(7 days)
The intended use of the Pride Mobility Products Corporation Victory XL 130, Four Wheel Scooter / Model # SC713 is to provide mobility to disabled persons having limited walking capabilities.
The Victory XL 130, Four Wheel Scooter / Model # SC713 is a Heavy Duty batteryoperated scooter having a Digital Controller, electrical system, Charger, Transaxle / Motor, Batteries, Seating and 2-Piece Frame. The Victory XL 130 Scooter is equipped with electronic regenerative and electromechanical disc brakes, off-board battery charger, removable 12 Volt 55AH batteries, and anti-tip rear wheels.
The scooter has various size foldable Contour seats that are removable. The seat interface is equipped with a clover leaf design allowing for seat rotation and locking at 90° intervals mounted on stationary seat post. The seat is also equipped with sliders for fore-aft adjustment.
The Victory XL 130, Four Wheel Scooter / Model # SC713 is designed with ultimate safety, stability, and performance in mind. The scooter is designed for, but not limited to Pride Mobility Products Corporation, providers/retailers and their consumers.
The provided text describes a 510(k) submission for a medical device, the "Victory XL 130, Four Wheel Scooter / Model # SC713," indicating substantial equivalence to a predicate device. This type of submission focuses on comparing a new device to an already legally marketed one rather than conducting extensive de novo clinical trials to prove efficacy from scratch. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to compliance with recognized standards and a demonstration of substantial equivalence, not a traditional clinical trial with specific performance metrics for an AI algorithm.
Based on the provided information, here's a breakdown of the requested points, noting where information is not applicable due to the nature of a 510(k) for a mobility scooter:
1. A table of acceptance criteria and the reported device performance
For a mobility scooter undergoing a 510(k) review, the "acceptance criteria" are compliance with relevant safety and performance standards. The "reported device performance" is the demonstration that the device meets these standards.
| Acceptance Criteria (Relevant Standards) | Reported Device Performance |
|---|---|
| RESNA WC Vol.1 2008 DRAFT - Requirements and Test Methods for Wheelchairs (Including Scooters) | Device showed compliance through non-clinical testing. |
| RESNA WC Vol. 2 2008 DRAFT - Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems | Device showed compliance through non-clinical testing. |
| ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility (EMC) | Device showed compliance through non-clinical testing. |
| IEC 601-1-1 - Medical Electrical Equipment, General Requirements for Safety | Device showed compliance through non-clinical testing. |
| CAL 117 - Flammability Testing | Device showed compliance through non-clinical testing. |
| Substantial Equivalence to Predicate Device (K944939) | The device has the same intended use and similar technological characteristics, and differences do not raise new safety or effectiveness concerns. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of a 510(k) for this type of device. The "test set" here refers to the compliance testing of a physical device sample against specific engineering and safety standards, not a patient dataset. The document does not specify the number of units tested.
- Data Provenance: Not applicable. The testing is non-clinical, focusing on product design and manufacturing compliance. No patient data or country of origin for such data is mentioned or relevant.
- Retrospective/Prospective: Not applicable.
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)
- Number of Experts & Qualifications: Not applicable. For engineering and safety standard compliance, "ground truth" is established by the specifications within the standards themselves and the expertise of the engineers and technicians conducting the tests. The document does not specify the number or qualifications of personnel involved in the non-clinical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This concept typically applies to clinical trials where human readers interpret data or images. In non-clinical device testing, the results are objectively measured against defined criteria within the 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
- MRMC Study: No. This is a non-AI, non-diagnostic medical device (a mobility scooter). An MRMC study is completely irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This is a physical mobility device; there is no AI algorithm involved in its operation as described.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the non-clinical testing, the "ground truth" is derived from the quantitative and qualitative requirements specified in the referenced industry standards (RESNA, ANSI/RESNA, IEC, CAL). The device is tested to demonstrate it meets these pre-defined performance and safety criteria.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. There is no AI model or "training set" for this device.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. There is no AI model or "training set" for this device.
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).