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The intended use of the iBed™ Wireless with iBed™ Mobile accessory is to assist healthcare professionals in setting, adjusting, and monitoring specific bed parameters from a different location within the healthcare delivery organization's campus. The iBed™ Wireless with iBed™ Mobile accessory is intended to be used only with Stryker Medical's AC-powered adjustable hospital beds that have been verified and validated with the iBed™ Wireless software and is not intended to provide information on non-Stryker Medical beds. The iBed™ Wireless with iBed™ Mobile accessory is intended to only transfer bed status and parameter data and does not store this data.

The Model 5212 iBed™ Wireless with iBed™ Mobile consists of iBed™ Wireless (WiFi module) and the iBed™ Mobile software application that is intended to be used with Stryker Medical's ACpowered adjustable hospital beds within a healthcare delivery organization. The iBed™ Wireless with iBed™ Mobile device accessory is an updated software platform that provides bi-directional data transmission between Stryker Medical's AC-powered adjustable hospital beds equipped with iBed™ Wireless, the healthcare delivery organization's server (owned and maintained by the healthcare delivery organization), and a healthcare professional's handheld electronic device. It is a convenience tool facilitating bi-directional data transmission of bed status data and parameters allowing healthcare professionals the ability to set, adjust, and monitor bed status from a remote location within the healthcare delivery organization facility.

This document is a 510(k) premarket notification for the "iBed™ Wireless with iBed™ Mobile" device, focusing on demonstrating substantial equivalence to a predicate device. It does not describe a clinical study that proves the device meets specific performance acceptance criteria for diagnostic or clinical effectiveness functions in the way an AI/ML medical device submission would.

The device is an accessory to hospital beds, providing healthcare professionals the ability to remotely set, adjust, and monitor bed parameters. The key difference from the predicate device (iBed™ Wireless with iBed™ Awareness, K103536) is the addition of bi-directional communication, allowing remote adjustment of parameters, whereas the predicate only allowed remote monitoring.

Therefore, the acceptance criteria and study described are related to engineering performance, software functionality, and safety rather than a diagnostic accuracy or clinical outcome study involving human readers or AI.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) typically seen in AI/ML medical device submissions. Instead, it describes general categories of testing and their purpose:

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

• Test Set Sample Size: Not specified in terms of number of beds, users, or distinct test cases beyond the general descriptions of "testing" and "design validation." This is typical for a 510(k) focusing on engineering and software validation for a non-AI accessory.
• Data Provenance: The testing appears to be primarily conducted internally by Stryker Medical in a simulated environment ("simulated-use environment"). No mention of external or real-world clinical data from specific countries. The testing is prospective in nature, as it's part of the development and validation process for the device.

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

• "Design validation testing was conducted in a simulated-use environment by health care professionals."
• The number of healthcare professionals is not specified.
• Their qualifications are generally stated as "health care professionals," but no specific details (e.g., specific roles, years of experience, board certifications) are provided. Their role in "establishing ground truth" is less about making a clinical judgment (like diagnosing a condition) and more about confirming the device's functionality and usability aligns with their professional needs for bed management.

4. Adjudication Method for the Test Set

• No formal adjudication method is mentioned, as the "ground truth" is based on the device's adherence to its functional specifications and successful operation by healthcare professionals in a simulated environment, rather than a subjective interpretation task (e.g., image reading). The focus is on technical verification and validation.

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

• No MRMC study was performed. The document explicitly states: "Clinical Studies were not required to demonstrate substantial equivalence to the predicate device."
• This device is an accessory for remote bed management, not a diagnostic tool where human readers interpret data. Therefore, a comparative effectiveness study measuring human reader improvement with AI assistance is not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No standalone performance study in the context of an AI algorithm's independent diagnostic accuracy was performed.
• The device's "standalone" performance would be its ability to transmit and receive data, and apply parameter changes correctly, as verified through "software verification testing" and "bench performance testing." This is covered by the engineering and software validation.

