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For use as a closed system for the repeated, safe delivery of therapeutic agents into the middle ear, to facilitate the control of disabling vertigo arising from active unilateral Meniere's Disease.

Incapacitating unilateral Menière's Disease

Device Description

This single use device consists of a silicone rubber catheter, 21cm in length, with a spring loaded Luer lock at one end and a soft rubber flange, to retain the device in the middle ear, at the other.

AI/ML Overview

This document is a 510(k) summary for Pfleiderer's Intratympanic Catheter and does not contain the detailed study information needed to describe acceptance criteria and device performance in the way requested. It primarily focuses on demonstrating substantial equivalence to a predicate device.

However, based on the provided text, I can infer some aspects and highlight what's missing:

Missing Information:

The document lacks critical details such as:

Specific quantitative acceptance criteria (e.g., success rates, infection rates, functional outcome scores).
Any performance metrics beyond a general statement of "function is the same" and "fit is similar."
Details of any formal study (clinical trial, bench test protocol, etc.) conducted to prove acceptance.
Sample sizes for test or training sets.
Data provenance, expert qualifications, adjudication methods, or ground truth establishment for any study.
Information on MRMC comparative effectiveness or standalone algorithm performance.

Based on the available information, here's what can be extracted and what remains unknown regarding acceptance criteria and a "study":

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied/Inferred)	Reported Device Performance
Functional Equivalence/Ability to Deliver Medication: The device must be able to deliver therapeutic agents into the middle ear.	"The function is the same, in that they both [Pfleiderer's Intratympanic Catheter and predicate device] deliver medication." This is a qualitative statement of functional comparability, not a quantitative performance metric.
Fit/Retention in Middle Ear: The device must be retained in the middle ear post-insertion.	"The fit is similar, except that a silicone flange replaces the lock mount, making it possible for the doctor or patient to perform a relatively, pain-free, self-administration of his/her medication." This implies a retained fit, with an added benefit of perceived ease of administration, but no specific performance data.
Material Biocompatibility/Safety: The materials used should be appropriate for medical use.	Implicitly met by using a silicone rubber catheter, a commonly used biocompatible material in medical devices, but no specific study on biocompatibility is reported here. The 510(k) process typically requires material safety documentation, but it's not detailed in this summary.
Sterility: As a single-use device, it must be sterile.	Implicitly required for a single-use invasive medical device, but no specific sterility testing results or acceptance criteria are provided in this summary.
Mechanical Integrity/Durability: The catheter should maintain its integrity during use.	Not explicitly stated or given performance data.
Ease of Use/Administration: Should allow for safe and potentially easy administration.	"making it possible for the doctor or patient to perform a relatively, pain-free, self-administration of his/her medication." This is a perceived benefit, not a measured performance.

Study Information (Based on 510(k) Submission Nature):

A 510(k) (Premarket Notification) submission like this primarily focuses on demonstrating "substantial equivalence" to a currently marketed device (predicate device). It generally relies on comparisons of device characteristics, materials, intended use, and existing performance data (often from bench testing or literature, rather than new, large-scale clinical trials) rather than new, extensive clinical studies proving efficacy and safety from scratch.

Therefore, the "study" referenced in your prompt is not explicitly detailed as a single, formal clinical trial or AI model validation study in this document. Instead, the "proof" is the comparison made against the predicate device.

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

Sample Size for Test Set: Not specified. This document does not describe a formal "test set" in the context of a new efficacy or performance study. The comparison is based on the device description and known characteristics of the predicate.
Data Provenance: Not specified. Any data used to support the comparison would likely come from manufacturer's specifications, material science data for silicone, and potentially existing clinical knowledge of intratympanic catheters, but this summary doesn't detail specific data sources or geographic origin.

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

Not applicable/Not specified. This type of information is generally relevant for AI/ML validation studies or complex diagnostic device studies involving expert interpretation, which is not the nature of this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable/Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document does not mention an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This device is a physical medical catheter, not an algorithm.

7. The Type of Ground Truth Used

For a 510(k) of this nature, the "ground truth" for demonstrating substantial equivalence typically involves:
- Device Specifications and Bench Testing: Comparing dimensions, materials, functional mechanisms (e.g., fluid delivery capacity, connection type) against the predicate.
- Clinical Literature/Expert Opinion: Relying on established medical understanding of materials (e.g., silicone's biocompatibility) and the function of similar catheters.
- Intended Use Alignment: Confirming the proposed indications are similar to those of the predicate device.
No "pathology" or "outcomes data" specifically for this device are presented here as ground truth from a new study.

8. The Sample Size for the Training Set

Not applicable/Not specified. This isn't an AI/ML device where a "training set" would be used.

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

Not applicable/Not specified.

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