Search Results

The AURA 10 PET/CT system is a cabinet diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The AURA 10 PET/CT system images harvested specimens from various anatomical regions in order to provide rapid verfication that the correct tissue has been excised during the surgical procedure. Images can be obtained as CT only, or a combination of both by surgeon's discretion.

The AURA 10 cabinet PET/CT system provides an image of extent and degree of intensity radiopharmaceutical uptake in the specimen by PET and the anatomical information by CT, which will help the surgeon with further patient management.

The AURA 10 PET/CT system is not validated for margin detection.

The AURA 10 PET/CT is a mobile, vertical-bore PET/CT system with a Field of View (FOV) suitable for small pathology specimens. It is intended to be used in both the operating room (OR) as well as the pathology department to image pathology specimens from various anatomical regions in order to provide rapid pathology imaging. The AURA 10 PET/CT is intended to image pathology specimens for a wide range of patient types, sizes, and extent of diseases. It is designed as a mobile cart so that it is easily portable by one person and can be moved to different surgical suites or between departments as needed.

The provided text describes the regulatory clearance for the AURA 10 PET/CT system, which is a cabinet diagnostic imaging device for imaging harvested specimens. However, it explicitly states, "Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device." This means that the submission does not include information about clinical performance data or a study proving the device meets acceptance criteria derived from clinical studies.

The document focuses on demonstrating substantial equivalence to a predicate device (Vereos PET/CT) and a reference device (Faxitron VisionCT) through non-clinical performance data, primarily bench testing, electrical safety, EMC, and software verification/validation.

Therefore, it is not possible to provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria from a clinical performance perspective. The clearance is based on technological characteristics and non-clinical testing demonstrating equivalency to existing cleared devices, not on a new clinical performance study.

Here's an explanation based on the provided text's limitations:

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

• Acceptance Criteria: No specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy against a clinical ground truth) are provided in the document. The acceptance for this device is based on meeting safety and performance standards through non-clinical testing and demonstrating technological equivalence to predicate devices.
• Reported Device Performance (Non-Clinical):
  • Electrical Safety & EMC: "The device passed all tests" for IEC 61010-1, IEC 61010-2-091, IEC 61010-2-101, and IEC 61326-2-6.
  • Software Verification & Validation: "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance... The software for this device was considered as a moderate level of concern." "The AURA 10 PET/CT was tested in accordance with IEC 62304:2006 + A1:2015...".
  • Bench Testing:
    • Analytical performance testing: "The AURA 10 PET/CT was tested in accordance with NEMA NU 4-2008 - Performance measurements of small animal positron emission tomographs (PETs)." (Specific performance numbers from this test, like spatial resolution or peak NEC rate, are listed in the "Technological characteristics" table, but it's not explicitly stated that these are the "acceptance criteria" for clearance, rather they are characteristics measured against the predicate.)
    • Usability testing: "The AURA 10 PET/CT was tested in accordance with IEC 62366-1:2015... Usability testing was conducted and documentation provided as recommended by FDA's Guidance...".

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

• Since no clinical studies were performed, there is no "test set" in the context of clinical data. The non-clinical tests involved hardware and software evaluations.

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

• Not applicable, as no clinical ground truth was established by experts for a clinical test set.

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

• Not applicable, as no clinical test set requiring adjudication was used.

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

• No MRMC study was done, as explicitly stated, "Clinical studies are not necessary to establish the substantial equivalence of this device." This device is an imaging system, not an AI-assisted diagnostic tool for human readers in the traditional sense of improving reader performance. Its purpose is to provide images for verification.

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

• The device is a medical imaging system (PET/CT), not an algorithm that produces a diagnostic output on its own. Its "performance" is in image generation and quality, which was evaluated through bench testing.

7. The type of ground truth used:

• For the non-clinical bench testing, the "ground truth" would be the known physical properties and performance characteristics of phantoms and test setups used in accordance with standards like NEMA NU 4-2008.

8. The sample size for the training set:

• Not applicable, as this documentation does not describe an AI/ML model that would require a "training set" of data for its primary function. It's a hardware imaging system.

