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

KP-10.3S is meant to provide mobility to persons who are not able to walk, stand or use a manual wheelchair, but who are very well able to control and use the interface of an electrically powered wheelchair is not suitable for persons who do not have the cognitive skills to drive an electrically powered wheelchair by themselves. Also, it is not suitable for visually impaired persons. This wheelchair is suitable for users up to 264 lbs. (120 kg) in weight.

KP-10.3S is classified as a class B mobility product for indoor and outdoor use. It also has an extremely durable steel frame with tough components and does not suffer in dramatic extremes of temperature (neither the operator nor the attendant need touch metal parts in normal use). The compact size of this wheelchair, the excellent speed range and battery capacity makes the wheelchair suitable for both indoor and outdoor use. The KP-10.3S can be disassembled into four parts easily and can also be quickly assembled, which is convenient for storage and transportation.

The powered wheelchair KP-10.3S is an affordable rear wheel drive power chair. It features the patented S-Ergo Seating System and promotes a comfortable seating and a good posture. The device is powered by two 12 volt / 22 Ah lead acid batteries with 8.75 miles travel range that can be recharged by an off-board battery charger that can be plugged into an AC outlet (100 -240 V, 50-60 Hz), when the device is not in use.

Compact design makes it ideal for confined spaces mobility and short distance journey. The 36 inches turning radius for easy entry and exit of small elevator, making indoor activity effortless. It is tool-free disassembly, and can be easily placed in a car trunk, making travel possible and simple.

There are flip-back and height adjustable armrest, swing-away detachable footrest for KP-10.3S, and tool-free inclination angle adjustable backrest (15° - 27°) for KP-10.3S. The optional quick release steering controller enables maneuvering switches from the user to the attendants in seconds. The user can activate the joystick to move in the direction of the joystick is actuated. When the user releases the joystick, the device slows to stop and the brakes are automatically re-engaged. The maximum weight capacity of KP-10.3S is 264 lbs and its maximum speed is 3.75 mph.

This document describes the Karma Powered Wheelchair, KP-10.3S, and its substantial equivalence to a predicate device, Comfort Powered Wheelchair, Traveler LY-EB103 (K030356). The document focuses on demonstrating that the new device is as safe and effective as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the KP-10.3S are implied by its compliance with various ISO 7176 standards, which are internationally recognized test methods for wheelchairs. The "device performance" in this context refers to the successful completion of these tests, demonstrating that the KP-10.3S meets the safety and effectiveness requirements outlined by these standards.

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

The document does not specify the exact sample sizes (number of devices) used for the non-clinical performance tests for the KP-10.3S. The tests appear to be conducted on the Karma Powered Wheelchair, KP-10.3S itself. The data provenance is implied to be from the manufacturer (Karma Medical Products Co., Ltd. in Taiwan), and the studies are understood to be prospective testing conducted specifically for this submission, as they refer to "the data generated from each test in the ISO 7176 series test reports of the subject device."

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

For non-clinical performance tests such as those specified by ISO and RESNA standards, "ground truth" is established by the standardized test methods themselves and the specified criteria for passing those tests. There isn't typically a panel of human experts in the medical sense to establish ground truth for mechanical and electrical performance. The "experts" are the engineers and technicians who perform the tests according to the standards and interpret the results against the defined acceptance thresholds. Their qualifications would involve expertise in test procedures, equipment operation, and understanding of the relevant ISO/RESNA standards. The document does not explicitly state the number or specific qualifications of these individuals but implies their involvement through the successful completion of the tests.

4. Adjudication Method for the Test Set

Not applicable. For non-clinical performance tests, adjudication (like 2+1 or 3+1 consensus among experts) is not typically used. The results are objectively measured against predefined technical specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The Karma Powered Wheelchair is a physical medical device for mobility, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is irrelevant to this device.

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

Not applicable. The Karma Powered Wheelchair is a physical device, not an algorithm. Its performance is evaluated through physical and electrical testing according to international standards.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the non-clinical performance tests is based on objective measurements and predefined acceptance criteria as established by recognized international and national standards (ISO 7176 series and RESNA WC-2). For biocompatibility, the ground truth is established by comparison to previously cleared predicate device materials with established biocompatibility, assuming identical formulation, processing, sterilization, and geometry for patient-contacting parts.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning algorithm, and thus does not involve 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, there is no ground truth to be established for it.

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

The KARMA Manual Wheelchair, S-Ergo 305 & S-Ergo 105 are indoor / outdoor wheelchairs that have the base with four-wheeled with a seat. The devices can be disassembled for transport and it is foldable easily. Back upholstery material is also the same resistance-ignitability fabric.

