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510(k) Data Aggregation
(82 days)
Trade/Device Name: Fit2Walk Monofilament Sensory Screening Tool Regulation Number: 21 CFR 882.1500
Sensory Screening Tool
Common Name: Sensory Screening Tool
Classification Name: Esthesiometer (21 CFR 882.1500
The Fit2Walk Monofilament Sensory Screening Tool is intended to determine whether a person with diabetes has the presence of an adequate level of protective sensation in their feet as indicated by having enough tactile sensitivity in order to perceive 10 grams of force against the skin of their feet.
It is indicated for use by adult Diabetic patients on a periodic basis to evaluate changes in sensory perception in the feet due to Diabetic peripheral sensory neuropathy. This device is not to be considered a replacement for routine sensory evaluation by a health care provider.
Monofilaments are devices that contain a small strand of filament attached to a handle. When placed upon the skin, they apply a certain amount of pressure before the filament bends or buckles. The point at which the filament bends or buckles is rated in grams of force. Monofilaments are primarily used to check for a certain level of sensation present in the skin in different parts of the body. The ten gram monofilament has been widely accepted by the medical community to evaluate the level of sensation in the skin of the feet for evaluating severe diabetic peripheral sensory neuropathy or LOPS (loss of protective sensation) of the feet.
The provided text describes the "Fit2Walk Monofilament Sensory Screening Tool" and its substantial equivalence to a predicate device. It references a study to support its performance.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for the Fit2Walk device in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it relies on demonstrating substantial equivalence to a predicate device ("Medical Monofilament Sensory Testing Filament") and references a study that supports the concept of self-administered monofilament testing for diabetic foot risk.
The key performance aspect for monofilaments is the force they apply and their ability to determine sensation.
| Feature | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Fit2Walk Monofilament Sensory Screening Tool) |
|---|---|---|
| Intended Use | Determine protective sensation in feet for diabetic patients (perceive 10 grams of force). | Same as predicate, with emphasis on self-administration and periodic evaluation. |
| Filament material | Polyester | Polyester |
| Semmes-Weinstein number (firmness) | 5.07 | 5.07 |
| Force Range | 10 gram (Range 8.5-11.5) | 10 gram (Range 8.5-11.5) |
| Availability | Available to medical practitioners. | Initially online, potentially retail stores, indicating OTC use. |
The study cited ("Evaluation of a Self-Administered Sensory Testing Tool...") aims to demonstrate the inter-rater reliability between patient and provider sensory evaluations using a monofilament, which is a performance characteristic relevant to the Fit2Walk's intended use as an over-the-counter device. However, specific numerical performance data (like agreement rates or statistical measures of reliability) from that study directly linked to the Fit2Walk device are not provided in this submission summary. The summary only mentions "a paper describes a study concerning the use of a self-administered sensory testing tool...and determine the inter-rater reliability between patient and provider sensory evaluations."
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary references a study, but does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature) of the study cited (Birke and Rolfsen, 1998). We only know it was published in "Diabetes Care, Vol. 21, Number 1, January 1998."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not specified in the provided document. The summary only mentions "inter-rater reliability between patient and provider sensory evaluations," implying that healthcare providers were involved in establishing a comparison, but their number and qualifications are not detailed.
4. Adjudication Method
Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The study referenced focuses on the reliability of patient self-assessment versus provider assessment, not AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The Fit2Walk Monofilament is a physical device, not an algorithm. Its "performance" relates to its physical properties (force applied) and the user's ability to interpret sensation.
7. Type of Ground Truth Used
Based on the description of the referenced study ("inter-rater reliability between patient and provider sensory evaluations"), the "ground truth" for comparison would likely be the assessment by a healthcare provider using a monofilament. This is a form of expert assessment.
8. Sample Size for the Training Set
Not applicable/Not specified. The Fit2Walk is a physical device, not an AI model requiring a training set. The study referenced would have involved a patient cohort, but it's not a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not specified. As there is no AI or machine learning component, the concept of a training set and its ground truth establishment is not relevant to this device submission.
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