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

• Not applicable.

In summary: The provided FDA 510(k) clearance letter and summary for the AURA 10 PET/CT system indicate that its clearance was based on demonstrating "substantial equivalence" to existing, legally marketed predicate devices through non-clinical testing (electrical safety, EMC, software V&V, and bench testing against industry standards like NEMA NU 4-2008) and a comparison of technological characteristics. No clinical performance studies, human reader studies, or AI algorithm performance studies were deemed necessary for this clearance.

Ask a specific question about this device

The Aura Storm air purifier is a device intended for medical purposes that is used to capture and destroy bacteria and viruses in the air through the multi-stage filtration system and exposure to ultraviolet radiation.
The Aura Storm air purifier has been demonstrated to destroy the following bacteria: Staphylococcus albicans, Staphylococcus aureus, and Escherichia Coli, and virus: A/PR8/34 HIN1 virus entrained on the filter of the subject device under the following exposure conditions:
Average Maximum log reduction / entrainment time (minutes) at Fan Speed 4. Room Temperature test: Log 4 (99.99%) / 60 minutes.
Average Maximum log reduction / entrainment time (minutes) at Fan Speed 1. Room Temperature test: Log 4 (99.99%) / 120 minutes.

The Aura Storm is a multi-stage UV-C air purifier that delivers air purification for rooms up to 2700 square feet (*52ft x 52ft). The Storm inactivates and eliminates bacteria and viruses in the Aura Storm may be used for medical purposes which can include hospitals, medical facilities, medical clinics, nursing facilities, and dental facilities. The Aura Storm is a standalone device that is controlled via buttons on the top of the unit.
The Aura Storm is a dual-sided system with each side consisting of four-stage is a prefilter. The second stage is a HEPA H13+ filter. The third stage is a TiO2 cold photo-catalyst filter. Finally, the UV-C sterilization lamp emits a 253.7mm designed to activate the photo-catalyst filter and eliminate bacteria and viruses. The anion generator is used strictly to increase the size of the particulate molecules to increase the ability to capture and eliminate the bacteria and viruses. This designed system delivers a third-party tested 99.99% (4-log) sterilization in 60 minutes at the highest fan speed. The Aura storm was also tested at the lowest fan speed and delivered a 99.99% (4-log) sterilization in 120 minutes. The air flow diagram has been submitted in the 510(k) submission.
There is an internal fan which draws in air from both sides of the unit, filters it through the multi-stage system and outputs the filtered air through the top of the unit features a capacitive touch button control to operate the On/Off, fan speed (4 speeds), Auto mode, UV lamp, Anion generator, Child lock, timer, and filter reset. There is also a particulate matter sensor and color bar to indicate the level of clean air.

The Invictus Aura Storm Air Purifier (K212644) has been tested for its ability to reduce bacteria and inactivate viruses, and for its filtration efficiency.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective.

• Bacteria Reduction Test: For each of the three bacteria (Staphylococcus albicans, Staphylococcus aureus, and Escherichia Coli), three separate tests were conducted. Each test involved a control group and a test group, indicating a total of 3 samples per bacteria type, or 9 samples for bacteria reduction.
• Virus Inactivation Test: Three separate tests were conducted for the A/PR8/34 H1N1 virus.
• Filtration Efficiency Testing: The sample size for this test is not specified, but it was conducted by a 3rd party accredited laboratory.

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

Not applicable. The ground truth for these tests (bacterial/viral counts, filtration efficiency) is established through laboratory measurements and standardized protocols, not by expert consensus or interpretation of images.

4. Adjudication Method

Not applicable for these types of laboratory tests. The results are quantitative measurements obtained through direct testing, rather than subjective assessments requiring adjudication.

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

Not applicable. The device is an air purifier, and its performance is measured through direct laboratory tests for microbial reduction and filtration efficiency, not through human reader interpretation or clinical assessment that would require an MRMC study.

6. Standalone Performance

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The reported performance metrics (log reduction, elimination rates, filtration efficiency) are direct measurements of the device's capability without human intervention in its operation or performance assessment.

