(21 days)
The intended use of this device (manual wheelchair) is to provide mobility to physically impaired individuals. The manual wheelchair is intended for on-going "everyday" use and/or recreational sports applications. The specific medical conditions for which the device is indicated are listed as, but not limited to: Spinal chord injury Post polio Spina Bifada Amputee
The Cross-Sport manual titanium wheelchair is a custom, rigid, everyday/sport chair manufactured to the specifications of the intended user.
Here's an analysis of the provided text regarding the TiSport Cross Sport wheelchair's acceptance criteria and studies:
Summary of Acceptance Criteria and Device Performance:
The document states that the TiSport Cross Sport meets the requirements of ISO Standards. However, it does not explicitly list specific, quantitative acceptance criteria that the device had to achieve (e.g., maximum deflection under load, minimum fatigue life cycles). Instead, the acceptance is based on compliance with general "ISO Standards."
The reported device performance, in the absence of specific numerical criteria, is primarily descriptive:
- Materials: Manufactured from titanium.
- Design: Custom, rigid, everyday/sport chair.
- Strength-to-Weight Ratio: Proven superior strength-to-weight ratio compared to chromoly (used in the predicate device).
- Customization: Offers a higher degree of customization for proper "fitting" to the operator.
- Safety: The superior material and customization are presented as benefits from a safety perspective.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated with numerical values) | Reported Device Performance |
|---|---|---|
| General Compliance | Meets ISO Standards | Meets the requirements of the ISO Standards. (No specific ISO standard numbers or section provided.) |
| Functional Equivalence to Predicate | No significant differences in fundamental operation/intended use from predicate device (K925451) | "There are no significant differences between the submitted device and the predicate device (K925451)." |
| Material Performance / Safety | (Implicit: Material should be at least as safe/strong as predicate) | Frame made of titanium, which offers "proven superior strength-to-weight ratio" and is a "benefit...from a safety perspective." |
| User Fit / Customization / Clinical Benefit | (Implicit: Allows for proper user fit and clinical effectiveness) | "The degree of customization allows for a better opportunity to properly 'fit' the operator in a clinical setting as well as ensuring better safety and access to the chairs options and accessories." |
Detailed Breakdown of Study Information:
Based on the provided 510(k) summary, the "study" conducted for this device is focused on conformance to ISO standards and a comparison to a predicate device for substantial equivalence, rather than a clinical trial or performance study against specific, measurable performance criteria.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "Testing Results: Meets the requirements of the ISO Standards." This typically implies that the device (or representative samples) underwent a series of engineering/mechanical tests. There is no mention of a human test set in the context of clinical performance.
- Data Provenance: Not explicitly stated, but assumed to be from engineering and manufacturing tests conducted by TiSport or an accredited testing facility, likely within the US given the submission to the FDA. The tests are focused on mechanical properties and standards, not human data.
- Retrospective or Prospective: Not applicable, as this refers to engineering testing, not a clinical study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in this context, would be established by the ISO standards themselves and the objective measurements demonstrating compliance (e.g., load capacities, fatigue cycles, material properties). The experts involved would be engineers/testers verifying adherence to test protocols and interpreting results, not clinical experts establishing a ground truth for diagnostic accuracy.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 are used in studies involving human interpretation or clinical outcomes where there might be disagreement among reviewers. This submission describes engineering and standards compliance testing.
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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. This is a medical device (wheelchair), not an AI diagnostic or assistance system. MRMC studies are not relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is compliance with established ISO (International Organization for Standardization) standards for mechanical wheelchairs and demonstrated equivalence in design and intended use to a legally marketed predicate device (Shadow Rigid, K925451). This involves engineering specifications, material properties, and a comparison of features.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set.
§ 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).