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The intended use of the Pride Mobility Products Corporation Kids ROCK 3 Chair is to provide mobility to persons limited to a seated position.

The Kids ROCK 3 Chair is a Mechanical Wheelchair that offers adjustable and customizable seating and positioning to meet the needs of a growing client. The Reaction Dynamic Seating System allows a user the freedom to move into flexion or extension in the chair while maintaining proper positioning and support.

This document is a 510(k) premarket notification for a mechanical wheelchair, specifically the Pride Mobility Products Corporation Kids ROCK 3 Chair. It demonstrates the device's substantial equivalence to a predicate device through non-clinical testing. It does not describe a study to prove the device meets acceptance criteria using performance metrics like sensitivity, specificity, or AUC, as would be common for AI/ML-based medical devices.

Therefore, many of the requested items (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC study, standalone performance, ground truth types) are not applicable to the provided document.

Here's a summary of the information that is available in the document, formatted to address your request where possible:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the physical product subjected to engineering and material tests according to international standards. The document doesn't provide specific sample sizes (e.g., number of wheelchairs tested) for these non-clinical tests, nor does it refer to "data provenance" in the context of medical imaging or AI/ML data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document pertains to the physical and mechanical testing of a medical device, not a diagnostic or AI algorithm requiring expert ground truth for interpretation. Compliance with standards is typically determined by testing against predefined physical criteria.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the reasons mentioned above.

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 document describes a mechanical wheelchair, not an AI/ML device, so no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This document describes a mechanical wheelchair.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's safety and effectiveness is its compliance with established engineering and safety standards (e.g., ISO, ANSI/RESNA) through non-clinical physical testing.

8. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable for the reasons mentioned above. The "ground truth" for the device's design and manufacturing is established by adherence to recognized engineering standards and good manufacturing practices.

Summary:
This document is a 510(k) summary for a mechanical wheelchair, which is a traditional medical device. The "acceptance criteria" discussed are compliance with established international and national standards for wheelchair safety, performance, and durability. The "study that proves the device meets the acceptance criteria" refers to non-clinical testing performed against these standards. It does not involve clinical studies or the type of performance evaluation (e.g., sensitivity, specificity, AUC) typically associated with AI/ML devices, and hence, many of the requested details are not relevant to this submission. The device was deemed substantially equivalent to a predicate device (Litestream 500E, K042444) based on similar intended use and technological characteristics, and compliance with the relevant standards.

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The Intended Use of the Pride Mobility T3 Lift Chair is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.

The Pride Mobility T3 Lift Chair is an upholstered chair having welded steel frame construction. The chair upholstery (foam and fabric) are compliant to Cal 117 and BS5852 Flammability requirements. The upholstered chair is assembled to a weldedsteel lifting frame mechanism, and a Hand Control Switch Device engages motor / actuators to position the chair to recline, sitting, or standing positions. The system is a low voltage DC motor system that reduces the standard household alternating current of 110V AC / 240V AC to direct current (24 / 39V DC). The electrical components include the external transformer with battery backup, two motor / actuators, and the Hand Control.

The provided text describes a 510(k) submission for the Pride Mobility T3 Lift Chair. This is a medical device that assists individuals with mobility challenges in transitioning from a seated to a standing position.

Here's an analysis of the provided information, specifically addressing the acceptance criteria and study details:

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

For the Pride Mobility T3 Lift Chair, the "acceptance criteria" are based on its compliance with specific safety and flammability standards, and its substantial equivalence to a predicate device. The device's performance is demonstrated by passing tests related to 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 does not specify a sample size for a "test set" in the context of clinical data. The testing performed was non-clinical testing of the device itself (flammability, electrical safety, mechanical fatigue). Therefore, "data provenance" in terms of subject data is not applicable. The tests were likely conducted in a controlled laboratory environment.

