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The Hillrom™ Heart and Respiration Rate Monitoring System powered by Early Sense is used with compatible bed system models and is intended for continuous measurement of respiration rate (RR) in an automatic, contact-less manner. The system is indicated for use in children, adolescents, and adults in hospitals or clinical settings. It is intended to be used for the same patient populations and the same settings, within these ranges, as the bed with which it is used. The system has been validated to withstand up to 700 lb (318 kg).

The Hillrom™ Heart and Respiration Rate Monitoring System powered by EarlySense is designed for continuous and contact-free measurement of heart and respiratory rate (also referred to as Bed Sensing Unit). This device is used with a hospital bed system which is exempt from 510(k) premarket submission requirements. The Bed Sensing Unit (sensor) plugs into the bed frame to both receive power and to transmit data. Data from the System is available on the bed's graphical caregiver interface (GCI)/display unit and can be transmitted through wired and wireless communication channels to Hillrom Connectivity Solution (also known as (aka)- Hillrom Digital Health Gateway) for display, use, and storage. Additionally, the System can transmit alerts to an existing hardwired Nurse Call system, speakers, and/or on/off alert lights within a bed system. The healthcare professional can adjust monitoring parameters by interacting with the bed's GCl. These parameters include hospital-defined alert thresholds, display settings, and alert configurations. The system provides alerts when patient heart rate and/or respiratory rate are recorded that are above or below the predefined thresholds.

The Hillrom™ Heart and Respiration Rate Monitoring System powered by EarlySense consists of:

• The Bed Sensing Unit, placed on a bed frame under the mattress
• Software for data analysis, display, and input
• The device hardware, specifically the connection between the sensor and appropriate bed system

This document describes the Hillrom™ Heart and Respiration Rate Monitoring System powered by EarlySense, which is intended for continuous, contact-less measurement of respiration rate (RR) and heart rate (HR) in children, adolescents, and adults in hospitals or clinical settings. It is validated to withstand up to 700 lb (318 kg).

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and data provenance:
   The document does not specify a distinct "test set" in terms of patient data for clinical performance evaluation, as clinical testing was not required to demonstrate substantial equivalence. The performance metrics listed above (accuracy, detection range) are identical to the predicate device (K180079), implying that the performance of the core sensing technology and algorithms remains unchanged. The new device's acceptance criteria primarily relate to updated hardware (extended usage life of the sensor) and connectivity features, along with regulatory compliance testing (EMC, software V&V, wireless coexistence).

   • Usage Life Testing:
     • Sample Size: Not specified for "Usage Life Testing."
     • Data Provenance: Not specified, but likely refers to lab-based or engineering durability testing, not patient data.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
   Not applicable, as clinical testing (which would typically involve expert ground truth establishment) was not required for this 510(k) submission. The performance metrics are based on the predicate device's established performance.

4. Adjudication method for the test set:
   Not applicable, as clinical testing was not required.

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 monitoring system and does not involve "human readers" interpreting AI output for diagnostic purposes in the context of an MRMC study. It provides raw physiological data (HR and RR) and alerts based on configurable thresholds.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Yes, the performance characteristics (Heart Rate Accuracy, Respiration Rate Accuracy) represent the standalone performance of the algorithm integrated into the device, measuring these parameters in a contact-less manner. The document states, "The data provided by this system is intended to aid a clinician in the evaluation process of a patient's clinical status and should be interpreted by a healthcare professional only. The Hillrom™ Heart and Respiration Rate Monitoring System powered by EarlySense has not been studied on any specific patient group, nor has it been studied as a diagnostic tool for any specific disease or medical condition. It is meant as an adjunctive tool only for contact-free measurement of respiration rate and heart rate." This confirms its standalone measurement capability.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the core physiological measurements (HR and RR), the ground truth referenced for the predicate device's performance would have likely been established through comparison with a gold-standard reference monitor (e.g., ECG for HR, capnography or respiratory plethysmography for RR) during its original validation. For the current submission, which establishes substantial equivalence, the performance specifications are stated to be the same as the predicate device, K180079.

8. The sample size for the training set:
   Not specified. The document states that the software for data analysis, display, and input is identical to that cleared in K180079. Therefore, any training data used for the algorithms would have been part of the development and validation of the predicate device, and details are not provided in this 510(k) summary.

