Search Results

T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button & T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button are to be used for fixation of bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. This device is employed in Knee ligament repair and reconstructive procedures, specifically for ACL/PCL repair and reconstruction.

The T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button & T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button is a permanently implantable Polyether Ether Ketone (PEEK) cortical tibial suspension fixation device which provides the orthopaedic surgeon a means of accurate fixation in ligament reconstructive surgeries and repair. The fixation device allows for endoscopic or open ligament reconstruction approaches. The Closed button is preloaded with UHMWPE adjustable loop and in Open Button the UHMWPE adjustable loop is non preloaded.

This is a 510(k) premarket notification for a medical device called the T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button and the T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button. This document does not describe a study involving AI or human readers. Instead, it focuses on demonstrating the substantial equivalence of the new device to existing predicate devices through non-clinical performance testing and material comparisons.

Therefore, many of the requested sections related to AI performance, such as sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, and standalone algorithm performance, are not applicable to this type of device submission.

Here's the information that can be extracted from the provided text regarding the device's acceptance criteria and the study proving it meets them:

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

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

• Sample Size: Not explicitly stated in the document. The document refers to "bench testing" and "studies" but does not quantify the number of devices tested for mechanical or biocompatibility assessments.
• Data Provenance: The studies are non-clinical (bench testing, in vitro, and in vivo animal studies for biocompatibility). India (Healthium Medtech Limited is based in Bangalore, India) is the location of the manufacturer and presumably where these tests were conducted or commissioned. The data is prospective, generated specifically for this submission.

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 is a physical medical device. "Ground truth" in this context refers to the validated methods and resulting measurements from mechanical and biological tests, not expert interpretation of data. These tests would be conducted by qualified laboratory personnel and validated against international standards.

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

• Not Applicable. As above, this is not an interpretive diagnostic device. Test results are quantitative measurements against predetermined specifications and international standards.

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 implant for orthopedic surgery, not an AI-powered diagnostic tool.

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 (expert consensus, pathology, outcomes data, etc.):

• For mechanical performance (Pull-Out, Cyclic Loading): Quantitative measurements of force, displacement, and cycles against predefined specifications and industry standards. The "ground truth" is that the device must withstand certain loads and cycles without failure, demonstrating "equipotent" performance to predicate devices.
• For biocompatibility: Adherence to international standards (e.g., ISO 10993) for biological evaluation of medical devices, using in vitro and in vivo (animal) models to assess toxicity, sensitization, pyrogenicity, and tissue reaction. The "ground truth" is the observation of "non-sensitizer," "non-reactive," "non-pyrogenic," "non-cytotoxic," and "minimal or no reaction" based on established biological endpoints.

8. The sample size for the training set:

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

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

• Not Applicable. As above, no training set for an AI model. For the device itself, the "ground truth" for its design and manufacturing is established through engineering specifications, material standards, and compliance with quality management systems.

Ask a specific question about this device