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The MS 3 Mini Scooter has been designed to help people who have a difficult time walking. The MS 3 Mini Scooter is designed for both indoor and limited outdoor use in clean and dry conditions.

The American Bantex MS 3 Mini Scooter is a Class II device that also is intended to provide assistance to individuals that are unable to walk long distances. The rear-wheel drive and single wheeled steering abilities allow the user to effortlessly control this device. The body (shell) is made of rigid Acrylonitrile-Butadiene-Styrene Copolymer. The shell is available to the consumer in two colors. The variable speed dial on the tiller column enables users single-handed operation while moving forward. The sealed (24 V) transaxle motor is quiet to operate. As with the predicate device, the MS 3 breaks-down into several components for easy, tool less assembly, disassembly and transportation.

The provided document describes a 510(k) premarket notification for the American Bantex MS 3 Mini Scooter, which is compared to a legally marketed predicate device, the Mega Motion Mega 3 Scooter. The document focuses on demonstrating substantial equivalence rather than presenting an independent study with detailed acceptance criteria and performance data as typically found in clinical trials for new medical devices.

Therefore, many of the requested elements for a detailed study description are not available in this type of submission. However, I will extract what is present.

Acceptance Criteria and Device Performance

The "Acceptance Criteria" for this submission are implicitly tied to demonstrating Substantial Equivalence (SE) to a predicate device. The performance tests conducted are to ensure the new device functions comparably to the predicate and meets basic safety requirements. The document does not list specific quantitative acceptance criteria values for each parameter, but rather states that "The EUT meets the requirements".

Table of Acceptance Criteria and Reported Device Performance

Additional Information Not Present in the Document:

Given the nature of a 510(k) summary, specific details regarding sample size, expert involvement, and ground truth establishment, as typically seen in clinical studies for novel devices, are not provided. The submission focuses on device description, comparison to a predicate, and basic functional testing to ensure safety and effectiveness.

• Sample Size for Test Set and Data Provenance: Not specified. The tests described are functional tests performed on "the EUT" (Equipment Under Test), implying a single device or a small sample for engineering verification rather than a large-scale clinical test set. The provenance is internal testing by American Bantex or a contract testing service.
• Number of Experts and Qualifications: Not specified. The testing described appears to be engineering/performance testing, not involving clinical expert assessment in the way envisioned by this question.
• Adjudication Method: Not applicable/specified for these engineering tests.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, this type of study was not performed. The device is a mobility scooter, not an imaging or diagnostic device that would typically involve MRMC studies.
• Standalone Performance: A standalone performance test was performed in the sense that the device was tested as an algorithm-only without human-in-the-loop, though the "algorithm" here is the mechanical and electrical function of the scooter, not a software algorithm. The "RESULTS" section states, "The EUT meets the requirements, There was no performance degradation detected during this test."
• Type of Ground Truth: Not explicitly stated as "ground truth" in a clinical sense. The "ground truth" for these engineering tests are industry standards for scooter performance and the functional specifications expected for such a device, implicitly benchmarked against the predicate device.
• Sample Size for Training Set: Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.
• How Ground Truth for Training Set Was Established: Not applicable.

Summary of Device and Rationale for Substantial Equivalence:

The American Bantex MS 3 Mini Scooter is a Class II, three-wheeled motorized scooter intended to assist individuals unable to walk long distances. It is deemed substantially equivalent to the Mega Motion, Inc. - Mega 3 Scooter (K982145) based on similarities in safety, efficacy, technology, and intended use. Both devices are designed for mobility assistance, operate on a 24V system, have sealed transaxle motors, and can be disassembled for transport. The submitter affirms compliance with 21 CFR Part 820 (Quality System Regulation) and European Medical Device Directive 93/42/EEC. Design History Files are maintained, and products are tested using independent testing services.

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The American Bantex Humidifier is intended for use with oxygen concentrators or gas sources in a patients home, physicians office or hospital / institutional environment. The humidifier increases the moisture content of the airstream gases for administration directly to the patient.

Single patient use only

Non-sterile

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

The American Bantex Humidifier is device that provides humidity in a non-heated pathway. The American Bantex Humidifier works with most all Oxygen Concentrators or to an oxygen source used in homes, doctors' office, hospital or institutional environments. The inlet uses an easy-to-grab winged styled nut that universally adapts to most all gas connections. The outlet is a push-on standard medical tubing connector with a tapered end. The American Bantex Humidifier is equipped with either a 3 or 6-PS1 safety valve that will alarm if there is a kink or blockage in the delivery system.

The provided text describes a 510(k) submission for the "American Bantex Humidifier" as a medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study with specific acceptance criteria and performance metrics against a defined ground truth.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement is not applicable in the context of this 510(k) submission document. The submission focuses on comparing the new device's technological characteristics and intended use to a predicate device to prove it is "as safe and effective."

Here's an explanation based on the provided document:

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

• Not applicable. The document does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) that would typically be associated with an algorithm or diagnostic device. Instead, it demonstrates substantial equivalence by comparing the new device's characteristics and operation to a predicate device. The "performance" mentioned is that the device "consistently performed within its design parameters," implying it met its functional specifications, not a clinical outcome metric.