9. How the ground truth for the training set was established:
   Not specified. Given the software's identity to the predicate device, the ground truth for any training would have been established during the development of the predicate device's algorithms, likely by comparing the device's measurements to gold-standard reference measurements from patients under various conditions.

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The Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® is used with compatible bed system models and is intended for continuous measurement of respiration rate and heart rate in an automatic, contact-less manner. The system is indicated for use in children, adolescents, and adults in hospitals or clinical settings. It is intended to be used for the same patient populations and the same settings, within these ranges, as the bed with which it is used. The system has been validated to withstand up to 700 lbs (318 kg).

The Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® is designed for continuous and contact-free measurement of heart and respiratory rate. This device is used with a hospital bed system which is exempt from premarket submission requirements. The Bed Sensing Unit (sensor) attaches to the bed frame and plugs into the bed to both receive power and to transmit data to the bed's graphical user interface/display unit. Additionally, the System can send alarms to an existing hardwired Nurse Call system, speakers, and/or on/off alarm lights within a bed system. The healthcare professional is able to adjust monitoring parameters by interacting with the bed's graphical user interface/display. These parameters include alarm thresholds, display settings, and alarm configurations. The system provides alarm when patient heart rate and/or respiratory rate excurse above or below the predefined thresholds.

The Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® consists of:

• . The Bed Sensing Unit, placed on the bed frame under the mattress
• . Software for data analysis, display, and input
• . The device hardware, specifically the connection between the sensor and appropriate bed system

The System also uses the graphical user interface of an appropriate bed system.

The data provided by this system is intended to provide trending information on monitored parameters which should be interpreted by a healthcare professional only. The Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® has not been studied on any specific patient group, nor has it been studied as a diagnostic tool for any specific disease or medical condition. It is meant as an adjunctive tool only for measuring respiration rate and heart rate. The system helps healthcare professionals detect unanticipated patient deterioration quickly by providing heart and respiratory rate continuously rather than through standard periodic caregiver rounding.

The provided text describes the Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® and its substantial equivalence to a predicate device (EarlySense® Insight System, K152911). It highlights several performance tests, but explicitly states "No clinical testing was performed." and instead focuses on demonstrating equivalence to the predicate device. Therefore, the information needed to fully answer some of the questions, particularly those related to human-in-the-loop performance and expert-established ground truth from a clinical study, is not present in this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not provide a specific table of defined acceptance criteria (e.g., target accuracy percentages for respiration rate) and corresponding reported performance metrics. Instead, it states that "Hill-Rom has verified and validated that the Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® meets its functional, and performance specifications and requirements." and that "Accuracy Testing" was conducted to determine the accuracy of the system compared to the predicate.

The table below summarizes the measurable performance characteristics mentioned and implies that the device is deemed acceptable if it performs comparably or within the ranges of the predicate device.

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

The document does not specify the sample size used for the "Accuracy Testing" or "Durability Testing." It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for these tests, as the focus is on technical equivalence rather than clinical study data.

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

This information is not provided. The testing described focuses on comparing the device's measurements to those of the predicate device or established technical standards, rather than using expert-established ground truth in a clinical context.

4. Adjudication method for the test set

This information is 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

No MRMC study was performed. The document explicitly states: "No clinical testing was performed." The device is intended as an "adjunctive tool" and "has not been studied on any specific patient group, nor has it been studied as a diagnostic tool for any specific disease or medical condition." Therefore, no effect size for human reader improvement with or without AI assistance is reported.

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

Yes, standalone performance testing was conducted. The "Accuracy Testing" and "Durability Testing" mentioned evaluate the device's (and its algorithms') performance characteristics (e.g., heart rate and respiration rate measurement accuracy, weight bearing capacity) without human intervention in the loop for interpretation or decision-making.

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

The document does not explicitly state the "ground truth" methodology. Instead, the accuracy testing was conducted "to determine the accuracy of the system compared to the predicate." This implies the predicate device's measurements served as a reference for comparison, or the comparison was against a known, controlled input in a laboratory setting for technical accuracy. It is not an expert consensus, pathology, or outcomes data ground truth in a clinical sense.

