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For the prevention and treatment of pressure ulcers.

The PressureGuard Site Select is an air flotation, alternating pressure support system which provides for customized selection of surface firmness for a head, upper torso, lower torso, and heel zones.

The provided 510(k) summary for the PressureGuard Site Select primarily focuses on demonstrating substantial equivalence to a predicate device (PressureGuard IV) based on similar function and intended use. It describes the features and modes of operation of the device but does not include information about specific acceptance criteria or a study proving that the device meets such criteria.

Therefore, I cannot populate most of the requested fields based on the given document.

However, I can extract the following:

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

• Acceptance Criteria: Not explicitly stated in the document.
• Reported Device Performance: Not explicitly stated as per specific performance metrics. The document focuses on describing the device's features and comparability to a predicate.

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

• Sample Size: Not provided.
• Data Provenance: Not provided.

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 provided, as there's no mention of a clinical or performance study with a test set requiring ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 is not an AI-powered device, and no MRMC study is mentioned.

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

• Not applicable. This is not an algorithm-only device.

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

• Not applicable/Not provided.

8. The sample size for the training set

• Not applicable/Not provided, as this is not an AI/machine learning device.

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

• Not applicable/Not provided.

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FOR The PREVENTION AND TREAT M [sic] PRESSURE ULCERS OF [sic]

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "ZAK-2000" for the prevention and treatment of pressure ulcers. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot fulfill your request based on the given input.

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The Mighty*Air is used to help prevent and treat pressure ulcers.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Mighty Air", which is used to help prevent and treat pressure ulcers. This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details requested in your prompt regarding a study proving the device meets acceptance criteria.

The letter only states that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976, and that it can be marketed subject to general controls. It does not elaborate on the specific testing or data that supported this determination.

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

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The intended use of this product is for the healing of Decubitus Ulcers through the minimization of chronic localized occlusive pressures.

Physio / 1000 Alternating Pressure Mattress System

This document is a 510(k) clearance letter from the FDA for a device called "Physio/1000 Alternating Pressure Mattress System." It primarily addresses the regulatory approval process and does not contain detailed information on acceptance criteria or the specific studies used to demonstrate device performance.

Therefore, I cannot provide the requested information based on the provided text. The document states that the device is "substantially equivalent" to predicate devices, but it does not elaborate on the specific performance data or studies that established this equivalence.

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The Simpulse mattress is for supporting bedridden patients in a manner that helps prevent and treat complications of immobility such as skin breakdown and decubitus ulcers. It employs a series of transverse inflatable cushions that can be sequentially inflated and deflated to provide pulsation pressures beneath the patient.

The Simpulse is indicated for patients who would benefit from: A pressure relieving surface with the additional benefit of pulsation to assist in the prevention and treatment of the complications of immobility such as skin breakdown and decubitus ulcers.

The Simpulse™ is a powered, Pulsating Therapy Mattress that can be used as an Overlay or Mattress Replacement System and is designed for use in all care settings (home, acute and extended). The Simpulse provides pulsating air suspension therapy that combines the benefits of pressure relief with the advantages of pulsation therapy.

The Simpulse" is comprised of two major components: the Air Supply Unit, and the Mattress Assembly.

The Mattress Assembly is comprised of: the pulsating air surface, the air base, the underliner and the cover sheet. The pulsating air surface is the component that pulses. It consists of ten separate interlocking air cushions that are plumbed to provide pulsation (five cushions are plumbed to Channel A and five are plumbed to Channel B). By only inflating the 5 inch pulsating air surface, the Simpulse " can be used as a mattress overlay.

When the Simpulse is used as a Mattress Replacement System, the 3 inch air base is inflated and serves as a static pressure air base that keeps the patient suspended when the bed is articulated. It also serves as an air support and remains inflated in case of a power outage. The underliner serves as an envelope to provide structure to the mattress. It has tie points that snap together and hold the pulsating air surface in place in relation to the air base. It also has straps that secure the entire Mattress Assembly to the bed frame.

The cover sheet is a fitted sheet made of nylon with a urethane backing that fits over the Mattress Assembly and provides a protective barrier between the patient and the air bladders.