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 is not applicable to this device. The "ground truth" for the non-clinical tests (flammability, electrical, mechanical) is typically the standard itself (e.g., "does the material ignite within X seconds under Y conditions?"). Expert consensus in the medical or diagnostic sense is not relevant for these types of engineering and safety tests. The reports from the testing labs would serve as the attestations to compliance.

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

This is not applicable as there was no clinical test set requiring adjudication of findings. The tests were objective assessments against established engineering and safety 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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI in radiology), not for a mechanical lift chair. The device's function is to directly provide lift assistance, not to assist humans in making a diagnostic interpretation.

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

No, a standalone algorithm-only performance study was not done. This device is a mechanical chair, not an algorithm.

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

The "ground truth" for the non-clinical tests was the objective pass/fail criteria defined by the respective safety and performance standards. For example, for flammability, the ground truth is whether the material meets the specified burn rates or self-extinguishing properties outlined in CAL 117 or BS5852. For fatigue testing, the ground truth is whether the components withstand the prescribed number of cycles or impact forces without failure. For substantial equivalence, the "ground truth" is whether the technical characteristics and intended use align sufficiently with the predicate device.

8. The sample size for the training set

This is not applicable as there is no "training set" in the context of an algorithm or AI model for this mechanical device.

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

This is not applicable for the same reason as above.

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The intended use of the Pride Mobility Products Corporation Jazzy Frontie is to provide mobility to disabled persons having limited walking capabilities. The intended use of the Jazzy Frontie is to provide mobility to those who are limited to a seated position that have the capability of operating a Powered Wheelchair.

The Jazzy Frontie is a Powered Wheelchair having a digital controller, electrical 140 outly motors, batteries, seating, and frame. The Jazzy Frontie is equipped with electronic, regenerative disc brakes, off-board battery charger, removable 12 Volt U1 batteries, front anti-tip wheels, and rear caster wheels. The Jazzy Frontie has a depth adjustable fold flat seat that provides fast, simple adjustment for enhanced, personalized comfort that is removable.

The provided text is a 510(k) summary for a powered wheelchair, the Jazzy Frontie. It details the device's description, intended use, and comparison to a predicate device, as well as non-clinical testing performed. However, it explicitly states "N/A" for "Discussion of Clinical Testing Performed."

Therefore, based on the provided document, the following points regarding acceptance criteria and a study proving the device meets them cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on regulatory compliance through non-clinical testing and substantial equivalence.
2. Sample size used for the test set and the data provenance: Not applicable as no clinical study was performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study was performed.
4. Adjudication method for the test set: Not applicable as no clinical study was performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable as no clinical study was performed, and the device is a powered wheelchair, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as the device is a powered wheelchair, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable as no clinical study was performed.
8. The sample size for the training set: Not applicable as no clinical study that would require a training set was performed.
9. How the ground truth for the training set was established: Not applicable as no clinical study that would require a training set was performed.

The document primarily relies on non-clinical testing and substantial equivalence to a predicate device (Pride Mobility Jet 1, K001970) to demonstrate safety and effectiveness.

Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Testing and Substantial Equivalence):

Study Proving Acceptance Criteria Met:

The study proving the device meets the acceptance criteria is non-clinical testing in conjunction with a substantial equivalence comparison to a predicate device.

• Non-Clinical Testing: The device underwent testing to comply with various standards including:

  • RESNA WC Vol.1 2008 DRAFT
  • RESNA WC Vol. 2 2008 DRAFT
  • ANSI/RESNA WC Vol. 2-1998 Section 21
  • IEC 601-1-1
  • CAL 117
    The document states the device "passed all the necessary testing."

• Substantial Equivalence Study: A comparison was made to the predicate device, Pride Mobility Jet 1 (K001970), demonstrating that the Jazzy Frontie

  • Has the same intended use.
  • Has similar technological characteristics.
  • Does not raise new questions of safety or effectiveness due to any differences in technological characteristics.

