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The ivWatch Model 400 is indicated for the detection of subcutaneous infiltrations and extravasations of 10 cc or less of optically clear infusates, as an adjunctive device to the clinical evaluation in the healthcare setting of adults and pediatrics with peripherally-inserted catheters (PIVs). The device is indicated to assess patients for subcutaneous infiltrations and extravasations but should not serve as a substitute for regular clinician assessment of the PIV site. The ivWatch Model 400 is intended for use by healthcare practitioners who have been trained in the use of the device.

The predicate device (K162478), the ivWatch® Model 400, consists of the ivWatch® Patient Monitor, a reusable Fiber Optic Sensor Cable and a single-use sterile Sensor Receptacle. The subject device includes the addition of Device Accessories to the ivWatch® Model 400 including an Extension Module, reusable Patient Cable and a single-use electronic SmartTouch™ Sensor. The Device Accessories expand the current ivWatch® Model 400 architecture to support the reusable Fiber Optic Sensor (predicate device) and an electronic single-use sterile SmartTouch™ Sensor (subject device). Both the predicate and subject device provide continuous, non-invasive monitoring of human tissue adjacent to peripheralintravenous (PIV) insertion sites to aid in the early detection of infiltration and extravasation events.

The ivWatch® Model 400 with Device Accessories uses visible and near-infrared light to measure changes in the optical properties of the tissue near a PIV insertion site. Light signals generated by the SmartTouch™ Sensor are sent to the patient's tissue near an PIV site. Changes to the light signals are received by the SmartTouch™ Sensor and electrical signals are transferred through the Patient Cable to the Extension Module where embedded software analyzes the data to determine whether conditions indicate that an infiltration event may have occurred. The information is then sent from the Extension Module to the ivWatch® Patient Monitor for display. If changes in the diffuse reflectance in the tissue near the PIV site are consistent with an infusate pooling in the subcutaneous tissue, the ivWatch® Patient Monitor emits audible and visual notifications intended to prompt the clinician to inspect the peripheral IV site for a possible infiltration event.

The provided text describes the performance data for the ivWatch Model 400 with Device Accessories, focusing on its ability to detect infiltrations and extravasations.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:

Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document does not explicitly list numerical acceptance criteria for many of the performance metrics. Instead, it presents the results of the performance testing and implies that these results demonstrate the device meets an acceptable level of performance, similar to the predicate device, thereby supporting its substantial equivalence. The "Pass" or "Compliant" remarks in the summary table for other tests (EMC, Biocompatibility, etc.) serve as their acceptance criteria.

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: The document mentions "series of five verification and two validation IRB-approved clinical studies." However, specific patient numbers for these studies are not provided.
     • For the non-infiltrated tissue study, it states "6 false red notifications in 922 hours" and "8 false yellow notifications in 922 hours." This suggests the "922 hours" represents the cumulative observation time across participants in that specific validation study. The number of individual patients or IV sites contributing to these hours is not specified.
     • For the infiltrated tissue study, it reports "99.0% (97/98)" detection, indicating that 98 infiltration events were analyzed in this validation study. It doesn't specify if these 98 events came from 98 different patients or multiple events from fewer patients.
   • Data Provenance: Not explicitly stated, but implied to be prospective clinical studies conducted for the device development and validation. The country of origin is not specified but given the FDA submission, it is likely that parts of these studies, or at least the analysis, were conducted in the US or in a manner compliant with US regulatory guidelines.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical studies. It mentions the device should be used as "an adjunctive device to the clinical evaluation" and "should not serve as a substitute for regular clinician assessment." This implies that clinical evaluation by healthcare practitioners would be the reference for ground truth on infiltration events, but no specific team or panel of experts is described for this purpose in the context of the study's ground truth establishment.

3. Adjudication Method for the Test Set:

   • No specific adjudication method (e.g., 2+1, 3+1) is mentioned for establishing the ground truth of infiltration events in the clinical studies. The reliance on "clinical evaluation" suggests standard clinical practice for identifying infiltrations.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study was mentioned. The study focuses on the device's standalone performance in detecting infiltrations rather than its impact on human reader performance. This device is described as an "adjunctive device" meant to provide alerts, not to replace human assessment, so a human-in-the-loop MRMC study might not be directly relevant to its primary function or regulatory pathway.

5. Standalone (Algorithm Only) Performance:

   • Yes, the performance data provided appears to be for the standalone performance of the algorithm and device. The device itself emits notifications (audible and visual) based on its internal analysis of optical signals. The reported percentages and volumes (e.g., 99.0% detection, average 2.13 mL for red notifications) refer to the device's direct output, not its interaction with a human reader's interpretation.

