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The SmartVest® Airway Clearance System, Model Clearway is designed to deliver high frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The SmartVest® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport.

The modified Electromed SmartVest® Airway Clearance System, Model Clearway is an electrically powered percussor device designed to deliver high frequency chest wall oscillation (HFCWO) to aid in freeing mucus deposits in the lungs to improve bronchial drainage and airway clearance under the order of a physician's prescription. The primary components of both the proposed modified and predicate HFCWO Airway Clearance Systems consist of an Air Pulse Generator, an Inflatable Vest, and an Air Hose that connects the Generator to the Inflatable Vest. The Air Pulse Generator produces small volumes of pressurized air pulses that are rapidly delivered to the Inflatable Vest via the Air Hose at a selected oscillatory frequency between 5-20 times per minute (Hz). The Inflatable Vest imparts the oscillatory air pulses to the patient's external chest wall. These pressurized air pulses promote transient increases in airflow within the lungs that loosens mucus sufficiently to facilitate expulsion by the patient when normal respiratory function is not capable.

The provided text is a 510(k) summary for the Electromed SmartVest® Airway Clearance System, Model Clearway. It describes modifications made to a previously cleared device, focusing on changes to the Air Pulse Generator. The primary objective was to reduce size and weight, update the graphic user interface (GUI) to a touchscreen, and refine certain features. The document highlights the testing performed to demonstrate substantial equivalence to the predicate device.

Based on the provided text, the device is the Electromed SmartVest® Airway Clearance System, Model Clearway, which is intended to deliver high-frequency chest wall oscillation for airway clearance and bronchial drainage.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Key Takeaway from the Document:
This document is a Special 510(k) Summary, indicating that the manufacturer is demonstrating substantial equivalence of a modified device to a previously cleared predicate device, rather than bringing a completely novel device to market. As such, the performance data presented is primarily focused on demonstrating that the changes do not adversely affect safety or effectiveness, and that the modified device performs comparably to the predicate. This is not a clinical trial designed to establish standalone effectiveness against a control or to show human reader improvement with AI assistance.

Details Regarding Acceptance Criteria and Study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance testing, but it does not provide a specific table with numerical acceptance criteria and a direct comparison to reported device performance in a quantitative, side-by-side format. Instead, it states the type of testing and the statistical method used to demonstrate equivalence.

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

• Sample Size for Comparative Performance Testing: The text states, "Testing was conducted on both the predicate and proposed Generators using multiple Inflatable Vests that included the smallest and the largest sizes using the full range of Generator settings for pressure and frequency." A specific numerical sample size is not provided.
• Data Provenance: The document does not specify the country of origin of the data. Given it's a US FDA submission, it's highly implied the testing was conducted under US regulatory and quality system standards. The testing appears to be prospective as it's part of the design verification and validation for a modified product being submitted for clearance.

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

• This information is not applicable in the context of this 510(k) summary. The testing described is primarily engineering and performance verification of a medical device, not a diagnostic or AI-driven system requiring expert ground truth for interpretation (e.g., radiologists for medical images). The "ground truth" for the performance tests would be the measurement standards themselves (e.g., calibrated sensors for pressure, frequency, time).

4. Adjudication Method for the Test Set:

• Not applicable. This isn't a study involving human interpretation where adjudication is needed. (See point 3).

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, an MRMC study was not done. This device is an airway clearance system, not an AI diagnostic tool. The "performance" described is the physical output of the device (air pulse pressure, frequency, time), not the diagnostic accuracy of an algorithm or its impact on human readers.

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

• Not Applicable. This is not an algorithm-only device. It is a physical medical device. The "performance" assessment is of the device's physical output and functional safety. The software component mentioned is for control of the device, not for diagnostic interpretation.

7. The Type of Ground Truth Used:

• For the comparative output performance testing: The ground truth is established by physical measurements against calibrated standards, with the predicate device's performance serving as the reference for equivalence.
• For electrical safety, EMC, and shipping testing: The ground truth is adherence to the specified international and industry standards (e.g., IEC 60601 series, ASTM D4169).

