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Batec is not intended for specific clinical use, but as a support to the mobility of active manual wheelchairs' users. It is designed to add auxiliary power to the manual wheelchair, increasing the mobility for the wheelchair's user. Therefore, bearing in mind the operating precautions described in this document, there is no need for professional, technical or aptitude requirements to operate or use a Batec device.

Batec devices are intended as add-on devices for wheelchairs, thus the intended user is a person with motor disability who needs of the wheelchair support for movement.

The Handbike Batec Electric is a handcycle mechanism that adapts to a manual wheelchair, forming a three-wheeled chair, allowing the user to move with the help of an electric motor located in the front wheel, optimizing the user's capabilities and increasing their autonomy.

Handbike Batec Electric aims to convert a manual wheelchair into an electrically propelled tricycle that allows the disabled collective to make larger and more complex movements and routes that can be made only with the manual wheelchair, increasing their independence and autonomy in daily life by performing recreational and sporting activities.

The operation of the Handbike Batec Electric is the same in all models, changing only the wheel size, maximum speed, and equipment. First the handbike must be coupled to the wheelchair. Once the two parts are attached, we will have a set consisting of three wheelchair seat, the transmission and traction on the front wheel. To operate the handbike, the transmission of the handbike must be operated by pedaling with the controls or by pressing the accelerator. In this way we will drive the front wheel with the manufactured product.

The device has two independent mechanical brakes (right and a parking brake. In addition. there is an automatic speed-limiting motor brake managed by software, which prevents exceeding 120% of the speed limit setting in each mode.

This document is a 510(k) Premarket Notification for the "Handbike Batec Electric." It seeks to establish substantial equivalence to a legally marketed predicate device, "Klick (Product Code ITI)."

The provided document describes a physical medical device (a powered add-on for manual wheelchairs), not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested criteria related to AI/SaMD performance studies (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone algorithm performance) are not applicable to this submission.

The acceptance criteria and proof of meeting those criteria for this non-SaMD device primarily rely on compliance with established performance standards and comparison to a predicate device.

Here's an analysis of the provided information based on the typical requirements for a physical medical device 510(k) submission:

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

The document doesn't present a formal "acceptance criteria" table in the way one might see for an SaMD with performance metrics like sensitivity, specificity, or AUC. Instead, it demonstrates compliance through non-clinical testing against recognized standards and a detailed comparison table with the predicate device. The "reported device performance" is implied by its adherence to these standards and the equivalence shown in the comparative table.

Here's a summary derived from the "SUMMARY OF COMPARISON WITH PREDICATE DEVICE" table and "SUMMARY DISCUSSION OF NON-CLINICAL DATA":

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

This information is not applicable in the context of this 510(k) submission, as it relates to the evaluation of a physical device against performance standards and comparison to a predicate, not to a data-driven or AI/SaMD evaluation. The tests performed are engineering/bench tests on the device itself, not on a dataset of patient information. No patient data or clinical data is mentioned for testing.

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 here. "Ground truth" in the context of medical devices like this typically refers to validation against established physical properties, engineering specifications, and safety standards, not interpretation by medical experts.

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

This is not applicable. Adjudication methods are relevant for subjective medical image interpretation or clinical outcomes, not for objective physical device testing against 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

This is not applicable. MRMC studies are for evaluating diagnostic performance of AI or imaging technologies with human readers, which is not the nature of this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical device, not an algorithm. However, the document does state that non-clinical testing was performed to demonstrate conformance to specifications and requirements. This is equivalent to "standalone" testing for a physical device.

The document lists the following standards for non-clinical testing:

• ISO 7176-1:2014, ISO 7176-2:2017, ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2008, ISO 7176-6:2018, ISO 7176-8:2014, ISO 7176-9:2009, ISO 7176-10:2014, ISO 7176-11:2012, ISO 7176-13:1989, ISO 7176-14:2008, ISO 7176-15:2014, ISO 7176-21:2009 (Wheelchairs)
• IEC 60601-1-2:2014 + A1:2020 (Medical electrical equipment)
• IEC 62133-2 Edition 1.0 2017-02 (Lithium batteries)

These tests are the "study" that proves the device meets the (implicit) acceptance criteria of safety and performance as defined by these consensus standards and substantial equivalence to the predicate.

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

For this physical device, "ground truth" is defined by:

• Engineering specifications and design requirements: The device's components and measurements are designed to meet certain performance metrics.
• International Consensus Standards (ISO/IEC): These standards define acceptable performance, safety, and durability criteria for wheelchairs and their components.
• Comparison to Predicate Device: The predicate device, having already been cleared by the FDA, serves as a benchmark for acceptable safety and effectiveness.

8. The sample size for the training set

This is not applicable. This refers to machine learning algorithms, which are not part of this device.

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

This is not applicable. This refers to machine learning algorithms, which are not part of this device.

In summary:

The "study" proving the Handbike Batec Electric meets its acceptance criteria is a series of non-clinical bench and engineering tests performed according to recognized international consensus standards (listed in point 6), and a direct comparison of its design, intended use, and technical specifications to a previously cleared predicate device. The acceptance criteria are implicitly defined by compliance with these standards and demonstrated substantial equivalence to the predicate, ensuring its safety and effectiveness for its intended use. No clinical data or human-in-the-loop performance studies were deemed necessary for this 510(k) submission.

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