7. Type of Ground Truth Used

The ground truth used is based on controlled laboratory measurements of:

• Bacterial colony-forming units (CFU/m3) for bacteria reduction tests.
• Viral activation/reduction measurements for virus inactivation tests.
• Particle counts for filtration efficiency tests.

These measurements are considered objective and quantitative.

8. Sample Size for the Training Set

Not applicable. The Invictus Aura Storm Air Purifier is a physical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable, as there is no training set for this device.

Ask a specific question about this device

The A123 is used for aspiration, harvesting, filtering and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be re-implanted, the harvested fat is to be used without any additional manipulation.

The A123 is intended for use in the following surgical specialties when aspiration of soft tissue is desired: plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.

The A123 is a suction lipoplasty system designed to be used in the operating room in conjunction with, and attached to, a user-provided liposuction cannula, a vacuum source, and a waste canister. The A123 allows the surgeon to conveniently and accurately harvest, wash, filter, concentrate, and transfer autologous adipose tissue for reinjection into the same patient for body contouring in cosmetic and reconstructive surgery applications during the same procedure in which autologous adipose tissue is collected. The system is a sterile, disposable unit for single patient use.

The A123 consists of the following components:

• Collection chamber
• Collection mesh basket
• Concentration chamber with fluid-absorbing pads
• AuraClens™ powder packets
• Outlet tube and drain valve with tube clamp
• Mixing spatula

The A123 is to be used together with FDA-cleared devices (such as a lipoplasty device [Product Code MUU, Requlation Number 21 CFR 878.50401, liposuction cannula, high vacuum tubing, waste container, syringes [e.g. 60 cc Toomev-tip svringes, Luer-Lock, Product Code KYZ1, and roomtemperature, sterile 0.9% normal saline solution, all provided by the user.

The provided text describes the 510(k) summary for the AuraGen 123™ Suction Lipoplasty System (A123). This device is a Class II medical device used for aspirating, harvesting, filtering, and transferring autologous adipose tissue for aesthetic body contouring. The summary details bench testing conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

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

The document mentions that "The A123 meets the acceptance criteria for all tests," but it does not provide a table detailing the specific acceptance criteria for each test nor the quantitative reported device performance values. It lists the bench tests performed but not the specific thresholds for "meeting" the criteria.

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

The document mentions "A123 units were tested" for various bench tests, but it does not specify the sample size (number of units) used for each test.
The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective in the sense that it's bench testing on manufactured units, rather than a prospective clinical trial.

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

This information is not applicable to this type of submission. The ground truth for bench testing of a lipoplasty system involves quantifiable physical measurements and material properties, rather than expert interpretation of medical images or conditions.

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

This is not applicable. Adjudication methods are typically used in studies involving subjective human interpretation (e.g., reading medical images) to resolve discrepancies. For bench testing, the results are typically objective measurements.

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

This is not applicable. This submission is for a medical device used for tissue processing, not an AI-assisted diagnostic tool that supports human readers/interpreters.

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

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

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

The "ground truth" for this device's performance evaluation is based on objective, quantitative measurements obtained through standardized bench testing methods (e.g., centrifugation for fat volume, time measurement for TTG, force measurement for tensile strength, and established ISO standards for sterility, biocompatibility, implosion, collapse, and leak tests).

8. The sample size for the training set:

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

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

This is not applicable. As stated above, the device is not an AI algorithm.

Ask a specific question about this device

The Branchpoint AURA™ ICP Monitoring System is intended for use by a qualified neurosurgeon in the direct monitoring of intracranial pressure in intraparenchymal applications.

