(103 days)
The G-FORCE® Gen 2 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 lateral stabilization tendons/ligaments, stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments, Tendon Transfers, tendon reattachments, and ligament reconstructions of the midfoot, forefoot, and hindfoot procedures associated with flatfoot reconstruction, hindfoot deformity, midfoot reconstruction, lateral/medial ankle reconstruction or instability, Hallux Valgus or Varus, and MTP instability including:
- o Achilles reattachment/reconstruction
- o Flexor Digitorum Longus Transfer
- Flexor Hallucis Longus Transfer o
- Extensor Hallucis Longus Transfer O
- Brostrom Procedures 0
- Peroneal Tendon Relocation 0
- Capsule Repair o
- Deltoid reconstruction / reattachment o
- Plantar Plate Repair o
- Spring Ligament Repair o
The G-FORCE® Gen 2 Ti Suture Anchor is a sterile, single-use, hand-held device intended to aid in the attachment of soft tissue to bone. The G-FORCE® Gen 2 Ti Suture Anchor comes preloaded with non-absorbable polyethylene sutures, needles and titanium alloy anchors. The anchors are available in a variety of sizes with correspondingly sized sutures.
The provided document, a 510(k) summary for the G-FORCE® Gen 2 Ti Suture Anchor System, describes the device's indications for use and performance data. However, it is a premarket notification for a medical device that demonstrates substantial equivalence to a predicate device, rather than a study proving a device meets specific acceptance criteria in the context of an AI/ML algorithm.
Therefore, the requested information regarding acceptance criteria and a study proving device performance as typically understood for AI/ML devices is not explicitly available in this document. The document focuses on demonstrating substantial equivalence through bench testing and comparison to a predicate device.
Here's an analysis based on the provided text, highlighting what is and isn't available for the requested categories:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Pullout strength equal to or superior to predicate device | "Bench testing was used to demonstrate that the pullout strength characteristics of the G-FORCE® Gen 2 Ti Suture Anchor System are substantially equivalent to the predicate." (The specific numerical values or comparison data for pullout strength are not provided in this summary but would have been part of the full 510(k) submission.) |
| Safety and Effectiveness | "The safety and effectiveness of the G-FORCE® Gen 2 Ti Suture Anchor System is adequately supported by the pullout testing performed, substantial equivalence information, literature review, and comparison of design characteristics provided within this premarket notification." |
| No new types of questions regarding safety or efficacy | "The design characteristics of the subject device do not raise any new types of questions in terms of either safety or efficacy." |
| Performance equal or superior to predicate device | "Based on the evidence submitted in this 510(k), the subject device can be expected to perform in a manner equal or superior to the predicate device and is substantially equivalent." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: This document describes bench testing for a physical medical device (suture anchor system), not a test set for an AI/ML algorithm. The "test set" in this context would refer to the samples used in the bench testing, which is not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable: This document describes bench testing for a physical medical device (suture anchor system), not a test set for an AI/ML algorithm that requires expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: This document describes bench testing for a physical medical device, not a test set for an AI/ML algorithm.
5. 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: This document is for a physical medical device, not an AI/ML system that would involve human readers or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This document is for a physical medical device, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Implied by Bench Testing: For a physical device like a suture anchor, the "ground truth" for performance is typically established through standardized physical tests (e.g., measuring pullout strength according to an established protocol) rather than expert consensus on medical images or pathology. The performance metrics themselves (e.g., maximum load, displacement) are the "ground truth" derived from the physical testing.
8. The sample size for the training set
- Not Applicable: This document describes bench testing for a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable: This document describes bench testing for a physical medical device, not an AI/ML algorithm that requires a training set.
Summary of the Study per the Document:
The study conducted to support the G-FORCE® Gen 2 Ti Suture Anchor System's safety and effectiveness was bench testing. This testing aimed to demonstrate that the device's pullout strength characteristics are substantially equivalent to a predicate device (G-FORCE® Ti Suture Anchor System, K100579). The document states that the safety and effectiveness are "adequately supported by the pullout testing performed, substantial equivalence information, literature review, and comparison of design characteristics." The specific details of the bench testing (e.g., exact number of samples tested, methodology) are not provided in this summary but were part of the full 510(k) submission.
§ 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.