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The Portable Oxygen Concentrator, model: Spirit-3, is intended to provide supplemental oxygen in a home, institutional, or travel environment. And the device is used with adult only, not used with pediatrics, infant, or neonate patients, etc.

Portable Oxygen Concentrator, model: Spirit-3, is a portable oxygen generator that is intended to release oxygen for respiratory therapy by means of physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to deliver oxygen from the concentrator to the patient. The Portable Oxygen Concentrator is small, portable and may be used in home, institutional, or travel environment. Portable Oxygen Concentrator, model: Spirit-3, is capable of continuous use in a home, institutional, or travel environment. Power options include 100 – 240 V (50/ 60Hz) AC power supply, DC power supply and rechargeable lithium-ion battery. The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories.

The FDA 510(k) clearance letter and supporting documentation for the Portable Oxygen Concentrator (Spirit-3) do not describe a study involving an AI/ML component or human readers. Therefore, there is no information available regarding acceptance criteria related to AI/ML performance, sample sizes for test or training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.

The provided document focuses on demonstrating the substantial equivalence of the Spirit-3 Portable Oxygen Concentrator to predicate devices through technical specifications, non-clinical performance testing (bench testing), and compliance with various international standards. The "performance" being discussed in the document refers to the physical and functional performance of the oxygen concentrator itself (e.g., oxygen concentration, flow control, electrical safety, biocompatibility), not the performance of an AI/ML algorithm in an image or data interpretation task.

Therefore, many of the requested categories are "Not Applicable" (N/A) in the context of this specific regulatory submission.

However, I can extract the acceptance criteria and reported device performance for the Spirit-3 Portable Oxygen Concentrator based on the non-clinical tests described.

Here's the information derived from the provided text, adapted to the requested format where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

The study conducted to prove the Spirit-3 Portable Oxygen Concentrator meets its acceptance criteria was a series of non-clinical bench tests and evaluations demonstrating compliance with recognized consensus standards and comparison to a legally marketed predicate device.

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

• Sample Size for Test Set: Not applicable in the context of an AI/ML algorithm being evaluated. For the performance testing of the physical device, it implicitly refers to the specific unit(s) of the Spirit-3 device undergoing testing. The document does not specify the number of devices tested but implies standard product testing.
• Data Provenance: The tests were conducted internally or by accredited labs as part of the manufacturing and submission process for Jiangsu Yuyue Medical Equipment & Supply Co., LTD. (China). This is prospective testing of the manufactured device.

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

• Not Applicable. This device is a physical oxygen concentrator, not an AI/ML diagnostic or interpretative device that requires expert ground truth for output validation.

4. Adjudication method for the test set:

• Not Applicable. As no expert interpretation was required. Device performance was objectively measured against predefined standard requirements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This type of study is relevant for AI/ML systems that assist human readers in tasks like image interpretation. The Spirit-3 is a portable oxygen concentrator and does not involve human reading or AI assistance in that capacity.

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

• Not Applicable. The device does not involve a standalone algorithm for diagnostic or interpretative purposes. "Standalone" performance in this context refers to the device's inherent mechanical, electrical, and oxygen delivery performance.

7. The type of ground truth used:

• The "ground truth" for the performance of the portable oxygen concentrator is defined by the international consensus standards mentioned (e.g., ISO 80601-2-69, ISO 80601-2-67, IEC 60601-1, ISO 10993 series) and the specifications of the predicate devices. These standards provide benchmarks and methodologies for evaluating physical and electrical safety, essential performance, and biocompatibility.

8. The sample size for the training set:

• Not Applicable. This device does not use an AI/ML training set.

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

• Not Applicable. No AI/ML training set was employed for this device.

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The Portable Oxygen Concentrator (Model: P2-K4.P2-S4. P2-S3) is intended to provide supplemental oxygen in a home, institutional, or travel environment. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Portable Oxygen Concentrator(Model:P2-K4,P2-K3,P2-S4,P2-S3) is small, portable and may be used in home, institution and various mobile environments. However, there is not any type of humidifier that is suitable for use with this device because of its pulse dose delivery mode.

Portable Oxygen Concentrator (Model:P2-K4,P2-K3,P2-S4,P2-S3) is a portable oxygen generator that is intended to release oxygen for respiratory therapy by means of physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Portable Oxygen Concentrator is small, portable and may be used in home, institutional, or travel environment. The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories. The oxygen concentrator is composed of compressor, battery, solenoid valve, molecular sieve, circuit control system, heat dissipation system, and a flow control device. Accessories include power adapters.

