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510(k) Data Aggregation
(176 days)
The device is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The subject device, Powered Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed. The Powered Wheelchairs consist of two foldable armrests, a backrest, a seat cushion, a safety belt, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller. The NXN20-209 Powered Wheelchair is intended to provide mobility to a disabled or elderly person limited to a seated position. The Powered Wheelchair has 7 inch front wheel and 12 inch rear tire. The motor of electric wheelchair is DC24V 200W; the battery is 24V 12AH, Li-ion battery; the charger is 24V/3A. Max. loading can not be over than 110Kgs. Max. distance of travel on the fully charged battery is 16.5 km and Max. speed forward is 6km/h. The braking time is about 2s, and the braking distance is less than or equal to 1.76m.
The provided text describes a 510(k) submission for a Powered Wheelchair (NXN20-209). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through a comparative study with a "human-in-the-loop" component as is common for AI/ML-driven diagnostics. The information provided is primarily related to engineering performance and safety standards for the physical device itself.
Therefore, the requested information regarding acceptance criteria and a study that proves the device meets the acceptance criteria, as phrased for AI/ML device performance (e.g., sample size for test set/training set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment), is not applicable in the context of this traditional medical device submission.
The document states: "No clinical study implemented for the electric wheelchair." This confirms that the typical clinical performance studies asked for in your prompt were not conducted or required for this device's clearance.
Instead of AI/ML-specific performance criteria, the acceptance criteria for this powered wheelchair are based on adherence to recognized international standards for wheelchairs and a comparison of its physical and performance characteristics to a predicate device.
Here's a breakdown of what the document does provide in relation to acceptance criteria and performance:
1. A table of acceptance criteria and the reported device performance:
The document includes two comparison tables (Table 1: General Comparison and Table 2: Performance Comparison) that demonstrate the similarity and conformance of the proposed device to a predicate device and relevant standards. While not "acceptance criteria" in the sense of a specific numerical threshold for a diagnostic outcome, these aspects represent the performance benchmarks the device successfully met.
Table 1 & 2 (summarized and adapted to your request format):
| Acceptance Criteria Category | Specific Metric/Standard | Reported Device Performance (NXN20-209) | Predicate Device (A08) Performance | Remark/Acceptance Demonstrated By |
|---|---|---|---|---|
| General Characteristics | Product Code | ITI | ITI | Same (Substantially Equivalent) |
| Regulation No. (21 CFR) | 890.3860 | 890.3860 | Same (Substantially Equivalent) | |
| Classification | Class II | Class II | Same (Substantially Equivalent) | |
| Intended Use | Motor driven, indoor/outdoor transportation for disabled/elderly limited to seated position | Motor driven, indoor/outdoor trans. for disabled/elderly limited to seated position | Same (Substantially Equivalent) | |
| Driving system | Direct drive on rear wheels | Direct drive on rear wheels | Same (Substantially Equivalent) | |
| Movement control method | By Joystick control | By Joystick control | Same (Substantially Equivalent) | |
| Number of wheels | 4 | 4 | Same (Substantially Equivalent) | |
| Brake system | Automatic electromagnetic brake system | Electromagnetic brake system | Same (Substantially Equivalent) | |
| Speed control method | Joystick control method | Joystick control method | Same (Substantially Equivalent) | |
| Performance Metrics | ISO 7176-1:2014 Static Stability | Forward: 18.9°, Rearward: 18.2°, Sideways: 20.7° | Not publicly available | Both devices evaluated according to same standard; differences in static stability will not impact safety and effectiveness. |
| ISO 7176-4:2008 Cruising Range | 16.5 km | 20 km | Complies with ISO 7176-4:2008; differences do not affect safety and effectiveness. | |
| ISO 7176-3:2012 Minimum Braking Distance | ≤ 1.76m | 1m | Similar; compliant with standard. | |
| ISO 7176-6:2018 Max Speed Forwards | 1.66 m/s (6 km/h) | 1.94m/s (7 km/h) | Both devices evaluated according to same standard; differences will not impact safety and effectiveness. | |
| ISO 7176-6:2018 Max Speed Backward | 0.8 m/s (2.88 km/h) | Not publicly available | Both devices evaluated according to same standard; differences will not impact safety and effectiveness. | |
| Max. loading (weight capacity) | 242.5 lbs (110 kg) | 220 lbs (100 kg) | Device supports more loading weight without raising new safety/effectiveness concerns. | |
| Min. Turning Radium | 870mm | 800mm | Similar performance. | |
| Obstacle climbing | 25 mm | 40 mm | Smaller height in obstacle climbing will not impact safety and effectiveness. | |
