(502 days)
The Tmax wheelchair are suitable for patients with walking impediments/inability due to, but not limited to:
- Palsies/Paralyses .
- Loss of limbs .
- Defective and/or deformed limbs .
- Joint contractures .
- Joint defects .
- Other diseases .
The Discovery Tmax is a manually operated, self/attendant propelled, mechanical wheelchair. It is intended exclusively for the adaptation of orthopedic seating systems (e.g. seating shells) for people who are unable to walk or have walking impediments. The Discovery Tmax can be used indoors and outdoors. In order to provide an optimized, individual fitting, the product is adjustable and/or adaptable.
The Discovery Tmax consists of a non-folding frame of aluminum, large wheels with hand rims, and small front pivoting casters. The width, depth, and height of seat are adjustable in 1 inch increments. The armrest is made of Polyurethane soft integral foam and is adjustable. It also has an adjustable backrest and removable footrest.
The Discovery Tmax includes a "Tilt in space" feature which allows the seat to be tilted. The seat angle can be adjusted from -5° to +50° in increments of 2.5°. The desired seat angle is achieved by moving the push handles/ push bar. The angle can be read from the angle indicator on the hole channel.
This 510(k) summary describes a manual wheelchair, not a software or AI-powered device. Therefore, many of the requested categories related to AI/software performance, such as MRMC studies, standalone algorithm performance, and training/test set details, are not applicable.
Here's the information that can be extracted relevant to the performance of this medical device (a manual wheelchair):
Acceptance Criteria and Device Performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Compliance) |
|---|---|
| DIN EN 12182:1999 (Technical aids for disabled persons) | Tested by TUV SUD, compliance implied by submission. |
| DIN EN 12183:1999 (Manually propelled wheelchairs requirements & test methods) | Tested by TUV SUD, compliance implied by submission. |
| ISO 7176-1:1999 (Wheelchairs Part 1: Determination of static stability) | Tested by TUV SUD, compliance implied by submission. |
| ISO 7176-3:2003 (Wheelchairs Part 3: Determination of efficiency of brake) | Tested by TUV SUD, compliance implied by submission. |
| ISO 7176-5:2008 (Wheelchairs -- Part 5: Determination of overall dimensions, mass and maneuvering space) | Tested by TUV SUD, compliance implied by submission. |
| ISO 7176-7:1998 (Wheelchairs part 7: Measurement of seating & wheel dimensions) | Tested by TUV SUD, compliance implied by submission. |
| ISO 7176-8:1998 (Wheelchairs Part 8: Requirements, static impact/fatigue strengths) | Tested by TUV SUD, compliance implied by submission. |
| ISO 7176-11:1992 (Wheelchairs Part 11: Test dummies) | Tested by TUV SUD, compliance implied by submission. |
| ISO 7176-13:1989 (Wheelchair Part 13: Determination of coefficient of friction of test surfaces) | Tested by TUV SUD, compliance implied by submission. |
| ISO 7176-15:1996 (Wheelchairs Part 15: Requirement for labeling) | Tested by TUV SUD, compliance implied by submission. |
| ISO 7176-16:1997 (Wheelchairs Part 16: Resistance to ignition of upholstered parts - Requirements and test methods) | Tested by TUV SUD, compliance implied by submission. |
| ISO 7176-19:2008 (Wheelchairs Part 19: Wheeled mobility devices for use in motor vehicles) | Tested by TUV SUD, compliance implied by submission. |
Study Details:
- Sample size used for the test set and the data provenance: Not applicable in the context of a physical device. The testing was conducted on the device itself.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance against standards is typically established by certified testing laboratories using specified protocols, not expert consensus on medical images or data.
- Adjudication method for the test set: Not applicable. Testing against performance standards for a physical device does not involve adjudication in the sense of expert review of data points.
- 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 non-AI device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical non-AI device.
- The type of ground truth used: Compliance with international and European ISO and DIN EN standards for wheelchairs. This is a form of objective engineering and safety ground truth, verified through physical testing.
- The sample size for the training set: Not applicable. This is a finished physical device, not an AI/software model.
- How the ground truth for the training set was established: Not applicable.
Summary based on provided text:
The Discovery Tmax Manual Wheelchair was tested by TUV SUD, Institute for Testing and Certification of Medical Devices, against a series of international and European standards (DIN EN 12182, DIN EN 12183, and various parts of ISO 7176). The compliance with these standards serves as the "acceptance criteria" and "device performance" proof for this physical medical device. The specific details of the testing (e.g., number of units tested, exact test results against each clause of the standards) are not provided in this 510(k) summary but are typically part of the full submission.
§ 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).