8. The sample size for the training set

The document does not provide information on the training set sample size. Since the device utilizes proprietary algorithms developed by EarlySense® (the predicate device manufacturer), and the "Software for data analysis is identical to that cleared in K152911," it's highly probable that any algorithm training occurred prior to the development of this specific Hill-Rom product, and details of that training are not included in this submission.

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

This information is not provided. As mentioned above, details about the training of EarlySense's proprietary algorithms are not part of this 510(k) summary.

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The Hill-Rom PrimaView Mouitor System is indicated for use in providing the clinician with a color video display of images that are generated from endoscopic, laproscopic or similar equipment (not supplied by Hill-Rom) during surgical procedures. This system may also be used to display radiographic images for reference only.

The Hill-Rom PrimaView Monitor System is considered and accessory item to an endoscopic or laproscopic system (not supplied by Hill-Rom) in that it provides a means to view images generated by an endoscopic or laparoscopic camera and their associated components. The PrimaView flat screen display is mounted in the operating room or other area of a medical facility where endoscopic or similar procedures are done. Output video signals from the camera and processing unit are fed into the appropriate input connector of the PrimaView System. The signal is then routed to the display for presentation to the clinician. The system can also be used to display reference quality (not for diagnosis) radiographic images

This document describes the Hill-Rom PrimaView Monitoring System, which is a video display system intended for use during surgical procedures with endoscopic or laparoscopic equipment. It also mentions its use for displaying radiographic images for reference.

Based on the provided text, a conventional acceptance criteria table and detailed study information as typically seen in AI/ML device submissions cannot be fully extracted for the following reasons:

• This document is a 510(k) summary for a medical device (a monitor), NOT an AI/ML algorithm. The criteria and study types requested (e.g., MRMC studies, ground truth establishment, training/test set sizes for algorithms, AI improvement effect size) are specifically relevant to AI/ML device performance evaluation, which this device is not.
• The document predates the widespread regulatory framework for AI/ML in medical devices. The K013709 clearance is from 2001, at which point AI/ML in medical imaging was not a primary focus of regulatory submissions in the same way it is today.
• The "performance data" section refers to compliance with electrical and safety standards, not diagnostic or interpretive accuracy.

However, I can interpret the document to provide information relevant to its own type of "acceptance criteria" and "study" as presented in the 510(k) summary.

Here's an attempt to structure the available information per your request, with significant caveats that it does not align with AI/ML specific criteria:

Acceptance Criteria and Device Performance (Interpreted for a Monitor Device)

Detailed Study Information (Applying AI/ML Questions to a Non-AI/ML Context where possible):

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

   • This question is not applicable in the context of a video monitor without any AI/ML components performing diagnostic or analytical tasks. The "testing" referred to is for electrical safety, electromagnetic compatibility, and functional performance (e.g., displaying a video signal), not image interpretation accuracy. The document does not specify a "test set" of medical images or patient data.

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. There is no diagnostic "ground truth" to be established for a monitor displaying images. The "ground truth" for this device would be its ability to correctly power on, display a clean video signal, and meet electrical safety specifications. These are verified by engineering tests, not expert clinical consensus on images.

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

   • Not applicable for the reasons stated above.

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 display monitor, not an AI assistance tool. There is no AI component to measure improvement for human readers.

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

   • Not applicable. There is no algorithm. The device's standalone performance refers to its ability to function as a monitor without human interaction in its core function of display, but this is a very different concept than "standalone algorithm performance."

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

   • As mentioned, "ground truth" in the AI/ML context is not relevant here. The 'ground truth' for monitor performance would be electrical engineering standards, functional specifications (e.g., color accuracy, refresh rate, resolution), and safety requirements as defined by the IEC, EN, CISPR, UL, and CSA standards listed.

7. The sample size for the training set:

   • Not applicable. There is no AI/ML algorithm requiring a training set.

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

   • Not applicable. There is no AI/ML algorithm.

In summary, the provided document is a regulatory submission for a basic medical display monitor from 2001. The regulatory requirements and evaluation metrics described are entirely different from those applicable to modern AI/ML medical devices. Therefore, most of your specific questions cannot be answered from the provided text, as they pertain to a different type of medical technology.