The Branchpoint AURA™ ICP Monitoring System is a device intended for monitoring intracranial pressure (ICP). The Branchpoint AURA™ ICP Monitoring System is composed of the following three packages:
Package 1) AURA™ Sensor Tray (Model SP101-A)

• AURA™ Sensor (Model 10025G)
• Disposable Scalp Retractor (Model OS0001B)
• Disposable Drill Bit with Collar (Model 10008C)
• Disposable Torque Wrench (Model OS0004C)
• Disposable Antenna Holster (Model 10007A)
  Package 2) AURA™ Monitor Pack (Model TK101-A)
• AURA™ Monitor (Model T0011B)
• AURA™ Antenna (Model T0010A)
• 2x Lithium-Ion 11v Rechargeable Batteries (Model T0032A)
• Two-bay battery charger (Model T0014A)
  Package 3) AURA™ Data Receiver Pack (Model DG101-A)
• AURA™ Data Receiver (Model D0004B)

Here's a breakdown of the acceptance criteria and the study information for the AURA™ ICP Monitoring System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary provides a list of non-clinical bench tests performed to support substantial equivalence and demonstrate device performance. For the direct ICP measurement, the relevant standard is ANSI/AAMI NS28:1988(r)2010. While specific numerical acceptance criteria and precise reported device performance values for ICP measurement itself are not detailed in the provided text beyond meeting the standard, the document states:

For Biocompatibility, specific results are provided:

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

The provided text only discusses "non-clinical bench tests" and "biocompatibility testing." It does not describe any clinical studies involving human patient data, nor does it mention machine learning algorithms that would typically involve test sets of data from a specific country or collected retrospectively/prospectively. The testing described is primarily focused on hardware and material performance, as well as adherence to recognized standards. Therefore, information about test set sample size or data provenance in the context of AI/ML is not available in this document.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This document describes a medical device clearance based on substantial equivalence through non-clinical bench testing and biocompatibility. It does not involve diagnostic image analysis or other applications where expert ground truth establishment for a test set would be relevant.

4. Adjudication Method for the Test Set

Not applicable, as no test set requiring expert adjudication is described in the provided document.

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

No. This document does not mention any MRMC study. The device is an ICP monitoring system, not a diagnostic imaging AI tool that would typically be evaluated with MRMC studies comparing human reader performance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The AURA™ ICP Monitoring System is a hardware device for direct physiological measurement, not an algorithm being deployed in a standalone capacity without human interaction for interpretation or diagnosis.

7. Type of Ground Truth Used

The "ground truth" for the tests described is the established scientific and engineering principles, and the specific pass/fail criteria outlined in the referenced national and international standards (e.g., ANSI/AAMI NS28 for ICP performance, ISO 10993 series for biocompatibility). For example, a score of 0 for cytotoxicity or a temperature increase < 0.5 °C for pyrogenicity constitutes the ground truth for those specific tests.

8. Sample Size for the Training Set

Not applicable. This document describes the clearance of a hardware medical device based on non-clinical testing and substantial equivalence, not an AI/ML algorithm that would typically involve a training set.

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

Not applicable, as no training set for an AI/ML algorithm is described in the provided document.

Ask a specific question about this device

The AURA DR 43C-AG detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. It is not to be used for mammography.

AURA DR 43C-AG is a digital X-ray flat panel detector which has 43cm x 43cm imaging area and communicates with a wired communication feature, Giga-bit Ethernet communication method through connecting a tether cable. The device intercepts x-ray photons and the scintillator (Gadox:Tb) and emits visible spectrum photons that illuminate an array of photo (a-SI) detector that creates electrical signals. After the electrical signals are generated, it is converted to digital values, and the images will be displayed on the monitor. This device should be integrated with an operating PC and an X-Ray generator. It can digitalize x-ray images and transfer them for radiography diagnostics. Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, and sharing of image information on network.

The provided text is a 510(k) summary for a medical device (AURA DR 43C-AG Digital Flat Panel X-ray Detector) and focuses on establishing substantial equivalence to a predicate device, rather than presenting a study demonstrating the device meets a specific set of acceptance criteria in the way one might for an AI/ML clinical study.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly extracted from this document, as the submission takes a different approach to demonstrating safety and effectiveness.

Here's an analysis based on the provided text:

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

The document doesn't define explicit acceptance criteria in the typical "pass/fail" numerical sense for clinical performance. Instead, it demonstrates performance by showing the proposed device is equivalent or superior to a predicate device based on specific technical characteristics and non-clinical tests.

