(84 days)
The devices are intended for soft tissue to bone suture fixation for the following indications:
Shoulder
- Bankart lesion repairs -
- SLAP lesion repairs -
- Acromio-clavicular separations repairs -
- Rotator cuff tear repairs ー
- Capsular shift or capsulolabral reconstructions -
- Biceps tenodesis -
- Deltoid repairs -
Foot and Ankle
- Medial or lateral instability repairs/reconstructions ー
- Achilles tendon repairs/reconstructions -
- Midfoot reconstructions -
- Hallux valgus reconstructions -
Elbow. Wrist, and Hand
- Scapholunate ligament reconstructions -
- Ulnar or radial collateral ligament reconstructions -
- Tennis elbow repair .
- Biceps tendon reattachment -
Knee
- Extra-capsular repairs
- medial collateral ligament --
- -lateral collateral ligament
- -posterior oblique ligament
- Iliotibial band tenodesis
- -Patellar tendon repairs
The RSTA device is manufactured using poly (L-lactic) acid in a proprietary process. The anchor is a fully threaded device 12 mm in length and 5.0 mm in diameter. The anchor contains an eyelet to which a USP Size No. 2 braided polyester nonabsorbable suture and two suture needles are attached. A hex drive at the proximal end of the anchor attaches to a disposable torque limiting driver used for insertion of the anchor. The anchor requires predrilling and tapping procedures prior to implantation. Following implantation of the anchor, the free ends of the suture are used to reattach the soft tissue to the bony site.
This document is a summary of safety and effectiveness for a medical device, not a study report. It describes the device, its intended use, and provides a brief statement about its Performance Data. However, it does not contain the detailed information required to answer your questions about acceptance criteria or a specific study proving the device meets those criteria.
Therefore, I cannot provide the requested information from the given text.
Here's why each point cannot be addressed:
- A table of acceptance criteria and the reported device performance: The document states, "The RSTA device demonstrated strength far above that of the No. 2 suture used clinically with the device, thereby ensuring that the suture will fail prior to any portion of the anchor. Pullout testing in white pine wood and porcine bone also demonstrated superior pullout strength when compared to the predicate devices." This is a general statement about performance, not a table with specific acceptance criteria (e.g., minimum pullout strength in Newtons) or the exact reported values.
- Sample sized used for the test set and the data provenance: Not mentioned. The document only states "varying types of porcine bone" and "dry white pine wood" were used.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a mechanical testing study, not one requiring expert human interpretation for ground truth.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable, as this is a mechanical testing study, not a human reader study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a mechanical testing study, not an algorithm study.
- The type of ground truth used: For pullout strength, the "ground truth" would be the measured force at which failure occurred. However, the exact methodology for defining "failure" (e.g., ultimate load, yield strength) and the specific values are not provided.
- The sample size for the training set: Not applicable, as this is laboratory testing, not a machine learning study with a training set.
- How the ground truth for the training set was established: Not applicable.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.