Search Results

The TiLink-P Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The TiLink-P SI Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint. The SurGenTec TiLink-P SI Joint Fixation System includes TiLink Implants and associated Instruments (sterile or non-sterile). The TiLink-P SI Joint Fusion System may be used via lateral or posterior oblique. Bone graft material is used with the TiLink-P SI Joint Fusion System to facilitate bone growth.

This document is a 510(k) premarket notification decision letter from the FDA to SurGenTec LLC for their TiLink-P SI Joint Fusion System. It states that the device has been determined to be substantially equivalent to legally marketed predicate devices.

Based on the provided text, the device discussed is NOT an AI/ML medical device. The document describes a physical medical device (components of a sacroiliac joint fusion system) and its mechanical, material, and biological performance testing.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance (e.g., sensitivity, specificity, MRMC studies, ground truth establishment with experts) is not applicable to this submission.

The document discusses performance testing relevant to a physical implantable device, such as:

• Axial Pullout Testing per ASTM F543: This likely measures the force required to pull the implant out of bone, assessing its fixation strength.
• Static and Dynamic Cantilever Test per ASTM F3574: This assesses the implant's resistance to bending under various loading conditions, relevant for its structural integrity.
• Sterilization, Packaging, and Shelf-Life Validations: These ensure the device remains sterile and functional over time.
• Biocompatibility Assessment per ISO 10993: This confirms the materials used in the device are safe for contact with human tissue.

The "acceptance criteria" for these tests would be specific parameters and thresholds (e.g., minimum pullout force, maximum deflection under load) defined by the manufacturer and often guided by relevant ASTM/ISO standards. The "study" proving it meets these criteria would be the results of the physical tests.

Since the prompt specifically asks for details relevant to an AI/ML device, and this document does not pertain to AI/ML, I cannot provide the requested information in that context.

Ask a specific question about this device

The TiLink-P SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The purpose of this Special 510(k) is to introduce the TiLink-P with Window variant to the TiLink-P SI Joint Fusion System. The Window feature is designed to promote osteointegration.

The TiLink-P SI Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint to transfix the joint. The SurGenTec TiLink-P SI Joint Fixation System includes TiLink Implants and associated Instruments. The TiLink-P implants may be used standalone. The TiLink-P SI Joint Fusion System fixates the sacroiliac joint by transfixing the cortices of the ilium and cortices of the sacrum.

The TiLink-P Compression Anchor is positioned so that it spans the cortices of ilium and cortices of sacrum, the TiLink-P Locking Screw is inserted through the TiLink-P Compression Anchor and along the SI Joint via a posterior approach, in order to compress the joint. Bone graft material is used with the TiLink-P SI Joint Fusion System to facilitate bone growth.

The FDA letter provided is a clearance letter for a medical device (TiLink-P SI Joint Fusion System), not an AI/ML device. Therefore, the document does not contain information about acceptance criteria or studies pertaining to AI/ML device performance. The information requested regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data is not applicable to the content of this document.

The document discusses the substantial equivalence of the "TiLink-P SI Joint Fusion System" to a predicate device (TiLink-P Joint Fusion System K240720) through mechanical strength tests.

Here is the information that is available in the document:

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

The document states that performance testing was conducted according to specific ASTM standards to demonstrate substantial equivalence to the predicate device. However, it does not provide a table of acceptance criteria (e.g., specific thresholds for pullout strength or shear strength) nor the reported numerical performance data. It only lists the types of tests performed.

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. The "test set" here refers to physical devices for mechanical testing, not a dataset for an AI/ML model. The document does not specify the number of devices tested. Data provenance such as country of origin or retrospective/prospective is not relevant for this type of device clearance.

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 as typically understood in AI/ML (e.g., expert labels on images) is not relevant for this type of mechanical device testing. The "ground truth" for mechanical testing is derived from established engineering principles and ASTM standards.

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

Not applicable. Adjudication methods are typically used for resolving disagreements among human experts in labeling datasets, which is not relevant for mechanical testing.

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 is a clearance for a physical medical implant, not an AI/ML diagnostic or assistive device. No MRMC study was conducted.

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

Not applicable. This device is not an algorithm.

