(98 days)
The G-FORCE® Suture Anchor System is indicated for use:
- In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;
- In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation;
- In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament;
- In the repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis;
- In the repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments.
The G-FORCE® Suture Anchor is a sterile, single-use, hand-held device intended to aid in the attachment of soft tissue to bone. The G-FORCE® Suture Anchor comes preloaded with non-absorbable polyethylene-based sutures, needles and PEEK-OPTIMA® anchors. The anchors are available in a variety of sizes with correspondingly sized suture.
The provided text is a 510(k) summary for a medical device called the "G-FORCE® Suture Anchor System." This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it does not detail acceptance criteria and a study in the way one might expect for a novel device or a clinical trial. Instead, it focuses on demonstrating substantial equivalence through comparison to an existing device and bench testing.
Here's an analysis of the available information, structured to answer your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify formal "acceptance criteria" with numerical thresholds for performance. Instead, it relies on demonstrating substantial equivalence to a predicate device. The performance data presented is "bench testing" to show equivalence in "torque and tensile strength characteristics."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantially equivalent torque characteristics to predicate | Bench testing demonstrated substantial equivalence to predicate. |
| Substantially equivalent tensile strength characteristics to predicate | Bench testing demonstrated substantial equivalence to predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states "Bench testing was used," implying laboratory tests, but does not provide details on the number of samples tested for torque or tensile strength.
- Data Provenance: The tests were "bench testing," meaning they were conducted in a laboratory setting, likely by the manufacturer (Wright Medical Technology, Inc.). The document does not indicate country of origin of the data beyond the manufacturer's location in Arlington, TN, USA. These tests are inherently prospective research undertaken to support the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This question is not applicable in the context of this 510(k) submission. "Ground truth" established by experts is typically relevant for studies involving subjective assessments (e.g., image interpretation by radiologists). In this case, "ground truth" for the bench tests would be the measured physical properties of the device and the predicate device. The comparison is objective, based on mechanical testing.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert opinions, which isn't relevant for objective bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiology AI). The G-FORCE® Suture Anchor System is a surgical implant, and its performance is evaluated through material properties and mechanical strength, not human interpretation of cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The G-FORCE® Suture Anchor System is a physical medical device, not an algorithm or AI system. Its performance is entirely "standalone" in the sense that it functions mechanically without an AI component.
7. The Type of Ground Truth Used
The "ground truth" for evaluating this device's performance is based on objective mechanical measurements of torque and tensile strength. The benchmark for "truth" is the performance of the legally marketed predicate device (ANCHORLOK® Soft Tissue Anchor System), as the goal is to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" as this is not an AI or machine learning device.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set.
§ 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.