8. The Sample Size for the Training Set:

• Not applicable. This document describes the clearance of a physical medical device, not an AI model that requires a "training set" in the machine learning sense. The "design input requirements" mentioned in the context of software testing refer to functional specifications, not data for training an algorithm.

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

• Not applicable. (See point 8).

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The SmartVest® Airway Clearance System, Model SQL is designed to deliver high frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The SmartVest System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport.

The modified Electromed SmartVest® Airway Clearance System, Model SQL is an electrically powered percussor device designed to deliver high frequency chest wall oscillation (HFCWO) to aid in freeing mucus deposits in the lungs in order to improve bronchial drainage under the order of a physician's prescription. The primary components of both the proposed modified and predicate HFCWO Airway Clearance Systems consist of an Air Pulse Generator, an Inflatable Vest, and an Air Hose that connects the Generator to the Inflatable Vest. The Air Pulse Generator produces small volumes of pressurized air pulses that are rapidly delivered to the Inflatable Vest via the Air Hose at a selected oscillatory frequency between 5-20 times per minute (Hz). The Inflatable Vest imparts the oscillatory air pulses as pressure forces to the patient's external chest wall. These pressurized air pulses promote transient increases in airflow within the lungs that loosens mucus sufficiently to facilitate expulsion by the patient when normal respiratory function is not capable.

The Electromed SmartVest® Airway Clearance System, Model SQL, is an electrically powered percussor device designed to deliver high-frequency chest wall oscillation (HFCWO) to aid in freeing mucus deposits in the lungs. The primary components are an Air Pulse Generator, an Inflatable Vest, and an Air Hose. The Air Pulse Generator produces pressurized air pulses (5-20 Hz) delivered to the Inflatable Vest via the Air Hose, which then applies these oscillatory pulses to the patient's chest wall. This action promotes transient increases in airflow to loosen mucus, facilitating expulsion.

The provided documentation describes the acceptance criteria and the study that proves the device meets the acceptance criteria as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

• Air Pulse Pressure
• Air Pulse Frequency
• Treatment Time | Demonstrated equivalence between the modified and predicate devices for air pulse pressure, air pulse frequency, and treatment time through comparison performance testing. |
  | Safety and Effectiveness (no new risks compared to predicate) | Formal risk analysis revealed no new risks.
  The modified device has identical indications for use, the same patient population, and the same fundamental scientific technology, not raising additional questions of safety or effectiveness. |
  | Design Control Compliance (21 CFR 820) | All modification and design activities were conducted in conformance to 21 CFR 820.30 Design Control. |
  | Design Verification (meeting design input requirements) | Design verification testing, including software, demonstrated that design output specifications met design input requirements. |
  | Usability/Human Factors (enhanced user operation, less potential for errors) | Usability/human factors testing demonstrated enhanced user operation with less potential for errors compared to the predicate. |
  | Electromagnetic Compatibility (EMC) | The modified design passed electromagnetic compatibility testing. |
  | Electrical Safety | The modified design passed electrical safety testing and UL testing. |
  | Compliance with Recognized Standards:
• IEC 60601-1 3rd edition
• IEC 60601-1-2 3rd edition
• IEC 60601-1-6 3rd edition
• IEC 60601-1-11 3rd edition
• UL testing
• ASTM D4169-09 DC13 (Performance Testing of Shipping Containers and Systems) | The device underwent and presumably passed testing in accordance with these standards. (The document states "Testing included" these and "The modified design passed... electrical safety testing and UL testing" and "Design verification testing... demonstrated that the design output specifications met the design input requirements" which implies passing criteria for these standards were met.) |

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

The document does not explicitly state a specific "test set" sample size or data provenance in terms of country of origin or whether data was retrospective or prospective for the performance and safety testing. The studies mentioned are primarily engineering and usability tests comparing the modified device to its predicate.

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

Not applicable. This device modification primarily involved engineering and usability changes to an existing, cleared device. The "ground truth" was established through comparison testing against the predicate device's established performance, compliance with regulatory standards, and internal design controls, rather than through expert-adjudicated clinical data of patient outcomes.

