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The C.T.M. Mobility Scooter HS-320 is an indoor/outdoor scooter that provides transportation for disabled or elderly persons.

The C.T.M. Mobility Scooter HS-320 is an indoor/outdoor electric scooter that is battery operated. It has a base with three wheels with adjustable padded seats, armrests and headrests. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. This modes can be disassembled for transport and is provided with a battery charger.

The provided 510(k) summary for the C.T.M. Mobility Scooter HS-320 does not contain acceptance criteria or a detailed study proving the device meets such criteria in the way typically expected for medical devices involving diagnostic performance or clinical outcomes. Instead, it focuses on substantial equivalence to a predicate device based on technological characteristics and general safety testing.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As stated, no explicit acceptance criteria with quantitative thresholds are provided in the document. The submission relies on demonstrating similarity to a legally marketed predicate device (Sunrunner TE-777-3). The "performance" mentioned refers to general device features and safety tests rather than diagnostic accuracy or clinical effectiveness.

Therefore, a table cannot be constructed as requested.

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

• Sample size: Not applicable. The submission states, "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This indicates that no specific test set of users or data for comparative performance was used.
• Data Provenance: Not applicable for comparative performance testing. The "Testing conducted" refers to general safety and design verification tests listed in a guidance document, but details on sample size or provenance for these tests are not provided and are not related to clinical or diagnostic performance.

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

Not applicable. No clinical or comparative performance test set was used, and thus no ground truth establishment by experts for such a set was performed or reported.

4. Adjudication Method for the Test Set

Not applicable. No clinical or comparative performance test set was used, and thus no adjudication method was employed.

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 mobility scooter, not a diagnostic imaging or AI-assisted device. Therefore, an MRMC study or assessment of AI assistance is irrelevant.

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

Not applicable. This device is a physical mobility scooter, not an algorithm or software-based device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of diagnostic or clinical performance. The "ground truth" for this device's safety and functionality would implicitly be established by engineering standards and internal testing to ensure the scooter operates as intended and meets safety specifications (e.g., braking performance, stability, battery life). The document mentions "Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995," which implies that the ground truth for these tests is defined by the standards and methodologies within that guidance document.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML or a diagnostic device that requires a "training set" in the conventional sense.

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

Not applicable. As above, no training set was used.

Summary of the Device's "Acceptance" Basis from the Provided Text:

The C.T.M. Mobility Scooter HS-320 received 510(k) clearance based on substantial equivalence to a previously marketed predicate device (Sunrunner TE-777-3). The primary arguments for substantial equivalence are:

• Similar Intended Use: Both are indoor/outdoor scooters for disabled or elderly persons.
• Similar Technological Characteristics: Both are battery-operated electric scooters with three wheels, adjustable seating, hand controls, and automatic braking systems.
• Performance Differences: The document acknowledges "varying only slightly with selected parameters, such as with the maximum distance that each scooter can be driven," implying these slight variations were not deemed significant enough to warrant a finding of non-equivalence.
• Conformance to Guidance Document: Tests outlined in the "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995" were conducted. While the specific results or acceptance criteria for these tests are not detailed in the summary, their completion contributes to the overall demonstration of safety and effectiveness consistent with the predicate.

Crucially, the submission explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This reinforces that the clearance was not based on demonstrating superior or even equivalent performance in a clinical study sense, but rather on the similarity of design, function, and intended use as well as compliance with recognized safety standards for this class of device.

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The C.T.M. Mobility Scooter HS-360 is an indoor/outdoor scooter that provides transportation for disabled or elderly persons.

The C.T.M. Mobility Scooter HS-360 is an indoor/outdoor electric scooter that is battery operated. It has a base with four wheels with adjustable padded seats, armrests and headrests. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. This modes can be disassembled for transport and is provided with a battery charger.

1. Table of acceptance criteria and reported device performance:

The provided document, K012792, is for a C.T.M. Mobility Scooter HS-360. This type of device is a motorized three-wheeled vehicle, Class II, 21 CFR 890.3800. The 510(k) summary states that "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." The acceptance for this device was based on substantial equivalence to a legally marketed predicate device (Sunrunner TE-777-4, K923193) and adherence to tests listed in the "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995."

