Search Results

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.

Ask a specific question about this device

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."

Ask a specific question about this device

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

The Iontophoresis System (IPS) is a single-use device that employs electric current to transport drug solution, salts, or ions in the ear, including the tympanic membrane. The Iontophoresis System consists of 6 accessories: Control Unit, Ear Electrodes, Electrode Cable, Ear Plugs, Return Electrode, and Fill Nozzle.

This document is a 510(k) K073276 summary for the Acclarent Iontophoresis System. It focuses on administrative information, device description, indications for use, and a statement of substantial equivalence to predicate devices, rather than detailed performance study results.

Therefore, it is impossible to extract the requested information regarding acceptance criteria, specific performance data, sample sizes, ground truth establishment, or details of a comparative effectiveness study from this document.

The only relevant line concerning performance is:
"The Iontophoresis System met all performance testing acceptance criteria."

This statement confirms that performance testing was conducted according to acceptance criteria, but it does not specify what those criteria were or detail the results of the performance testing.

Ask a specific question about this device

The Empi Dupel Transport Smart Iontophoresis System can be used for the local administration of ionic solutions into the body for medical purposes and as an alternative to injections.

The Empi Dupel Transport Iontophoresis System is a disposable, single-use iontophoresis device with a self-contained battery and electrical circuitry. The system includes a power module, delivery electrode, return electrode and lead wires. The Dupel Transport is capable of delivering both negatively and positively charged ionic solutions. The device uses a microprocessor to precisely control the delivery time of 3 hours. An LED is utilized to confirm the device is turned on and provides an indication of how much time is remaining in the treatment period.

Here's a summary of the acceptance criteria and the study information regarding the Empi Dupel Transport Iontophoresis System, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance: Not applicable. No clinical studies were conducted that involved a "test set" in the context of evaluating a medical device's diagnostic or predictive performance on patient data. Non-clinical testing was performed on the device itself. The text explicitly states: "No prospective clinical studies are required to demonstrate safety and efficacy of the in support of applications for regulatory approval/clearance in the target markets."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical studies were conducted that involved human interpretation or a "ground truth" derived from expert consensus.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

4. 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 iontophoresis system, not an imaging or diagnostic AI system that would typically involve human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes "non-clinical testing" which included "electrical and mechanical tests" and "validation testing...to show the device meets according to marketing requirements." These tests would be considered standalone for the device's functional performance, but not in the context of an algorithm or AI.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" would be defined by the device's product specifications and marketing requirements. For example, if a specification states the device must deliver a specific current for a specific duration, the measured current and duration from the device's operation would be compared against that specification.

7. The sample size for the training set: Not applicable. No training set was involved as this is not an AI/machine learning device. The non-clinical tests verified the device against engineering specifications and marketing requirements.

8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Empi Action Patch Iontophoresis System is indicated for the local administration of ionic solutions into the body for medical purposes and can be used as an alternative to injections.

The Empi Action Patch Iontophoresis System is a disposable single-use iontophoresis device with a self-contained battery and electrical circuitry. A single adhesive patch unifies both the battery-powered iontophoresis device and the active and return electrodes. The Empi Action Patch is designed to deliver a calibrated and fixed dose of ionic solution (between 1 and 160 mAmp * min.) over a specified time. After delivery of the specified dose, an LED indicator light extinguishes indicating that that the Patch can be removed.

This 510(k) premarket notification for the Empi Action Patch Iontophoresis System does not contain the detailed study information regarding acceptance criteria and performance data that you've requested.

The document primarily focuses on establishing substantial equivalence to predicate devices. This means that instead of presenting new clinical performance studies against defined acceptance criteria, the manufacturer is demonstrating that their new device is as safe and effective as devices already on the market.

Therefore, for your specific request, I can only provide the following based on the provided text:

1. A table of acceptance criteria and the reported device performance

This document does not define specific quantitative "acceptance criteria" and "reported device performance" in the way one would expect from a clinical trial or performance study aiming to prove efficacy against a predefined standard. The evaluation of this device is based on its substantial equivalence to predicate devices, focusing on:

The following information cannot be provided from the given document, as it pertains to clinical performance studies, which are typically not required for 510(k) submissions based on substantial equivalence to predicate devices for this type of medical device.

• 2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
  • Not provided. This document does not describe a test set or associated data provenance from a performance study.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
  • Not applicable/provided. No test set or ground truth establishment by experts is described.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
  • Not applicable/provided. No test set or adjudication method is described.
• 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/provided. This device is an iontophoresis system, not an AI-assisted diagnostic tool. An MRMC study is irrelevant in this context.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
  • Not applicable/provided. This is not an algorithm-based device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
  • Not applicable/provided. No clinical studies requiring ground truth are described. The "ground truth" for 510(k) equivalence is generally the established safety and efficacy of the predicate devices.
• 8. The sample size for the training set
  • Not applicable/provided. No training set for an algorithm is relevant to this device submission.
• 9. How the ground truth for the training set was established
  • Not applicable/provided. No training set for an algorithm is relevant to this device submission.

Ask a specific question about this device

Iontophoresis drug delivery systems are indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.

The Empi Lead Wire Adapter will allow the use of currently marketed Dupel Electrodes with other commercially available iontophoresis devices.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dupel Iontophoresis Lead Wire Adapter:

Missing Information Disclosure:

It's important to note that the provided documents are a 510(k) premarket notification summary and an FDA clearance letter. These types of documents typically summarize the rationale for substantial equivalence rather than providing a detailed technical report of a clinical study with granular data on acceptance criteria, reader performance, or ground truth establishment. Therefore, much of the requested information (especially quantitative details about studies, sample sizes, and expert qualifications) is not present in the provided text.

Acceptance Criteria and Device Performance:

The document states: "Qualification was performed to establish suitability of performance between Dupel electrodes and lead wire adapters with other commercially available iontophoresis devices." This indicates that the core acceptance criterion was the "suitability of performance" when the Dupel adapter was used with existing devices.

A table of specific numerical acceptance criteria and reported device performance is not provided in the document, as the focus is on substantial equivalence rather than a detailed performance study against pre-defined quantitative metrics.

Study Details (Based on available information):

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated. The document refers to "Qualification" being performed, which is a non-clinical test.
   • Data Provenance: The document does not specify a country of origin for any data or whether it was retrospective or prospective. Given it's a non-clinical qualification, it would likely be laboratory-based testing rather than patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not stated. The "qualification" appears to be a technical, non-clinical assessment of device compatibility and electrical performance, rather than a clinical study requiring expert ground truth in the medical sense.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable/Not stated. This is typically relevant for clinical studies with subjective assessments.

4. 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:

   • No MRMC study was done. This device is an iontophoresis lead wire adapter, not an AI-powered diagnostic or assistive technology.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is not an algorithm-based device. "Qualification was performed to establish suitability of performance" suggests engineering and compatibility testing rather than algorithm evaluation.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not explicitly stated, but for a "qualification" of a lead wire adapter, the "ground truth" would likely involve objective engineering and electrical parameters (e.g., conductivity, impedance, physical fit, current delivery consistency) verified against technical specifications or predicate device performance. It would not be medical ground truth like pathology or outcomes data.

7. The sample size for the training set:

   • Not applicable/Not stated. No "training set" is mentioned as this device does not involve machine learning or AI.

8. How the ground truth for the training set was established:

   • Not applicable. No training set for AI was used.

Ask a specific question about this device