(40 days)
Sunrise mechanical wheelchairs empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages such as : Arthritis Amputee Paraplegic Cerebral Palsy Hemiplegic Tetraplegic Quadriplegic Spina Bifida Head Injury or Trauma Muscular Dystrophy Multiple Sclerosis Polio Geriatric conditions And other immobilizeing or debilitating conditions
Sunrise Medical Suspension Wheelchairs consists of typical components found on most wheelchairs, such as push handles, armrests, backrest, seat frame, cushion, footrest and casters. Many of these components are available in a range of sizes, shapes, angles, forms, materials or coverings. These variations allow the chairs to be configured to meet the specific desires and needs of the user. The kev change covered by this submission is the suspension feature, which allows the user to traverse uneven terrain or obstacles with greater comfort.
The provided text describes a 510(k) submission for a Suspension Wheelchair Series. For this type of medical device, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically demonstrated through substantial equivalence to a predicate device, supported by performance testing against established standards.
Here's an analysis based on the provided text, addressing your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Safety & Efficacy | Substantial Equivalence to predicate devices; Does not raise new issues of safety and effectiveness. | Concluded that the device is "substantially equivalent to the predicated devices" and "the technology and construction... does not raise any new issues of safety and effectiveness." This is the overarching "performance." |
| Mechanical Performance | Meet ISO7176 Wheelchair Standards | Device has been "tested to both ISO7176 and ANSI/RESNA Wheelchair Standards." |
| Meet ANSI/RESNA Wheelchair Standards | Device has been "tested to both ISO7176 and ANSI/RESNA Wheelchair Standards." | |
| Static Stability | Testing mentioned as including "Static Stability." | |
| Overall Dimensions | Testing mentioned as including "Overall Dimensions." | |
| Fatigue Strength | Testing mentioned as including "Fatigue Strength." | |
| Complaint Analysis | Analysis of complaints against Sunrise manual chairs for the period from 4/1/97 through 2/28/98 to demonstrate no unique use issues. | Analysis completed and charted; "demonstrated common issues across all manufacturers product lines, and varying levels approximately comparable to relative market share. Sunrise has concluded that there are no use issues exclusive to Sunrise chairs at this time." |
| Intended Use | Provide mobility for physically challenged persons with various conditions (e.g., Arthritis, Amputee, Paraplegic, etc.). | Device is a "light weight manual chair which is intended to provide mobility based on an individual users' needs and capabilities." The stated "Indications for Use" directly align with the conditions listed in the "Intended use" section. |
| Key Change Performance (Suspension Feature) | Allows the user to traverse uneven terrain or obstacles with greater comfort. | The "kev change covered by this submission is the suspension feature, which allows the user to traverse uneven terrain or obstacles with greater comfort." (This is a description of the feature's intended performance rather than a measured performance metric from a specific test, implying that meeting the standards for general wheelchair performance covers this new feature adequately in the context of substantial equivalence). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in terms of how many wheelchairs were tested for ISO7176 and ANSI/RESNA standards. These standards typically involve testing a representative number of units, but the exact count is not given. For the complaint analysis, the "sample" was complaints received against Sunrise manual chairs from 4/1/97 through 2/28/98, and "MDR's and recalls that have been reported to the FDA concerning wheelchairs in general," but no specific numerical count is provided.
- Data Provenance:
- Standards Testing (ISO7176, ANSI/RESNA): This performance data would be generated directly by Sunrise Medical or a contracted testing facility (not specified) based on tests performed on their Suspension Wheelchair Series. The context suggests this is internal testing for the specific device for the submission.
- Complaint Analysis: Originates from "complaints against Sunrise manual chairs" (internal company data) and a "literature search" for FDA complaints, MDR's, and recalls "concerning wheelchairs in general" (external, potentially public data). This appears to be retrospective analysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this 510(k) submission. "Ground truth" and "expert evaluation" in the sense of clinical consensus or pathology are typically relevant for diagnostic devices, AI/ML-driven analyses, or certain therapeutic devices where expert judgment is central to accuracy. For a manual wheelchair, the "ground truth" for performance is compliance with established safety and performance standards (like ISO/ANSI/RESNA) and the absence of new safety concerns compared to predicate devices. These standards define objective pass/fail criteria.
4. Adjudication Method for the Test Set
This is not applicable to this 510(k) submission. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple experts when establishing ground truth for subjective or complex diagnostic/interpretive tasks, often in clinical studies. For mechanical testing against standards, the results are typically objective measurements.
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
This is not applicable. An MRMC study is relevant for diagnostic devices, particularly those involving human interpretation (e.g., radiologists reading images) where AI assistance might change their performance. This is a mechanical mobility device; there are no "human readers" interpreting outputs in a clinical context that would be assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a manual wheelchair, not an algorithm or AI-driven system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's safety and effectiveness is primarily established by:
- Compliance with recognized industry standards: ISO7176 and ANSI/RESNA Wheelchair Standards define objective performance criteria (e.g., static stability, fatigue strength).
- Demonstration of substantial equivalence to predicate devices: This implies that the device's design, materials, and intended use are similar enough to already-marketed legally devices that it presents no new safety or effectiveness concerns.
- Retrospective complaint analysis: Review of existing adverse event data to demonstrate that the manufacturer's products, and wheelchairs generally, do not have unique or unacceptable safety issues.
- Intended Use Alignment: The device meets the needs for mobility for specific patient populations as outlined in the "Indications for Use."
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of a mechanical wheelchair submission. Training sets are used in machine learning or AI development.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 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).