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The Sleeve and Button Soft Tissue Devices utilizing ZipLoop™ Technology are intended for soft tissue to bone fixation for the following indications:

Shoulder
Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps tenodesis

Foot and Ankle
Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair

Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment

Knee
Extra-capsular repair: MCL, LCL, and posterior oblique ligament Iliotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure

Hand and Wrist
Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction

Hip
Acetabular labral repair

In addition to the aforementioned indications, the Button Soft Tissue Devices (all sizes) and size specific Sleeve Soft Tissue Devices (as shown in Table 1) are indicated for the following:

Knee
ACL/PCL repair/reconstruction ACL/PCL patellar bone-tendon-bone grafts Double-Tunnel ACL reconstruction

The Sleeve and Button Soft Tissue Devices are comprised of a ZipLoop™ , a Button or a coreless Sleeve structure, and a passing suture. A ZipLoop™ is constructed from ultra high molecular weight polyethylene (UHMWPE) or polyester. It is passed through the Sleeve or Button, thus creating a soft tissue fixation device that bunches or locks against the bone when deployed.

The Biomet Sleeve and Button Soft Tissue Devices received 510(k) clearance (K071704) based on substantial equivalence to legally marketed predicate devices, rather than through a study demonstrating direct achievement of specific performance acceptance criteria for a novel device. Therefore, the information provided in the document does not include a detailed table of acceptance criteria and reported device performance in the way typically seen for a new technology requiring such validation.

Instead, the submission relied on non-clinical testing and comparison to predicates.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly available in the provided 510(k) summary. The submission states: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This is a general statement rather than a detailed report of specific performance metrics against defined acceptance criteria. Without a specific new performance claim, the FDA typically assesses substantial equivalence based on materials, design, and intended use being similar enough to established predicates.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable/not specified. Clinical testing was not provided as a basis for substantial equivalence. The non-clinical testing details are not provided.
• Data Provenance: Not applicable, as no clinical studies were performed. The non-clinical testing details (e.g., in vitro, cadaveric) are not specified, nor is the country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical studies requiring expert ground truth establishment for a test set were conducted.

4. Adjudication method for the test set

Not applicable, as no clinical studies requiring adjudication were conducted.

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 surgical fixation device, not an AI-assisted diagnostic or imaging tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical surgical implant, not an algorithm.

7. The type of ground truth used

Not applicable for clinical studies for this submission. For the non-clinical testing, the "ground truth" would implicitly be relevant engineering standards, biomechanical properties, and the established performance of the predicate devices.

8. The sample size for the training set

Not applicable, as no machine learning algorithm was involved.

9. How the ground truth for the training set was established

Not applicable, as no machine learning algorithm was involved.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" that proves the device meets the acceptance criteria, in this context, is the non-clinical testing mentioned in the 510(k) summary. The nature of a 510(k) clearance for this type of device (soft tissue fixation) primarily relies on demonstrating that the new device is substantially equivalent to existing legally marketed predicate devices.

The document states: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."

This indicates that Biomet performed tests (likely mechanical, biomechanical, and material characterization tests) to ensure the physical properties and performance characteristics of the Sleeve and Button Soft Tissue Devices were comparable to the predicate devices. The "acceptance criteria" were therefore implicitly that the new device's performance would fall within ranges deemed acceptable and safe, consistent with the performance of the chosen predicate devices, for the stated indications for use.

The predicates listed are:

• Multitak SS Suture System™ (K973015) - Bonutti Research
• BioRaptor™ (K053344) - Smith & Nephew
• Cruciate Ligament Button (PolySuture Button) (K813581) - Biomet Sports Medicine

The "study" was a set of non-clinical tests designed to show that the new device's materials, design, sizing, and ability to perform soft tissue to bone fixation did not raise new questions of safety or effectiveness when compared to these existing devices. The specifics of these tests (e.g., pull-out strength, fatigue testing, material biocompatibility) are not detailed in this summary but would have been part of the full 510(k) submission.

In essence, for a 510(k) based on substantial equivalence and non-clinical data alone for a device like this, the "acceptance criteria" are that the device performs functionally within its intended use and is comparable enough to predicates that it doesn't require a new PMA.

Ask a specific question about this device

The Multitak SS Buttons are new fixation devices indicated in orthopedic fracture and in ligament and tendon repair. The buttons allow for stabilization and linear fixation of bone fragments in fracture procedures. The buttons also serve as fixation posts for distributing suture tension over areas of ligament and tendon repair. The buttons are made of titanium, polypropylene, or polyethylene and are provided sterile with or without suture attached and are not intended for reuse. Maximum suture size to be used with each of the buttons are outlined in the following table:

The Multitak SS Buttons are fixation devices indicated in orthopedic fracture and in ligament and tendon repair They are intended to stabilize two or more bone hagments and distribute suture tension over the fracture site in order to facilitate healing. The buttons also serve as fixation posts for distributing surure tension over areas of ligament and renden repair The cyundneal buttons are made from titanium, polypropylene, or polyethylene and have an overali ratio of approximately 3 1, length to diameter. The buttons are available in the tollowing sizes ( ! ) ! 2 mm in diameter and 4 0 mm in length, (2) 1 8 mm in diameter and o 0 mm in length (3) 2 5 mm in diameter and 8 3 mm in length, and (4) 3 0 mm in diameter and I min in lengin The buttons are applied to the outer bone cortex over a prednilled hole across the manufe she Bone fragments are stabilized with suture running through the drill bone hole and off at the button The buttons provide linear fixation and compression of the bone trapments promoting healing at the fracture site Buttons can also be used as fixation posts and are praced outside the corucal bone in ligament and tendon repair. They provide a means of distributing suture tension over areas of repaired ligaments and tendons. The buttons are provided sterile with or without attached suture in packs of two and are not intended for reuse.

The provided text is a 510(k) Premarket Notification for the Bonutti Research, Inc. Multitak SS Buttons. This document describes a medical device (fracture fixation device and surgical buttons) and its intended use, rather than an AI/ML powered device.

Therefore, the prompt questions regarding acceptance criteria, study details, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable to this document. The submission is for a physical medical device, not a diagnostic algorithm or AI system.

Ask a specific question about this device