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

Not applicable. For mechanical testing, the "ground truth" is provided by the established ASTM standards and the physical properties and performance of the predicate device.

8. The sample size for the training set

Not applicable. There is no AI/ML model, and therefore no training set.

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

Not applicable. There is no AI/ML model, and therefore no training set or ground truth for a training set.

Ask a specific question about this device

The TiLink-P SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The TiLink-P SI Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint to transfix the joint.

The SurGenTec TiLink-P SI Joint Fixation System includes TiLink Implants and associated Instruments. The TiLink Implant may be used standalone. The TiLink Implants are manufactured from titanium alloy and include the TiLink Locking Screw and the TiLink Compression Anchor. The TiLink Compression Anchor is designed to transfix the ilium and sacrum while compressing the SI joint. The TiLink Compression Anchor includes an opening to insert the TiLink Locking Screw. During the Procedure, the TiLink Compression Anchor is positioned so that it spans the ilium and sacrum, the TiLink Locking Screw is inserted through the TiLink Compression Anchor via a posterior approach. Bone graft material is placed within the TiLink implant to facilitate bone growth.

The SurGenTec TiLink-P SI Joint System may be provided sterile single-use or non-sterile.

This document describes an FDA 510(k) clearance for a medical device, the "TiLink-P SI Joint Fusion System." The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically involves performance testing to show the new device meets the same safety and effectiveness standards as the predicate.

However, the provided text does not contain any information about an AI/ML-based device or a study involving AI assistance for human readers. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the mechanical, material, and biological properties of the physical implant device (TiLink-P SI Joint Fusion System), not the performance of an AI algorithm or its impact on human readers.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study for an AI device. The text focuses on:

• Device Name: TiLink-P SI Joint Fusion System
• Intended Use: Sacroiliac joint fusion
• Materials: Titanium alloy
• Performance Testing:
  • Dynamic vertical shear testing (ASTM F3574)
  • Foam block pullout testing (ASTM F543)
  • Biocompatibility (ISO 10993)
  • Sterilization Validation

The closest thing to "acceptance criteria" in this context is that the device "met the pre-determined acceptance criteria for the verification activities" for these specific mechanical, biological, and sterilization tests. The "study" mentioned is the "Performance Testing" which consists of these engineering and and biocompatibility evaluations.

There is no information in the provided document about:

• A table of acceptance criteria and reported device performance (in the context of AI metrics like sensitivity, specificity, etc.)
• Sample sizes for AI test sets
• Data provenance for AI data
• Number of experts for AI ground truth
• Adjudication methods for AI ground truth
• MRMC comparative effectiveness study
• Standalone AI performance
• Type of ground truth for AI (expert consensus, pathology, etc.)
• Sample size for AI training set
• How AI training set ground truth was established

In summary, the provided document is for a physical medical implant device, not an AI/ML diagnostic or assistive tool. Thus, the specific criteria and study details requested for an AI device are not applicable to the information given.

Ask a specific question about this device

The TiLink-P SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The TiLink-P SI Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint to transfix the joint.

The SurGenTec TiLink-P SI Joint Fixation System includes TiLink Implants and associated Instruments. The TiLink implant may be used standalone. The TiLink Implants are manufactured from titanium alloy and include the TiLink Locking Screw and the TiLink Compression Anchor. The TiLink Compression Anchor is designed to transfix the ilium and sacrum while compressing the SI joint. The TiLink Compression Anchor includes an opening to insert the TiLink Locking Screw. During the Procedure, the TiLink Compression Anchor is positioned so that it spans the ilium and sacrum, the TiLink Locking Screw is inserted through the TiLink Compression Anchor and along the SI Joint via a posterior approach. Bone graft material is placed within the TiLink implant to facilitate bone growth.

The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device. The document is an FDA 510(k) clearance letter for a TiLink-P SI Joint Fusion System, which is a physical implant for sacroiliac joint fusion, not an AI/ML device.

Therefore, I cannot provide the requested information, including:

1. Table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Instead, the document details the regulatory clearance for a medical implant and lists non-clinical performance data for mechanical testing, biocompatibility, sterilization validation, and a side-by-side cadaver study to demonstrate substantial equivalence to predicate devices.

Ask a specific question about this device