(184 days)
The Next Generation iBOT is intended to provide indoor and outdoor mobility to persons restricted to a sitting position who meet the requirements of the user assessment and training certification program. The device is intended to climb stairs. Companions who are required to provide assistance during Assisted Stair Climbing Mode must meet the requirements of the training certification program.
The proposed device is a multi-mode powered wheelchair that enables users to maneuver in confined spaces, climb curbs, stairs, and other obstacles. The device is intended to provide indoor and outdoor mobility, including stair climbing, to persons limited to a seated position who are capable of operating a powered wheelchair. The Next Gen iBOT includes active stabilization in multiple driving modes and allows for traversing aggressive and difficult terrain and operation at an elevated seat height. This elevated seat height offers benefits in activities of daily living (e.g., accessing higher shelves) and interaction with other people at "eye level" while either stationary or moving. The proposed device incorporates updates to the iBOT 4000 design to take advantage of advances in component and process technology while maintaining the same fundamental capabilities.
The provided text is a 510(k) summary for the DEKA Research & Development Corp's "Next Generation iBOT" stair-climbing wheelchair. It primarily focuses on demonstrating substantial equivalence to a predicate device (iBOT 4000 Mobility System) rather than details about a comparative effectiveness study with AI assistance or a standalone algorithm. Therefore, many of the requested details about acceptance criteria, study design for AI-driven devices, and human reader performance are not present in this document.
However, I can extract the information relevant to the device's performance characteristics and the testing conducted to support its safety and effectiveness relative to its predicate.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" for an AI or algorithmic medical device in the typical sense (e.g., AUC > X, Sensitivity > Y). Instead, it provides a comparison table of the proposed device ("Next Generation iBOT") with its predicate device ("iBOT 4000") across various characteristics, including performance metrics. The implicit acceptance criterion is that the proposed device performs comparably or better than the predicate for relevant metrics, thereby demonstrating substantial equivalence.
| Characteristic | Predicate (iBOT 4000) Performance | Proposed (Next Generation iBOT) Performance | Assessment of difference (if applicable) |
|---|---|---|---|
| Device Performance | |||
| Driving Range | 15.5 miles | 15.5 miles (with 4 batteries) | No change |
| Dynamic Stability | 5 degrees (standard) | ||
| 10 degrees (4 wheel) | |||
| 5 degrees (balance) | 10 degrees (standard) | ||
| 12 degrees (4 wheel) | |||
| 8 degrees (balance) | The change represents equivalent or increased dynamic stability when compared to the predicate device. | ||
| Max Speed Settings by Mode | Standard: 6.8 mph | ||
| 4-Wheel: 4.8 mph | |||
| Balance: 3.2 mph | Standard: 6.7 mph | ||
| 4-Wheel: 5.2 mph | |||
| Balance: 3.3 mph | Maximum speed is comparable to the predicate device. | ||
| Maximum user weight capacity | 250 lb. | 300 lb. | Update allows additional users. All testing performed with expanded weight range. |
| Obstacle Climbing | 5 in. (in 4 wheel mode) | 5 in. (in 4 wheel mode) | No change |
| Turning Radius | 29.5 in. - 38.6 in. (dependent on mode) | 24.5 in. – 33.8 in. (dependent on mode) | Turning radius is comparable to the predicate device. |
| Weight (including batteries) | 280 lb. | 242.5 lb. | The weight is comparable to the predicate device. |
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 bench testing against various ISO and IEC standards, software testing according to FDA guidance and IEC 62304, and usability testing. It does not specify a "test set" in the context of an AI/ML algorithm's performance on human data (e.g., patient images). Instead, the performance evaluations are for the physical device itself.
- Sample Size for Bench Testing: Not specified in terms of units tested. It indicates that "the proposed device has been demonstrated to comply with the following standards." This implies standard compliance testing rather than a statistical sample size from a patient population.
- Data Provenance: Not applicable in the context of patient data. The testing is described as occurring within the manufacturer's development and validation processes. No country of origin for "data" is mentioned, as it's physical device performance rather than patient data. The testing appears to be prospective in the sense of being performed on the newly developed device.
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 concept is not applicable to the type of device and testing described in the document. The device is a stair-climbing wheelchair, not an AI/ML diagnostic or prognostic tool that interprets patient data requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this relates to expert review and ground truth establishment for diagnostic/prognostic AI models, which is not the subject of this submission. The "test sets" here are the physical device itself and its components.
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
No such study was conducted or is mentioned. The device is a physical medical device (wheelchair), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an AI algorithm's performance without human interaction. This is not relevant to a stair-climbing wheelchair. The device itself (the "Next Generation iBOT") is analogous to the "standalone" product being evaluated, and its performance is assessed against engineering standards and comparison to a predicate, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established through adherence to recognized international standards (e.g., ISO, IEC, UL, UN), internal DEKA research and development testing protocols, and comparison to the performance of the previously approved predicate device. For example:
- Static and Dynamic Stability: Measured against the requirements of ISO 7176-1 and ISO 7176-2.
- Speed, Acceleration, Retardation: Measured against ISO 7176-6.
- Obstacle Climbing: Measured against ISO 7176-10.
- Battery Performance: Measured against IEC 62133, UL 2054, and UN 38.3.
- Software Validation: Assessed per IEC 62304 and FDA guidance on software validation.
- Usability: Evaluated directly for human factors and user interaction changes.
8. The sample size for the training set
The concept of a "training set" is not applicable. This is a physical device submission, not an AI/ML model.
9. How the ground truth for the training set was established
Not applicable. There is no training set in the context of AI/ML. All "testing" and "evaluation" refers to physical and software verification and validation of the manufactured device.
§ 890.3890 Stair-climbing wheelchair.
(a)
Identification. A stair-climbing wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use.
(2) Performance testing must demonstrate adequate mechanical performance under simulated use conditions and environments. Performance testing must include the following:
(i) Fatigue testing;
(ii) Resistance to dynamic loads (impact testing);
(iii) Effective use of the braking mechanism and how the device stops in case of an electrical brake failure;
(iv) Demonstration of adequate stability of the device on inclined planes (forward, backward, and lateral);
(v) Demonstration of the ability of the device to safely ascend and descend obstacles (i.e., stairs, curb); and
(vi) Demonstration of ability to effectively use the device during adverse temperatures and following storage in adverse temperatures and humidity conditions.
(3) The skin-contacting components of the device must be demonstrated to be biocompatible.
(4) Software design, verification, and validation must demonstrate that the device controls, alarms, and user interfaces function as intended.
(5) Appropriate analysis and performance testing must be conducted to verify electrical safety and electromagnetic compatibility of the device.
(6) Performance testing must demonstrate battery safety and evaluate longevity.
(7) Performance testing must evaluate the flammability of device components.
(8) Patient labeling must bear all information required for the safe and effective use of the device, specifically including the following:
(i) A clear description of the technological features of the device and the principles of how the device works;
(ii) A clear description of the appropriate use environments/conditions, including prohibited environments;
(iii) Preventive maintenance recommendations;
(iv) Operating specifications for proper use of the device such as patient weight limitations, device width, and clearance for maneuverability; and
(v) A detailed summary of the device-related adverse events and how to report any complications.
(9) Clinician labeling must include all the information in the Patient labeling noted in paragraph (b)(8) of this section but must also include the following:
(i) Identification of patients who can effectively operate the device; and
(ii) Instructions on how to fit, modify, or calibrate the device.
(10) Usability studies of the device must demonstrate that the device can be used by the patient in the intended use environment with the instructions for use and user training.