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The contOR® Table Surface is intended to be used on existing operating room table in all surgical procedures to greatly reduce the likelihood of complications as a result of placement on the operating table surface, such as:

• pressure ulcers (pressure relief)
• tissue compromise (positioning)

The contOR® Table Surface is intended to be used to support and position the patient and to provide warming and cooling during surgery. The surface will greatly reduce the likelihood of complications as a result of placement on the operating table surface such as:

• Pressure ulcers
• Tissue compromise

The control unit is a self-contained unit requiring only input of the local power system. The control unit contains the heat exchanger used to heat/cool the medium. In addition, the controi unit contains a pressure/vacuum pump and valve network for Inflating the positioning air bladders and deflating the beaded vacuum bags. The control unit also contains all the controls required to manipulate and monitor the previously mentioned subsystems as well as any other subsystems that might be required for the patient and/or table surface pad while being used in the O. R. Suite. The control unit, which utilizes membrane switch technology and LED screen display the functions of the contOR® Table Surface. Additionally there is a remote pendant that is wired to the control unit that performs the same functions as the main control unit's screen.

The mattress set of the contOR® Table Surface Unit is designed to be used on different operating room tables in lieu of the standard mattress set. The mattress is 21 Inches wide, 72 to 84 inches long and 4 inches high. All aspects of the OR table surface pad are as modular in design as possible to facilitate serviceability and repair. The OR surface pad consists of 3 sections: a head section, a main body section, and a footleg section. The OR surface pad is a multi-ply system contained in an outer cover. The outer cover material has bi-directional stretch and is a nylon web substrate with urethane laminated on both sides. This outer cover will be cleanable throughout the life of the product using standard Hospital disinfectants that are alcohol or phosphate detergent based. The multi-ply system contained in the outer cover consists of several different layers.

The contOR® Table Surface pads are interconnected using Colder fittings for air, vacuum and water supply. Each section is secured to the OR table by longitudinal Velcro strips placed down the center of the under surface each section.

This appears to be a 510(k) summary for the Hill-Rom contOR® Table Surface, a medical device intended for use on operating room tables. However, the provided document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document primarily focuses on:

• Device identification: Names, submitter, contact information.
• Predicate devices: Devices used for comparison to establish substantial equivalence.
• Device description: Details about the control unit and mattress set.
• Indications for use: Preventing pressure ulcers and tissue compromise, and providing warming/cooling.
• Comparison to predicates: Highlighting differences in design, but stating they don't significantly affect safety and efficacy.
• FDA clearance letter: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information as it is not present in the given text.

To answer your request, I would need a different document that details the performance study and its results against specific acceptance criteria.

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The BRIGHTSTAR Surgical Light is intended for use in surgical and non-surgical applications to provide illumination of the surgical field or the patient. It is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.

The light is available in a single, double or 3 light head version. Each model offers the option of wall controls, integrated light controls or a combination of both. The light from a single bulb is distributed off a reflector in a controlled manner to provide a defined pattern. The size of the pattern is adjusted by changing the focal point of the bulb relative to the reflector. The light is comprised of seven main components: Suspension Arm, Extension Arm, Counterbalance Arm, Yoke, Light Housing, Light Core, and Controls. The BRIGHTSTAR uses software to coordinate the wall mounted and light mounted controls.

Based on the provided text, the document is a 510(k) Pre-market Notification for the BRIGHTSTAR Surgical Light, submitted by Hill-Rom, Inc. in 1998. The primary goal of this submission is to demonstrate substantial equivalence to existing predicate devices, rather than establishing de novo performance criteria for a novel device. Therefore, the "acceptance criteria" discussed are largely based on matching or exceeding the performance of the predicate devices. There is no traditional "study that proves the device meets the acceptance criteria" in the sense of a clinical trial or a statistically powered performance study against defined thresholds. Instead, the submission relies on a comparison table and a summary of similarities and differences in design and performance specifications against already cleared devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a surgical light, the "acceptance criteria" are implied by the performance of the predicate devices. The new device (BRIGHTSTAR) aims to be substantially equivalent or better in key performance metrics.

