ISO 10993-1, ISO 11135-1, IEC 60601 series, USP <788>, ASTM F1980-16). These standards specify acceptable limits or methodologies.
• Physical and Performance Specifications: Internal product specifications verified through direct measurement.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this device is not an AI/ML algorithm. The non-clinical studies described are for verification and validation of the device's physical and functional properties, not for training a model.

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

Not applicable, as there is no training set mentioned.

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