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The LSC offers electrically powered seated and standing mobility to users with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.

The LSC is a powered standup wheelchair. It is propelled and steered by varying the speed of the two back wheels. Front castors support the front of the caain and allow indirect steering through the turning back wheels. An electric lineanan anot system puts the seat into a seating or standing position.

The provided document describes the LSC device, a powered standup wheelchair, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/ML medical device submission.

This document is a 510(k) summary for a physical medical device (a wheelchair). The Acceptance Criteria and Study sections below are tailored to what is presented in the document regarding the device's conformity to standards and safety/effectiveness, rather than AI-specific performance metrics.

Here's the information extracted and interpreted based on the provided text:

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

For the LSC powered standup wheelchair, the "acceptance criteria" are the specific requirements and test methods outlined in various EN and ISO standards for wheelchairs. The "reported device performance" is the successful completion of tests according to these standards, as stated: "To approve the performance of the LSC, tests according to current applicable standards where performed at test-laboratories of European notified bodies."

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 explicitly detailed in the provided 510(k) summary for each specific test mentioned. For physical devices, compliance with standards often involves testing a specific number of units from a production batch, rather than data sets in the AI/ML context. The tests were performed "at test-laboratories of European notified bodies," implying European provenance. The nature of these tests (e.g., fatigue, stability, brake effectiveness) suggests a controlled laboratory environment.

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 to the type of device and testing described. The "ground truth" here is objective physical measurements and adherence to engineering and safety standards, performed by qualified personnel at accredited test laboratories, not by medical experts establishing diagnostic ground truth.

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

Not applicable. The tests are based on objective performance metrics against established standards, not on expert consensus or adjudication of subjective 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. This is a physical medical device (wheelchair), not an AI/ML diagnostic or assistive tool for human readers. No MRMC study was performed.

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

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

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

The "ground truth" for this device's performance is adherence to established international and European standards (EN and ISO) for wheelchairs, which involve objective physical measurements, mechanical stress tests, electrical component tests, and biological safety evaluations.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. As above, this is a physical medical device and does not involve a training set or corresponding ground truth establishment in the AI/ML sense.

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The LSA Helium offers seated and standing mobility to users with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.

The LSA Helium is a manually propelled standup wheelchair. It is propelled and steered by varying the speed of the two back wheels. Front castors support the front of the chair and allow indirect steering through the turning back wheels. A gas-spring-system supports the customer in putting the seat manually into a seating or standing position.

The provided document describes a 510(k) premarket notification for a medical device, the LSA Helium manually propelled standup wheelchair. This document focuses on demonstrating substantial equivalence to a predicate device, not on proving new clinical efficacy or performance beyond established safety standards. Therefore, many of the typical "acceptance criteria" and "study" components you'd expect for a novel AI/software medical device are not applicable here.

Here's a breakdown based on the information provided, highlighting the differences:

The "acceptance criteria" in this context refer to compliance with internationally recognized safety and performance standards for wheelchairs, rather than specific performance metrics for an AI algorithm. The "study" is the battery of non-clinical tests performed to meet these standards.

1. Table of Acceptance Criteria (Standards) and Reported Device Performance (Compliance):

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

• Sample Size: Not explicitly stated in terms of number of devices tested for each standard. The phrasing "tests according to current applicable standards where performed at test-laboratories" implies that the device (or representative samples) underwent testing as prescribed by these standards, which typically involve specific sample sizes or test configurations defined within the standard itself.
• Data Provenance: The tests were performed at "test-laboratories of European notified bodies." This indicates an external, accredited testing facility within Europe. The tests are non-clinical (i.e., not involving human subjects).

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

• Not applicable. This pertains to an AI/software device where ground truth is typically established by human experts reviewing medical images or patient data. For a physical medical device like a wheelchair, "ground truth" refers to the objective physical measurements and mechanical properties as defined by the engineering standards. The "experts" are the technicians and engineers at the notified body laboratories who conduct the tests according to the standard protocols. Their qualifications are inherent in the accreditation of the notified body.

4. Adjudication Method for the Test Set:

• Not applicable. This term is usually relevant for clinical studies or AI performance evaluations where there can be disagreement among reviewers or a need for a consensus mechanism. For compliance with engineering standards, the results are typically objective measurements against defined pass/fail criteria.

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 type of study is specifically for evaluating the impact of AI on human reader performance, usually in diagnostics. The LSA Helium is a physical mobility device and does not involve "human readers" or "AI assistance" in this context.

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

• Not applicable. As an entirely mechanical device, there is no "algorithm" to be evaluated in a standalone manner.

7. The type of ground truth used:

• Engineering Standards and Objective Measurements: The "ground truth" for this device's compliance is defined by the specific parameters, test methods, and acceptance limits outlined in the referenced EN and ISO standards (e.g., static stability, brake effectiveness, dimensions, strength, flammability). The tests yield objective, measurable data that is compared against these predetermined criteria.

8. The sample size for the training set:

• Not applicable. This is a non-AI/ML device. There is no "training set" in the context of an algorithm learning from data. The device itself is designed and manufactured, and then tested for compliance.

