(90 days)
Osteoarthritis. Where the use of a more conservative procedure has failed or is unacceptable. The device is intended for non-cemented use.
The Signal Medical Corporation Great Toe Implants are manufactured from ASTM F75 Cobalt Chrome. The porus coating is ASTM F75 sintered beads, -45+60 mesh. The device is intended for non-cemented use. The stem of the device is intended to be inserted into the proximal end or base of the first phalangel bone. The convex surface of the implant is intended to articulate with the distal end or head of the first metatarsal bone. The design is made available in multiple sizes equivalent to the toe implants in the Townley Great Toe Joint 510K (K911378) and the Zimmer Great Toe 510K (K823405).
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets them.
The document is a 510(k) summary and an FDA clearance letter for the Signal Medical Corporation Great Toe Implants. It focuses on:
- Device Description: What the device is made of and its general function.
- Intended Use/Indications for Use: What the device is for (osteoarthritis, when conservative procedures fail).
- Substantial Equivalence: The FDA's determination that this device is substantially equivalent to previously marketed predicate devices (Townley Great Toe Joint 510K (K911378) and Zimmer Great Toe 510K (K823405)). This is the core of a 510(k) submission, confirming that a new device is as safe and effective as a legally marketed one without requiring new clinical trials or extensive performance testing if the predicate device itself didn't necessitate them.
- Regulatory Information: FDA regulations, general controls, and contact information.
This type of submission typically relies on comparison to predicate devices, material testing, and sometimes bench testing, rather than extensive clinical studies with specified acceptance criteria as would be found in a Premarket Approval (PMA) application or a more complex medical device.
Therefore, I cannot provide the requested table or answer the questions related to acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment because this information is not present in the given text.
§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.