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The TotalCare® Bed System is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy. The TotalCare® Bed System is intended to provide a patient support to be used in health care environments. The TotalCare® Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare® Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.

The TotalCare® Bed System, dependent upon model, is capable of supporting patient populations up to 500 lbs.

The TotalCare® Modular Therapy (Bed) System is a control unit (GUI) and frame which can house several therapeutic surfaces. The system can articulate to provide different positions for treatment, sleeping, up-in-bed, and other physician recommended positions. The Graphical Caregiver Interface/ Graphical User Interface can be set for alarms such as patient egress and head-of-bed angle.

The Hill-Rom TotalCare® Modular Therapy (Bed) System is a medical bed designed to provide patient support and therapy.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The provided summary does not mention any specific sample sizes for a test set related to clinical performance or algorithm evaluation. Instead, it explicitly states:

• "Clinical testing was not required for determination of substantial equivalence."
• "A literature review was compiled of articles related to safe patient handling and benefits of therapy surfaces and beds of this type for patients experiencing prolonged immobility."

This indicates that the device's acceptance was primarily based on non-clinical performance and substantial equivalence to predicate devices, without a dedicated clinical test set for this specific submission.

3. Number of Experts and Qualifications for Ground Truth

Given that "Clinical testing was not required," there is no mention of experts used to establish ground truth for a test set in the context of this 510(k) summary. The evaluation relied on compliance with engineering standards and comparison to existing products.

4. Adjudication Method for the Test Set

As there was no clinical test set requiring human assessment, no adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done as clinical testing was not required. The device is a medical bed, not an AI-assisted diagnostic tool for which such studies are typically performed.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study was done as the device is a medical bed and not an algorithm-based system requiring such evaluation. The evaluation focused on the physical device's compliance with safety and performance standards.

7. Type of Ground Truth Used

The "ground truth" for the device's acceptance was:

• Compliance with international engineering and safety standards: This forms the basis for the non-clinical performance summary (e.g., IEC 60601 series).
• Substantial equivalence to predicate devices: This involves comparing the new device's technological characteristics and intended use to existing, legally marketed similar devices, rather than a clinical ground truth like pathology or outcome data.

8. Sample Size for the Training Set

Since there are no indications of a machine learning or AI algorithm being developed or deployed within this device, there is no mention of a training set sample size.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set, the question of how its ground truth was established is not applicable.

In Summary:

The Hill-Rom TotalCare® Modular Therapy (Bed) System's acceptance was based on non-clinical performance validation against established international safety and performance standards, and demonstrating substantial equivalence to predicate medical beds. Clinical testing was not deemed necessary for this 510(k) submission, and therefore, typical metrics associated with AI device evaluation (like test set size, expert ground truth, MRMC studies, or training sets) are not present in this documentation.

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The KinAir IV and Therpulse II beds are for supporting bedridden patients in a manner that helps prevent and treat complications of immobility such as skin breakdown and decubitus ulcers. More particularly, it employs a patient supporting mattress overlay having an arrangement of transverse inflatable cushions that can be controlled to provide slowly pulsating pressures beneath the patient, as well as bladders to assist in turning the patient to one side or the other.

The KinAir IV, Therapulse II Air Bed bed is indicated to assist in the prevention and treatment of the complications of immobility, especially for patients who would benefit from a pressure relieving surface with the additional optional benefit of pneumatic pulsation.

The KinAir IV, Therapulse II (a.k.a. KT Air Bed) device is a pulsating low air-loss support mattress replacement system mounted on a commercially-available Stryker 3000 Acute Care Bed Frame, that also includes a Turn Assist feature. The mattress replacement system itself is essentially of the same general construction as the predicate Therapulse (510(k) No. K875321) and the KinAir (510(k) No. K880340 and the substantially equivalent TriaDyne device (510(k) No. K944094). It consists of the fabric support and the various cushions. The fabric support is a Gore-Tex fabric assembly for supporting and containing the twenty five upper cushions. Two additional inflatable cushions are on the underside of the fabric support, to assist the caregiver when turning the patient. All inflatable cushions are made of a vinyl Gore-Tex fabric to provide a low shear, low friction surface that is washable and durable.

The KinAir IV, Therapulse II Air Bed has two general modes of operation: 1) static, and 2) turn assist, with an optional third mode, pulsation, available only on the Therapulse II. The Display membrane panel mounted on the footboard and in each foot siderail, are used to select the static and pulsing modes. For the static mode, four individually adjustable sections of upper cushions are inflated to support the patient with minimal air pressures. For the pulsing mode, over an adjustable cycle of between 2 1/2 and 40 minutes, some cushions are inflated and deflated more or less than others in order to alternate the pressures supporting the patient. The cycle repeats continuously until the pulse mode is deactivated.

