Search Results
Found 1 results
510(k) Data Aggregation
(89 days)
TULA Iontophoresis System with Earset
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets design inputs and intended performance characteristics | Bench verification testing conducted; meets design inputs and intended performance characteristics. |
| System functionality (e.g., electrical current delivery) | System test conducted. |
| Ear canal pressure and leak integrity | Ear canal pressure and leak test conducted. |
| Fill system burst capacity | Fill system burst test conducted. |
| Secure attachment of ear plug (peel force) | Plug peel force test conducted. |
| Initial adhesion of ear plug to patient (tack force) | Tack force test conducted. |
| Biocompatibility of materials | Biocompatibility tests conducted. |
| Compliance with electrical safety standards (IEC 60601-1, IEC 60601-1-2) | Electrical testing demonstrated that the subject device (IPSES) meets all applicable requirements of IEC 60601-1 and IEC 60601-1-2. |
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.
Ask a specific question about this device
Page 1 of 1