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Motorized five-wheeled battery powered scooter intended for medical purposes by disabled persons and other non-medical purposes.

The Fusion is an indoor/outdoor scooter that is battery operated. Fusic standard technology seating, thumb operated throttle, digital controller rarger, motor, brake, transaxle, frame material and till we have used for years on our - - Saver units. The Fusion frame separates for transport and has removable batteries anc تحتوب Accessories include a front light and a basket.

The provided text describes a 510(k) premarket notification for a medical device called "Fusion" (later referred to as PaceSaver Fusion), a 3-wheel power scooter.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a numerical or pass/fail threshold format for performance metrics. Instead, it refers to compliance with applicable Testing Standards. The reported device performance is that the Fusion "passed the necessary testing to recognized consensus standards."

The document implies that meeting these standards constitutes the acceptance criteria.

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

• Sample Size: The document does not specify a separate "test set" or its sample size. The testing refers to the device (Fusion) itself being subjected to the standards listed. It does not involve a cohort of subjects or data collection in the way a clinical study would.
• Data Provenance: Not applicable in the traditional sense of retrospective or prospective human clinical data. The data provenance would be from the engineering and product testing performed on the device by Burke, Inc.

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

Not applicable. The ground truth for the device's performance is established by its compliance with the specified ANSI/RESNA standards, which define objective measurement methods and pass/fail criteria. It does not rely on expert consensus for interpreting results.

4. Adjudication Method for the Test Set:

Not applicable. There's no mention of an adjudication process as there would be in a study involving human interpretation. The testing is based on objective measurements against engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not performed. The document explicitly states: "Clinical testing is not appropriate and not required for the proposed device. Clinical testing was not performed." Therefore, there is no effect size of human reader improvement with or without AI assistance as AI is not part of this device.

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

Not applicable. This device is a physical power scooter, not an algorithm or a software-as-a-medical-device (SaMD). There is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used:

The ground truth used is compliance with recognized consensus standards (ANSI/RESNA WC series). These standards provide objective criteria and methodologies for evaluating the mechanical and performance characteristics of power wheelchairs and scooters.

8. The Sample Size for the Training Set:

Not applicable. There is no mention of a "training set" as this is not an AI/ML device requiring training data. The testing involves the physical device itself.

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

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

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The SCOUT BOSS is a motorized, battery powered wheelchair for indoor/outdoor mobility purposes by larger disabled individuals.

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This is a medical device marketing authorization from the FDA for a powered wheelchair, the "Scout Boss." It is not a study describing a device that uses AI/ML or an algorithm-based diagnostic. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is not applicable to this document.

This document is a 510(k) clearance letter, which means the device (a powered wheelchair) was found to be "substantially equivalent" to a legally marketed predicate device. This process typically involves demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate device, often through engineering tests and comparisons rather than clinical studies in the context of diagnostic accuracy.

Therefore, I cannot provide the requested information as it is not present in the provided text.

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Motorized battery powered wheelchair for mobility purposes by disabled persons.

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This 510(k) submission (K982158) is for a "Power Wheelchair" and focuses on regulatory clearance based on substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria or performance studies of the device against such criteria. The document is a clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts to establish ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information would typically be found in a more detailed technical review or a summary of safety and effectiveness, which are not part of this FDA clearance letter.

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Motorized three-wheeled and four-wheeled battery powered scooters are intended for medical purposes by disabled persons and other non-medical purposes.

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This is a 510(k) clearance letter for the PaceSaver Espree Scooter, dated July 17, 1997. The document primarily focuses on the regulatory approval of the scooter and explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This type of submission (510(k)) for devices like the PaceSaver Espree Scooter does not typically require the detailed performance studies, acceptance criteria, and ground truth analysis that would be associated with AI/ML-based medical devices or novel technologies. The basis for clearance is demonstrating substantial equivalence to a predicate device, not proving novel clinical effectiveness through extensive studies with acceptance criteria, expert ground truth, or MRMC studies.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not provided within this document because it is not relevant to a 510(k) clearance for this type of device.

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