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The power wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The power wheelchair, model name:D26, is an indoor/outdoor, foldable, battery-operated 2-wheel (rear-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-Ion battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion.

The control system, including the controller handle (joystick), is equipped on the control pad that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop.

The power wheelchair, model name: D26, can be controlled by joystick or remote controller via Bluetooth Low Energy (BLE) wireless communication interface. The user can lock and unlock the device remotely via the BLE interface using the remote controller. For safety, controller rocker control is priority over the remote control by design.

The power wheelchair can be folded/ expanded manually. The Left and right handrails (joystick) can be interchange.

This document is a 510(k) clearance letter for a Power Wheelchair (D26), not a software or AI-enabled medical device. Therefore, the provided information does not contain the details typically sought in an acceptance criteria and study report for AI/ML devices.

The 510(k) process for a physical device like a power wheelchair focuses on demonstrating substantial equivalence to a previously cleared predicate device, primarily through engineering and performance testing against recognized standards, rather than clinical studies with human subjects in the same way an AI-driven diagnostic tool would be evaluated.

Here's why the AI/ML-specific questions cannot be answered from this document:

• No AI/ML Component: The device description clearly indicates it's a "motor driven, indoor and outdoor transportation vehicle" with components like motors, brakes, joystick control, and Bluetooth remote control. There is no mention of artificial intelligence, machine learning, or algorithms that perform diagnostic or interpretative functions.
• Performance Evaluation Type: The "study that proves the device meets the acceptance criteria" in this context refers to various engineering and safety tests outlined in the ISO 7176 series and IEC 60601-1-2 standards (e.g., static ability, dynamic stability, brake performance, biocompatibility, EMC). These are objective, quantitative tests of the device's physical properties and functionality.

Therefore, it is not possible to fill out the table and answer the questions about AI/ML device performance, ground truth, expert adjudication, or MRMC studies based on the provided FDA 510(k) document.

This document demonstrates substantial equivalence for a physical medical device by comparing its technical specifications and performance against international standards for wheelchairs.

However, if you're looking for an example of how a 510(k) for a non-AI/ML device does define acceptance criteria and demonstrates compliance, here's an interpretation based on the provided text:

Acceptance Criteria and Study for Power Wheelchair (D26)

The device, a Power Wheelchair (D26), is primarily evaluated based on its adherence to established international standards for wheelchairs and its substantial equivalence to a predicate device (K242448, Power Wheelchair, D26 from the same manufacturer). The "acceptance criteria" are derived from these standards and the comparative analysis with the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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The Manual Wheelchair is to provide mobility to persons limited to a sitting position.

The S002, S004, S005, S006, S007, S008, S009 series are mechanical wheelchairs which are a manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bring the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to manoeuvre the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.

Main Components: Main frame, Backrest, Seat cushion, handgrip, front wheel, rear wheel, hand rim, crossbar, footrests, brake, Anti-tipper, Seat belt.

The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.

This FDA 510(k) summary describes a Manual Wheelchair (Models: S002, S004, S005, S006, S007, S008, S009) and its substantial equivalence to a predicate device (K232230). The information provided is for a physical medical device, not an AI/software device. Therefore, many of the requested categories related to AI/software performance criteria (such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document.

However, I can extract the acceptance criteria related to the physical device's performance and the study details that demonstrate it meets those criteria.

1. Table of acceptance criteria and the reported device performance:

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

• Sample size: Not specified in the document. For physical device performance testing, samples are typically a representative number of units, but specific numbers are not usually detailed in a 510(k) summary unless a specific statistical power is claimed for a particular test.
• Data provenance: The tests were conducted by the applicant, Anhui JBH Medical Apparatus Co., Ltd, in China (No.116 QiCang Road Industrial District MingGuang Chuzhou,Anhui, China). The data is retrospective in the sense that the tests were performed on finished devices to demonstrate compliance.

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

This information is not applicable. For physical device performance, "ground truth" is established through standardized testing procedures and objective measurements as defined by the referenced ISO standards, not through expert consensus on interpretation.

