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Provide mobility to persons physically challenged and limited to sitting positions due to:

• Palsies/Paralyses
• Loss of limbs
• Defective and/or deformed limbs
• Joint contractures
• Joint defects
• Other diseases

The C2000 power wheelchair is suitable for indoor and outdoor use. It is compactly designed and easy to maneuver for use indoors. Two 12 V batteries power its high-performance drive system, which allows the C2000, along with spring mounted drive wheels, to overcome obstacles (category C of EN 12184) and to ensure safe operation.

The C2000 power wheelchair is controlled by an enAble50 wheelchair control system. It includes a control panel to enter driving commands and display the current status as well as a controller that controls that drive motors and other electrical functions based on the input data. Data transmission is realized via a bus system.

The enAble50 can be programmed to the personal requirements of the user; e. g. the speed, acceleration and deceleration values can all be personalized.

This document describes a 510(k) submission for the Otto Bock C2000 Powered Wheelchair. It focuses on demonstrating substantial equivalence to a predicate device (C1000 Powered Wheelchair) and meeting safety standards, rather than proving the performance of an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML studies are not applicable.

Here's the 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

The document refers to testing conducted to various EN and ISO standards for wheelchairs. These standards typically involve a defined number of test samples (devices) to evaluate performance and safety characteristics. However, the exact "sample size" of wheelchairs tested is not specified in this summary.

The data provenance is from testing conducted by TÜV in Hanover, Germany. This indicates the data is from a prospective testing process following established engineering and safety standards, rather than a clinical dataset of patient information.

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 as this is a physical device submission for a powered wheelchair, not an AI/ML algorithm for diagnostic purposes. "Ground truth" in this context refers to compliance with established engineering and safety standards, which are evaluated through standardized tests and measurements, not expert human interpretation of data. The "experts" would be the engineers and technicians performing the tests at TÜV.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discrepancies in expert interpretations of medical images or data, which is not relevant to the testing of a physical medical device against engineering standards. The compliance is determined by whether the device passes the specified tests.

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 as this is a physical device submission for a powered wheelchair, not an AI/ML algorithm.

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

This information is not applicable as this is a physical device submission for a powered wheelchair, not an AI/ML algorithm.

7. The type of ground truth used

The "ground truth" used for this device is based on established international and European engineering safety and performance standards (DIN EN, IEC, ISO). The device's performance is measured directly against the requirements and test methods defined within these standards.

8. The sample size for the training set

This information is not applicable as this is a physical device submission for a powered wheelchair, not an AI/ML algorithm that requires a training set.

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

This information is not applicable as this is a physical device submission for a powered wheelchair, not an AI/ML algorithm that requires a training set.

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The BRAVOracer is a lightweight, rigid, high strength aluminum wheelchair for everyday use. This wheelchair provides mobility to physically challenged children. This wheelchair can be moved by the user propelling the hand rims, which are attached to the rear (drive) wheels. This wheelchair can also be pushed by an assistant grasping the pushbar attached to the back rest.
Children who are unable to walk or who have a walking impediment.

The BRAVOracer is a lightweight, adaptive, and multifunctional wheelchair. It was designed for children who are unable to walk or who have a walking impediment. This wheelchair can be moved either by the patient him/herself or by another person. The BRAVOracer is a rigid frame of aluminum.Seat height is front and rear adjustable, with various widths and heights. It has a width of 47-66 cm. The seat material is nylon upholstery. All backs are adjustable and all armrests are removable. It has a swing-away footrest with a weight capacity of 60 kg or approximately 132 pounds.

The BRAVOracer is a manual wheelchair that was determined to be substantially equivalent to the predicate device, Start Junior (K073512), based on performance testing to recognized international standards.

Here's a breakdown of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not explicitly state the number of BRAVOracer units tested. However, compliance with a suite of international standards (EN, ISO, ANSI/RESNA series) generally implies testing on a representative sample of devices to ensure robustness and consistency.
• Data Provenance: The standards testing was conducted by Berlin Cert. While the country isn't explicitly stated for "Berlin Cert", it generally refers to a certification body based in Berlin, Germany. The testing conducted to these standards is typically prospective, meaning the tests are designed and performed specifically to assess the device's adherence to the standard criteria.

