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510(k) Data Aggregation
(226 days)
Hill-Rom, Inc.
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).
- Table of acceptance criteria and reported device performance:
| Metric | Acceptance Criteria | Reported Performance |
|---|---|---|
| Total System Accuracy | 90% (including undetected signals) | 90% |
| Heart Rate Detection | 30 – 170 BPM | 30 – 170 BPM |
| Heart Rate Accuracy | ±4% or ±5 BPM whichever is greater | ±4% or ±5 BPM whichever is greater |
| Respiration Rate Detection Range | 6 - 45 Br./min | 6 - 45 Br./min |
| Respiration Rate Accuracy | ±4% or ±1.5 Br./min whichever is greater | ±4% or ±1.5 Br./min whichever is greater |
| Usage Life of Sensor | 5 years of continuous use | 5 years of continuous use (tested) |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 | Complies with IEC 60601-1-2 |
| Software Verification & Validation | As per FDA guidance for "moderate" concern level software | Performed and documented |
| Wireless Coexistence | Meets acceptance criteria for wireless coexistence (IEEE/ANSI C63.27) | Meets acceptance criteria |
-
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.
- Usage Life Testing:
-
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. -
Adjudication method for the test set:
Not applicable, as clinical testing was not required. -
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. -
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. -
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. -
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. -
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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(41 days)
Hill-Rom Services Pte Ltd
The Maximus™ System provides features of both the Synclara™ System and the Volara™ System.
The Maximus™ System, when used as a Synclara™ Cough System is intended for use on patients who are unable to cough or clear secretions effectively due to reduced peak cough expiratory flow or respiratory muscle weakness.
The Maximus™ System, when used as a Volara™ System is intended for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and has the ability to provide supplemental oxygen when used with oxygen supply.
The Maximus™ System is a 2 in 1 device which combines 2 main types of therapies referred to as:
- MIE (Mechanical Insufflation-Exsufflation) Synclara®
- OLE (Oscillation and Lung Expansion) - Volara™
The modification is to add the ability to provide aerosol from the nebulizer via the Ventilator Tee adaptor during Continuous High Frequency Oscillations (CHFO) mode when connected to a ventilator. All components were cleared under K192143.
The provided text describes a 510(k) premarket notification for the Maximus™ System, a noncontinuous ventilator. The submission is for a modification to an already cleared device (K192143) to add the ability to provide aerosol from the nebulizer via a Ventilator Tee adapter during Continuous High Frequency Oscillations (CHFO) mode when connected to a ventilator.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparative testing conducted, aiming to demonstrate equivalence to the predicate device. The performance metrics reported are related to aerosol delivery, specifically Mass Median Aerodynamic Diameter (MMAD), Total Respirable Dose, and Fine Particle. The acceptance criteria for these metrics were that they should be "equivalent" across different patient interfaces.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Aerosol delivery parameters (MMAD, Total Respirable Dose, Fine Particle) for the new Ventilator Tee Adaptor should be equivalent to those of already cleared patient interfaces (Mouthpiece, Face Mask). | "Testing parameters included the key particle parameters, Mass Median Aerodynamic Diameter (MMAD), Total Respirable Dose and Fine Particle, are equivalent. The comparative testing supports that the different patient interfaces are not significantly different in their delivery of aerosol." |
| No new or different questions of safety or effectiveness are raised by the modification. | "The differences presented above have not raised new or different questions of safety or effectiveness from the predicate." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of devices or clinical cases. The testing was described as "comparative particle characterization testing comparing the following patient interfaces: Mouthpiece, Face Mask (already cleared under K192143) and delivery through the already cleared Ventilator Tee Adaptor." It was performed at "Adult flow rates (28 Lpm) and Pediatric flow rates (12 Lpm) with 1 drug at the lowest and highest set pressures (5 and 70 cmH2O)." This indicates bench testing rather than patient data.
- Data Provenance: The data is from bench testing performed by the manufacturer, Hill-Rom Services Pte Ltd. There is no mention of country of origin for the data or if it was retrospective or prospective, as it is not human subject data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for this submission is based on objective measurements from bench testing of aerosol delivery parameters, not expert human assessment.