| Software Verification and Validation Testing | Compliant with FDA Guidance | Included | Compliance with FDA guidance for software functions documented. | |
| Safety & Materials | Biocompatibility of materials contacting user | Compliant with FDA Guidance, ISO 10993-1 | Compliant with ISO 10993-1, FDA Guidance (tests included) | Biocompatibility evaluation carried out per ISO 10993-1; no new safety and effectiveness concerns due to differences. |
| Compliance with EMC standards (IEC 60601-1-2:2020, ISO 7176-21:2009) | Performed (Implied by inclusion in Non-Clinical Testing Summary) | Performed (Implied by inclusion in Non-Clinical Testing Summary) | Test results demonstrated compliance. | |
| Compliance with other ISO 7176 series for safety, fatigue, dimensions etc. | Performed and Compliant | Performed (Implied by predicate clearance) | Test results demonstrated compliance with numerous ISO standards for wheelchairs. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. No human subjects "test set" was used for performance evaluation in the context of an AI/ML algorithm. The testing was non-clinical (bench and engineering tests) based on international standards for mechanical and electrical safety and performance of wheelchairs. The document does not specify a "sample size" for these non-clinical tests in the way one would for a clinical study. Data provenance is implied by the testing standards and the manufacturer's location (China), but not detailed as typical for clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. Ground truth, in the AI/ML sense, is not established for this type of device. Performance is determined through objective, standardized engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Not a clinical study 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:
- Not Applicable. This is not an AI-assisted diagnostic or image analysis device, so MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical powered wheelchair, not an AI algorithm. Software verification and validation (standalone) was done for the device's control software, ensuring it functions correctly, but this is distinct from AI/ML performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable/Objective Standards. The "ground truth" for this device's performance is compliance with established international engineering and safety standards (e.g., ISO 7176 series, IEC 60601-1-2) which define objective, measurable criteria for stability, speed, braking, etc.
8. The sample size for the training set:
- Not Applicable. No AI/ML training set is mentioned or relevant for this device.
9. How the ground truth for the training set was established:
- Not Applicable. No AI/ML training set is mentioned or relevant for this device.
In summary: The provided document is for a traditional powered medical device, not an AI/ML-driven diagnostic or imaging device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to documented compliance with relevant recognized industry standards (primarily ISO and IEC) through non-clinical testing, and demonstrated substantial equivalence to a predicate device.
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(169 days)
The device is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The subject device, Powered Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed. The Powered Wheelchairs consist of two foldable armrests, a backrest, a seat cushion, a safety belt, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller.
The NXN20-208 and NXN20-211 Powered Wheelchair is intended to provide mobility to a disabled or elderly person limited to a seated position.
The Powered Wheelchair has 7 inch front wheel and 11 inch rear tire.
The motor of electric wheelchair is DC24V 200W; the battery is 24V 12AH, Li-ion battery; the charger is 24V/3A.
Max. loading can not be over than 110Kgs.
Max. distance of travel on the fully charged battery is 16 km and Max. speed forward is 6km/h.
The braking time is about 2s, and the braking distance is
The provided document is a 510(k) premarket notification for a Powered Wheelchair (models NXN20-208, NXN20-211). It focuses on demonstrating substantial equivalence to a predicate device (A08 Power Wheelchair, K163204) rather than presenting a study to prove acceptance criteria for a novel device. Therefore, much of the requested information regarding clinical studies, ground truth establishment, expert adjudication, and AI performance is not applicable to this submission.
However, the document does contain "acceptance criteria" through a demonstration of compliance with recognized standards and a comparison of performance characteristics to a predicate device, which serves as a benchmark for safety and effectiveness in this regulatory context.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria (Standard Compliance) and Reported Device Performance
For a medical device like a powered wheelchair, acceptance criteria are generally defined by compliance with a set of established performance standards. The "reported device performance" is demonstrated by the completion of non-clinical tests verifying compliance with these standards.
