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Bridging the stapes and incus in cases of otosclerosis and defects of the ossicular chain between manubrium mallei and vestibulum (malleovestibulopexy)

The all-titanium prosthesis consists of an undulated, selfretaining, two-limbed clip that is laser-welded to a rectangular shaft which is connected with a conventional KURZ piston shaft by means of a unique ball joint.

The provided document is a 510(k) summary for a medical device and does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics. It focuses on demonstrating substantial equivalence to predicate devices based on design and safety characteristics, rather than reporting on specific performance outcomes from a clinical study with predefined acceptance criteria.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and comparative effectiveness simply does not exist within this 510(k) submission.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/Not provided in the 510(k) summary.

The 510(k) summary focuses on demonstrating substantial equivalence based on design similarities and a qualitative assessment of safety and effectiveness, rather than quantitative performance against pre-defined acceptance criteria from a specific study.

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

Not provided in the 510(k) summary.

No specific "test set" and its sample size are mentioned, as this is a premarket notification based on design changes and comparison to predicate devices, not a clinical trial reporting on performance data.

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

Not applicable/Not provided in the 510(k) summary.

No "ground truth" establishment in a clinical context is described, as there is no reported performance study with a test set.

4. Adjudication Method for the Test Set

Not applicable/Not provided in the 510(k) summary.

No adjudication method is described, as there is no reported performance study with a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done or reported in this 510(k) summary.

The submission focuses on design modifications and claims that the new device, by improving handling and reducing risks, is "expected to result in equal if not better audiological postoperative hearing gain." This is a qualitative statement of expectation, not a result from a comparative effectiveness study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable/Not provided in the 510(k) summary.

This device is a physical medical implant, not an algorithm or AI system. Therefore, the concept of "standalone performance" in that context is not relevant.

7. The Type of Ground Truth Used

Not applicable/Not provided in the 510(k) summary.

No ground truth is described in the context of a performance study. The "safety and effectiveness" claims are based on design comparisons to predicate devices and theoretical advantages of the new design features. The statement "Clinical test results confirm the safety and effectiveness of this design" is made, but no details of these "clinical test results" are provided, nor is the nature of the "ground truth" used.

8. The Sample Size for the Training Set

Not applicable/Not provided in the 510(k) summary.

No training set is mentioned, as this is not an AI/algorithm-based device and no such study is described.

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

Not applicable/Not provided in the 510(k) summary.

No training set is mentioned, and therefore, no ground truth establishment for it.

Summary of what is present in the document relevant to safety and effectiveness:

• Rationale for Design Changes: The document clearly outlines the reasons for modifying the device, primarily focusing on facilitating intraoperative handling, reducing risks of patient trauma, and improving post-operative sound transmission.
• Safety Features: Mention of reduced tissue necrosis by improving vascular circulation, standardization and shortening of surgical procedures, elimination of instruments and crimping, and reduction of potential risks.
• Theoretical Performance Improvement: Expectation of "equal if not better audiological postoperative hearing gain" due to gentle clip-on attachment and alignment with sound transmission axis.
• MRI Compatibility: Testing in a 3.0 Tesla NMR tomograph revealed no implant movement and no adverse tissue effects attributable to MRI-generated heating.
• Comparison to Predicate Devices: A detailed table compares the new device (CliP® Piston MVP) to its predicate devices (Titanium K-Piston and CliP® àWengen) in terms of design, intended use, materials, and specific features, highlighting the modifications and their perceived benefits.
• Conclusion on Safety and Effectiveness: The document concludes that the results of design validation raise no new issues of safety and effectiveness, and that "clinical test results confirm the safety and effectiveness of this design," though these results are not detailed.

Essentially, this 510(k) submission argues for substantial equivalence primarily through comparison of design features and theoretical benefits based on those design changes, rather than providing detailed data from a quantitative performance study with explicit acceptance criteria.

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