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The Explorer Mini is a pediatric powered wheelchair with the intention to provide mobility to pediatric users weighing up to 35 pounds and maximum length of up to 39 inches tall, between 12-36 months of age, who position themselves in a sitting position in the wheelchair and have the capacity to operate a joy stick hand control.

The Explorer Mini includes a base to which the wheels and casters are attached. An adjustable height, vertical column is attached to the base. The driver control (joystick) is integrated at the top of the column and the seating system is attached to the column. The Explorer Mini speed and direction are controlled via a control system comprising a power module and joystick. The Explorer Mini has the appearance of a "ride on toy" and weighs between 60% and 90% less than typical power chairs available to this population today. Explorer Mini seat is configured with a permanent 360degree support assembly positioned around the upper torso for added user safety and stability. This assembly supports both sitting and standing. An adjustable-position saddle shaped seat is used for sitting. The saddle shape allows for 'straddle' standing or alternately the seat can be removed to open the area for full active standing. The 360degree support assembly adjusts to accommodate and support standing while driving. The Explorer Mini is powered by two 5 Amp. batteries providing an approximate driving range up to 4.6 miles. The base provides the propulsion which is derived from two (left and right) front mounted gear-motor wheel assemblies supported by two rear mounted 360degree swiveling casters. Also incorporated in the base are the batteries and control module. When the user activates the joystick, the controller receives a signal to move the device in the direction the joystick is pointed. Simultaneously, the controller directs the gear-motors to respond appropriately. When the user releases the joystick, the chair decelerates to a stop. The inherent gear ratio holds the device in place like a park brake.

Please note that the provided text is a 510(k) summary for a medical device (Explorer Mini, a pediatric powered wheelchair). It describes the device, its intended use, comparison to a predicate device, and the non-clinical and clinical testing performed to demonstrate substantial equivalence to a legally marketed predicate device.

Crucially, this document does NOT describe the acceptance criteria and study for an AI/ML-based medical device. It details the regulatory clearance process for a powered wheelchair, which involves proving its safety and effectiveness through engineering and human factors testing, not through AI performance metrics like sensitivity, specificity, or reader studies common for AI/ML devices.

Therefore, many of the requested points regarding AI/ML device testing (e.g., ground truth establishment, sample size for training data, MRMC studies, standalone performance) are not applicable to the information contained in this 510(k) summary.

However, I can extract the information relevant to the acceptance criteria and the studies that were performed for this specific device.

Here's a breakdown based on the provided document, addressing the applicable points and explaining why others are not relevant:

Acceptance Criteria and Device Performance (Based on "Non-Clinical Testing" Section)

The acceptance criteria for the Explorer Mini are primarily defined by successful passage of various ISO 7176 standards, which evaluate the physical and functional characteristics of wheelchairs.

Study Details:

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

   • Non-Clinical Testing: The document refers to "the Explorer Mini" being tested according to the ISO standards. This implies testing of the device itself, likely multiple units for robustness, rather than a "test set" in the sense of patient data for an AI algorithm. The provenance is implied to be from the manufacturer's testing facilities based on compliance with international standards. Details like number of devices tested or specific test runs are not provided.
   • Clinical Testing (Usability Study): 33 children with mobility impairments were included. This was a usability study, not a clinical trial to prove efficacy in the traditional sense, but focused on how users interact with the device.
   • Clinical Testing (Label Comprehension Study): 15 physiotherapists/occupational therapists and 15 parents participated.
   • Data Provenance: Not explicitly stated (e.g., country of origin for the usability study participants), but the studies were conducted by the manufacturer Permobil AB (Sweden). The studies appear to be
     • Usability Study: Prospective, as it involved real children interacting with the device.
     • Label Comprehension Study: Prospective, as it involved participants reviewing the user manual.

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

   • Not Applicable in the traditional AI sense. For a physical device like a wheelchair, "ground truth" is established by direct measurement against engineering standards and specifications (e.g., speed, dimensions, stability tests). The experts involved would be engineers, technicians, and potentially clinical professionals ensuring the device meets the needs of pediatric users.
   • For the Usability Study, the "ground truth" would be observed user behavior and feedback, assessed by human factors engineers/clinicians.
   • For the Label Comprehension Study, the "ground truth" was whether participants could correctly understand the label, assessed by the study design and interpretation of responses from "physiotherapists/occupational therapists and parents." Their qualifications are stated by their profession.

