(99 days)
Tornier® Insite™ Suture Anchors are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulabral reconstruction
Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction
Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial band tenodesis
Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction
Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction
Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females
The devices described in this 510(k) Notice are exactly the same device as the predicate Axya Medical Suture anchors described in the 510(k) Notices listed above. The various anchors are fabricated from titanium, PLLA absorbable polymer and acetal polymer. They are provided in diameters of 3mm, 5mm and 6.5mm to facilitate the attachment of soft tissue to bone.
No changes have been made to the devices.
This document is a 510(k) summary for a medical device called Insite™ Suture Anchors. It does not describe a study involving acceptance criteria or device performance in the way a clinical trial or AI model validation would. Instead, it argues for "substantial equivalence" to previously cleared predicate devices.
Therefore, many of the requested sections about acceptance criteria, detailed study design, and ground truth establishment are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the traditional sense of a clinical trial or AI model. The "acceptance criteria" here is that the device is "substantially equivalent" to predicate devices, meaning it has the same intended use, technological characteristics, and performs as safely and effectively. The "performance" is implicitly deemed equivalent to the predicates.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Implicit from Substantial Equivalence Claim) |
|---|---|
| Same intended use | Intended for reattachment of soft tissue to bone for specified indications (Shoulder, Foot/Ankle, Knee, Hand/Wrist, Elbow, Pelvis). |
| Same technological characteristics | Fabricated from titanium, PLLA absorbable polymer, and acetal polymer; provided in 3mm, 5mm, and 6.5mm diameters; "exactly the same device as the predicate Axya Medical Suture anchors". |
| Performs as safely and effectively | Established by demonstrating equivalence to previously cleared devices which have an established history of use and were tested against applicable FDA guidelines. |
| Materials have an established history of use | Confirmed. |
| Tested in accordance with applicable FDA guidelines | Confirmed. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a claim of substantial equivalence for a physical medical device, not a data-driven study with a test set. There is no "test set" in the context of an algorithm or diagnostic accuracy study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There is no ground truth establishment in the context of a data analysis or diagnostic accuracy study. The "ground truth" for the predicate devices' safety and effectiveness would have been established through their initial clearances and post-market surveillance.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication in this context.
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 device is a physical suture anchor, not an AI or diagnostic imaging system that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
Not applicable in the sense of a data-driven study. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices (Axya Medical Suture anchors) based on their prior 510(k) clearances, their established history of use, and testing performed according to FDA guidelines. The claim is that the Insite™ Suture anchors are identical and therefore have the same "ground truth" performance.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" for physical device equivalence.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" for physical device equivalence.
§ 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.