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

This type of information (expert consensus, qualifications) is not applicable to the testing performed for the BRAVOracer. The "ground truth" in this context is defined by objective engineering and safety standards (e.g., strength, stability, durability, biocompatibility), not by expert interpretation of images or clinical outcomes. The testing involves standardized procedures and measurements as defined by the listed EN, ISO, and ANSI/RESNA standards.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation is based on objective measurements and adherence to specified performance limits within the engineering standards, rather than subjective expert review 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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation plays a role. The BRAVOracer is a mechanical wheelchair and its evaluation focuses on engineering performance and safety.

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

Not Applicable. The BRAVOracer is a mechanical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used was objective engineering and safety standards. These standards define the acceptable performance parameters and test methods for manual wheelchairs. Compliance with these established standards serves as the "ground truth" for ensuring the device's safety and effectiveness.

8. The Sample Size for the Training Set

Not Applicable. The BRAVOracer is a mechanical device, not a machine learning model, 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, this question is not relevant.

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• Children who are unable to walk or who have a walking impediment.

Manual Wheelchair

The provided text is a 510(k) summary for the Otto Bock Start Junior manual wheelchair and does not contain information about acceptance criteria, device performance metrics, or details of any studies (such as sample sizes, expert qualifications, or ground truth establishment) typically associated with software or AI/ML-based medical devices.

The document primarily focuses on:

• Administrative information: Submitter's name, address, contact, date prepared, registration number.
• Device identification: Name, trade name, common name, classification name, product code, class, regulation number.
• FDA communication: Confirmation of substantial equivalence to a predicate device, regulatory class, and general controls provisions.
• Indications for Use: Children who are unable to walk or who have a walking impediment.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text. This document is a regulatory submission for a physical medical device (manual wheelchair), not a software device, and thus the requested AI/ML specific information is irrelevant to this submission.

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The SensorWalk is intended to lock the knee joint during the stance phase and to unlock the knee joint during the swing phase when walking forward on level surfaces. It is intended solely for the orthotic fitting of the lower limbs of patients who are community ambulators and who:

• Exhibit knee instability in the sagittal plane while bearing weight during the stance phase of their gait cycle;
• Have hip extensor strength of at least grade 3 (against gravity);
• Have the muscle strength in their torso or pelvis required to swing the SensorWalk forward while they are walking;
• Have a gait in which the step length on level ground exceeds the length of the opposing foot;
• Weigh 300 pounds or less; and
• Are able to understand and carry out the instructions.

The Sensor Walk is a microprocessor-controlled Knee Ankle Foot Orthosis (KAFO) designed to help wearers achieve a safer, more physiologically correct gait. It does this by unlocking the knee joint when the wearer is ready for swing phase and locking it again for stability during stance phase.

The Sensor Walk system includes an onboard microprocessor, a clutch spring knee joint, foot pressure sensors, a knee angle sensor, a battery, and a battery charger. When the sound limb has been loaded during walking and the affected side is about to enter swing phase (with the toe still on the ground) the microprocessor reads signal information from the foot and knee sensors and allows the knee to go into flexion. When the orthosis begins to extend again, the knee will enter a stable phase, preventing any flexion while allowing full extension for stance phase. The Sensor Walk will support the wearer if they load it at any point while it is extending, offering them exceptional stability. Wearers can disengage the knee joint, such as for sitting, simply by pressing the manual release switch.

The Sensor Walk offers 12 hours of continuous use before it needs to be recharged, and contains an audible warning to alert the use if the battery is running low.

When the Sensor Walk is turned off, it offers the stability of a traditional locked KAFO throughout the gait cycle.

The Sensor Walk has Manual Release Function. A control collar at the knee joint can be manually pushed back to temporarily override the locking mechanism and put the joint into free swing mode. As soon as the collar is reling meetialism und be able to lock.

To override the Sensor Walk's locking mechanism for a longer period, a Manual Release Rocker Switch can be pressed to lock the control collar in the free swing mode. When the Manual Release Rocker Switch is pressed and the joint is in free-swing mode, the switch will show an amber dot to indicate that caution should be used. In normal operating mode, the switch will show a green dot indicating that the locking feature will function normally.

The Sensor Walk™ is comprised of the following parts: a traditional, doubleupright KAFO with a free-articulating medial knee joint; a lateral mechanical clutch, 6 spring knee joint, microprocessor-controlled electronics, foot sensors, a battery, and a battery charger.

