(41 days)
The VCS S4T scooter is motor driven, indoor and outdoor transportation, vchicles with the intended use to provide mobility to disabled or civerly persons limited to a seated position.
The VCS S4T scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
The provided text pertains to a 510(k) premarket notification for a medical device, specifically the VCS S4T scooter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through clinical trials or performance studies with ground truth.
Therefore, most of the information requested in your prompt related to clinical studies, acceptance criteria tables, sample sizes, expert ground truth establishment, adjudication methods, and MRMC studies is not available within this 510(k) summary.
Here's an explanation of why and what information can be extracted:
Why the requested information is largely absent:
- 510(k) Substantial Equivalence: The 510(k) pathway is for devices that are "substantially equivalent" to predicate devices already on the market. It doesn't typically require new clinical studies to establish safety and effectiveness from scratch. Instead, it relies on demonstrating that the new device has the same intended use, technological characteristics, and performs similarly to a predicate. Performance data often involves engineering testing or comparisons of specifications, not extensive clinical trials with human subjects to determine diagnostic accuracy against a "ground truth."
- Device Type: The VCS S4T scooter is a "Motorized three-wheeled vehicle" (an electrical scooter). For such devices, acceptance criteria usually relate to safety standards (e.g., electrical safety, braking, stability), performance specifications (e.g., speed, range, turning radius, weight capacity), and durability, rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC which are common for AI/imaging devices.
Information Extracted from the provided text:
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Acceptance Criteria & Reported Device Performance:
- The document explicitly states: "There are minor differences in performance specifications of the scooters, 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 implies that the acceptance criteria are implicitly met if the device's performance specifications are comparable to or within acceptable deviations from the predicate device (Bewell SC 20).
- However, no specific table of quantitative acceptance criteria values or the reported performance metrics of the VCS S4T scooter are provided in this summary. The document only makes a general statement of equivalency in performance.
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Sample Size Used for the Test Set and Data Provenance:
- Not applicable/Not provided. This 510(k) summary does not describe a "test set" in the context of clinical or AI performance evaluation. The substantial equivalence argument is based on comparing the device's design and specifications to a predicate.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable/Not provided. Ground truth establishment is not relevant for this type of device and submission.
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Adjudication Method for the Test Set:
- Not applicable/Not provided.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is typically for evaluating the impact of AI on human reader performance for diagnostic tasks (e.g., radiologists reading images). This is a mobility scooter, so such a study would not be relevant.
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Standalone (Algorithm Only) Performance Study:
- No. This refers to AI algorithm performance without human intervention. The device is a physical mobility scooter; there is no "algorithm only" performance separate from the user.
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Type of Ground Truth Used:
- Not applicable/Not provided.
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Sample Size for the Training Set:
- Not applicable/Not provided. There is no "training set" for an AI model mentioned.
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How the Ground Truth for the Training Set Was Established:
- Not applicable/Not provided.
Summary Table of Unavailable Information:
| Information Requested | Status (Not Applicable/Not Provided) | Explanation |
|---|---|---|
| Table of Acceptance Criteria & Reported Performance | Not Provided | The document states "minor differences in performance specifications" to the predicate, implying performance met acceptance, but no specific values or a table are presented. The 510(k) focuses on substantial equivalence, not detailed performance data. |
| Sample size (test set) & Data Provenance | Not Applicable/Not Provided | This type of 510(k) for a mobility scooter does not involve clinical "test sets" for diagnostic accuracy. |
| Number of Experts (ground truth) & Qualifications | Not Applicable/Not Provided | Not relevant for this device type. |
| Adjudication method (test set) | Not Applicable/Not Provided | Not relevant for this device type. |
| MRMC Comparative Effectiveness Study | No | Not relevant for a mobility scooter. |
| Standalone performance study | No | Not relevant for a mobility scooter. |
| Type of ground truth | Not Applicable/Not Provided | Not relevant for this device type. |
| Sample size for the training set | Not Applicable/Not Provided | Not relevant, as this is not an AI device with a training set. |
| How ground truth for the training set was established | Not Applicable/Not Provided | Not relevant, as this is not an AI device with a training set. |
In conclusion, this 510(k) submission successfully establishes substantial equivalence for the VCS S4T scooter to a predicate device (Bewell SC 20) based on intended use and comparable technological characteristics, but it does not contain the detailed performance study information typically associated with AI/diagnostic devices that require "acceptance criteria" and "ground truth" as described in your prompt.
§ 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).