(233 days)
For the prevention and treatment of pressure ulcers. Patient lateral rotation of up to 30 degrees may also be used as a preventive tool against further complications associated with critically ill patients or immobility.
The PressureGuard Turn Select is an air flotation, alternating pressure support system. It consists of a foam shell manufactured with medical grade, polyurethane foam that meets the California Technical Bulletin 117. The perimeter bolsters are designed to safely prompt the patient toward the center of the surface, facilitating safe transfers and edge-of-bed sittings. The inflation system is cradled and securely positioned within the foam shell. Through computerized technology, the internal air pressures of the inflation system are controlled to achieve four operating modes. The CENTER Mode provides a level supine surface. The FIXED ROLL Mode provides automatic turning, turning the patient to the left followed by a 2 hour dwell time, then returning to center for a 2 hour dwell time, followed by a turn to the right followed by a 2 hour dwell time. The CUSTOM ROLL Mode provides for selection of roll patterns, roll angles and dwell times to meet individual patient needs. The CPR Mode provides a firm surface to aid in CPR Procedures (with a crash board). A Service Required Feature is provided to alert the health care provider in the event of system malfunction. CPR Alarm and Lock-Out features are also included.
The provided text describes a 510(k) submission for the "PressureGuard Turn Select" alternating pressure mattress, which is intended for the prevention and treatment of pressure ulcers and for patient lateral rotation. The submission focuses on demonstrating substantial equivalence to a predicate device (PressureGuard IV, 510K953503) rather than defining and proving specific acceptance criteria through a clinical study with performance metrics.
Therefore, many of the requested categories for a study that proves device meets acceptance criteria cannot be directly answered from the given document, as this submission is for a medical device cleared via substantial equivalence, not typically a clinical trial demonstrating performance against quantitative acceptance criteria for software or an AI algorithm.
However, I can extract information related to the closest aspects from the provided text.
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A table of acceptance criteria and the reported device performance
No quantifiable acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) are provided in the document for the PressureGuard Turn Select. The demonstration is based on "substantial equivalence" to a predicate device. The performance is implied to be similar to the predicate device.
Acceptance Criterion Reported Device Performance Not specified Not specified (Implied) Substantial Equivalence to predicate device for intended use and safety The device is similar in function and intended use to the predicate. (Implied) Pressure-management Verified through interface pressure testing (no results or criteria provided). (Implied) Conformance to UL 544 and CSA 122.25 System is designed to conform to these standards. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a "test set" in the context of clinical data or AI validation. The "interface pressure testing" mentioned is likely an engineering or bench test, not a clinical study on a patient sample. No sample size for such testing is provided, nor is the provenance of any data.
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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. The submission does not describe a clinical study requiring expert-established ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication method is described.
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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 mattress system, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is for a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The concept of "ground truth" for clinical outcomes or diagnostic accuracy is not relevant to this 510(k) submission, which focuses on similarity to a predicate device and engineering testing.
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The sample size for the training set
Not applicable. A "training set" is relevant for AI/ML algorithms. This is a physical medical device.
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How the ground truth for the training set was established
Not applicable.
§ 890.5225 Powered patient rotation bed.
(a)
Identification. A powered patient rotation bed is a device that turns a patient who is restricted to a reclining position. It is intended for medical purposes to treat or prevent bedsores, to treat severe and extensive burns, urinary tract blockage, and to aid circulation.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.