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The LERADOTECH SC scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

The LERADOTECH SC scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.

The provided text pertains to a 510(k) premarket notification for a medical device, the LERADOTECH SC scooter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study proving performance against explicit acceptance criteria in the manner typically seen for novel diagnostic or therapeutic devices.

Therefore, the information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set ground truth) is not applicable to this type of regulatory submission for a scooter. The "study" here is primarily a comparison to a predicate device and adherence to performance standards, not a clinical trial with human subjects in the traditional sense.

Let's break down what is available and how it relates to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the performance characteristics of the predicate device (AVANTICARE SA4022) and compliance with relevant industry performance standards. The "reported device performance" for the LERADOTECH SC is its specifications, which are compared against the predicate.

Study Description and How Acceptance Criteria Are Met

The "study" presented is a substantial equivalence comparison and adherence to recognized performance standards. The sponsor (LERADO CHINA LIMITED) asserts that the LERADOTECH SC scooter is substantially equivalent to the AVANTICARE SA4022 (K051538) manufactured by the same company.

The mechanism for meeting "acceptance criteria" is two-fold:

1. Direct Comparison to Predicate: The LERADOTECH SC's specifications are compared feature-by-feature to the predicate device. Where there are differences (e.g., battery capacity, wheel size, maximum loading, motor output, specific controller model), the sponsor explicitly states that these "do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness." In some cases, the new device exhibits improved specifications (e.g., higher maximum loading, higher motor output, additional safety features like a hand brake, or convenience features like a battery level indicator or foldable armrest).
2. Compliance with Recognized Performance Standards: The device has been tested against and meets the applicable performance requirements specified in a list of international and national standards:
   • ANSI/RESNA WC/Vo1.1 section 1-1998 / ISO7176-1-1999 (Determination of static stability)
   • ANSI/RESNA WC/Vo1.1 section 6-1998 / ISO7176-6-2001 (Determination of max speed, acceleration and deceleration of electric wheelchair)
   • ANSI/RESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003 (EMC of powered wheelchairs and motorized scooters)
   • CISPR 11-1990 (Industrial, scientific and medical (ISM) Radio-Frequency equipment - electromagnetic disturbance characteristics - limits and methods of measurement)
   • IEC 61000-4-2-1995 (EMC - Electrostatic discharge immunity test (ESD))
   • IEC 61000-4-3-1995 (EMC - Radiated, RF, electromagnetic field immunity test)
   • California Bureau of Home Furnishings 116 (Flammability Standards)

By demonstrating substantial equivalence to a legally marketed predicate and showing compliance with these recognized safety and performance standards, the device is deemed to meet the necessary "acceptance criteria" for market clearance in a 510(k) context.

Not Applicable/Not Provided Information for this Type of Device Submission:

As mentioned, most of the specific clinical study-related questions are not relevant here because this is a mechanical mobility device, not an AI/diagnostic/therapeutic device requiring clinical validation in the same way.

• 2. Sample size used for the test set and the data provenance: Not applicable. Performance is based on engineering testing to standards and comparison of specifications. No "test set" of patient data is used in this context.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for engineered performance is defined by the standards and the predicate device's specifications.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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/diagnostic device.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-based device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the technical performance aspects, the "ground truth" is established by the specifications of the predicate device and the test limits/methodologies defined in the cited national and international performance standards (e.g., for stability, speed, EMC, flammability).
• 8. The sample size for the training set: Not applicable. No training set as this is not a machine learning device.
• 9. How the ground truth for the training set was established: Not applicable.

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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The LERADOTECH Scooter, SB is an indoor / outdoor Electrical Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

The provided 510(k) summary for the LERADOTECH Scooter, SB details a submission for a power mobility device, like an electric scooter, and therefore does not have acceptance criteria or associated studies in the way that an AI/ML medical device would. The information provided heavily focuses on demonstrating "substantial equivalence" to a predicate device, as is customary for 510(k) submissions.