In summary, no clinical study was performed or required for the 510(k) clearance of the Jazzy Frontie powered wheelchair. The evidence supporting its safety and effectiveness is based on adherence to recognized non-clinical performance standards and a demonstration of substantial equivalence to an already legally marketed device.

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The intended use of the Pride Mobility Products Corporation Victory XL 130, Four Wheel Scooter / Model # SC713 is to provide mobility to disabled persons having limited walking capabilities.

The Victory XL 130, Four Wheel Scooter / Model # SC713 is a Heavy Duty batteryoperated scooter having a Digital Controller, electrical system, Charger, Transaxle / Motor, Batteries, Seating and 2-Piece Frame. The Victory XL 130 Scooter is equipped with electronic regenerative and electromechanical disc brakes, off-board battery charger, removable 12 Volt 55AH batteries, and anti-tip rear wheels.

The scooter has various size foldable Contour seats that are removable. The seat interface is equipped with a clover leaf design allowing for seat rotation and locking at 90° intervals mounted on stationary seat post. The seat is also equipped with sliders for fore-aft adjustment.

The Victory XL 130, Four Wheel Scooter / Model # SC713 is designed with ultimate safety, stability, and performance in mind. The scooter is designed for, but not limited to Pride Mobility Products Corporation, providers/retailers and their consumers.

The provided text describes a 510(k) submission for a medical device, the "Victory XL 130, Four Wheel Scooter / Model # SC713," indicating substantial equivalence to a predicate device. This type of submission focuses on comparing a new device to an already legally marketed one rather than conducting extensive de novo clinical trials to prove efficacy from scratch. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to compliance with recognized standards and a demonstration of substantial equivalence, not a traditional clinical trial with specific performance metrics for an AI algorithm.

Based on the provided information, here's a breakdown of the requested points, noting where information is not applicable due to the nature of a 510(k) for a mobility scooter:

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

For a mobility scooter undergoing a 510(k) review, the "acceptance criteria" are compliance with relevant safety and performance standards. The "reported device performance" is the demonstration that the device meets these standards.

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

• Sample Size: Not applicable in the context of a 510(k) for this type of device. The "test set" here refers to the compliance testing of a physical device sample against specific engineering and safety standards, not a patient dataset. The document does not specify the number of units tested.
• Data Provenance: Not applicable. The testing is non-clinical, focusing on product design and manufacturing compliance. No patient data or country of origin for such data is mentioned or relevant.
• Retrospective/Prospective: Not applicable.

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)

• Number of Experts & Qualifications: Not applicable. For engineering and safety standard compliance, "ground truth" is established by the specifications within the standards themselves and the expertise of the engineers and technicians conducting the tests. The document does not specify the number or qualifications of personnel involved in the non-clinical testing.

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

• Adjudication Method: Not applicable. This concept typically applies to clinical trials where human readers interpret data or images. In non-clinical device testing, the results are objectively measured against defined criteria within the 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

• MRMC Study: No. This is a non-AI, non-diagnostic medical device (a mobility scooter). An MRMC study is completely irrelevant here.

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

• Standalone Performance: No. This is a physical mobility device; there is no AI algorithm involved in its operation as described.

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

• Type of Ground Truth: For the non-clinical testing, the "ground truth" is derived from the quantitative and qualitative requirements specified in the referenced industry standards (RESNA, ANSI/RESNA, IEC, CAL). The device is tested to demonstrate it meets these pre-defined performance and safety criteria.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. There is no AI model or "training set" for this device.

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

• Ground Truth for Training Set: Not applicable. There is no AI model or "training set" for this device.

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The intended use of the Pride Mobility Products Corporation Maxima V, Three and Four Wheel Scooters is to provide mobility to disabled persons having limited walking capabilities.

