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The intended use for the Hill-Rom Wireless Connectivity Module is to assist clinical staff to monitor bed parameters on specific Hill-Rom beds. The Hill-Rom Wireless Connectivity Module is intended to be used only with specifically enabled Hill-Rom beds that have been verified and validated with the Hill-Rom Wireless Connectivity Module, and is not intended to provide bed status information for non-Hill-Rom beds. The Hill- Rom Wireless Connectivity Module is not intended to permanently store any type of data. The Hill-Rom Wireless Connectivity Module is not intended to provide automated treatment decisions or as a substitute for professional healthcare judgment. The Hill- Rom Wireless Connectivity Module is not a replacement or substitute for existing alert equipment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate health care professional.

The Hill-Rom Wireless Connectivity Module is a wireless module installed on specific Hill-Rom bed models. The Hill-Rom Wireless Connectivity Module is integrated into existing bed platforms via a USB connection to the bed's electrical system and provides connectivity to a remote server application.

The Hill-Rom Wireless Connectivity Module is used to assist staff to monitor hospital bed status and to assist the healthcare provider in providing patient care. The optional feature is mounted onto Hill-Rom hospital beds to wirelessly transmit bed information such as: bed exit status, bed side rail status, bed brake status, head of bed angle, and patient weight from bed scale. The Hill-Rom Wireless Connectivity Module is a tool that facilitates the wireless transmission of the bed status data using a wireless hardware and software device which communicates with a remote server in the hospital. The bed status data may be displayed at user-defined locations, such as nursing stations. It may also be shared with EMR (Electronic Medical Record) Systems through integration with 3rd party systems.

This document describes regulatory approval for a medical device called the "Hill-Rom Wireless Connectivity Module," which is a wireless module installed on specific Hill-Rom bed models to transmit bed parameters to a remote server. The information provided is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria for device performance in a diagnostic or clinical decision-making context.

Therefore, the requested information cannot be fully provided as the device is not an AI/ML algorithm or a diagnostic tool that would typically undergo such a rigorous performance study. The submission focuses on regulatory compliance, safety, and functionality.

Here's an attempt to answer the questions based on the provided document, highlighting where the requested information is not applicable or not explicitly stated:

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

This document does not provide acceptance criteria and reported performance in the typical sense for a diagnostic device or AI algorithm (e.g., sensitivity, specificity, AUC). Instead, the "performance" is assessed against compliance with international standards for electromagnetic compatibility and usability engineering.

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

Not applicable. This device is a hardware module for transmitting existing bed data, not a diagnostic or AI algorithm requiring a test set of patient data. The testing mentioned refers to hardware and software verification and validation, and compliance with standards. No information regarding patient-specific data provenance or sample size for a test set is provided as it's not relevant to this type of device submission.

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. As explained above, there is no "test set" in the context of diagnostic performance requiring ground truth established by medical experts for this device.

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

Not applicable. There is no test set requiring ground truth adjudication by experts for this device.

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 wireless connectivity module for monitoring bed parameters, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant or performed.

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

Not applicable. This device is a hardware module that transmits data. It does not perform an "algorithm only" task in the sense of an AI model making diagnostic predictions. Its function is to communicate existing bed status data wirelessly.

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

Not applicable in the typical sense for a diagnostic device. The "ground truth" for this device would be the actual state of the bed parameters (e.g., bed exit status, side rail status, brake status, head of bed angle, patient weight) as measured inherently by the bed's sensors. The device's performance would be validated by ensuring it accurately transmits these existing bed status data points. The document states "The Wireless Connectivity Module communicates existing bed status data. Clinical testing was therefore not required for determination of substantial equivalence as there is no new data involved in the wireless communication..." This implies the "ground truth" is the direct measurement from the bed itself.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that is "trained" on a dataset.

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

Not applicable. This device is not an AI/ML algorithm requiring a training set with established ground truth.

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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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This device is used to provide cushioning, torso support and totation (by manually-controlled alternating pressure) with pressure-relieving capabilities, as well as provide an aid to a nurse or other care-giver, in the home, we read foinical setting, to assist a patient in shifting their body position, to minimize possibility of bed sores, or other problems that can result from lying or sitting in one position for excessive periods of time.

