(72 days)
The PULLUP® BTB, BT LOOP®, PULLUP® CLIP and PULLUP® TEX CLIP devices are designed to be used as cortical fixation for ACL reconstruction.
The device is proposed in the following variants:
- -PULLUP®: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, and is designed to be used with a soft tissue graft.
- PULLUP® BTB: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, as well as a temporary splice suture, and is designed to be used with a bone-tendon-bone graft.
- -BT LOOP®: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, as well as a temporary splice suture, and is designed to be used with a bone-tendon-bone graft. It is assembled on a holder that must be mounted on the GraftTech® preparation station.
- -PULLUP® CLIP: comprises a titanium button-plate only, is designed to be used with a soft tissue graft, and can either be connected to another PULLUP® CLIP button-plate by using the PULLUP® TEX CLIP nonabsorbable braided loop, or can be connected to another PULLUP® device.
Standard models are used for cortical tunnels with a diameter of 4.5 mm; XL models are used for cortical tunnels with a diameter between 5 and 10 mm.
The implants are supplied sterile, individually packaged, ready to use.
This is a 510(k) premarket notification for a medical device, not a study evaluating an AI algorithm. Therefore, the standard information requested for describing acceptance criteria and a study proving device performance for an AI algorithm is not applicable here.
Here's a breakdown of why the requested information cannot be provided from the given document:
- This is not an AI/Software as a Medical Device (SaMD) submission: The document describes PULLUP® BTB, PULLUP® CLIP, PULLUP® TEX CLIP adjustable fixation systems, and BT LOOP® for ligament reconstruction. These are physical implants, not AI algorithms.
- The document focuses on substantial equivalence to a predicate device: The purpose of a 510(k) submission is to demonstrate that a new device is as safe and effective as a legally marketed predicate device. It doesn't typically involve new clinical studies with acceptance criteria in the way AI algorithm validation does.
- "Device performance" refers to mechanical and biological properties: In this context, "device performance" refers to the biocompatibility, biological, and mechanical properties of the physical implant, not the diagnostic or predictive performance of an algorithm.
Based on the provided text, I can extract the following relevant information regarding non-clinical performance:
1. Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Not impacted by changes. Satisfactory. |
| Biological Performance | Not impacted by changes. Satisfactory. |
| Mechanical Performance | Not impacted by changes. Satisfactory; devices functional within intended use. |
| Non-pyrogenic | Device determined to be non-pyrogenic. |
Explanation: The document states that "Non-clinical testing including biocompatibility, biological and mechanical performances were not impacted by the change. The results indicated that the devices were functional within their intended use and equivalent to the predicate devices. The proposed device has been determined to be non-pyrogenic." This indicates that the new variants met the established non-clinical performance and safety profiles, thus fulfilling the acceptance criteria for these aspects.
The following requested information is NOT APPLICABLE or NOT AVAILABLE in the provided document, as it pertains to AI/algorithm validation, not to the premarket notification of a physical medical device:
- Sample size used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, this document describes the substantial equivalence of a physical medical device (ligament fixation systems) through non-clinical testing, not the performance validation of an AI algorithm.
§ 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.