The Maxima V, Three and Four Wheel Scooters are heavy duty battery-operated scooters with programmable controllers. Features include various size removable seats, a foldable tiller, and an off board charger. The Scooter can be disassembled into four parts: the rear section, the front section, batteries, and seat; this allows for ease of use when travelling or storing the scooter. Safety features include electronic speed control, rear anti-tip wheels, and front anti-tip wheels on the three wheel model.

The provided document is a 510(k) summary for the Pride Mobility Products Corporation's Maxima V, Three and Four Wheel Scooter. It is a premarket notification for a medical device that claims substantial equivalence to previously cleared devices.

Based on the content, this device is a power scooter, and the "acceptance criteria" are related to its compliance with established testing standards for wheelchairs and scooters, rather than performance metrics from a diagnostic or screening study. There is no "study" in the traditional sense of a clinical trial proving diagnostic accuracy or treatment efficacy. Instead, the "study" is a series of non-clinical tests to demonstrate compliance with safety and performance standards.

Here's the information extracted and formatted as requested, with "N/A" where the information is not present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. This typically refers to the number of units tested.
• Data Provenance: The document does not specify the country of origin for the data or whether the tests were retrospective or prospective. Given the nature of medical device testing for regulatory clearance, these would be prospective, controlled tests conducted in a laboratory or test facility according to the standards.

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

N/A. This is not applicable as this is a non-clinical device safety and performance evaluation, not a study involving human subjects or expert assessment for ground truth in a diagnostic context. "Ground truth" here is defined by the technical specifications of the standards.

4. Adjudication method for the test set

N/A. Not applicable to non-clinical device testing against established 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

N/A. This is a non-clinical device and does not involve AI or human readers for diagnostic interpretation.

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

N/A. This device is a mobility scooter, not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the non-clinical testing is defined by the requirements and test methods outlined in the cited industry standards (RESNA WC Vol.1, RESNA WC Vol. 2, ANSI/RESNA WC Vol. 2-1998 Section 21, IEC 601-1-1, CAL 117). Compliance with these standards indicates the device meets the accepted safety and performance criteria.

8. The sample size for the training set

N/A. This is a physical device, and the concept of a "training set" is not applicable in the context of its non-clinical testing for regulatory clearance, as it's not a machine learning model.

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

N/A. As above, the concept of a "training set" and its "ground truth" is not relevant to this type of device and its regulatory submission.

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The intended use of the Pride Mobility Products Corporation V Series Scooters is to provide mobility to disabled persons having limited walking capabilities.

The V Series Scooters are three and four wheeled battery-operated scooters. Features include a programmable controller, removable seat, a foldable tiller, two piece frame, and an off board charger; specific models include a Power Seat actuator. Additional safety features include electronic regenerative and electromechanical disc brakes, and rear anti-tip wheels. The Scooters can be disassembled into four parts: the rear section, the front section, batteries, and the seat; this allows for ease of use when traveling or storing the unit.

The V Series Scooters are designed with ultimate safety, stability, and performance in mind and are designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers.

This document describes a 510(k) premarket notification for Pride Mobility Products Corporation's V Series Scooters. A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the requested information regarding acceptance criteria, specific device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not available within this document. This submission relies on non-clinical testing and comparison to predicate devices to establish safety and effectiveness.

Here's a breakdown of what can be extracted from the provided text, and where your requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable for this type of submission. A 510(k) generally does not present a table of specific acceptance criteria with corresponding performance statistics in the way a clinical trial might. The "performance" is implicitly demonstrated through compliance with standards and comparison to a predicate device.

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

• Not applicable. This submission does not describe a clinical "test set" with human or AI performance data. The "testing" mentioned is non-clinical.

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

• Not applicable. There is no "test set" with expert-established ground truth described.

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

• Not applicable. No such adjudication method is mentioned for this type of non-clinical testing.

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, an MRMC study was not done. This device is a mobility scooter, not a diagnostic AI system, therefore such a study is irrelevant.

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

• Not applicable. This device is a mobility scooter, not a standalone algorithm.