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

• Not applicable. This document describes a medical device (humidifier) that is compared to a predicate device based on its design, materials, and intended use. There is no "test set" of data or patient samples in the context of an algorithm or diagnostic test. The evaluation is centered on engineering and functional comparison.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. As there is no "test set" of data requiring ground truth establishment, no experts were used for this purpose in the context of this 510(k) submission.

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

• Not applicable. No adjudication method was used as there was no test set of data.

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. A multi-reader multi-case (MRMC) study is typically performed for diagnostic imaging devices or algorithms that assist human interpretation. The American Bantex Humidifier is a respiratory gas humidifier, which is a physical device, not an AI-powered diagnostic tool.

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

• Not applicable. This document is for a physical medical device (humidifier), not a standalone algorithm.

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

• Not applicable. Ground truth is not a concept applied in this 510(k) submission, as it relates to evaluating the accuracy of a diagnostic or predictive system against a definitive standard. This submission is about demonstrating equivalence of a physical device.

8. The sample size for the training set

• Not applicable. As this is not an artificial intelligence or machine learning device, there is no "training set" of data.

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

• Not applicable. There is no training set mentioned in the document.

Summary of the Study (as described in the document):

The "study" described in the provided document is a 510(k) premarket notification process for the American Bantex Humidifier. Instead of a clinical trial with acceptance criteria, the manufacturer performed a comparison to a legally marketed predicate device (K991484 - Airlife Bubble Humidifier, Allegiance Healthcare Corporation).

The core of the "study" was to demonstrate substantial equivalence through:

• Comparison of Intended Use: Both devices are intended to moisten breathing gases delivered directly to the patient for breathing.
• Comparison of Technological Characteristics: A table (Table Ib) is provided comparing components, materials (clear polypropylene for humidifier bottle, ABS for lid, brass/ABS for check valve and lid, PVC/PVC for filter tube/bulb), method of operation, accessory use, and single-patient use.
• Material Biocompatibility: The document states that the materials used are identical to the predicate and have been previously tested and accepted for biocompatibility, being widely accepted industry standards. Both devices are latex-free.
• Safety Features: Both devices include a safety valve (3 or 6-PSI for the submitted device) to alarm for kinks or blockages.
• Functional Testing: The conclusion states, "The successful testing demonstrated the device consistently performed within its design parameters," implying internal functional and engineering tests were conducted to ensure it operates as intended. However, details of these functional tests (e.g., flow rate consistency, humidification effectiveness, pressure relief accuracy) are not provided in this summary.

The "study" successfully concluded that the American Bantex Humidifier is "as safe and effective, and performs as well as, or better than, the predicated device." This conclusion led to the FDA's "substantial equivalence determination" and permitted the device to be marketed.

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The MS 4 Mini Scooter has been designed to help people who have a difficult time walking. The user must have use of hands and upper-body mobility. People who have some mobility, but cannot walk for long distances or people that may need crutches to walk will generally purchase this scooter. The MS 4 Mini Scooter is designed for both indoor and limited outdoor use in clean and dry conditions.

The American Bantex MS 4 Mini Scooter is a Class II device that also is intended to provide assistance to individuals that are unable to walk long distances. The rear-wheel drive and two wheel steering abilities allow the user to effortlessly control this device. The body (shell) is made of rigid Acrylonitrile-Butadiene-Styrene Copolymer. The shell is available to the consumer in two colors. The variable speed dial on the tiller column enables users single-handed operation while moving forward. The sealed (24 V) transaxle motor is quiet to operate. As with the predicate device, the MS 4 breaksdown into several components for easy, tool less assembly, disassembly and transportation.

The provided document describes a 510(k) premarket notification for the American Bantex MS 4 Mini Scooter, seeking substantial equivalence to a predicate device, the Mega Motion, Inc. - Mega 4 Scooter. This document focuses on demonstrating that the new device is as safe and effective as the predicate, rather than establishing de novo acceptance criteria through a clinical study with ground truth. Therefore, many of the requested data points related to a diagnostic device's performance study (like sample size for test sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or present in this submission.

However, based on the information provided, we can infer the "acceptance criteria" as the comparable specifications and safety/performance characteristics of the predicate device, and the "study" demonstrating that the MS 4 Mini Scooter meets these criteria is the performance testing and comparison against those specifications.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria are implicitly the specifications and performance of the predicate device, the Mega Motions, Mega 4 Scooter. The reported device performance is that of the American Bantex MS 4.

