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Use of the Talley TableGard Pressure Relieving Patient Warming Mattress is indicated for use for patients that may be benefited by the application of heat during surgical procedures to help maintain normothermia. It is intended for use in the operating rooms, recovery rooms, intensive care departments, emergency rooms in hospitals and outpatient clinics to assist patients to maintain normal body temperature. The TableGard mattress also includes alternating air support to relieve pressure against soft tissues during prolonged periods of immobilization.

The TableGard Pressure Relieving Patient Warming Mattress system consists of an alternating air mattress (patient support surface) with air pump, and a connectable and thermally regulated warm air blower unit. The air mattress is enclosed in a vinyl and polyurethane cover, which is in turn fitted with air inlet and outlet ports to receive and recirculate warmed air within the air mattress cover under the patient. The patient is warmed by conduction of heat (regulated between 34° and 40° C) thru the polyurethane cover. The air pump and air blower unit operate on 110V, but there is no electrical contact between the control devices and the patient support mattress. The air pump alternately cycles pressures between sections of the mattress to relieve interface pressure against the patient's soft tissues.

The provided text describes the TableGard Pressure Relieving Patient Warming Mattress (K080763). It focuses on the device's functional and safety testing to support its substantial equivalence to predicate devices, rather than a clinical study evaluating its performance against specific acceptance criteria in a human population.

Therefore, much of the requested information (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC study details, training set information, and specific effect sizes) is not applicable or not available in the provided 510(k) summary.

However, I can extract the acceptance criteria related to the device's functional performance and how it was tested.

Acceptance Criteria and Reported Device Performance

This 510(k) summary focuses on functional and safety testing, establishing that the device's performance is acceptable and does not introduce new safety or effectiveness concerns compared to predicate devices. The "acceptance criteria" here are implicitly related to the prevention of thermal injury and effective pressure relief, ensuring the device operates within safe and intended parameters.

Study Details (Based on available information):

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

   • Test Set Sample Size: Not specified. The testing described is "functional and safety testing" and "simulated skin temperatures," implying laboratory or engineering tests, not a clinical study with a patient cohort.
   • Data Provenance: Not explicitly stated, but the nature of the tests suggests they were internal laboratory tests conducted by the manufacturer, Talley Medical/Jaxports. These are not human subject data (retrospective or prospective).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the functional tests would be the physical measurements taken by instruments according to engineering specifications and safety standards, not expert consensus on clinical outcomes.

3. Adjudication method for the test set: Not applicable. This concept is for clinical studies involving human interpretation or outcomes, not functional device testing.

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. This device is a patient warming mattress, not an imaging or diagnostic AI device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm. The device's performance (temperature regulation, pressure relief) is "standalone" in the sense that it operates according to its design parameters.

6. The type of ground truth used: For temperature testing, the "ground truth" was established by measurements of "simulated skin temperatures" against predetermined safety limits (likely based on established thresholds for thermal injury). For pressure relief, the "ground truth" was the physical measurement of "interface pressure" by instruments, demonstrating cyclical and consistent relief according to the device's design.

7. The sample size for the training set: Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.

8. How the ground truth for the training set was established: Not applicable. See point 7.

Summary of the study:

The study described is a series of functional and safety tests performed on the TableGard Pressure Relieving Patient Warming Mattress system. These were engineering/laboratory tests, not clinical studies involving human subjects.

• The tests evaluated:
  • Thermal Regulation: Achieved surface temperatures were measured under normal operating conditions and in conditions of possible single-fault failures. The goal was to confirm that the warming system would not cause thermal injury.
  • Pressure Relief: Interface pressure between the patient support surface and the patient was measured to confirm that it was fully relieved on a cyclical and consistent basis.

The conclusion drawn from these tests was that the device met its functional and safety requirements, demonstrating substantial equivalence to predicate devices and not introducing new safety or effectiveness issues.

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For the prevention and treatment of pressure ulcers. Patient lateral rotation of up to 30 degrees may also be used as a preventive tool against further complications associated with critically ill patients or immobility.

The PressureGuard Turn Select is an air flotation, alternating pressure support system. It consists of a foam shell manufactured with medical grade, polyurethane foam that meets the California Technical Bulletin 117. The perimeter bolsters are designed to safely prompt the patient toward the center of the surface, facilitating safe transfers and edge-of-bed sittings. The inflation system is cradled and securely positioned within the foam shell. Through computerized technology, the internal air pressures of the inflation system are controlled to achieve four operating modes. The CENTER Mode provides a level supine surface. The FIXED ROLL Mode provides automatic turning, turning the patient to the left followed by a 2 hour dwell time, then returning to center for a 2 hour dwell time, followed by a turn to the right followed by a 2 hour dwell time. The CUSTOM ROLL Mode provides for selection of roll patterns, roll angles and dwell times to meet individual patient needs. The CPR Mode provides a firm surface to aid in CPR Procedures (with a crash board). A Service Required Feature is provided to alert the health care provider in the event of system malfunction. CPR Alarm and Lock-Out features are also included.