The Turn Assist mode is only available on the Home Display membrane panel mounted on the footboard. When the caregiver selects this mode to turn the patient either left or right, either the left or right bladder cushion will inflate and lean the patient approximately 15-20 degrees and stay inflated until the caregiver deactivates the turn assist mode. This feature was added to assist the caregiver when performing routine patient care, such as bathing, bedpan placement, etc.

The blower unit and Air Supply Unit are mounted on the Stryker bed frame, beneath the mattress. They are controlled to achieve the various modes of operation according to user input through switches on the membrane panels mounted on the footboard and on the outside of the foot siderails. All user input is accomplished through these membrane panels. The membrane panels with the various settings and displays are illustrated throughout the KinAir IV and Therapulse II Quick Reference Guides.

The Air Supply Unit's warmer is provided to warm air in the mattress for patient comfort. The blower is mechanically and electrically isolated to help prevent injury and reduce The warming element itself is a conventional resistive silicon heater. The warmer noise. actually warms the air in the Air Supply Unit's manifold, and the air then passively warms the patient to the degree selected by the patient's attendant. There are three settings: 1) LOW, 2) MEDIUM and 3) HIGH. At the HIGH setting, the heating element is capable of achieving maximum temperatures of roughly ten degrees Fahrenheit above ambient. Temperature feedback from sensors adjacent to the blower manifold allows for control of such temperatures. This is the same system that was used in the predicates Therapulse and KinAir.

When first inflated, the KinAir IV and the Therapulse II are automatically set in the static mode. Pulsation therapy, available on the Therapulse II, only, when activated, begins alternating pressure between sets of cushions. When pulsation is first activated, the cushion closest to the footboard decreases its pressure, together with every other cushion along the mattress length, while the other pressures are increased. Once the first set of cushions reaches its lowest point and starts to increase, the second set of cushions starts to decrease. The second set reaches its minimum just as the first set reaches its maximum. The cycle then repeats all over again, resulting in a pulsating effect. The minimum cycle time of 2 1/2 minutes is the it takes for a pulsating cushion to partially deflate and then inflate again.

This document is a 510(k) summary for the KinAir IV/Therapulse II (KT Air Bed) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of its own performance against set acceptance criteria. The document describes the device, its intended use, indications, contraindications, and differences from predicate devices. It does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria, as typically seen in a clinical trial or performance validation report.

The comparison provided is against existing predicate devices (KinAir, Therapulse, TriaDyne Plus) to establish substantial equivalence, which is a regulatory pathway for medical devices. This type of submission generally relies on demonstrating that a new device is as safe and effective as a legally marketed device, and therefore often focuses on technological characteristics and functional equivalence rather than new performance studies with pre-defined acceptance criteria.

Therefore, many of the requested elements cannot be extracted from this document, as they are not part of a typical 510(k) submission focused on substantial equivalence based on device design and existing predicate devices.

However, based on the provided text, here's what can be gathered, with an emphasis on what is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available in the provided text. The document does not describe specific numerical acceptance criteria (e.g., minimum pressure reduction percentage, specific decubitus ulcer prevention rates) or present a study with quantitative performance results against such criteria for the KinAir IV/Therapulse II. Instead, it compares the new device's features to those of predicate devices in a table (see page 4 of the document). This table is for "Comparative Information" of features, not performance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

This information is not available. No test set (e.g., patient cohort for a clinical study) is described. The 510(k) submission is based on demonstrating substantial equivalence through design and functional comparison, not on a new clinical study with a test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not available. No test set or ground truth establishment process is described.

4. Adjudication Method for the Test Set:

This information is not available. No test set or adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size:

This information is not available. The document does not describe any MRMC study or any study involving human readers or AI assistance. The device is a medical bed, not an imaging or diagnostic AI system.

6. Standalone (Algorithm Only) Performance Study:

This information is not available. The device is a physical medical bed, not an algorithm.

7. Type of Ground Truth Used:

This information is not applicable/not available as no new performance study generating "ground truth" for the KinAir IV/Therapulse II is presented. The "ground truth" for the 510(k) pathway is essentially the established safety and effectiveness of the predicate devices that the new device is compared against.

8. Sample Size for the Training Set:

This information is not available. No training set (as in machine learning) is described.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable/not available.

