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The Manual Wheelchair is to provide mobility to persons limited to a sitting position.

The S002, S004, S005, S006, S007, S008, S009 series are mechanical wheelchairs which are a manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bring the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to manoeuvre the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.

Main Components: Main frame, Backrest, Seat cushion, handgrip, front wheel, rear wheel, hand rim, crossbar, footrests, brake, Anti-tipper, Seat belt.

The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.

This FDA 510(k) summary describes a Manual Wheelchair (Models: S002, S004, S005, S006, S007, S008, S009) and its substantial equivalence to a predicate device (K232230). The information provided is for a physical medical device, not an AI/software device. Therefore, many of the requested categories related to AI/software performance criteria (such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document.

However, I can extract the acceptance criteria related to the physical device's performance and the study details that demonstrate it meets those criteria.

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 specified in the document. For physical device performance testing, samples are typically a representative number of units, but specific numbers are not usually detailed in a 510(k) summary unless a specific statistical power is claimed for a particular test.
• Data provenance: The tests were conducted by the applicant, Anhui JBH Medical Apparatus Co., Ltd, in China (No.116 QiCang Road Industrial District MingGuang Chuzhou,Anhui, China). The data is retrospective in the sense that the tests were performed on finished devices to demonstrate compliance.

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. For physical device performance, "ground truth" is established through standardized testing procedures and objective measurements as defined by the referenced ISO standards, not through expert consensus on interpretation.

4. Adjudication method for the test set:

Not applicable. Physical device performance is determined by meeting objective criteria defined in the ISO standards, not by an adjudication process as used in clinical or imaging studies.

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/software device.

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 AI/software device.

7. The type of ground truth used:

The "ground truth" for the device's performance is established by its adherence to the technical specifications and performance limits defined within the cited international ISO standards (e.g., ISO 7176 series for wheelchairs and ISO 10993 series for biocompatibility). This is essentially objective measurement against predefined engineering and biocompatibility standards.

8. The sample size for the training set:

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

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

Not applicable. This is a physical medical device, not an AI/software device.

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The Bowhead ERA Wheelchairs are manually operated wheelchairs intended to be used as a means of mobility for individuals restricted to a sitting position.

The Bowhead ERA Wheelchairs are composite based mechanical, manually operated, wheelchairs intended to be used as a means of mobility for adults restricted to a sitting position. Using the push ring on the rear wheels, users can self-propel themselves forward or backwards. The chairs are designed for riding over various indoor and outdoor surfaces. The Bowhead ERA Wheelchairs include four (4) mechanical wheelchair models with each model containing slightly different design features. Each wheelchair is provided assembled with a sling backrest, seat, seat post, brakes, frame, rear wheels, and casters. The overall length, width and height, backrest angle, COG, wheelbase, and seat width and height are adjustable ensuring comfort for the patient.

The provided text is a 510(k) summary for the Bowhead ERA Wheelchairs. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, the information you've requested regarding acceptance criteria, a study proving the device meets them, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types and establishment is not available in this document.

The document details a comparison of technological characteristics between the Bowhead ERA Wheelchairs and two predicate devices (APEX Manual Wheelchair and Panthera X) and lists non-clinical tests performed to support substantial equivalence. These non-clinical tests are against established standards for wheelchairs, not against a specific set of acceptance criteria derived from a clinical study for this particular device.

Here's a breakdown of what is available in the document related to performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of specific acceptance criteria for the device's performance in the sense of clinical accuracy or diagnostic capabilities. Instead, it lists the non-clinical tests performed and concludes that the device is "as safe and effective as the predicate devices" based on these tests.

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

• Sample Size: Not applicable. The "tests" mentioned are non-clinical engineering and performance tests on the device itself, not clinical trials with human subjects.
• Data Provenance: Not applicable. The data comes from physical testing of the device, not from human data.

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

• Not applicable, as this is related to clinical evaluation and ground truth for diagnostic accuracy, which is not the subject of this 510(k) summary. The "tests" are against engineering standards.

4. Adjudication Method for the Test Set:

• Not applicable for the same reasons as above.

