(126 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
The SUNTEC Mechanical Wheelchair, model ST-WL-1000 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, and the upholstery fabric meets the Requirements of Section E, Part I for Upholstery Fabrics of California Technical Bulletin CAL 117: 2000 standard for flame retardance.
The document provided is a 510(k) premarket notification for a mechanical wheelchair, the SUNTEC Mechanical Wheelchair, model ST-WL-1000. For medical devices like this, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically demonstrated through performance testing against recognized national or international standards, and a comparison to a legally marketed predicate device.
Here's the breakdown of the information requested based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally established by the performance standards (ISO standards in this case), and the device performance is reported implicitly by the statement that the device "completed the performance tests in accordance with ISO 7176 series standards" and "function safely and effectively" and "performs as well as the legally marketed device." The comparison table directly addresses the performance relative to the predicate by noting "Same" or explaining why differences do not affect safety or effectiveness.
Acceptance Criteria (ISO Standards) and Reported Device Performance (as summarized by the manufacturer):
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 7176-1:1999 (Static Stability) | Passed (Implicitly, as device completed performance tests in accordance with ISO standards and functions safely and effectively). |
| ISO 7176-3:2012 (Effectiveness of Brakes) | Passed (Implicitly, as device completed performance tests in accordance with ISO standards and functions safely and effectively). |
| ISO 7176-5:2008 (Overall Dimensions, Mass, Maneuvering Space) | Overall Length: 41" / 1050 mm (Same as predicate: No change in safety or effectiveness). |
| Overall Width: 25" / 640 mm (Same as predicate: No change in safety or effectiveness). | |
| Handgrip Height: 29" / 740 mm (19.5% lower; not a change in safety/effectiveness if attendant's height is not too large). | |
| Stowage Length: 35.4" / 900 mm (Shorter length, increased convenience; no safety/effectiveness change). | |
| Stowage Width: 14.5" / 370 mm (Larger width, cannot stack more stuff; no safety/effectiveness change). | |
| Stowage Height: 36.2" / 915 mm (Same, no safety/effectiveness change). | |
| Total Mass: 38.5 lb / 17.5 kg (2.7% lighter, easier to maneuver). | |
| Mass of Heaviest Part: 25.5 lb / 11.7 kg (Lighter, easier to maneuver). | |
| Ground Clearance: 2.3" / 58.4 mm (Same, no safety/effectiveness change). | |
| Required Width of Angled Corridor: 34.4" / 875 mm (3.8% less; no safety/effectiveness change). | |
| Required Doorway Entry Depth: 59" / 1500 mm (13.6% larger; may bring inconvenience, but "ALWAYS ASK FOR HELP"; no safety/effectiveness change). | |
| Required Corridor Width for Side Opening: 28.5" / 725 mm (23.6% narrower, easier movement; no safety/effectiveness change). | |
| ISO 7176-7:1998 (Seating Dimensions) Definitions and Measuring Method | Seat Plane Angle: 4° (5.3% larger; no safety/effectiveness change). |
| Effective Seat Depth: 16.9"/430 mm (16% less; may bring less free space, but no safety/effectiveness change). | |
| Seat Width: 17.3" - 18.1" / 440-460 mm (Larger, more comfortable; no safety/effectiveness change). | |
| Effective Seat Width: 17.3"- 17.5"/ 440 - 445 mm (Less effective; no safety/effectiveness change). | |
| Seat Surface Height Front Edge: 18.9"/480 mm (1.6% lower, negligible difference; no safety/effectiveness change). | |
| Backrest Angle: 10° (19% larger, more comfortable; passes static/dynamic stability tests; no safety/effectiveness change). | |
| Backrest Height: 16.9"/430 mm (2% less, negligible; no safety/effectiveness change). | |
| Backrest Width: 18.1"/460 mm (12% larger, more space; no safety/effectiveness change). | |
| Footrest-to-Seat: 16.5"/420 mm (15% longer, fits taller person; no safety/effectiveness change). | |
| Footrest Clearance: 6.7"/170 mm (14.8% higher, overcomes obstacles; no safety/effectiveness change). | |
| Footrest Length: 5.9"/150 mm (18.7% shorter, still holds foot; no safety/effectiveness change). | |
| Footrest-to-Leg Angle: 90° (4.8% smaller, negligible; no safety/effectiveness change). | |
| Leg-to-Seat-Surface Angle: 97° (5.8% larger, negligible; no safety/effectiveness change). | |
| Armrest Height: 10.2"/260 mm (7.4% larger; no safety/effectiveness change). | |
| Front-of-Armrest to Backrest: 11.4"/290 mm (18.9% less, limited space but no safety/effectiveness change). | |
| Armrest Length: Same as predicate (No safety/effectiveness change). | |