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

• Sample Size: The document does not mention a "test set" in the context of clinical images or patient data. The non-clinical performance testing involved measurements of physical values (DQE, MTF NPS) usually conducted on a device itself or phantoms, not a patient sample. No clinical studies were conducted for this 510(k) submission.
• Data Provenance: Not applicable as no clinical data was used for testing.

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

• Not applicable as no clinical studies were performed, and thus no expert ground truth was established for a test set of images.

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

• Not applicable as no clinical studies were performed.

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

• No MRMC study was done, as this is an X-ray detector, not an AI-powered diagnostic tool. The submission focuses on device characteristics and substantial equivalence to a predicate, not on human reader performance with or without AI assistance.

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

• Not applicable. This is an imaging hardware device, not an algorithm.

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

• Not applicable as no clinical images or patient data requiring ground truth were used in the testing described in this 510(k) summary. The "ground truth" for the non-clinical performance relied on standardized measurement methods for DQE, MTF, and NPS.

8. The sample size for the training set

• Not applicable, as this is an X-ray detector and not an AI/ML device that requires a training set of data.

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

• Not applicable, as no training set was used.

Ask a specific question about this device

The Auradorm sleep appliance is a dentist prescribed mandibular repositioning device worn during sleep to reduce the incidence of snoring and reduce the effects of mild to moderate obstructive sleep apnea for patients 18 years or older.

The Auradorm Sleep Appliance is a one piece oral appliance used for reducing snoring and the effects of mild to moderate obstructive sleep apnea. The one piece upper and lower tooth engaging appliance covers the occlusal and buccal aspects of the entire lower arch teeth and the occlusal and buccal aspects of the posterior maxillary teeth to include the maxillary canines. The maxillary central and lateral incisors do not touch the appliance. The device does not rest or impinge on soft tissue. The oral appliance is prescribed by a dentist and custom fit to the patient's mouth in the dental clinic. The oral appliance is made of FDA approved dental acrylic or resin, stainless steel ball clasps and orthodontic stainless steel braid embedded in the acrylic for strengthening purposes. The appliance is designed to limit the amount of material on the lingual aspect of the teeth and still maintain the anti-snoring functionality based on the predicate devices. The appliance has an anterior opening to prevent restriction of mouth breathing and is reinforced with orthodontic stainless steel metal braid embedded in the acrylic. Ball clasps are situated in the appliance to provide upper and lower tooth retention and adjustability for patient comfort.

Here's an analysis of the provided text regarding the Auradorm Sleep Appliance, focusing on acceptance criteria and supporting study details.

Important Note: The provided document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. It typically does not contain detailed information about a comprehensive clinical study to prove the device meets specific performance acceptance criteria through quantitative metrics like accuracy, sensitivity, or specificity. Instead, the focus is on showing similarity in intended use, technological characteristics, and safety/efficacy principles to existing, approved devices. Therefore, many of the requested items (e.g., sample sizes for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, specific ground truth types with quantitative results) are not present in this type of submission.

Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the "acceptance criteria" are primarily related to demonstrating substantial equivalence to predicate devices, rather than meeting specific quantifiable performance metrics from a dedicated clinical trial for a novel device. The criteria are implicitly met by showing similarity in design, materials, and intended use, and by highlighting the device's design features that address potential risks.

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

• Not Applicable / Not Provided: The 510(k) summary does not describe a specific clinical study with a "test set" in the context of device performance metrics (e.g., accuracy, sensitivity) for a diagnostic or therapeutic effect. The demonstration of substantial equivalence relies on comparing the device's characteristics to already legally marketed devices, not on new clinical data proving effectiveness quantitatively in a test cohort.

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

• Not Applicable / Not Provided: As no specific clinical test set for performance comparison is described, there's no mention of experts or ground truth establishment in this manner. The "ground truth" for the device's claims is largely based on the established effectiveness and safety profile of the predicate devices and the general understanding of mandibular repositioning for sleep apnea/snoring by the dental/medical community.

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

• Not Applicable / Not Provided: No adjudication method is mentioned as there is no specific clinical test set or review process involving multiple experts for quantitative performance.

