Search Results

The device is intended to be used through a laryngoscope for the therapeutic injection the larynx for various laryngeal disorders such as paralysis, tissue deficiency, contact ulcers and spasmodic dysphonia.

The device consists of an outer catheter and an inner catheter to which a needle is mounted. The inner catheter slides within the outer catheter such that the needle tip may advance a pre-determined distance past the end of the outer catheter and remains totally within the lumen catheter when the needle is fully retracted.

The provided text describes a medical device (Mill-Rose Laryngoscopic Injection Needle) and its 510(k) summary for regulatory approval. However, it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

The document focuses on:

• Administrative details: Submitter, contact person, preparation date, classification, and common/proprietary names.
• Predicate devices: Listing similar, previously approved devices (K914181, K820973).
• Device description: Explaining the physical components (outer catheter, inner catheter, needle).
• Intended use: Specifying its therapeutic purpose for laryngeal injection.
• Technological characteristics: Stating it's similar to predicate devices in materials and design.

**Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, adjudication method for a test set.
3. MRMC study details or effect size.
4. Standalone performance details.
5. Type of ground truth used.
6. Training set details (sample size, ground truth establishment).**

This type of information (device performance, clinical study results, acceptance criteria) would typically be found in a separate section of a 510(k) submission, not in the summary provided. The summary confirms the device's substantial equivalence to previously cleared devices based on its intended use, technological characteristics, and safety and effectiveness, rather than presenting new performance data.

Ask a specific question about this device