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

• Not applicable. As above, there is no training set.

Summary of the Study:

The "study" described is a series of non-clinical performance tests conducted to demonstrate that the LSA Helium manually propelled standup wheelchair meets internationally recognized safety and performance standards for such devices. These tests were performed by accredited European notified bodies. The purpose was to show substantial equivalence to a legally marketed predicate device (LEVO Active Easy, K971873) by demonstrating compliance with established (non-AI/ML specific) medical device standards. Clinical tests were explicitly stated as NOT performed.

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The LSC Lifestand Compact offers electrical powered seated and standing mobility to users with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.

The LSC Lifestand Compact is a powered standup wheelchair. It is propelled and steered by varying the speed of the two back wheels using independent motors. Front castors support the front of the chair and allow indirect steering through the turning hack wheels. The system is controlled with a standard e-fix wheelchair controller, with direct user operation through standard wheelchair joystick. Two high quality maintenance-free watertight rechargeable electrolyte gel batteries, connected in series, supply the energy for the system. A Lincar actuator drives the seat into seating or standing position. Another linear actuator drives the backrest into an individual seating-inclination. Both linear actuators are also direct user operated through the standard wheelchair ion: Dots.

Chassis: Rigid, made from treated steel with epoxy resin paint
Tibia support: adjustable in height and inclination
Seat: Depth adjustable with cushion
Backrest: electrically adjustable
Armrest: Retractable, can be converted to adjustable chest support
Footrest: Height can be adjusted
Upholstery: Fire-resistant (M4), washable fabric
Front wheels: diameter 7" x 1 3/4"
Rear wheels: diameter 12 1/2" x 2 1/4"
Brakes: manual by pushing and electromagnetic in the back wheels
User weight: max. 120kg
Idle weight: 76kg
Batteries: 2x12V, 17Ah, watertight rechargeable electrolyte gel batteries
Driving-motor: e-fix by Ulrich Alber GmbH + Co. KG – Germany, 24V DC
Linear actuator seat: Linac LA 31.1
Linear actuator back: Linac 314210

The provided document describes a 510(k) premarket notification for the LSC Lifestand Compact, an electrically powered standup wheelchair. The submission focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized standards and non-clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of non-clinical tests performed on the LSC Lifestand Compact. The document states: "The following tests where performed on the LSC standup wheelchair to approve its safety" and then lists a comprehensive set of national and international standards related to electrically powered wheelchairs, general technical aids for disabled persons, and various aspects of safety, performance, and electromagnetic compatibility.

The implicit finding from this submission is that the LSC Lifestand Compact successfully met the requirements of all listed standards, thereby demonstrating its safety and effectiveness for its intended use, and establishing substantial equivalence to the predicate device.

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

• Sample Size for Test Set: The document does not explicitly state the sample size of the LSC Lifestand Compact devices used for these non-clinical tests. Typically, for such product safety and performance testing against standards, a representative sample (often one or a few units) of the manufactured device is subjected to the tests.
• Data Provenance: The tests are non-clinical, meaning they were performed on the device itself, not on human subjects. The company is based in France ("Lifestand Rond Point de Rosarge 40, rue Palverne F-01700 Les Echets - France"), suggesting the testing may have occurred in Europe or by laboratories accredited to perform these standards. The data is retrospective in the sense that the testing was completed prior to the 510(k) submission.

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

These are non-clinical engineering and performance tests, not clinical studies involving expert interpretation of data like medical imaging. Therefore, the concept of "experts establishing ground truth" in the clinical sense does not apply here. The "ground truth" for these tests is defined by the objective pass/fail criteria set forth in each listed international and national standard. The evaluations would have been performed by qualified testing personnel and engineers, whose qualifications would be in the field of mechanical, electrical, and materials engineering, and testing methodologies specific to medical devices and wheelchairs.

4. Adjudication Method for the Test Set

Not applicable. Since these are objective performance tests against predefined standards, there is no "adjudication method" in the sense of resolving discrepancies between human readers or experts. The outcome of each test is determined by whether the device's performance meets the specified thresholds or criteria in the respective standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is a type of clinical study typically used to compare the performance of human readers (e.g., radiologists) with and without the assistance of an AI algorithm when interpreting medical data. This document describes the non-clinical testing of a physical medical device (an electric wheelchair) against established engineering and safety standards. No clinical studies, and therefore no MRMC studies, were performed or are relevant to this submission.

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

Not applicable. This device is a physical, electrically powered wheelchair; it is not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

For non-clinical performance and safety testing of a physical device, the "ground truth" is established by the objective, predefined pass/fail criteria and specifications outlined in the referenced national and international standards (e.g., EN 12184, ISO 7176 series, ANSI/RESNA, EN 61000, etc.). For example, the "ground truth" for static stability (ISO 7176-1) would be the device remaining stable under specific load and incline conditions, as defined by that standard.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned or implied in this document. The device is a physical product, not an AI algorithm that requires training 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 and submission.

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