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Medline's Zippered Sleeved Vests are intended to be utilized as a patient safety device when physical restraint of the patient is deemed necessary. TThey may be utilized in either a bed or wheelchair. The short sleeves and zippered back make the vest more difficult for the patient to remove. Vest may be used with detachable shoulder straps (provided) to help prevent sliding down in the wheelchair or bed.

Medline Zippered Sleeved Vest Restraints may be used either in a bed or wheelchair. They are intended for use with patients or residents that need a "gentle reminder" for the patient to stay in their bed or wheelchair. These products are designed for use with a carefully defined medical treatment program which addresses (but is not limited to) restorative nursing, patient release, and pressure sore prevention. Aggressive, agitated or restless patients require increased monitoring and a systematic review and evaluation of both their physical and psychological status.

Medline Patient Safety Products are intended to be used for those patients suffering from temporary medical related cognitive deficits, for agitated patients, or to help patients feel safer in a bed or wheelchair.

These devices are for use in hospitals and/or nursing homes to help maximize patient safety and are not intended to preclude good nursing care and common sense.

Medline's Zippered Sleeved Vests are intended to be utilized as a patient safety device when physical restraint of the patient is deemed necessary. TThey may be utilized in either a bed or wheelchair. The short sleeves and zippered back make the vest more difficult for the patient to remove. Vest may be used with detachable shoulder straps (provided) to help prevent sliding down in the wheelchair or bed.

The provided text describes a medical device, the Medline Zippered Sleeved Vest Restraint, and discusses its safety and effectiveness based on a review of existing literature. However, it does not contain information about a specific study conducted to prove the device meets acceptance criteria. Instead, it relies on a summary of and citation to safety and effectiveness data found in a search of medical literature and company documents.

Therefore, the following information is not present in the provided text:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information about a standalone (algorithm only) performance study.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a specific device study.
• Sample size for the training set.
• How ground truth for the training set was established.

The text does explain the device's intended use, general description, and lists potential hazards and benefits identified in a literature review. It explicitly states: "A total of thirteen articles were reviewed for this 510(k) submission. The articles listed in the citation contained pertinent data for establishing the safety and efficacy of protective restraints."

Summary of what can be extracted related to "acceptance criteria" and "study":

1. Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria (Implied from Literature Review): The device is safe and effective when used correctly and for indicated circumstances. This is derived from the "Specific safety and effectiveness data outlined in the literature" which discusses both complications and benefits. The implication is that the device should avoid the listed complications and achieve the listed benefits.
  • Saftey: Avoidance of emotional desolation, agitation, fractures, chafing, burns, nerve damage, circulatory impairment, decubitus ulcers, death, and strangulation due to inappropriate use or application.
  • Effectiveness: Precluding patients with temporary medical-related cognitive deficits from impairing the resolution of their physical problems; temporarily reducing the mobility of agitated patients; helping patients feel safer in a bed or wheelchair.
• Reported Device Performance: The document does not provide specific performance metrics for the Medline Zippered Sleeved Vest Restraint itself. Instead, it refers to a general understanding of protective restraints' safety and efficacy based on the reviewed articles.

2. The "Study" (Literature Review) that Proves the Device Meets Acceptance Criteria:

The "study" referenced is a literature review conducted for the 510(k) submission.

• Nature of the Study: A reasonable search of all information known or otherwise presently available to Medline Industries, Inc. was conducted, specifically examining articles in medical literature and company documents concerning safety and effectiveness information for safety restraints.
• Data Provenance (Source of "Study" Data): The data comes from 13 reviewed articles in medical literature, including publications from the FDA, nursing journals, and conference papers from various years (e.g., 1985, 1986, 1991, 1992). The data is retrospective, as it's based on existing published information. The countries of origin for the data are not explicitly stated for all articles, but references to the American Journal of Nursing and FDA Medical Alerts suggest a significant U.S. origin.
• Sample Size: The sample size is not applicable in the traditional sense of a clinical trial. The "sample" is the set of 13 articles reviewed. The number of patients or cases discussed within those articles is not specified.
• Number of Experts and Qualifications: Not specified. The literature itself would have been written by experts, but the process of Medline's review does not detail the number or qualifications of the individuals who performed the literature search and summary.
• Adjudication Method: Not applicable. This was a literature review, not a study involving expert adjudication of cases.
• MRMC Comparative Effectiveness Study: No.
• Standalone Performance Study: No. This document describes a review of existing literature, not a standalone study of the Medline device.
• Type of Ground Truth: The "ground truth" is derived from the consensus and findings reported in the peer-reviewed medical literature and regulatory alerts regarding the safety and effectiveness of protective restraints in general. This includes reported outcomes data (complications, benefits) from various clinical experiences and expert opinions within those publications.
• Sample Size for Training Set: Not applicable. There is no "training set" as this is not an AI or machine learning device, nor is it a de novo clinical trial.
• How Ground Truth for Training Set was Established: Not applicable.

In essence, the document asserts the device's safety and effectiveness by demonstrating that its characteristics align with generally accepted knowledge and research on protective restraints, as summarized from existing medical literature. It's a pre-market notification (510(k)) where equivalence to legally marketed predicate devices and established safety/effectiveness principles from literature are the primary means of demonstrating compliance, rather than a new standalone clinical study.

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