6. Type of Ground Truth Used:

   • The ground truth for infiltration events appears to be based on clinical evaluation of actual or simulated infiltrations in patients. The document refers to "early stage infiltrations" and "infiltrated saline," suggesting direct observation or controlled induction of infiltrations confirmed by clinical signs, rather than solely pathology or outcomes data.

7. Sample Size for the Training Set:

   • The document does not provide a specific sample size for the training set. It mentions "a series of five verification and two validation IRB-approved clinical studies were performed for the development and validation." This implies that data from some of these studies (likely verification studies) might have been used for development and refinement of the device's algorithms, which would include training. However, explicit training set details are missing.

8. How the Ground Truth for the Training Set Was Established:

   • Similar to the test set, the method for establishing ground truth for any potential training data is not explicitly detailed. Given the nature of the device and its function, it can be inferred that ground truth was established through clinical observation and assessment by healthcare professionals of IV sites. This would involve noting when an infiltration occurred, confirming it, and correlating it with the device's readings.

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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 sensors 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 document does not contain acceptance criteria or a study that proves a device meets specific performance criteria. Instead, it is an FDA 510(k) summary for the "SmartTouch" device.

Here's a breakdown of the information that can be extracted from the document, and what is missing:

Information extracted from the document:

• Device Name: SmartTouch
• Intended Use: Medication reminder and electronic data capture accessory for recording actuations of prescribed MDI usage. Compatible only with Symbicort MDI. Not intended to indicate remaining medication quantity or for dose counting.
• Operating Principle: Clip-on device that attaches externally to an MDI. Uses optical and mechanical sensors to detect MDI presence and actuation. Logs date and time of MDI actuation using an internal clock. Has LED indicators, control buttons, and Bluetooth interface for data exchange.
• Predicate Device: K163485, SmartTouch, Adherium (NZ) Limited. The current device is stated to have "identical features" in technological characteristics to the predicate, with minor software-only change for "spurious actuation log prevention improvements."
• Test Type: Non-clinical (bench testing) was performed. Clinical testing was not required.
• Tests Performed: Functional verification, device performance, usability of the user interface. Specifically, "performance testing of the MDI presence and actuation sensor system to ensure data is logged accurately for MDI usage."
• Standards/Regulations Complied with (external lab testing):
  • AAMI/ANSI ES60601-1:2005 +A1:2012, C1:2010 (general safety)
  • AAMI/ANSI HA60601-1-11:2015 (home-use safety)
  • AAMI/ANSI/IEC 60601-1-2:2014 (electromagnetic compatibility)
  • AAMI/ANSI/ISO 10993-1:2009, AAMI/ANSI/ISO 10993-5:2009, AAMI/ANSI/ISO 10993-10:2010, AAMI/ANSI/ISO 10993-12:2012 (biocompatibility)
  • ANSI C63.10:2013 / 47 CFR Part 15 FCC regulations for RF devices.

Missing Information (and why it's missing from this type of document):

This document is a 510(k) summary submitted to the FDA to demonstrate substantial equivalence, not a detailed study report. Therefore, it does not contain:

1. A table of acceptance criteria and the reported device performance: The document states that "performance testing of the MDI presence and actuation sensor system to ensure data is logged accurately for MDI usage" was done but does not provide specific metrics, acceptance criteria, or quantitative results (e.g., accuracy percentage, false positive/negative rates).
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this was non-clinical bench testing.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not done, as clinical testing was not required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is standalone in its function as a recorder, but the performance metrics of its accuracy are not provided.
7. The type of ground truth used: For the bench testing, the ground truth would likely be based on controlled, known MDI actuations verified by direct observation or automated mechanical means. However, the document does not specify this.
8. The sample size for the training set: Not applicable, as this is hardware/firmware, not a machine learning algorithm requiring a "training set" in the typical sense. The "spurious actuation log prevention improvements" are a software change, but the data used to develop this improvement is not detailed.
9. How the ground truth for the training set was established: Not applicable.

Summary regarding acceptance criteria and study:

The 510(k) summary indicates that the device underwent non-clinical bench testing including "performance testing of the MDI presence and actuation sensor system to ensure data is logged accurately for MDI usage." It states that this testing "established correct functionality and compatibility of the SmartTouch with the Symbicort MDI according to requirements." However, it does not provide the specific numerical acceptance criteria (e.g., 99% accuracy for actuation detection) or the quantitative results of these performance tests. The basis for declaring "equivalent performance" to the predicate for "minor design changes" was also non-clinical testing.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through shared technological characteristics and compliance with recognized safety and performance standards for medical devices, rather than presenting a detailed performance study against specific acceptance criteria for a novel functionality.

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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.

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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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