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The ULTRABUTTON QUAD, BB, and TIB Adjustable Fixation Devices are indicated for soft tissue to bone or bone-tendon to bone fixation for: ACL/PCL Repair/Reconstruction and soft tissue to bone fixation for Extracapsular Repair: MCL, LCL.

The Smith & Nephew ULTRABUTTON QUAD, BB, and TIB Adjustable Fixation Devices consist of an ultra-high molecular weight polyethylene graft suspension loop and a titanium cortical button. The devices facilitate knee ligament repair/reconstruction through placement and retention of soft tissue or bone-tendon within bone.

The ULTRABUTTON QUAD Adjustable Fixation Device and the ULTRABUTTON BB Adjustable Fixation Device is available in one size. The UTLRABUTTON TIB Adjustable Fixation Device is available in a small, medium, or large size.

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-based medical device. Instead, it is an FDA 510(k) clearance letter and summary for a physical medical device: the ULTRABUTTON QUAD, BB, and TIB Adjustable Fixation Devices.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance (for an AI/ML device)
2. Sample size used for the test set and data provenance
3. Number and qualifications of experts for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The available text describes the device, its intended use, indications for use, and a summary of performance data for non-clinical testing to demonstrate substantial equivalence to a predicate device. This performance data relates to mechanical and material characteristics of the physical device, not an AI algorithm.

Specifically, the "Summary of Performance Data" section states:

• "Device cyclic displacement, device repair strength, and construct stiffness met the acceptance criteria established by the predicate device (K153186)."
• "Biocompatibility testing per ISO 10993-1:2018 demonstrated passing results."
• "Bacterial endotoxin testing was completed and met acceptable limits per ANSI/AAMI ST72:2019."
• "The devices have a three (3) year shelf-life. Storage and stability is based on completed packaging material storage stability testing, device storage stability testing, and distribution testing. Packaging testing per ISO 11607-1:2019 demonstrated passing results."
• "Sterile adoption was completed per ISO 11135:2014+A1:2018."

These are typical performance tests for surgical fixation devices to ensure mechanical integrity, biocompatibility, sterility, and shelf-life, not for assessing the diagnostic or predictive performance of an AI algorithm.

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The Adjustable Fixation Device is indicated for soft tissue to bone fixation for:

• ACL/PCL repair / reconstruction
• ACL/PCL patellar bone-tendon-bone grafts
• Double-Tunnel ACL reconstruction
• Extracapsular repair: MCL, LCL, and posterior oblique ligament
• Illiotibial band tenodesis
• Patellar tendon repair
• VMO advancement
• Joint capsule closure

The Adjustable Fixation Device consists of a graft suspension loop and a titanium cortical button. The suspension loop is threaded through the titanium cortical button to form a graft suspension construction. The device facilitates repair through placement and retention of the soft tissue graft within bone.

The provided text is a 510(k) Summary for the ArthroCare Adjustable Fixation Device. It describes the device, its intended use, and non-clinical data establishing substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of AI/algorithm performance.

Instead, it refers to:

• Bench testing: "Comparative testing of the proposed and predicate devices in which the proposed and predicate devices were inserted into a simulated human bone substrate and subjected to cyclic and static loading."
• Design Verification testing: "to demonstrate conformance to design and performance specifications."

The document explicitly states: "No clinical or animal data are included in this submission." This indicates that the regulatory submission primarily relies on non-clinical (bench) testing and comparison to predicate devices, rather than a study with human subjects, AI standalone performance, or MRMC studies.

Therefore, many of the requested categories for AI/algorithm-related studies cannot be filled from this document.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what cannot:

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

The document mentions "conformance to design and performance specifications" and that "All test results confirm that Adjustable Fixation Device is substantially equivalent to the predicate devices" and "meet their design, performance, and safety specifications." However, no specific quantitative acceptance criteria (e.g., minimum tensile strength, fatigue life cycles) or the exact reported performance values are provided in this summary. It only states that the device passes these unspecified criteria.

Regarding the study that proves the device meets the acceptance criteria:

Since this is a physical medical device (Adjustable Fixation Device for soft tissue to bone fixation), the "study" referred to is a series of non-clinical, bench-top tests, not a study of an AI algorithm's performance.

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

• Test Set Sample Size: Not specified for the bench testing.
• Data Provenance: The document only mentions "simulated human bone substrate" for comparative testing, indicating laboratory-based, non-clinical data. No country of origin for data is relevant or mentioned as it's not a human study.
• Retrospective or Prospective: Not applicable as this is bench testing on simulated materials.

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 bench testing is typically based on engineering standards, material properties, and standardized testing protocols, not expert human interpretation.

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

Not applicable, as this refers to adjudication for human-interpreted data (like radiology reads) which is not part of this submission. The "ground truth" for bench tests is determined by physical measurements and engineering analyses.

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. An MRMC study is for evaluating diagnostic image interpretation by humans, often with and without AI assistance. This submission is for a physical orthopedic fixation device and does not involve AI or human readers for diagnostic tasks.

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

No. This device is not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

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

The "ground truth" for the non-clinical bench testing would be engineering specifications, material science properties, and adherence to established biomechanical testing standards. For instance, a certain load (in Newtons) or number of cycles might be the "ground truth" performance requirement that the device must meet or exceed.

8. The sample size for the training set

Not applicable. There is no AI algorithm being trained for this device.

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

Not applicable, as there is no AI algorithm being trained.

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