(42 days)
The Zip'r PC powered wheelchair is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
The Zip'r PC powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market. By providing a powered wheelchair that breaks down into two manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.
The provided text is a 510(k) summary for the Zip'r PC powered wheelchair. It describes the device and claims substantial equivalence to a predicate device (CWD01). However, it does not include information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding ground truth establishment, expert adjudication, or sample sizes for testing or training sets that would be expected for a diagnostic or AI-driven device.
The document primarily focuses on demonstrating that the Zip'r PC powered wheelchair is substantially equivalent to an existing device (CWD01) based on its intended use, design, and performance specifications. This type of submission relies on comparing physical and operational parameters rather than statistical performance against a defined ground truth using a clinical study.
Therefore, many of the requested details are not present in the provided text.
Here's a breakdown of the information that can be extracted and what is missing:
Acceptance Criteria and Reported Device Performance (Table)
The document lists performance specifications for the Zip'r PC and compares them to the predicate device, CWD01. While these are performance characteristics, they are presented as part of a substantial equivalence claim rather than formal acceptance criteria for a clinical study. The acceptance criteria for a physical medical device typically revolve around safety standards and functional equivalence to predicate devices, which is what this document addresses through comparison.
Note: For a device like a wheelchair, acceptance criteria are generally established through adherence to recognized standards (e.g., ISO standards for wheelchairs) and comparison to a predicate device's safety and functional output, rather than clinical efficacy studies with specific performance metrics against a "ground truth" as might be seen with diagnostic AI.
| Acceptance Criteria (Implied by Comparison) | Reported Zip'r PC Performance | Reported CWD01 (Predicate) Performance |
|---|---|---|
| Net weight w/battery | 68 kg (150 lbs) | 83.5 kg (183.7 lbs) |
| Slope grade ability | 8 degree | 12 degree |
| Per-charge distance | Up to 40 km (25 miles) | 40 km (24 miles) |
| Maximum speed | Up to 6.4 km/hr (4 mph), variable | 5 km/h (3.2 mph) |
| Turning radius | 0.51 m (20") | Not specified |
| Maximum curb height | 25 mm (1") | Not specified |
| Armrest | Fixed | Removable |
| Brake system | Intelligent regenerative electromagnetic brake | Not specified |
| Braking distance | Forward: 1.4 m (56") at max speed | Not specified |
| Suspension | Front: No, Rear: No | Cross brace |
| Horn | Yes | Yes |
| Anti-tip wheels | Yes | Yes |
| Intended Use | Provides mobility to disabled or elderly persons limited to a seated position. | Provides mobility to disabled or elderly persons limited to a seated position. |
| Power Source | Lead-Acid 12V x 33AH x 2 | Lead-Acid 12V x 35AH x 2 |
| Motor Output | DC 24V, 320 W, 2 Pcs | 60W x DC24V x 2Pc |
| Front Wheel | PG Solid tire x 2 | Numatic tire x 2 |
| Rear Wheel | PG Solid tire x 2 | U foaming tire x 2 |
| Weight Capacity | 136 kg (300 lbs) | 136 kg (300 lbs) |
Note: The document states, "There are minor differences in performance specifications of the powered wheelchairs, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness." This statement implies that the differences observed in the table are within acceptable limits for substantial equivalence.
Missing Information Regarding a Study Proving Acceptance Criteria
The provided text does not contain any information about a specific study designed to "prove the device meets acceptance criteria" in the sense of a clinical trial or performance study against a defined ground truth, as would be conducted for a diagnostic or AI-enabled device. The submission relies on a comparison to a predicate device to establish substantial equivalence.
Therefore, the following information cannot be provided from the given text:
- Sample size used for the test set and the data provenance: Not applicable/Not provided. The submission is not a clinical study on a test set; it's a comparison to a predicate device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. No "ground truth" in the diagnostic sense is established or used.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided.
- 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/Not provided. This is a medical device, not an AI-assisted diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided. The "ground truth" here is arguably the performance and safety profile of the predicate device and adherence to relevant standards.
- The sample size for the training set: Not applicable/Not provided. This is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable/Not provided.
Summary of what the document IS:
This is a 510(k) Premarket Notification for a Class II powered wheelchair. The manufacturer claims substantial equivalence to a predicate device (CWD01) already on the market. The "evidence" provided consists of a comparison table of specifications and a statement that minor differences do not affect safety or effectiveness. This is a common pathway for demonstrating safety and effectiveness for many medical devices that are functionally similar to existing ones, rather than requiring new clinical trials that establish performance against a defined ground truth like diagnostic devices.
§ 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).