This document describes acceptance criteria and testing for a Portable Oxygen Concentrator (Models: P2-K4, P2-K3, P2-S4, P2-S3).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by compliance with various international and national standards for medical electrical equipment, biocompatibility, and specific oxygen concentrator requirements. The reported device performance is demonstrated by the successful completion of tests against these standards.

Differences Noted in Comparison to Predicate Device and their Mitigation:

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

The document does not specify a "test set" in the context of clinical trials or AI model validation with a specific number of cases. Instead, it refers to conformity testing against established standards. For such conformity testing, the "sample size" typically refers to the number of devices or components tested to ensure consistent performance across the production. This information (specific number of devices tested for each standard) is not provided in this summary.

Data provenance: The testing appears to be primarily non-clinical bench testing and verification, likely conducted at the manufacturer's facility or by a certified testing laboratory. There is no mention of country of origin of data for a "test set" as understood in a clinical study.

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

Not applicable. This is not an AI/ML-driven diagnostic device that requires expert-established ground truth on a test set of medical images or patient data. The device's performance is validated against engineering and medical device standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not a diagnostic device requiring adjudication of expert interpretations for ground truth.

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 medical device for oxygen delivery, not a diagnostic AI system, therefore, an MRMC comparative effectiveness study is not relevant or mentioned.

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

Not applicable. This device is a hardware-based oxygen concentrator with embedded software; it is not a standalone AI algorithm.

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

The "ground truth" for this device's performance is defined by compliance with a comprehensive set of international and national standards for medical devices, electrical safety, EMC, biocompatibility, and specific oxygen concentrator requirements (e.g., ISO 80601-2-69, ISO 80601-2-67). This is a technical and performance-based "ground truth" rather than clinical diagnostic ground truth.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/ML device trained on data, there is no "training set."

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

Not applicable. There is no "training set" or associated ground truth for this device.

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The Portable Oxygen Concentrator (Model: P2-E7, P2-E) is intended to provide supplemental oxygen in a home, institutional, or travel environment.

Portable Oxygen Concentrator (Model: P2-E7, P2-E) is a portable oxygen generator that is intended to release oxygen for respiratory by means of physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Portable Oxygen Concentrator is small, portable and may be used in home, institutional, or travel environment.

The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories. The oxygen concentrator is composed of compressor, battery, solenoid valve, molecular sieve, circuit control system, heat dissipation system, and a flow control device. Accessories include power adapters.

Model difference: The only different between model P2-E7 and P2-E is that P2-E7 has biggest output oxygen flow of 1.4L/min (at 7 gears) and P2-E has biggest output oxygen flow of 1.0L/min (at 5 gears).

The provided document is a 510(k) Summary for a Portable Oxygen Concentrator. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence for regulatory clearance. It does not present information about a study that assesses the device's performance against clinical acceptance criteria using human subjects or an AI algorithm.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance (in a clinical context).
• Sample size used for a test set or data provenance related to clinical performance.
• Number of experts or their qualifications for establishing ground truth for a clinical test set.
• Adjudication method for a clinical test set.
• MRMC comparative effectiveness study or related effect sizes.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical evaluation.
• Sample size for a training set (as no AI algorithm requiring a training set is discussed).
• How ground truth for a training set was established.

The document focuses on non-clinical testing and engineering standards to demonstrate safety and effectiveness, and substantial equivalence to a predicate device, not clinical performance against acceptance criteria in a human study, nor does it involve an AI component.

The relevant information from the document related to testing and "acceptance" is as follows:

Acceptance Criteria (Implied by Standards and Comparison to Predicate):

While not explicitly stated as "acceptance criteria" in a clinical performance sense, the document demonstrates the device meets various safety, performance, and compatibility standards. The "reported device performance" in this context refers to the device's adherence to these standards and its characteristics in comparison to the predicate.

Study Proving Device Meets Criteria:

The "study" in this context refers to the non-clinical testing and validation performed to demonstrate substantial equivalence and adherence to recognized standards.