The foot sensor plate includes 4 sensors arranged in a straight line on the bottom of the foot plate. They are numbered from 1 to 4, beginning with the most posterior. The sensors overlap by 3/8 inch (10mm), and are wired to a sensor selection switch located in the electronics of the Sensor Walk. The Sensor Walk comes delivered with sensors 1 and 2 activated, but, if necessary, other sensors can be selected to optimize patient fitting.

The Sensor Walk is delivered with the following components:

• Fabricated KAFO with Sensor Walk (17B500) knee joint and foot sensor (520E500)
• Battery (517B20) and Charger (517L20)
• Sensor Walk Instructions for Use

The Sensor Walk comes in either a right or left, laminated or thermoplastic. The Order Numbers are as follows:

• 17B500 == R-L300 == Laminated Right
• 17B500 = L-L300 Laminated Left
• 17B59() = R-T300 Thermoplastic Right
• 178500 -- L-T300 -- Thermoplastic Left

The provided text describes the "Sensor Walk" device, a microprocessor-controlled Knee Ankle Foot Orthosis (KAFO). However, it is a 510(k) summary for a medical device and not a study proving the device meets acceptance criteria.

The 510(k) summary focuses on demonstrating "substantial equivalence" to a legally marketed predicate device (OTTO BOCK FreeWalk), not on reporting specific performance against acceptance criteria from a standalone study. Therefore, the requested information about acceptance criteria, detailed study parameters, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness is largely not present in the provided document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

This information is not provided in the document. The 510(k) summary focuses on comparing the Sensor Walk to a predicate device and outlining its intended use and technological characteristics, rather than reporting performance against specific, quantifiable acceptance criteria.

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. The document does not describe any specific test set or study conducted for the Sensor Walk. It mentions that "None of the differences [between Sensor Walk and FreeWalk] raise any new questions of safety or effectiveness that have not been addressed by the developers (OTTO BOCK and Mayo Clinic)," which implies reliance on existing knowledge or internal assessments rather than a specific clinical trial detailed here.

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

This information is not provided. No test set is described, so no ground truth establishment by experts is detailed.

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

This information is not provided. No test set is described, so no adjudication method is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable as the Sensor Walk is a physical orthotic device, not an AI diagnostic or image analysis tool that would involve human readers.

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

This is not directly applicable in the context of a standalone algorithm performance in the way it's usually asked for AI/software devices. The entire device is the "standalone" unit in terms of its function (microprocessor-controlled KAFO). However, no specific performance metrics for the device are reported that could be compared to typical "standalone algorithm" evaluations.

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

This information is not provided. As no specific test data or study with ground truth is described, the type of ground truth used is unknown.

8. The sample size for the training set:

This information is not provided. The document does not mention any training set for an algorithm. While the device is microprocessor-controlled, the text does not describe a machine learning algorithm that undergoes a training phase.

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

This information is not provided. As no training set is mentioned, the method of establishing its ground truth is also not described.

Summary of what is available from the document (related to acceptance/testing):

• The device (Sensor Walk) aims to provide a safer, more physiologically correct gait by unlocking the knee joint for swing phase and locking it for stability during stance phase.
• Intended Use & Indications for Use: These outline the specific conditions and patient characteristics for which the device is designed. These act as high-level "acceptance criteria" for the device's application.
  • Intended Use: Orthotic fitting of lower limbs, for community ambulators, forward walking on level surfaces, with power turned on. Not for sports or aggressive use.
  • Indications for Use (Patient Criteria):
    • Knee instability in the sagittal plane during stance phase.
    • Hip extensor strength of at least grade 3 (against gravity).
    • Muscle strength in torso/pelvis to swing KAFO forward.
    • Gait where step length on level ground exceeds length of opposing foot.
    • Weigh 300 pounds or less.
    • Able to understand and carry out instructions.
• Functional Features: The document describes the device's operation (e.g., 12 hours continuous use, audible low battery warning, manual release function). Implied "acceptance" is that these features function as described.
• Substantial Equivalence: The key "study" or basis for clearance is the demonstration of substantial equivalence to the OTTO BOCK FreeWalk, a Class I exempt device. This comparison focuses on technological characteristics and intended use rather than specific endpoint performance data from a clinical trial. The developers (OTTO BOCK and Mayo Clinic) have attested that differences do not raise new safety or effectiveness questions.

Therefore, while the document explains the purpose and features of the Sensor Walk, it does not provide the detailed study information typically requested when evaluating acceptance criteria for a device, particularly one involving advanced algorithms or diagnostic capabilities. The 510(k) process for this Class I device relied on demonstrating similarity to a legally marketed predicate, rather than an independent clinical performance study with defined acceptance criteria.

