(88 days)
The purchaser shall sufficiently inform themselves regarding the use of silicone materials in any surgical procedure to insure its proper use. Sil-Tec Medical Grade Oval Shape is a soft, radiopaque silicon elastomer shape intended for reconstruction and surgical repair procedures. Some uses have been: As temporary stents for the formation of new tendon sheaths. Other surgical repair procedures demanding a highly inert and flexible oval shaped material.
Sil-Tec Medical Grade Oval Shape is a soft, radiopaque silicon elastomer shape intended for reconstruction and surgical repair procedures.
I am sorry, but based on the limited information provided in the given text, I cannot answer the questions about acceptance criteria and study details. The document is an FDA 510(k) clearance letter for a medical device called "SilTec™ Oval Shapes," issued in 1997.
This type of letter indicates that the FDA has found the device to be substantially equivalent to a legally marketed predicate device, meaning it doesn't require a new premarket approval. However, it does not contain the detailed acceptance criteria or the specific study results. It mentions the device's intended use and regulatory classification but doesn't elaborate on performance metrics or the studies used to establish substantial equivalence.
To answer your questions, I would need access to the actual 510(k) submission (which often includes performance data and acceptance criteria) or a separate study report for the SilTec™ Oval Shapes.
§ 888.3025 Passive tendon prosthesis.
(a)
Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a polyester reinforced medical grade silicone elastomer intended for use in the surgical reconstruction of a flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to function as a replacement for the ligament or tendon nor to function as a scaffold for soft tissue ingrowth.(b)
Classification. Class II.