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510(k) Data Aggregation
(24 days)
Otosclerosis Surgery: Replacement of the stapes after stapedotomy and stapedectomy.
SCHOBEL: Initial and secondary surgery
SCHOBEL-CAUSSE: Initial surgery with retention of stapedial muscle reflex.
Funnel-shaped titanium stapes prosthesis (piston) which is articulated to the lenticular process of the long limb of the incus. Thus, neither a loop nor a frame are necessary for linking the prosthesis.
The Schobel-Causse model is equipped with a process perpendicular to the piston stem. The stapedius reflex is reconstructed by latching the stapedius tendon into the u-shaped process end. (indicated for first-time procedures).
The shaft of both prosthesis models (Schobel + Schobel-Causse) is placed on the membrane (vein or fascia) in the oval window. With this technique, the graft interposition serves as a replacement of the annular ligament, discourages the piston shaft from pressing into the saccule, and effectively inhibits the development of possible perilymphatic fistula.
The provided document is a 510(k) summary for a medical device (stapes prostheses) and does not contain the detailed study information needed to fully address all aspects of the request. However, based on the available information, here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to predicate devices rather than specific quantitative performance metrics. The document asserts that the device compares favorably and shows at least equal, if not better improvement of all hearing parameters compared to predicate devices. It also highlights design features intended to improve safety and effectiveness.
| Acceptance Criteria (Inferred from 510(k) Submission) | Reported Device Performance (as stated in the document) |
|---|---|
| Intended Use Equivalence: Same intended use as predicate devices (replacement of stapes after stapedotomy or stapedectomy in otosclerosis surgery). | The KURZ stapes prostheses have the same intended use as predicate devices. |
| Material Biocompatibility: Material used is biocompatible. | ASTM F67 medical grade titanium has a proven record of excellent biocompatibility. |
| Design Safety/Effectiveness: Design differences do not adversely affect safety and effectiveness; ideally, enhance them. | "The different material (titanium) and design modification (socket top - no loop) do not adversely affect the safety and effectiveness of these implants, but rather enhance biocompatibility, implant stability and long-term problem-free fixation, and audio results achieved." |
| Fixation Stability: Stable fixation to the incus. | "Eliminates loosening of loop (SE devices) with resulting Benefit: hearing loss and associated risks due to pressure at the incudal process such as atrophy, necrosis, detachment of incudal process)." |
| Prevention of Complications: Reduced risk of perilymphatic fistula or necrosis. | "Drastic Reduction of Perilymphatic Fistula or Necrosis Formation" and "Substitution of Stapedial Annular Ligament drastically reduces perilymphatic fistula formation." |
| Hearing Improvement: Comparable or improved hearing parameters. | "At least equal, if not better improvement of all hearing parameters can be achieved when compared to SE devices." |
| MRI Compatibility: Safe in MRI environment. | "Testing in a 0.5 Tesla nuclear magnetic resonance tomograph has revealed no implant movement and no adverse tissue effects attributable to MRI-generated heating." |
| Manufacturing/Compliance: Compliance with relevant industry standards for manufacturing, packaging, labeling, and sterilization. | KURZ certifies compliance with required ISO/EN/ASTM/AAM//ANSI and other device-related standards. |
2. Sample size used for the test set and the data provenance
The document refers to "Clinical results to date," "Intermediate Report on clinical investigation on titanium middle-ear implants in comparison to other materials," and "Long-Term Clinical Results" since 1979 for the Schobel socket piston. However, specific sample sizes for a dedicated test set are not provided. The provenance of the data is generally clinical (implants in patients) but the country of origin is not explicitly stated, although the manufacturer is German. It appears to be retrospective data analysis ("Since 1979 the Schobel socket piston... has been implanted").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "ground truth" for the clinical results would implicitly be the observed patient outcomes and surgeon assessments.
4. Adjudication method for the test set
This information is not provided in the document.
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
No MRMC study was mentioned or implied. This device is a surgical implant, not an AI-driven diagnostic tool that would typically involve human "readers" in the context of interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth appears to be based on clinical outcomes data ("excellent hearing improvement," "not a single case of incus necrosis, loosening of articulation with lenticular processus, or membrane penetration into the vestibulum," and general statements about "audio results achieved" and "hearing parameters"). For MRI compatibility, the ground truth was derived from testing in a nuclear magnetic resonance tomograph.
8. The sample size for the training set
The concept of a "training set" in the context of device validation for this type of implant (pre-2000 510(k) submission) is not applicable in the same way as it would be for an AI/ML device. The "training" here refers to cumulative clinical experience with the device and similar concepts. The "Long-Term Clinical Results" state that the Schobel socket piston "Since 1979... has been implanted," implying a substantial number of cases over two decades, but an exact numerical "training set" size is not given.
9. How the ground truth for the training set was established
As above, the "training set" is not a formal concept here. The "ground truth" for the long-term clinical results was established through patient follow-up and observation of clinical outcomes after implantation by surgeons. The document cites "Prof. H. Schobel, On Development of New Stapes Prosthesis in Otosclerosis Surgery" in relation to these results, suggesting clinical studies and expert observation.
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