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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.

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 Medical Stapes Prostheses are manufactured from the same or similar materials as the predicate devices. Various designs of Stapes Prostheses are available to meet physician preference. Materials include Titanium, Fluoroplastic, Stainless Steel, Platinum, Tantalum, Silicone, and Nitinol. Shaft diameters range from 0.3 to 0.8 mm and functional lengths range from 3.0 to 6.5 mm. The devices are supplied sterile.

The provided documents do not contain information about specific acceptance criteria or a study designed to prove that the Grace Medical Partial Ossicular Replacement Prostheses meet such criteria.

The documents are a 510(k) summary for a medical device (Partial Ossicular Replacement Prostheses). In a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a dedicated study with defined acceptance criteria and statistical analysis.

Instead, the submission provides:

• Comparison Charts (Tables in sections {1} and {2}): These tables compare the Grace Medical device with several predicate devices based on attributes like:
  • Intended Use
  • Material(s)
  • Shaft Diameter (mm)
  • Functional Length (mm)
  • Loop Dia (mm)
  • How Supplied (Sterile)

The stated rationale for substantial equivalence is that "Differences between the Grace Medical Modified Partial Ossicular Replacement Prostheses and the predicate devices should not affect the safety or effectiveness."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving their fulfillment as it is not present in the provided text.

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SMart Offset Stapes Piston Prosthesis: Bridging the stapes in cases of otosclerosis: specifically for surgical revision in patients with a shortened incudal process, and also in primary surgery with this anatomical condition.
SMart ISJ Prosthesis: Bridging defects at the long incudal process with otherwise intact mobile chain.

SMart Offset Stapes Piston: Middle Ear Piston, Partial Ossicular Replacement Prosthesis. Utilizes nitinol wire embedded in a fluoroplastic shaft. Offered in lengths of 3.0 mm through 6.0 mm (functional length) and shaft diameters of .4, .6, .8 mm. Offset lengths between 1mm and 2mm. Supplied sterile.
SMart ISJ Prosthesis: Partial Ossicular Replacement Prosthesis. Utilizes nitinol shaft and loops welded to a titanium bell. Offered in lengths of offset of 2.25 mm, 3.25 mm. Supplied sterile.

The provided text does not contain information about acceptance criteria or a study proving device performance in the context of a diagnostic or AI-powered medical device. The documents are 510(k) notifications for two medical devices: the SMart™ Offset Stapes Piston Prosthesis and the SMart™ ISJ Prosthesis.

These notifications focus on demonstrating substantial equivalence to predicate devices rather than proving a specific performance against acceptance criteria through a clinical study or AI performance evaluation. The substantial equivalence argument is based on similar intended use, comparable materials (with acknowledged differences whose biocompatibility is asserted), and similar design features.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and a study that proves the device meets them, as this kind of information is not present in the provided FDA 510(k) summary. The document does not describe:

1. Acceptance criteria in terms of numerical performance targets (e.g., sensitivity, specificity, accuracy).
2. A study (clinical or otherwise) designed to measure the device's performance against such criteria.
3. Sample sizes for test or training sets, as it's not an AI/diagnostic device.
4. Expert ground truth establishment, adjudications, or MRMC studies, as these relate to performance evaluation of diagnostic tools, which these prostheses are not.
5. Standalone algorithm performance as there is no algorithm.
6. Type of ground truth (pathology, outcomes data) as this relates to diagnostic accuracy.
7. Training set sample size or how its ground truth was established, as this is irrelevant for a physical medical implant.

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