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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 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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The MR Fiber Optic Intubating Laryngoscope Handle, Standard ("MINRAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Standard") is used to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

The MR Fiber Optic Intubating Laryngoscope Handle, Standard

This document is a 510(k) summary for a medical device called the "MINRAD INC.'s MR Fiber Optic Intubating Laryngoscope Handle, Standard." It outlines the device's information, intended use, and substantial equivalence to predicate devices, leading to its clearance by the FDA in 2006.

1. Table of acceptance criteria and the reported device performance

This document does not list specific acceptance criteria related to quantifiable performance metrics (e.g., accuracy, precision, sensitivity, specificity) or any reported device performance data in that context. The clearance is based on substantial equivalence, implying the device performs similarly to predicate devices without needing a new clinical performance study for this specific 510(k). The primary "acceptance criteria" for this submission are related to its similarity in technological characteristics and intended use to existing, legally marketed devices.

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. This 510(k) summary does not describe a clinical study with a test set in the traditional sense of evaluating performance metrics like sensitivity or specificity. The submission is based on demonstrating substantial equivalence to predicate devices, not on original clinical performance data for the new device.

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 noted above, there is no mention of a test set with ground truth established by experts.

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

Not applicable. No test set adjudication method is described.

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 medical instrument (a laryngoscope handle), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

Not applicable. This is not an algorithm-based device.

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

Not applicable. No ground truth is described as having been established for this submission.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that would require a training set.

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

Not applicable. No training set or ground truth for it is relevant to this device submission.

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The MR MR MR Fiber Optic Intubating Laryngoscope Handle, Short ("MINRAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Short") is used, together with a Laryngoscope blade, to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

MR Fiber Optic Intubating Laryngoscope Handle, Short

The provided text is a 510(k) summary for the "MINRAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Short." This document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a performance study with acceptance criteria.

Therefore, the requested information about acceptance criteria, device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, and standalone performance is not available in the provided text.

The document primarily states:

• The device's intended use: to facilitate and aid in tracheal intubation in an MRI or interventional MR environment (not exceeding 3.0 Tesla).
• Its classification: Laryngoscope, Rigid (21 CFR 868.5540, Product Code CCW).
• Predicate devices it is substantially equivalent to: MINRAD INC. MR Tested Fiber Optic Short Laryngoscope Handle (K041852), Welch Allyn Laryngoscope, and Sun Med Laryngoscope.
• The assertion that it "raises no new issues of safety or effectiveness" due to its similar technological characteristics to predicate devices.

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The MR Tested Fiber Optic Short Laryngoscope Handle ("MINRAD INC. MR Tested Fiber Optic Laryngoscope Handle") is used, together with a Laryngoscope blade, to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 1.5 Tesla static magnetic field.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding a medical device, the "MINRAD INC. MR Tested Fiber Optic Short Laryngoscope Handle."

Based on the provided text, there is no study described that proves the device meets specific acceptance criteria in the manner of a performance study for an AI/CADe device.

This document is a regulatory clearance for a traditional medical device (a laryngoscope handle) based on substantial equivalence to a predicate device, not on specific performance metrics from a clinical or technical study outlined in your request. The FDA's determination of substantial equivalence (510(k)) means they believe the new device is as safe and effective as a legally marketed predicate device.

Therefore, I cannot provide the requested information in the table or answer the subsequent questions. The document does not contain:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes for test sets, data provenance, or ground truth.
• Details about expert reviews, adjudication methods, or MRMC studies.
• Any mention of standalone algorithm performance.
• Information about training sets or their ground truth establishment.

The clearance is based on the device conforming to general controls and being equivalent to existing devices, specifically for use in an MRI environment up to 1.5 Tesla. The "indications for use" (Attachment 8, Page 2) simply state its purpose: "to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 1.5 Tesla static magnetic field." This is a statement of intended use, not a performance metric or acceptance criteria.

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The Flexiblade™ - Flexible Laryngoscope is intended for use as an aid for placement of tracheal tube and examination and visualization of patient's upper airway.

The Flexiblade™ is a rigid laryngoscope featuring a flexible blade. The flexibility of the blade is achieved as a result of the motion of a trigger on the larvngoscope handle that its front end is fixed to the front part of the blade and its rear end is free. This control over the blade flexibility allows the operator performing intubation to place the blade end exactly in the vallecula area elevating the epiglottis with his/her fingers (by gently squeezing the trigger) without changing the device position.

The provided text describes a 510(k) submission for the Flexiblade™ - Flexible Laryngoscope. This is a Class I (exempt) device, and the submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance criteria through a detailed study with acceptance criteria.

Therefore, many of the requested sections about acceptance criteria, study design, expert ground truth, and statistical analyses are not applicable or cannot be extracted from this type of regulatory document.

Here's an analysis of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific numerical acceptance criteria or quantified device performance metrics are provided in the document. The substantial equivalence claim is based on a series of performance testing and clinical experience, but the details of these tests and their outcomes against pre-defined criteria are not disclosed in this summary.

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

• Sample Size: Not specified. The document only mentions "a series of performance testing and clinical experience" without indicating the number of subjects, cases, or tests conducted.
• Data Provenance: Not specified. It's unclear if the "clinical experience" or "performance testing" was retrospective or prospective, or the country of origin.

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

Not applicable. The document does not describe a study involving expert-established ground truth for a test set. This type of analysis is common for diagnostic algorithms, but not for a physical device like a laryngoscope demonstrating substantial equivalence.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring adjudication is described.

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

No, an MRMC comparative effectiveness study is not mentioned or described. This type of study comparing human readers with and without AI assistance is not relevant to a physical medical device like a laryngoscope.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a physical instrument, not an algorithm, so a "standalone" algorithmic performance study is irrelevant.

7. Type of Ground Truth Used:

Not applicable in the context of an "algorithm" or "diagnostic" ground truth. For a physical device demonstrating substantial equivalence, the "ground truth" would be its functional performance in comparison to predicate devices and general safety/effectiveness considerations. The document indicates this was evaluated through "performance testing and clinical experience" against "voluntary standards ASTM F965-85 and ISO 7376-1."

8. Sample Size for the Training Set:

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable. This device is not an AI algorithm.

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