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

• No. MRMC studies are typically for medical imaging or diagnostic devices where human interpretation is involved. This device is a mechanical wheelchair.

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

• Not applicable. This device does not involve algorithms or AI.

7. The Type of Ground Truth Used:

• Not applicable in the context of clinical ground truth. The "ground truth" for the non-clinical tests is adherence to the specified RESNA WC-1:2019 standards and flammability requirements.

8. The Sample Size for the Training Set:

• Not applicable. There is no AI or machine learning model being trained for this device.

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

• Not applicable.

In summary, the provided document is for a mechanical wheelchair, which falls under a different regulatory pathway (510(k) for substantial equivalence to a predicate device) than, for example, an AI/ML-driven diagnostic tool. Therefore, the types of clinical and performance studies you're asking about are not relevant to this specific device submission. The "study" proving the device meets criteria is a series of non-clinical, engineering-based performance tests against recognized standards.

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The Manual Wheelchair is to provide mobility to persons limited to a sitting position.

The MASY23 manual wheelchair is a mechanical wheelchair which is a manually operated, attendant and self-propelled transport device in a health care environment such as a hospital, nursing home or extended care facility. It is intended for medical purpose to provide mobility to persons limited to a sitting position. It can be folded for transport by bring two sides together.

The MASY23 Manual Wheelchair incorporates a main frame, a seat, two hand rims and four wheels. The wheelchair is designed with two small rear wheels and two gearing with hand rim, it can be manually moved forward and in reverse. The wheelchair can support users of up to 136 kg.

The provided text is a 510(k) Premarket Notification from the FDA regarding a Manual Wheelchair (MASY23). It does not describe a study, acceptance criteria, or performance data for an AI/ML-driven medical device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established, as these concepts are not applicable to the clearance of a manual wheelchair.

The document focuses on demonstrating substantial equivalence of the manual wheelchair to a predicate device through non-clinical performance and biocompatibility testing, primarily against ISO standards.

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The SYIV100-CA9221 manual wheelchair is to provide mobility to persons limited to a sitting position

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Manual Wheelchair (SYIV100-CA9221)" does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) process for a mechanical wheelchair, as is the case here (Regulation Number: 21 CFR 890.3850, Product Code: IOR), focuses on demonstrating substantial equivalence to a predicate device. This typically involves comparing features, specifications, and sometimes basic functional tests to ensure the new device performs as safely and effectively as a legally marketed predicate.

The document is a standard FDA clearance letter and discusses:

• The determination of substantial equivalence.
• General controls and regulations applicable to the device (e.g., annual registration, listing, GMP, labeling, UDI).
• Contact information for various FDA departments.
• The indications for use of the wheelchair: "to provide mobility to persons limited to a sitting position."

It does not contain the type of AI/algorithm performance study information you are asking for, which would be typical for a software as a medical device (SaMD) or AI-powered medical device clearance.

Therefore, I cannot populate the requested table or answer your specific questions about acceptance criteria, study design, expert consensus, ground truth, or MRMC studies based on the provided text. This document is for a simple mechanical device, not an AI or algorithm-driven one.

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The Manual Wheelchair is to provide mobility to persons limited to a sitting position.

MW18 manual wheelchair is a mechanical which is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bring the two sides together. The manual wheelchair incorporates a foldable frame, a seat, two footrests and four wheels. The larger rear wheels have push-rims of slightly smaller diameter projecting just beyond the user to manoeuvre the chair by pushing them on without requiring them to grasp the tyres. The manual wheelchairs have brakes that bear on the tyres of there are two push handles at the upper rear of the frame to allow for manual propulsion by a second person, e.g. caregiver. The wheelchair can support users of up to 120kg.

Main Components:

Main frame, back upholstery, seat upholstery, handgrip, armrest, front wheel, hand rim, crossbar, footrest, skirt guard, brake, anti-tipper (optional)

The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.

The provided FDA 510(k) summary is for a Manual Wheelchair (MW18), a Class I, reserved medical device. This type of device does not typically involve AI components or require the complex statistical studies, multi-reader multi-case studies, and expert ground truth establishment that are common for AI/ML-driven diagnostic devices.