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance Status) |
|---|---|
| ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability | Complies |
| ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electrically powered wheelchairs | Complies |
| ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes | Complies |
| ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range | Complies |
| ISO 7176-5:2008 Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space | Complies |
| ISO 7176-6:2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs | Complies |
| ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions | Complies |
| ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatique strengths | Complies |
| ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs | Complies |
| ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs | Complies |
| ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies | Complies |
| ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces | Complies |
| ISO 7176-14:2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods | Complies |
| ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling | Complies |
| ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers | Complies |
| ISO 7176-22:2014 Wheelchairs - Part 22: Set-up procedures | Complies |
| ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs | Complies |
| ISO 16840-10:2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method | Complies |
| IEC 60601-1-2:2020 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests | Complies |
| Software Verification and Validation Testing (according to FDA Guidance) | Complies |
| Biocompatibility of materials contacting user (Comply with FDA Guidance) | Complies |
Performance Characteristics (Comparison with Predicate Device):
| Item | Proposed Device | Predicate Device | Acceptance (Remark) |
|---|---|---|---|
| Overall length | NXN20-208: 1000mm; NXN20-211: 950mm | 890 mm | Minor differences will not impact safety and effectiveness. |
| Overall width | 600mm | 603 mm | Minor differences will not impact safety and effectiveness. |
| Stowage length | 340mm | 324 mm | Minor differences will not impact safety and effectiveness. |
| Stowage width | 600mm | 603 mm | Minor differences will not impact safety and effectiveness. |
| Stowage height | NXN20-208: 775mm; NXN20-211: 765mm | 670 mm | Minor differences will not impact safety and effectiveness. |
| Weight, w/ Battery | NXN20-208: 42.99 lbs./19.5kg; NXN20-211: 36.48 lbs./16.55kg | 61.7 lbs. /28 kg | The difference will not raise any new safety and effectiveness concerns. |
| Front wheel (inch) | 7 (PU solid tire) | 8 (PU solid tire) | Smaller sizes of front wheels. |
| Rear tire (inch) | 11 (PU solid tire) | 10 (PU solid tire) | Larger sizes of rear wheels bring steadier pivoting function than the predicate device. |
| Cruising Range (km) | 16 | 20 | The subject device complies with ISO 7176-4:2008 for energy consumption; these differences do not affect safety and effectiveness. |
| Obstacle climbing (mm) | 25 | 40 | The smaller height in the obstacle climbing will not impact the safety and effectiveness of the subject device. |
| Static stability forward | 18.8° | Not publicly available | Both devices evaluated per ISO 7176-1:2014; different static stability will not impact safety and effectiveness. |
| Static stability rearward | 20.4° | Not publicly available | Both devices evaluated per ISO 7176-1:2014; different static stability will not impact safety and effectiveness. |
| Static stability sideways | 20.5° | Not publicly available | Both devices evaluated per ISO 7176-1:2014; different static stability will not impact safety and effectiveness. |
| Max. loading (kg) | 242.5lbs (110kg) | 220 lbs (100 kg) | More loading weight means more convenient for transportation. |
| Min. Turning radium | NXN20-208: 850mm; NXN20-211: 840mm | 800mm | Similar |
| Minimum braking distance |
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(124 days)
The device is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The subject device, Powered Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed. The Powered Wheelchairs consist of two foldable armrests, a backrest, a seat cushion, a safety belt, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller. The NXN20-205 and NXN20-205M Powered Wheelchair is intended to provide mobility to a disabled or elderly person limited to a seated position. The Powered Wheelchair has 7 inch front wheel and 12 inch rear tire. The motor of electric wheelchair is DC24V 200W; the battery is 24V 12AH, Li-ion battery; the charger is 24V/3A. Max. loading can not be over than 110Kgs. Max. distance of travel on the fully charged battery is 16km and Max. speed forward is 5.5km/h. The braking time is about 2s, and the braking distance is ≤790m.
The provided text is a 510(k) Summary for a Powered Wheelchair (NXN20-205, NXN20-205M) and does not contain details about acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device.
The document describes a traditional medical device (a powered wheelchair) and its substantial equivalence to a predicate device based on non-clinical testing against established ISO standards for wheelchairs. There is no mention of AI or machine learning in this report.
Therefore, I cannot provide the requested information, such as:
- Table of acceptance criteria and reported device performance for an AI/ML device: This document details performance specifications for a physical wheelchair (e.g., speed, range, loading capacity, stability), not AI/ML metrics.
- Sample size used for the test set and data provenance: No test set or data provenance for an AI/ML model is mentioned.
- Number of experts used to establish ground truth and qualifications: This is irrelevant for a physical powered wheelchair.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not conducted as no AI assistance is involved.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable in the context of an AI/ML device.
- Sample size for the training set: No training set is mentioned.
- How the ground truth for the training set was established: Not applicable.
The document indicates that "Software Verification and Validation Testing" was performed in accordance with FDA Guidance for device software functions, but this refers to traditional software engineering validation, not AI/ML model validation with ground truth and performance metrics.
In summary, the provided text does not contain the information required to answer the prompt about acceptance criteria and studies for an AI/ML device.
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