4. Adjudication method for the test set:

Not applicable. Physical device performance is determined by meeting objective criteria defined in the ISO standards, not by an adjudication process as used in clinical or imaging studies.

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 is a physical medical device, not an AI/software device.

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 an AI/software device.

7. The type of ground truth used:

The "ground truth" for the device's performance is established by its adherence to the technical specifications and performance limits defined within the cited international ISO standards (e.g., ISO 7176 series for wheelchairs and ISO 10993 series for biocompatibility). This is essentially objective measurement against predefined engineering and biocompatibility standards.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/software device that requires a training set.

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

Not applicable. This is a physical medical device, not an AI/software device.

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The power wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The power wheelchair, model name: D03, D05, D06, D09, D11, D16, D22, D23, D26, D36, is an indoor/outdoor, foldable, battery-operated 2-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-lon battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion. The control system, including the controller handle (joystick), is equipped on the control pad that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop. The power wheelchair, model name: D03, D05, D06, D09, D11, D16, D22, D23, D26, D36, can be controlled by joystick or remote controller via Bluetooth Low Energy (BLE) wireless communication interface. The user can lock and unlock the device remotely via the BLE interface using the remote controller. For safety, controller rocker control is priority over the remote control by design. The power wheelchair can be folded/ expanded manually. The Left and right handrails (joystick) can be interchange.

Here's a breakdown of the acceptance criteria and study information for the Power Wheelchair, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Power Wheelchair (models D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) are implicitly defined by compliance with a comprehensive set of ISO standards. The reported device performance is indicated by the statement that the device met all design specifications and passed all tests.

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

• Sample Size for Test Set: The document does not specify a distinct "test set" in terms of patient data or images. Instead, the testing refers to physical devices (the specific models D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) and their components. The tests performed are bench tests conducted on these physical devices to verify their performance against engineering standards.
• Data Provenance: Not applicable as the testing involves physical device performance, not data from human subjects. The testing is prospective in the sense that the manufacturer tested their newly designed device models to confirm compliance. The manufacturing location is Anhui, China.

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

Not applicable. This is a technical performance study of a physical device against engineering standards. Ground truth as typically defined for AI/diagnostic studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" is defined by the technical specifications and requirements of the referenced ISO standards.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or consensus required for the test results; the tests involve quantifiable measurements (e.g., stability angles, braking distances, electrical properties) that either meet or do not meet the specified criteria in the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant for this type of device (a power wheelchair). It's typically used for evaluating diagnostic or screening tools where human readers interpret patient data (e.g., radiology images).

6. If a Standalone Study (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in essence, the entire suite of non-clinical bench testing constitutes a "standalone" evaluation of the device's physical and electrical performance without human operation as a variable beyond what is required to execute the test protocols. The Bluetooth remote control functionality (a form of "algorithm") was also tested in a standalone manner for effectiveness and cybersecurity.

7. The Type of Ground Truth Used

The "ground truth" (or reference standard) for these tests is the quantitative and qualitative requirements set forth in the extensive list of ISO and IEC engineering standards (e.g., ISO 7176 series, IEC 62133-2, IEC 60601-1-2, ANSI C63.27, ISO 14971, ISO 10993 series). These standards define the acceptable performance limits and test methodologies for power wheelchairs.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device where a "training set" of data is used for model development. The development process would involve engineering design and iterative prototyping, not data-driven model training.

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

Not applicable, as there is no training set for an AI/ML model.

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The power wheelchair is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The power wheelchair, model name: D10, D12, D15, D17, D20, D37, is an indoor/outdoor, foldable, battery-operated 2-wheel (rear-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-lon battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion. The control system, including the controller handle (joystick), is equipped on the control pad that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop. The power wheelchair, model name: D10, D12, D15, D17, D20, D37, can be controlled by joystick or remote controller via Bluetooth Low Energy (BLE) wireless communication interface. The user can lock and unlock the device remotely via the BLE interface using the remote controller. For safety, controller rocker control is priority over the remote control by design. The power wheelchair (Model D10, D12, D15, D17, D20, D37) can be folded/ expanded manually. The Left and right handrails (joystick) can be interchange. The D17 power wheelchair has an additional headrest and its seat unit can be adjusted by a remote control key to a largest angle of 30°.