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

2. Sample sized used for the test set and the data provenance: Not applicable in the context of human clinical data for this submission. The "test sets" refer to the specific units of the device models (P2-E7, P2-E) subjected to various engineering and functional tests. The data provenance is from Qingdao Kingon Medical Science and Technology Co., Ltd. (China) through bench testing. The document refers to "non-clinical tests performed." The testing is retrospective in the sense that the results were submitted for regulatory review after completion.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in this context, is established by adherence to internationally recognized engineering and medical device standards (e.g., ISO, IEC, AAMI ANSI) and direct measurement of device characteristics. The expertise would lie in the engineers and testing personnel who conducted these standard tests.

4. Adjudication method: Not applicable. Standard technical testing and comparison against predicate.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating human performance, often with or without AI assistance, in diagnostic tasks. This device is a portable oxygen concentrator, not an imaging or diagnostic AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The "software" in this device controls hardware functions (e.g., alarms, breath detection, display) and is deeply embedded, not a standalone AI algorithm for interpretation or diagnosis.

7. The type of ground truth used: For hardware performance, the ground truth is defined by the specifications in the relevant industry standards (e.g., oxygen concentration, pressure, noise levels) and the functional requirements of the device. For software, the "ground truth" is adherence to software development life cycle processes (IEC 62304) and correct execution of defined functions without critical errors.

8. The sample size for the training set: Not applicable. This device does not use an AI algorithm that requires a training set in the typical machine learning sense. The software is embedded control software.

9. How the ground truth for the training set was established: Not applicable. See point 8.

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The APA Oxy Blade™ is a multi-functional, single-use, disposable larynoscope blade intended to assist in direct and indirect laryngoscopy and to facilitate and aid in tracheal intubation in routine and difficult airways in adult patients. The APA Oxy Blade™ incorporates an oxygen tube adaptor and tubing to provide supplemental oxygen to the patient while undergoing endotracheal intubation.

The APA Oxy Blade is a laryngoscope blade intended to be used with the Venner Medical APA™ Video Laryngoscope. The APA Oxy Blade is a standard MacIntosh laryngoscope blade with the addition of an oxygen tube adaptor/holder and tubing to provide supplemental oxygen to the patient when using the Venner APA Video Laryngoscope. The Venner APA Video Laryngoscope, like other rigid laryngoscopes, provides a clear view of the upper airway (trachea/airway) and aids in the placement of an endotracheal tube for intubation.

The provided text describes the 510(k) premarket notification for the APA Oxy Blade, a rigid laryngoscope. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving the device meets specific acceptance criteria in the manner of a clinical trial or algorithm performance study.

Therefore, many of the requested elements (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, training set details) are not applicable as this submission is for a Class I medical device, which typically relies on comparisons to predicates and engineering/performance verification for regulatory clearance, not extensive clinical performance studies or AI algorithm validation.

Here's a breakdown of the available information:

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

The document outlines performance data categories and successful outcomes, which effectively serve as the acceptance criteria and reported performance.

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

• Sample Size: The document does not explicitly state the numerical sample size for each test (e.g., "n=X blades were tested"). Instead, it uses phrases like "The results from testing were provided," "all devices and pouches passed the tests," "All blades successfully passed," and "All devices successfully met the acceptance criteria." This implies that a sufficient number of samples were tested to demonstrate conformity, as per standard engineering verification practices for medical devices of this class.
• Data Provenance: The tests are described as "Performance testing was performed to characterize the APA Oxy Blade," indicating that these were prospective engineering and bench tests conducted specifically for this submission. The country of origin of the testing data is not specified, but the applicant, Venner Medical (Singapore) Pte Ltd, is based in Singapore.

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

• Not Applicable. This device is a physical medical instrument (laryngoscope blade) and its performance is evaluated through engineering and biocompatibility testing, not through expert-reviewed "ground truth" like in an AI/diagnostic study. The "ground truth" here is objective measurement against engineering specifications and biological safety standards.

4. Adjudication method for the test set:

• Not Applicable. As per point 3, this is not an expert-driven diagnostic study requiring adjudication. The tests involve objective measurements (e.g., dimensions, flow rate, pull strength, visual inspection for fogging/leaks, lab results for biocompatibility).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This type of study is typically performed to evaluate the diagnostic performance of software or imaging devices, often involving human readers. The APA Oxy Blade is a physical instrument, and its clearance relies on substantial equivalence and bench testing, not MRMC studies.

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

• No. This device does not involve an algorithm. The "standalone performance" is demonstrated through the various engineering and biocompatibility tests described (e.g., flow rate, anti-fogging, mechanical strength, material safety).