Summary of what the document does provide regarding substantial equivalence:

The document focuses on comparing the KinAir IV/Therapulse II to predicate devices (KinAir, Therapulse, TriaDyne Plus) to establish substantial equivalence.

• Key Differences and Similarities: The primary difference highlighted is the use of a Stryker MPS 3000 frame for the platform, instead of the Hill-Rom frame used by the original KinAir and Therapulse. The low air-loss mattress replacement system itself is stated to be "essentially the same" as the predicates.
• Operational Modes: The new device offers static, turn assist, and an optional pulsation mode (on Therapulse II), similar to the predicate devices' functionalities.
• Intended Use & Indications: The intended use and indications (prevention and treatment of immobility complications like skin breakdown and decubitus ulcers) are consistent with the predicate devices.
• Comparative Table (Page 4): This table provides a detailed feature-by-feature comparison, including dimensions, maximum patient weight, patient surface material, various therapy features (low air-loss, percussion/vibration, rotation, turn assist, pulsation, warmed air), and electrical data. This table implicitly acts as the "proof" of substantial equivalence by showing that the new device's characteristics are either the same or functionally equivalent to the predicate devices. For example, while the original KinAir had "Rotation" with a 45-degree angle, the new KT Air Bed has "Turn Assist" (Yes) but "Rotation" (No), suggesting a functional alternative for patient repositioning. The maximum patient weight is higher for the KT Air Bed (700 lbs) compared to KinAir (300 lbs) and Therapulse (500 lbs), indicating an improvement in capacity.

In conclusion, this 510(k) summary is a regulatory submission demonstrating substantial equivalence through design and functional comparison to existing devices, not a study presenting primary performance data against pre-defined acceptance criteria.

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Prevention and treatment of decubitus ulcers, treatment of burns, flaps and grafts and to aid circulation.

This product provides the therapeutic surface features and leg elevation bed features of the Flexicair® Low Airloss Therapy Unit while eliminating the hospital bed frame. The intent of the design of the SILKAIR™ Low Airloss Therapy is to provide a zoned low airloss surface with the capabilities of head and leg elevation for non articulating bed frames or mattress box springs. SILKAIR attaches the low airloss surface to a positioning base which provides the head and leg articulation features. This positioning base can be attached to any flat surface such as a box spring, converting a regular bed into a hospital bed. The SILKAIR™ Low Airloss Therapy System is a zoned low airloss surface. The system distributes different pressures in different zones relative to the main air manifold pressure. This system uses basic, simple mechanical and electrical components. Head and leg articulation required by many patients in the home is achieved through the use of a positioning base. This positioning base consists of plastic support plates and accordion bladders to raise and lower the head and leg sections of the surface.

The provided 510(k) summary for the SILKAIR™ Low Airloss Therapy device does not contain information about specific acceptance criteria or a study proving that the device meets those criteria.

This document is a premarket notification for a medical device (510(k)), which primarily focuses on demonstrating substantial equivalence to a predicate device already on the market. It outlines the device's general description, indications for use, and a comparison to the predicate, but it does not typically include detailed performance studies with acceptance criteria in the same way a clinical trial or a performance data summary might.

Therefore, many of the requested details cannot be extracted from this document, as they are not present in a typical 510(k) submission of this nature (particularly for devices prior to more rigorous performance mandates).

Here's an analysis based on the information provided, and where information is missing or not applicable:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information: Specific numerical or qualitative acceptance criteria (e.g., pressure reduction thresholds, comfort metrics, durability standards, etc.) are not provided. The summary relies on the assertion of equivalence to a legally marketed predicate device (Flexicair® Low Airloss Therapy Unit K863047) rather than presenting new performance data against specific benchmarks.

Study Details

Given the nature of this 510(k) summary, specific performance studies with detailed methodologies (sample size, ground truth, expert adjudication, etc.) are not included. The "study" here is essentially the comparison and justification for substantial equivalence.

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

• Sample size: Not applicable/Not provided. There is no mention of a dedicated "test set" in the context of a performance study.
• Data provenance: Not applicable/Not provided.

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

• Not applicable/Not provided. No "ground truth" or expert adjudication for a test set is mentioned.

4. Adjudication method for the test set:

• Not applicable/Not provided.

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 physical therapy bed system, not an AI diagnostic or assistance tool. Therefore, an MRMC study related to human reader performance with AI is irrelevant.

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

• Not applicable. This device is a physical therapy bed system, not an algorithm.

7. The type of ground truth used:

• Not applicable/Not provided. The "ground truth" in a 510(k) for such a device is implicitly the established safety and efficacy of the predicate device.