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

   • Not Applicable. This is an AI/ML specific term for resolving discrepancies in expert labeling. For physical device performance tests (ISO standards), the results are typically objectively measured and don't require expert adjudication in the same way. For the usability/label comprehension studies, detailed adjudication methods are not provided, but such studies typically involve qualitative and quantitative analysis of user interactions and feedback.

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 specific to AI/ML devices where AI assists human interpretation (e.g., radiologists reading images). This product is a physical mobility device and does not involve AI assistance for human readers.

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

   • Not Applicable. As above, this is an AI/ML specific concept. The device's performance is inherently tied to its physical interaction with a user ("human-in-the-loop" is a given for a wheelchair).

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

   • Non-Clinical Testing: Engineering specifications and standardized test methods (ISO 7176 series). The "ground truth" is adherence to these defined performance benchmarks.
   • Clinical Testing (Usability/Label Comprehension): User behavior, performance, and understanding as observed and measured through structured studies.

7. The sample size for the training set:

   • Not Applicable. This device is a physical product, not an AI/ML algorithm that requires a training set of data.

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

   • Not Applicable. (See point 7).

In summary, the provided document outlines the process for clearance of a physical medical device (a pediatric powered wheelchair) by demonstrating its safety and effectiveness through compliance with recognized international standards for wheelchairs and human factors studies. It does not pertain to the development or validation of an AI/ML diagnostic or assistive algorithm.

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The F5 Corpus VS powered wheelchair is to provide indoor mobility, including stand-up feature, to persons limited to a seating position that are capable of operating a powered wheelchair.

F5 Corpus VS Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the R-net 120 amp controller. The user interface is a joystick. The F5 Corpus VS is powered by two 12VDC, Group M24, approximate driving range on fully charged batteries is up to 25km (15.5 miles), depending on use and the terrain the chair is driven on. The chair frame is a steel construction and includes two front drive units (motor, gear and brake), two batteries and two rear pivoting casters. Depending on the user's needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user to stop by letting go of the joystick. F5 Corpus VS will enable the user to stand up, completely or partially, to facilitate reaching, working eye to eye with colleagues. The standing sequence is controlled by the joystick and gives the user the possibility to come to a standing position. The seating, chest support and knee stop stabilize the user during the stand-up or sitdown operation.

This document (K191874) is a 510(k) premarket notification for a powered wheelchair, the F5 Corpus VS. It compares the device to two predicates: the Quickie® Q700-UP M (K172384) and the F5 (K143014).

Based on the provided text, here is an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally demonstrated by compliance with various ISO and RESNA standards for wheelchairs. The document does not present a single table explicitly listing "acceptance criteria" against "reported device performance" in a quantitative manner for all aspects. Instead, it states compliance with standards and provides some performance specifications when comparing the device to its predicates.

Here's an attempt to compile relevant information, though a direct "acceptance criteria" column is not explicitly defined in the document for each performance characteristic:

The document emphasizes that the F5 Corpus VS passes the requirements in ISO 7176 and RESNA WC-1:2009 Section 20.

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

The document refers to "Non-Clinical Testing" which involves compliance with a long list of ISO standards and RESNA WC-1. These are physical performance tests for the device itself (e.g., stability, brake effectiveness, strength).

• Sample size for the test set: Not explicitly stated as a number of devices or units. Typically, for device performance testing against standards, a representative sample (e.g., a few units or prototypes) is tested. The nature of these tests does not involve patient data or human subjects for the "test set" in the context of an AI/algorithm study.
• Data provenance: Not applicable in the context of patient data for an algorithm. The tests are for the physical wheelchair device. The Permobil AB company is based in Sweden. The tests were conducted to international standards.

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 as the device is a physical powered wheelchair, not an AI/algorithm that requires expert-established ground truth from medical images or patient data. The "ground truth" here is the physical performance of the device as measured by standardized engineering and safety tests.

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

This information is not applicable as the device is a physical powered wheelchair, not an AI/algorithm study involving adjudication of clinical findings. Compliance with standards is typically measured objectively through specified test procedures.

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. The device is a physical powered wheelchair. There is no AI component or human reader in the context of medical image interpretation that would warrant an MRMC study.

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

This information is not applicable. The device is a physical powered wheelchair, not a standalone algorithm.