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Persons who are unable to walk or who have a walking impediment.

Not Found

The provided text is a 510(k) summary for a manual wheelchair, which is a physical device, not a digital health device or an AI/ML-driven device. As such, it does not contain the information required to answer the questions about acceptance criteria, study details, ground truth, or AI/ML performance.

Therefore, I cannot extract the requested information from this document.

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The B-500 is rear wheel drive powered wheelchair for active users. These wheelchairs provide mobility to physically challenged persons. The wheelchair can be moved by the user operating the remote control. The wheelchair can also be pushed by an assistant grasping the handles attached to the back rest.
Provide mobility to persons physically challenged and limited to sitting position.

The B-500 Powered Wheelchair is a rear wheel drive powered wheelchair, manufactured in Germany at production facilities of OTTO BOCK HealthCare. The B-500 has an "H" frame, controlled by a P&G Controller, electronic regenerative disc brakes and Micro Motor.

This document does not contain an acceptance criteria table or a study description as typically found for complex medical devices that rely on AI or extensive performance testing against defined metrics.

Instead, this document is a 510(k) summary for a powered wheelchair (B-500 Powered Wheelchair) seeking market clearance through the substantial equivalence pathway. The "study" mentioned for this type of device is usually compliance with recognized international and national standards, rather than a clinical trial or performance study against specific acceptance criteria in the way a diagnostic AI algorithm would be evaluated.

Here's a breakdown of the information that is present in the document, formatted to address your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: For a powered wheelchair, "acceptance criteria" are typically defined by compliance with established safety and performance standards. The document states that the B-500 was tested by TÜV Product Service to the listed standards, and the conclusion was that "the test sample fulfills the requirements." This indicates that the device met the requirements outlined in these standards, which serve as the de facto acceptance criteria for this type of medical device.

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

This document does not specify a "test set sample size" or "data provenance" in the context of clinical data or AI model evaluation. The "test sample" refers to the physical wheelchair(s) that underwent testing against the specified engineering standards. The typical number of units tested for such compliance would be a limited number of production or prototype units, not a large patient cohort.

• Sample Size: Not explicitly stated, but typically a small number of physical units for engineering standard compliance testing.
• Data Provenance: Not applicable in the context of clinical data. The tests were performed by TÜV Product Service. The manufacturing location is stated as Germany.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this document. The "ground truth" for a powered wheelchair's compliance is determined by its adherence to engineering standards and functional performance, not by expert consensus on clinical findings.

4. Adjudication Method for the Test Set

This information is not applicable. The testing was against engineering and safety standards, not a clinical trial requiring adjudication of patient outcomes or interpretations.

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

A MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret images with and without AI assistance. This document describes a powered wheelchair, which is a therapeutic device, not a diagnostic one.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Standalone performance, in the context of an algorithm, is not applicable to this device. The B-500 is a physical device, and its performance is evaluated through physical testing against standards, not through an algorithm's output.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is its compliance with established engineering and safety standards (EN 12184, ISO 7176 Series, and ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC).

8. Sample Size for the Training Set

This information is not applicable. The device manufacturing process does not involve a "training set" in the context of AI or machine learning.

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

This information is not applicable as there is no "training set" for this device.

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The B-600 is rear wheel drive powered wheelchair for active users. These wheelchairs provide mobility to physically challenged persons. The wheelchair can be moved by the user operating the remote control. The wheelchair can also be pushed by an assistant grasping the handles attached to the back rest.

The B-600 Powered Wheelchair is a rear wheel drive powered wheelchair, manufactured in Germany at production facilities of OTTO BOCK HealthCare. The B-600 has an "H" frame, controlled by Curtis Instruments Controller, electronic regenerative disc brakes, and Micro Motor.

This document is a 510(k) summary for the Otto Bock B-600 Powered Wheelchair. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria in the context of diagnostic accuracy or performance like an AI/ML medical device.

Therefore, many of the requested categories for AI/ML device studies (such as sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance) are not applicable or extractable from this document.

However, I can extract information related to the demonstration of technological characteristics and standards used.

Device: B-600 Powered Wheelchair

Predicate Device: Quickie Designs (Sunrise Medical) P200 (P220) Wheelchair (K924278)

Here's the information that can be extracted, adapting to the nature of this submission:

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 explicitly stated as a numerical count of wheelchairs tested, but it refers to "the test sample" which implies at least one B-600 Powered Wheelchair was subjected to the listed standards.
• Data Provenance: The standards testing was conducted by TÜV Product Service and Montena EMC SA. The device is manufactured in Germany.