4. Adjudication Method for the Test Set
Not applicable, as the evaluation is based on objective measurements from bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This submission describes a modification to a medical device (ventilator) and involves bench testing of its physical performance (aerosol delivery), not a diagnostic algorithm or human interpretation task. Therefore, an MRMC study is not relevant.
6. Standalone (Algorithm Only) Performance Study
No. This is a physical device, and the testing focuses on its mechanical and delivery performance. There is no AI or algorithm involved in the direct clinical function being evaluated.
7. Type of Ground Truth Used
The ground truth is established through objective physical measurements of aerosol particle characteristics (MMAD, Total Respirable Dose, Fine Particle) using standardized test methods.
8. Sample Size for the Training Set
Not applicable. This device does not involve a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth to establish for it.
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(190 days)
Hill-Rom Services Pte Ltd
The Maximus™ System provides features of both the Synclara™ System and the Volara™ System.
The Maximus™ System, when used as a Synclara™ Cough System is intended for use on patients who are unable to cough or clear secretions effectively due to reduced peak cough expiratory flow or respiratory muscle weakness.
The Maximus™ System, when used as a Volara™ System is intended for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and has the ability to provide supplemental oxygen when used with oxygen supply.
The Maximus™ System is a 2 in 1 device which is a combination of two (2) already cleared devices. The Maximus™ System provides the individual therapies of the predicates: Vital Cough and MetaNeb®. The Maximus™ can be programmed to allow the user to provide both therapies or one only. The 2 main types of therapies are referred to as:
- . MIE (Mechanical Insufflation-Exsufflation)
- OLE (Oscillation and Lung Expansion) ●
The provided text is a 510(k) premarket notification for the Maximus™ System, a medical device for respiratory therapy. It outlines the device's indications for use and compares it to predicate devices to establish substantial equivalence with respect to safety and effectiveness.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a formal "acceptance criteria" table with numerical targets, as is common for diagnostic accuracy studies. Instead, it argues for substantial equivalence to predicate devices. This means the primary acceptance criterion is that the Maximus™ System performs functionally and safely similar to its predicates (MetaNeb® and Vital Cough) and does not raise new or different questions of safety or effectiveness.
The comparison tables (Table 1, Table 2, Table 3 – although some are presented partially) serve as the 'reported device performance' against the implicit acceptance criterion of equivalence to the predicates.
| Feature / Performance Metric | Acceptance Criteria (Implicit - Equivalence to Predicates) | Reported Maximus™ System Performance |
|---|---|---|
| Indications for Use | Identical to predicates (MetaNeb® K124032, K151689; Vital Cough K132988) | Identical for mobilization of secretions, lung expansion therapy, treatment and prevention of pulmonary atelectasis, ability to provide supplemental oxygen. The Maximus™ System combines features of Synclara™ (MIE) and Volara™ (OLE). |
| Patient Population | Identical to predicates | Volara™ mode: Adult, Child > 2 years old (acute); >5 years old (home care). Synclara™ mode: Adult and pediatric. (Identical to respective predicates). |
| Environment of Use | Identical to predicates | Hospital, sub-acute facilities, nursing care, homecare. (Identical to respective predicates). |
| OLE: Peak Positive Pressures | ≤ 30 cmH2O (Predicate MetaNeb®) | Up to 70 cmH2O (Supported by reference device Bird IPV K895425 with 80 cmH2O) |
| OLE: Patient Circuit - Adjustable Resistance | Present (Predicate MetaNeb®) | No resistance adjustment feature; therapy settings done at control unit. |
| MIE: Max Positive and Negative Pressures | +50 cmH2O / -50 cmH2O (Predicate Vital Cough) | +70 cmH2O / -70 cmH2O (Supported by reference device Philips Respironics Cough Assist T70 K121955 with same pressures). Max pre-set of +50 cmH2O in home setting. |
| Nebulizer Performance | Substantially equivalent to predicate | Comparative nebulizer performance across all therapy modes and pressure ranges demonstrated substantial equivalence with the Philips SideStream nebulizer. Mouthpiece vs. face mask performance also equivalent. |
| Software Control / User Interface | Manual (Predicates) | Software-controlled, GUI screen. Performance and usability evaluated. |