Instead, the acceptance criteria for a manual wheelchair primarily focus on functional performance, safety, and compliance with established industry standards. The study proving the device meets these criteria is a series of non-clinical performance tests conducted in accordance with international standards for wheelchairs.

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

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

The document lists the ISO standards that the device complies with, which effectively serve as the acceptance criteria. The "reported device performance" is the statement of compliance with these standards.

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

The document does not specify a "test set" in the context of patient data, as this is a mechanical device. The "test set" refers to the physical units of the Manual Wheelchair (MW18) that were subjected to the non-clinical tests. The document does not explicitly state the number of sample units used for these tests. Data provenance is not applicable in the context of patient data as it's not an AI/ML 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 to this device. "Ground truth" in the context of AI/ML performance is not relevant for a mechanical manual wheelchair. The "truth" is established by the ability of the device to meet the defined performance specifications and safety standards through physical testing.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical image interpretation, not for mechanical device testing. Compliance with standards is typically assessed by conformity to predefined pass/fail criteria for each test.

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. An MRMC study is designed for evaluating the performance of diagnostic algorithms, often with human readers in the loop. This device is a manual wheelchair, not a diagnostic AI tool.

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

This is not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device is the compliance with established international performance and safety standards (ISO standards) for manual wheelchairs. This is determined through objective, quantifiable physical tests, rather than expert consensus, pathology, or outcomes data in the way it's understood for diagnostic devices.

8. The sample size for the training set

This is not applicable. There is no "training set" for a mechanical device like a manual wheelchair.

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

This is not applicable. There is no "training set" or "ground truth for a training set" for this type of device.

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The Merlexi Craft Bariatric series of manual wheelchairs are intended for use to empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions for which manual wheelchairs are generally prescribed for use. In particular, the Merlexi Craft Bariatric wheelchairs are intended for users up to 425 pounds. They are not for MRI environment use.

Not Found

Due to the nature of the provided document, which is a letter from the FDA regarding a 510(k) premarket notification for a medical device (manual wheelchairs), the requested information about acceptance criteria and a study proving those criteria are met is not present in the document.

This document is primarily concerned with confirming that the Merlexi Craft Bariatric series of manual wheelchairs is substantially equivalent to legally marketed predicate devices, and it outlines regulatory requirements and general controls for marketing such a device.

Here's why the requested information is not found:

• Acceptance Criteria and Device Performance: The letter states the device is "substantially equivalent" to predicate devices. This means it has similar technological characteristics and is intended for the same use as a device already on the market. It does not provide specific performance metrics or acceptance criteria for the new device itself. Information like wheelchair weight capacity (up to 425 pounds) is an "indication for use" rather than a performance criterion for a study.
• Study Details: A 510(k) submission generally relies on comparisons to predicate devices or on non-clinical (bench) testing to demonstrate substantial equivalence, rather than a clinical study with human subjects, especially for a Class I device like a manual wheelchair. The letter itself does not describe any specific study, sample sizes, ground truth, or expert involvement as typically would be found for AI/software devices requiring detailed performance evaluation.
• AI/Software-Specific Information: Questions 5, 6, 8, and 9 are highly specific to AI/software performance studies (MRMC, standalone algorithm, training set size, etc.). The Merlexi Craft Bariatric series of manual wheelchairs is a mechanical device, and these types of studies are not applicable.

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document serves a different regulatory purpose than detailing performance study results.

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The YJ-K1/K2 Manual Wheelchair is to provide mobility to persons limited to a sitting position.

The YJ- K1,K2 series are mechanical wheelchairs which are a manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bring the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to manoeuvre the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.

The provided document pertains to a 510(k) premarket notification for a manual wheelchair (YJ-K1/K2 Wheelchair) and does not describe acceptance criteria or a study related to an AI/ML-driven device. The document primarily focuses on demonstrating substantial equivalence to a predicate manual wheelchair through non-clinical performance testing and biocompatibility testing.

Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training sets is not available within this document.

The document states:

• "No clinical study is included in this submission." (Page 8)
• The tests conducted are non-clinical, focusing on mechanical performance and biocompatibility to standards like ISO 7176 series and ISO 10993 series. (Page 8)
• The device is a "mechanical wheelchair" (Page 5).

Since the request is specifically for a device that would require such studies (e.g., an AI/ML diagnostic device), and this document describes a manual wheelchair, it is not possible to extract the requested information.

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The YJ-010B Manual Wheelchair is to provide mobility to persons limited to a sitting position.

The YJ-010B series is a mechanical wheelchair which is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bringing the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footplates and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to maneuver the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.

The provided document is a 510(k) premarket notification for a Bariatric Heavy Duty Wheelchair. It does not describe an AI medical device or a study involving AI assistance or human readers. Therefore, I cannot extract information related to acceptance criteria and study proving a device meets those criteria for an AI-powered device, as the document pertains to a mechanical wheelchair.

The document discusses:

• Acceptance criteria (implicitly): The device (a manual wheelchair) needs to demonstrate substantial equivalence to a predicate device, primarily through non-clinical performance testing and biocompatibility assessments, adhering to various ISO standards.
• Device performance: The document lists various specifications of the proposed wheelchair (e.g., dimensions, weight capacity, stability angles, brake effectiveness) and states that these comply with relevant ISO standards.
• Ground Truth: For a mechanical device like a wheelchair, "ground truth" would relate to its physical properties and performance metrics as measured according to established engineering and safety standards (e.g., ISO 7176 series).
• Sample Size: Not applicable in the context of an AI test set. This refers to physical samples of the wheelchair models being tested.
• Experts/Adjudication/MRMC/Standalone: These concepts are not applicable to the evaluation of a mechanical wheelchair. There is no AI algorithm being evaluated.
• There is no clinical study included in this submission.

To answer your request, here's a blank template for an AI medical device study, illustrating the elements you've asked for, as this document does not contain the necessary information.

Acceptance Criteria and Study for an AI Medical Device

Study Description:
(This section would be filled if the document were about an AI device. As it is not, this remains a template.)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The above table is a placeholder for a hypothetical AI device study and cannot be populated from the provided document, which describes a mechanical wheelchair.

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

• Test Set Sample Size: [Number of cases/patients/images]
• Data Provenance: [e.g., Retrospective or Prospective; Country of origin (e.g., Multi-site from US, Europe, Asia)]

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

• Number of Experts: [ e.g., 3]
• Qualifications of Experts: [e.g., Board-certified Radiologists with >10 years of experience in [specific domain, e.g., chest imaging, mammography]; Certified Pathologists with >5 years of experience]

4. Adjudication Method for the Test Set

• Adjudication Method: [e.g., 2+1 (two initial readers, third independent reader for discordance); 3+1 (three initial readers, fourth independent reader for discordance if majority not reached); Consensus meeting; None (if single reader ground truth)]

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance?

• MRMC Study Conducted?: [Yes/No]
• Effect Size (e.g., improvement in AUC or F-measure for human readers with AI assistance vs. without AI): [e.g., Human readers' AUC improved from X to Y (an absolute increase of Z); F-measure increased by Z%]

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

• Standalone Performance Study Conducted?: [Yes/No]
• Key Performance Metrics (if Yes): [e.g., Sensitivity: X%, Specificity: Y%, AUC: Z]

7. The Type of Ground Truth Used

• Type of Ground Truth: [e.g., Expert consensus (radiologist readings); Pathological diagnosis (biopsy/histology); Clinical outcomes data (e.g., hospital discharge codes, follow-up imaging); Longitudinal follow-up data]

8. The Sample Size for the Training Set

• Training Set Sample Size: [Number of cases/patients/images]

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

• Ground Truth Establishment for Training Set: [e.g., Clinical reports by attending physicians; Single expert review; Automated label extraction; A subset might be expert-reviewed, while the majority are from routine clinical practice.]

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The YJ-011S Manual Wheelchair is to provide mobility to persons limited to a sitting position.