An air-flotation, alternating pressure mattress, with detachable electric pump/compressor, reuseable, with available washable/disposable mattress cover.

The provided text describes a flotation mattress called "Nurse's Aid Patient Rotation System." This is a Class II medical device (Product Code: IOQ) intended to cushion patients, provide torso support and rotation with pressure-relieving capabilities, and assist caregivers in shifting a patient's body position to minimize issues like bed sores.

The submission is a 510(k) premarket notification, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" here are actually the criteria for demonstrating substantial equivalence, and the "study" is the comparison made against the predicate devices.

Here's an analysis of the provided text based on your requested information points:

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

Since this is a 510(k) submission demonstrating substantial equivalence, the "acceptance criteria" are implied to be the characteristics and performance of the predicate devices. The "reported device performance" is the claim that the new device meets or is equivalent to these.

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

This submission does not describe a formal clinical "test set" in the way one might for a novel diagnostic or therapeutic device. It is a substantial equivalence claim based on comparison to predicate devices, material safety, and independent lab testing for EMC and safety. Therefore, concepts like "sample size for the test set" or "data provenance" related to patient outcomes are not applicable in this type of submission. The "test set" is the device itself and its components, evaluated against known standards and predicate device characteristics.

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 "ground truth" here is established by the characteristics and safety of the predicate devices and general medical practice regarding flotation mattresses. There is no mention of external experts used to establish a "ground truth" for a specific test set of this device. The FDA's review process itself involves expert evaluation by the Division of General and Restorative Devices.

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

Not applicable. There is no human-involved "test set" requiring adjudication or consensus for this type of substantial equivalence claim.

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 medical mattress, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is a physical medical mattress, not an algorithm. However, the device itself does function "standalone" in its ability to alternate pressure, cushion, and provide support, performing its intended function without continuous human intervention once set up. The "aid to a nurse or other care-giver" is about facilitating their tasks, not replacing judgment.

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

The "ground truth" for this device's substantial equivalence claim relies on:

• Predicate Device Characteristics: The established design, function, and safety profile of the legally marketed predicate devices (K931594 and K933091).
• Material Safety Data: Historical use of materials/components in the medical industry without adverse events.
• Engineering and Safety Standards: Compliance with independent laboratory testing for EMC and safety (implied to be against recognized standards, though specific standards aren't listed).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI or machine learning algorithm requiring a "training set."

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

Not applicable, as there is no "training set" for this physical device.

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The Apex Metal HydroTec™ is indicated for the prevention and treatment of pressure ulcers ( bed sores).

Not Found

The provided documents (K970363) are a 510(k) clearance letter for the HydroTec™ Low Air Loss Therapy Bed. This kind of document typically doesn't contain a detailed report of a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study report would.

The FDA 510(k) process is primarily about demonstrating substantial equivalence to a legally marketed predicate device, not necessarily proving efficacy through new, rigorous clinical trials with detailed acceptance criteria for a new class of device. Therefore, much of the requested information (like specific acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in these specific documents.

However, based on the provided text, I can infer some information relevant to the device's intended use and the nature of product clearance:

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

• No specific acceptance criteria or tabulated performance data are present in these documents. The 510(k) clearance indicates that the device is "substantially equivalent" to predicate devices, meaning it has the same intended use and similar technological characteristics, or if there are differences, they do not raise new questions of safety and effectiveness.
• Intended Use (from the document): "The Apex Metal HydroTec™ is indicated for the prevention and treatment of pressure ulcers (bed sores)."

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

• Not explicitly mentioned in these documents. For a 510(k) submission, the "test set" would typically refer to data submitted to demonstrate substantial equivalence, which could include engineering testing, biocompatibility data, or potentially clinical data if differences from the predicate raised new questions. However, the details of such studies (sample sizes, provenance) are not provided in this clearance letter.

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/not mentioned. The concept of "ground truth" established by experts, particularly regarding interpretations like in imaging, is not relevant to this type of device (a therapy bed) and the documentation provided.