7. Type of Ground Truth Used

• The "ground truth" for this device's validation is primarily engineering specifications, functional requirements, and user-defined operational needs.
  • For software and bench testing, ground truth is whether the system performs "according to specification."
  • For usability/design validation, ground truth is whether healthcare professionals can "successfully set, adjust, and monitor bed status parameters... as intended."
• It is not expert consensus on a clinical condition, pathology reports, or patient outcomes data.

8. Sample Size for the Training Set

• Not applicable. This device is an accessory with defined functional capabilities, not a machine learning or AI algorithm that "learns" from a training set. Its functionality is hard-coded based on design specifications.

9. How Ground Truth for the Training Set Was Established

• Not applicable. As stated above, there is no "training set" for this device. Its "ground truth" relates to its engineered design and verified performance against those design requirements.

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

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

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

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

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

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

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

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

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

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

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

Not applicable. As explained above, there is no "test set" in the context of diagnostic performance requiring ground truth established by medical experts for this device.

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

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

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

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

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

3. Number of Experts and Qualifications for Ground Truth

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

4. Adjudication Method for the Test Set

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

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

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

6. Standalone (Algorithm Only) Performance Study

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

7. Type of Ground Truth Used

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

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

8. Sample Size for the Training Set

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

9. How Ground Truth for the Training Set Was Established

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

In Summary:

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

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The intended use for the iBed™ Wireless (with iBed™ Awareness) is to assist clinical staff to monitor bed parameters on specific Stryker beds. The desired bed parameters will be set by clinicians at the bedside. The iBed™ Wireless software is intended to be used only with specifically enabled Stryker beds that have been verified and validated with the iBed™ Wireless software, and is not intended to provide bed status information for non-Stryker beds. The iBed™ Wireless software is not intended to communicate any patient status information, nor to permanently store any type of data. The iBed™ Wireless with iBed™ Awareness System is not intended to provide automated treatment decisions or as a substitute for professional healthcare judgment. The iBed™ Wireless with iBed™ Awareness System is not a replacement or substitute for vital signs monitoring or alert equipment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate health care professional.

The iBed™ Awareness is used to monitor hospital bed status and to assist the Healthcare Provider in providing patient care. The system is integrated into Stryker hospital bed to monitor bed information such as: iBed™ Awareness status, bed exit status, siderail status, bed brake status, fowler angle, and weight on bed, for example. The Healthcare Professional can set the alerting function (audible and lights) to activate if bed status has changed. The iBed™ Wireless device is a tool that facilitates the wireless transmission of the bed status data using a wireless hardware and software device to the hospital server. The data can be captured by hospital data collection systems (developed and provided by Third Parties; not part of this submission). Through the use of the third party software, the data may be displayed at user-defined locations, such as nursing stations.

This document describes the regulatory submission for the iBed™ Wireless with iBed™ Awareness system, a device that monitors hospital bed status. The provided text, however, does not contain specific acceptance criteria or a detailed study proving the device meets those criteria in the typical format of clinical performance evaluation (e.g., sensitivity, specificity, accuracy against a recognized gold standard).

Instead, the document focuses on demonstrating substantial equivalence to predicate devices and adherence to existing safety and performance standards for similar medical devices.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., minimum accuracy rates for bed status detection) or specific performance metrics in a tabulated format. Instead, it states that the device "meets its functional, performance, safety and efficacy specifications and requirements."

The "performance" is generally described as compliance with established international standards for medical devices and software, rather than a clinical performance study with specific outcomes.

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

The document does not mention a specific "test set" in the context of a clinical performance study with a defined sample size (e.g., number of patients, number of bed events). The testing described is primarily related to product verification and validation, adherence to safety standards, and electromagnetic compatibility.

• Test Set Sample Size: Not specified for a clinical performance study.
• Data Provenance: Not specified. The testing seems to be internal verification and validation by Stryker Medical.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not provided. The document does not describe a study involving human experts establishing ground truth for performance evaluation of the device's monitoring capabilities.

4. Adjudication Method for the Test Set

Not applicable, as a study involving expert adjudication for a test set (e.g., clinical images, event logs) is not described.