The YJ-011S series is a mechanical wheelchair which is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bringing the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to maneuver the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.

The provided text describes a 510(k) premarket notification for a reclining wheelchair, which is a Class I device. As such, the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing, rather than a clinical study or AI/software validation. Therefore, many of the requested elements regarding acceptance criteria for AI performance, clinical study details, expert review, effect size, and training/test set specifics are not applicable or not present in this type of regulatory submission.

Applicable Information from the Submission:

This submission for the Zhenjiang Assure Medical Equipment Co., Ltd. Reclining Wheelchair (K232198) primarily relies on demonstrating compliance with recognized performance standards for mechanical wheelchairs and biocompatibility testing. The "acceptance criteria" are implied by the successful execution and results of these tests, showing the device meets the safety and performance benchmarks established by the standards and is comparable to the predicate device.

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

The submission does not present a formal "acceptance criteria" table with specific quantitative thresholds that would be typical for an AI/software device. Instead, acceptance is demonstrated by compliance with international standards for wheelchairs and biocompatibility. The "reported device performance" is that the device complied with these standards.

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

This information is not applicable. The evaluations were non-clinical performance and biocompatibility tests of the physical device, not an assessment of software or AI performance on a data set. Therefore, there is no "test set" in the context of data or images, nor data provenance.

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. There was no test set requiring expert ground truth establishment for this type of medical device submission.

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

This information is not applicable. There was no test set requiring adjudication in this type of submission.

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

This information is not applicable. This device is a mechanical wheelchair, not an AI-assisted diagnostic or interpretative device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

This information is not applicable. This device is a mechanical wheelchair and does not involve an algorithm.

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

This information is not applicable in the context of "ground truth" for AI/software. The "ground truth" for this device's performance is defined by the established criteria and methods within the referenced ISO standards for mechanical wheelchairs and biocompatibility.

8. The sample size for the training set

This information is not applicable. This device is a mechanical wheelchair and does not involve AI or machine learning that would require a training set.

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

This information is not applicable. This device is a mechanical wheelchair and does not involve AI or machine learning that would require a training set or its associated ground truth establishment.

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The Ki Mobility Focus CR manual wheelchair is a manually operated device with wheels that is intended to provide mobility to adults restricted to a sitting position.

The Ki Mobility Focus CR manual wheelchair is intended to provide mobility to adults limited to a sitting position. The primary use is by adult users in need of manual wheeled mobility offering an operator adjustable body support system. The Focus CR offers both seat tilt and an optional reclining backrest, with both adjustable by the attendant.

The Focus CR manual wheelchair can be propelled by the occupant with access to hand-rims on the rear wheels or moved by an attendant with access to push handles are used by the attendant to control the seat tilt function and recline of the backrest. Hand control levers on the push handles or a foot-operated pedal on the frame are used to release a slide-locking mechanism for changing the seat tilt angle. The backrest recline is controlled through hand control levers on the push handles which release sliding mechanical wrapped spring rod locks to change the backrest angle.

The Focus CR wheelbase is of a welded high-strength aluminum frame, upon which an inner high-strength forged aluminum frame can rotate on four rollers (two on each side) fixed to the base frame. The use of two control paths rolling on the fixed rollers is designed to create a complex rotation (CR) with a neutral resting angle of 20° tilt and minimizes the translation of the user-loaded system weight for safely controlling the change in seat tilt angle. The high-strength tubular aluminum seat frame assembles to the inner rotating frame and can be adjusted for seat depth and to adjust the user loaded center of gravity (CG) relative to the frame. Seat adjustment is optimal when the user-loaded and unlocked seating system will rest without force applied at 20°. CG adjustment is made with two easily accessed bolts are align to a series of holes through the seat frame and connected to the inner rotating frame.