This 510(k) premarket notification for the KARMA Manual Wheelchair, S-Ergo 305 & S-Ergo 105, focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria for a complex clinical outcome. The "acceptance criteria" here are the performance requirements of recognized standards, which the device is declared to meet.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific numerical outcomes for each test within these standards. It simply states that the devices meet the applicable requirements. The core of this 510(k) is a comparison to a predicate device, not a novel clinical study for the subject device.

Study Details:

This submission is a premarket notification (510(k)) that relies on performance testing against recognized standards and comparison to a legally marketed predicate device to establish substantial equivalence. It is not a clinical study in the typical sense of evaluating a device's performance in a patient population to determine specific clinical acceptance criteria. Therefore, many of the requested study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set) are not applicable to this type of regulatory submission.

Specifically:

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

   • Sample Size: Not explicitly stated as a "test set" in the context of human data. For mechanical performance testing, the sample size would typically refer to the number of wheelchairs tested to meet the ANSI/RESNA and ISO standards. This specific number is not provided in the summary.
   • Data Provenance: Not applicable for a human data test set. The performance testing was conducted by KARMA Medical Products Co., Ltd. (Taiwan, R.O.C.) against international standards for mechanical wheelchairs.

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

   • Not Applicable. The "ground truth" for this type of submission is the adherence to established engineering and performance standards (ANSI/RESNA, ISO 7176) for mechanical wheelchairs. There is no expert clinical review of "cases" to establish ground truth in this context.

3. Adjudication method for the test set:

   • Not Applicable. There is no clinical test set requiring adjudication in this regulatory summary.

4. 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 a mechanical wheelchair. MRMC studies, AI assistance, and "human readers" are not relevant to this device or its regulatory pathway.

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

   • Not Applicable. This is a mechanical device, not an algorithm.

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

   • The "ground truth" (or basis for acceptance) is the conformance to established international performance standards for wheelchairs (ANSI/RESNA WC Vol. 1 and ISO 7176) and the demonstration of substantial equivalence to a legally marketed predicate device (WH Convertible Lightweight Wheelchair, WHL100 - K060251) based on intended use, technology, and safety/effectiveness profiles.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" in the context of an algorithm or AI for this mechanical device.

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

   • Not Applicable. As there is no training set mentioned or implied for this device, this question is not relevant.

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

The KARMA Manual Wheelchair, Budget 800 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. Back upholstery material is also the same resistance-ignitability fabric.

Here's an analysis of the provided text regarding the KARMA Manual Wheelchair, Budget 800, focusing on acceptance criteria and supporting studies:

Acceptance Criteria and Study for KARMA Manual Wheelchair, Budget 800

Based on the provided document, the KARMA Manual Wheelchair, Budget 800 demonstrates compliance by meeting established performance standards.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. The document refers to "Performance Testing" indicating a device or devices were tested, but does not specify the number of units or the specific test protocols followed beyond citing the standards.
• Data Provenance: Not explicitly stated beyond the fact that the testing was performed, presumably by or for the manufacturer, KARMA Medical Products Co., Ltd., based in Taiwan, R.O.C. The document does not specify if the tests were conducted retrospectively or prospectively.

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

• This type of information is not applicable to this device and its regulatory submission. The "ground truth" for a mechanical device like a wheelchair is established by standardized performance tests (e.g., durability, stability, strength, static loads) against international and national engineering standards (ANSI/RESNA WC Vol. 1, ISO 7176). There is no "expert consensus" on diagnostic images or clinical outcomes required to determine if a wheelchair meets mechanical safety and performance criteria.

4. Adjudication Method for the Test Set:

• This concept is not applicable to this device. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or evaluations of subjective interpretations (e.g., reading medical images) where multiple experts might disagree on an outcome and a method is needed to reach a definitive "ground truth." For mechanical performance testing, the results are typically quantitative and objective measurements against defined pass/fail criteria in a standard.

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

• No MRMC study was performed or is relevant for this device. An MRMC study is used to assess the change in diagnostic performance of human readers (e.g., radiologists) when assisted by an AI algorithm, compared to reading without AI. This is a mechanical device, not a diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

• No standalone algorithm performance study was performed or is relevant for this device. This is a mechanical wheelchair; there is no embedded algorithm requiring standalone performance evaluation.

7. Type of Ground Truth Used:

• The "ground truth" for this device's performance is established by objective measurements and observations against the pass/fail criteria defined in the referenced standards: ANSI/RESNA WC Vol. 1 and ISO 7176 Wheelchair Standards. These standards quantify safety, durability, static strength, impact resistance, stability, and other mechanical aspects.

8. Sample Size for the Training Set:

• Not applicable. This is a mechanical device, not an AI/ML algorithm that requires a "training set" of data.

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

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

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

The KARMA Scooter KS747.2 is an indoor / outdoor Powered 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.

