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To assist caregivers in turning patients to or from the supine or prone position. Turning immobile patients can assist in treating pulmonary complications or disorders commonly associated with immobility.

The Vollman Pronc Positioner Device is an independent, non-powered, portable accessory to any med-surg or critical care hospital bed with a flat surface that allows an immobile patient with respiratory complications, such as Acute Respiratory Distress Syndrome (ARDS) to be moved from a supine position to a prone position and held there. This position change occurs while the patient remains on either a regulation hospital frame (critical care or med-surg frame) or a therapeutic air support surface. This device allows this position change to be accomplished in most cases with only three caregivers. Currently, the most common method of proning a patient is manually lifting the patient and placing them prone. Other methods of proning a patient are the Stryker Wedge Turning Frame and the Stryker Circ-O-lectric Bed.

This 510(k) submission for the Vollman Prone Positioner does not include the detailed information required to describe acceptance criteria and a study proving device performance as requested.

The provided text is a 510(k) summary, which focuses on the device's description, intended use, and comparison to predicate devices, rather than a clinical study report or performance evaluation.

Therefore, I cannot provide answers to the following questions based on the input:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance evaluation was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

Explanation of Missing Information:

The 510(k) summary provided primarily focuses on:

• Device Identification: Trade name, common name, classification name.
• Predicate Device Comparison: Listing similar existing devices (Stryker Circ-O-lectric Bed, Stryker Wedge Turning Frame).
• Device Description: What the device is, its function (assisting in turning patients to prone position with 3 caregivers), and how it works (independent, non-powered, accessory to existing hospital beds).
• Intended Use: Assisting caregivers in turning patients to or from supine/prone positions to treat pulmonary complications.
• Technological Characteristics: General features like metal frames, manual patient securing (straps/padded surface), and manual operation.

It does not contain any information about:

• Specific performance metrics (e.g., how effectively it turns patients, safety outcomes, time taken).
• Clinical studies, trials, or performance tests.
• Data collection, ground truth establishment, or expert reviews.
• Statistical analyses or results demonstrating adherence to performance criteria.

To answer your questions, a document detailing the device's performance testing, such as a validation study report or a more comprehensive section of the 510(k) submission itself (beyond just the summary), would be required.

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