7. The type of ground truth used:

• The "ground truth" for this device's performance is established by engineering specifications, standardized test methods (e.g., ISO standards for biocompatibility), and pre-defined acceptance criteria for physical and functional properties. For example, "acceptance criterion of > 15 L/min" for flow testing.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning or AI device that requires a "training set."

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

• Not Applicable. As per point 8.

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The Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) is indicated to improve direct visualization of larynx and assist in both non-complicated and difficult intubation of unpredictable airway condition.

GSV200.DBL is designed to assist in tracheal intubation procedure by direct visualization of laryngeal anatomy in closed position and use movable blade with camera as accessory from different angle in open position. The physical shape of GSV200.DBL is a modification of traditional Macintosh blade similar to Propper flip tip laryngoscope with added movable blade with camera as accessory to provide visualization to insert endotracheal tube.

Girgis Scope Video DBL is designed to use two power sources, one in the stationary handle for fiber optic illumination of the airway and the second in the DVR monitor to illuminate the Larynx for the video camera. Battery chargers, cables to computer and cable to connect to TV screen are accessories included in the kit. The GSV200.DBL is provided non-sterile and is reusable and can be disassembled to provide cleaning and disinfection.

The provided document is a 510(k) summary for the Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL). It outlines the device's characteristics and compares it to a predicate device, concluding that it is substantially equivalent. However, it explicitly states, "No clinical studies were conducted." Therefore, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria with a specified performance, sample sizes, ground truth establishment, or expert evaluations.

The document primarily focuses on non-clinical performance data, which consists of adherence to various electrical safety and biocompatibility standards, and a simulated use/usability study.

Here's a breakdown of the available information and a direct statement about what is not present:

1. Table of acceptance criteria and reported device performance:

The document does not provide a table of acceptance criteria with corresponding device performance metrics from a clinical study. The conclusion section mentions that "the usability study demonstrated ease-of-use of the system," but no specific performance metrics or acceptance criteria for this usability are detailed.

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

• Test set sample size: Not applicable, as no clinical efficacy study was performed. For the "Simulated Use/Usability study," the sample size is not specified, only the roles of the participants: Anesthesiologists, Emergency Room Physicians, and Emergency Medical Service (EMS).
• Data provenance: Not applicable for a clinical study. For the usability study, it's a simulated use, likely conducted in a controlled environment, not a retrospective or prospective study from a specific country.

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

Not applicable, as no clinical efficacy study was performed requiring ground truth established by experts.

4. Adjudication method for the test set:

Not applicable, as no clinical efficacy study was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size:

No MRMC comparative effectiveness study was done.

6. If a standalone performance study was done:

No standalone (algorithm only without human-in-the-loop performance) study was done, as this refers to a medical device, not an AI algorithm.

7. The type of ground truth used:

Not applicable, as no clinical efficacy study was performed.

8. The sample size for the training set:

Not applicable, as no AI algorithm was developed or trained.

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

Not applicable, as no AI algorithm was developed or trained.

Summary of Non-Clinical Performance Data (as mentioned in the document):

The device's performance is demonstrated through adherence to various industry and safety standards, rather than clinical efficacy studies. These include:

• Electrical Safety Standards: IEC 60335-1, IEC 60335-2-29, IEC 60950-1, IEC 60601-1, IEC 60601-1-2.
• Biocompatibility Standards: USP 24, NF 19 Biological Test for Plastics (Class VI 70 degrees C), ISO 10933-5 (in vitro Cytotoxicity), ISO 10993-10 (Irritation and Skin Sensitization - Kligman Maximization Test and Intracutaneous Injection Test), ISO 10993-11 (Systemic Toxicity), ASTM F 756-08 (Hemolytic Properties), ASTN F 619-03 (Extraction of Medical Plastics).
• Sterilization Standard: AAMI/ANSI ST79 (Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities).
• Software Validation: "Software Validation per Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
• Usability Study: "A Simulated Use/Usability study was conducted using Anesthesiologists, Emergency Room Physicians, and Emergency Medical Service (EMS)." The conclusion states this study "demonstrated ease-of-use of the system," but no specific performance metrics or acceptance criteria for usability are provided in the document.

The core argument for substantial equivalence relies on the device's design and indications for use being "identical" or "similar" to the predicate device (Propper Flip-Tip™ Laryngoscope, K915804), coupled with adherence to the aforementioned non-clinical standards and the usability study.

