(519 days)
The prostheses are intended for partial ossicular replacement to restore functionality to the middle ear in cases of pathological changes of the sound transmission system. The NiTiBOND Stapes Prosthesis act as a bridge between the long process of the incus and the base of the stapes, with the piston extending into the perilymphatic space of the inner ear.
The loop consists of a nickel-titanium alloy (Nitinol), while the piston is made of pure titanium.
Specifically, the devices are designed for the treatment of
- Otosclerosis (stapedial fixation) / congenital stapedial fixation 1.
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- Traumatic injury to the ossicular chain
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- Malformation of the middle ear
- Revision surgery to correct inadequate hearing improvement, e.g. through dislocation 4. of a prosthesis
The stapes prosthesis consists of a Nitinol loop and the standard KURZ shaft made of pure titanium (ASTM F67).
The flat loop band diffuses the impact of pressure on the incus. When applying heat to the ContactFree Zones, the shape memory features of Nitinol cause the loop to close. The ContactFree Zones serve as heat blockers, limit heat dispersion on the mucosa and minimize the risk of incus stranqulation. The prosthesis comes with an accessory, the Thermo-Dummy®, to predetermine the lowest laser setting that will close the prosthesis loop outside the patient's ear before inserting the implant.
Here's an analysis of the provided 510(k) summary regarding the NiTiBOND Stapes Prosthesis, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly define acceptance criteria with quantifiable metrics for clinical performance. Instead, it relies on the concept of substantial equivalence to predicate devices. The "performance specifications were met" statement refers to non-clinical tests rather than clinical outcomes.
| Acceptance Criterion (Implicit) | Reported Device Performance (NiTiBOND Stapes Prosthesis) |
|---|---|
| Clinical Performance: | |
| Equivalent hearing improvement | "post-operative hearing improvement is substantially equivalent when compared to legally marketed SE devices." |
| Safety | "as safe and effective as the predicate devices." |
| Effectiveness | "as safe and effective as the predicate devices." |
| No new safety/effectiveness issues | "The results of non-clinical and clinical design and performance validations raise no new issues of safety and effectiveness." |
| Non-Clinical Performance: | |
| Coupling Effectiveness | "The performance specifications were met." |
| Stability of Coupling during Sound Transmission | "The performance specifications were met." |
| MRI Environment Compatibility | "MR Conditional 1.5, 3 + 7 Tesla" (demonstrated compatibility with predicate devices) |
| Biocompatibility | "Yes" (demonstrated compatibility with predicate devices) |
| Shelf Life | "The performance specifications were met." |
| Sterilization Validation | "The performance specifications were met." |
| Packaging Validation | "The performance specifications were met." |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "According to published literature, post-operative hearing improvement is substantially equivalent when compared to legally marketed SE devices." This implies that the clinical performance claim is based on literature review and comparison with published data for other legally marketed stapes prostheses (the predicate devices).
- Sample Size for Test Set: Not explicitly stated for this device's clinical performance assessment. The statement refers to "published literature" for predicate devices, so the sample sizes would be those of the studies included in that literature.
- Data Provenance: Not explicitly stated for this device's clinical performance, other than "published literature." For predicate devices, the original studies would have their own provenance (e.g., country, retrospective/prospective). This submission does not provide original clinical data for the NiTiBOND Stapes Prosthesis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There was no specific "test set" and no panel of experts convened to establish ground truth for this device's clinical performance in this 510(k) submission. The evaluation relies on comparability to existing devices whose performance is presumably established in published literature.
4. Adjudication Method for the Test Set
Not applicable. As there was no specific clinical test set for the NiTiBOND Stapes Prosthesis with original data collection, no adjudication method was used.
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 device is a medical implant (stapes prosthesis), not an AI diagnostic or assistance tool. Therefore, an MRMC study and AI-related improvement effects are irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a medical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the clinical performance claim is the established clinical performance and safety profiles of legally marketed predicate devices, as documented in "published literature." This implicitly means that the predicate devices' performance was established through clinical outcomes data (e.g., audiometry results, patient reported outcomes, complication rates from clinical trials or retrospective studies).
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not a machine learning model. There is no concept of a "training set" in this context. The non-clinical tests (e.g., MRI compatibility, biocompatibility) are conducted on samples of the device itself.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device. For the non-clinical tests, the "ground truth" would be established by validated test methodologies and standards (e.g., ASTM standards for material properties, ISO standards for biocompatibility).
§ 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.