(144 days)
An 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. Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include:
(a) Chronic middle ear disease,
(b) Otosclerosis,
(c) Congenital fixation of the stapes,
(d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and
(e) Surgically correctible injury to the middle ear from trauma.
The Grace Dynamic Ossicular Replacement Prostheses are manufactured from the same materials as the predicate devices:
(i) Unalloyed titanium (ASTM F67)
(ii) Titanium alloy (ASTM F136)
(iii) Medical Grade Silicone
(iv) ASTM F1185 Hydroxylapatite
The provided document is a 510(k) summary for the Grace Dynamic Ossicular Replacement Prostheses. This type of regulatory document focuses on establishing substantial equivalence to predicate devices based on intended use, materials, and technological characteristics. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way a clinical or performance study report for a diagnostic AI device would.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, or training set details) because this document does not contain that type of data.
The 510(k) summary states: "Differences between the Grace Dynamic Ossicular Replacement Prostheses and the predicate devices should not affect the safety or effectiveness." This statement, along with the comparison of materials and intended use to predicate devices, forms the basis of the "proof" for substantial equivalence in this context, rather than a detailed performance study with quantifiable acceptance criteria.
§ 874.3495 Total ossicular replacement prosthesis.
(a)
Identification. A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.