The Focus CR manual wheelchair has a folding backrest frame for ease of storage for transport. A non-folding backrest and a reclining backrest are options. The adjustable tubular aluminum seat and backrest frame assembly is made to adapt to planar seating systems which have hardware adapted to mount to tubes. A solid mounted and depth adjustable aluminum seat pan is available for use with wheelchair seat cushions and the backrest frame accepts contoured wheelchair backrests. The seating system is a separate medical device adapted for use to the Focus CR and is the primary contact surface to the occupant. Focus CR components such as armrests and footrests will also have contact to the occupant.

The Focus CR wheelchair is custom configured to the user requirements by order form selection of components and accessories. The standard weight capacity for all models is 300 pounds, with an option for configuration as a heavy-duty weight capacity of 400 lbs. The seat tilt range is -5° to 50° with an accessory tilt stop available to limit the range. The backrest recline option range is available from 0 to 65°, 10° to 75° or 20° to 85°. The Focus CR, CRe & TTL are the same product with order form variations to meet different market configuration requirements only for pricing.

This document is a 510(k) Summary for a medical device called the "Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL," which is a mechanical wheelchair. The purpose of this summary is to demonstrate substantial equivalence to previously marketed predicate devices (Ki Mobility Focus CR to Invacare (K181090) and Sunrise Medical, Quickie IRIS (K123975)).

The acceptance criteria and study that proves the device meets these criteria are primarily based on non-clinical performance testing against recognized international standards for wheelchairs. There are no clinical studies mentioned or required for this submission. Therefore, for a device like a mechanical wheelchair, the "performance" is demonstrated through adherence to engineering and safety standards, rather than clinical efficacy or diagnostic accuracy.

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

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

The acceptance criteria are generally "Pass/Fail Limits" as defined by the recognized standards, or "Informative" for comparison data. The reported device performance is "PASS" for tests with pass/fail limits and "Comparison Data" for informative tests.

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

• Sample Size: The document does not specify a numerical sample size for the mechanical wheelchairs tested. It implies that "the Focus CR" (singular, referring to the model) was tested according to the standards. For non-clinical, bench testing of physical devices, "sample size" typically refers to the number of units tested. However, the standards themselves often dictate the number of test pieces required (e.g., prototypes, production units). It's reasonable to assume standard engineering practices were followed, which usually involve testing a small number of representative units to destruction or for endurance.
• Data Provenance: The tests were conducted by a "Third party lab testing." The country of origin is not explicitly stated, but the standards cited (ANSI/RESNA, ISO) are international. The nature of the testing is retrospective in the context of the 510(k) submission, as these tests were completed before the submission to demonstrate compliance. They are not prospective clinical trials.

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

This question is not applicable in the context of this device. The "ground truth" for a mechanical wheelchair's performance is established by objective engineering measurements and adherence to predefined specifications within recognized international standards. There are no human experts "establishing ground truth" in the way radiologists interpret images for an AI study. The "experts" here would be the engineers and technicians at the third-party lab who conduct the tests and ensure they conform to the standard's methodology. Their qualifications would be expertise in mechanical testing and adherence to quality systems.

4. Adjudication method for the test set

Not applicable. There is no subjective interpretation that requires adjudication. The tests involve quantifiable measurements (e.g., angles, forces, dimensions) and observations (e.g., breakage, slippage) against pass/fail criteria defined by the standards.

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 mechanical wheelchair, not an AI-powered diagnostic or assistive technology 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 device is a mechanical wheelchair. There is no "algorithm only" performance separate from the physical device itself.

7. The type of ground truth used

The "ground truth" for the performance evaluation of this mechanical wheelchair is:

• Established engineering standards and specifications: Compliance with objective, quantifiable metrics defined by ANSI/RESNA WC-1:2009, WC-4:2012, and the ISO 7176 series (e.g., static stability angles, brake effectiveness, fatigue strength limits).
• Physical performance measurements and observations: Direct measurements and observations during bench testing conducted by a third-party laboratory.

8. The sample size for the training set

Not applicable. This is a physical mechanical device, not a machine learning model. Therefore, there is no "training set."

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

Not applicable, as there is no training set for a mechanical wheelchair. For this specific device, the closest analog to "ground truth establishment" would be the initial design specifications, engineering calculations, and component testing, long before full product integration and final performance testing against standards.

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