(291 days)
The Flosense is intended to be used as a disposable pneumotach for Puritan-Bennett spirometers which currently use the Puritan Bennett FS200 Flow Sensor.
Not Found
This is a traditional 510(k) clearance letter for a medical device (Flosense, Model 29-8010) and does not contain the detailed information about acceptance criteria and a study design that you've requested. These sections are typically found in the 510(k) submission itself or in a summary document (like a 510(k) summary or a clinical study report), not in the FDA's clearance letter. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device.
Therefore, I cannot provide the requested information based on the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 868.2550 Pneumotachometer.
(a)
Identification. A pneumotachometer is a device intended for medical purposes that is used to determine gas flow by measuring the pressure differential across a known resistance. The device may use a set of capillaries or a metal screen for the resistive element.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.