Therefore, there is no explicit table of acceptance criteria with corresponding device performance metrics in the provided text. The acceptance criterion was primarily demonstrating substantial equivalence to a predicate device and complying with general guidance documents rather than specific quantitative performance targets.

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

No specific test set or data provenance (e.g., country of origin, retrospective/prospective) is mentioned because "Comparative performance testing and clinical evaluations were not submitted."

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

No experts were used to establish ground truth for a test set, as no such testing was performed or submitted.

4. Adjudication method for the test set:

Not applicable, as no test set requiring ground truth adjudication was submitted.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs. without AI assistance:

Not applicable. This is a medical device (mobility scooter), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study with AI assistance is not relevant to this submission.

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

Not applicable. This is a physical, battery-operated mobility scooter, not an algorithm.

7. The type of ground truth used:

Not applicable. No ground truth was established through expert consensus, pathology, or outcomes data because "Comparative performance testing and clinical evaluations were not submitted." The "ground truth" for this submission was implicitly the established safety and effectiveness of the legally marketed predicate device.

8. The sample size for the training set:

Not applicable, as this is not an AI/machine learning device.

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

Not applicable, as this is not an AI/machine learning device.

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The C.T.M. Mobility Scooter HS-686 is an indoor/outdoor scooter which provides transportation for a disabled or elderly person.

The C.T.M. Mobility Scooter HS-686 is an indoor/outdoor four-wheeled scooter which is battery operated. It consists of a platform which connects the four wheels, an adjustable steering column, and a seat for the rider. The rider drives the scooter using hand controls located at the top of the steering column. It can be disassembled into five parts for transport in a car trunk. It comes with a battery charger.

The provided 510(k) summary for the C.T.M. Mobility Scooter HS-686 does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document states: "Performance testing: Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This explicitly indicates that the type of study you're asking for was not conducted or submitted for this specific device clearance.

Therefore, I cannot fulfill your request for the specific details outlined (table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information).

The 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device (Shoprider The TE889) based on intended use, technological characteristics, and conformance to general guidance documents rather than specific performance metrics and extensive clinical or performance studies. The "Testing conducted" section vaguely refers to "Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995," but does not provide the results or specific acceptance criteria for these tests within the provided text.

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The C.T.M. Mobility Scooter HS-666 is an indoor/outdoor scooter which provides transportation for a disabled or elderly person.

The C.T.M. Mobility Scooter HS-666 is an indoor/outdoor three-wheeled scooter which is battery operated. It consists of a platform which connects the wheels, an adjustable steering column, and a seat for the rider drives the scooter using hand controls located at the top of the steering column. It can be disassembled into five parts for transport in a car trunk. It comes with a battery charger.

The provided document is a 510(k) premarket notification for a medical device (CTM Mobility Scooter HS-666), not a study report. As such, it does not contain the detailed information typically found in a study or clinical trial report regarding acceptance criteria and performance against those criteria. The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer many of the subsequent questions related to study design, ground truth, or expert involvement.

However, I can extract the information that is present:

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

• Acceptance Criteria: Not explicitly stated as pass/fail criteria for a study. The relevant "acceptance criteria" here are the requirements outlined in the "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995." The device aims to demonstrate substantial equivalence to a predicate device.
• Reported Device Performance: The document describes the device's technical characteristics and how they compare to a predicate device. The performance details are descriptive rather than quantitative from a formal study.

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. No performance or clinical test set was submitted or described. The testing conducted primarily refers to compliance with a "Guidance Document," implying engineering and design verification rather than a clinical study.

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. No ground truth was established for a test set in the context of a clinical or performance study.

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

• Not applicable. No test set was used requiring adjudication.

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 diagnostic device. No MRMC study was conducted.

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

• Not applicable. This is not an algorithm, but a physical mobility device.

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

• Not applicable. No ground truth was established as no clinical or performance study was conducted in the manner of diagnostic or treatment efficacy evaluation. The "ground truth" for this submission is substantial equivalence to the predicate device based on technical characteristics and intended use.

8. The sample size for the training set

• Not applicable. This is not a machine learning device; therefore, no training set was used.

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

• Not applicable. No training set was used.

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