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

This document does not describe a "test set" in the context of a clinical performance study with human subjects or a large dataset analysis. The comparison is based on the technical specifications of the BRIGHTSTAR surgical light and those of the identified predicate devices (Amsco SQ240 Surgical Light and Berchtold Chromophare). The data provenance is internal Hill-Rom specifications and presumably publicly available specifications or regulatory filings of the predicate devices. It is a retrospective comparison of device specifications, not a prospective study.

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

Not applicable. No "ground truth" establishment by experts for a test set is described. The comparison is based on objective device specifications.

4. Adjudication Method for the Test Set

Not applicable. No "adjudication method" for a test set is described, as there is no traditional test set or expert assessment of subjective outcomes.

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 a pre-AI era device (1998) and a surgical light, not an image analysis or diagnostic device. There is no mention of AI or human reader improvement studies.

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

Not applicable. This is a surgical light, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" here is the established performance and safety characteristics of already legally marketed predicate surgical lights. The BRIGHTSTAR demonstrates substantial equivalence to these established devices through a direct comparison of specifications and features.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device (surgical light), not a machine learning algorithm requiring a training set.

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

Not applicable. This is a physical medical device (surgical light), not a machine learning algorithm.

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

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

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

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

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

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

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

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

1. Table of acceptance criteria and the reported device performance

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

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

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

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

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

4. Adjudication method for the test set

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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The IncuWarmer is a mobile, caster mounted, neonatal device which is used to assist in maintaining an infant's skin temperature and thermal environment. The device accomplishes this through the use of radiant and convective heat. Accessories and options to the device permit environmental control and monitoring including phototherapy capability, scale, and humidification. It is intended for in-patient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities.

The IncuWarmer is a warming device that combines the heating technologies of both incubators and radiant warmers into one product. The IncuWarmer provides thermal isolation primarily through a convective air system with canopies and side panels to form an enclosure that isolates the air surrounding the infant from the room air. The IncuWarmer offers access to the infant by allowing the cargiver to open port holes, side panels, canopies, and, if more access is needed, raising up of the over head arm. The over head arm is the upper half of the infant enclosure containing the canopies. The over head arm can be is raised to obtain full access to the infant. The over head arm contains two tubular stainless steel infrared heaters that provide supplementary heat when the canopies and side panels are closed and primary heat when the canopies are opened or the over head arm is raised.

In addition to providing thermal support, the IncuWarmer is capable of controlling options and accessories to aid the caregiver in rendering care to the infant. The IncuWarmer accessories are designed to operate with the IncuWarmer and consist of a humidification accessory, phototherapy accessory, and scale accessory for weighing the infant.

This document is a 510(k) summary for the IncuWarmer, an infant radiant warmer. It does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices.

Therefore, the requested information cannot be extracted from the provided text. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. A multi-reader multi-case (MRMC) comparative effectiveness study.
6. A standalone (algorithm only) performance study.
7. The type of ground truth used.
8. The 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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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 CLINITRON® RITE®HITE™ Air Fluidized Therapy is intended for medical purposes to treat or prevent bedsores, to treat severe or extensive burns, or to aid in circulation. This bed will be an ideal support for patients who have advanced pressure ulcers, flaps, grafts, or burns, and require frequent transfers or variable head elevation and any other conditions appropriate for air-fluidized therapy. The bed also can be used for intractable pain, extensive epidermal detachment, Stevens-Johnson Syndrome, purpura fulminans, aid in infection control, induce relaxation which may reduce need for sedative and pain medication, improve patient outcome, and reduce wound healing time. The bed will permit easy positioning and egress, thereby enhancing the independence of residents.