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

The "ground truth" for the F5 Corpus VS device is its physical performance, safety, and functional characteristics as measured and validated against established international standards (ISO 7176 series and RESNA WC-1:2009 Section 20). These standards define objective test methods and acceptable performance limits.

8. The sample size for the training set

This information is not applicable. The device is a physical powered wheelchair. There is no AI/algorithm being trained on a dataset. The design and manufacturing process would involve engineering principles and testing, not machine learning training.

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

This information is not applicable for the same reasons as in point 8.

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The intended use of the F3 powered wheelchair is to provide indoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair.
The intended use of the F3 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

F3 Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the R-net 120 amp controller. The user interface is a joystick. The F3 is powered by two 12VDC 60Ah or tow 12VDC 73Ah. Group M34 batteries or Group M24. approximate driving range on fully charged batteries is up to 25km (15.5 miles), depending on use and the terrain the chair is driven on. The chair frame is a steel construction and includes two front drive wheels with drive units (motor, gear and brake), two batteries and two rear pivoting casters. Depending on the user's needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically reengaged. The solenoid electromechanical brakes allow the user to stop by letting go of the joystick.

This is a 510(k) premarket notification for a powered wheelchair (Permobil F3) and does not involve a diagnostic AI/ML device. Therefore, the specific information requested about acceptance criteria, study design, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, is not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Permobil M300 & M400) by comparing intended use, technological characteristics, and conformance to recognized standards.

However, I can extract information related to the device's performance based on the non-clinical testing:

1. Table of acceptance criteria and the reported device performance:

The document states that "The F3 complies to the below standards." This implies that the device met the requirements outlined in each standard, which serve as the acceptance criteria for those specific performance aspects. The document does not explicitly list numerical acceptance criteria or reported device performance values for each standard but asserts compliance.

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 provided in the document. For non-clinical performance testing of a physical device like a wheelchair, the "sample size" would typically refer to the number of units tested, and the "data provenance" would relate to the testing facility and methodology. These details are not elaborated upon beyond stating compliance with international standards.

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. This is not an AI/ML device requiring expert ground truth for classification. The "ground truth" for a physical device is derived from the objective physical and functional measurements performed according to the specified test methods in the ISO standards.

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

Not applicable. This is not an AI/ML device involving human interpretation needing 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 is a physical medical device, not an AI/ML diagnostic tool.

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

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

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

For this type of device, the "ground truth" is established by adherence to the objective measurements and protocols defined within the referenced international standards (e.g., ISO 7176 series). It relies on physical testing and measurement rather than expert consensus or pathology.

8. The sample size for the training set

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

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

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

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The intended use of the F5 powered wheelchair is to provide indoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair.

The intended use of the F5 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

F5 Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the R-net 120 amp controller. The user interface is a joystick.

The F5 is powered by two 12VDC 73Ah. Group M24. approximate driving range on fully charged batteries is up to 25km (15.5 miles), depending on use and the terrain the chair is driven on. The chair frame is a steel construction and includes two front drive units (motor, gear and brake), two batteries and two rear pivoting casters. Depending on the user's needs, the joystick motor control is mounted to the left or right armrest.

When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically reengaged. The solenoid electromechanical brakes allow the user to stop by letting go of the joystick.

This document is a 510(k) premarket notification for the Permobil F5 Powered Wheelchair. It does not describe a study involving an AI/ML device, but rather a traditional medical device (a powered wheelchair). Therefore, most of the questions relating to acceptance criteria, ground truth, expert adjudication, and AI performance metrics are not applicable.

However, I can extract information related to the device's performance based on the provided safety and performance standards.

Here's the relevant information based on the provided text:

1. Table of acceptance criteria and the reported device performance

For a traditional medical device like a powered wheelchair, "acceptance criteria" are typically defined by compliance with recognized performance standards. The "reported device performance" is implicitly that the device met these standards, as indicated by the statement "The F5 complies to the below standards" and "The submitted device are tested and having same or improved results as the already predicated 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 provided in the document. For a physical device like a wheelchair, "test set" would typically refer to the specific units or prototypes of the device that underwent testing. The document states "The submitted device are tested," implying testing was performed on at least one F5 unit, but the exact number is not specified. The manufacturer, Permobil AB, is based in Timrå, Sweden, so the testing would likely have been conducted there or by a certified testing facility.