| Armrest Width: Same as predicate (No safety/effectiveness change). | |
| Armrest Angle: 4° (16.6% smaller, related to arm feeling, not safety/effectiveness). | |
| Distance Between Armrests: 18.1"/460 mm (0.64% shorter, no safety/effectiveness change). | |
| Front Location of Armrest Structure: 11"/280 mm (21% less, provides enough holding space; no safety/effectiveness change). | |
| Handrim Diameter: 19.8"/505 mm (7.6% smaller; not related to safety/effectiveness change). | |
| Propelling Wheel Diameter: 23.6"/600 mm (1.9% smaller; no safety/effectiveness change). | |
| Horizontal Location of Axle: 1.18"/ 30 mm (43.4% shorter; no safety/effectiveness change). | |
| Vertical Location of Axle: 7"/180 mm (78% larger; no safety/effectiveness change). | |
| Castor Wheel Diameter: 7.8"/200 mm (4.7% larger, more capability; no safety/effectiveness change). | |
| ISO 7176-8:2014 (Static, Impact and Fatigue Strength) | Passed (Implicitly, as device completed performance tests in accordance with ISO standards and functions safely and effectively). |
| ISO 7176-11:2012 (Test Dummies) | Passed (Implicitly, as device completed performance tests in accordance with ISO standards and functions safely and effectively). |
| ISO 7176-13:1989 (Coefficient of Friction of Test Surfaces) | Passed (Implicitly, as device completed performance tests in accordance with ISO standards and functions safely and effectively). |
| ISO 7176-15:1996 (Information Disclosure, Documentation, Labeling) | Passed (Implicitly, as device completed performance tests in accordance with ISO standards and functions safely and effectively). |
| ISO 7176-16:2012 (Resistance to Ignition of Upholstered Parts) | Passed (Meets California Technical Bulletin CAL 117: 2000 standard for flame retardance, which would be covered by this ISO standard, and stated as "same resistance-ignitability fabric" as predicate). |
| ISO 7176-22:2014 (Set-up Procedures) | Passed (Implicitly, as device completed performance tests in accordance with ISO standards and functions safely and effectively). |
| Other Differences: | |
| Weight Capacity: 220 lbs / 100 kg (Predicate: 250 lbs) | |
| Casters Tire Type: PVC solid material (Predicate: PU solid material) | |
| Weight of Chair: 38.5 lb / 17.5 kg (Predicate: 39.6 lb) | |
| Warranty: 3 years for chair side frames (Predicate: 5 years) | Weight Capacity: Lighter wheelchair is maneuvered more easily; no change in safety or effectiveness. |
| Casters Tire Type: PVC endures longer than PU; no change in safety or effectiveness. | |
| Weight of Chair: 2.7% lighter, easier to maneuver. | |
| Warranty: Shorter guarantee period means user pays more, not related to safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes performance testing against ISO standards for the device itself. These are typically engineering tests performed on a sample of the manufactured device. The document does not specify a "sample size" in terms of subject count or a specific number of devices tested for each standard. It only states that the "subject devices completed the performance tests." There is no mention of data provenance (e.g., country of origin, retrospective/prospective). This type of submission relies on engineering test reports rather than clinical trial 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)
This is not applicable to a submission for a mechanical wheelchair based on performance standards. "Ground truth" in this context would be the objective measurements and outcomes of the engineering tests according to the ISO standards. There are no human "experts" establishing conventional ground truth as one might find in an imaging or diagnostic AI study. The "experts" would be the engineers and technicians performing the standardized tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is an engineering performance test, not a subjective evaluation requiring an adjudication method. Test results are objective measurements against defined criteria within the ISO 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 and does not involve AI or human "readers" or multi-reader multi-case studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical wheelchair and does not involve an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by the objective measurements and pass/fail criteria defined within the referenced ISO performance standards. For example, static stability is measured against a specific angle without tipping, and brake effectiveness is measured by the stopping distance.
8. The sample size for the training set
Not applicable. This document is for a mechanical wheelchair, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This document is for a mechanical wheelchair, not an AI/ML algorithm that requires a training set.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).