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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.

• 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.

• 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.

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The SmartTrack System is intended for single-patient use as an electronic data capture accessory for recording and monitoring 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, and nurse educators need to know if a patient has actuated their prescribed MDI medication.
  The SmartTrack is not intended to indicate remaining quantity of medication in an MDI and does not include a dose counting function.

The SmartTrack System consists of three modules used to provide a compliance monitoring function for use of a Metered Dose Inhaler (MDI).

• SmartTrack is a clip-on module that attaches externally around the enclosure of an MDI, using an optical sensor to detect MDI actuation, to log the usage history of the MDI. The device includes an LCD display and control buttons to review basic data and adjust device settings. Various device status conditions are indicated to the user, and logged to provide potentially relevant context for later review of MDI usage history data.
• SmartTrack Docking Station is an optical interface cradle used to download data stored on the SmartTrack module, via USB cable connection to a PC, and allow for interaction by the offline software with device settings and status monitoring.
• Respiratory Analyzer is a software application for use on a PC that provides for offline review of the MDI compliance data logged by the SmartTrack module. Data is stored in database files with patient, medication, and prescribed dose information, and is available for review and export in various table and graph formats to highlight MDI usage characteristics.

Here's an analysis of the provided text regarding the SmartTrack System's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document states "performance testing of the MDI actuation sensor system" was conducted, but no details on the number of devices tested, number of actuations, or the type of MDIs used are provided.
• Data Provenance: The testing was "non-clinical testing" and "bench testing." There is no mention of human subjects, geographical origin of data, or whether it was retrospective or prospective. It appears to be entirely laboratory-based.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not provided. Given that the testing was hardware and software functional verification (bench testing), it's unlikely that external medical experts were used to establish "ground truth" in the typical clinical sense. The ground truth for actuation detection would have been established by direct observation or automated mechanical means during the bench testing.

4. Adjudication Method for the Test Set

• Not applicable/Not specified. As the testing was internal functional verification focusing on accurate data logging from a sensor, a formal adjudication method (like 2+1 or 3+1 used in image interpretation studies) is not described or implied. The "ground truth" for actuation detection would have been determined by the test setup itself.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate the safety and effectiveness of the SmartTrack System. The product functionality has been adequately assessed by bench testing as above." An MRMC study involves human readers, and the submitted information indicates absence of clinical testing involving human evaluation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, a standalone (algorithm only) performance assessment was done within the scope of "bench testing." The "performance testing of the MDI actuation sensor system to ensure data is logged accurately for MDI usage" represents the device's standalone performance in detecting and logging actuations. There is no human-in-the-loop component described for this specific performance assessment.

7. The Type of Ground Truth Used

• The ground truth for the "performance testing of the MDI actuation sensor system" was likely established through direct observation or mechanical measurement/simulation of MDI actuations during bench testing. For example, actuations could have been manually performed while simultaneously verifying the device's logged data, or automated systems could have repeatedly actuated MDIs, allowing for comparison with the SmartTrack's recorded events. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• Not applicable/Not specified. This device uses an optical sensor for actuation detection, not a machine learning model that would typically require a "training set" of data in the common sense. Therefore, there's no mention of a training set sample size.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no mention of a training set, the method for establishing its ground truth is also not applicable.

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