8. The sample size for the training set:

• Not applicable/Not provided. There is no mention of a "training set" in the context of this device.

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

• Not applicable/Not provided.

Summary of Missing Information and Context

The provided document is a 510(k) premarket notification for a physical medical device (a low airloss therapy bed). For such devices, especially from 1997, the primary regulatory pathway is to demonstrate "substantial equivalence" to a predicate device already on the market. This often means showing that the new device has similar technological characteristics and indications for use, and does not raise new questions of safety or effectiveness, without necessarily conducting entirely new, extensive performance studies with detailed acceptance criteria as one might see for a novel diagnostic or treatment technology today.

The key statements in the document regarding performance are:

• "The safety characteristics of this product compare to those of the predicate devices."
• "No significant changes have been made which impact the safety and efficacy of the SILKAR™ Low Airloss Therapy System as compared to the predicate device."
• "There are no performance standards established for this classification." (This is a crucial point regarding the absence of specific, pre-defined acceptance criteria for this device type at the time.)

Therefore, the "proof" the device meets acceptance criteria is primarily the FDA's concurrence that it is substantially equivalent to the predicate device (Flexicair® Low Airloss Therapy Unit, K863047), implying that if the predicate was safe and effective, this device is as well. No specific performance study data is presented in this summary to quantify device performance against defined criteria.

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Not Found

Portable powered low air loss flotation therapy mattress.

This document, K963674, is a 510(k) summary for the LUMEXAIR portable powered low air loss flotation therapy mattress. It is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.

There is no information in this document regarding a clinical study to prove the device meets acceptance criteria.

The document primarily focuses on establishing "substantial equivalence" of the LUMEXAIR mattress to other legally marketed predicate devices, such as the Orthoderm HC System®, Akrotech 4000®, and Plexus 3000®. This means the submission argues that the new device is as safe and effective as these existing devices, often by demonstrating similar design, materials, and intended use.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment because these details are not present in the provided 510(k) summary. The 510(k) process for devices like this typically relies on performance data and comparisons to predicate devices, rather than robust clinical trials with specific acceptance criteria as you might see for novel, high-risk devices or pharmaceuticals.

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Not Found

The device, brand name AkroTech 4000T Kinetic Turning Low Air Loss (LAL) System, is substantially equivalent to the AkroTech 4000 Dynamic Low Air Loss (LAL) (K923077) (K923977). Both Low Air Loss support systems consist of two operating components: 1. The electromechanical, computer controlled Air Control unit (ACU) 2. The Air Floatation Mattress. Both Systems promote pressure reduction by redistributing patient weight over a surface area / medium or by shifting patient we in a area / medium or by shifting patient weight of redistributing patient weight over a

The provided text is a 510(k) summary for the AkroTech 4000T Kinetic Turning Low Air Loss (LAL) System. This document focuses on demonstrating substantial equivalence to a previously cleared device (AkroTech 4000 Dynamic Low Air Loss (LAL) - K923077/K923977), rather than presenting a study with specific acceptance criteria and performance metrics in the way a clinical trial or algorithm validation study would.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, effect size of human readers with AI assistance, standalone performance, training set data) are not applicable to this type of regulatory submission.

However, I can extract information related to the device's features and safety standards, which serve as the implicit "acceptance criteria" for substantial equivalence.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

Since this is a submission for substantial equivalence, the "acceptance criteria" are not predefined performance metrics in the traditional sense. Instead, the device needs to demonstrate that it is as safe and effective as the predicate device. The performance is reported in terms of feature comparison and adherence to safety standards.

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

• Not Applicable. This document describes a comparison to a predicate device based on features and specifications, not a clinical study or performance test involving a specific test set of data.

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

• Not Applicable. See point 2. The "ground truth" here is the established safety and effectiveness of the predicate device, against which the new device's features are compared by the engineers and regulatory reviewers.

4. Adjudication method for the test set

• Not Applicable. See point 2.

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 medical bed 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 device is a medical bed system, not an algorithm.

7. The type of ground truth used

• The "ground truth" in this context is the established safety and effectiveness of the predicate device (AkroTech 4000 Dynamic Low Air Loss (LAL) - K923077/K923977) as determined by its previous FDA clearance. The new device demonstrates "substantial equivalence" by having similar intended use, technological characteristics, and safety/effectiveness profile, potentially with some differences that do not raise new questions of safety or effectiveness.

8. The sample size for the training set

• Not Applicable. This device is a medical bed system. There is no "training set" in the context of an algorithm. Development would involve engineering design, testing, and verification, not machine learning model training.

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

• Not Applicable. See point 8.

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