(10 days)
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
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain identical indications and intended use as predicate device. | Adopted identical indications and intended use as the predicate device. |
| Maintain identical technological characteristics and principles of operation as predicate device. | Uses the same technological characteristics and principles of operation (dual acting pneumatic diaphragm technology) as the predicate device. |
| No change in output performance compared to predicate device. | Functional performance testing demonstrated no change in output performance. |
| No new safety issues compared to predicate device. | Electrical safety tests demonstrated no new safety issues. |
| Ability to adjust air pulse frequency and pressure amplitude. | User can adjust air pulse frequency and pressure amplitude in the same manner as the predicate system. |
| Ability to view Control Panel in multiple directions. | New feature added to the Control Panel allows viewing in multiple directions. |
| Inclusion of a "Sleep Mode" function. | New "Sleep Mode" automatically shuts off the device if unattended. |
| Addition of a hospital-dedicated vest and additional vest sizes. | A vest dedicated for hospital use and additional vest sizes were added. |
| Softer vest lining for user comfort. | Softer vest lining proposed to accommodate user comfort. |
| Pressure imparted to the chest wall comparable to predicate device. | Measured pressure imparted to the chest wall of both proposed and predicate systems (implicitly found to be comparable or acceptable). |
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.
§ 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).