The provided text describes a 510(k) submission for the "PressureGuard Turn Select" alternating pressure mattress, which is intended for the prevention and treatment of pressure ulcers and for patient lateral rotation. The submission focuses on demonstrating substantial equivalence to a predicate device (PressureGuard IV, 510K953503) rather than defining and proving specific acceptance criteria through a clinical study with performance metrics.

Therefore, many of the requested categories for a study that proves device meets acceptance criteria cannot be directly answered from the given document, as this submission is for a medical device cleared via substantial equivalence, not typically a clinical trial demonstrating performance against quantitative acceptance criteria for software or an AI algorithm.

However, I can extract information related to the closest aspects from the provided text.

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

   No quantifiable acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) are provided in the document for the PressureGuard Turn Select. The demonstration is based on "substantial equivalence" to a predicate device. The performance is implied to be similar to the predicate device.

   Acceptance Criterion	Reported Device Performance
   Not specified	Not specified
   (Implied) Substantial Equivalence to predicate device for intended use and safety	The device is similar in function and intended use to the predicate.
   (Implied) Pressure-management	Verified through interface pressure testing (no results or criteria provided).
   (Implied) Conformance to UL 544 and CSA 122.25	System is designed to conform to these standards.

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

   The document does not describe a "test set" in the context of clinical data or AI validation. The "interface pressure testing" mentioned is likely an engineering or bench test, not a clinical study on a patient sample. No sample size for such testing is provided, nor is the provenance of any data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

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

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

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   Not applicable. This device is a mattress system, not an AI-assisted diagnostic tool.

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

   Not applicable. This submission is for a physical medical device, not an algorithm.

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

   Not applicable. The concept of "ground truth" for clinical outcomes or diagnostic accuracy is not relevant to this 510(k) submission, which focuses on similarity to a predicate device and engineering testing.

8. The sample size for the training set

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

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

   Not applicable.

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

4. Adjudication method for the test set

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. MRMC studies are used for evaluating diagnostic performance, often in conjunction with AI. This document is for a physical patient support system.

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

• Not Applicable. This is not an AI algorithm.

7. The type of ground truth used

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

8. The sample size for the training set

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

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

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

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The SPR+II overlay system is a pressure relieving support system intended to reduce the potential for development of pressure ulcers on at risk patients or to be used in the treatment of existing pressure ulcers.

The SPR+II System consists of an electromechanical inflation pump control unit which is connected to an overlay through a hose assembly connected to the inflation pump.

This is a premarket notification [510(k)] summary for the SPR+II System, a low air loss system designed to prevent and treat pressure ulcers. It primarily establishes substantial equivalence to a predicate device, the CLA 1500 System, rather than presenting a performance study with acceptance criteria and a detailed statistical analysis against those criteria. Therefore, most of the information requested cannot be extracted directly from the provided text.

Here is an attempt to address the request based on the available information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the typical sense of a target performance metric (e.g., accuracy, sensitivity, specificity) for a diagnostic or AI-driven device. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technological characteristics and nonclinical performance data.

The "acceptance criteria" here are implicitly that the SPR+II System performs similarly to or better than the CLA 1500 System in the listed characteristics, especially regarding safety and intended use.

Table of Acceptance Criteria and Reported Device Performance (based on Substantial Equivalence):

Study Details (Based on the provided document)

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

   • The document describes a submission for substantial equivalence based on a comparison of technological characteristics and nonclinical performance data between the SPR+II System and the predicate device (CLA 1500). It does not describe a clinical "test set" in the context of an algorithm or diagnostic device. The "performance data" referred to are related to the device's physical and functional properties, not data derived from patient testing or a specific dataset for algorithm evaluation.
   • Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a test set is not applicable here.

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):

   • As this is a submission for a medical device (a low air loss system) and not an AI or diagnostic algorithm that requires "ground truth" derived from expert interpretation, this information is not applicable. The "ground truth" here is the established function and performance of the predicate device against which the new device is compared.

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

   • This is not applicable as there is no "test set" in the context of expert adjudication for an algorithm.

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:

   • This is not applicable. The device is an electromechanical low air loss system, not an AI or diagnostic tool that would be used in an MRMC study to compare human reader performance.

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

   • This is not applicable. The device is a physical medical support system, not an algorithm.

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

   • For this type of device, "ground truth" refers to established engineering specifications, functional requirements, and safety standards, as well as the documented performance of the predicate device (CLA 1500). The "truth" is that the device meets these specifications and performs equivalently to a legally marketed predicate.

7. The sample size for the training set:

   • This is not applicable as the device is not an AI or machine learning algorithm requiring a "training set."

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

   • This is not applicable as the device is not an AI or machine learning algorithm.

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