The provided text is a 510(k) Premarket Notification from the FDA for a Power Wheelchair. It describes the device, compares it to predicate devices, and outlines the non-clinical testing performed to establish substantial equivalence. However, it does not contain information about a study proving the device meets acceptance criteria related to AI/ML performance, human reader improvement with AI assistance, or expert ground truth establishment for medical imaging or similar AI applications.

The document explicitly states:

• "No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the power wheelchair to its predicate device." (Page 17, Section IX)
• The comparison tables (Table 1, Table 2, Table 3) detail physical, mechanical, and electrical characteristics, and safety standards met (ISO, IEC, EMC, biocompatibility). These are engineering and safety performance criteria for a wheelchair, not AI/ML performance.

Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria and a study that proves the device meets those criteria, as the provided text pertains to a power wheelchair and not a medical device involving AI/ML for diagnostic or therapeutic purposes.

If you have a document describing an AI/ML medical device and its validation study, please provide that, and I will be able to answer your questions.

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The power wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The power wheelchair, model name: DC01, DC02, DC03, DC05, DC06, DC07L, DC08L, DC09L, DC10L, is an indoor/outdoor, foldable, battery-operated 2-wheel (rear-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-lon battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion. The control system, including the controller handle (joystick), is equipped on the control pad that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop. The power wheelchair, model name: DC01, DC02, DC03, DC05, DC06, DC07L, DC08L, DC09L, DC10L, can be controlled by joystick or remote controller via Bluetooth Low Energy (BLE) wireless communication interface. The user can lock and unlock the device remotely via the BLE interface using the remote controller. For safety, controller rocker control is priority over the remote control by design. The wheelchair can be folded/expanded manually. The Left and right handrails (joystick) can be interchange.

The provided text describes a 510(k) submission for a power wheelchair and does not contain information about acceptance criteria and a study that proves a device meets those criteria in the context of an AI/ML medical device.

The document is a letter from the FDA regarding a premarket notification for a Power Wheelchair. It focuses on the substantial equivalence of the proposed device to legally marketed predicate devices based on non-clinical performance testing (bench testing), adherence to ISO standards for wheelchairs, and material biocompatibility.

Therefore, I cannot extract the requested information (such as AI/ML performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies) because the document does not pertain to an AI/ML device study.

The closest information available is related to non-clinical performance testing for the physical safety and performance of a wheelchair, not an AI/ML algorithm.

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The power wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The D25 power wheelchair is a four wheeled personal mobile device with a complementary chair support system that is powered by two motors. The traveling speed is controlled by the motor, and the traveling direction is controlled by the passenger. This product is a device suitable for disabled people with mobility difficulties and elderly people and it is intended to provide mobility to a disabled or elderly person limited to a seated position. The power wheelchair can be travelled on flat and obstacle ground surface, and direction and speed of the wheelchair can be controlled by the passenger's hand with the help of the joystick. The device can be used to provide indoor and outdoor mobility at a certain distance but not allowed to be travelled on the road or highway. The wheelchair (Model D25) has a base with aluminum alloy frame, two front wheels, two rear wheels, a seat, an adjustable steering column, a tiller console, two electric motors, an electromagnetic brake, 1 rechargeable Lithium-lon Battery with an off-board charger. The movement of the wheelchair is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the wheelchair is not in use and the brake cannot be used manually.

The provided document is a 510(k) premarket notification for a Power Wheelchair (Model D25). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets a specific set of acceptance criteria through a clinical study or performance goals with associated metrics and thresholds.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study design for proving device performance against these criteria, sample sizes, expert involvement, ground truth establishment, or comparative effectiveness studies (MRMC).