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

• Not Applicable: This device is a physical oral appliance, not an AI-powered diagnostic or assistance tool for human readers. Therefore, an MRMC study or AI-related effectiveness metrics are irrelevant and not part of the submission.

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

• Not Applicable: This is a physical medical device, not a standalone algorithm.

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

• The "ground truth" for this 510(k) submission is primarily derived from:
  • Regulatory Predicate Equivalence: The established safety and effectiveness of the legally marketed predicate devices (Lamberg Sleep Well Device K062333, Snore Guard K103004, Acrylic Herbst Appliance K083209).
  • Commonly Accepted Dental/Medical Principles: The document references "It is commonly accepted in the dental community that anterior positioning of the tongue and mandible increases pharyngeal space that improves air exchange." and "The Auradorm Sleep Appliance is based on the principles of repositioning the mandible to open the airway which is similar to many marketed anti-snoring devices."
  • Material Safety: The use of "FDA approved dental acrylic or resin" and "known dental materials used for decades throughout the industry."

8. The sample size for the training set

• Not Applicable / Not Provided: There is no "training set" in the context of an algorithm or a clinical trial for this type of 510(k) submission. The device design and safety principles are based on existing knowledge and predicate devices.

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

• Not Applicable / Not Provided: As there is no training set mentioned, this question is not relevant to the information provided.

Ask a specific question about this device

Direct anterior/posterior restorations and veneers. Core build ups. Indirect inlays, onlays and veneers. Splinting. Composite and porcelain repair. Sandwich technique with glass ionomers. For professional use only.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding a dental device called "Aura." It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria for the device's performance, the results of any studies demonstrating the device meets such criteria, or details regarding study design, sample sizes, expert involvement, or adjudication methods.

Therefore, I cannot provide the requested table and study details. The document primarily focuses on regulatory approval based on substantial equivalence, rather than detailed performance study results.

Ask a specific question about this device

The Auragen™ Cortical Surface Electrodes are intended for the intraoperative recording of EEG signals at the cortical surface of the brain.

The cortical surface electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are placed on the exposed cortical surface or inserted into the subdural space to contact the cortical surface. Cortical electrodes vary in size according to the number of contacts. The type of cortical electrode used is dependent on the procedure and the size of area being tested. The Auragen Cortical Electrodes are available with platinum/iridium contacts, with 4 to 64 contacts. The electrodes are connected to Integra recording cables themselves connected to the hospital EEG recording equipment.

The provided text describes a 510(k) submission for the Auragen™ Cortical Surface Electrodes, focusing on demonstrating substantial equivalence to a predicate device rather than a comprehensive study to establish new performance metrics against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and performance studies for a new AI/medical device (like sample sizes, ground truth procedures, multi-reader studies, etc.) is not applicable to this document.

However, the document does mention some performance testing related to safety. I will extract what is available and indicate where information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document states "An array of cortical electrodes were subjected to MRI testing…" and implies individual electrodes were tested for dimensional, physical, and electrical performance. Specific numbers are not provided.
• Data Provenance: Not applicable in the context of clinical data for AI/medical device performance. This testing appears to be primarily bench testing (e.g., MRI compatibility, physical/electrical tests) and manufacturing process checks (sterility, non-pyrogenic).

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

• Not applicable. The ground truth for bench testing (e.g., MRI compatibility, dimensional checks) would typically be established by standardized testing protocols and measurements, not expert consensus in the way clinical ground truth is established.

4. Adjudication method for the test set

• Not applicable. Adjudication methods (e.g., 2+1) are typically used for establishing ground truth from expert readings of medical images or data. Bench testing relies on objective measurements against predefined specifications.

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

• No. This is a 510(k) for a physical medical device (cortical electrodes), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to this submission.

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

• No. This is a physical medical device. Standalone algorithm performance is not applicable.

7. The type of ground truth used

• Bench Test Standards: For MRI compatibility, the ground truth was established by adherence to ASTM F 2503-05, a standard practice for marking medical devices for safety in the MR environment.
• Product Specifications: For dimensional, physical, and electrical performance, the ground truth was "defined requirements of the product specification."