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

No MRMC comparative effectiveness study is mentioned. The device's purpose is to monitor bed parameters, not to assist human readers in interpretation or diagnosis. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Yes, the testing described appears to be for the standalone performance of the device's hardware and software. The text states:

• "Software testing and hardware testing of each component and of the final device have been conducted extensively."
• "The extensive performance testing that has been conducted on the individual components and on the finished system demonstrate that the iBed™ Wireless with iBed™ Awareness are safe and effective, and perform as well or better than the predicate devices."

This implies that the system itself was tested for its ability to accurately detect and transmit bed status information without direct human intervention in the detection process. The device's intended use is to "assist clinical staff to monitor bed parameters," meaning the device provides data, and staff then act upon it.

7. Type of Ground Truth Used

The document does not explicitly define the "ground truth" used for testing the iBed™ Wireless system. Given the nature of the device (monitoring bed parameters like siderail status, brake status, fowler angle, and weight on bed), the ground truth would likely be established through:

• Direct physical observation/measurement: For mechanical parameters like siderail position or brake engagement, this would involve physically checking and comparing to the device's report.
• Engineered test conditions: For parameters like weight, a known weight placed on the bed would serve as ground truth for calibration and accuracy testing.
• Internal reference systems: For angle measurements, an independent reference sensor could be used.

However, the document does not detail these ground truth establishment methods.

8. Sample Size for the Training Set

No training set is mentioned. This device appears to be rule-based or sensor-based, rather than employing machine learning algorithms that would require a "training set" in the conventional sense. The "software testing" refers to verification and validation of its programmed logic and functionality.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no training set is mentioned for this device.

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The Martin Chair Model C4S1 is indicated for providing mobility to persons limited to a sitting position. It is also specifically indicated to transfer a patient to and from the Martin Examination Table.

The Martin Examination Table is indicated for use during diagnostic examinations or surgical procedures to support and position a patient.

The Martin Chair Model C4S1 mechanical wheelchair is an indoor/outdoor wheelchair that has a base with two larger rear wheels and two smaller front wheels and a seat. The wheelchair is intended to be manually propelled by a person seated in the wheelchair or by an attendant or clinician. The device is made from composites of steel, plastics and fabrics. The wheelchair is for use by adult persons.

The wheelchair can be secured to a compatible, electrically elevated examination table which allows for the seat of the wheelchair to become part of the examination table. This removes the need for the patient to be lifted during transfer from the wheelchair to the examination table. The wheelchair is latched to the examination table and the side frame and wheels are removed for the examination. The sides and wheels are replaced prior to lowering the examination table allowing the wheelchair to be used according to its intended use.

The Martin Examination Table is a 510(k) exempt device, 21 CFR 878.4960, product code LGX. It is an accessory to the Martin Chair. It is a device intended as a powered examination table to provide positioning and support to patients during general examinations and procedures. It is intended for medical purposes as an electrically operated table with movable components that can be adjusted to various positions, the same intended use as other currently marketed powered tables. The Martin Examination Table is a standard powered examination table that includes standard components and features of other currently marketed powered examination tables including side rails for additional safety. The Martin Examination Table includes latches under the seat cushion that are compatible with the fixed metal receivers of the Martin Chair Model C4S1,

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Koso506 Martin Chair C4S1:

Important Note: The provided document is a 510(k) Summary for a mechanical wheelchair, which is a relatively low-risk Class I device. As such, the depth of performance testing and the types of studies typically required for more complex or higher-risk devices (like those involving AI algorithms, for instance) are not present here. The questions you've asked are more geared towards AI/software as a medical device (SaMD) clearances. I will answer them to the best of my ability based only on the provided text, and will explicitly state if information is not available.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: Not specified in the provided text. The document states that the devices (Martin Chair C4S1 and Martin Examination Table) were "tested" and "passed testing" according to specific standards (ANSI/RESNA, UL, CSA). These standards typically involve a defined number of test samples (e.g., specific units of the wheelchair or examination table) for various mechanical, safety, and performance evaluations, but the exact number isn't detailed in this summary.
   • Data Provenance: Not explicitly stated. The testing was performed by "Human Engineering Research Laboratories (HERL)" for the wheelchair and implicitly by a qualified entity for the examination table standards (UL/CSA). The country of origin of testing data is not mentioned, but given the US FDA submission, it's presumed to be from a reputable testing facility. The nature of these tests is prospective (the actual devices are subjected to specified physical tests).