The CLINITRON® RITE®HITE™ Air Fluidized Therapy Unit combines the best features of the predicate devices, CLINITRON ELEXIS® (K943385)and the CLINITRON AT+HOME® (K942184), in order to meet the design objectives. The intent of the design is to provide an economical combinational therapeutic support surface on a mobile articulating frame specifically for use in the Long Term Care setting. Another design objective was to provide this type of surface on a frame that would go as low as possible. The CLINITRON® RITE®HITE™ tank edge is at 21.5 inches in its lowest position. This will permit easier positioning and egress. The combinational support surface includes both low airloss and air fluidized therapies. The upper half delivers low air loss therapy through low-friction support cushions which supports the upper half of the body (above the waist) and the lower half consists of air fluidized therapy which supports the lower half of the body (below the waist). This type of sleep surface is common to both the CLINITRON ELEXIS and the CLINITRON AT.HOME®

The provided text describes a 510(k) premarket notification for the CLINITRON® RITE•HITE™ Air Fluidized Therapy unit. The core of this submission is to demonstrate substantial equivalence to predicate devices, rather than establishing new safety and efficacy through a detailed clinical study with acceptance criteria and a detailed study design as typically seen for novel devices.

Therefore, the document does not provide the specific information requested about acceptance criteria, a standalone study to prove performance against those criteria, sample sizes, expert qualifications, or adjudication methods for a novel device. Instead, it focuses on comparing the new device's features and intended use to existing, legally marketed devices.

Here's how the provided information relates to your request:

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

• Acceptance Criteria: Not explicitly stated as this is a substantial equivalence submission, not a de novo clearance requiring novel performance criteria. The "acceptance criteria" are effectively that the device is "substantially equivalent" in safety and efficacy to the predicate devices.
• Reported Device Performance: The document states, "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 CLINITRON® RITE. HITE™ Air Fluidized Therapy Unit as compared to the predicate devices." No specific quantitative performance metrics are provided beyond this qualitative statement.

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

• Not Applicable: No "test set" in the context of a performance study is described. The demonstration of substantial equivalence relies on comparative analysis with predicate devices, not on a new clinical trial.

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: No "test set" requiring expert ground truth establishment is described.

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

• Not Applicable: No "test set" requiring adjudication 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 an air-fluidized therapy unit, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human reader improvement with AI is not relevant.

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

• Not Applicable: This is a physical medical device, not an algorithm.

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

• Not Applicable: No "ground truth" data from a performance study is mentioned. The "truth" in this submission is the established safety and efficacy of the predicate devices.

8. The sample size for the training set

• Not Applicable: This is a physical medical device, not a machine learning model requiring a training set.

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

• Not Applicable: As above, no training set is relevant here.

Summary of Device and Evidence for Substantial Equivalence:

The CLINITRON® RITE•HITE™ Air Fluidized Therapy unit is intended for medical purposes to treat or prevent bedsores, severe burns, or to aid circulation. It combines features of two predicate devices: CLINITRON ELEXIS® (K943385) and CLINITRON AT•HOME® (K942184).

Key arguments for substantial equivalence (which serve as the "proof" the device meets the regulatory requirements for market clearance):

• Intended Use: The CLINITRON® RITE•HITE™ has the same intended uses as the predicate devices: providing a pressure-relieving sleep surface for patients with pressure ulcers, burns, flaps, grafts, and other conditions suitable for air-fluidized therapy.
• Technological Characteristics:
  • Uses the same air fluidization medium (silicon-coated glass microspheres).
  • Employs the same principle of passing pressurized air through a diffuser board to fluidize microspheres and through a filter sheet to the patient.
  • Uses the same microspheres, filter sheet fabric, and similar closure systems.
  • Incorporates similar cushion sections for pressure relief and articulable head sections.
  • Has air cushions organized into zones continuously monitored by a microprocessor to adjust pressures.
  • Uses identical cushion material and construction to predicate devices.
  • Operated and controlled by a microprocessor.
• Safety and Efficacy: The submission explicitly states: "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 CLINITRON® RITE. HITE™ Air Fluidized Therapy Unit as compared to the predicate devices."
• Differences and Justification: While there are differences (e.g., design for long-term care vs. acute care, specific features like CPR function, X-ray plates, built-in scales, remote control design, siderail mechanisms, specific alarm behaviors), the manufacturer argues that "Although these differences provide servicing and user benefits, none of the differences adversely affects the safety or efficacy of the device."

In conclusion, this 510(k) submission successfully demonstrated substantial equivalence by highlighting the similarities in intended use and technological characteristics to already-approved predicate devices, and by arguing that differences did not compromise safety or efficacy. It did not involve performance testing against specific acceptance criteria in the manner of a clinical trial for a novel device.

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