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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.

1. 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.

2. 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.

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. The submission does not describe a clinical study requiring expert-established ground truth.

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

   Not applicable. No clinical test set or adjudication method is described.

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 mattress system, not an AI-assisted diagnostic tool.

6. 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.

7. 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.

8. The sample size for the training set

   Not applicable. A "training set" is relevant for AI/ML algorithms. This is a physical medical device.

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

   Not applicable.

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The RUMORS Dynamic Air Therapy® Unit is intended to be used on existing bed frames in areas throughout the patient care environment to treat or prevent pulmonary complications and pressure ulcers.

The Unit can operate in rotation mode to reduce pressure shear, friction and maceration while gently rotating the patient from side to side; it can operate in percussion and vibration mode by delivering percussion and vibration to the patient's chest to loosen secretions from the lung wall; and it can also be programmed to operate in a sequential mode of percussion and vibration therapies with and without rotation with patients up to 400 lbs. in weight. The RUMORS Unit also provides low airloss therapy. Low airloss therapy has been demonstrated to reduce the risk of pressure ulcers caused by loss of capillary circulation as well as be a valuable aid in the treatment of bed sores.

The RUMORS Dynamic Air Therapy® Unit is intended to be used to treat or prevent pulmonary complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from Continuous Lateral Rotation Therapy.

The RUMORS Dynamic Air Therapy® Unit consists of an Air Supply Unit, a Mattress, and Valves. The Air Supply Unit contains the blower and controller, which utilizes touchscreen technology and can be programmed for patients up to 84 inches tall and 400 lbs. The controller manages low airloss, rotation, percussion, vibration, and combinations of these therapies. The mattress is 8 inches high, 80 inches long, and has adjustable width (32 or 35 inches). It has two layers of cushions: a top sleep surface with five independently controlled cushions and a bottom working surface containing proportional and percussion/vibration valves. The Unit utilizes twelve proportional valves and one percussion/vibration valve capable of producing percussion from 1Hz to 5Hz and vibration from 6Hz to 25Hz.

This is a 510(k) premarket notification for a medical device (K972111 for the RUMORS Dynamic Air Therapy® Unit), not a study report with acceptance criteria and results. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness is not present in the provided text.

The document primarily focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for approval rather than a scientific study validating specific performance metrics against pre-defined acceptance criteria.

However, I can extract the "Indications for Use" which serve as a high-level description of what the device is intended to do, and which implicitly define the areas where its performance would be assessed if a performance study were to be conducted.

Here's a breakdown of what can and cannot be answered from the provided text:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria (Implied from Indications for Use):
  • Prevention and treatment of pulmonary complications associated with immobility.
  • Prevention and treatment of pressure ulcers.
  • Providing medical benefits from Continuous Lateral Rotation Therapy.
  • Low airloss therapy to reduce risk of pressure ulcers and treat bed sores.
  • Reduction of pressure shear, friction, and maceration through rotation.
  • Delivery of percussion and vibration to the chest to loosen secretions.
• Reported Device Performance:
  The document does not report specific quantitative performance metrics or test results against these implied criteria. It states that the device "is able to accomplish these functions" and describes its operational modes (rotation, percussion, vibration, low airloss), implying it is designed to meet these needs, but no data or performance values are provided.

2. Sample size used for the test set and the data provenance

• Not Applicable. The document does not describe a clinical performance study with a test set. This is a 510(k) submission, which relies on demonstrating substantial equivalence to existing predicate devices, often through engineering analysis and comparison of features, rather than new clinical trials demonstrating performance against specific endpoints in a patient population.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. No clinical test set or ground truth establishment process is described in this regulatory submission.

4. Adjudication method for the test set

• Not Applicable. No clinical test set or adjudication process is described.

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 therapeutic medical bed/mattress system, not an imaging or diagnostic device involving "human readers" or "AI assistance." Therefore, an MRMC study is not relevant to this product.

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

• Not Applicable. This is a hardware-based therapeutic device with integrated control software, not an "algorithm only" product in the sense of AI/software as a medical device. Its operation is intended to be autonomous based on programmed settings. While it operates "standalone" in terms of its functions (rotation, percussion, etc.), this isn't the same context as standalone performance for an AI diagnostic algorithm.

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

• Not Applicable. As no performance study is detailed, no ground truth is mentioned. The submission's "ground truth" for regulatory approval is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not Applicable. This document describes a physical medical device, not a machine learning model, so there is no concept of a "training set" in the context of AI.