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 as this is a physical device, not an AI/ML diagnostic tool requiring expert interpretation for ground truth. The "ground truth" for a wheelchair's performance is determined by meeting objective engineering and safety standards.

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

Not applicable for a physical device compliance testing.

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 device, not an AI/ML-assisted diagnostic tool.

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

Not applicable. This is a physical device.

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

The "ground truth" for the F5 Powered Wheelchair is defined by its compliance with internationally recognized safety and performance standards (ISO 7176 series). This involves objective measurements and tests rather than subjective expert consensus.

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.

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The intended use of the M300 & M400 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

M300 & M400 Powered Wheelchair is battery powered, center wheel motor driven and is controlled by the PG power wheelchair VR-2 90 amp or R-net 120 amp controller. The user interface is a joystick. M300 & M400 is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 25km (15,5 miles), depending on use and the terrain the chair is driven on. The chair frame is a rived nut and welded steel construction and includes two center drive wheels with drive units (motor, gear, brake), batteries and front and rear pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.

The Permobil M300 & M400 powered wheelchairs were assessed for substantial equivalence to the predicate device Permobil C350 (K071650). The performance data indicates that the M300 & M400 functioned as intended in all instances based on various ISO and RESNA standards.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" but lists various characteristics and their values for both the new device and the predicate device, implying these are the performance metrics against which substantial equivalence is judged. The "reported device performance" are the values for the M300 & M400.

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

The document does not explicitly state the sample size for a "test set" in the context of human subjects or a specific data set. The performance testing was based on compliance with various international and national standards for wheelchairs (ISO and RESNA). These standards typically involve testing a representative sample of the devices. The data provenance is derived from the testing conducted by Permobil AB, based in Timrå, Sweden. The testing described is likely prospective, as it's part of the premarket notification for a new device.

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

This information is not applicable and not provided in the document. The device is a powered wheelchair; its performance is evaluated against engineering and safety standards, not against "ground truth" established by medical experts in diagnosing conditions.

4. Adjudication method for the test set:

This information is not applicable and not provided in the document. As mentioned above, the evaluation is against established engineering and safety standards, not expert consensus requiring 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:

This information is not applicable and not provided in the document. The device is a powered wheelchair; it is not an AI-assisted diagnostic tool involving human readers.

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

This information is not applicable and not provided in the document. The device is a physical powered wheelchair, not an algorithm.

7. The type of ground truth used:

The "ground truth" in this context is the fulfillment of requirements outlined in the specified international and national standards (ISO 7176 series and RESNA WC-1/WC-2). These standards define objective performance thresholds and test methodologies for characteristics like climatic resistance, power and control systems, electromagnetic compatibility, weight bearing capacity, speed, braking, etc.

8. The sample size for the training set:

This information is not applicable and not provided in the document. The development of a powered wheelchair does not typically involve a "training set" in the way that machine learning algorithms do. The design and engineering process is iterative, based on established mechanical and electrical engineering principles, and validated through testing against standards.

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

This information is not applicable and not provided in the document for the reasons stated in point 8.

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The intended use of the M300 & M400 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

M300 & M400 Powered Wheelchair is battery powered, center wheel motor driven and is controlled by the PG power wheelchair VR-2 90 amp or R-net 120 amp controller. The user interface is a joystick. M300 & M400 is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 25km (15,5 miles), depending on use and the terrain the chair is driven on. The chair frame is a rived nut and welded steel construction and includes two center drive wheels with drive units (motor, gear, brake), batteries and front and rear pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.

The provided document is a 510(k) Summary for a Permobil M300 & M400 Powered Wheelchair. It is a regulatory filing for a medical device that establishes substantial equivalence to a legally marketed predicate device, rather than a study demonstrating clinical performance or acceptance criteria in the context of diagnostic accuracy or similar AI/algorithm-driven devices.

Therefore, many of the requested elements (like acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of regulatory submission for a powered wheelchair.

However, I can extract the relevant information from the document as requested, interpreting "acceptance criteria" and "device performance" in the context of device function and regulatory equivalence.

Acceptance Criteria and Device Performance (Permobil M300 & M400 Powered Wheelchair)

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not applicable. This is a regulatory submission for a physical device, not an AI/algorithm. Performance data is mentioned generally ("In all instances, the M300 & M400 functioned as intended"), but no specific test set sample size (e.g., number of units tested, number of user trials) or data provenance for such a test set is provided in this summary.
• Data Provenance: Not applicable in the context of "country of origin of the data, retrospective or prospective." The manufacturer, Permobil AB, is located in Timrå, Sweden.