The document primarily focuses on:

• Comparison to a predicate device (K113463): It lists similarities and differences in technical characteristics.
• Compliance with consensus standards: It states that the device complies with numerous ISO and IEC standards related to wheelchairs, general medical device safety, and biocompatibility. These standards contain test methods and passing criteria, which implicitly serve as "acceptance criteria" for demonstrating safety and performance in the context of a 510(k) submission for this type of device.

However, the document does not explicitly present:

• A table of "acceptance criteria" with specific quantitative thresholds (like accuracy, sensitivity, specificity, or AUC) that the device itself must meet, alongside its "reported device performance" against those thresholds.
• Details of a standalone algorithm performance study or a multi-reader, multi-case (MRMC) comparative effectiveness study, as these are typically relevant for AI/ML-enabled software devices that perform diagnostic or interpretative functions. This power wheelchair is a physical medical device for mobility.

To answer your request based on the provided text, I must state that the information is not present in the format you've asked for because the submission type (510(k) for a power wheelchair) does not typically require that level of performance study detail as would an AI/ML diagnostic device.

The "study" that proves the device meets the "acceptance criteria" (which are implicitly the requirements of the cited standards) is the non-clinical performance testing summarized in Section VIII.

Here's a breakdown of what is available vs. what is not:

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

• Not explicitly provided in the requested format with quantitative metrics like accuracy, sensitivity, etc.
• Implicit Acceptance Criteria: Compliance with the listed ISO and IEC standards (e.g., ISO 7176 series for wheelchairs, ISO 10993 series for biocompatibility, IEC 60601-1-2 for EMC). The "reported device performance" is that the device "complied with the requirements of" these standards. For example, for "Minimum braking distance from maximum speed" the subjective device reports "Forward: 0.9 m" while the predicate reports "Forward: 1.5 m". The discussion notes that the subject device has a shorter braking distance, which is considered a positive difference, ensuring safety.
• The "Discussion/Conclusion" column in the comparison table indirectly serves as reported performance against implicitly accepted characteristics.

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

• For physical device testing against standards, the "sample size" is typically a limited number of test units of the device itself (e.g., one or more new units manufactured according to specifications). This is not a "data set" in the way AI/ML models use it.
• Data provenance: Testing was performed by Anhui JBH Medical Apparatus Co., Ltd. in China, as per the manufacturer's location. The document does not specify if the testing was retrospective or prospective, but performance testing of a physical product is inherently prospective.

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

• Not applicable/Not provided. This type of information (expert review for ground truth) is for diagnostic or interpretative devices, not a power wheelchair. The "ground truth" for a power wheelchair's performance is determined by physical measurements, engineering tests, and adherence to established safety and performance standards by qualified testing personnel and engineers, not by medical experts establishing diagnostic ground truth.

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

• Not applicable/Not provided. This is relevant for image interpretation or diagnostic studies where human agreement on a diagnosis or finding is needed. For a power wheelchair, adherence to a standard is binary (pass/fail) for each test.

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, not done. This is explicitly for AI/ML-driven diagnostic aids. This document is for a physical mobility device.

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

• Not applicable. This refers to AI algorithm performance. While the device has an "Electronic controller" (software), its performance is integrated into the physical device's function and verified through the ISO 7176-14 standard and general software validation, not a standalone algorithmic performance study as understood in AI/ML.

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

• Engineering specifications and compliance with international consensus standards. For example, braking distance is measured against a standard, not determined by expert consensus on a diagnosis. Stability is tested against physical requirements. Biocompatibility is tested against established ISO standards for material safety.

8. The sample size for the training set:

• Not applicable. This term is exclusively for machine learning models. The power wheelchair is a physical product, not a software algorithm that undergoes machine learning training.

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

• Not applicable. (See answer to #8).

In summary, the document describes a traditional 510(k) submission for a physical medical device. The "proof" of meeting "acceptance criteria" comes from demonstrating compliance with established international performance and safety standards through bench testing, rather than an AI/ML-style clinical study with human readers and ground truth data sets.

