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Intended Use: The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.

Indications for Use: The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The CONMED CrossFT™ Knotless Deep Thread Suture Anchors are manufactured from stable PolyEtherEtherKetone (PEEK). The CrossFT Knotless Deep Thread Anchors are a threaded screw-in suture anchor design. The CrossFT™ Knotless Deep Thread Suture Anchors are provided sterile, preloaded on a single-use driver and some include a preloaded sliding #2 (5 metric) Hi-Fi® Suture. The device is EO sterilized.

The provided text describes a 510(k) premarket notification for a medical device called the CrossFT™ Knotless Deep Thread Suture Anchor with Disposable Driver. It asserts that the device is substantially equivalent to a predicate device. However, it does not contain a detailed "acceptance criteria and the study that proves the device meets the acceptance criteria" in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device, which is a different regulatory pathway than providing detailed performance studies with acceptance criteria for a new, non-equivalent device.

Here's a breakdown of why the requested information cannot be fully extracted and what is available:

The document lists various "Verification Testing" and "Validation Testing" that were completed. These tests are implicitly meant to demonstrate that the new device performs as intended and is substantially equivalent. However, specific acceptance criteria for each test (e.g., minimum ultimate fixation strength in Newtons) and the quantitative results are not provided in this summary.

Information NOT available in the provided text:

• A table of acceptance criteria and the reported device performance: While types of tests are listed (e.g., Ultimate Fixation Strength, Cyclic), the specific numerical acceptance criteria for these tests and the device's measured performance against them are not included.
• Sample size used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device and testing. These are mechanical/biological performance tests, not AI-driven diagnostic studies requiring expert ground truth.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is a physical medical device, not an AI diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not directly applicable in the sense of expert consensus or pathology for an AI device. The "ground truth" for these engineering tests would be established by standardized testing methods and measurement against predefined specifications based on the predicate device or industry standards.
• The sample size for the training set: Not applicable (not an AI device).
• How the ground truth for the training set was established: Not applicable (not an AI device).

Information that can be inferred or directly stated from the text:

While a table of acceptance criteria and performance data is not explicitly given, the document states that "Testing has been completed to demonstrate that the CrossFT™ Knotless Deep Thread Suture Anchor performs as intended and is substantially equivalent to the predicate device. Bacterial endotoxin testing was conducted and met the endotoxin limits." This implies that acceptance criteria were met, even if not detailed here.

General Purpose/Type of Device:
The device is a CrossFT™ Knotless Deep Thread Suture Anchor with Disposable Driver, intended to reattach soft tissue to bone in orthopedic surgical procedures.

Predicate Device:
The predicate device is the CrossFT™ Knotless Suture Anchor with Disposable Driver (K163258) by ConMed.

Studies Conducted (as listed):

• Verification Testing:
  • Reliability
  • Ultimate Fixation Strength
  • Cyclic
  • Sterilization
  • Pyrogen
  • Biocompatibility
  • Shelf-life
  • Post Aging Functional Testing
  • MR Safety Testing
• Validation Testing:
  • User Validation
  • Packaging
  • Transportation

Conclusion stated regarding performance:
"The CrossFTTM Knotless Deep Thread Suture Anchor with Disposable Driver is either substantially equivalent or identical in design, materials, intended use, principles of operation, and technical characteristics to the predicate ConMed CrossFT™ Knotless Suture Anchor with Disposable Driver. Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy, and the CrossFTM Knotless Deep Thread Suture Anchor with Disposable Driver is substantially equivalent to the ConMed CrossFT™ Knotless Suture Anchor with Disposable Driver (K163258)."

In summary, the provided document from the FDA 510(k) process states that various performance tests were completed and that these tests demonstrated substantial equivalence to a predicate device, meaning the new device "performs as intended" and met necessary safety and efficacy benchmarks. However, it does not provide the specific quantitative acceptance criteria or detailed results of these tests, which are typically found in the full submission, not the summary document.

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The CrossFT™ Knotless Suture Anchor with Disposable Driver is intended to reattach soft tissue to bone in orthopedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The CrossFT™ Knotless Suture Anchors with Disposable Driver are sterile, single use devices. The CrossFT™ Knotless Suture Anchors are manufactured from PolyEtherEtherKetone (PEEK™). The anchors are provided sterile, single use and preloaded on a disposable driver. The anchors are available in three sizes and nine configurations.

The provided document describes the "CrossFT™ Knotless Suture Anchor with Disposable Driver" and its substantial equivalence to a predicate device (K091549). This is a medical device, not an AI/ML device, and therefore the concepts of acceptance criteria related to algorithmic performance (like sensitivity, specificity, MRMC studies, standalone performance, ground truth establishment by experts, training/test set sizes, and data provenance) are not applicable in this context.

The document focuses on demonstrating substantial equivalence for a medical device through engineering and biological performance testing.

Here's an interpretation of the relevant information provided, focusing on what is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a table format with corresponding reported performance values for each criterion. It broadly mentions completed performance testing to demonstrate the device performs as intended and is substantially equivalent.

However, based on the types of testing listed, we can infer general areas of acceptance. The "Reported Device Performance" is stated generally as having "met the endotoxin limits" and that the testing "demonstrates that the CrossFT™ Knotless Suture Anchor with Disposable Driver performs as intended and is substantially equivalent to the predicate device."

2. Sample Size for Test Set and Data Provenance

This information is not provided in the document. For a physical medical device, "test set" typically refers to the number of units or samples subjected to each performance test. The document also does not specify the country of origin of data or whether tests were retrospective/prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable for this type of medical device submission. "Ground truth" established by experts is a concept central to evaluating diagnostic or AI/ML device performance. For this physical device, "ground truth" relates to engineering specifications, material properties, and biological safety standards.

4. Adjudication Method for the Test Set

This information is not applicable for this type of medical device submission. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers/experts when establishing ground truth for diagnostic or AI/ML performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

This is not applicable. MRMC studies are used to evaluate the comparative effectiveness of diagnostic methods (e.g., human readers with and without AI assistance) on a set of cases. This document describes a physical surgical implant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This is not applicable. This refers to algorithmic performance without human intervention, which is relevant for AI/ML devices.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would be defined by engineering specifications, material science standards, and established biological safety standards. For example, the "ultimate fixation strength" would have a specific quantifiable standard that the device must meet, derived from biomechanical requirements. The "met the endotoxin limits" is an example of meeting a specific biological safety standard, which acts as a "ground truth" for endotoxin levels.

8. The Sample Size for the Training Set

This is not applicable. "Training set" refers to data used to train an AI/ML algorithm. This document describes a physical medical device.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated above.

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