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The Iontophoresis System with Earset is indicated for the administration of drug solution, salts, or ions into the ear, including the tympanic membrane, for medical purposes.

The Acclarent Iontophoresis System with Earset (IPSES) is a single-use device that employs electric current to transport drug solution, salts, or ions into the ear, including the tympanic membrane. The TULA Iontophoresis System consists of three components, namely an Iontophoresis Control Unit, Iontophoresis Earsets and a Return Electrode Patch. Accessories to the IPSES include a Syringe and Earset Sizers. All components of the IPSES are provided non-sterile and no sterilization is required.

This document is a 510(k) summary for the Acclarent TULA® Iontophoresis System with Earset. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the context of clinical performance metrics. Therefore, many of the requested details regarding clinical study design, sample sizes, expert involvement, and ground truth are not present in this type of regulatory submission.

However, I can extract the available information regarding performance data and acceptance criteria based on bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily describes bench verification testing performed to demonstrate substantial equivalence to a predicate device, focusing on design inputs and intended performance characteristics. Specific quantitative acceptance criteria are not explicitly listed in a table format, but the performance data indicates that the device met these criteria.

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

The document describes bench verification testing, not a clinical trial. Therefore, information regarding a "test set" in the context of patient data, sample sizes for such a set, or data provenance (country of origin, retrospective/prospective) is not provided and is not applicable to the reported testing. The tests would involve physical device units rather than patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

As the provided text focuses on bench testing and substantial equivalence, there is no mention of "experts" being used to establish "ground truth" in a clinical sense. The testing performed would have been evaluated against engineering specifications and industry standards by technical personnel.

4. Adjudication Method

Not applicable, as this refers to adjudication of clinical data, which is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The document describes a 510(k) submission for a medical device (iontophoresis system) based on substantial equivalence. This type of submission typically involves bench testing and comparison to a predicate device, not MRMC studies comparing human readers' performance with and without AI assistance.

6. Standalone Performance Study

The document describes bench verification testing of the device's functional and safety characteristics. This can be considered a form of standalone performance evaluation for the device itself (e.g., electrical safety, mechanical integrity). However, it is not a "standalone algorithm performance" in the context of an AI/ML device, as this is a physical medical device. The "Performance Data" section lists various tests performed on the device to ensure it meets design inputs and standards.

7. Type of Ground Truth Used

For the bench testing described, the "ground truth" would be established by:

• Engineering specifications and design inputs: The device's performance was compared against predetermined technical requirements.
• Industry standards: Compliance with standards like IEC 60601-1 and IEC 60601-1-2 served as the "ground truth" for electrical safety.
• Predicate device characteristics: Performance was also implicitly compared to the characteristics of the predicate device to demonstrate substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This document does not describe an AI/ML device, so there is no concept of a "training set" in the context of machine learning.

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

Not applicable, as there is no training set for an AI/ML model described in this document.

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The Iontophoresis System with Headset is indicated for the administration of drug solution, salts, or ions into the ear, including the tympanic membrane, for medical purposes.

The Iontophoresis System with Headset (IPSHS) is a single-use device that employs electric current to transport drug solution, salts, or ions in the ear, including the tympanic membrane. IPSHS consists of four components: a Control Unit, a Headset, Ear Plugs, and a Return Electrode Patch. The accessories to IPSHS include a Syringe, a Fill Nozzle, and a set of Ear Plug Sizers.

The provided text describes a 510(k) submission for the Acclarent Tula™ Iontophoresis System. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria in the way an AI/ML device would.

Based on the provided text, the specific acceptance criteria and the detailed study proving the device meets these criteria (with specific metrics like sensitivity, specificity, or reader improvement) are not included. The document primarily states:

• "IPSHS met all performance testing acceptance criteria."
• "Summary of IPSHS is substantially equivalent to the predicate Device as confirmed through relevant performance tests."

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details on sample size, data provenance, expert involvement, or MRMC studies, as this information is not present in the provided 510(k) summary.

A 510(k) submission for a non-AI/ML device typically involves engineering and functional performance testing (e.g., electrical safety, biocompatibility, mechanical integrity, current delivery accuracy for an iontophoresis system) to demonstrate that the new device performs as intended and is safe and effective when compared to a legally marketed predicate device. The summary provided here only states that these tests were met, not the specific criteria or results of those tests.

Summary of Information NOT Available in the Provided Text:

1. A table of acceptance criteria and the reported device performance: Not provided. The text only states that the device "met all performance testing acceptance criteria."
2. Sample sizes used for the test set and the data provenance: Not provided. This type of detail is typical for clinical studies, not generally for 510(k) summaries of non-AI/ML devices unless a specific clinical performance claim is being made that requires clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable/provided. This device is not an AI/ML diagnostic tool, so "ground truth" in the context of expert consensus on medical images or diagnoses is not relevant here.
4. Adjudication method for the test set: Not applicable/provided for the same reasons as above.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a non-AI/ML device for drug administration, not an AI/ML diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a hardware device; this concept is not applicable.
7. The type of ground truth used: Not applicable. For a medical device like an iontophoresis system, performance is measured against engineering specifications (e.g., accurate current delivery) and safety standards, not against "ground truth" of a medical condition.
8. The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established: Not applicable.

What is available from the text:

• Device Name: Tula™ Iontophoresis System
• Purpose: Delivers electrical current to transport drug solution, salts, or ions into the ear.
• Regulatory Pathway: Traditional 510(k)
• Classification: Class III, Product Code EGJ
• Predicate Device: Iontophoresis System (K073276) manufactured by Acclarent.
• Performance Statement: "IPSHS met all performance testing acceptance criteria." and "IPSHS is substantially equivalent to the predicate Device as confirmed through relevant performance tests."

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