(121 days)
The LUNG FLUTE™ is indicated for the collection of sputum samples for laboratory analysis and pathologic examination.
The LUNG FLUTE™ is shaped like a pipe or flute with a plastic mouthpiece at one end. A Mylar reed is attached inside a square hardened plastic tube that flairs on the end to increase the internal air mass, which provides acoustical impedance. When the patient exhales through the "flute-like" device, the reed inside the tube oscillates and acts in tandem with the rest of the device and the lung cavity itself to produce a sound frequency that approximates the resonance frequency of pulmonary secretions. The LUNG FLUTE™ facilitates mucus clearing by generating and delivering a specific low frequency sound that vibrates the airways and lung secretions, causing lung secretions to thin and become expelled.
The provided text describes the LUNG FLUTE™ device and its clinical performance study. Here's an analysis of the requested information based on the given text:
Acceptance Criteria and Study Details for LUNG FLUTE™ (K060439)
The LUNG FLUTE™ is a device designed to facilitate mucus clearing by generating a specific low-frequency sound, primarily indicated for the collection of sputum samples for laboratory analysis and pathologic examination.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Sputum samples collected by the LUNG FLUTE™ should contain biomarkers indicative of lower respiratory tract samples. | A cohort of chronic bronchitis patients underwent sputum induction using the LUNG FLUTE™. Sputum samples were analyzed for biomarkers (Neutrophil, Macrophages, Squamous Cells, Interleukin-8, Fibrinogen, and Elastase). Salivary samples (representing upper respiratory tract) were also analyzed. |
| Biomarker concentrations in LUNG FLUTE™ induced sputum samples should be similar to those obtained via nebulized hypertonic saline (predicate device). | The LUNG FLUTE™ and nebulized hypertonic saline produced similar concentrations for Neutrophils, Macrophages, Squamous Cells, and Interleukin-8. |
| Biomarker concentrations in LUNG FLUTE™ induced sputum samples should be significantly different from salivary samples (to distinguish lower vs. upper respiratory tract). | Concentrations of Neutrophils, Macrophages, Squamous Cells, and Interleukin-8 in LUNG FLUTE™ induced sputum were significantly different from saliva. |
| The device should be substantially equivalent to the predicate device (sputum induction by nebulized hypertonic saline) based on clinical performance. | Conclusion: Biomarkers found in sputum from samples obtained by nebulized hypertonic saline were similar to those found in sputum samples obtained using the LUNG FLUTE™. Based on this clinical performance, the LUNG FLUTE™ is considered substantially equivalent to sputum induction by nebulized hypertonic saline. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "A cohort of chronic bronchitis patients" was used. The exact number of patients is not specified in the provided text.
- Data Provenance: The text does not explicitly state the country of origin. It describes a clinical study being submitted for FDA approval in the US. The study appears to be prospective as it involved patients undergoing sputum induction for comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts used to establish ground truth in the traditional sense, as this study focuses on objective biomarker analysis. Laboratory analysis was performed on the collected sputum and salivary samples. The qualifications of the individuals who performed the laboratory analysis are not specified.
4. Adjudication Method for the Test Set
There is no mention of an adjudication method in the provided text. The evaluation relied on quantitative biomarker analysis and statistical comparison.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as the LUNG FLUTE™ is a device for sputum collection, not an AI or imaging diagnostic tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the LUNG FLUTE™ is a physical medical device, not an algorithm or AI system. Its performance is evaluated by the characteristics of the sputum it helps collect.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used was biomarker analysis of sputum and salivary samples. This is a form of objective laboratory data, not expert consensus or pathology on its own (though pathology would be performed on the collected sputum after collection). The comparison was made against a well-established method (nebulized hypertonic saline) and control samples (saliva).
8. The Sample Size for the Training Set
There is no mention of a training set. This study describes a clinical trial evaluating the performance of a medical device, not the development or training of an algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there was no mention of a training set for an algorithm.
§ 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).