(226 days)
The Navigator (model: FMNVG15) and Navigator XL (model: FMNVX06) 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 Navigator (model: FMNVG15) and Navigator XL (model: FMNVX06) is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people.
The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, safety belt, pedal, battery box and charger. The device is powered by Li-ion Battery pack (24V 6Ah*2) with 16 Km range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.
The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.
The provided document, a 510(k) Pre-market Notification for the Navigator and Navigator XL powered wheelchairs, does not describe a study involving an AI/Machine Learning device, expert adjudication, or complex ground truth establishment. Instead, it focuses on demonstrating substantial equivalence to a predicate device through adherence to established performance standards for medical devices like powered wheelchairs.
Therefore, many of the requested details, such as those related to AI/ML performance, human readers, training/test sets, and expert consensus for ground truth, are not applicable to this document.
However, I can extract the acceptance criteria and the "device performance" in terms of meeting those criteria.
Here's a breakdown of the information that is available in the document, formatted to the extent possible according to your request:
Acceptance Criteria and Device Performance (for a Powered Wheelchair)
This section describes the performance evaluation of the Forcemech International LLC Navigator and Navigator XL powered wheelchairs against established international standards for wheelchairs. The study's purpose was to demonstrate substantial equivalence to a predicate device (K232193) by meeting these standards.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by adherence to various parts of the ISO 7176 series of standards and ISO 10993 series for biocompatibility. The reported device performance is that the device meets or complies with these standards.
| Acceptance Criteria (Standard & Clause) | Specific Performance Requirement (Implicit from Standard) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| ISO 10993-5: 2009 | Tests For In Vitro Cytotoxicity | All user directly contacting materials are compliant. |
| ISO 10993-10: 2021 | Tests For Irritation And Skin Sensitization | All user directly contacting materials are compliant. |
| ISO 10993-23: 2021 | Tests For Irritation | All user directly contacting materials are compliant. |
| Performance (ISO 7176 Series) | ||
| ISO 7176-1: 2014 | Determination of static stability | Test results meet its design specification. |
| ISO 7176-2: 2017 | Determination of dynamic stability of Powered Wheelchairs | Test results meet its design specification. |
| ISO 7176-3: 2012 | Determination of effectiveness of brakes | Test results meet its design specification. |
| ISO 7176-4: 2008 | Determination of theoretical distance range | Test results meet its design specification. |
| ISO 7176-5: 2008 | Determination of overall dimensions, mass and manoeuvring space | Dimensions and mass determined after testing. |
| ISO 7176-6: 2018 | Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs | Dimensions and mass determined after testing (likely refers to speeds, acceleration, deceleration). |
| ISO 7176-7 | Measurement of seating and wheel dimensions | Seating and wheel dimensions determined after testing. |
| ISO 7176-8: 2014 | Requirements and test methods for static, impact and fatigue strengths | All test results meet the requirements in Clause 4. |
| ISO 7176-9: 2009 | Climatic tests for Powered Wheelchairs | Device continued to function according to manufacturer's specification after tests. |
| ISO 7176-10: 2008 | Determination of obstacle-climbing ability of electrically powered wheelchairs | Obstacle-climbing ability determined after testing. |
| ISO 7176-11: 2012 | Test dummies | Test dummies used meet the requirements of ISO 7176-11. |
| ISO 7176-13: 1989 | Determination of coefficient of friction of test surfaces | Coefficient of friction of test surfaces determined. |
| ISO 7176-14: 2008 | Power and control systems for electrically powered wheelchairs and wheelchairs - Requirements and test methods | All test results meet requirements in Clauses 7, 8, 9, 10, 11, 12, 13, 14, 15, 17. |
| ISO 7176-15: 1996 | Requirements for information disclosure, documentation and labeling | Information disclosure, documentation, and labeling meet requirements. |
| ISO 7176-16: 2012 | Resistance to ignition of postural support devices | Performance meets the requirements. |
| ISO 7176-21: 2009 | Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and wheelchairs, and battery chargers | EMC performance results meet the requirements. |
| ISO 7176-25: 2013 | Batteries and chargers for powered wheelchairs | Performance of batteries and charger meet requirements in Clause 5 and 6. |
| Electrical Safety | ||
| IEC 60601-1-2 (related to EMC) | Electromagnetic Compatibility | Compliant. (Note: ISO 7176-21 overlaps here primarily). |
| Labeling | ||
| FDA Regulatory | General labeling requirements | Conforms to FDA Regulatory. |
The document also provides specific performance values for some parameters, as compared to the predicate device, although these are not explicitly presented as "acceptance criteria" but rather as "comparison elements" that need to demonstrate substantial equivalence:
| Parameter | Acceptance Criteria (implied, if different from predicate, must be shown safe/effective) | Reported Device Performance | Predicate Device Performance |
|---|---|---|---|
| Braking distance | ≤1.5 m | ≤1.5 m | ≤1.5 m |
| Max safe operational incline degree | 6° | 6° | 6° |
| Battery (Type) | Li-ion battery, rechargeable | Li-ion battery, rechargeable | Li-ion battery, rechargeable |
| Max speed forward | Up to 6 km/h | Up to 6 km/h | Up to 6 km/h |
| Max Speed backward | Less than 3 km/h (0.8 m/s) | Less than 3 km/h (0.8 m/s) | Less than 3 km/h (0.8 m/s) |
| Max loading weight | 120 Kg | 120 Kg | 120 Kg |
| Maximum obstacle climbing | 40 mm | 40 mm | 40 mm |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: The document describes non-clinical testing performed on the device itself. For each standard mentioned (e.g., ISO 7176 series, ISO 10993 series), tests are conducted on a statistically appropriate number of units or materials according to the specific standard's requirements. This is not a patient-based test set but rather a device-based test set. The exact number of units tested for each standard is not specified in this summary but would be detailed in the full test reports.
- Data Provenance: The tests are "non-clinical tests" conducted to verify compliance with design specifications and substantially equivalence. The location of testing is implicitly China, given the applicant's contact person is in Shanghai, China, and the submission correspondent is also from Shanghai, China. The data would be prospective in the sense that the manufacturer specifically conducted these tests on their device models.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a non-clinical device performance study against engineering and safety standards, not a diagnostic AI/ML study requiring expert radiologists for image interpretation or clinical ground truth. The "ground truth" here is the adherence to the published ISO/IEC standards, which are developed by international expert committees through a consensus process.
4. Adjudication Method for the Test Set
Not applicable. This is a non-clinical device performance study. The "adjudication" is met by passing the specified tests against the published standard criteria.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done
No. This document explicitly states: "No clinical study is included in this submission." This type of study is for evaluating human performance, typically in diagnostic imaging, and is not relevant for a powered wheelchair's non-clinical safety and performance testing.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (powered wheelchair), not an AI/ML algorithm. The performance evaluation is for the physical device and its electrical/mechanical systems.
7. The Type of Ground Truth Used
The ground truth used for this device's acceptance is adherence to well-defined, internationally recognized engineering and safety standards (ISO 7176 series for wheelchairs, ISO 10993 series for biocompatibility, and IEC 60601-1-2 for EMC). These standards dictate specific test methods and acceptance criteria that the device must meet to be considered safe and effective for its intended use.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI/ML training set.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).