(261 days)
The Smart Touch is intended for single-patient use in the home environment as a medication reminder and 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 compatible only with the Symbicort MDI. 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 medication reminder and actuation recording function for use as an accessory with a Metered Dose Inhaler (MDI) as part of normal daily use of the MDI.
SmartTouch is a clip-on device that attaches externally around the housing of an MDI. SmartTouch is compatible only with the Symbicort MDI. Optical and mechanical sensor methods are used to detect MDI presence and actuation, and the device logs the usage history of the MDI. The SmartTouch contains an electronic clock and calendar that is used to log the date and time of MDI actuation.
The SmartTouch user interface consists of two LED indicators and three control buttons to check device status, initiate communications functions, and provide reminder features. The SmartTouch has a Bluetooth interface to wirelessly exchange medication and reminder setting data with a paired communications device and compatible mobile software applications.
The provided text describes the SmartTouch device, an accessory for Metered Dose Inhalers, and outlines its 510(k) summary for FDA submission. However, it does not contain specific acceptance criteria, a detailed study proving performance against those criteria, or the precise information requested in the prompt (e.g., sample sizes, expert qualifications, clear performance metrics).
The document focuses on demonstrating substantial equivalence to a predicate device (K133951, SmartTouch, Nexus6 Limited) through non-clinical testing. While it mentions "performance testing of the MDI presence and actuation sensor system to ensure data is logged accurately for MDI usage," it does not quantify this accuracy or provide acceptance criteria for it.
Therefore, I cannot directly answer the prompt's questions with the provided input. The prompt asks for specific details about "acceptance criteria and the study that proves the device meets the acceptance criteria," but this level of detail is not available in the given FDA submission summary.
Here's a breakdown of what can be inferred or what is explicitly stated, alongside what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Missing. The document states that performance testing was done "to ensure data is logged accurately for MDI usage," but it does not define specific accuracy metrics (e.g., percentage of actuations detected, false positive rate) nor provide a table showing claimed performance against these (unspecified) criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Missing. The document mentions "performance testing of the MDI presence and actuation sensor system," but does not specify the number of MDI actuations or devices tested, nor the type of data (e.g., simulated, real-world, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable/Missing. The testing described is "non-clinical" and focuses on the device's sensor accuracy. No human expert review for establishing ground truth is mentioned, as is common in clinical imaging studies, for example.
4. Adjudication Method:
- Not applicable/Missing. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document explicitly states: "Clinical testing was not required for a determination of substantial equivalence of the SmartTouch." Therefore, an MRMC study, which typically involves human readers in a clinical context, was not performed.
6. Standalone Performance Study:
- Implied, but details missing. The mention of "performance testing of the MDI presence and actuation sensor system to ensure data is logged accurately for MDI usage" suggests a standalone algorithm (device) performance assessment. However, the specific metrics, methods, and results of this standalone performance are not provided.
7. Type of Ground Truth Used:
- Implied: Benchmarking against known mechanical or optical events. For "MDI presence and actuation sensor system" performance, the ground truth would typically be established by mechanically or optically verified MDI actuations in a lab setting. The document doesn't explicitly state how ground truth was established, but this is the most logical inference from the "non-clinical testing" description.
8. Sample Size for the Training Set:
- Not applicable/Missing. The device is described as using "Optical and mechanical sensor methods" to detect MDI presence and actuation. This generally implies engineered sensor logic rather than a machine learning model that would require a "training set" in the context of AI/ML. The document does not mention any machine learning components that would necessitate training data.
9. How Ground Truth for the Training Set was Established:
- Not applicable/Missing. See point 8.
§ 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).