(106 days)
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:
-
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.
-
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.
-
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.
-
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.
-
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.
-
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:
-
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.
-
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.
§ 868.5665 Powered percussor.
(a)
Identification. A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.(b)
Classification. Class II (performance standards).