(220 days)
The Mini-Ciser is a Positive Expiratory Pressure (PEP) device and Inspiratory Muscle Trainer (IMT) in one device. The Mini-Ciser may be helpful in loosening and removal of mucus.
The Mini-Ciser is a Positive Expiratory Pressure (PEP) device and Inspiratory Muscle Trainer (IMT) in one device.
The provided text is a 510(k) summary for the Mini-Ciser, a Positive Expiratory Pressure (PEP) device and Inspiratory Muscle Trainer (IMT). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies against specific acceptance criteria. Therefore, much of the requested information regarding detailed acceptance criteria and study design (e.g., sample sizes, expert involvement, ground truth methods, MRMC studies, standalone performance) is not present in the provided document.
However, based on the information available, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states, "Our bench testing has demonstrated substantial equivalence to another marketed device (Breather)." This implies that the acceptance criterion was likely "substantial equivalence" as determined by bench testing, specifically comparing the Mini-Ciser to the Breather device (K944412). The performance reported is that this substantial equivalence was achieved.
- Acceptance Criteria: Demonstration of substantial equivalence to the predicate device (Breather, K944412) through bench testing.
- Reported Device Performance: "Our bench testing has demonstrated substantial equivalence to another marketed device (Breather)."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified. The document only mentions "bench testing," which typically refers to laboratory or engineering tests, not a clinical test set with human subjects.
- Data Provenance: Not specified, but "bench testing" usually implies testing performed by the manufacturer in a controlled environment. It would be retrospective in the sense that the device was already designed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not applicable. For bench testing demonstrating substantial equivalence, expert consensus on a "ground truth" for clinical performance is not typically part of the submission in this format. The testing would focus on engineering specifications.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. This concept is relevant for clinical studies involving human interpretation or performance, which is not described here.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
- MRMC Study Done: No, an MRMC comparative effectiveness study was not done or reported in this document. The focus was on "bench testing" for substantial equivalence.
- Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Standalone Performance Study Done: Not applicable. This device is a physical medical device, not an AI algorithm. "Bench testing" would be the closest analogue to evaluating the device's inherent physical performance.
7. The Type of Ground Truth Used:
- Type of Ground Truth: Not explicitly stated as "ground truth" in the clinical sense. For bench testing, the "ground truth" would be the established specifications and performance characteristics of the predicate device, against which the Mini-Ciser's measured performance from bench tests would be compared.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set Establishment: Not applicable, as there is 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).