Here's why the requested information cannot be fully provided from the given document:

• Type of Device: The LERADOTECH Scooter, SB is a physical medical device (an electric scooter), not an AI/ML algorithm or software. The concepts of "acceptance criteria," "test set," "ground truth," "MRMC study," and "training set" are primarily relevant to the evaluation of AI/ML-based medical devices or diagnostic tools.
• Regulatory Pathway (510(k)): The 510(k) pathway for traditional medical devices primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This involves comparing technical characteristics, indications for use, and performance data to show the new device is as safe and effective as the predicate. It does not typically involve the rigorous clinical performance studies (like multi-reader multi-case studies or standalone algorithm performance) that are common for AI/ML devices.

However, I can extract and interpret the information related to performance testing as described for this type of device, which serves a similar function to demonstrating that the device meets certain standards.

Interpretation and Information Extraction Based on the Provided Document:

Given the context of a 510(k) for an electric scooter, the "acceptance criteria" can be interpreted as compliance with relevant industry standards and safety certifications. The "study" refers to the performance testing conducted to meet these standards.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Substantial Equivalence and Performance Aspects (Not "Acceptance Criteria" in the AI/ML sense):

The document primarily focuses on demonstrating substantial equivalence to the COMFORT Scooter LY-EW415 (K063032). Key comparisons made include:

• Intended Uses: Same.
• Warranty Period: Same.
• Electronic Systems: Both passed UL certification; same controller and switching power supplier.
• Back Upholstery: Same material, passed resistance ignition test by SGS.
• Differences (Agreed Not to Affect Safety/Effectiveness):
  • Tire size
  • Weight limit
  • Weight capabilities
  • Smaller/more agile dimensions (leads to smaller turning radius and safe climbing angle)
  • Maximum speed: New device 6.0 mph vs. predicate 5.0 mph (both under 6 mph limit, speeds adjustable).
  • Cruising range: New device 36 km vs. predicate 75 km (due to smaller batteries, real range depends on environment, deemed substantially equivalent).

Regarding the remaining specific questions (2-9), these are not applicable to the provided document for the following reasons:

• 2. Sample sized used for the test set and the data provenance: Not applicable. Performance testing for an electric scooter involves physical testing against standards, not a "test set" of data in the AI/ML context. Physical testing would be conducted on a representative sample of the manufactured device. Data provenance (country of origin, retrospective/prospective) is typically for clinical data used in studies, which is not described here.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in this context would be whether the device physically meets a standard (e.g., does it emit less than X radiation per CISPR 11). This is determined by instrumental measurement and trained technicians/engineers, not clinical experts establishing diagnostic "ground truth."
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are for resolving discrepancies in expert interpretations, which is not part of an electric scooter's performance testing for regulatory submission.
• 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 specific to AI/ML devices that assist human interpretation or diagnosis.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is specific to AI/ML algorithms.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance would be the physical properties and functionality measured against engineering and electrical safety standards.
• 8. The sample size for the training set: Not applicable. There is no "training set" for a physical device like an electric scooter.
• 9. How the ground truth for the training set was established: Not applicable, as there is no training set.

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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The LERADO Power Wheelchair, PB is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

The provided text is a 510(k) summary for the LERADO Power Wheelchair, PB. It does not describe an AI/ML powered medical device, but rather a traditional powered wheelchair seeking substantial equivalence to a predicate device. Therefore, much of the requested information regarding acceptance criteria for an AI/ML device and specific study details (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not applicable or present in this document.

However, I can extract information related to the device's performance testing and comparison to the predicate device to infer some "acceptance criteria" through the lens of substantial equivalence.

Here's the closest interpretation of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable or not specified in the document. This is not an AI/ML device where a 'test set' of data would be used to evaluate an algorithm's performance. The "test set" here would refer to the physical device undergoing performance testing.
• Data Provenance: The device underwent performance testing according to international standards (listed above). The document doesn't specify if these tests involved human subjects or specific data sets in the way an AI/ML study would. It refers to the testing of the physical wheelchair.

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

• Not applicable. This is a traditional device. The "ground truth" is established by the specifications and performance standards themselves, not by expert consensus on data interpretation.

4. Adjudication method for the test set

• Not applicable for the type of device and submission. Adjudication methods like 2+1 or 3+1 are typically used for expert review of medical images or other complex data where varying interpretations are possible to establish a consensus ground truth, which is not relevant here.