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)

   • This question is not applicable to the type of device and testing described. The "ground truth" for a mechanical wheelchair and examination table is established by direct physical measurement, stress testing, and functional evaluation against engineering and safety standards, not by expert interpretation of data like in medical imaging. The "experts" involved would be engineers and technicians at the testing laboratories (HERL, UL, CSA labs) who are qualified to perform and interpret the results of these standards-based tests. Their specific numbers and qualifications are not detailed in this 510(k) summary.

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

   • Not applicable. Adjudication methods like 2+1 are used for human interpretation tasks, especially in clinical studies or for establishing ground truth in AI model training/testing. This submission pertains to physical device testing against established engineering and safety standards, where outcomes are typically objectively measured (e.g., "passed" or "failed" a specific physical test).

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

   • No. An MRMC study is relevant for AI-assisted image interpretation or diagnostic tools, where human readers (e.g., radiologists) are involved. This submission is for a mechanical wheelchair and examination table, which do not involve human "readers" or AI assistance in a diagnostic context.

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

   • No. This device is a mechanical wheelchair and an examination table; it does not contain an AI algorithm. Therefore, "standalone" algorithm performance is not relevant.

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

   • The "ground truth" for this device's performance is objective compliance with recognized consensus standards (ANSI/RESNA for wheelchairs, UL/CSA for examination tables) and physical performance criteria (e.g., successful flame retardancy, meeting specified mechanical stress tolerances, electrical safety adherence). There is no "expert consensus" or "pathology" in the sense of medical diagnosis; rather, it's engineering and safety validation.

7. The sample size for the training set

   • Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

   • Not applicable, as there is no AI or machine learning "training set" for this device.

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The bed mover is intended to assist a single operator in the moving of wheeled beds and stretchers from one location to another within a healthcare facility.

Examples of usage include:

• a single operator may move empty beds to staging or storage areas within the healthcare facility.
• a single operator may move patient-laden beds from one location to another within the healthcare facility.

The IRSG i-mover for beds is a battery-powered, temporary accessory to most wheeled hospitals beds and stretchers. It is unit operated by a single caregiver to assist in the movement of most wheeled hospital beds and stretchers commonly used within a healthcare facility.

Only the caregiver, not the patient, can control this powered assistive device.

This device is not permanently attached to or made a part of the stretcher or bed.

The FDA has classified this device as an accessory to the wheeled bed or stretcher which the device will assist in moving. These beds and stretchers are Class I (hydraulic or manual beds) and Class II (powered adjustable beds and wheeled stretchers). The FDA has classified this device as a Class I device when used with non-patient laden beds and a Class II device when assisting in movement of a patient-laden bed.

The provided text describes a 510(k) summary for the IRSG Bed Mover, a device intended to assist a single caregiver in moving hospital beds and stretchers. However, it does not contain information about acceptance criteria or a study that rigorously proves the device meets those criteria in the way typically expected for a medical device with performance metrics (e.g., accuracy, sensitivity, specificity, or improvement in human performance).

The submission focuses on establishing substantial equivalence to predicate devices based on intended use, basic movement technology, and performance characteristics, but it does not detail specific performance studies with quantitative acceptance criteria.