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

• Not applicable. There is no "ground truth" established in the context of clinical data for performance evaluation in this submission. Safety and effectiveness are demonstrated through compliance with engineering standards and substantial equivalence to existing devices.

8. The sample size for the training set:

• Not applicable. This is a hardware device (scooter), not an AI algorithm requiring a training set.

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

• Not applicable. (See point 8).

What is available regarding testing and performance:

The document states:

• Non-Clinical Testing: Compliance to applicable Testing Standards is as follows:

  • RESNA WC Vol.1 2008 DRAFT - Requirements and Test Methods for Wheelchairs (Including Scooters)
  • RESNA WC Vol. 2 2008 DRAFT - Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems
  • ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility.
  • IEC 601-1-1 Medical Electrical Equipment, General Requirements for Safety
  • CAL 117 - Flammability Testing

• Discussion of Clinical Testing Performed: N/A (Not Applicable)

• Comparison to Predicate Devices: "The V Series Scooters are substantially equivalent to the Pride Mobility, Victory Three Wheel Scooter (K072165) and the Victory Four Wheel Scooter (K071949) when comparing, performance, maneuverability, stability, and structure."

Conclusion:

The V Series Scooters demonstrated substantial equivalence to predicate devices (Pride Mobility, Victory Three Wheel Scooter K072165 and Victory Four Wheel Scooter K071949) based on non-clinical testing and comparison of performance, maneuverability, stability, and structure. The non-clinical testing indicated compliance with several RESNA, ANSI/RESNA, IEC, and CAL flammability standards. No clinical testing or AI-specific performance evaluation with acceptance criteria, ground truth, or expert review was performed or reported in this 510(k) submission.

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The intended use of the Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter, is to provide mobility to persons having limited walking capabilities. The compact design and ease of assembly and disassembly, also rrovides a mobility product that transports easily for travel usage.
The intended use of the Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter, is to provide mobility to disabled persons.

The Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter is a compact battery-operated scooter having a digital programmable Controller. Features include a removable molded plastic seat, a foldable tiller, and an off board charger. Additional safety features include electronic regenerative and electromechanical disc brakes, and rear anti-tip wheels. The Go Go Elite Traveller V, Three Wheel Scooter is designed for but not limited to Pride Mobility Products Corp. providers / retailers and their consumers, The Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter is designed with ultimate safety, stability, performance, and portability in mind. The main feature of the Scooter is that it can be disassembled into 4 parts: the rear section, the front section, the battery pack, and the seat. This allows for ease of use when traveling or stority the unit.

This document describes the 510(k) summary for the Pride Mobility Products Corporation Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter. It focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study to prove performance against those criteria.

Therefore, much of the requested information regarding a specific study, acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not available in the provided text. The submission is a non-clinical testing submission for substantial equivalence.

Here's an attempt to extract and infer information based on the provided text, and point out what is explicitly not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated. The testing seems to be based on evaluating the design and performance characteristics of the single device model, the Go Go Elite Traveller V / Model SC40EV, against the standards and the predicate device. It's likely one or a few units were tested to demonstrate compliance.
• Data Provenance: Not explicitly stated, but given it's a 510(k) submission from Pride Mobility Products Corporation, it can be inferred that the data comes from internal testing and validation activities of the manufacturer. It is retrospective in the sense that the data was collected prior to the submission for regulatory approval. There is no indication of country of origin of the data beyond the manufacturer's location (Exeter, PA, USA).

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

• Number of Experts: Not applicable/not stated. This was a non-clinical device testing submission focusing on compliance with performance standards and comparison to a predicate device, not a diagnostic or AI device requiring expert ground truth for a test set. The "experts" involved would be the engineers and quality assurance personnel performing the tests according to the standards.
• Qualifications: Not applicable/not stated.

