(123 days)
The SmartTouch is intended for single-patient use as an electronic data capture accessory for recording actuations of prescribed MDI usage. This may be used in the following applications:
- In clinical trials, where researchers need to know when a patient has actuated their trial MDI . medication;
- In clinical practice, where specialists, general practitioners, nurses, and educators need to know if . a patient has actuated their prescribed MDI medication.
- In self-management, where patients need to track their medication use as part of their . management plan.
The SmartTouch is not intended to indicate remaining quantity of medication in an MDI and does not include a dose counting function.
SmartTouch is used to provide a compliance monitoring for use of a Metered Dose Inhaler (MDI).
SmartTouch is a clip-on device that attaches externally around the enclosure of an MDI. Optical and pressure sensor methods are used to detect MDI presence and actuation, and the device logs the usage history of the MDI. The device includes an LED indicator and control button to check device status and manually initiate communications functions. The SmartTouch has a Bluetooth interface to wirelessly exchange data with a communications device.
The provided document describes the SmartTouch device, which is an electronic data capture accessory for recording actuations of Metered Dose Inhalers (MDIs). The submission is a 510(k) premarket notification, indicating the device's substantial equivalence to a legally marketed predicate device (K091803, SmartTrack System, Nexus6 Limited).
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria and reported device performance in a quantitative manner as typically seen in clinical studies. Instead, it states that "non-clinical testing of the SmartTouch has been carried out to cover functional verification and device performance. This included completion of software and device verification procedures, with performance testing of the MDI presence and actuation sensor system to ensure data is logged accurately for MDI usage. This established correct functionality of the SmartTouch according to requirements."
Therefore, the acceptance criteria are implicitly related to the "correct functionality according to requirements" and "equivalent performance to the predicate device" for the MDI presence and actuation sensor system. The reported device performance is that it met these implicit criteria through bench testing.
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Acceptance Criteria (Implicit):
- Accurate detection of MDI presence.
- Accurate detection of MDI actuation.
- Accurate logging of MDI usage history (date and time of actuations).
- Correct functionality of software and device features.
- Compliance with IEC 60601 series standards (electrical safety, EMC, environmental performance).
- Compliance with FCC regulations for radio frequency devices.
- Equivalent performance to the predicate device (K091803) for the MDI presence and actuation sensor system and communications technology.
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Reported Device Performance:
- "Performance testing of the MDI presence and actuation sensor system to ensure data is logged accurately for MDI usage. This established correct functionality of the SmartTouch according to requirements."
- "Review and testing of the SmartTouch for compliance to IEC 60601 series standards... and FCC regulations... has been completed by external laboratories."
- "Finished device testing carried out for the SmartTouch indicates it meets design and performance functional requirements."
- "Software verification demonstrates that device features are effective, and functions equivalently to the predicate device meets standard requirements for wireless communications, electrical safety, electromagnetic compatibility, and environmental performance."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of human clinical data or a specific number of MDI actuations or devices used for performance testing. All testing mentioned is non-clinical bench testing.
- Sample size for test set: Not specified beyond general "non-clinical testing" and "performance testing."
- Data provenance: Not applicable, as no clinical human data or geographical origin of data is mentioned. The testing was described as "bench testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for functional verification would have been established by engineering specifications and direct observation of MDI actuation mechanics, not by clinical expert consensus. "External laboratories" conducted compliance testing, implying qualified technical personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The testing described is functional and compliance bench testing, not a clinical study requiring adjudication of expert interpretations.
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 an electronic data capture accessory, not an AI-powered diagnostic or interpretive tool that assists human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence, the "performance testing of the MDI presence and actuation sensor system to ensure data is logged accurately for MDI usage" constitutes standalone performance testing of the device's core functionality (the algorithm and sensors for detecting actuation). There is no "human-in-the-loop" component in the primary function of detecting and logging MDI actuations.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical performance testing would have been based on:
- Direct observation/measurement: For MDI actuation (e.g., physically actuating the MDI and verifying the device logs it).
- Engineering specifications/requirements: For correct functionality, software verification, and compliance with standards (IEC, FCC).
- Predicate device performance: For establishing equivalence in certain technological characteristics.
8. The sample size for the training set
Not applicable. There is no mention of machine learning or AI models requiring a training set in the classical sense. The device uses optical and pressure sensors with microprocessor control, falling under traditional embedded systems and signal processing, not a system that is "trained" on data.
9. How the ground truth for the training set was established
Not applicable, as no training set for machine learning was used.
§ 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).