(72 days)
The Mills Columella is intended to improve or restore hearing by replacing an absent or defective incus and stapes.
The treatment of an absent or defective stapes.
The Mills Columella Prosthesis is manufactured from p.t.f.e., a material which has been used for the reconstruction of the middle ear for many years. It can be combined with an ossicular or cortical bone graft for the treatment of ossicular defects, including loss of stapes arch.
The provided text is a 510(k) premarket notification for the Mills Columella Prosthesis. It does not contain information about a study proving the device meets acceptance criteria or detailed performance data as typically found in a clinical trial report.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the provided document. A 510(k) submission typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance against specific acceptance criteria from a dedicated study.
2. Sample Size Used for the Test Set and Data Provenance
This information is not present in the provided document. No specific test set or associated data provenance is discussed.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not present in the provided document. There is no mention of experts establishing a ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not present in the provided document. No test set or adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not present in the provided document. There is no mention of an MRMC study or any analysis of human reader improvement with or without AI assistance. The device is a physical prosthesis, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
This information is not present in the provided document. The device is a physical prosthesis for surgical implantation, not an algorithm.
7. Type of Ground Truth Used
This information is not present in the provided document. The submission focuses on substantial equivalence based on material and intended use compared to predicate devices.
8. Sample Size for the Training Set
This information is not present in the provided document. As this is not an AI/algorithm-based device, there would not be a "training set" in that context.
9. How the Ground Truth for the Training Set Was Established
This information is not present in the provided document.
Summary of Device Information from the Document:
- Device Name: Mills Columella Prosthesis
- Common Name: Prosthesis, Ear, Internal
- Classification Name: Ossicular Replacement Prosthesis
- Intended Use: To improve or restore hearing by replacing an absent or defective incus and stapes, or for the treatment of ossicular defects including loss of stapes arch, often combined with an ossicular or cortical bone graft.
- Material: p.t.f.e. (a non-porous material)
- Predicate Devices: Shea Plasti-Pore, TORP and Austin Off Centered, TORP (both manufactured from Plasti-Pore).
- Comparison with Predicate Devices: The subject device is manufactured from p.t.f.e., which is described as "a non-porous but otherwise very similar material" to Plasti-Pore. The subject device is "on average, smaller than the predicate devices but performs exactly the same function." The p.t.f.e. material has been "used for the reconstruction of the middle ear for many years."
- Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. The substantial equivalence is based on the indications for use.
In essence, the document serves as a regulatory filing demonstrating equivalence to existing devices, not a detailed performance study with 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.