(27 days)
The Small Hammer Toe Pin is indicated for proximal interphalangeal (PIP) joint arthrodesis.
The Small Hammer Toe Pin is made out of the oriented Lactosorb® material and is indicated for proximal interphalangeal joint (PIP) joint arthrodesis. LactoSorb® is a polyester derivative of L-Lactic and glycolic acids. Poly Llactic/polyglycolic acid copolymer degrades and resorbs IN VIVO by hydrolysis into Llactic and glycolic acids, which are then metabolized by the body. The device has threads on one end and barbs on the other.
The provided document is a 510(k) premarket notification summary for a medical device (Small Hammer Toe Pin). It does not contain any information about acceptance criteria, device performance metrics, or the details of a study that would prove the device meets such criteria.
Instead, the document focuses on:
- Device identification: Proprietary name, common name, classification, product code, and predicate device.
- Intended Use: Proximal interphalangeal (PIP) joint arthrodesis.
- Device Description: Material (Lactosorb® - a resorbable polymer), and physical features (threads on one end, barbs on the other).
- Non-Clinical Testing: Mentions that non-clinical testing "demonstrated statistical equivalence between this device and the predicate." However, it does not provide any specific acceptance criteria or results of this testing.
- Clinical Testing: Explicitly states, "Clinical testing was not used to establish substantial equivalence." This means there's no clinical study described in this document to evaluate the device's performance against acceptance criteria.
- FDA determination: A letter from the FDA stating that the device is substantially equivalent to a legally marketed predicate device. This is a regulatory finding for market clearance, not an evaluation of performance against specific acceptance criteria.
Therefore, I cannot provide the requested information for acceptance criteria and study details because it is not present in the provided text.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.