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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 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 Vail 1000 Enclosed Bed is a soft-sided enclosed bed for patients who are at risk to harming themselves or others by intentionally or unintentionally leaving the bed unasisted

Vail 1000 Enclosed Bed

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.

The document is a US FDA 510(k) clearance letter for a device called "Vail 1000 Enclosed Bed". It states that the device is substantially equivalent to a legally marketed predicate device and outlines the general controls provisions of the Act it falls under. It also includes the "Indications For Use" for the device, which describes its intended purpose.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from this document.

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To provide added comfort during periods of bedrest by permitting the user to adjust the surface contour of the bed to various positions.

The Model 720 Series Full/Semi Electric and 1120 Full Electric Beds are a series of nursing home beds with an intended function of providing added comfort during periods of bedrest. Additionally they permit the user to adjust the surface contour of the bed to various positions which best suit the specific needs of the bed user.

The 720 and 1120 product lines include a steel frame construction with motorized adjustments which are controlled through a pendant. The pendant controls are completely sealed and are available in four or six button configurations. Each series has variety of options and accessories which vary according to model number. Some options include floor locks, lock-out switches and perforated pans. Accessories include various side rails, IV sockets, IV rods and trapeze.

The provided document, K974296, is a 510(k) summary for Invacare Corporation's Model 720 Series Full/Semi Electric and 1120 Full Electric Beds. It describes typical regulatory submission information for medical devices, focusing on substantial equivalence to predicate devices and adherence to relevant safety standards.

Based on the content of the document, here's a breakdown regarding acceptance criteria and the study:

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 separate "test set" in the context of clinical or performance data for the device. The testing mentioned refers to compliance with safety standards. Therefore, information on sample size and data provenance for a test set in the sense of clinical evaluation is not applicable or provided.

3. Number of Experts and Their Qualifications for Ground Truth

This information is not applicable. The device is a hospital bed, and its compliance is assessed against engineering safety standards (U.L. 544), not through expert-derived clinical ground truth.

4. Adjudication Method

This information is not applicable. Adjudication methods are typically used in studies involving subjective assessments or disagreements among experts, which is not the nature of the testing described here.

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

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic or image interpretation devices where human performance with and without AI assistance is evaluated. The Invacare beds are mechanical devices.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study for an algorithm was done. This device is a bed, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the device's acceptable performance is defined by the requirements and standards outlined in the Underwriters Laboratories (U.L.) 544 Standard for Safety, for Medical and Dental Equipment. This is a set of objective engineering and safety criteria.

8. Sample Size for the Training Set

This information is not applicable. The product is a physical device, not an AI model that requires a training set.

9. How Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for an AI model. The "ground truth" for the device's safety and effectiveness is established by compliance with the U.L. 544 standard, which is determined through defined testing procedures.

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NURSING HOME + LONG TERM CARE SLEEPING SURFACES. TO PROVIDE SUPPORT & COMFORT. TO RESIDENTS OF NURSING HOMES OR LONG TERM CARE Facilities

HOSPITAL BED.

The provided document is a 510(k) clearance letter from the FDA for a hospital bed. This type of document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for AI/ML devices. Therefore, I cannot provide the requested information based on the input document.

The letter explicitly states:
"We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."

"This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market."

This indicates that the device (a hospital bed) was cleared based on substantial equivalence to an existing predicate device, not on clinical performance studies or specific acceptance criteria for an AI/ML component. The information requested pertains to the evaluation of AI/ML software, which is not applicable to a physical medical device like a hospital bed under a 510(k) clearance in 1997.

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This device is intended for medical purposes in hospitals or nursing homes for use by the staff to adjust the surface contour of the bed using built-in electric motors and wheels for movement of the bed to different locations.

The device includes bed using built-in electric motors and wheels for movement of the bed to different locations.

The provided text is a 510(k) premarket notification letter from the FDA regarding a hospital bed (Volker Hospital Bed, Model K-960). This type of document is an approval for a medical device to be marketed, based on its substantial equivalence to a legally marketed predicate device.

It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or multi-reader multi-case studies.

Therefore, I cannot provide the requested information from this document. The letter explicitly states that the device is approved "subject to the general controls provisions of the Act," confirming its substantial equivalence rather than providing detailed performance study results against specific acceptance criteria.

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The Soma™ Safe Transport Bed is to be used for the management of patients who are excessive in size and those who are the most difficult to care for. The use of this device will assure the prevention of personal injury to the patient and staff.

Soma 900 Transport Bed

I apologize, but the provided text from the FDA 510(k) K971546 approval letter for the "Soma 900 Transport Bed" (later referred to as "Soma Safe Transport Bed") does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

This document is a regulatory approval letter, specifically a "substantially equivalent" determination letter, which indicates the device can be marketed. It refers to the "indications for use" but does not detail the technical performance studies that would have been submitted as part of the 510(k) application.

Therefore, I cannot extract the information required to populate the table and answer the subsequent questions about acceptance criteria and the study that proves the device meets them from the provided text. The document focuses on regulatory compliance and approval, not on the technical performance data.

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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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