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

• Adjudication Method: Not applicable/not stated. This type of adjudication is typically used in clinical studies for diagnostic accuracy, which is not the nature of this submission. The "adjudication" for this type of submission would be the review by regulatory bodies (FDA) of the presented test results against the specified 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

• MRMC Study: No. This is not an AI device or a diagnostic medical device that would involve human "readers." The submission explicitly states "Discussion of Clinical Testing Performed: N/A."

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

• Standalone Performance: Not applicable. This is a physical mobility device, not an algorithm.

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

• Ground Truth: For this device, "ground truth" would be the objective measurements and adherence to engineering specifications and performance standards (e.g., stability measurements, brake effectiveness, flammability rating, electromagnetic compatibility readings) as defined by the RESNA and IEC standards. The predicate device's established safety and effectiveness also serves as a "ground truth" for comparison.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is not a machine learning or AI device. "Training set" is not relevant here.

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

• Ground Truth Establishment for Training Set: Not applicable. As this is not an AI device, there is no "training set" or ground truth to establish for such a purpose.

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The intended use of the Pride Mobility Products Corporation Victory Three Wheel Scooter, is to provide mobility to persons having limited walking capabilities.

The Victory Three Wheel Scooter is a mid-size battery-operated scooter having a programmable 70-amp Digital Controller. Features include a removable molded plastic seat, a foldable tiller, and an off board charger. Additional safety features include electronic reqenerative and electromechanical disc brakes, and rear anti-tip wheels. The Victory Three Wheel Scooter is designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers. The Victory Three Wheel Scooter is designed with ultimate safety, stability, performance, and portability in mind. The main feature of the Scooter is a narrow wheelbase (22"), which allows better maneuverability from a mid-sized product.

This document is a 510(k) premarket notification for a medical device, specifically a Victory Three Wheel Scooter. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data for a new, AI-driven diagnostic or therapeutic device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment is not applicable to this document as it is a submission for a durable medical equipment (DME) device, not a diagnostic or AI-enabled device requiring such detailed performance evaluation against clinical endpoints.

The document states:

• "Discussion of Clinical Testing Performed: N/A"
• "The nonclinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."

This indicates that clinical testing, in the sense of a performance study with human subjects, was not performed or deemed necessary for this 510(k) submission. Instead, the submission relies on non-clinical testing against established industry standards and comparison to a legally marketed predicate device.

To directly address your request given the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. The document refers to non-clinical testing against standards for the device itself, not a test set of data like in an AI/diagnostic study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth established by experts for a test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set adjudication is mentioned.

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 not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this type of device is compliance with engineering and safety standards, as well as functional equivalence to a predicate device, rather than a clinical ground truth.

8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. No training set is mentioned.

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The intended use of the Pride Mobility Products Corporation Victory Four Wheel Scooter, is to provide mobility to persons having limited walking capabilities.

The Victory Four Wheel Scooter is a mid-size battery-operated scooter having a programmable 70-amp Digital Controller. Features include a removable molded plastic seat, a foldable tiller, and an off board charger. Additional safety features include electronic regenerative and electromechanical disc brakes, and rear anti-tip wheels. The Victory Four Wheel Scooter is designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers.

The Victory Four Wheel Scooter is designed with ultimate safety, stability, performance, and portability in mind. The main feature of the Scooter is a narrow wheelbase (22"), which allows better maneuverability from a mid-sized product.

The provided text describes the regulatory submission for the "Victory Four Wheel Scooter" and primarily focuses on its substantial equivalence to a predicate device, the Pride Mobility SC340 (K930952). The content does not describe a study that involves acceptance criteria, device performance, sample sizes, ground truth from experts, or comparative effectiveness studies in the context of AI/algorithm performance.

Instead, the document details non-clinical testing for compliance with established standards for wheelchairs and scooters. Since the request specifically asks for information related to AI/algorithm performance studies, and this document pertains to a physical medical device (a scooter) and its regulatory approval based on non-clinical testing and predicate device comparison, most of the requested information is not applicable.

