(37 days)
The Parcus Actiflip is used for fixation of bone or soft tissue to bone, and is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications: anterior cruciate ligament, posterior cruciate ligament, pectoralis repari (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.
The Parcus ActiFlip is also intended for fixation of suture (soft tissue) to bone in the foot and ankle for midfoot reconstruction and hindfoot reconstruction with the following procedures: FHL Tendon Transfer, Posterior Tibialis Tendon Transfer, Anterior Tibialis Tendon Transfer.
The Parcus ActiFlip device consists of a titanium implantable button that is mounted onto an inserter shaft that allows for placement and deployment of the button. ActiFlip is available in three (3) configurations, with or without UHMWPE suture – Naked (without suture), CINCH, WHIP.
The provided text is a 510(k) summary for the Parcus ActiFlip device. It outlines the device's indications for use, its characteristics, and how its substantial equivalence to predicate devices was established. However, it explicitly states that "Clinical testing was deemed not necessary for demonstrating substantial equivalence to the predicate devices" and that "Performance was established based on acceptance criteria with the rationale that the new specific indications...do not introduce a worst-case for mechanical performance of the subject device."
This type of submission for a medical device (a 510(k)) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's performance through a clinical trial with specific performance metrics and acceptance criteria for algorithm-based diagnostic or prognostic devices.
Therefore, the document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria, as typically seen for AI/ML-driven diagnostic devices. Specifically, it lacks:
- A table of acceptance criteria and reported device performance: No such table or performance metrics are provided. The "performance" mentioned refers to mechanical performance, not diagnostic accuracy.
- Sample size used for the test set and data provenance: No test dataset details are given.
- Number of experts used to establish ground truth and qualifications: Not applicable as there's no clinical data or ground truth establishment for a diagnostic study.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study was performed or is mentioned.
- Standalone (algorithm-only) performance: Not applicable as this is a physical implant, not an algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable as there's no algorithm training mentioned.
- How ground truth for the training set was established: Not applicable.
The document describes a physical medical device (a fixation fastener), not an AI/ML-driven diagnostic or image analysis tool. The "performance" mentioned is mechanical validation (implicitly, by showing it's not a 'worst-case' scenario compared to predicates), not the type of performance evaluation relevant to AI diagnostics.
§ 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.