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

• Sample Size: Not applicable in the context of a 510(k) for a mobility device comparing specifications. The "test set" in this case refers to the single device being submitted (American Bantex MS 4 Mini Scooter) and its performance against predefined standards and the predicate device's specifications. It's not a statistical sample from a larger population for diagnostic accuracy.
• Data Provenance: The data comes from the applicant's internal testing and comparison to publicly available specifications of the predicate device. It is retrospective in the sense that the predicate device's data already exists, but the testing on the American Bantex MS 4 would have been conducted prospectively for this submission. The country of origin for the data is not explicitly stated beyond American Bantex Corporation being in California (and later Bountiful, Utah), but the testing methods refer to international standards (ANSI / RESNA, ISO).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Number of Experts: Not applicable. There is no "ground truth" expert consensus required for performance characteristics like speed, turning radius, or weight capacity. These are objectively measured specifications. For regulatory compliance and safety testing (e.g., ANSI/RESNA standards), the "experts" would be the accredited testing laboratories and their personnel.
• Qualifications of Experts: The document states that testing was done by "Independent Testing Services." The specific qualifications of the personnel at these services are not detailed, but it is implied they are competent to perform testing according to the cited standards.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. This type of submission does not involve clinical trial data requiring adjudication of patient outcomes or diagnostic interpretations. The "adjudication" is essentially the FDA's review of the submitted test results and comparison to the predicate device's specifications and relevant standards.

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

• Was it done?: No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the effect of an AI algorithm on their performance is being evaluated. The American Bantex MS 4 Mini Scooter is a physical mobility device, not a diagnostic tool.

6. Standalone Performance Study:

• Was it done?: Yes, in a sense. The "standalone" performance of the American Bantex MS 4 Mini Scooter was evaluated through various engineering and safety tests. The document states: "The evaluation and performance verification included performance testing in accordance with ANSI / RESNA WC/Vol. 2-1998, Section 21, Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters. The results of such testing as well as, certifications from upholstery testing, functional performance testing, stability (ISO 7176-1 & -2) and electrical immunity testing required by the FDA and European Agencies are included in this submission." This demonstrates the device's inherent performance characteristics.

7. Type of Ground Truth Used:

• Type of Ground Truth: The "ground truth" in this context refers to established engineering specifications, safety standards (like ANSI/RESNA, ISO), and the published specifications of the legally marketed predicate device. There is no pathology, expert consensus, or outcomes data used as ground truth for this type of device comparison.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. This refers to AI/machine learning models. The American Bantex MS 4 Mini Scooter is a mechanical and electrical device, not an AI-driven algorithm, so there is no training set in this context.

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

• How Established: Not applicable, as there is no training set for this type of device.

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The Tango Series Powered Wheelchairs are indicated to provide enhanced mobility to physically challenged persons/patients who are limited to a sitting position for various medical reasons. Some, but not all of the specific indications for use for powered wheelchairs are: paraplegia, muscular sclerosis, lower limb amputation, neurologic or other muscular diseases which render lower-limbs too weak or unstable for normal use or activity.

The Tango Powered Wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The two models are identical, except the frame. The BP1 has a steel frame and the BP1A has an aluminum frame. The wheelchair has four wheels, an adjustable seat with armrests, and a joystick controller for an attendant and the ability to disengage the wheel motor gear so that an attendant may use the chair as a free-wheel device. The automatic braking systems are an integral part of the controller and when the controller is released. Both models can be disassembled for easy transportation and reassembly and use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tango Powered Wheelchair, Models BP1 & BP1A:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K031711) for the Tango Powered Wheelchair does not explicitly list specific numerical acceptance criteria or performance metrics in a table format. Instead, it relies on substantial equivalence to predicate devices and compliance with voluntary standards.

However, based on the text, we can infer the general areas of "performance" that the manufacturer claims the device meets, primarily through equivalence.

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

The document explicitly states:

• "Comparative performance testing and clinical evaluations were not conducted nor submitted as part of this 510(k)."

This means:

• Sample Size for Test Set: Not applicable, as no comparative performance testing with a specific test set of users or data was conducted or submitted.
• Data Provenance: Not applicable, as no specific test data was generated for the Tango device to demonstrate performance against acceptance criteria directly. The substantial equivalence relies on the known performance and safety of the predicate devices and general compliance with standards.

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

• Not applicable. Since no specific performance testing or clinical evaluation with a test set was conducted for the device against specific ground truth, there was no need for experts to establish ground truth for such a test set.

4. Adjudication Method for the Test Set

• Not applicable. As no performance testing with a test set was conducted that required expert review or 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 device (powered wheelchair) is a purely mechanical/electrical device, not an AI-assisted diagnostic or interpretation tool. Therefore, an MRMC study related to human "readers" or AI assistance is irrelevant and was not performed.

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

• Not applicable. This device is a powered wheelchair and does not involve any algorithms or AI to be evaluated in a standalone manner.

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

• Not applicable directly for the Tango device. The "ground truth" in this 510(k) submission is effectively the established safety and effectiveness of the predicate devices and the compliance with recognized industry standards and guidance documents. The claim is that because the Tango is substantially equivalent in design and function to these, it inherently meets the same underlying "ground truth" of safety and effectiveness.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a "training set."

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

• Not applicable. As there is no training set for this device.

In summary, the K031711 submission for the Tango Powered Wheelchair relies on the concept of "substantial equivalence" to predicate devices and general compliance with recognized standards rather than conducting and presenting specific performance studies with acceptance criteria, test sets, or ground truth for the device itself. The FDA's clearance (DEC 18 2003) indicates that they accepted this approach for this Class II device.

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