| Pulse Oximeter Connection | Not offered (Predicates) | Can connect via Bluetooth to cleared Beijing Choice Electronic Technology Co., Ltd. Fingertip Pulse Oximeter (K142888). Displays heart rate and SpO2. (This is an added feature, not a comparative one, but is deemed not to raise new safety/effectiveness questions). |
| Biocompatibility | Meet applicable requirements (ISO 10993, ISO 18562) | Materials in gas and fluid pathway tested per ISO 10993-1 and ISO 18562 and found to meet applicable requirements. |
| Bench Testing Performance | Substantially equivalent to predicates | Demonstrated equivalence through: Simulated Life Cycle, Biocompatibility, Software V&V, Electrical safety/EMC, Comparative Performance in CHFO, CPEP, Aerosol and MIE modes, Comparative Nebulizer Performance, Inter-/Intra-sample variability, pre-/post-cleaning nebulizer performance, Usability. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench testing and comparative performance testing against predicate devices and reference devices. It does not refer to clinical studies with patient test sets in the context of diagnostic accuracy. Therefore, details regarding "sample size for the test set" or "data provenance (country of origin, retrospective/prospective)" for patient data are not applicable to this 510(k) submission, which focuses on substantial equivalence based on performance and safety characteristics compared to existing devices.
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)
This information is not provided. As this is a medical device submitting for substantial equivalence based on engineering and performance criteria rather than diagnostic accuracy with a ground truth established by experts, this type of detail is not expected or relevant in this context. The "ground truth" here is the established safe and effective operation of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no human adjudication of a "test set" in the context of diagnostic performance as described in the document.
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 Maximus™ System is a therapeutic device (noncontinuous ventilator), not a diagnostic AI system that "assists human readers." Therefore, an MRMC comparative effectiveness study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The Maximus™ System is a physical electro-mechanical device that delivers therapy, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this 510(k) submission for substantial equivalence is the established safe and effective performance of the predicate devices (Hill-Rom MetaNeb® and Vital Cough), as well as reference devices (Bird IPV and Philips Respironics Cough Assist T70) for specific performance parameters. The device's performance is compared against these established benchmarks through various bench tests.
8. The sample size for the training set
Not applicable. The document describes a physical medical device, not a machine learning model that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no machine learning model or "training set," this question is not relevant.
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(337 days)
Hill-Rom Holdings, Inc.
The Monarch™ product is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physician's choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging. The Monarch™ Airway Clearance System is intended to be used in the Home Care environment by patients, 15 years and older.
The Monarch® Airway Clearance System Model 1000 (hereinafter referred to as Monarch®) consists of a garment which contains actuators together with the Main Control Box and pendant controller. The Main control box contains the electronics used to control the actuators which are organized into 8 discrete zones. The pendant controller is tethered to the garment and consists of an LCD display and selection controls to facilitate visual feedback of the therapy and system information while allowing the user to adjust the therapy settings to adhere to the prescribed therapy ordered by the physician. It has adjustment mechanisms over each shoulder and on each side of the mid torso area to provide the wearer with a personal and evenly distributed snug fit. The buckles on each side of the device together with the front zipper help provide a repeatable fitting by allowing the wearer to wear and remove the garment without making changes to the adjustment mechanisms. The product also includes an external charger for the battery and can run on either power source as per desired by the user. The major components to the Monarch® Airway Clearance System are: . Garment - which contains the "pods" Garment shell covers the underlying the garment ● Pendant controls the device function ● Battery installed in the backpack cover ● Garment adjustment mechanisms means to secure and adjust the fit of the Garment to the user . This submission is specific to an expansion of the contraindication related to active implants. The device is identical to that cleared under K163378.