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable. There is no training set for this device.

Ask a specific question about this device

AURAVeneer Cement is a self-adhesive cement recommended for the bonding of ceramic and composite restorations.

AURAVeneer Cement is a self-adhesive cement recommended for the bonding of ceramic and composite restorations. This veneer cement is made from a complimentary hydrophilic resin and filler system, which creates compatibility between the tooth surface and restorative materials. AURAVeneer Cement is a unique gel-like product that does not slump and will hold veneers in place without drifting. AURAVeneer is a single component, light cured product. AURAVeneer is provided in clear, enamel/white, and dentin/yellow shades. Corresponding try-in gels of the same colors are also available. It is recommended that enamel surfaces, which are uncut, be etched or micro-abraded to optimize bonding of this product to the dental surface. Etching or the use of bonding agents when bonding to dentin is not required. Equally, the surface of the restoration should also be pretreated to optimize bonding of the restoration. Bonding agents and silage coupling agents are not required for the use of this product.

The provided text is a 510(k) Premarket Notification for AURAVeneer Cement, a dental cement. It does not contain any information about a study with acceptance criteria, sample sizes, expert involvement, or any performance metrics typically associated with AI/ML device evaluations.

The document primarily focuses on establishing "substantial equivalence" of AURAVeneer Cement to existing predicate devices based on design, composition, and intended use, rather than presenting a performance study against specific acceptance criteria. This type of regulatory submission (510(k)) for a dental cement typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through a comparison of physical and chemical properties, and intended use, rather than through extensive clinical trials with performance metrics.

Therefore, I cannot fulfill your request as the necessary information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided text.

Ask a specific question about this device

AuraLay Pit & Fissure Sealant is used the pits and fissures of teeth. AuraLay is comprised of hydrophilic resins and an HLB composition of fillers. Together these provide optimum properties for sealing and excellent tooth wetting. AuraLay has an extremely high compressive strength. This strength combined with excellent sealing and great esthetics make an excellent choice for sealing of teeth. Aural.ay is available in different fluoride concentrations for different patient use.

AuraLay Pit & Fissure Sealant is used the pits and fissures of teeth. AuraLay is comprised of hydrophilic resins and an HLB composition of fillers. Together these provide optimum properties for sealing and excellent tooth wetting. Aural ay has an extremely high compressive strength. This strength combined with excellent sealing and great esthetics make an excellent choice for sealing of teeth. AuraLay is available in different fluoride concentrations for different patient use.

The provided text is a 510(k) premarket notification for the "AuraLay Pit & Fissure Sealant." This type of submission is a claim of substantial equivalence to a legally marketed predicate device, rather than a submission that presents de novo clinical study data to demonstrate safety and effectiveness.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, ground truth establishment, or specific performance metrics from a dedicated clinical study.

Instead, the submission relies on the following:

• Substantial Equivalence: The core of this document is the claim that AuraLay Pit & Fissure Sealant is substantially equivalent in design, composition, performance, intended use, and effectiveness to existing predicate devices (CosmeSeal Pit and Fissure Sealant, UltraSeal XT Pit and Fissure Sealant and Flowable Composite Kit, and Delton Clear Pit and Fissure Sealant Kit).
• Predicate Device Performance: The safety and effectiveness are supported by the track record of these predicate devices, which have been found to be substantially equivalent themselves and have been in general usage for about 30 years with a "high benefit-to-risk ratio" and no evidence of short-term or long-term risk.
• NIH Technology Assessment: A reference is made to an NIH Technology Assessment conference regarding "Effects and Side-Effects of Dental Restorative Materials," which states that such materials are "relatively trouble-free" and have "no suspicion of any problems after virtually billions of procedures in the United States."

In summary, there is no direct study described in this document that establishes specific acceptance criteria for the AuraLay Pit & Fissure Sealant and then demonstrates its performance against those criteria using a dedicated test set, ground truth, or statistical analysis (e.g., MRMC or standalone performance). The approval is based on equivalence to already approved and widely used devices.

Ask a specific question about this device