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 is not an AI/ML device, and no MRMC study was performed or is relevant for this type of submission.

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

• No. This is not an AI/ML device.

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

• The "ground truth" for this device's performance is established by engineering and safety standards (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3, UL certification) which the device is tested against. The claim of substantial equivalence is based on meeting these standards and having similar performance characteristics to a legally marketed predicate device.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable. As there is no training set for an AI/ML model, there is no ground truth to be established for such a set.

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The AVANTICARE SA4021 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

The AVANTICARE SA4021 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.

The provided text K060068 is a 510(k) summary for a medical device called AVANTICARE SA4021 scooter. It outlines the device description, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with performance evaluations for AI/software-based medical devices.

The document is for a physical medical device (an electric scooter) and the provided information focuses on regulatory classification and substantial equivalence to legally marketed devices based on inherent technical specifications and intended use, rather than performance metrics from a clinical study or benchmark testing.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them because the provided text does not contain this information.

Specifically, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human reader improvement with AI.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The LERADO, AVANTICARE Electrical Scooter SM3021 is an indoor / outdoor Electrical Scooter that is battery operated. It has a base with three-wheeled The movement of the Wheelchair is controlled by the rider who uses with a seat. hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

This document is a 510(k) summary for the LERADO, AVANTICARE Electrical Scooter, SM3021. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria.

Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies cannot be fully extracted as they are not explicitly present in the provided text.

Based on the available information:

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

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

This information is not provided in the document. The document describes a substantial equivalence comparison, not a clinical study with a test set of users. The performance testing section lists compliance with specific electrical and mechanical standards, which would involve testing the device itself, not a "test set" of patient data.

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 information is not provided. The assessment relies on engineering and regulatory compliance, not expert clinical ground truth for a test set.

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

This information is not provided. This concept is not applicable to the type of safety and performance testing described.

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 information is not provided. An MRMC study is not relevant to an electrical scooter. The document does not mention any AI component or human readers/interpreters.

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

This information is not provided. This concept is not applicable to an electrical scooter.

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

The "ground truth" in this context is the compliance with published industry standards and specifications (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995) and the specifications of the predicate device. The document states that the electronic components were "all passed by the UL certificated," indicating adherence to safety standards.

8. The sample size for the training set

This information is not provided. There is no "training set" in the context of an electrical scooter.

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

This information is not provided as there is no training set involved.

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The AVANTICARE SA4022 scoter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated po lition.

The AVANTICARE SA4022 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.

The provided text is a 510(k) summary for the AVANTICARE SA4022 scooter, a motorized three-wheeled vehicle. The document explicitly states that there are minor differences in performance specifications between the AVANTICARE SA4022 scooter and its predicate device, the Bewell SC 20 (K043326). However, the submission asserts that "these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness."

Crucially, the provided document does not contain explicit acceptance criteria or a detailed study demonstrating that the device meets specific performance criteria. The basis for substantial equivalence is the assertion that any differences in performance specifications are minor and do not impact safety or effectiveness.

Therefore, many of the requested details cannot be extracted from this document.

Here's an attempt to answer based on the provided text, with clear indications where the information is not present:

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

   Acceptance Criterion	Reported Device Performance
   Not explicitly stated in the document. The submission focuses on substantial equivalence to a predicate device rather than specific performance metrics.	"minor differences in performance specifications" compared to Bewell SC 20 (K043326). These differences are asserted not to alter intended function/use or raise new safety/effectiveness questions.

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

   • Sample size: Not specified.
   • Data provenance: Not specified.

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 information is not applicable and not present in the document. The substantial equivalence argument is based on comparing device specifications and intended use against a legally marketed predicate device, not on clinical performance evaluated by experts against a ground truth.

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

   • Not applicable and not present.

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 and not present. This device is a mobility scooter, not an AI-assisted diagnostic tool.

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

   • Not applicable and not present.

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

   • Not applicable. The "ground truth" in this context is the predicate device's established safety and effectiveness, implied by its legal market status.

8. The sample size for the training set

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

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

   • Not applicable and not present.

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