The provided text describes a 510(k) premarket notification for the Monarch Airway Clearance System Model 1000. This submission specifically addresses an expansion of the contraindication related to active implants, rather than an entirely new device or performance claim where a traditional acceptance criteria study would be performed. The device itself is stated to be identical to that cleared under K163378.
Therefore, the information presented focuses on demonstrating substantial equivalence to a predicate device, particularly regarding the magnetic interference for active implants, rather than proving the device meets new performance criteria.
Here's an analysis of the provided information, framed to address your questions as much as possible given the context:
1. Table of Acceptance Criteria and Reported Device Performance
Because this submission is an amendment to an existing clearance, focusing on a contraindication, the "acceptance criteria" here relate to demonstrating safety regarding magnetic interference with active implants. There aren't traditional performance metrics like sensitivity or specificity for a diagnostic device.
| Acceptance Criterion (for this 510(k) amendment) | Reported Device Performance |
|---|---|
| Magnetic Interference with Active Implants (Static Flux Density) |
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(117 days)
Hill-Rom Inc.
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.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance |
|---|---|---|
| Respiration Rate Range | 6 - 45 Breaths/minute | 6 - 45 Breaths/minute |
| Heart Rate Range | 30 – 170 beats per minute | 30 – 170 beats per minute |
| Durability (Weight) | Withstand up to 440 lbs (200 kg) (predicate's limit) | Withstand up to 700 lbs (318 kg) |
| Accuracy Testing | Comparable to predicate device | Conducted and deemed equivalent to predicate |
| Compliance with Standards | Adherence to specified IEC, ISO, AAMI/ANSI standards | Adherence to specified IEC, ISO, AAMI/ANSI standards |
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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(106 days)
HILL-ROM SERVICES PTE LTD
The Monarch™ product is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physician's choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging.
The Monarch™ Airway Clearance System is intended to be used in the Home Care environment by patients, 15 years and older.
The Monarch™ Airway Clearance System consists of a garment which contains actuators together with the Main Control Box and pendant controller. The Main control box contains the electronics used to control the actuators which are organized into 8 discrete zones. The pendant controller is tethered to the garment and consists of a LCD display and selection controls to facilitate visual feedback of the therapy and system information while allowing the user to adjust the therapy settings to adhere to the prescribed therapy ordered by the physician.
It has adjustment mechanisms over each shoulder and on each side of the mid chest area to provide the wearer with a personal and evenly distributed snug fit. The buckles on each side of the device together with the front zipper help provide a repeatable fitting by allowing the wearer to wear and remove the garment without making changes to the adjustment mechanisms. The product also includes an external charger for the battery and can run on either power source as per desired by the user.
The major components to the Monarch™ Airway Clearance System are:
- Garment which contains the "pods" .
- . Garment shell - covers the underlying the garment
- . Pendant – controls the device function
- . Battery - installed in the backpack cover
- Garment adjustment mechanisms means to secure and adjust the fit of the Garment to the . user
Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance for the Monarch™ Airway Clearance System:
It's important to note that the provided document is a 510(k) Summary, which aims to demonstrate substantial equivalence to a predicate device rather than providing a detailed clinical trial report or a comprehensive standalone performance study. Therefore, some information typically found in a full study report (like the exact statistical methods used for comparison or detailed effect sizes for human-in-the-loop studies) might not be present or explicitly stated.
Acceptance Criteria and Reported Device Performance
The document describes the device's performance in comparison to predicate and reference devices, rather than against specific, pre-defined quantitative acceptance criteria in a strict sense. The "acceptance criteria" appear to be based on the concept of "substantial equivalence" to the identified predicate devices, particularly regarding performance parameters.