4. Adjudication Method for the Test Set:

Not applicable. No clinical adjudication of results is mentioned, as the studies are focused on product performance, safety, and equivalence to a predicate.

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

No, an MRMC comparative effectiveness study was not done. The documentation focuses on engineering, performance and safety testing of the device itself and its equivalence to a predicate, not on the comparative effectiveness of human readers with or without AI assistance.

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

Not applicable. This device is a medical apparatus (a percussor) and not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for the device's performance relies on several factors:

• Predicate Device Performance: The primary ground truth for output performance (air pulse pressure, frequency, treatment time) was the performance of the legally marketed predicate device (SmartVest® Airway Clearance System, Model TL: K053248).
• Regulatory Standards: Compliance with established electrical safety and medical device standards (e.g., IEC 60601 series, UL, ASTM) served as a ground truth for safety and general performance.
• Design Input Requirements: The pre-defined design input requirements served as the ground truth for design verification.
• Usability Principles: Principles of usability and human factors served as the ground truth for usability testing.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical device, not an AI or machine learning algorithm requiring a "training set."

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

Not applicable, as there is no "training set" for this physical device.

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The Electromed SmartVest® Airway Clearance System, Model TL is designed to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The SmartVest® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport.

The proposed SmartVest® Airway Clearance System, Model TL is designed to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The SmartVest® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport. The primary components of the SmartVest® System include an Air-Pulse Generator, an Inflatable Vest and Vest/Generator Connector Hose. The Air-Pulse Generator produces oscillating pressurized air-pulses that are delivered to the Inflatable Vest by the Vest/Generator Hose. The air-pulses produced by the Generator cause the Vest to rapidly inflate and deflate against the external chest wall of a patient to promote airway clearance by creating high-frequency chest wall oscillation (HFCWO) resulting in mobilization of bronchial secretions.

The provided text describes the Electromed SmartVest® Airway Clearance System, Model TL, and its substantial equivalence to a predicate device, the MedPulse® Respiratory Vest System, Model 2000 ez. This is a medical device submission, not an AI/ML device, therefore, many of the requested categories (like number of experts, adjudication methods, MRMC study, sample size for training data, etc.) are not applicable.

Here's the information that can be extracted and inferred from the document:

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

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 does not specify a distinct "test set" sample size for patients or data. The performance testing section mentions: "Testing included measuring the pressure imparted to the chest wall of both the proposed and predicate systems." This implies testing was done on the physical devices themselves, likely in a laboratory or simulated environment, rather than on a patient population.

Therefore, information on:

• Sample size for the test set: Not specified, as the testing focuses on device performance and safety rather than clinical efficacy evaluated on a patient cohort in this type of submission.
• Data provenance: Not applicable in the context of clinical patient data, as the tests described are technical device performance evaluations. The device manufacturer is Electromed, Inc., based in New Prague, MN, USA, implying the testing would have occurred domestically.
• Retrospective or prospective: Not applicable for device performance testing.

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. This device is a powered percussor, not an AI/ML diagnostic or prognostic tool. The "ground truth" here is established by engineering and safety standards, and by comparison to the predicate device's established performance. Experts involved would be engineering and regulatory professionals, but their number and specific qualifications in the context of "ground truth for a test set" are not relevant or provided.

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

Not applicable. This is not a study requiring adjudication of expert opinions on medical images or clinical outcomes.

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

Not applicable. This is not an AI/ML device, and no MRMC study was conducted or is relevant for this type of device submission.

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

Not applicable. This is a physical medical device, not a standalone algorithm.

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

The "ground truth" for this submission is implicitly:

• Engineering specifications and performance standards for powered percussors.
• The established, safe, and effective performance of the predicate device (MedPulse® Respiratory Vest System Model 2000 ez).
• Compliance with electrical safety standards.
• The indications for use of the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires training data.

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

Not applicable. As
this is not an AI/ML device, no training set or its ground truth establishment is relevant.

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