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 clearance for a powered wheelchair based on performance against established standards and substantial equivalence to a predicate device, not a diagnostic device requiring expert interpretation of results. The "ground truth" here is compliance with engineering and safety standards, determined by testing facilities.

4. Adjudication method for the test set:

• Not Applicable. See point 3.

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/ML diagnostic device.

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

• Not Applicable. This is not an AI/ML diagnostic device.

7. The type of ground truth used:

• Compliance with established international and national standards for electric wheelchairs and electromagnetic compatibility (EN 12184, ISO 7176 Series, ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC).

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML diagnostic device. There is no concept of a "training set" in this context.

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

• Not Applicable. See point 8.

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The C-1000 is front wheel drive powered wheelchair for active users. These wheelchairs provide mobility to physically challenged persons. The wheelchair can be moved by the user operating the remote control. The wheelchair can also be pushed by an assistant grasping the handles attached to the back rest.
Provide mobility to persons physically challenged and limited to sitting position.

The C-1000 Powered Wheelchair is a front wheel drive powered wheelchair, manufactured in Germany at production facilities of OTTO BOCK HealthCare. The C-1000 has an "H" frame, controlled by a Curtis Instruments MC-2, electronic regenerative disc brakes and Micro Motor.

The provided text describes a 510(k) submission for the Otto Bock C-1000 Powered Wheelchair, seeking clearance for marketing. The nature of this submission and the device itself (a powered wheelchair) means that the "acceptance criteria" and "device performance" are primarily related to safety, functionality, and equivalence to a predicate device, rather than diagnostic accuracy or predictive power as would be seen in a medical imaging AI product.

Therefore, many of the typical acceptance criteria points for an AI/ML device, such as sensitivity, specificity, AUC, and aspects related to human reader studies, are not applicable in this context. The study described focuses on compliance with established engineering and safety standards for wheelchairs.

Here's a breakdown of the requested information based on the provided text, acknowledging the differences due to the device type:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The text states "the test sample" was used, implying one or a small number of C-1000 Powered Wheelchair units were subjected to testing. A specific numerical sample size is not provided.
• Data Provenance: The device was manufactured in Germany at OTTO BOCK HealthCare production facilities. The testing was conducted by TÜV Product Service, an organization based in Europe, which suggests the tests were likely performed in Europe. This was a prospective study, as the tests were conducted specifically for this 510(k) submission.

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

• This concept is not directly applicable here. The "ground truth" for the performance of a powered wheelchair is its adherence to established engineering and safety standards. The "experts" would be the engineers and technicians at TÜV Product Service who conducted the tests and assessed compliance with the specified standards. Their qualifications would be expertise in mechanical, electrical, and medical device safety testing, and specifically in the standards listed (EN 12184, ISO 7176 Series, ANSI/RESNA WA Vol. 2 Section 21). The number of such individuals is not specified.

4. Adjudication Method for the Test Set

• Not applicable in the context of compliance testing against engineering standards. The results are typically objective measurements against predefined limits or pass/fail criteria within the standards.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for assessing the impact of a diagnostic aid (often AI-based) on human reader performance, which is not the purpose of this device or its clearance pathway.

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

• Not applicable. The C-1000 Powered Wheelchair is a physical medical device, not an algorithm. Its performance is inherent to the device itself.

7. The Type of Ground Truth Used

• The "ground truth" used for assessing the device's performance was the requirements outlined in the recognized international and national engineering and safety standards:
  • EN 12184 (Electrically-powered wheelchairs)
  • ISO 7176 Series (Wheelchairs)
  • ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC (Electromagnetic Compatibility)

8. The Sample Size for the Training Set

• Not applicable. The C-1000 Powered Wheelchair is a physical product designed and manufactured according to established engineering principles, not an AI/ML model that requires a training set.

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

• Not applicable, as there is no training set for this type of device. The design and manufacturing processes are guided by established engineering specifications and quality control measures, which ensure the device's intended characteristics.

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The Cranial Helmet (cranial orthosis) is a device that is intended for medical purposes to apply pressure to the prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with a diagnosis of moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
Contraindications: Infants with Synostosis or Hydroccphalus.
Prescription Device.