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

• Not Applicable. As there is no training set for an AI model, this question is not applicable.

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The CLINI-DYNE rotational/low air loss system is a patient rotation, pressure relieving support system used for the treatment and prevention of decubitus ulcers, urinary tract blockage, to aid circulation and for complications associated with immobility.

The CLINI-DYNE Rotational Therapy System consists of an electromechanical inflation pump control unit which is connected to a mattress with cells (air filled bladders) through hose assemblies connected to the inflation pump. The system affords programmed patient position changes by gently turning the patient from supine to left side or right side and back to supine position when staff is unable to do so or needs assistance.

The provided text describes a Premarket Notification [510(K)] Summary for the GAYMAR INDUSTRIES, INC. CLINI-DYNE Rotational Therapy System. This document focuses on demonstrating substantial equivalence to a predicate device (CLA 1400 System) rather than reporting on a study demonstrating the device meets pre-defined acceptance criteria in the way a clinical trial for a novel AI device would.

Therefore, the requested information elements related to AI device performance studies (like sample size for test sets, expert consensus, MRMC studies, standalone performance, training sets, etc.) are not applicable to this document. This is a regulatory submission for a medical device that predates the common application of AI in medical imaging or diagnosis.

However, I can extract information related to the device's technical specifications and safety testing, which serve as a form of "acceptance criteria" for demonstrating substantial equivalence.

Here's the information that can be extracted from the provided text, adapted to the requested format where possible:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of 510(k) submission, "acceptance criteria" are typically defined by demonstrating that the new device is as safe and effective as the predicate device. The performance is compared feature-by-feature for substantial equivalence.

NOTE 1: The document notes "See Substantial Equivalence" for these differences, implying that despite the direct difference, the total package of features and safety data still allows for a claim of substantial equivalence for the intended use.

2. Sample size used for the test set and the data provenance

• Not Applicable. This document describes a Traditional 510(k) for a physical medical device (Rotational Therapy System). The "test set" and "data provenance" as understood in AI/ML performance studies (e.g., patient data, image sets) are not relevant here. The "testing" involved physical and electrical safety standards (e.g., biocompatibility on materials, flammability, UL standards).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. Ground truth in the context of expert consensus on data interpretation is not relevant for this device's regulatory submission. Safety and performance were assessed against established technical standards and by comparison to a predicate device.

4. Adjudication method for the test set

• Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among multiple experts interpreting data, which is not applicable to the type of testing described here.

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. MRMC studies are used for evaluating diagnostic performance, often in conjunction with AI. This document is for a physical patient support system.

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

• Not Applicable. This is not an AI algorithm.

7. The type of ground truth used

• For Biocompatibility, Tissue Interface Testing, and Flammability: The "ground truth" was established by standardized laboratory testing procedures against pass/fail criteria for physical and chemical properties.
• For UL Approvals: "Ground truth" is compliance with Underwriters Laboratories (UL) standards.
• For comparative features: "Ground truth" is the demonstrated performance and characteristics of the predicate device (CLA-1400).

8. The sample size for the training set

• Not Applicable. This device does not involve a "training set" in the context of AI/ML.

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

• Not Applicable. This device does not involve a "training set."

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The Freedom Bed PAR 3 is used to automatically reposition immobilized persons from side to side either manually or on a programmed schedule aide in the prevention of decubitus ulcers in bed ridden patients.

The device is a programmable, automatically or manually operated repositioning bed designed for the prevention of decubitus ulcers. The device consists of 3 separate platen sections joined together with flexible hinges. The center section rotates left and right to a maximum of 30 degrees on each side, while the appropriate outer section rotates up to support and contain the sleeper. This provides a surface to transfer weight onto, as well as prevents the user from sliding or falling out of bed. The microprocessor based controller provides adjustment of time, angle and speed, as well as a choice of manual operation, automatic operation, or patient control. This allows most users to achieve independence from night time attendants and higher quality and duration of sleep. The bed has received UL 544, CSA, and FCC approvals.

This document is a 510(k) summary for a medical device (Freedom Bed™ Model PAR3) and does not contain the specific information requested regarding acceptance criteria and a study proving device performance in the context of diagnostic accuracy, AI, or expert review. The provided text is a regulatory submission for a physical medical bed designed to prevent decubitus ulcers and focuses on its description, intended use, and comparison to predicate devices, not on a performance study involving diagnostic metrics.

Therefore, I cannot provide the requested information based on the input text.

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