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510(k) Data Aggregation
(29 days)
Incomplete glottis closure during phonation and/or swallowing, especially unilateral vocal cord paralysis.
The TVFMI and custom accessories are exclusively intended for use by qualified medical personnel trained in laryngosurgical techniques.
The KURZ TVFMI is made of medical grade, smoothly finished titanium.
The preformed titanium sheet implant can be adjusted intra-operatively to exactly fit the anatomic conditions and size of the patient. The angular shape, the bent flanges and the fastening with monofilament non-absorbable sutures prevent implant dislocation with great certainty.
The device comes in two (2) sizes - one each for mostly female and male patients.
The provided text is a 510(k) summary for a medical device (Titanium Vocal Fold Medializing Implant - TVFMI) and does not contain detailed information about specific acceptance criteria or an analytical study comparing the device to these criteria in a structured manner. Instead, it focuses on demonstrating substantial equivalence to predicate devices and highlighting performance advantages.
However, I can extract and infer some information based on the document's content, particularly from the "Discussion of Safety and Effectiveness" section.
Here's a breakdown of the requested information, with qualifications where the information is not explicitly stated:
Acceptance Criteria and Device Performance Study for Titanium Vocal Fold Medializing Implant (TVFMI)
The document is a 510(k) premarket notification summary, which primarily aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than providing a detailed study against pre-defined acceptance criteria in the format typically seen in a clinical trial report. The "acceptance criteria" can be inferred from the claims made regarding safety and effectiveness in comparison to predicate devices. The study referenced is a clinical study whose findings are summarized in the 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the 510(k) summary, specific numerical acceptance criteria (e.g., "must achieve X% improvement") are not explicitly defined. Instead, the "acceptance criteria" are implied by the claims of equivalence or superiority to predicate devices.
| Acceptance Criteria (Implied from 510(k)) | Reported Device Performance (as summarized in 510(k)) |
|---|---|
| Safety: Biocompatibility (compared to predicate devices) | Biocompatibility: ASTM F67 medical grade titanium has a proven record of excellent biocompatibility. (Implied to be at least equivalent, if not superior, to predicate devices' materials like silicone and dense hydroxylapatite). |
| Safety: No adverse effects due to MRI (implant movement, heating) | MRI Safety: Testing in a 0.5 Tesla nuclear magnetic resonance tomograph revealed no implant movement and no adverse tissue effects attributable to MRI-generated heating. (Acknowledges potential image quality impediment in direct vicinity, but no reported adverse effects to date). |
| Effectiveness: Achieve similar or better glottal closure and voice parameters | Voice Parameters: "At least equal, if not better improvement of all voice parameters can be achieved when compared to SE devices (s. Exh. 2, p. 80 re voice function tests and p. 81 for overview table of pre/postoperative glottal gap + voice dysfunction index)." (Direct claim of comparable or superior effectiveness). Specific numerical improvements are referenced in Exhibit 2, but not detailed in this summary. |
| Effectiveness: Secure fixation, minimal dislocation | Good Fixation: Design assures optimal fixation and stabilization, minimizing dislocation. Fastening with monofilament non-absorbable sutures further eliminates movement. Extrusion highly unlikely. |
| Operative Procedure: Simplified and shortened procedure (compared to predicates) | Simplified & Shortened Procedure: Comes in 2 sizes (male/female) easily adjustable to patient needs, simplifying and shortening the surgical procedure. This is claimed to improve results due to reduced intralaryngeal swelling and hematoma. The Montgomery Thyroplasty Implant comes in 10 sizes, and VoCoM in 5, suggesting TVFMI offers a more standardized approach. |
| Handling: Easy adjustability and handling intra-operatively | Minimal Implant Adjustments/Easy Handling: Balance of elasticity and rigidity allows easy bending and adjustment, which are permanently 'remembered' by the titanium. Implantation technique and handling are simple and time-saving. The special U-shape design allows for self-locking/snapping into place under slight tension. |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "Clinical results" and "Exhibit 2: Titanium Vocal Fold Medializing Implant: Introducing a Novel Implant System for External Vocal Fold Medialization by Gerhard Friedrich, MD; reprint from ANNALS OF OTOLOGY, RHINOLOGY & LARYNGOLOGY, Jan. 99, Vol. 108, No. 1."
- Sample Size for Test Set: The sample size is not explicitly stated in this 510(k) summary. The referenced Exhibit 2 (Friedrich, MD, 1999) would contain this information.
- Data Provenance: The study is referenced as a "reprint from ANNALS OF OTOLOGY, RHINOLOGY & LARYNGOLOGY." The author, Gerhard Friedrich, MD, suggests the study likely originates from Germany, as the device manufacturer (Heinz Kurz GmbH Medizintechnik) is based in Germany and Dr. Friedrich is a prominent German otolaryngologist. It is a prospective clinical study as implied by "Clinical results to date."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the 510(k) summary. The clinical study (Exhibit 2) would detail how voice parameters, glottal gaps, and other outcomes were assessed, and by whom.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done or at least not mentioned in this 510(k) summary. The comparison is primarily focused on the device's technical characteristics and overall clinical outcomes (voice parameters, glottal gap) as documented in the referenced clinical study, rather than comparing human reader performance with and without AI assistance. This device is an implant, not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a titanium vocal fold implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
Based on the reference to "voice function tests" and "pre/postoperative glottal gap + voice dysfunction index" (Exhibit 2, p. 80 and 81), the ground truth for effectiveness would have been established through clinical assessments of voice parameters and glottal closure, likely involving objective measurements (e.g., acoustic analysis, videostroboscopy, aerodynamic measurements) and subjective evaluations by speech-language pathologists or otolaryngologists. This would fall under expert clinical assessment and objective physiological measurements.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical implant and does not involve AI/machine learning requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is a physical implant and does not involve AI/machine learning.
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