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

• Not applicable/not mentioned. Adjudication methods are typically used in studies involving subjective assessments (e.g., image interpretation), which is not the primary focus for a therapy bed's substantial equivalence demonstration.

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 type of study (MRMC for AI assistance) is not relevant to a low air loss therapy bed.

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

• Not applicable. This concept pertains to AI/software as a medical device, not a physical therapy bed.

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

• Not applicable in the sense of expert review for diagnostic purposes. For a therapy bed, "ground truth" would relate to performance characteristics (e.g., pressure redistribution, air loss rates, safety features) verified through engineering tests, and potentially clinical outcomes if clinical data were required to demonstrate substantial equivalence, but such details are not in the clearance letter itself.

8. The sample size for the training set

• Not applicable. This concept is relevant for machine learning algorithms, not a physical therapy bed.

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

• Not applicable. As above, this relates to machine learning.

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The Apex Metal AirTec2 Low Air Loss Therapy Bed is indicated for pressure relief for patients with pressure sores, burns, amputations, shin flap or graft surgery, that may be in Neurology, Dermatology, Rehabilitation or Orthopedics. For pain management and pressure relief consider the AirTec2 for patients with arthritis, AIDS or cancer.

AirTec2™ Low Air Loss Therapy Bed

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the HydroTec™ Low Air Loss Therapy Bed and AirTec2™ Low Air Loss Therapy Bed, indicating they are substantially equivalent to devices marketed prior to May 28, 1976. This type of document typically does not contain details of specific performance studies or acceptance criteria beyond regulatory compliance.

The information provided only includes:

• Trade Name: HydroTec™ Low Air Loss Therapy Bed and AirTec2™ Low Air Loss Therapy Bed
• Regulatory Class: II
• Product Code: IOQ
• Indications for Use: Pressure relief for patients with pressure sores, burns, amputations, shin flap or graft surgery (in Neurology, Dermatology, Rehabilitation or Orthopedics), and pain management and pressure relief for patients with arthritis, AIDS or cancer.

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The product is a device intended for medical purposes that consists of a mattress and a control unit which provides automatic changes in distribution and control of interface pressure. It is used to prevent and treat conditions where reduction of interface pressure is beneficial. The device is intended to provide a patient surface suitable for use with the general patient population in a variety of health care environments as determined appropriate by health care professionals. The TotalCare.. Modular Therapy System (MTS) is intended to be used in conjunction with the TotalCare. Patient Support System (PSS). The MTS is not intended for use with patients with unstable cervical fractures.

The TotalCare~ Modular Therapy System (MTS) is a patient Air Flotation Bed surface operated by a microprocessor controlled air system and proportional air valves. The mattress surface is of a modular design This allows the healthcare facility to add treatment and/or prevention opiions as the patient condition requires. The Surface Control Modules contain the software and proportional air valves and dock with the TotalCarem Patient Support System (PSS) Bed. The MTS surface maintains peripheral circulation by even distribution of the patient's weight over bladders filled with air. The even distribution of pressure on the skin reduces capillary closure, thereby helping maintain tissue viability around bony prominences, such as the buttocks and heels, both areas prone to ulceration and bed sores. The surface cover is non-permeable and will not allow the accumulation of perspiration and other bacteria producing body fluids within the cover or bladder of the bed. By wiping of the cover to remove any accumulation of fluids, followed by wiping of the surface of the cover with an antiseptic agent, contamination of the patient is reduced or eliminated.

This document is a 510(k) summary for the Totalcare™ Modular Therapy System (MTS), an alternating pressure air flotation mattress. It focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against such criteria. The submission is primarily a regulatory filing rather than a scientific study report.

Therefore, many of the requested sections regarding acceptance criteria and study details cannot be fully addressed from the provided text.

Here's an analysis based on the available information:

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

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the Totalcare™ MTS against such criteria. The focus is on demonstrating "substantial equivalence" to predicate devices rather than proving performance against predefined clinical or engineering benchmarks.

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

Not applicable. The document does not describe a performance study with a test set of 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 document does not describe a performance study with ground truth established by experts.

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

Not applicable. The document does not describe a performance study with adjudication.