Table of Acceptance Criteria (as inferred from the "Discussion of Substantial Equivalence" and "Bench Testing" sections):
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Comparative) |
|---|---|
| Indications: Similar indications for use related to airway clearance via chest wall oscillation. | The Monarch™ product provides Airway Clearance Therapy and promotes bronchial drainage where external manipulation of the thorax is the physician's choice of treatment, indicated for patients having difficulty with secretion clearance or atelectasis caused by mucus plugging. This is similar to the Vest® Airway Clearance Systems (K142482) and IBC AffloVest (K122480). |
| Patient Population: Within the age range of the predicate and reference devices. (Narrower range is acceptable if it doesn't raise new safety/effectiveness concerns). | Intended for patients 15 years and older. This is a narrower range than the predicate (Pediatric to Geriatrics) but within its scope, deemed not to raise new safety/effectiveness concerns. |
| Environment of Use: Similar to predicate (home care settings). (Narrower range is acceptable if it doesn't raise new safety/effectiveness concerns). | Intended for Home Care environment. This is a narrower environment of use compared to the predicate (which has a broad range), but deemed not to raise new safety/effectiveness concerns as it's the target market. |
| Technology: High frequency chest wall oscillation with similar design and technology (electrical actuator/motor in zones in a vest). | Utilizes oscillating electromechanical actuators organized into eight zones. This is similar to the reference device (IBC AffloVest with 6 zones of oscillating vibratory motors). Comparative testing was performed to demonstrate equivalence in force and frequency generation, suggesting acceptable performance compared to the predicate's air-pocket system. |
| Performance: Performance features and parameters comparable to predicate and reference devices. Expected to perform "in-between the 2 devices" in some aspects. | Bench testing comparison performed across modes. "Performance results were substantially equivalent." Specific objective for peak force: "Monarch performance would be higher than AffloVest (K122480) but below the predicate Vest Model 105 (K142482)." |
Specific parameters cited:
- Peak Force (N): 2.2 to 25.9 (Monarch™)
- Predicate (Vest Model 105): 3.1 to 31.7
- Reference (AffloVest): 4.9 to 9.5
(Monarch™ falls largely within or near the range of the predicate and reference, consistent with the objective.)
- Acoustic energy: 43.6 dBA @ 0.3 m (Monarch™)
- Predicate (Vest Model 105): 82.8 dBA @ 1 m
- Reference (AffloVest): 48 dBA @ 1 m
(Monarch™ appears quieter than both, which is typically a positive attribute.)
- Weight of worn components: 6.0 kg (Monarch™)
- Predicate (Vest Model 105): 1.0 kg
- Reference (AffloVest): 5.4 kg
(Monarch™ is heavier than the predicate but comparable to the reference.)
- Durability: Garment cover durability to cleaning tested (5 years/60 cycles).
- Simulated Life Cycle Testing: Performed.
- Usability: Demonstrated for home environment. |
| Biocompatibility: No direct patient contact, similar to predicate/reference. | No direct patient contact; user wears an undergarment. Similar to predicate and reference devices. |
| Electrical Safety: Compliance with relevant standards. | Complies with ES 60601-1, CAN/CSA C22.2 No. 60601-1, IEC 60601-1-2, IEC 60601-1-11. |
| Operating/Environmental Conditions: Within acceptable ranges for operation and storage. | Operating: Temp 41-95°F, Humidity 15-90%, Pressure 70-106 kPa. Environmental: Temp -4-140°F, Humidity 15-90%, Pressure 50-106 kPa. These ranges are comparable to or within the ranges of the predicate and reference devices. |
Study Details:
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Sample sizes used for the test set and the data provenance:
- The document describes "Non-clinical Bench Testing" and "Human Factors / Usability Testing."
- Bench Testing: No specific numerical sample sizes (e.g., number of garments, number of tests run) are provided for the bench tests (Peak Force, Durability, Simulated Life Cycle). The "test set" here refers to measurements taken on the device itself under various conditions (different chest locations on a mannequin, frequencies, intensity levels).
- Human Factors / Usability Testing: The test included "individuals representing two distinct user groups." The exact number of participants is not specified.
- Data Provenance: Not explicitly stated for bench testing, but typically performed in a controlled lab environment. Human Factors testing would involve human participants (countries not specified, but the applicant company is Hill-Rom Services Pte Ltd, Singapore, with a US consultant, so testing could have occurred in Singapore or the US). The document implies these were prospective tests performed to support the 510(k) submission.
