(15 days)
The LC Star is a handheld nebulizer, designed to aerosolize medication approved for nebulization and prescribed by a physician. The nasal adapter facilitates delivery to the upper airways. The LC Star with nasal adapter is intended for adult and pediatric patients consistent with the indications for aerosol medication.
The LC Star reusable nebulizer with nasal adapter is a small, single patient use, reusable air-powered nebulizer for the inhalation treatment of aerosolized medications. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.
The provided text is a 510(k) summary for the LC Star Reusable Nebulizer with Nasal Adapter. It details the device, its intended use, and a non-clinical test summary. However, it explicitly states that clinical testing was not completed/is not required to show substantial equivalence. Therefore, it does not contain information about acceptance criteria for device performance based on a study, nor does it provide details about sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance studies, or training set information.
Based on the provided information, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state numerical acceptance criteria. Instead, it uses comparative language.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| MMAD comparable to predicate devices | LC Star with nasal adapter MMAD is comparable to the predicate devices |
| RM comparable to predicate devices | LC Star with nasal adapter RM is comparable to the predicate devices |
| Total Mass comparable to predicate devices | LC Star with nasal adapter Total Mass is comparable to the predicate devices |
2. Sample sized used for the test set and the data provenance:
Not applicable. The document states "Clinical testing was not completed/is not required." Non-clinical tests typically involve device measurements and performance characteristics rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No clinical study for substantial equivalence was conducted, therefore no expert ground truth was established from patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No clinical study for substantial equivalence was conducted.
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 device is a medical device (nebulizer) and not an AI-powered diagnostic tool. No MRMC study was mentioned or would be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a medical device and not an algorithm. Performance was assessed based on non-clinical measurements described in the summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. For the non-clinical tests (MMAD, RM, Total Mass), the "ground truth" would be the measured values from the predicate devices, against which the new device's measurements were compared.
8. The sample size for the training set:
Not applicable. No clinical study with a training set was conducted.
9. How the ground truth for the training set was established:
Not applicable. No clinical study with a training set was conducted.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets acceptance criteria was non-clinical testing. The 510(k) summary explicitly states: "The LC Star with nasal adapter was tested to compare performance to the predicate devices, including: MMAD: LC Star with nasal adapter MMAD is comparable to the predicate devices, RM: LC Star with nasal adapter RM is comparable to the predicate devices, Total Mass: LC Star with nasal adapter Total Mass is comparable to the predicate devices."
The conclusion from this non-clinical testing was that "LC Star with nasal adapter meets performance requirements and raises no new issues of safety or effectiveness." This comparison to legally marketed predicate devices (MABIS NB-02 Ultrasonic Nebulizer and PARI LC® Star Nebulizer) forms the basis for the substantial equivalence determination and indicates that the device's technical specifications are within an acceptable range relative to established devices. No clinical data or human subject studies were required or performed to demonstrate equivalence.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).