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The wheelchair (Model: DC01) is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The device is Electric Wheelchair, model no. is DC01. An electric wheelchair is a four-wheeled personal mobile device with a complementary chair support system that is powered by two motors. The traveling speed is controlled by the motor, and the traveling direction is controlled by the passenger. This product is a device suitabled people with mobility difficulties and elderly people and it is intended to provide mobility to a disabled or elderly person limited to a seated position. The electric wheelchair can be travelled on flat and obstacle ground surface, and direction and speed of the wheelchair can be controlled by the passenger's hand with the help of the joystick. The device can be used to provide indoor and outdoor mobility at a certain distance but not allowed to be travelled on the road or highway.

The device consists of two parts: the electrical part and the wheelchair main body. The electrical part includes motor, electromagnetic brake system, battery box, controller and battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, seat and back cushion.

The device is powered by Li-ion Battery pack (24V 6Ah, 144Wh) with 20 Km (12.5 miles) range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.

The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic intelligent electromagnetic brake system starts to work. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

This document describes the premarket notification (510(k)) for the Anhui JBH Medical Apparatus Co., Ltd.'s Portable Folding Electric Wheelchair, Model DC01. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K113463, PL001 power wheelchair, SUZHOU KID MEDICAL APPLIANCE CO., LTD.).

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

The acceptance criteria for this device are based on compliance with various international standards for wheelchairs. The "device performance" column below indicates compliance with these standards, effectively stating that the device meets the functional and safety requirements outlined by these standards.

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

The document primarily relies on bench testing and compliance with international standards for manufactured goods. Therefore, the concept of "sample size" for a clinical test set or data provenance in the traditional sense (e.g., patient data) is not applicable here. The "test set" refers to the specific physical device (Model DC01) and its components that underwent various engineering and safety tests outlined by the ISO and IEC standards. The data provenance would be the results generated from these bench tests, conducted by the manufacturer or a certified testing facility, likely in China given the manufacturer's location.

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 product is a medical device (powered wheelchair), not an AI/diagnostic software. Therefore, the concept of "experts establishing ground truth" in the context of clinical interpretation or diagnostic accuracy is not applicable. The "ground truth" for this device's performance is defined by its adherence to the technical specifications and safety requirements outlined in the referenced ISO and IEC standards. The expertise involved would be in engineering, materials science, and regulatory compliance, ensuring the tests are conducted correctly and the results are interpreted against the standard's pass/fail criteria.

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

This concept is not applicable to the type of device and testing performed. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or diagnostic results, where multiple human readers assess cases and discrepancies are resolved by a senior expert. For a physical device like an electric wheelchair, tests are objective measurements against defined performance thresholds in engineering standards.

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

Absolutely no MRMC study was done. This device is a physical product (electric wheelchair), not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

This refers to AI algorithm performance. As the device is an electric wheelchair, an "algorithm only" performance study is not applicable. The device's operation involves a human user in control via a joystick, and its performance is assessed against physical and electrical safety standards.

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

The "ground truth" for this device is established by compliance with international safety and performance standards for powered wheelchairs (e.g., ISO 7176 series, IEC 60601-1-2, IEC 62133-2) and biocompatibility standards (ISO 10993 series). These standards define objective, measurable criteria for a device to be considered safe and effective for its intended purpose.

8. The sample size for the training set

This concept is not applicable. A "training set" typically refers to data used to train a machine learning algorithm. This submission is for a physical medical device, not an AI/ML product.

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

This concept is not applicable for the reasons stated above.

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The Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Disposable Medical Masks are single use, three-layer, flat –folded masks with ear strings or ties and nose clip. The two models are exact same except the loop versus tie on design. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The three layers fabric are held together by ultrasonic welding. The earloops/tie-on ties are held in place over the users' mouth and nose by two strings welded to the facemask. The earloops are made of 19cm spandex and the tie-on ties are made of 90cm spandex. The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is not touch with the users' skin directly. The Disposable Medical Masks will be provided in blue. The Disposable Medical Masks are sold non-sterile and are intended to be single use, disposable devices.

The provided document is a 510(k) premarket notification for a Disposable Medical Mask (Models: JBHY01, JBHY02). It details non-clinical performance testing to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against ASTM F2100-19 Level 3 acceptance criteria for medical face masks.

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