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 physical product (powered wheelchair). Ground truth in the sense of expert annotation or clinical diagnosis is not relevant here.

4. Adjudication method for the test set

• Not applicable. No adjudication method for a test set (e.g., consensus among experts) is mentioned or relevant for this type of device 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 not an AI/diagnostic imaging device.

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

• Not applicable. This is a powered wheelchair; it does not have a "standalone algorithm performance" in this context.

7. The type of ground truth used

• The "ground truth" for a device like this would be its functional performance against engineering specifications, safety standards, and its intended use. The document states "In all instances, the M300 & M400 functioned as intended," which implies it met its design and functional requirements. Substantial equivalence relies on comparing these functional and safety aspects to a predicate device.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

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The intended use of the K450 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
The intended use of the K450 series of the powered wheelchair is to provide indoor and outdoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair.

K450 Powered Wheelchair is battery powered, rear wheel motor driven and is controlled by the PG power wheelchair R-net PM120 amp controller. The user interface is a joystick. The K450 is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 26,9 km (16,7 miles), depending on use and the terrain the chair is driven on. The chair frame is a welded steel construction and includes two rear drive wheels with drive units (motor, gear, brake), batteries and front pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.

This is a 510(k) summary for a powered wheelchair (K450). The document states that the K450 functioned as intended in all instances but does not provide specific acceptance criteria or details of a study to prove conformance. It primarily focuses on demonstrating substantial equivalence to a predicate device (C350, K071650).

Here's an breakdown based on the provided text, highlighting what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document doesn't detail any specific clinical or non-clinical testing data beyond a general statement of functioning as intended.

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

• Not applicable. This device is a powered wheelchair and the submission does not involve an AI/imaging diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set:

• Not applicable. This device is a powered wheelchair and the submission does not involve an AI/imaging diagnostic device requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is not an AI/imaging diagnostic device.

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

• Not applicable. This is not an AI/imaging diagnostic device. The device itself is a powered wheelchair that a human operates.

7. The Type of Ground Truth Used:

• Not explicitly defined in the context of "ground truth" as it would be for an AI diagnostic device. For a powered wheelchair, "ground truth" would typically refer to objective performance standards (e.g., speed, range, stability, braking distance) and user functionality, but the document only states "functioned as intended."

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.

Summary of what is missing/not applicable for an AI device:

The provided document is a 510(k) summary for a powered wheelchair, not a medical imaging or AI diagnostic device. Therefore, many of the requested criteria (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of device submission.

The submission primarily relies on demonstrating substantial equivalence to an existing predicate device (C350, K071650) by stating that the K450 has "the same intended uses and similar indications, technological characteristics and principles of operation." The "performance data" mentioned is very high-level: "In all instances, the K450 functioned as intended." This suggests that internal testing was conducted that validated its functionality, likely against a set of engineering and safety specifications, but these specific criteria and the detailed data are not provided in this summary.

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The intended use of the C350 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

C350 Powered Wheelchair is battery powered, rear wheel motor driven and is controlled by the PG power wheelchair VR-2 70 amp controller. The user interface is a joystick. The C350 is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 22 km (13.75 miles), depending on use and the terrain the chair is driven on. The chair frame is a rived nut and welded steel construction and includes two rear drive wheels with drive units (motor, gear, brake), batteries and front pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.

The provided document, K071650 for the Permobil Powered Wheelchair: C350, does not contain information typically found in studies for AI/ML-driven medical devices. This is a premarket notification for a physical medical device (a powered wheelchair) from 2007, which predates the widespread acceptance and integration of AI/ML into medical device regulations.

Therefore, the requested information regarding acceptance criteria and studies for an AI device, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment, is not present in this document.

The "Performance Data" section merely states: "In all instances, the C350 functioned as intended." This indicates a fundamental functional performance assessment rather than a study with statistical metrics. The substantial equivalence argument relies on comparing the C350 to its predicate device, the C300 (K041219), and asserting that "The minor technological differences between the Electro and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the C350 is as safe and effective as the C300(Electro)."

Since the document pertains to a traditional physical medical device and not an AI/ML-driven one, I cannot extract the requested information as it is not applicable to the content provided.

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