The Air Supply Unit is mountable on the footboard of a standard hospital bed or can be placed upright on the floor and is microprocessor controlled to achieve the two modes of operation (Pulsation and/or Static). All user input to the microprocessor control is accomplished through the membrane panel switch are located on the Air Supply Unit.

The Air Supply Unit utilizes two separate pump and valve assemblies to channel compressed air to the Mattress Assembly, creating two sections referred to as Channel A and Channel B. This provides a single target pressure for the entire mattress as well as the means for the mattress to pulsate. The hose set has a connection on one end that mates to an air connection on the side of the Air Supply Unit. This connection also serves as a CPR emergency air deflation system by simply disconnecting the hose from the Air Supply Unit. The other end connects to the air cushions (Channel A, Channel B and the Air Base).

The target pressure is set by pressing the "Soft/Firm" buttons located on the membrane control panel. These buttons have five LED's evenly spaced between them and the user can adjust the firmness of the mattress within the range of these five LED's. If the user pushes and holds one of the buttons, the LED location will not increment until the user releases the button and pushes it again. Once the user selects the pressure setting, the pressure feedback system will automatically maintain the pressure setting within a target pressure range of plus or minus 1" H2O. If the actual pressure moves out of the target pressure range, the microprocessor controller will activate the corresponding pump to increase the pressure or open the corresponding valve to decrease the pressure until the pressure is within the target pressure range.

In the Static mode, all of the cushions in the air surface are inflated to an equal pressure and operate in a continuous pressure feedback mode as previously described. In the Pulsating On mode, the cushion closest to the footboard will decrease in pressure together with every other cushion along the mattresses length (Channel A), while the other set of cushions (Channel B) increase in pressure. Once the cushions of Channel A reach the lowest point and begin to increase in pressure, the cushions of Channel B start to decrease in pressure. When the Channel B cushions reach the minimum pressure and then begin to increase in pressure, the cushions of Channel A will once again begin to decrease in pressure. This completes a full cycle. By pressing the "Pulsation Cycle Time" button, the pulsation cycle time can be adjusted over a range of between 5, 10 or 20 minutes. An LED light will indicate which time period has been selected.

The "Auto Firm" control will fill Channels A & B and the Air Base to a maximum inflation level. During the time that Auto Firm is activated, The Pulsation On/Off buttors, Pulsation Cycle Time Button and the Soft/Firm buttons as well as their respective LED indicators will be disabled. The mattress will stay at the maximum inflation level until the Auto Firm Off button is pushed or twenty minutes elapse from the time the Auto Firm On button was first pushed. The Simpulse will then default to the same settings of operation as before the AutoFirm was activated.

This document is a 510(k) Summary for the Simpulse™ mattress, dating from 1997. It describes a medical device and its intended use, but it does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The 510(k) summary is a regulatory document submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. It typically focuses on device description, indications for use, contraindications, and comparisons to predicate devices, rather than detailed performance studies with acceptance criteria in the manner requested.

Therefore, I cannot provide the requested information based on the provided text. The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

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The Cathay Consolidated Super Air 9000 is indicated for the prevention and treatment of pressure ulcers ( bed sores).

Super Air 9000 Alternating Air Flotation Mattress System

The provided text is a 510(k) premarket notification approval letter for the "Super Air 9000 Alternating Air Flotation Mattress System." This document grants permission to market the device based on its substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it describe an AI-powered device or its performance metrics.

The letter focuses on regulatory approval, classification, and general controls applicable to the device. It states the indications for use (prevention and treatment of pressure ulcers) but does not provide performance data or study results.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as this information is not present in the provided document.

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The BariAir bed is indicated for patients weighing up to 850 pounds to aid in the prevention and treatment of complications of immobility. Particularly:

• · patients who would benefit from a pressure relieving surface with the additional benefits of pulsation, percussion and/or continuous or regular turning from side to side.
• · patients whose body weight and size pose a significant risk of injury to the patient or nursing staff during the performance of routine nursing care procedures.

