(190 days)
The DHD Roadrunner is indicated for use as a Positive Expiratory Pressure (PEP) Device.
Claims:
- The use of DHD Roadrunner improves clearance of secretions
- The use of DHD Roadrunner may reduce the need for postural drainage
- DHD Roadrunner facilitates opening of airways in patients with Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems
- The DHD Roadrunner may be used to prevent or reverse atelectasis
The DHD Roadrunner is indicated for use as a single patient use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when a patient exhales through the device.
The provided text describes the DHD Roadrunner, a Positive Expiratory Pressure (PEP) device, and its substantial equivalence to predicate devices, but it does not explicitly state specific acceptance criteria or provide a detailed study report that proves the device meets those criteria with numerical performance metrics. Instead, it broadly claims that the device "met its specifications" and was "substantially equivalent."
Therefore, I cannot populate a table of acceptance criteria and reported device performance with specific quantitative values from the provided text.
However, I can extract the available information regarding the "Summary of Studies" and other relevant details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., Pressure Range, Flow Rate, Vibration Frequency) | Reported Device Performance |
|---|---|
| Not explicitly stated in the provided text. The document broadly claims the device "met its specifications." | Not explicitly stated in the provided text. The document broadly claims the device "met its specifications" and was "substantially equivalent to the predicates." The study compared Roadrunner to Flutter and against its own performance specifications. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "bench & human testing" but does not provide the number of participants or samples.
- Data Provenance: Not specified (e.g., country of origin). The document implies the testing was conducted by DHD Healthcare Corporation. It's unclear if the "human testing" involved a retrospective or prospective study design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a mechanical medical device, not a diagnostic algorithm. Ground truth for performance would typically be established through engineering specifications, physical measurements, and clinical outcomes/physiological effects, rather than expert consensus on interpretations of data.
4. Adjudication method for the test set
Not applicable. As a mechanical device performance evaluation, adjudication would typically involve adherence to test protocols and measurement standards rather than expert consensus on interpretations.
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 a medical device, not an AI or imaging diagnostic tool. An MRMC study is inappropriate for evaluating a PEP device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a physical, human-operated medical device. The concept of "standalone" performance (algorithm only) does not apply. The device's performance is inherently tied to a human user's exhalation. The "bench testing" component could be considered "standalone" in the sense of evaluating the device's physical output independent of a patient, but this is a different context than algorithm performance.
7. The type of ground truth used
The ground truth for the device's performance is implied to be based on:
- Engineering Specifications: The device "met its specifications."
- Comparison to Predicate Devices: Performance was compared to the Flutter® and TheraPEP® devices to establish "substantial equivalence" in terms of mechanisms (creating vibrating positive expiratory pressure) and intended physiological effects (secretion clearance, airway opening, preventing/reversing atelectasis). The predicates' established performance and safety serve implicitly as a form of ground truth for what is considered an effective PEP device.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
§ 868.5690 Incentive spirometer.
(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).