(13 days)
Bridging the stapes in cases of otosclerosis
The all-titanium prosthesis consists of an undulated, selfretaining, two-limbed clip that is laser-welded to a conventional KURZ piston shaft.
The provided document is a 510(k) summary for the "CliP Piston àWengen" device, which is a modification of an existing middle ear prosthesis. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than performing extensive novel clinical studies with detailed acceptance criteria and standalone performance metrics in the way a PMA (Pre-Market Approval) might.
Therefore, much of the requested information (like specific acceptance criteria for performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, and standalone algorithm performance) is not present in the provided 510(k) summary, as it's not typically required for a 510(k) for a device modification. The "study" here is primarily a comparison to the predicate device and validation of the design changes.
Here's a breakdown of what can be extracted from the document based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The document implies acceptance criteria by stating the reasons for device modification and the expected improvements:
- Reduce risk of tissue necrosis by improving vascular circulation.
- Standardize and significantly shorten surgical procedure.
- Eliminate need for instruments and crimping and reduce potential risks.
- Improve audiological results.
- No adverse effects attributable to MRI-generated heating.
- No implant movement in MRI environment.
- Maintain safety and effectiveness compared to the predicate device.
- Clinical test results confirm safety and effectiveness.
- Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reduce risk of tissue necrosis by improving vascular circulation | "reduces risk of tissue necrosis on incudal process by improving vascular circulation" (Claimed due to design) |
| Standardize and significantly shorten surgical procedure | "shortens surgical procedure" (Claimed due to 'click-on' mechanism) |
| Eliminate need for instruments and crimping and reduce risks | "eliminates need for instruments and crimping and to reduce potential risks connected therewith" (Claimed due to 'click-on' mechanism) |
| Improve audiological results | "potentially improves long-term hearing gain with appropriate physiological conditions." and "expected to result in equal if not better audiological post-operative hearing gain." (Anticipated, not definitively proven as a primary endpoint in this summary) |
| No adverse effects attributable to MRI-generated heating | "Testing in a 0.5 Tesla nuclear magnetic resonance (NMR) tomograph has revealed no... adverse tissue effects attributable to MRI-generated heating." (Specific testing result) |
| No implant movement in MRI environment | "Testing in a 0.5 Tesla nuclear magnetic resonance (NMR) tomograph has revealed no implant movement" (Specific testing result) |
| Maintain safety and effectiveness compared to predicate | "There are no additional characteristics known that should adversely affect the safety and effectiveness of these implants." and "The results of design validation raise no new issues of safety and effectiveness." and "Clinical test results to date confirm the safety and effectiveness of the new design." (General statements of compliance and safety, but no specific comparative metrics are provided in the summary for the clinical test results). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided 510(k) summary. The document mentions "Clinical test results to date" but does not give any details on the number of patients or cases.
- Data Provenance: Not specified for the clinical test results. The submitter is based in Germany, and the contact person in the Netherlands, but this doesn't tell us where the clinical data, if any, was collected.
- Retrospective/Prospective: Not specified.
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/Not specified. The clinical "test results" mentioned pertain to the device's functional performance in patients, not interpretation of data by experts for ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
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. This is a medical device (prosthesis), not an AI/software. No MRMC studies were performed or are relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- Not applicable. This is a medical device (prosthesis), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" here would be the actual clinical outcomes following surgical implantation of the device (or predicate device). This falls under "outcomes data." The summary broadly mentions "Clinical test results to date confirm the safety and effectiveness of the new design," implying that patient outcomes were assessed to some extent, but no specifics are provided. For MRI compatibility, the ground truth was direct observation/measurement in a 0.5 Tesla NMR tomograph.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable.
§ 874.3450 Partial ossicular replacement prosthesis.
(a)
Identification. A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.