BariAir is a bariatric patient care system that combines the flexible patient-positioning capabilities of the predicato device (BariKare Plus) with a pressure relieving, dynamic low-air-loss mattress. The BariAir mattess is a three-section air mattress consisting of a scries of transverse, inflatable cushions that can be alternately inflated and deflated to provide pulsation therapy, four turning bladders to rotate the patient side to side, and an air bladder beneath the patient chest region cushions to provide vibration/percussion therapy. The BariAir device includes support and caster frames substantially the same as the predicate device.

BariAir also provides continuous lateral rotation therapy, automatically turning the patient, as well as other adjunct therapies such as pulsation and vibration/percussion.

This 510(k) summary (K955243) describes a device called BariAir, a low air loss bed. However, the provided document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria beyond establishing substantial equivalence to a predicate device.

The document is a 510(k) submission summary, which primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This regulatory pathway often relies on comparison to a predicate device and does not typically include detailed performance studies with acceptance criteria in the same way a Premarket Approval (PMA) application would.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text because it is not present.

The 510(k) summary highlights:

• Predicate Device: BariKare Plus.
• Device Description: BariAir combines features of the predicate device (flexible patient positioning, built-in scale) with a pressure-relieving, dynamic low-air-loss mattress. It offers pulsation, four turning bladders for rotation, and air bladders for vibration/percussion therapy.
• Intended Use: For patients up to 850 pounds to prevent and treat immobility complications, especially those needing pressure relief with pulsation, percussion, and/or turning, or where patient weight/size poses risk to patient/staff during routine care.
• Contraindication: Unstable spinal cord injuries.
• Substantial Equivalence: The FDA determined the BariAir device is substantially equivalent to devices marketed prior to May 28, 1976.

The FDA's finding of "substantial equivalence" is based on the comparison of the new device to a predicate device, focusing on similar technological characteristics and intended use. This typically does not involve new clinical performance studies with predefined acceptance criteria.

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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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The RID-Decube II Alternating Pressure Mattress System is intended for medical purposes to be used to prevent and treat decubitus ulcers.

The RID-decube II is an alternating pressure air flotation mattress intended for medical purposes with multiple air cells that can be filled and emptied in an alternating pattern by associated control units to provide regular, frequent and automatic changes in the distribution of body pressure.

The provided text is a 510(k) summary for the RID-Decube II, an alternating pressure air flotation mattress. This type of document is for premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Based on the information provided, the document does not contain acceptance criteria for device performance or any study details that would prove the device meets such criteria.

Here's why and what information is available:

• Purpose of a 510(k) Summary: A 510(k) is primarily to demonstrate that a new device is "substantially equivalent" to a predicate device already on the market. This often means showing similar design, materials, intended use, and performance characteristics, but typically doesn't involve presenting detailed clinical study results with acceptance criteria in the summary document unless specific performance claims are being made that exceed the predicate's established use.
• Missing Information: The provided text is essentially a cover letter and a brief description of the device and its intended use. It does not include:
  • Specific performance metrics (e.g., pressure redistribution efficacy, durability, patient comfort levels)
  • Acceptance criteria for any performance metrics
  • Details of any study (clinical or non-clinical) conducted to evaluate the device's performance
  • Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
  • Any information regarding MRMC studies or standalone algorithm performance, as this device is a physical medical mattress, not an AI/software device.

Table of Acceptance Criteria and Reported Device Performance:

(No acceptance criteria or device performance data is provided in the document.)

Other Information based on the provided text:

1. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided.
2. 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 no study or ground truth establishment details are provided.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no study or adjudication details are provided.
4. 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 RID-Decube II is an alternating pressure air flotation mattress, not an AI/software device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The RID-Decube II is an alternating pressure air flotation mattress, not an AI/software device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no study or ground truth establishment details are provided.
7. The sample size for the training set: Not applicable, as no training set (relevant for AI/ML) or study details are provided.
8. How the ground truth for the training set was established: Not applicable, as no training set or ground truth establishment details are provided.

Summary from the provided documents:

The RID-Decube II is an alternating pressure air flotation mattress intended for medical purposes to prevent and treat decubitus ulcers. It was found substantially equivalent to the Air Flow 5000 Manufactured by Atlantis Medical. The 510(k) process focuses on demonstrating equivalence to an already approved device rather than presenting detailed performance studies with acceptance criteria in the summary itself.

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