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The Yeescope laryngoscope is a single use, disposable laryngoscope blade and handle that is intended to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

Yeescope laryngoscope blades and handles are single use, fully disposable laryngoscopes identical to our standard units except we have exchanged the battery to one that is less magnetic and thus would meet the requirements for MR conditional environments.

Yeescope laryngoscope are offered in one (1) style and two (2) sizes; Macintosh style (curved) and in Sizes 3 and 4.

The Yeescope Laryngoscope is a single use, disposable laryngoscope blade and handle intended to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment up to a 3.0 Tesla static magnetic field.

1. Table of Acceptance Criteria and Reported Device Performance:

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Airtraq® SP - MR and Airtraq® Avant are intended to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

Airtraq® Optical laryngoscope is an anatomical shaped rigid laryngoscope which allows the user to see the airway anatomy during insertion and intubation. It is designed with a guide channel in which one loads the endotracheal tube ("ET tube") that is then advanced once the glottis opening has been identified and centered in the view field of the Airtraq® optics. Prodol Meditec offers two (2) models.

Airtraq® SP - single patient
This model is a completely self-contained unit that operates on standard non-magnetic AAA batteries. It is a single patient use, disposable.

Airtraq® Avant
Avant once assembled is identical in its design and function as the Airtraq@ SP model.
Avant is designed as 2 components unlike the Airtraq® SP model.

1. Optics This is a limited life reusable components which contains the lenses and mirrors of the optical system plus the rechargeable, non-magnetic battery, and PCB which controls the LED light, heater and diagnostics for the battery.
2. Blade There are 2 blade sizes, Regular (ET tube size 7.0 mm to 8.5 mm) and Small (ET tube 6.0 mm to 7.5 mm). These are single use disposables in which the Optics are inserted and then the assembled device used. There is an eye cap that incorporates a protective lens that fits over the Optics once it has been inserted into the Blade.

Acceptance Criteria and Study for Airtraq® MR and Airtraq® Avant

This summary details the acceptance criteria a medical device needs to meet and the study conducted to prove it, based on the provided 510(k) Premarket Notification.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Airtraq® MR and Airtraq® Avant devices, as described in the provided document, primarily relate to their magnetic resonance (MR) compatibility.

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The CAIRE Companion 5, Oxygen Concentrator, is Intended for the administration of supplemental oxygen up to 5 liters/minute. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Not Found

I am sorry, but based on the provided document, there is no information available regarding an acceptance criteria table, device performance report, or any study involving AI or human readers.

The document is a letter from the FDA regarding the 510(k) premarket notification for the "CAIRE Companion 5 Oxygen Concentrator." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. The "Indications for Use Form" specifies that the device provides supplemental oxygen up to 5 liters/minute and is not intended for life support or patient monitoring.

The document discusses regulatory compliance and the device's intended use, but it does not contain any data or discussion about:

• Acceptance criteria for device performance.
• Reported device performance metrics (e.g., accuracy, sensitivity, specificity).
• Any studies involving test sets, training sets, ground truth establishment, or expert reviews.
• AI algorithm performance, human-in-the-loop studies, or standalone algorithm performance.
• Sample sizes or data provenance for any studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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The NovaMed MRI Conditional laryngoscope set is used to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

The NovaMed MRI Conditional laryngoscope handle, battery, and blades are standard blades and handles that have been specially treated to be useable in a magnetic resonance (MR) environment. Testing has been performed according to ASTM F2052-02 in a 3.0 Tesla environment. There are many handle and blade configurations offered.

The NovaMed MRI Conditional Laryngoscope set was evaluated for safety in a Magnetic Resonance (MR) environment up to 3.0 Tesla. The primary study was to determine the device's magnetic attraction in this environment.

1. Acceptance Criteria and Reported Device Performance

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The Tru-MR TM laryngoscope set is used to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

The Truphatek Tru-MRTM MR conditional laryngoscope handle, battery, and blades are standard blades and handles that have been specially treated to be useable in a magnetic resonance (MR) environment. Testing has been performed according to ASTM F2052-02 in a 3.0 Tesla environment. There are many handle and blade configurations offered.

Here's a breakdown of the acceptance criteria and the study details for the Truphatek Tru-MR™ Laryngoscope set, based on the provided documents:

1. Table of Acceptance Criteria and Reported Device Performance

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