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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):
- For this type of device (Powered Percussor), the "ground truth" is primarily based on engineering specifications and comparative physical performance measurements rather than expert interpretation of medical images or conditions.
- For the Human Factors / Usability testing, the "ground truth" is whether users can safely and effectively interact with the device. This is established by observing representative users. The document doesn't specify the number or qualifications of experts involved in the observation or assessment of usability, but usually, human factors specialists are involved.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable in the context of physical performance testing of a device or usability testing. Adjudication methods like '2+1' (two readers agree, third is tie-breaker) are common in diagnostic imaging studies where subjective interpretation is key. Here, the "truth" is either a measured physical parameter or an observed behavior.
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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 comparative effectiveness study was not done. This device is a therapeutic medical device (airway clearance system), not an AI-powered diagnostic imaging tool. Therefore, a study comparing human readers with and without AI assistance is not relevant to this product. The evaluation focuses on the physical performance of the device and its usability.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit, standalone performance was assessed for the physical device. The "Non-clinical Comparative Performance" bench testing section describes tests of the device's physical output (Peak Force, Durability, Life Cycle) operating on its own (or with a mannequin) without continuous human-in-the-loop real-time control other than setting parameters.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance evaluation relied on:
- Physical measurements/benchtop data: Quantifiable output (peak force, acoustic energy, weight) directly measured from the device.
- Engineering specifications/standards: Compliance with electrical safety (IEC 60601-1 series).
- Comparative data: The performance of the predicate and reference devices served as the comparative "truth" against which the new device was evaluated for substantial equivalence.
- Observed user interaction/usability: For the human factors testing, the ability of users to successfully perform tasks with the device.
- The "ground truth" for the performance evaluation relied on:
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The sample size for the training set:
- Not applicable. This document describes the testing and comparison of a physical medical device, not an AI/ML algorithm that requires a "training set." The device's control system is likely based on traditional embedded software and hardware logic, not a machine learning model that learns from data.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.
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(268 days)
Hill-Rom Services Pte Ltd
The MetaNeb® 4 System is indicated for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen.
The MetaNeb® 4 System is a therapeutic device that uses a systematic approach to enhance normal mucus clearance and resolve or prevent patchy atelectasis. The system has three modes: Aerosol, CHFO (Continuous High Frequency Oscillation), and CPEP (Continuous Positive Expiratory Pressure). There are three major components: Circuit, Controller, and Stand.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria, structured according to your request:
Device Name: MetaNeb® 4 System
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to predicate devices, particularly the MetaNeb® (K124032), rather than establishing new, specific performance acceptance criteria for the MetaNeb® 4 System itself. The acceptance criteria are implicitly met by showing the MetaNeb® 4 System performs equivalently or better than the identified predicates in key performance parameters.
The key performance comparisons are related to peak pressure in different therapy modes.
| Acceptance Criteria (Implicitly, equivalence to predicate performance) | Reported Device Performance (MetaNeb® 4 System) | Predicate Performance (MetaNeb® K124032) |
|---|---|---|
| CPEP Mode @ High Flow Peak Pressure (cmH2O): Equivalent to predicate. | 10.7 to 29.9 | 10.7 to 29.9 |
| CPEP Mode @ Medium Flow Peak Pressure (cmH2O): Equivalent to predicate. | 7.7 to 14.6 | 7.7 to 14.6 |
| CPEP Mode @ Low Flow Peak Pressure (cmH2O): Equivalent to predicate. | 0.2 to 2.0 | 0.2 to 2.0 |
| CHFO Mode @ High Flow Peak Pressure (cmH2O): Equivalent to predicate. | 11.2 to 25.4 | 11.2 to 25.4 |
| CHFO Mode @ Low Flow Peak Pressure (cmH2O): Equivalent to predicate, specifically referencing K124032 data. | 8.7 to 20.3 | 8.7 to 20.3 |
| Usability (Home Environment): All critical tasks completed successfully without use errors leading to unacceptable harm. | 100% of participants (caregivers and lay users) completed all tasks successfully without use errors that could lead to unacceptable risk of harm. | Not directly comparable, as the predicate did not include home use. |
2. Sample Size Used for the Test Set and Data Provenance
- Performance Comparison (Peak Pressure): The sample size for the bench tests is not explicitly stated as a numerical value (i.e., 'n'). The testing involved comparing the MetaNeb® 4 System to the MetaNeb® (K124032), PowerNeb (K051964), and IPV (K895485). The data provenance is generally "bench testing" performed by the manufacturer (Hill-Rom Services Pte Ltd). It's a prospective study of the device's physical performance characteristics.
