(83 days)
The Lifestyle Circulatory Enhancer (CE) is indicated for the temporary increase in blood circulation as prescribed by a physician or licensed practitioner. The Lifestyle CE may benefit people who suffer from states of poor circulation and low blood flow, including those individuals who suffer from orthostatic hypotension symptoms, such as lightheadedness, when moving from a sitting or reclining position to a standing position.
The Lifestyle Circulatory Enhancer (CE) device is a non-sterile, single user device that is used within the external airway channel. Inspiration through the Lifestyle CE device provides temporary circulatory enhancement. Temporary circulation enhancement increases blood pressure, which has a positive effect on the symptoms of orthostatic hypotension. The technology providing temporary circulatory enhancement is the same as in the predicate ResQPOD CE devices.
The provided document does not contain acceptance criteria or detailed study results with specific performance metrics. It is a 510(k) summary for the "Lifestyle Circulatory Enhancer (CE)" device, focusing on its substantial equivalence to predicate devices and its intended use.
However, based on the information provided, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., specific blood pressure increase, or reduction in orthostatic hypotension symptoms). The document focuses on "temporary circulatory enhancement" having a "positive effect on the symptoms of orthostatic hypotension."
- Reported Device Performance: The document states that the "safety and effectiveness of use of the Lifestyle CE device was demonstrated by bench qualification, animal study and a review of investigator sponsored clinical studies." However, no specific performance data (e.g., blood pressure changes, symptom reduction rates) from these studies are provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not provided. The document mentions "investigator sponsored clinical studies" but does not specify the number of participants.
- Data Provenance: Not provided. It's unclear if the studies were prospective, retrospective, or where they were conducted.
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)
- Number of Experts & Qualifications: Not applicable as the provided document does not describe a study involving expert assessment or ground truth establishment in that context (e.g., image interpretation). The "ground truth" for this device would likely be physiological measurements or patient-reported outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This concept is typically relevant for studies where multiple readers or experts assess data and disagreements need resolution. The provided document doesn't detail such a process for the clinical studies mentioned.
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
- MRMC Study: Not applicable. This device is a "Circulatory Enhancer," not an AI diagnostic tool. Therefore, a multi-reader multi-case study comparing human readers with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a medical device for circulatory enhancement, not an algorithm, so "standalone performance" in the AI sense is not relevant. The device is used by a single user within the external airway channel.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Based on the device's function, the "ground truth" would likely involve objective physiological measurements (e.g., blood pressure, heart rate) and patient-reported outcomes (e.g., changes in lightheadedness, symptoms of orthostatic hypotension). However, the document does not specify how these were measured or confirmed in the mentioned studies.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As per point 8, there's no training set for this type of 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).