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510(k) Data Aggregation
(458 days)
Aluna 2 is intended for monitoring FEV1 (Forced exhalation in the first second) and PEF (Peak Expired Flow Rate) for home use. The device is designed for pediatric to adult users. Aluna is not recommended for children under 5 years of age. Additionally, the device may be used by clinicians for in-office monitoring.
Aluna 2 consists of three main components:
- A small hand-held peak flow meter that captures differential pressure, converts it to digital data points, and transmits the data to a mobile device via Bluetooth.
- A mobile application that collects and transmits the differential pressure readings from the spirometry device and processes it to estimate the exhaled air flow rate and volume.
- An Application Programming Interface (API) to facilitate communication with a cloud server used for data storage.
The provided text is a 510(k) summary for the medical device Aluna 2, a peak flow meter for spirometry. It compares the Aluna 2 to its predicate device, the original Aluna, and details the non-clinical testing performed to establish substantial equivalence.
However, the document explicitly states: "Clinical testing was not required." This means there was no clinical study conducted involving human subjects to directly prove the device meets acceptance criteria for improved human reader performance with AI assistance, or standalone performance against clinical ground truth.
Therefore, many of the requested points regarding acceptance criteria and study design for clinical or AI-driven performance cannot be answered from the provided text, as this type of study was not performed. The device's substantial equivalence was demonstrated through non-clinical bench testing and adherence to standards for accuracy, safety, and software.
Here's an analysis of what can be extracted from the document regarding acceptance criteria and performance, focusing on the technical specifications and non-clinical testing:
Acceptance Criteria and Reported Device Performance (Non-Clinical)
The acceptance criteria are derived from the specified accuracy, linearity, repeatability, and impedance/resistance limits required by the "2019 ATS Update v. 2005 ATS Guidelines" and ISO standards. The reported device performance is implicitly demonstrated by the statement: "The results of these tests indicate that Aluna 2 is substantially equivalent to the predicate device." and the fact that it tightened some specifications compared to the predicate.
| Acceptance Criteria Category | Subject Device (Aluna 2) Acceptance Criteria / Performance | Predicate Device (Aluna) Performance | Comparison to Predicate / Notes |
|---|---|---|---|
| FEV1 Accuracy | ±2.5% or 0.05 L whichever is greater | ±3% or 0.05 L whichever is greater | Tightened: Required by 2019 ATS Update v. 2005 ATS Guidelines. This indicates improved or more stringent accuracy. |
| FEV1 Linearity | <2.5% | Unspecified | New Parameter / Similar: Stating new parameter and limit required by 2019 ATS Update that was not required in 2005 ATS Guidelines. The "Similar" classification here means similar in that it meets modern standards, not that it's numerically similar to a predicate value (since none existed). |
| FEV1 Repeatability | ±2.5% or 0.05 L whichever is greater | Unspecified | New Parameter / Similar: Stating new parameter and limit required by 2019 ATS Update that was not required in 2005 ATS Guidelines. |
| FEV1 Impedance | ≤0.15 kPa/(l/s) | Unspecified | New Parameter / Similar: Stating new parameter and limit required by 2019 ATS Update that was not required in 2005 ATS Guidelines. |
| PEF Accuracy | ±10% or 0.17 L/s whichever is greater | ±10% or 0.3 L/s whichever is greater | Tightened: Required by 2019 ATS Guidelines v. 2005 ATS Guidelines. This indicates improved or more stringent accuracy. |
| PEF Linearity | ≤5% | Unspecified | New Parameter / Similar: Stating new parameter and limit required by 2019 ATS Update that was not required in 2005 ATS Guidelines. |
| PEF Resistance to Flow | ≤0.36 kPa/l/s | Unspecified | New Parameter / Similar: Stating new parameter and limit required by 2019 ATS Update that was not required in 2005 ATS Guidelines. |
| PEF Frequency Response | ≤0.25 l/s), or 12 %, whichever is greater | Unspecified | New Parameter / Similar: Stating new parameter and limit required by 2019 ATS Update that was not required in 2005 ATS Guidelines. |
| Electrical Safety | Meets IEC 60601-1, IEC 60601-1-6, IEC 60601-1-11 | Implied by predicate clearance | Compliance demonstrated via testing. |
| EMC | Meets IEC 60601-1-2 | Implied by predicate clearance | Compliance demonstrated via testing. |
| Battery | Meets IEC 62133-2 | Implied by predicate clearance | Compliance demonstrated via testing. |
| Software Verification | Meets IEC 62304 | Implied by predicate clearance | Compliance demonstrated via testing. |
| Biocompatibility | Leveraged from predicate device (identical materials) | Meets ISO 10993-1 | Demonstrated by leveraging predicate data; implies continued compliance. |
| Cybersecurity | Meets FDA Guidance (Sept 27, 2023) | Implicit, but perhaps not as strict as new guidance | Compliance demonstrated via testing to contemporary guidance. |
As for the specific questions regarding a study that proves the device meets acceptance criteria, based on clinical performance or AI-driven insights, the document explicitly states:
- Sample sizes used for the test set and the data provenance: Not applicable. No clinical test set involving human data was used for a clinical study comparing AI performance or human reader improvement. The "test set" for non-clinical performance would be the calibrated flow and volume generators used in the lab. Data provenance is not specified beyond "non-clinical performance bench testing."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human experts were involved in establishing ground truth for a clinical or AI performance test, as there was no clinical study. The ground truth for bench testing would be from calibrated reference standards.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication.
- 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: No. The device is a direct measurement spirometer, not an AI-assisted diagnostic imaging or classification tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is largely standalone in its primary operation (measuring FEV1 and PEF). The "algorithm only" performance is evaluated by the non-clinical bench testing for accuracy, linearity, and repeatability against calibrated flows and volumes. The table above details these performance metrics.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance (accuracy, linearity, repeatability) of the device, the ground truth was established by calibrated reference standards/simulators as per ISO and ATS guidelines during bench testing. No biological or clinical ground truth (like pathology or outcomes) was used for device functional performance evaluation for this 510(k).
- The sample size for the training set: Not applicable. This refers to an AI/machine learning training set. The Aluna 2 is a measurement device that calculates FEV1 and PEF based on differential pressure readings, not a device that uses machine learning models trained on large datasets.
- How the ground truth for the training set was established: Not applicable, for the same reason as above.
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