This document describes a 510(k) submission for the KARMA Scooter, KS747.2, an electrical scooter. The information provided focuses on the device's substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and performance metrics typically associated with AI/software devices. Therefore, much of the requested information regarding AI device evaluation cannot be extracted from this document.

Here's an analysis of the provided text in relation to your request:

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

The document does not provide a table of acceptance criteria for specific performance metrics (e.g., accuracy, sensitivity, specificity) of the KARMA Scooter. Instead, it relies on demonstrating substantial equivalence to a predicate device, the WELL SUCCESS A&I Scooter, SC-402 (K041193).

The "performance testing" mentioned is related to safety and electrical standards, not functional performance metrics in the way you might expect for an AI device.

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 and not provided in the document as it describes a hardware device submitting for substantial equivalence based on engineering and safety testing, not a clinical study or AI performance evaluation with a "test set" of 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 applicable and not provided. The "ground truth" for this device's submission is its adherence to established safety standards and its functional equivalence to a predicate device, not, for example, expert consensus on disease diagnosis which would be relevant for an AI system. The "experts" involved would likely be engineers, safety testers, and regulatory compliance specialists.

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

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies involving human interpretation or AI output, which is not the nature of this 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

This information is not applicable and not provided. An MRMC study is relevant for evaluating the impact of AI assistance on human performance in diagnostic tasks. The KARMA Scooter is a mobility device, not a diagnostic AI system.

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

This information is not applicable and not provided. "Standalone performance" refers to the performance of an AI algorithm independent of human interaction. The KARMA Scooter is a physical device controlled by a human, not an algorithm, so this concept does not apply.

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

The "ground truth" implicitly used for this submission is:

• Adherence to recognized performance and safety standards: ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995.
• Demonstration of equivalence in critical specifications and materials to the predicate device, WELL SUCCESS A&I Scooter, SC-402 (K041193), which itself would have met relevant standards and safety requirements. This involves direct comparison of specifications and material certifications (e.g., UL certification for electronic systems, SGS test for back upholstery ignition resistance).

8. The sample size for the training set

This information is not applicable and not provided. "Training set" refers to data used to train an AI model.

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

This information is not applicable and not provided. This concept is specific to AI/machine learning development.

In summary: The provided document is a 510(k) summary for a physical medical device (an electrical scooter). Its acceptance criteria are based on demonstrating substantial equivalence to an existing legally marketed predicate device and conformance to safety and performance standards. The study described focuses on these aspects rather than on the type of AI/software performance evaluation queries you've asked.

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

The KARMA Power Wheelchair, KP-25 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.

Here's a breakdown of the acceptance criteria and the study details for the KARMA Power Wheelchair, KP-25, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full de novo clinical study with extensive acceptance criteria and detailed performance statistics. Therefore, the information available is limited to what's typically required for a 510(k) submission.

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., speed, range, turning radius, battery life) with corresponding target values. Instead, the "acceptance criteria" are implicitly met by demonstrating compliance with recognized standards and substantial equivalence to a legally marketed predicate device.

Study Details

The provided document describes a bench and engineering testing approach to demonstrate substantial equivalence, rather than a clinical study with a test set of data, human readers, or ground truth developed by experts.

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

   • No "test set" of patient data is mentioned in the context of a clinical study.
   • The "test set" for performance testing refers to the physical device itself. The tests were performed on the KARMA Power Wheelchair, KP-25.
   • Data Provenance: The testing appears to be conducted in a laboratory/engineering setting, likely by KARMA Medical Products Co., Ltd. or contracted testing facilities (e.g., UL, SGS). The manufacturer is in Taiwan, R.O.C., so the testing likely occurred there or by international certification bodies. The document does not specify whether the data is retrospective or prospective, but in the context of device performance testing against standards, it would be prospective data generated specifically for the submission.

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

   • Not applicable. There's no "ground truth" established by clinical experts for a test set in this type of submission. Ground truth for engineering tests is typically defined by the specified parameters and methodologies within the adopted standards (e.g., a certain current, a specific speed measurement, a strength test).

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

   • Not applicable. There's no adjudication process as described for clinical interpretation. The performance testing against standards involves objective measurements and pass/fail criteria as defined by the standards.

4. 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 a medical device (power wheelchair), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI are not relevant.

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

   • Not applicable. This device does not feature an algorithm that would be tested in a standalone capacity.

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

   • The "ground truth" for the device's performance is objective measurements against engineering standards (e.g., EMC compliance, structural integrity, speed). This is determined by the test methodologies of standards like ANSI / RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, and IEC61000-3-3, and independent certification bodies like UL and SGS.

7. The sample size for the training set:

   • Not applicable. There is no machine learning or AI component requiring a training set mentioned in this submission.

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

   • Not applicable (as above).

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