(85 days)
Surgical indications for the Single Size Tendon Spacers include: Scarred or adhering tendons due to trauma or failed primary repair. Absence of tendon sheath. Scarred or adherent non-functional tendon pulleys. Ruptured tendon. The device is single use, temporary implantation for 2 to 6 months.
The Single Size Tendon Spacer is designed to facilitate the two-step tendon reconstruction surgery. The device is 50 cm long, and its oval cross section increases progressively over its length from 3.0 x 1.5 mm to 3.0 mm. The spacer slope is designed to match shapes and dimensions of the digital canal. The spacers are made of high performance medical grade silicone elastomer containing barium suffate to provide radio-opacity. During the first stage of the reconstruction surger is placed into the reconstructed tendon bed and slid until optimum fit is achieved. The tendon is attached to the distal phalanx and the proximal spacer end is left free in the palm or forelimb. Excess spacer material is cut off. The second stage of surgery is performed 2 to 6 months later, once an appropriate pseudo-sheath has been created around the spacer, and tissues are soft and pliable. The spacer is then removed and replaced by a permanent active tendon autograft. The device is not intended as permanent implant or to function as a replacement for a ligament or tendon.
I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) summary for a "Single Size Tendon Spacer" and primarily focuses on establishing substantial equivalence to a predicate device.
The document does not contain any information regarding:
- Specific acceptance criteria metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical thresholds beyond "equivalent mechanical strength").
- A detailed study design or reported device performance metrics against defined criteria.
- Sample sizes for test sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
- Training set details or how their ground truth was established.
The "Performance data" section only states: "Studies demonstrated that the Single Size Tendon Spacer devices have the equivalent mechanical strength and biocompatibility performances to the predicate device." This is a very high-level statement without any specific data or methodology.
Therefore, I cannot fulfill your request as the necessary information is not present in the provided text.
§ 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.