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. The Totalcare™ MTS is a medical device (a mattress and control unit), not an AI-based diagnostic or assistive technology for human readers.

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

Not applicable. The Totalcare™ MTS is a medical device, not an algorithm.

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

Not applicable. The document does not describe a performance study that would require establishing ground truth. The primary basis of the 510(k) is comparison to predicate devices, implying that the predicates' established safety and effectiveness serve as a de facto "ground truth" for the new device's substantial equivalence.

8. The sample size for the training set

Not applicable. The document does not describe a performance study that would involve a training set.

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

Not applicable. The document does not describe a performance study that would involve a training set.

Summary of what the document does provide regarding device evaluation:

The document establishes that the Totalcare™ Modular Therapy System (MTS) is substantially equivalent to two predicate devices:

• Hill-Rom "Flexicair® Eclipse™" (K951001)
• Hill-Rom "Zoneaire™" (K945729)

Key points for substantial equivalence:

• Intended Use: The intended use for the Totalcare™ MTS is described as the same as the predicate devices: "to prevent and treat conditions where pressure maintenance is beneficial." It provides a patient surface suitable for the general patient population in healthcare environments.
• Materials, Technology, and Performance Characteristics: The document states that the subject device "has the same or similar materials, technology and performance characteristics as the predicate devices."
• Differences:
  • Air Supply: The MTS air supply is integrated into the Totalcare™ Patient Support System bed, while predicates have external or footboard-mounted units.
  • Mattress Construction: The MTS has a modular design, allowing addition of treatment options, unlike the fixed construction of predicates. It is also exclusive to the Totalcare™ PSS bed, whereas the predicates could be mounted on various beds.
  • Valves: The MTS (and Flexicair Eclipse) use proportional valves with feedback loops for self-controlling set pressure, while the Zoneaire uses valves controlled directly by voltage without a feedback loop.

The conclusion is that "Any differences between the subject and predicate devices are insignificant" in terms of safety and effectiveness, thus demonstrating substantial equivalence. The FDA concurred with this assessment in their letter.

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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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The standard FLEXICAIR® ECLIPSE™ , the FLEXICAIR® ECLIPSE™ PLUS the FLEXICAIR® ECLIPSE™ ULTRA Mattress Replacements are intended to provide low-airloss therapy for different ranges of patient weights. The standard FLEXICAIR® ECLIPSE™ , used on general Med-Surg or specialty beds covers all patient weights up to 300 lbs. The FLEXICAIR® ECLIPSE™ PLUS covers patient weights from 301 lbs to 450 lbs on Hill-Rom Centra and Advance 1000 bed frames and on the Stryker MPS bed frame. The FLEXICAIR® ECLIPSE™ ULTRA covers patient weights from 451 to 800 lbs on the Hill-Rom Magnum/Magnum II bed frames.

Air-fluidized and low airloss beds have been used for comfort and therapy for individuals who could not move themselves. 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.

Low airloss therapy maintains patient's peripheral circulation by distributing the patient's weight over cushions filled with air. The even distribution of pressure on the skin limits capillary closure, thereby helping maintain tissue viability around bony prominence such as the sacrum and heels. The numerous cushions in the FLEXICAIR® ECLIPSE™ help to decrease shear forces against the skin by moving independently of one another while the fabric helps to decrease friction.

A non-permeable cover, or coverlet, placed over the cushions prevents the transmission of perspiration and body fluids to the cushions.

The FLEXICAIR® ECLIPSE™ is a Portable Powered Flotation Therapy Mattress system. It consists of an air supply unit and mattresses. The air supply unit contains a blower, controller, and valves. The mattresses are composed of multiple air cushions attached to a substrate, with variations in height, number of cushions, and zoning depending on the specific model (Standard, PLUS, or ULTRA). The system utilizes proportional valves to control air pressure.

The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for a medical device (FLEXICAIR® ECLIPSE™), which describes the device, its indications for use, and a comparison to predicate devices, but it does not detail specific performance studies or acceptance criteria that would typically be found in a clinical or performance validation report.

Therefore, I cannot fulfill the request using only the provided text.

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