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Medline Pelvic Holders may be used either in a bed or wheelchair. They are intended to be used to help keep the patient upright and to help prevent them from sliding down in a wheelchair or for use in a bed to help prevent the patient from sliding down. They may be used alone or in tandem with a vest restraint.

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, to help patients maintain position or to help prevent them from sliding down in a bed or wheelchair, or they may be used to help patients feel safer in a bed or wheelchair.

Mediine Pelvic Holders are not intended for use with stretchers, on toilets or shower chairs or in the shower or tub, and should always be secured to the movable portion of the bed frame, never to the side rails.

Medline Patient Safety Products are not intended for use in a motorized vehicle, as they are not designed to withstand the force of a crash. Medline Patient Safety Products are not intended for home use.

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 Pelvic Holders are designed for use with either a bed or wheelchair. They are used to help hold the patient upright and help prevent sliding in a wheelchair, or to help prevent the patient from sliding down in bed. They may be used alone or in combination with a vest restraint. They are made of canton flannel and are secured by polyester web straps.

This document, K963404, is a 510(k) premarket notification for a Class I medical device (Protective Restraint, Pelvic Holder). As such, it does not contain the kind of detailed study design, acceptance criteria, and performance data typically associated with a clinical trial for a novel device. Instead, the focus is on demonstrating substantial equivalence to a legally marketed predicate device.

Here's why many of your requested items cannot be found in this document:

• Acceptance Criteria & Reported Device Performance (Table): This document does not establish new, quantitative acceptance criteria for device performance because it's not a de novo clearance or a clinical trial for a new technology. The "performance" is inherently based on the established safety and effectiveness of predicate devices and general medical literature regarding restraints.
• Sample Size (Test Set), Data Provenance, Experts for Ground Truth, Adjudication, MRMC Study, Standalone Study, Type of Ground Truth, Training Set Size, Training Set Ground Truth: These concepts are central to clinical validation studies for devices that require proof of clinical efficacy or diagnostic accuracy. A 510(k) for a Class I mechanical restraint, especially one legally marketed prior to the submission, does not involve such studies. The "study" here is a literature review to confirm the general safety and effectiveness principles of such devices.

What is present in the document and how it relates to "acceptance criteria" and "study":

The "study" performed for this 510(k) is a literature review of existing safety and effectiveness data for protective restraint devices.

1. A table of acceptance criteria and the reported device performance:

As explained, there isn't a table of quantitative acceptance criteria for this specific device in the clinical sense. The "acceptance criteria" for a 510(k) of this nature are that the device is substantially equivalent to a predicate device and adheres to general safety principles for its class, as evidenced by existing medical literature.

The "reported device performance" is qualitative and based on the established understanding of pelvic holders from the cited literature.

• Precluding patients with temporary medical-related cognitive deficits from impairing resolution of physical problems.
• Temporarily reducing mobility of agitated patients.
• Helping patients maintain an upright position in a wheelchair.
• Helping to prevent patients from sliding down in a bed or wheelchair.
• Helping patients feel safer in a bed or wheelchair. |
  | Substantial Equivalence: Device shares fundamental technological characteristics with legally marketed predicate devices and has the same intended use. (Not explicitly stated as "performance" but a core "acceptance criterion" for 510(k) submission). | The submission states: "These devices have been legally marketed prior to the date of this submission. The intended use and claims, technological features, materials and physical and mechanical specifications have not been changed." This is the basis for substantial equivalence, implying performance similar to existing, accepted devices. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: Not applicable. There was no specific "test set" of patients or devices. The "data" comes from a review of previously published medical and regulatory literature.
• Data Provenance: The articles cited in the literature review would have their own provenance, but this document does not detail it. The journals cited (e.g., American Journal of Nursing, Journal of Psychosocial Nursing) suggest a retrospective review of existing publications, likely originating from the US and possibly other countries (e.g., article from St. James Hospital Dublin).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. There was no "test set" with "ground truth" to be established by experts for this specific device. The experts involved would be the authors of the cited articles and the FDA personnel who developed the alerts and rules referenced. The qualifications of these individuals are not detailed in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No test set requiring expert adjudication was used.

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:

• No. This device is a mechanical restraint, not an imaging or diagnostic device. AI assistance and MRMC studies are not relevant to its regulatory pathway or testing.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No. This is a mechanical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable in the context of a prospective study. The "truth" or understanding of safety and effectiveness is derived from published medical literature, regulatory alerts (FDA), and company documents concerning protective restraints in general. This includes descriptions of potential complications (outcomes data) and general expert understanding summarized in those publications.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established:

• Not applicable.

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