Here's a breakdown of why the requested information cannot be fully provided from the given text:

1. Table of acceptance criteria and reported device performance: This information is not present. The document focuses on regulatory classification, intended use, device description, and comparison to predicate devices, asserting "substantial equivalence" rather than reporting distinct performance metrics against predefined acceptance criteria.
2. Sample size used for the test set and the data provenance: Not applicable in this context. There isn't a "test set" of data in the sense of a machine learning or diagnostic device that requires data for evaluation. The device is a bed mover, and its evaluation relies on comparison to existing devices and compliance with safety 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 for diagnostic accuracy is not relevant to a bed mover.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-powered diagnostic tool, so there are no "human readers" in this context, nor an AI component to compare against. Its purpose is mechanical assistance, not diagnostic improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a human-operated mechanical aid, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable. The device is a hardware product, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

What is present in the document related to "acceptance criteria" and "study":

The "acceptance criteria" for this type of device, as per the 510(k) summary, are primarily centered around substantial equivalence to predicate devices and compliance with voluntary standards for safety.

• Acceptance Criteria (Implicit - based on 510(k) requirements):

  • Substantial Equivalence: The IRSG Bed Mover must be substantially equivalent in intended use, technological characteristics, and performance to legally marketed predicate devices.
  • Safety Standards: Compliance with relevant voluntary safety standards, specifically IEC 60601-1 (Medical Electrical Equipment – Part 1: General Requirements for Safety).
  • No New Issues of Safety or Effectiveness: The minor differences from predicate devices should not raise new concerns.
  • Biocompatibility: Not applicable since the device does not contact the patient.
  • Labeling and Instructions: Provision of clear labels and manuals for safe operation.

• "Study" (as described):
  The document doesn't describe a formal clinical study or a quantitative performance validation study with specific metrics. Instead, the "study" is implicitly the 510(k) submission process itself, which argues for substantial equivalence based on:

  1. Device Comparison: Directly comparing the IRSG Bed Mover to two predicate devices:
     • Stryker Powered Wheeled Stretcher with Zoom™ Drive Wheel (K022309)
     • Paramed Systems Paraglyde™ DCS TM-1 (FPO, 880.6910, Class II, 510k exempt)
       The comparison asserts that the IRSG bed mover is "substantially equivalent... in function, technological characteristics and intended use."
  2. Safety Standard Compliance: A statement that "The bed mover will comply with the following voluntary standards IEC 60601-1..." This implies that the device was designed to meet these standards, and presumably evidence of this compliance was provided in the full 510(k) submission (though not detailed in the summary).
  3. Risk Assessment (Implicit): Discussion points address potential safety concerns, stating that "The IRSG i-mover for beds does not contact the patient, so biocompatibility is not a concern," and that labeling addresses safe operation.

In summary, for the IRSG Bed Mover, the "acceptance criteria" were met by demonstrating substantial equivalence to predicate devices and adherence to relevant safety standards, rather than through a performance study with quantitative metrics for the device itself.

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• (1) May Provide Temporary Relief of Low Back Pain;
• May Provide Temporary Relief of Minor Aches and Pains Due to Muscular Fatirue (2) or: Overexertion;
• May Provide Temporary Relief of Edema or Swelling of the Legs; (3)
• May Provide Temporary Relief of Poor Local Blood Circulation of the Legs;" (4)
• May Provide Temporary Relief from Symptoms of Hiatus Hernia; (5)
• May Provide Temporary Relief from the Symptoms of Gastric Reflux; (6)
• May Provide Temporary Relief of Nighttime Heattburn; (7)
• The Optional Heating Accessory Provides Temporary Relief from Mild Arthritis (8) and Joint Pain, as well as Muscle Pain Associated with Stress and Tension; and
• Sleeping in an Upright Position May Reduce or Fase Light and Occasional (ව) Snoring. **

Craftmatic® Adjustable Beds are electrically powered adjustable beds for home use that adjust into 1001 various positions (e.g., raising the torso, the legs, or both to various heights). The beds have three primary components: (1) a steel bed frame with lift motors, (2) a mattress, and (3) a pendant control. Powered heating pads, which cover the entire mattress, and physical therapy pulsators (built-in massage units) are optional.

This 510(k) premarket notification (K022387) for the Craftmatic® Adjustable Beds with Optional Heat and Massage does not contain the detailed study information typically found for devices that rely on performance data against acceptance criteria. The submission primarily focuses on establishing substantial equivalence to a previously cleared predicate device (K840787B) rather than presenting new performance studies with acceptance criteria for the "new" device.

