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510(k) Data Aggregation
(34 days)
Safety Vest is intended for patients who require restraint while in the wheelchair or bed.
Economy Safety Vest is intended for patients who require restraint while in the wheelchair or bed.
Vest with Shoulder Straps is intended for patients who require restraint and posture support while in the wheelchair.
Safety Vest: A vest-style, upper body device made from either woven polyester or polyester mesh. A 1 1'8-inch-wide polyester strap attached to one side of the vest at the waist is threaded through a slot on the other causing the vest to criss-cross and close in front of the patient. The waist strap secures to the kickspurs of the wheelchair or to the bed frame. The edges of the garment are finished with a bias cut binding, the color of which corresponds to a size chart included on the package insert. Device is intended for wheelchair or bed use.
Economy Safety Vest: Identical to above except that it is made from a lighter weight woven polyester material and is not available in polvester mesh. Unlike the above device which is intended for multiple uses, this is a singe-patient-use device. This fact is noted on the garment label along with a notation that it is not to be laundered.
Vest with Shoulder Straps: Identical with Safety Vest with the addition of 1 1/8-inchwide webbing straps sewn to the shoulder area. These straps are secured to the pushhandles to provide patient posture support. This device is for wheelchair use only.
The provided text describes a 510(k) summary for Skil-Care Corporation's Safety Vests. This document is a premarket notification to the FDA for a medical device and is primarily focused on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, many of the requested categories for a study that "proves the device meets the acceptance criteria" are not applicable in this context. The document explicitly states: "These devices are currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations and are legally marketed by Skil-Care Corporation as of the date of this submission." This indicates that the submission is about changing labeling to align with FDA guidance, rather than demonstrating new performance or safety from scratch.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not applicable:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in terms of measurable performance metrics typically found in clinical studies for novel devices. The primary "acceptance" for this submission seems to be substantial equivalence to already marketed predicate devices and compliance with labeling guidance. | The devices are described as "Safety Vest," "Economy Safety Vest," and "Vest with Shoulder Straps." These are "identical" or similar to devices "currently marketed as described in this submission" and have been "marketing and commercially distributing... for approximately 18 years." The performance is implied to be acceptable based on this long-standing market presence and the fact they were "exempt from 510(k) Premarket Notification Procedures." |
2. Sample size used for the test set and the data provenance
- Not applicable. This document does not describe a clinical test set with a sample size. It refers to already marketed devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no described test set requiring ground truth established by experts.
4. Adjudication method for the test set
- Not applicable. There is no described test set requiring an adjudication method.
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
- Not applicable. This device is a physical restraint vest, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.
6. 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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. There is no described study requiring ground truth. The "ground truth" for the submission is the long-standing market history and accepted use of similar predicate devices, and the alignment with FDA's draft "Guidance on the Content of Premarket Notification [510(k)] Submissions for Protective Restraints."
8. The sample size for the training set
- Not applicable. There is no algorithm or training set involved.
9. How the ground truth for the training set was established
- Not applicable. There is no algorithm or training set involved.
In summary: This document is a 510(k) summary focused on demonstrating substantial equivalence and compliance with labeling guidance for existing medical devices (safety vests) that were previously exempt from 510(k) notification. It does not present a new study with acceptance criteria, test sets, or performance data in the way one would for a novel device undergoing clinical trials. The "proof" of the device's acceptability relies on its long history of marketing and commercial distribution, and its substantial equivalence to previously cleared (or exempt) products.
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