Here's a breakdown based on the provided text, highlighting where information is N/A (Not Applicable) or not provided.

Acceptance Criteria and Device Performance (Not Applicable for AI/Algorithm Study)

The document lists compliance with various testing standards for the physical scooter. These are "acceptance criteria" in the sense of regulatory compliance for a physical device, but not in the context of an AI/algorithm performance study.

Table of Acceptance Criteria and Reported Device Performance:

Study Details (Not Applicable for AI/Algorithm Study)

This section is largely N/A as the document explicitly states "N/A" for "Discussion of Clinical Testing Performed" and focuses on non-clinical engineering and design compliance.

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

   • N/A. This device is a physical scooter, not an AI/algorithm. Test sets, in the context of AI, are not relevant here. The "testing" involved physical product performance against engineering standards.
   • Data provenance: N/A.

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

   • N/A. Ground truth, in the context of expert review for AI, is not applicable. Regulatory compliance is assessed by adherence to established engineering standards, presumably by qualified engineers/testers.

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

   • N/A. Adjudication methods for expert consensus on ground truth are not applicable to non-clinical engineering tests.

4. 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:

   • N/A. This is a physical device, not an AI solution designed to "assist human readers."

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

   • N/A. This is a physical product, not an algorithm.

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

   • N/A (in the AI sense). For this device, "ground truth" would be compliance with objective engineering specifications and safety standards (e.g., a specific torque, speed, stability angle, or flammability resistance measured during testing).

7. The sample size for the training set:

   • N/A. No AI training set is involved.

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

   • N/A. No AI training set is involved.

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The Intended Use of the Pride Mobility C5 Lift Chair is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.

The Pride Mobility C5 Lift Chair is an upholstered chair assembly constructed of a welded steel frame, and foam and fabric compliant to Cal 117 Flammability requirements. The chair is assembled to a welded steel lifting frame mechanism having a 24 VDC motor / actuator powered by standard 110 volt AC power from a wall outlet. A Hand Held Switch Control Device engages the actuators to position the chair to a recline, sitting, or standing position.

Based on the provided text, the Acceptance Criteria and Study information for the Pride Mobility C5 Lift Chair is as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document states "The Pride Mobility C5 Lift Chair was tested to the following Safety Standards". This implies that one or more C5 Lift Chair units were tested. The exact number of units or the "sample size" is not explicitly stated.
• Data Provenance: The testing was conducted by Pride Mobility Products Corporation as a "Non-Clinical Testing" phase during the development and submission of the 510(k) application. This is internal testing data. The country of origin is implicitly the United States (where Pride Mobility is located). The testing is prospective in nature, as it's part of the development and validation of a new product.

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 mechanical lift chair, and the testing outlined is non-clinical safety standard compliance. It does not involve interpretation of medical images or patient data that would require "experts to establish ground truth" in the way a diagnostic AI would. The "ground truth" here is compliance with established engineering and safety standards, which is determined through laboratory testing and measurement.

4. Adjudication method for the test set:

• Not Applicable. As mentioned above, the testing is for compliance with engineering and safety standards. There is no concept of "adjudication" in the sense of resolving disagreements between human expert interpretations. The results are objective measurements against predefined thresholds of the 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:

• No. This document explicitly states "Discussion of Clinical Testing Performed: N/A". This device is a physical product (a lift chair), not a diagnostic AI or an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with AI assistance is not relevant and was not performed.

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

• No. This device is a mechanical lift chair, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable.

7. The type of ground truth used:

• The "ground truth" for this device's performance is compliance with established safety and performance standards (CAL 117, EN 61000-6-3, EN 61000-6-1, EN60601-1/A2:1995). These are objective, measurable criteria defined by regulatory bodies and industry associations.

8. The sample size for the training set:

• Not Applicable. This is a mechanical device, not a machine learning model. There is no "training set" in the context of AI.

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

• Not Applicable. As stated in point 8, there is no training set for this type of device.

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