Therefore, many of the requested sections below cannot be fully populated as the information is not present in the provided text.

Here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This section is not applicable in the traditional sense for this submission. The "new" Craftmatic® Adjustable Beds are stated to be "essentially identical" to the predicate device in structural and functional features. The new indications for use are also described as "similar to, based upon the same principles as, and substantially equivalent to the indications for use for the predicate bed."

The submission argues for equivalence based on the technological and functional similarity to a previously cleared device, not on meeting specific, quantifiable performance acceptance criteria from a new study.

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

Not Applicable. The submission does not describe a new test set or performance study that would involve a sample size or data provenance. The focus is on the technological comparison to the predicate device.

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

Not Applicable. No new test set or ground truth establishment by experts is described in the provided text.

4. Adjudication Method for the Test Set

Not Applicable. No new test set or adjudication process is described in the provided text.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. A Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or described in this submission. The submission is not focused on comparing human reader performance with or without AI assistance, as the device is an adjustable bed, not an AI-driven diagnostic or therapeutic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This device is an adjustable bed and does not involve an algorithm or AI component that would perform standalone functions.

7. The Type of Ground Truth Used

Not Applicable. No specific ground truth was established for the "new" device's performance in this submission. The basis for clearance is the substantial equivalence to a predicate device that was previously cleared for similar indications. The original predicate device's clearance (K840787B) in 1984 would have been based on the understanding of the underlying physiological principles for adjustable beds and their ability to provide temporary relief for certain conditions.

8. The Sample Size for the Training Set

Not Applicable. This device does not involve a training set as it is not an AI/ML-based device.

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

Not Applicable. As there is no training set mentioned, there is no ground truth establishment for it.

Summary of Approach in K022387:

The provided 510(k) summary for K022387 indicates that the Craftmatic® Adjustable Beds with Optional Heat and Massage seek clearance through substantial equivalence to a previously cleared predicate device (Craftmatic® Adjustable Bed, K840787B). The argument for substantial equivalence is based on:

• Technological Similarity: The "new" beds are described as "essentially identical" to the predicate, sharing the same general structural and functional features (electrically powered adjustable beds, steel frame, lift motors, mattress, pendant control, optional heating pads, and pulsators). Minor technological upgrades (memory positioning, timers, mattress quality improvements) are noted but are considered not to alter the fundamental functions or safety.
• Similarity of Intended Uses: The new indications for use are described as "similar to, based upon the same principles as, and substantially equivalent to the indications for use for the predicate bed." The predicate device was already cleared for temporary relief of low back pain, minor aches, edema, and poor local blood circulation of the legs. The new indications extend this to temporary relief from symptoms of hiatus hernia, gastric reflux, nighttime heartburn, mild arthritis/joint pain (with heating accessory), and reduction of light snoring (sleeping upright).

Therefore, this submission does not present new performance data against specific acceptance criteria but rather leverages the regulatory precedent established by the predicate device.

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The subject device is intended to be used as a comprehensive product ideally suited to be used in health care environments. The product may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The product is capable of being used with a broad patient population as determined appropriate by the caregiver or institution. The device is intended to provide significant improvements in caregiving and a safer environment for caregiver and patient

The product consists of mechanical, electromechanical, hydraulic, and electronic components. These may be selected by the caregiver or institution to customize the bed to specific patient population needs.

This document is a 510(k) Premarket Notification Summary for an AC powered hospital bed (TotalCare®). The provided text describes the device's intended use, classification, and lists performance standards it complies with.

However, the provided text does not contain any information about acceptance criteria, device performance metrics (such as sensitivity, specificity, accuracy), or any study details that would prove the device meets such criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for establishing ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document focuses on regulatory compliance with electrical and safety standards for an AC powered hospital bed, not on clinical performance metrics typically associated with AI/medical imaging devices where such detailed performance studies and acceptance criteria are relevant.

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