Search Results

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

Fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

The Titanium Toggle Buttons are a toggle bar designed with one or two eyelets through which multiple loops of suture are threaded. There are two types of Toggle Buttons, the standard toggle button with two eyelets and the NS toggle button with one larger eyelet only. The suture loops provide a means to attach the soft tissue grafts to the toggle buttons. The loops are attached to the toggle button by putting the loops through the eyelet(s). This device is used to anchor the suture loops to bone.

The provided text describes a 510(k) premarket notification for a medical device called "Titanium Toggle Button(s)". This submission is for a physical medical device, not a software algorithm or an AI-powered diagnostic tool. Therefore, the questions related to acceptance criteria for algorithmic performance, sample sizes for test/training sets in AI, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through material similarity, intended use, size comparisons, and non-clinical mechanical testing.

Here's a breakdown of the relevant information from the provided text:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: Not specified for the mechanical testing.
• Data Provenance: Not specified (implied to be internal laboratory testing).

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. Ground truth for mechanical testing is based on physical measurements and engineering standards, not expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. Mechanical testing data is objective.

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:

• No. This is a physical device, not an AI diagnostic tool.

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

• No. This is a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the mechanical testing, the "ground truth" would be the objective measurements of pull-out strength according to established engineering standards or test protocols.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI model requiring a training set.

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

• Not applicable.

Additional Information from the Document:

• Clinical Testing: None provided as a basis for substantial equivalence. The submission relies solely on non-clinical (mechanical) testing and comparison to predicate devices.
• Summary of Technologies: "The titanium Toggle Buttons are similar to or identical to predicate devices in terms of material, intended use, and size."

Ask a specific question about this device