The Cranial Helmet is a cranial orthosis custom fabricated to apply pressure to the prominent regions of an infant's cranium to improve cranial symmetry and shape. The Cranial Helmet is comprised of the same materials as the P.A.P. Orthosis (K012804). It is not packaged for sale, as it is custom fabricated. It will be fitted to the infant at the time of delivery. The Cranial Helmet has no accessories, and no options are available for the infant or the caregiver (parent). Caregivers are instructed as to: wear, care, cautions, and risks. The transparent thermoplastic is Surlyn which varies in thickness from 1/8 inch to 3/8 inch depending upon the desired characteristics. The helmet is fabricated from a cast taken of an infant's head. There are no standard sizes, models, variances, etc. A polyurethane foam strip is applied to the posterior border at the base of the occipital to provide suspension and anti-rotation. Each Cranial Helmet is fastened with a Velcro strap. Each infant with a Cranial Helmet must be under the care of a physician. The helmet is a Prescription Device.

This 510(k) premarket notification for the Otto Bock Cranial Helmet does not include a study that proves the device meets specific performance acceptance criteria.

Instead, the submission relies on demonstrating substantial equivalence to a previously legally marketed device (the Fit Well's P.A.P. Orthosis, K012804). This means that the Cranial Helmet is deemed safe and effective because it has the same intended use and similar technological characteristics (materials, function, purpose, etc.) as the predicate device, which has already been cleared by the FDA.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, and ground truth establishment are not applicable to this type of submission.

Here's a breakdown of the information that is available based on the provided document:

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

This information is not provided in the document. The submission focuses on substantial equivalence rather than fulfilling specific performance metrics through a new study.

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

Not Applicable. No new performance study with a test set was conducted for this 510(k) submission.

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. No new performance study with a test set was conducted.

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

Not Applicable. No new performance study with a test set was conducted.

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 device is a physical orthosis, not an AI software, and no comparative effectiveness study of this nature was conducted.

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

Not Applicable. This device is a physical orthosis, not an algorithm.

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

Not Applicable. As no new performance study was conducted, there was no specific ground truth established for a test set. The "ground truth" for regulatory clearance is the substantial equivalence to the predicate device, implicitly relying on the established safety and effectiveness of that predicate.

8. The sample size for the training set:

Not Applicable. No AI model or algorithm was developed for this device; therefore, there is no training set.

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

Not Applicable. As no AI model or algorithm was developed, there is no training set or corresponding ground truth establishment.

Summary of Device Acceptance (based on provided text):

The Otto Bock Cranial Helmet was accepted by the FDA on the basis of Substantial Equivalence to the predicate device, Fit Well's P.A.P. Orthosis (K012804). The similarities cited for substantial equivalence include:

• Identical Indications for Use
• Same Materials (Surlyn, Polyurethane, Silicone and Velcro)
• Custom Fabrication
• Same Function
• Same Purpose
• Same Shape
• Same Diagnosis
• Prescription Devices
• Follow FDA Special Controls

The differences noted were minor (manufacturing location), which did not alter the fundamental safety and effectiveness profile compared to the predicate.

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The MyoSystem with Customizing is intended for adult(s) who require an external electric upper extremity system.

The MyoSystem with Customizing is an adult external electric upper extremity system which allows the CPO to adjust all relevant parameters of the control of an external powered upper extremity prosthesis by a Personal Computer (PC). The system allows the connection of the control of a prosthesis with a PC by serial communication. A PC Software program allows the monitoring of how the patient performs with the prosthesis and enables the practitioner to change the control parameters according to the patient's needs. In addition, the practitioner can do the same program changes between control programs of a component as he/she can do by changing a colored coding plug. As it is a much faster process to change a program by the click of a button rather than to dismantle the prosthesis to gain access to the coding plug of a component, there is less disruption in the fitting process. This makes it less tiring for the patient and practitioner. As this system allows only additional adjustments to the existing adjustment possibilities by dials, there is no program change in the components, The same components which are used by the current conventional adjustment process are used with the adjustment process by CUSTOMIZING.

The provided text is a 510(k) summary for the Otto Bock MyoSystem with Customizing. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a regulatory submission for premarket notification, focusing on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting specific performance study results against defined acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

Here's why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on describing the device and asserting substantial equivalence.
2. Sample sized used for the test set and the data provenance: No test set or study data are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set or ground truth establishment is described.
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 device is an external limb prosthetic system, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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