- Usability Study: The sample size is referred to as "2 user groups: caregivers and lay users." The specific number of participants within each group is not provided in this summary. The data provenance is a usability study conducted to evaluate the device's use in the home environment, likely a prospective study. The country of origin of the data is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for the performance tests (peak pressure) is the physical measurement of the device's output, compared against its own specifications and the previously cleared predicate devices' performance. For the usability study, the "ground truth" is the observation of user performance, not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
This information is not applicable as it typically refers to methods for resolving discrepancies in expert interpretations (e.g., in medical image analysis). For bench testing, direct measurement and data collection are used. For the usability study, observations of user performance were recorded, often with predefined criteria for success/failure, but an adjudication method for conflicting expert opinions is not mentioned because experts (in the sense of adjudicators) are not setting the "ground truth."
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
This information is not applicable. The MetaNeb® 4 System is a therapeutic medical device (non-continuous ventilator), not an AI/CAD (Computer-Aided Detection/Diagnosis) system. Therefore, MRMC studies and AI-assisted improvements for human readers are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The MetaNeb® 4 System is a physical device, not an algorithm.
7. The Type of Ground Truth Used
- Performance Comparison (Peak Pressure): The ground truth is established through physical measurements and engineering specifications of the device's output in various modes, compared to the previously established performance of predicate devices. This falls under bench testing data.
- Usability Study: The ground truth is established through direct observation of user performance in conducting critical tasks with the device in a simulated environment. This is a form of empirical user performance data.
8. The Sample Size for the Training Set
This information is not applicable. Since this is a physical medical device (MetaNeb® 4 System) and its development involved engineering design and validation against performance specifications and predicate devices, there isn't a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above (not an AI/ML device). Engineering validation and design controls are used during device development, which are different from establishing ground truth for a "training set" in AI.
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(245 days)
Hill-Rom Services Private Limited
The Vest® Airway Clearance Systems is intended to provide airway clearance therapy when external manipulation of the thorax is the physician's choice or treatment. Indications for this form of therapy are described by the American Association of Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy. According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the Vest® Airway Clearance System is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for the purposes of collecting mucus for diagnostic evaluation.
The Vest® Airway Clearance System consists of an inflatable garment attached to an Air Pulse Generator that rapidly inflates and deflates the inflatable garment. This causes the chest wall to be gently compressed and released, which creates airflow within the lungs. This process moves the mucus toward the large airways where it can be cleared by coughing or suctioning. This type of Airway Clearance Therapy is referred to as High Frequency Chest Wall Oscillation (HFCWO).
The system consists of an Air Pulse Generator, connecting hose, and multiple styles and sizes of garments. The garments are single patient, multi-use.
The provided text is a 510(k) Summary for the Hill-Rom "The Vest® Airway Clearance Systems (Model 105)". This document states that the new device is substantially equivalent to a previously cleared predicate device (K024309) and therefore does not include a study demonstrating the new device meets specific acceptance criteria based on clinical outcomes or performance metrics like accuracy, sensitivity, or specificity. Instead, the focus is on comparative non-clinical bench testing to prove equivalence.
Therefore, much of the requested information, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets, is not applicable in the context of this 510(k) submission as it relies on substantial equivalence to a predicate device rather than novel performance demonstration.
However, I can extract the information provided regarding the testing performed to support substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence claim based on non-clinical testing rather than clinical performance metrics, the "acceptance criteria" here refer to the successful completion and comparison of non-clinical tests to demonstrate that modifications do not raise new safety or effectiveness concerns compared to the predicate device.
| Acceptance Criteria (Success of Test) | Reported Device Performance (Outcome) |
|---|---|
| - Comparative Pressure mapping | Demonstrated equivalent performance between the proposed Air Pulse Generator and garments and the predicate Vest® Airway Clearance System (K024309). |
| - Environmental and Mechanical testing | Demonstrated that the modifications (software update, additional garment styles, locking connecting hose) do not raise new safety or risks compared to the predicate. |
| - Electrical Safety (Various Standards) | Compliance with ANSI/AAMI ES60601-1:2005/(R)2012, C1:2009/(R)2012, A2:2010/(R)2012, IEC 60601-1:2005+CORR,1 (2006) + CORR. 2 (2007), EN 60601-1:2006 +CORR: 2010, CAN/CSA-C22.2 No. 6060101 (2008), EN 60601-102: 2007. |
| - Electromagnetic Compatibility (EMC) | Compliance with 47 CFR FCC Part 15B:2012 (CLASS B), ETSI EN 300 328 V1.7.1:2006, ETSI EN 301 489-1 V1.9.2:2011, ETSI EN 301 489-17 V2.2.1:2012. |
| - Biocompatibility Review | Biocompatibility testing was not needed as materials are identical to the predicate and do not have direct or indirect contact with patient skin or tissue. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is described as "comparative non-clinical bench testing." The tests performed are listed in the table above and in the "Non-clinical Testing Summary" section of the 510(k) summary (page 6 of the document). These tests were conducted to demonstrate that the updated device, with its minor modifications, performs equivalently to the predicate device and does not introduce new safety or effectiveness risks.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to this 510(k) submission. The document describes non-clinical bench testing, which typically does not involve human sample sizes or data provenance in the same way clinical studies do. The testing involved comparing the proposed device components (Air Pulse Generator, connecting hose, garments) with the predicate device.
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)
This information is not applicable. The ground truth for this type of non-clinical bench testing is based on engineering specifications and compliance with established standards, not expert clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the testing is non-clinical bench testing against engineering standards.
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
This information is not applicable. The device is an airway clearance system, not an AI-powered diagnostic device, and therefore MRMC studies are not relevant to its clearance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical medical device, not an algorithm, so standalone performance in this context is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission are the established engineering specifications and international standards (e.g., IEC 60601-1, FCC Part 15B, etc.) that the device must meet, and the performance characteristics of the predicate device (K024309), which the new device aims to be substantially equivalent to.
8. The sample size for the training set
This information is not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of device submission.
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(102 days)
HILL-ROM
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.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Functional & Performance | Meets specifications |
| Safety | Meets specifications |
| Efficacy | Meets specifications |
| Electromagnetic Immunity | Compliant with EN 55024:2010 |
| Radio Disturbance | Compliant with EN 55022:2010 |
| Usability Engineering | Compliant with IEC 62366:2007/(R)2013 |
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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(293 days)
HILL-ROM
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
| Acceptance Criteria Category | Source | Reported Device Performance |
|---|---|---|
| Functional, Performance, Safety, and Efficacy | Hill-Rom's verification and validation based on international standards | Meets functional, performance, safety, and efficacy specifications and requirements in compliance with listed international standards. |
| Compliance with International Standards | IEC 60601-1 (General Safety) | Compliant |
| IEC 60601-1-2 (EMC Requirements) | Compliant | |
| IEC 60601-1-4 (Programmable Electrical Medical Systems) | Compliant | |
| IEC 60601-2-38 (Safety of Electrically Operated Hospital Beds) | Compliant | |
| Substantial Equivalence to Predicate Devices | FDA's 510(k) review process | Determined to be substantially equivalent to legally marketed predicate devices. |
| Intended Use | Device Description and Indications for Use | Functions as a patient support system in healthcare environments; treats/prevents pulmonary/immobility complications, pressure ulcers; provides Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy; supports patients up to 500 lbs. |
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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